In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Alfred Botchway, CEO of Attentive Science, to discuss his journey in biomedical science and the groundbreaking work being done at the intersection of AI, non-clinical safety, and drug discovery. Dr. Botchway shares his insights on the role of AI in refining toxicology studies, how stress impacts human health, and his experience founding companies like Xenometrics and Attentive Science.

The conversation dives deep into the complexities of Good Laboratory Practices (GLP), the importance of regulatory standards, and the exciting research happening in anxiety and PTSD treatments. Dr. Botchway also discusses the future of biomedical research, the need for greater collaboration between academia and industry, and how innovations in sample collection are transforming clinical trials.

Whether you’re interested in AI, biomedical innovation, or the future of drug discovery, this episode offers valuable insights from a leader shaping the industry.

Don’t forget to subscribe and let us know your thoughts in the comments below!

Dr. Alfred Botchway

https://www.linkedin.com/in/alfred-botchway-41b01a6/

CEO of Attentive Science: https://www.attentivescience.com/

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Celerion - https://www.celerion.com/

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

Celerion - https://www.celerion.com/

00:00 Introduction to BioTalk Unzipped

02:32 Dr. Alfred Botchway's Journey in Biomedical Science

03:48 Challenges Founding and Growing Xenometrics

07:30 Starting Attentive Science: A New Venture

09:37 Love of the Work - Variations

10:26 The Role of AI in Non-Clinical Safety Assessments

13:04 The Three Rs: Replace, Reduce, Refine, and AI

15:46 Regulatory Standards and Good Laboratory Practices

20:42 New News! - Research on Anxiety and Drug Discovery

27:07 Cortical Stimulation and Stress Management

27:45 Bridging Academia and Industry

29:26 Engaging the Next Generation in Science

32:42 The Value of Vocational Training in Science

34:47 Community Involvement and Giving Back

37:00 Cultural Influences on Leadership

42:39 Global Expansion and Strategic Goals

48:41 Innovations in Sample Collection for Clinical Trials

Digital Twin Episodes reference with Tomas Helikar:

Transforming Immunology: The Promise of Digital Twins with Dr. Tomáš Helikar

https://youtu.be/jTM_Zlt3wxU

Digital Twins: The Future of Drug Discovery with Dr. Tomáš Helikar

https://youtu.be/NM5X0jTd6UA

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe reflect on their journey over the past year, discussing key themes and insights gained from their guests. They explore the humanistic approach to healthcare, the impact of AI in drug development, common threads among successful individuals, personal growth through conversations, and the importance of leadership and mentorship in the industry. The episode concludes with exciting plans for future series focused on drug development and global healthcare innovations.

Thanks to CREO Consulting for hosting this episode!

https://creoconsulting.com/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

Takeaways

• Every sample is a person, a patient, a loved one.
• Embrace the fear, take more risks.
• The importance of human connection in drug development.
• AI is becoming integral in drug discovery and development.
• Successful individuals often wish they had taken more risks.
• Leadership in the industry is about raising others up.
• Mentorship plays a crucial role in professional growth.
• Personal growth can come from listening and engaging with others.
• Innovative approaches are essential in addressing industry challenges.
• 
  

Keywords

BioTalk, drug development, AI, mentorship, leadership, podcast, healthcare, innovation, personal growth, industry insights

EP-23. In the second half of this compelling conversation on BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their deep dive with Scott Ogle, CEO of TruLab. They explore the surprising parallels between the banking and pharma industries, the game-changing role of digital twinning in clinical trials, and the biotech funding landscape. Scott also shares his thoughts on leadership, mentorship, and the impact of the Inflation Reduction Act on pharma innovation. This episode offers listeners valuable insights into the future of drug development and the challenges of balancing professional and personal life in a fast-paced industry.

Chapters

1:09 - Comparison of the Banking Industry to the Pharma Industry

5:18 - Data Integrity, Same For Decentralized Trials?

8:33 - Biotech Funding Trends

11:18 - NEW NEWS! – Digital Twinning in Clinical Trials

16:15 - What Advice Would You Give to Your Younger Self?

20:57 - Mentorship and Its Impact, How it Shaped Scott

23:45 - Balancing Work and Personal Life

24:32 - The Inflation Reduction Act and Innovation

Takeaways

• The regulatory environment in pharma can slow down innovation.

• Digital twinning in clinical trials could revolutionize drug development.

• Family influences play a significant role in shaping business perspectives.

• The need for a strong company culture to maintain values during growth.

• Biotech funding trends are influenced by macroeconomic factors like interest rates.

• The importance of mentorship in professional development.

Sound Bites

• “The similarities between the banking industry and the pharma industry is eerily similar.”

• “Quality is really what we do.”

• “Being quality is core to software.”

• “It’s really clear people care more about their money than they do their healthcare.”

• “Biotech and large pharma seem to balance each other out.”

• “The career for you is at the intersection of what you are good at and what you like to do.” 

• “If you’re good at something and you like to do it, it fuels your energy to keep getting better.”

• “Enjoy the impact in what you’re doing and accomplishing!”

New News Story: 

• Digital “Twinning”: Clinical Trials Powered by AI

• https://www.sanofi.com/en/magazine/our-science/digital-twinning-clinical-trials-ai

How to reach us:

Scott Ogle

https://www.linkedin.com/in/scott-ogle/ 

TruLab - https://trulab.com/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image Credits

Digital Twinning - Credit Getty Images

Simulation - Credit: andrush / Adobe Stock

Tomáš Helikar - https://www.linkedin.com/in/tomashelikar/ 

Nebraska Swan computer - https://newsroom.unl.edu/announce/cse/16380/90600

Brian Hamilton - https://inmatestoentrepreneurs.org/board/brian-hamilton/ 

Summary

In this 22nd episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Scott Ogle, CEO of TrueLab, discussing his journey from finance to the pharmaceutical industry, the impact of personal experiences on innovation, and the importance of technology in clinical trials. They explore how to hire the best employees in this climate, the significance of company culture, and the influence of family on business perspectives. 

Chapters

00:00 Introduction to BioTalk Unzipped

03:15 The Impact of Personal Experience on Innovation

08:47 TruLab's Technology and Its Role in Clinical Trials

14:33 The Importance of Sample Management and the Genesis of TruLab

20:33 NEW NEWS! – The Future of Cancer Treatments

23:34 Hiring Patterns and the value of Company Culture

Takeaways

• Scott Ogle's personal experience with his father's illness inspired the creation of TruLab.

• TruLab focuses on eliminating inefficiencies in clinical trial sample management.

• The importance of having fun in one's career for productivity and happiness.

• Hiring for energy and cultural fit is crucial for company success.

• More young people out of college actually prefer working in the office, so it’s a hiring advantage.

Sound Bites

• “Entrepreneurs get excited about their solution but can forget about what problem they’re solving.”

• "We need to iterate on technology in clinical trials."

• “20-25% of biological samples get tossed out.”

• "You can't coach energy in a candidate."

• “Company values. Senior leadership must beat it like a drum.”

• “Interviewing candidates on company values is your North Star.”

• “Go by what people do, not by what they say.” 

• “Hallway meetings, that’s where stuff gets done.”

New News Story: 

• ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells

• https://www.nature.com/articles/s43018-024-00821-1

How to reach us:

Scott Ogle

https://www.linkedin.com/in/scott-ogle/ 

TruLab - https://trulab.com/ 

Leukemia & Lymphoma Society - https://www.lls.org/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Keywords: Scott Ogle, TruLab, clinical trial technology, biotech innovation, sample management in clinical trials, hiring for company culture, company values in leadership, finance to pharma journey, revolutionizing clinical trials, impact of personal experience on innovation, biotechnology leadership, clinical trial inefficiencies, cancer treatment news, digital transformation in pharma, family influence in business, company culture in biotech, pharmaceutical funding challenges, ISB 2001 trispecific T cell engager.

Tags: #ScottOgle, #TruLab, #ClinicalTrials, #Biotech, #PharmaInnovation, #Sample Management, #Company Culture, #Hiring Tips, #BiotechLeadership, #PharmaTechnology, #CancerTreatment, #PersonalInnovation, #BiotechFunding, #LeadershipInPharma, #BusinessLeadership, #PharmaceuticalIndustry.

Mentoring in Pharmaceutical Science with Dr. Jim Shen

Summary

In Episode 21 of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the executive director and head of regulated bioanalysis operations at BMS. Jim discusses his early career in bioanalysis and the importance of mentorship. He emphasizes the need to recognize and appreciate the success and expertise of others, as well as the importance of building a network of champions, allies, and sponsors. The conversation also touches on the topic of psychedelics as a drug therapy and the recent retraction of scientific papers on MDMA-assisted therapy. Jim shares his passion for photography, particularly infrared photography, and the resurgence of film photography.

Chapters

01:14 - Jim’s Favorite Publication and His Journey into Bioanalysis

04:15 - Finding Joy in Your Work: Pursuing Your Interests and Making a Difference 

05:10 - Early Career in Bioanalysis

07:35 - The Importance of Mentorship and Dealing With Adversaries

17:35 - NEW NEWS: Retraction of Scientific Papers on Drug Therapy

24:55 - Personal Interests: Photography and Gaming

Takeaways

• Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans.

• Building a supportive and collaborative community is crucial in the field of bioanalysis, where knowledge sharing and networking play a significant role in advancing research and innovation. Recognize and appreciate the success and expertise of others

• Build a network of champions, allies, and sponsors

• Be open to new career opportunities and emerging fields

• Maintain integrity and transparency in scientific research

• Explore different hobbies and interests outside of work

Sound Bites

• “Sponsors are those with the power to change your career. Those people don't come along very often, so you need to really grab them when you see them.”

• “EQ is so important in being successful in your larger pharmaceutical company.”

• “I first tell my staff to divide people into 3 groups, champions, allies, and sponsors.”

• “And it is very hard to be in this field, to be a scientist, but you know, it's the people that make it worthwhile.”

New News Story: 

• Following FDA rejection, a journal retracts papers on MDMA-assisted therapy

• https://www.biopharmadive.com/news/lykos-journal-mdma-retractions-maps-ptsd-unethical-conduct/723945/ 

How to reach us:

Dr. Jim Shen

https://www.linkedin.com/in/jimxshen/ 

Bristol Myers Squibb - https://www.bms.com/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image Credits

Travis Kelce:

https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DQY8xlVldVp8&psig=AOvVaw2yCKg3oh923dt0beIIR8w3&ust=1726284386832000&source=images&cd=vfe&opi=89978449&ved=0CBcQjhxqFwoTCICN_OD8vogDFQAAAAAdAAAAABB2

https://www.te-university.com/posts

https://people.com/travis-kelce-says-hes-his-own-worst-critic-on-the-field-8684839

https://www.marca.com/en/nfl/kansas-city-chiefs/2023/07/12/64aec11a268e3e242d8b458e.html

https://www.newheightshow.com/ 

https://www.aol.com/fans-think-moment-travis-kelce-185629668.html

World of Warcraft Guilds

https://www.dexerto.com/world-of-warcraft/wow-players-critical-of-unrealistic-guild-expectations-for-season-of-discovery-2392361/ 

Infrared Photography: Jim Shen

Keywords

Pharmaceutical, Mentor, Mentorship, Mentoring, Science, Biotech, Biotechnology, Gaming, Photography, Bioanalysis

In this episode (EP20) of BioTalk Unzipped, host Gregory Austin and co-host Dr. Chad Briscoe interview Dr. Jim Shen, the Executive Director and Head of Regulated Bioanalysis Operations at BMS. They discuss topics such as the advancements in cancer therapies, the integration of AI and mechanistic modeling in drug development, and the complexities of regulatory submissions. Dr. Shen shares his journey into bioanalysis and his passion for mass spectrometry. 

Chapters

01:15 - Introduction, Background, and Passion for The American Cancer Society

03:46 - Advancements in Cancer Therapies, Opdualag 

08:03 - From Small Molecule to Large to Hybrid

12:52 - NEW NEWS! - Halda Raises $126M for a New Targeted Cancer Therapy

18:30 - Dr. Shen’s Journey from Computers to Chemistry into Bioanalysis

27:00 - The Integration of AI and Mechanistic Modeling in Drug Development

34:30 - Navigating the Complexities of Regulatory Submissions

Takeaways

• Advancements in cancer therapies, such as immunotherapy and antibody drug conjugates, have revolutionized the treatment landscape and improved patient outcomes.

• The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy. More research and collaboration between software and hardware engineers are needed to fully realize its potential.

• Navigating the complexities of regulatory submissions requires adherence to international guidelines and validation of analytical methods to ensure accuracy and precision.

• Dr. Shen's journey into bioanalysis highlights the importance of pursuing your interests and finding enjoyment in your work, even if it may not align with your initial plans.

Sound Bites

• "Advancements in cancer therapies have revolutionized the treatment landscape."

• "Antibody drug conjugates are one of the most exciting and interesting types of molecules."

• "The integration of AI and mechanistic modeling in drug development shows promise but is still in its infancy."

New News Story: 

• Startup Halda raises $126M to advance new type of targeted cancer therapy

• https://www.biopharmadive.com/news/halda-series-b-riptac-prostate-cancer/723933/

How to reach us:

American Cancer Society

https://www.cancer.org/ 

Dr. Jim Shen

• https://www.linkedin.com/in/jimxshen/ 

• Bristol Myers Squibb - https://www.bms.com/ 

Dr. Chad Briscoe

• https://www.linkedin.com/in/chadbriscoe/ 

• Celerion - https://www.celerion.com/  

Gregory Austin

• https://www.linkedin.com/in/gregoryaustin1/ 

• ECI - https://eci-rx.com / 

Images

ADC Mechanism of Action

https://www.researchgate.net/figure/Antibody-drug-conjugate-ADC-structure-and-mechanistic-schematic-Inset-in-upper-right_fig1_364183953 

https://www.researchgate.net/figure/General-structure-of-antibody-drug-conjugate_fig1_355319441 

Keywords

Bioanalysis, Cancer, Oncology, Research, Drug Development, Compliance, Regulatory Compliance, AI, ADC, Antibody Drug Conjugates, immunotherapy, Pharmaceutical, Biotechnology, Podcast, Science, Pharmaceutical Science

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe continue their conversation with Zealic CEO, Chuck Piccirillo. They delve into the unique challenges of the patient journey and the increasing demand for hybrid healthcare solutions that offer more flexibility. The discussion highlights the rise of virtual health, particularly in Europe, and introduces exciting developments in ion channels as a goldmine for new medicines. They also explore the financial intricacies of drug development, the importance of leadership through incremental steps, the value of in-person interactions, and hard-earned lessons in the industry. Finally, Chuck offers invaluable advice for entrepreneurs in the life sciences sector.

Chapters

00:17 - Adapting to what is unique in the patient journey.

07:08 - Push for hybrid solutions - more flexibility.

09:20 - Virtual health is emerging, especially in Europe.

14:02 - New News! - Ion Channels are a goldmine for new medicines

19:23 - The Financial Side of Drug Development

21:50 - Leadership - Incremental Steps, the Value of In-Person Interactions, Learning Hard Lessons

30:58 - Advice For Entrepreneurs in Life Science

Takeaways

• Building blocks to build the digital patient experience, then tweak it to the individual drug and form a complex digital and personal adaptive health journey.
• The healthcare industry needs to find a balance between safety and innovation to ensure patients have access to the best possible care. Remote patient monitoring and decentralized clinical trials are crucial in improving patient engagement and outcomes in the healthcare industry.
• Virtual visits and technology integration can enhance patient engagement and make healthcare more accessible.
• While there has been an increase in decentralized trials, the focus is currently on commercial solutions due to the crowded nature of the clinical trial technology space.
• Virtual health and routine monitoring have the potential to alleviate the burden on healthcare providers and improve patient care.
• Ion channel research holds promise for developing new medicines and treatments for various conditions.
• Incremental progress and persistence are key in entrepreneurship and leadership.

Sound Bites

• (regarding adaptability in clinical software) “Imagine if LinkedIn only every 6 months. How engaging would that be?”
• "And it would actually integrate with like Uber, for example, and help them get a ride if they had to go to the doctor and actually, and all of that is based on these building blocks that we're able to assemble and then press a button."
• “I think everybody wants whatever aspect of life nowadays to be hybrid anything.”
• “It’s why we always talk about pragmatic innovation.”
• “Persistence in the face of opposition of all sorts.”

New News Story:  These microscopic tunnels are a goldmine for new medicines

https://www.biopharmadive.com/news/ion-channels-drug-research-vertex-biohaven-jazz/719337/ 

How to reach us:

Crohn's & Colitis Foundation

https://www.crohnscolitisfoundation.org/ 

Chuck Piccirillo

https://www.linkedin.com/in/cpiccirillo/ 

Zealic Health - http://www.zealichealth.com

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Keywords

Patient Journey, Hybrid Healthcare Solutions, Drug Development Finance, Leadership in Life Sciences, Entrepreneurship in Life Sciences, Remote Patient Monitoring, Decentralized Clinical Trials, Healthcare Technology Integration, Digital Patient Experience, Clinical Software Adaptability, Pragmatic Innovation, Persistence in Entrepreneurship, Leadership

#HealthcareInnovation

#VirtualHealth

#DrugDevelopment

#LifeSciences

#Entrepreneurship

#DigitalHealth

#HybridHealthcare

#IonChannels

#PatientCare

#RemoteMonitoring

#ClinicalTrials

#Leadership

#HealthTech

#PragmaticInnovation

#Persistence

#pharmaceutical

#biotech

#science

#CEO

Summary

In this conversation, Dr. Jonathon Hill discusses the unique partnership between his lab and the university, which allows students to become entrepreneurs, develop their own projects, and become the CEO. Dr. Hill discusses the potential for AI to better diagnose disease based on the individual’s genome. He also talks about Lumicell's fluorescent system for highlighting residual breast cancer tissue and the importance of genetic diagnostics in personalized medicine. Dr. Hill shares his advice for students interested in genetics and biotechnology research, emphasizing the value of research experience and taking risks. He also discusses the challenges of regulatory pathways in the biotech industry.

 Takeaways

• The unique partnership between academic institutions and companies can provide students with opportunities to develop their own ideas and become entrepreneurs, fostering innovation and impact in the biotechnology industry. 

• Lumicell's fluorescent system can help detect residual breast cancer tissue, reducing the need for additional surgeries

• Genetic diagnostics will play a crucial role in personalized medicine, but there are limitations to relying solely on genetic sequencing

• Navigating regulatory pathways is a challenge in the biotech industry

Sound Bites

• “We like to say that we are creating CEOs in our labs … CEO at age 23.”

• “When you go to the doctor, they do a guess and check model.”

• “Why did you not carefully diagnose the problem and give me the right treatment the first time?”

• “And medicine needs to go in the direction of AI-aided diagnosis because it's going to lower costs, make things faster and more efficient and better in the long run if we can create if we can create accurate diagnoses.”

• “Typically about 50% of high school seniors indicate they will go to college. This year it’s down to 37%”

Chapters

01:01-The balance between being professor and running a lab

02:00-The unique partnership between university and industry

03:55-More students are looking to pursue entrepreneurship out of college

06:31-How will AI affect genetics research and the industry?  The impact of AI in future diagnoses.

12:58-New News! Lumcell’s breakthrough in residual breast cancer imaging detection.

16:10-Dr Hill’s passions within and outside his professional life.

17:37-Advice for young scientists and budding biotech entrepreneurs.

21:00-Growth of bioinnovations and training scientific students for business success vs. backlash of the cost of education.

28:48-The regulatory hurdles and progress for Wasatch and their DNA research.

New News Article

The FDA has granted a groundbreaking approval to a fluorescent light system that illuminates leftov...https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer 

How to reach us:

Dr. Jonathon Hill

https://www.linkedin.com/in/jonathon-t-hill/ 

Wasatch Labs: https://www.wasatchbiolabs.com/ 

Rainforest Trust - https://www.rainforesttrust.org/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image Credits

Gattaca

https://www.justwatch.com/us/movie/gattaca

Lumicell Fluorescent System

https://www.fiercebiotech.com/medtech/fda-delivers-approval-lumicells-fluorescent-system-highlighting-residual-breast-cancer 

https://www.laserfocusworld.com/bio-life-sciences/article/14294960/fluorescence-imaging-system-may-improve-cancer-care 

https://vimeo.com/807609920 

https://healthandpharma.net/fda-approves-imaging-tumor-detection-breast-cancer-surgeries#google_vignette 

Keywords

nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation

#nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA

Summary

In this conversation, Gregory Austin and Chad Briscoe interview Chuck Piccirillo, CEO of Zealic Health, about his experience in the healthcare industry and the focus on patient-centric solutions. Chuck shares his personal journey with colitis and how it ultimately inspired him to start Zealic Health. The company aims to provide highly patient-centric digital platforms to improve care and treatment in the healthcare industry. Chuck also shares the story of how Zealic Health adapted to the war in Ukraine and relocated their employees to Poland. The panel tackles the tough questions around the new LDT as a Medical Device final ruling by the FDA. They then discuss how AI is helping doctors detect cancer and in making better diagnostic decisions. Takeaways

• Zealic Health focuses on providing patient-centric digital platforms to improve care and treatment in the healthcare industry.
• The use of AI in healthcare can help accelerate drug development, improve diagnostics, and enhance patient engagement.
• Zealic Health adapted to the war in Ukraine by relocating their employees to Poland, demonstrating their commitment to their team and their mission.
• The FDA final ruling is clearly to improve safety but the confusion is in the interpretation of that ruling and 

Sound Bites

• “The biggest challenge is the interpretation of these (LDT) rules.”

• “Typically I’m not in favor of what Congress is doing.”

• “Trying to understand how we’re going to navigate the space … it’s just been confusing.”

• "The FDA is trying to protect us, but they need to navigate these things and engage industry experts."

• “(regarding AI) Where does marketing end and reality begin?”

• "AI isn't going to say, 'We don't need the doctor, just use AI.'"

• “The people who are out of their jobs won't be the ones using AI. The people who are out of their jobs will be the ones who don't.”

• “The whole promise of AI is taking massive amounts of data and finding those patterns

Chapters

01:33 Introduction and Background

04:03 The Crohn’s & Colitis Foundation and Chuck’s struggle with Colitis

07:49 Patient-Centric Solutions in Healthcare and Zealic Health

13:26 Plan B - Moving offices from Ukraine to Poland

20:02 New News!! - The Controversy of LDTs Becoming Medical Devices

27:20 Implications of healthcare and regulations as it applies to AI

30:07 How AI Aids in Diagnosis

New News Story: House committee tells FDA to suspend lab developed test rule

https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/ 

How to reach us:

Crohn's & Colitis Foundation

https://www.crohnscolitisfoundation.org/ 

Chuck Piccirillo

https://www.linkedin.com/in/cpiccirillo/ 

Zealic Health - http://www.zealichealth.com

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image credits:

https://www.crohnscolitisfoundation.org/ 

LDT/FDA, https://x.com/FDADeviceInfo/status/1784965525522493657 

Congress, https://worldstrides.com/blog/2013/07/u-s-capitol/ 

Cost, https://www.freepik.com/photos/increasing-costs 

Cancer patient, https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm 

CAD - Computer Aided Detection, https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/ 

#BioTalkUnzipped #Podcast #HealthcareInnovation #PatientCare #AIinHealthcare #FDARegulations #Ukraine #LifeSciences #DigitalHealth #AI #pharmaceutical #biotechnology #medicaldevice

Summary

Dr. Andy Vick shares some of the things that surprised him throughout his career and he discusses his passion for reptiles and his experience discussing the pharmaceutical potential of venom with future toxicologists at Ashland University. Next, Andrew Vick discusses his role as an adjunct professor at Ohio State University, his involvement in academia, and how he got into it. We discuss a story about a clinical study that restored hearing in children with gene therapy. The conversation concludes with a discussion about the impact of professional organizations like AAPS on the industry and the importance of networking and fellowship.

Takeaways

• Cancer doesn’t have the same death sentence - fear factor it used to have 30+ years ago.

• It takes about 10 years for a newly discovered compound to make it on the market.

• Andrew Vick is passionate about reptiles and has a collection of rare reptiles. He enjoys educating others about reptiles and their pharmaceutical potential, particularly venom.

• There’s a shift from small molecules to biologics in the past 5 years.

• Andrew Vick visited Ashland University to discuss the pharmaceutical potential of venom with future toxicologists, combining his passion for reptiles and pharmaceutical science. Andrew Vick is an adjunct professor at Ohio State University, where he teaches in the College of Pharmacy Division of Pharmaceutical Chemistry.

• His role as an adjunct professor involves giving guest lectures, providing career and professional development for students, and serving on the Dean's Corporate Council.

• Andrew Vick is also involved in evaluating assets developed in academia and collaborating with industry to develop strategies for bringing products to the clinic.

• We discuss a study by Regeneron that used gene therapy to restore hearing in children with mutations in the otoferlin gene.

• Regarding Cell-Gene Therapy we have a lot to learn both from the positive pharmacological potential, but also from a safety and tolerability standpoint.

• Professional organizations like AAPS play a crucial role in networking and fellowship, providing opportunities for collaboration and learning in the pharmaceutical industry.

Sound Bites

• "I have just a passion for reptiles and have accumulated a small and pretty rare collection of reptiles from around the world."

• “It's probably a good 10 years from the glimmer in a biochemist's eyes to on the market.”

• “There’s a logarithmic difference between great and good.”

• “Just use your imagination on a way to tackle a disease and then find a way.”

• “Cell and gene therapy opens the door to a whole different category of opportunities.”

• “AAPS is just kind of part of my DNA.”

Chapters

00:21 - Surprises in Dr. Vick’s Career

02:24 - The Cyclical Nature of Technology

03:30 - Exploring the Pharmaceutical Potential of Venom

05:35 - Improvements in Cancer and Other Diseases In The Past 30 Years

10:13 - Educating Future Toxicologists about Reptiles and Pharmaceuticals

15:45 - Andrew Vick's Role as an Adjunct Professor at Ohio State University

21:21 - New News!! - Restoring Hearing in Children with Gene Therapy

27:27 - The Impact of Professional Organizations on the Industry, AAPS

New News Story:  The 'little protein factory' that could: Regeneron gene therapy restores hearing in 2 children

https://www.fiercebiotech.com/biotech/little-protein-factory-could-regeneron-gene-therapy-restores-hearing-2-kids 

How to reach us:

Dr. Andy Vick

https://www.linkedin.com/in/andy-vick-4467189/  

Attralus: https://www.attralus.com/

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image credits:

Pharmacognosy - https://pharmacognosy-phytochemistry-natural-products.pharmaceuticalconferences.com/events-list/industrial-pharmacognosy

#biotechnology #science #research #toxicology #reptiles  #academia #cellgenetherapy #AAPS

Summary

Dr. Andy Vick discusses his work at Attralus Therapeutics, a biotech company focused on developing treatments for systemic amyloidosis. He explains the etiology of the disease and how Attralus is attacking it using therapeutic antibodies with a pan amyloid reactive peptide sequence. The company is also developing a diagnostic tool to visualize amyloid burden in patients. Dr. Vick emphasizes the importance of toxicology in drug discovery and development, describing its role in evaluating the adverse side effects of drugs and ensuring safety. He also highlights the challenges of finding animal models for rare diseases like amyloidosis. In this part of the conversation, Andrew Vick discusses his transition from working in a contract research organization (CRO) to a small biotech company. He highlights the similarities and differences between working in biotech, pharma, and CROs, emphasizing the motivation to help others and improve the quality of life. The conversation then shifts to a discussion about a novel mRNA-based cancer vaccine for glioblastoma, which shows promise in early research. The vaccine wraps the RNA specific to a patient's tumor in lipid nanoparticles, stimulating a robust immune response against the cancer. 

Takeaways

• Attralus Therapeutics is focused on developing treatments for systemic amyloidosis using therapeutic antibodies with a panamyloid reactive peptide sequence.

• The company is also developing a diagnostic tool to visualize amyloid burden in patients.

• Toxicology plays a crucial role in drug discovery and development, evaluating the adverse side effects of drugs and ensuring safety.

• Finding animal models for rare diseases like amyloidosis can be challenging. Andrew Vick transitioned from working in a contract research organization (CRO) to a small biotech company, highlighting the similarities and differences between the two.

• The motivation to help others and improve the quality of life is a common thread in biotech, pharma, and CROs.

• A novel mRNA-based cancer vaccine for glioblastoma shows promise in early research, stimulating a robust immune response against the cancer.

Sound Bites

"Attralus Therapeutics is focusing on biologic-based therapeutics and diagnostics related to amyloidosis."

"Toxicology is the science of evaluating the adverse side effects of drugs."

"Attralus Therapeutics' lead product is a therapeutic antibody with a panamyloid reactive peptide sequence."

"This novel mRNA vaccine shows promise against deadly brain cancer."

Chapters

02:22 Dr. Vick’s Charity Work in Brazil

06:30 Introduction to Attralus Therapeutics

07:41 Developing Treatments for Systemic Amyloidosis

10:35 The Role of Toxicology in Drug Discovery and Development

16:38 Using Animal Models Studying Amyloidosis 

22:06 The History of Attralus and Dr. Vick’s Transition There from CRO

32:45 New News! - Promising Results of an mRNA-Based Brain Cancer Vaccine

New News Story:  Glioblastoma vaccine turns brain tumors from cold to hot in humans and dogs

https://www.fiercebiotech.com/research/glioblastoma-vaccine-turns-brain-tumors-cold-hot-humans-and-dogs 

Media credits:

Pilot

https://www.amazon.com/Military-Aircraft-Cockpit-Photograph-Picture/dp/B07Z2KM6KY

UF

https://www.clickorlando.com/news/florida/2024/03/11/university-of-florida-axes-diversity-and-inclusion-office-under-gop-led-law-aimed-at-ridding-similar-programs/ 

Music

Track: "CLARITY", Mifune

Music provided by https://slip.stream 

Download / Stream: https://get.slip.stream/KFCilm 

Keywords

Attralus Therapeutics, systemic amyloidosis, therapeutic antibodies, panamyloid reactive peptide sequence, diagnostic tool, toxicology, drug discovery, drug development, animal models, rare diseases, transition, contract research organization, CRO, biotech, pharma, motivation, quality of life, mRNA-based cancer vaccine, glioblastoma, lipid nanoparticles, immune response

#biotechnology #science #research #toxicology #glioblastoma #braincancer #vaccine #amyloidosis

A Diagnostic Breakthrough for Alzheimer’s

Summary

In this conversation, Dr. Jonathan Hill discusses his work in nanopore sequencing-based technology and its applications in genetic and epigenetic research. He shares his experiences working in Brazil and his passion for preserving the rainforest. The conversation also explores the use of AI in analyzing the genetic underpinnings of tobacco addiction and the potential impact on addiction treatment. Dr. Hill highlights his lab's breakthrough in identifying early biomarkers for Alzheimer's disease using DNA methylation signatures. 

Takeaways

• Nanopore sequencing is a powerful technology that allows for real-time analysis of native DNA and RNA, regardless of length, and provides valuable insights into genetic and epigenetic research.

• Preserving the rainforest is crucial, and initiatives like the Rainforest Trust play a vital role in protecting the biodiversity and resources found in these ecosystems.

• AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment.

• The integration of AI technologies in genetic research should be approached with caution, as the black box nature of AI can limit our understanding of the underlying biology. It is important to carefully test and explain AI models to build trust among users.

• The use of nanopore sequencing and DNA methylation signatures shows promise in the early detection of Alzheimer's disease, potentially allowing for personalized approaches to treatment and intervention.

Sound Bites

• "One of my bucket list items, one of my dreams would be to set up a nanopore sequencing lab in the Amazon and just sequence that biodiversity and create that data so we could glean it for everything it's worth and learn so much about how our world works."

• "Nanopore sequencing is based on protein nanopores that exist in nature, and these particular nanopores can pass DNA through the pore."

• "AI technologies, when used in conjunction with genetic research, can accelerate the identification of candidate genes associated with complex conditions like tobacco addiction, leading to personalized approaches for smoking cessation and addiction treatment."

• “Biology is not rocket science, it’s much harder.”

• "Better diagnosis comes better treatment."

Chapters

00:00 Introduction 

02:51 Donation to the Rainforest Trust & Time in Brazil

06:37 How Nanopore Sequencing Works

12:45 New News!  AI and the Genetic Code of Tobacco Addiction

15:20 Using AI in Nanopore Sequencing at Wasatch Labs and Diagnostics

21:14 Finding Cell-Free DNA for Fertility Treatments

22:56 Breakthrough - Finding Early Biomarkers for Alzheimer’s

New News Article

Breaking the Genetic Code of Tobacco Addiction

https://neurosciencenews.com/genetics-tobacco-addiction-ai-25937/ 

How to reach us:

Dr. Jonathan Hill

https://www.linkedin.com/in/jonathon-t-hill/ 

Wasatch Labs: https://www.wasatchbiolabs.com/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image Credits

Rainforest Trust - https://www.rainforesttrust.org/ 

https://www.envirobuild.com/blog/rainforest-trust

Fire Sponge

https://stock.adobe.com/ 

Amazon

Photos: Shutterstock 

Medicine Man

https://www.rollingstone.com/music/music-lists/stills-from-the-movie-medicine-man-32217/medicine-man-5-159239/ 

https://www.solarnavigator.net/films_movies_actors/medicine_man.htm

Oxford Nanopore Technologies

How nanopore sequencing works

https://www.youtube.com/watch?v=RcP85JHLmnI 

Keywords

nanopore sequencing, genetic research, epigenetics, rainforest preservation, AI, tobacco addiction, addiction treatment, Alzheimer's disease, DNA methylation

#nanopore, #geneticresearch, #epigenetics, #AI, #addiction, #alzheimers, #DNA

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Ines Santos and Dr. Julia Sable to discuss their experiences and contributions in the pharmaceutical sciences, particularly focusing on women's roles in the field. The conversation covers their personal journeys into science, the importance of STEAMpark.org in education, exciting projects they've worked on, challenges in CMC for cell and gene therapies, innovations in chiral bioanalysis, and recent industry developments. The panel emphasizes the significance of collaboration and mentorship in advancing medical progress. This conversation delves into the evolving landscape of cancer treatment, particularly the integration of combination therapies like CAR T and oncolytic viruses. It also highlights the importance of empowering women in pharmaceutical sciences through mentorship and community engagement, while emphasizing the role of allyship in fostering an inclusive environment.

01:20 Introduction to BioTalk Unzipped

02:01 Celebrating Women in Pharmaceutical Sciences

03:21 The Importance of STEAM Education

04:09 Personal Journeys into Science

08:02 Exciting Projects and Discoveries

13:52 Challenges in CMC for Cell and Gene Therapies

18:51 Innovations in Chiral Bioanalysis

22:46 NEW NEWS! - New ADC Approved

28:33 Exploring Combination Therapies in Cancer Treatment

32:26 Empowering Women in Pharmaceutical Sciences

37:30 Mentorship and Community Engagement

45:18 The Role of Allyship in Science

47:19 Breaking Barriers and Challenging Stereotypes

54:15 Engaging Diverse Voices in Discussions

56:49 Creating Inclusive Spaces for Feedback & Speaking Up

01:01:15 Avoiding Assumptions in Professional Settings

01:02:04 Setting Boundaries for Work-Life Balance

01:05:24 Measuring Success in Life

01:07:06 Connecting and Networking Effectively

Dr. Ines Santos

https://www.linkedin.com/in/insantos/ 

Dr. Julia Sable

https://www.linkedin.com/in/julia-sable-5b794385/ 

STEAMpark

https://www.steampark.org/ 

WIPS in AAPS

https://community.aaps.org/communities/community-home?CommunityKey=fbfeb62a-884a-46cf-a5ed-24ef7eb43100 

https://www.aaps.org/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

New News Story: 

In Fierce Pharma - Pfizer's blockbuster ADC Adcetris nabs FDA approval to treat large B-cell lymphoma

• https://www.fiercepharma.com/pharma/pfizers-blockbuster-adc-adcetris-nabs-fda-approval-treat-large-b-cell-lymphoma 

Journal Article mentioned:

Emerging applications of quantitative supercritical fluid chromatography-tandem mass spectrometry for chiral bioanalysis

https://www.sciencedirect.com/science/article/abs/pii/S0021967325000767 

Sound Bites

"We want to build our next generation."

"We all want the same result."

"You have to have a level of extrovert."

"If you see something, say something."

"Take action this year."

Image Credits:

AAPS & WIPS logos: https://www.aaps.org/ 

Keywords

BioTalk, pharmaceutical sciences, women in science, CMC challenges, chiral bioanalysis, CAR-T therapies, STEAM education, innovations in medicine, healthcare advancements, biotechnology, cancer treatment, CAR T therapy, women in science, mentorship, allyship, pharmaceutical sciences, community engagement, combination therapies, empowerment, gender equality, engagement, feedback, inclusivity, allyship, professional development, work-life balance, success, networking

#pharmaceutical #women #womenempowerment #science #drugdevelopment #biotech #biopharma #mentor #mentorship  #AAPS #WIPS

The AI Prescription: Revolutionizing Pharma & Patient Care with Jason Burke

Summary

In Episode 13, Jason Burke discusses the unique approach of the Duke program in providing real-world healthcare data to students. He also highlights the breakthrough in AI-generated drug discovery and its potential impact on investors and startups. The process of assessing technologies for companies and patients is explored, with a focus on evaluating business and technology aspects. The importance of unique intellectual property is emphasized, and the future of AI and software is discussed. The conversation concludes with insights into using AI in everyday life and the role of search engine companies in AI. In this conversation, Chad and Jason discuss the interface between pharma companies and the healthcare industry, highlighting the lack of interplay between the two. They explore the challenges faced by the healthcare industry, including the complexity of the operating environment and the limited infrastructure for research. Jason emphasizes the potential for life sciences firms to become service companies and overcome these challenges. They also delve into Jason's interest in amateur radio and the fascinating world of ham radio, where he has been learning and discovering new things.

Takeaways

• The Duke program provides students with real-world healthcare data, giving them a unique advantage in the job market.

• AI-generated drug discovery has the potential to revolutionize the pharmaceutical industry and attract more investment to startups.

• Assessing technologies for companies and patients involves evaluating both the business and technology aspects, including intellectual property.

• The future of AI and software will see the emergence of new forms of experiences and collaboration between humans and machines.

• Search engine companies have been late to adopt AI technologies like ChatGPT, but they have already been utilizing AI in their search algorithms. 

• \There is a need for more interplay between pharma companies and the healthcare industry to ensure better understanding of customer needs and feedback.

• The healthcare industry faces challenges due to the complexity of the operating environment and limited infrastructure for research.

• Life sciences firms have the potential to become not just product companies, but service companies and provide valuable solutions to overcome the challenges in the healthcare industry.

• Doctors want to help patients at the highest level possible but continually grapple with the complexity of the healthcare environment and the sheer volume of patients.

• Amateur radio, or ham radio, offers a fascinating world of learning and discovery, with a community of innovators constantly finding new and creative ways to use the technology.

Chapters

00:29 Unique Approach in Duke Program

05:14 New News! The First AI-Generated Drug Discovery

09:33 Assessing Technologies for Companies and Patients. 

11:52 The Importance of Unique Intellectual Property

12:35 The Future of AI and Software

13:36 Data as a Commodity

15:10 Innovation Curves and Technology, AI Compressing it

16:41 Using AI in Everyday Life

19:04 Why were Search Engine Companies Late to the Generative AI Game?

20:05 New Forms of Software and Experiences

22:53 The Future of Healthcare and Pharma - Enough Interfacing?

25:08 The Difficulty of Doctors in Complex Environments and Implementing Precision Medicine

29:03 Jason's Interest in Amateur Radio and Exploring the Ham Radio Community

31:39 Bouncing a Radio Signal Off the Moon & Sending Emails over Radio Waves

How to reach us:

Jason Burke

https://www.linkedin.com/in/jasonburke/

Creo Inc. -  https://www.creoinc.net/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Celerion - https://www.celerion.com/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

ECI - https://eci-rx.com/ 

#AI  #pharmaceutical #healthcare #drugdiscovery #futuretech #lifesciences

Summary

In this episode of BioTalk Unzipped, the hosts discuss the applications and ethical concerns surrounding organoids, which are 3D cell clusters that mimic the features of full-sized organs. They explore the potential of brain organoids in brain-computer interfaces and neuroplasticity. The conversation then shifts to the impact of AI and data sciences in healthcare, with a focus on the challenges and opportunities in implementing AI strategies. The hosts also discuss the future of quantum computing in healthcare and the FDA's IT strategy with 21 CFR Part 11. 

Chapters

01:14 - Introduction to BioTalk Unzipped

03:30 - NEW NEWS: Discussion on Organoids and Their Applications 

04:45 - Ethical Concerns with Brain Organoids as mini bio-computers

06:31 - Organoid Possibilities in Drug Discovery Research and Brain Interfaces

08:59 - The Potential of Brain Training and Neuroplasticity

10:51 - The Impact of AI and Data Sciences in Healthcare

11:18 - Jason’s Background and Emerging Technologies Transforming Clinical Research

13:43 - The Role of AI in Precision Medicine, Quantum Computing and Business Growth

24:15 - FDA's IT Strategy and the Challenges of Implementing AI

26:32 - The Importance of Strategy and Prioritization in IT, Data Integrity, and 21 CFR Part 11

How to reach us:

Jason Burke

https://www.linkedin.com/in/jasonburke/

Creo Inc. -  https://www.creoinc.net/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Celerion - https://www.celerion.com/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

ECI - https://eci-rx.com/ 

New News Link:

The many uses of mini-organs

https://www.technologyreview.com/2024/03/08/1089612/the-many-uses-of-mini-organs/ 

Image Credits

Brain - https://www.vecteezy.com/vector-art/658977-kawaii-cute-happy-brain-with-arms-and-legs

UFO - https://www.pinterest.com/pin/swampthingy--675891856570360044/

#HealthcareInnovation #Organoids #AI #QuantumComputing #Podcast #BioTalkUnzipped #drugdiscovery

Summary

In this episode, Scott Schliebner discusses the unique challenges and complexities of rare disease trials. He highlights the difficulties in recruiting patients, the multidisciplinary nature of care, and the importance of collaboration among various stakeholders. The role of AI in rare disease trials is also explored, with a focus on its potential for patient recruitment and data analysis. 

Scott shares success stories in the field and discusses the expanding use of gene therapy to target multiple genes. The conversation concludes with a discussion on the recent FDA approval of Iovance's Amtogvy as the first T-cell therapy for a solid tumor, Melanoma. In this conversation, Scott discusses the potential of cell therapy in targeting solid tumors, particularly melanoma. He highlights the importance of expanding the use of cell therapy to other tumor types and the potential for curative treatments. The conversation also delves into the challenges and questions surrounding pricing and ethics in the gene and cell therapy space. The impact of curative therapies on quality of life and healthcare costs is explored, along with the success of curative therapies in hepatitis C. The high bar of clinical development and regulatory standards is discussed, as well as the potential for cost-effective treatments. The conversation concludes with advice for young professionals and established clinical professionals in the field of drug development.

Takeaways

• Cell therapy shows promise in targeting solid tumors, such as the breakthrough in melanoma treatment, and has the potential to provide curative treatments for various cancer types.

• The pricing and ethical considerations surrounding gene and cell therapy raise important questions about accessibility and affordability.

• Curative therapies have the potential to significantly improve quality of life and reduce healthcare costs by eliminating the need for long-term treatments.

• The success of curative therapies in hepatitis C demonstrates the potential for similar breakthroughs in other disease areas.

• Young professionals interested in a career in clinical drug development should seek opportunities to gain experience and consider starting in roles such as clinical research coordinators or clinical research associates.

• Rare Givers is a nonprofit organization that supports caregivers in the rare disease space.

Chapters

00:21 - Collaborative Approach in Rare Disease Trials

3:32 - The Role of AI in Rare Disease Trials

6:11 - Success Stories in Rare Disease Trials

11:34 - Expanding Gene Therapy to Target Multiple Genes

16:56 - New News: FDA Approval of Iovance's Amtagvi, The Breakthrough of IOVANCE for Melanoma

19:27 - Targeting Solid Tumors with Cell Therapy, Expanding the Potential of Cell Therapy

20:23 - The Impact of Curative Therapies on Quality of Life and Healthcare Costs

21:11 - Challenges and Questions around Pricing and Ethics

22:37 - Cures for Hepatitis C

23:25 - The High Bar of Clinical Development and Regulatory Standards

24:05 - Pricing Considerations for Different Cancer Types, The Potential for Cost-Effective Treatments

27:45 - Advice for Young Professionals in Clinical Drug Development

31:49 - Advice for Established Clinical Professionals

33:21 - Scott's Hobbies and Interests

Learn about and DONATE to Rare Givers:

https://www.raregivers.global/ 

How to reach us:

Scott Schliebner

https://www.linkedin.com/in/scott-schliebner-1087789/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

New News Link:

https://www.fiercepharma.com/pharma/fda-approves-iovances-amtagvi-first-cell-therapy-solid-tumor 

Image Credits

Iovance, https://www.iovance.com/ 

FDA approved, https://www.tipranks.com/news/iovance-nasdaqiova-fda-approves-cell-therapy-stock-gains

Amtagvi, https://www.amtagvi.com/ 

Impact of AI in Rare Disease Trials with Scott Schliebner

Summary

In this episode, the hosts welcome Scott Schliebner as their guest and kick off with a charitable act, donating to Rare Givers. They delve into the Epitomee weight loss capsule's potential impact, then shift to discussing the challenges of establishing a North American infrastructure for a MedTech CRO, navigating cross-cultural dynamics. Later, they investigate the transformative potential of AI and machine learning in clinical trials. Scott Schliebner weighs in on the intricacies of rare disease trials, emphasizing patient recruitment hurdles, interdisciplinary care, and stakeholder collaboration. The conversation also delves into AI's role in addressing these challenges, particularly in patient recruitment and data analysis.

#clinicaltrials #science #ai #raredisease #drugdevelopment
Takeaways

• Rare Givers (https://www.raregivers.global/) is a nonprofit organization that supports caregivers in the rare disease space.

• The Epitome weight loss capsule is an innovative medical device that tricks the body into feeling full, aiding in weight loss.

• Building a North American infrastructure for a MedTech CRO requires navigating cultural differences and finding key leaders who can adapt to a startup environment.

• AI and machine learning have the potential to transform clinical trials by improving drug discovery, analyzing large datasets, and enhancing patient retention. 

Chapters

00:00 - Introduction and Charity Donation - Rare Givers

02:30 - Discussion on Rare Givers

04:08 - What inspired Scott to the Clinical space

06:12 - New News: Epitomee Weight Loss Capsule

11:25 - Epitomee target drug delivery application weight loss competition with Wegovy

14:05 - Building a North American infrastructure for EU-based MedTech focused CRO

16:35 - Cultural idiosyncrasies to be aware of doing business with different countries

23:53 - The Impact of AI and Machine Learning, and generative AI in Clinical Trials, drug development, FDA compliance, and quality control

30:13 - Understanding Rare Disease Trials, and overcoming challenges 

33:12 - Is it a Zebra or a Horse?

DONATE to Rare Givers:

https://www.raregivers.global/ 

How to reach us:

Scott Schliebner

https://www.linkedin.com/in/scott-schliebner-1087789/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

New News Link:

• Epitomee® announces the filing of a novel Weight Loss Capsule for FDA clearance

• https://www.prnewswire.com/news-releases/epitomee-announces-the-filing-of-a-novel-weight-loss-capsule-for-fda-clearance-302081225.html




• NIH Study publication: Safety, tolerability and efficacy of a novel self‐use biodegradable device for management of obesity

• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6700511/ 

Image Credits

Zebra - https://www.rarediseaseday.org/event/6th-annual-rare-disease-day-virtual-race/ 

Description:

In Episode 8 of BioTalk Unzipped, we dive deep into the scientific mind of Dr. Russell Grant, exploring how he navigates groundbreaking publications with a healthy dose of skepticism. From microsampling blood spots to dissecting experimental execution gaps, Dr. Grant reveals his strategies for separating scientific sizzle from substance.

In our latest segment of "New News," we discuss Elon Musk's Neurolink gaining FDA approval for clinical trials, sparking debates about neuroscience's role in the 21st century. With insights into the risks and rewards of understanding brain biochemistry, this episode challenges conventional thinking.

Discover the secrets behind Dr. Grant’s legendary leadership with the Triangle Area Mass Spec (TAMS) group, where mentorship, empowerment, and strong networks bridge academia and industry. Uncover how Dr. Grant encourages scientists to stay focused on foundational processes while striving for brilliance in their work.

From unexpected breakthroughs in sensitive testosterone measurements to fostering career development in his team, Dr. Grant shares invaluable lessons in leadership and personal growth. Tune in for memorable quotes, career insights, and a glimpse into Dr. Grant's life beyond the lab.

Join us as we unzip the world of science with Dr. Russell Grant on BioTalk Unzipped!

#biotechnology #diagnostics #science #innovation #leadership #pharmaceutical

SEGMENTS:

• 1:22 - What does Russ Grant’s brain do when he sees a groundbreaking publication?  7:47 - New News!

• 13:10 - Dr. Grant’s leadership with the TAMS (Triangle Area Mass Spec) group and why it’s so successful. 

• 24:05 - Has the challenges for grad students changed in the past 2 decades?

• 26:49 - When Russ’ work led to something truly unexpected, 

• 30:56 - Leadership in career development and the people they lead

• 35:51 - More memorable quotes

• 37:30 - What Russ does for fun.

How to reach us:

Dr. Russell Grant

grantr@labcorp.com

https://www.linkedin.com/in/russell-grant-5144a26/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

Conferences mentioned:

ASMS - https://www.asms.org/ 

MSACL - https://www.msacl.org/ 

ADLM - https://www.myadlm.org/ 

TAMS, Triangle Area Mass Spectrometry Discussion Group - https://tamsgroup.org/ 

New News Link:

https://www.fiercebiotech.com/medtech/neuralink-implants-brain-computer-interface-first-human-trial-participant 

Image Credits

Client Eastwood, Firefox - https://www.youtube.com/watch?v=eJJXIcig2h8 

Neuralink - https://dig.watch/updates/neuralinks-first-human-implant-shows-promising-results 

Tricorder Tech: That Star Trek Medical Scanner Is Getting Much Closer

https://astrobiology.com/2023/11/tricorder-tech-that-star-trek-medical-scanner-is-getting-much-closer.html 

Neuralizer - https://meninblack.fandom.com/wiki/Neuralyzer 

Join us for Episode 7 of our podcast as we delve into the fascinating journey of Dr. Russell Grant, from the UK to America, navigating through large pharma to the field of diagnostics. Discover the nuances between bioanalytical approaches in clinical trials versus clinical healthcare, and Russ's insights on GLP environments. Learn how Russ tackled the challenges of COVID, and hear the incredible New News breakthrough in restoring hearing in an 11-year-old using gene therapy. Russ shares his American dream, his passion for diagnostics, and his thoughts on scientific integrity. Tune in for a captivating discussion on the critical role of diagnostics in saving lives and the pursuit of scientific excellence.

#biotechnology #diagnostics #science #innovation #patientcare

SEGMENTS:

1. Transitioning Across Continents: A Tale of Professional Evolution - From the UK to America, Exploring Pharma to Diagnostics.

2. Navigating Bioanalytics: Unraveling the Contrast Between Clinical Trials and Healthcare Applications, with a Focus on Mass Spec.

3. Efficiency in Action: Revolutionizing Patient Care by Shaving Seconds Off Injections, One Assay at a Time.

4. COVID Chronicles: Dr. Russel Grant's Vital Role Amidst the Pandemic's Chaos.

5. New News!: A Landmark Achievement in Gene Therapy Unveiled.

6. Crossing Borders: Dr. Russel Grant's Journey to America - Dreams, Challenges, and Triumphs.

7. Fueling Passion: Understanding Russ' Zeal for the Field of Diagnostics.

8. The Power of Diagnosis: Unveiling How Diagnostics Serve as Lifelines in Healthcare.

9. Navigating Integrity: A Candid Discussion on Scientific Literature, Academic Fraud, and the Path Forward for Scientists.

Connect with:

Dr. Russell Grant: https://www.linkedin.com/in/russell-grant-5144a26/ 

Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ 

New News link:

Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss

Image Credits:

David Gilmour (Getty Images)

Sir Isaac Newton, https://en.wikipedia.org/wiki/Isaac_Newton

Welcome to Episode 6 of our podcast featuring Dr. Stephanie Pasas Farmer! 🎙️ Join us as we delve into the intricate world of data integrity, unveiling new software tools and the transformative impact they bring. Discover how virtual audits post-COVID, coupled with cloud security measures, are reshaping the landscape. 🔍

Explore the regulatory challenges amidst the technology and the AI explosion, with insights into the FDA's evolving role and its mission for public safety. Learn how ChatGPT transcends boundaries, from revolutionizing travel planning to enhancing workplace productivity. 💼

Delve into the nuances of ChatGPT's capabilities and limitations, navigating the fine line between its potential and pitfalls. Uncover concerns surrounding AI detectors in academia and the intricate realm of Deep Fakes. 🤖

Step into the conversational realm of ChatGPT, contrasting its prowess with conventional assistants like Alexa. 

Follow Dr. Stephanie Pasas Farmer's impactful journey, from combating malaria in South Africa to her unique career trajectory. 🌍

Tune in as she shares the most surprising moments of her career and imparts invaluable advice for aspiring scientists and entrepreneurs. Don't miss out on this riveting exploration of innovation, integrity, and entrepreneurship in the scientific realm! 🚀

#Science  #ChatGPT  #Innovation  #Entrepreneurship  #LifeScience  #SoftwareTools  #FDA  #AI  #CareerAdvice

01:00 - Data integrity concerns and new software tools. 

05:43 - How are Regulators dealing with this technology and AI explosion? Regulatory Challenges and FDA’s Role. FDA agents speaking about AI at conferences.

10:00 - Using ChatGPT in your non-work life for things like Travel Planning.

13:15 - Using ChatGPT for Work.   

14:40 - Limitations of ChatGPT.

16:19 - Concerns about False Positives for AI detectors in academics and Deep Fakes, which are so difficult to detect.  

17:13 - The Conversational Nature of ChatGPT.   

19:57 - Stephanie’s Work in South Africa.  She helps a non-profit for malaria and unmet medical needs globally. Building out the laboratory capabilities there. . 

22:22 - The most surprising thing in her career.  Advice for Aspiring Scientists and Entrepreneurs.

Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/

spfarmer@bdatasolutions.com

Ariadne Software: https://www.ariadnesolutions.com/

BioData Solutions: https://www.bdatasolutions.com/ 

Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ 

Image Credits

KU basketball, stubhub, https://www.stubhub.com/kansas-jayhawks-basketball-tickets/performer/6849 

BTS, https://www.teenvogue.com/story/bts-billboard-music-awards-2018

Cardi B, https://www.xxlmag.com/cardi-b-reacts-criticism-not-dropping-album-tour/ 

Taylor Swift, https://www.tiktok.com/discover/You-broke-my-hand-and-you-didnt-even-seems-sorry-taylor-swift

Costa Rica, https://www.pixelstalk.net/ 

Deep fake, https://www.trymaverick.com/blog-posts/are-deep-fakes-all-evil-when-can-they-be-used-for-good

Korean food, https://spoonuniversity.com/lifestyle/i-learned-the-secret-to-mastering-korean-bbq-by-growing-up-in-my-familys-restaurant

Africa, https://en.wikipedia.org/wiki/Africa 

WRIB, https://www.wrib.org/

AAPS, https://www.aaps.org/home 

APA, https://www.bostonsociety.org/APA/ 

🎙️ Episode 5 of BioTalk Unzipped is here! Join hosts Gregory Austin and Dr. Chad Briscoe as they chat with Dr. Stephanie Pasas Farmer, founder of Ariadne Software and BioData Solutions. Explore the origins of Stephanie's companies, and the creation of RedThread, an AI-Enabled Auditing Tool that blends human intelligence with AI.

🧠 Dive into the practical side of Stephanie's software and the ever-evolving landscape of machine learning regulations. Get a glimpse into Stephanie's perspective on machine learning vs. expert systems and the challenges of navigating this dynamic field.

🌐 Discover what lies ahead for AI in Stephanie's software and the integration of her companies. The conversation extends to QPCR Analysis, exploring the monitoring of DNA and RNA for safety and efficacy. Uncover the resurgence of PCR technology with new applications.

🔍 Join us for a casual chat packed with insights, anecdotes, and a peek into the future of bioanalysis. Tune in now and enjoy the exploration of BioTech innovation with BioTalk Unzipped! 🧬🎧 #biotechnology #AIInnovation #Podcast #pharmaceutical #science 

Segment list:

3:22 - Journey into Bioanalysis

7:56 - Stephanie starting her own company - Ariadne Software - the problem that inspired a company

12:44 - RedThread: An AI-Enabled Auditing Tool - human augmented intelligence

15:54 - What is the learning aspect of the software? Vigilante Computer Scientist? Regulations for machine learning.

19:04 - Machine Learning vs. Expert Systems. Machine learning analysis

20:52 - What is next for AI in Stephanie’s software and combining her companies.

22:23 - Expanding into QPCR Analysis. Monitoring DNA and RNA, safety and efficacy.

25:05 - PCR - what’s old is new again based on new applications.

Dr. Stephanie Pasas Farmer: https://www.linkedin.com/in/stephanie-pasas-farmer/

Ariadne Software: https://www.ariadnesolutions.com/

BioData Solutions: https://www.bdatasolutions.com/ 

Dr. Chad Briscoe: https://www.linkedin.com/in/chadbriscoe/ 

Gregory Austin: https://www.linkedin.com/in/gregoryaustin1/ 

Image Credits

KU logo, https://www.amazon.com/Open-Road-Brands-Jayhawk-Framed/dp/B07QJ4CK32 

KU banner, https://www.amazon.com/Kansas-Jayhawks-Chalk-University-College/dp/B005RON6UA 

In Episode 4, (Part 2 of our conversation with Dr. Russ Weiner - a top scientific leader at Takeda), we boldly explore the Cell and Gene Therapy Industry, questioning its trajectory and potential impact on insurance companies.

Shifting focus, we delve into a groundbreaking Sickle Cell Therapy breakthrough, discussing its triumphs, challenges, and the crucial aspect of affordability. Despite the hurdles faced by payers and insurance companies, we find inspiration in the thrill of witnessing healing.

Discover the role of AAPS in shaping the biotech future and efforts to engage students. Episode 4 also highlights Russ’ passions, including a heartfelt case study and insights into his AAPS Presidential platform. Explore surprising career moments, the transformative power of AI, and personal aspects of Russ’ life, from scuba diving to family.

The episode concludes with valuable advice on mentoring, self-worth, and navigating the intricacies of career development. 

Join us on BioTalk Unzipped for a captivating journey where science meets stories, leaving you enlightened and inspired.

#biotechnology  #AI

#careerdevelopment #cellgenetherapy  #science #career

SEGMENTS

1:15 - Be Brutal to the Cell and Gene Therapy Industry - Where is CGT really going?  Will it bankrupt insurance companies?

3:50 - Sickle Cell Therapy breakthrough, side effects, and affordability

4:22 - Difficulty for payers, insurance companies, but the thrill of people getting healed

8:20 - Role in AAPS. Bringing in students to AAPS.

10:16 - Russ’ #1 Passion and a Heartbreaking case study of a young woman.

11:06 - Russ’ #2 Passion and his AAPS Presidential platform and amazing science done outside the US

15:07 - What we need to do to help the world and realities we don’t often see

17:51 - What’s the most surprising thing in Russ’ career?

19:31 - AI changed everything

23:43 - Russ’ other passions: scuba diving and family

27:37 - Funny stories and knowing your worth

29:24 - Always mentoring and always find a mentor

31:09 - Who’s in charge of your career?

33:51 - The difference between career development and promotion

How to find our guest, Dr. Russ Weiner, Head Oncology and Cell Therapy Clinical Biomarker Sciences and Operations at Takeda:

https://www.linkedin.com/in/russellweiner/

Your BioTalk Unzipped Cohosts:

Gregory Austin, Business Development Manager at ProPharma Group

https://www.linkedin.com/in/gregoryaustin1/

Dr. Chad Briscoe, Executive Vice President of Global Bioanalytical Services at Celerion

https://www.linkedin.com/in/chadbriscoe/

Image credits: Image by Tumisu from Pixabay Giphy: The Chemical Brothers; PBS Digital Studios; http://www.gizmodo.com.au/2015/07/did-an-australian-university-just-say-wi-fi-gives-you-and-your-kids-cancer/; http://dynamicoceans.tumblr.com/post/99418047836/manta-ray-glittering-in-the-sunlight-despite Photo by Andres Siimon on Unsplash Tenor AAPS Cardiac cell beating courtesy of IGI Deputy Director Bruce Conklin Liquid Diving Adventures, https://www.liquiddivingadventures.com/blog/post/2020/11/27/socorro-islands-mexico-only-by-liveaboard

In Episode 3 of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe dive deep into the world of biotech with an exclusive interview featuring the esteemed Dr. Russ Weiner. As a senior-level biopharmaceutical professional with over 30 years of hands-on experience, Dr. Weiner shares invaluable insights into pharmaceutical and biologic drug discovery/development, clinical trial conduct, and project leadership. The episode unfolds with a detailed exploration of Dr. Weiner's impressive career, starting with his journey into the industry and an incredible success story in hospice care. The conversation transitions into the dynamic changes witnessed in the past three decades, particularly the pivotal shift into biologics. Dr. Weiner's experiences with large molecules, mass spec, and the challenges faced in the evolving CRO space are discussed. Key Highlights: **Podcast Episode 3 Tracks, Miraculous Cures: From Hospice to Survivor** 🔬 1:36 - Russ’ Bio: Delve into the professional journey of Dr. Russ Weiner, a senior-level biopharmaceutical professional with over 30 years of hands-on experience. 🌟 4:29 - What Got You into This Industry?: Uncover the motivations and inspirations that led Dr. Weiner to a distinguished career in the biotech industry. 🏥 6:29 - Hospice Success: Explore a noteworthy success story from Dr. Weiner's career, shedding light on the impact of his work. 🔄 8:08 - Changes in the Past 30 Years: Trace the dynamic changes in the biotech industry over the last three decades, with a spotlight on the significant move into biologics. 🌐 12:30 - Biggest Challenges in Biologics: Dr. Weiner discusses the current hurdles in biologics, including pre-analytics, training, and the logistics of sample handling. 🦠 16:00 - COVID's Impact on the Process: Gain insights into how the COVID pandemic has influenced the biotech process and its day-to-day operations. 🌦️ 19:20 - Weather's Effect on Science: Explore how weather conditions can impact scientific processes in biotech. 🤝 21:30 - Improved Communication: Dr. Weiner reflects on the enhanced communication between sponsor companies, CROs, and laboratories in the biotech ecosystem. 🏗️ 24:00 - Building Labs and Transformational Leadership: Uncover what drives Dr. Weiner's role as a builder of labs and a transformational leader, emphasizing his passion for both science and leadership. 👥 26:00 - Building Cohesive Lab Teams: Gain insights into Dr. Weiner's approach to building cohesive and successful lab teams. 🌟 29:37 - Success Tips for Young Leaders: Dr. Weiner shares valuable advice for aspiring young leaders on how to achieve success in the dynamic field of biotech. 🏢 32:40 - Russ’ Career at Takeda: Explore Dr. Weiner's impactful career at Takeda Oncology, touching on his experiences in a start-up-like environment and his strategies for supporting his team. 🎙️ **Subscribe for more exclusive content and in-depth conversations in the world of biotech! 🚀 #BiotechJourney #LeadershipStories #BioTalkUnzippedPodcast #biotechnology #pharmaceutical #science #interview #hospice

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device.

Chapters

02:26 Introduction to BioTalk Unzipped

03:40 Charity Spotlight: Americares

05:01 Dr. Alex Friedman's Career Journey

11:52 The Regulatory Landscape of Medical Device Classifications

18:52 Regulatory Gameshow!: Classifying Medical Devices

22:28 AI Enabled Software as a Medical Device: An Overview 

25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike

30:31 The Evolution of Wearable Health Technology

41:17 Liability and Risk in Medical Device Development

43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare

47:13 Self Updating AI Doctors?? - The Future of AI in Public Health

49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box

56:27 New News!! - The Intersection of AI, Regulation, and Innovation

01:07:28 Measuring Success in Life and Work

HOW TO REACH US:

Alex Friedman

https://www.linkedin.com/in/alexfriedman/ 

Alex’s Charity: Americares

https://www.americares.org/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device data

• https://www.accessnewswire.com/newsroom/en/computers-technology-and-internet/new-ai-powered-mobile-app-delivers-early-prediction-of-heart-attack-or-stroke-944424
• 
  
• 
  

New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech

• https://www.fiercebiotech.com/medtech/2025-forecast-how-will-ai-regulators-and-government-intersect
• 
  
• 
  

Mentioned in the podcast:

Concussion Mouthguard Sensors:

SISU Sense - https://www.sisuguard.com/sisusense/ 

HIT-IQ - https://www.hitiq.com/smart-mouthguard 

Prevent Biometrics - https://preventbiometrics.com/ 

IDX-DR - Diagnosing Software

https://www.healthvisors.com/en/idx-dr/ 

Sound Bites

"The common thread is the science."

"Regulatory has to catch up."

"You can't sell snake oil."

"It's a multidisciplinary effort."

"Software as a medical device is a hot thing."

Image Credits:

Aliens - 

https://www.reddit.com/r/LV426/comments/9i8omb/mildly_disappointing_according_to_the_viewscreens/

https://filmmusiccentral.com/2018/10/16/my-thoughts-on-aliens-1986/

keywords

medical devices, regulatory affairs, FDA, bioengineering, clinical decision support, AI in healthcare, Americares, healthcare innovation, medical technology, software as a medical device, AI in healthcare, regulatory challenges, wearable technology, health apps, FDA regulations, medical device liability, cardiovascular health, quality management system, innovative health solutions, AI, healthcare, clinical decision support, FDA regulations, public health, adaptive software, medical devices, innovation, technology, regulatory affairs

Welcome to another engaging episode of "BioTalk Unzipped" – the podcast where we unravel the fascinating world of biotechnology and drug discovery and unzip the stories behind medical progress. In Episode 2, we delve into the heart of the matter, exploring the new and painful challenges faced in the realm of drug discovery and development, as well as examining the public's perception of this critical science.  Gregory makes a declarative statement about science.

Join our insightful co-host, Chad Briscoe, as he and Gregory discuss the exciting possibilities surrounding the use of AI in drug discovery and development. Discover how cutting-edge technology is transforming the landscape. Gain unique insights into the passion that drives scientists striving to create new medicines that could change lives.

But that's not all – in this episode, we bring you an intimate conversation with Gregory, a seasoned professional in the industry. Gregory shares his personal journey that led him into the heart of the pharmaceutical and biotechnology industries.. 

Get ready to embark on a journey through the triumphs, trials, and transformative power of science. Tune in to "BioTalk Unzipped" Episode 2 for a captivating exploration of the pain points, the promise of AI, and the dedicated individuals shaping the future of drug discovery.  This podcast is for scientists and non-scientists alike!

0:56 - Chad Briscoe’s take on one of the greatest challenges to drug discovery/development.

5:41 - A declaration about science.

10:02 - Use of AI in biopharmaceutical science.

15:17 - How AI is affecting education and learning.

16:57 - Swifties and science.

17:42 - What drives scientists in medical progress.

20:18 - Gregory’s story about his journey into biotech and pharma.

**Resources:**

Explore more about The Boston Society, APA - Applied Pharmaceutical Analysis: https://www.bostonsociety.org 

Tom Shull on LinkedIn: https://www.linkedin.com/in/tomshull/

Don't miss our future episodes, dropping on the 1st and 15th of each month. Next month, we're bringing in industry leaders with fascinating stories. Thanks for tuning in to "BioTalk Unzipped" – your go-to podcast for a blend of knowledge and entertainment in the world of biochemistry. See you soon!

#biotechnology⁠ ⁠#pharmaceutical⁠ ⁠#science⁠ ⁠#drugdevelopment⁠ ⁠#drugdiscovery #research

Dr. Chad Briscoe Unveils the Vision - When Bar Conversations Meet Scientific Breakthroughs. Bringing great pharmaceutical science to the people in a light, fun, and inspirational manner.

⁠#biotechnology⁠ ⁠#pharmaceutical⁠ ⁠#science⁠ ⁠#drugdevelopment⁠ ⁠#drugdiscovery⁠

#research

Welcome to the premiere of BioTalk Unzipped, the podcast where the complex world of biotechnology gets unzipped by your hosts, Gregory Austin and Dr. Chad Briscoe. In this inaugural episode, we invite you to pull up a virtual chair and join us in an enlightening conversation that transcends the boundaries of traditional scientific discussions.

What's on the Table?

Discover the pulse of the biotech industry as we dive into the latest headlines and unravel the stories shaping the future. Gregory and Dr. Chad bring their unique perspectives to the table, shedding light on the trends and surprises that define the ever-evolving landscape of biotechnology. Meet Gregory and Chad and get a feel for their backgrounds and careers.

Facing the Unknown: When Biotech Companies Fail

Explore the candid dialogue as we navigate the often uncharted territory of failure in biotech companies. What happens when the best-laid plans go awry? How do setbacks contribute to the industry's overall resilience? Join us as we share insights, lessons learned, and the silver linings that emerge from the challenges.

Behind the Curtain: Dr. Chad Briscoe's Biotech Revelations

Join us as we delve into the riveting world of biotech surprises with none other than our co-host, Dr. Chad Briscoe. In this episode, Dr. Briscoe unveils the moments in his distinguished career that left him utterly surprised.

Blueprints for Success: Navigating the Scientist's Journey

Ever wondered what it takes to be a successful scientist in the fast-paced world of biotech? Gregory and Dr. Chad pull back the curtain on their own experiences, offering valuable insights, tips, and strategies for aspiring scientists. Whether you're a seasoned professional or just starting your journey, this episode is a compass for success in the field.

Join the Conversation

BioTalk Unzipped isn't just a podcast; it's an invitation to join a community of curious minds passionate about biotechnology. Engage with us as we unravel the complexities, share stories, and explore the fascinating intersection of great science and life.

Tune in to the BioTalk Unzipped Premiere and embark on a journey through the realms of biotech that goes beyond the ordinary. Don't miss out on the conversation - because the future of biotechnology is unzipped here!

To connect with the Cohosts directly, visit their LinkedIn pages:

Gregory Austin - https://www.linkedin.com/in/gregoryaustin1/ 

Dr. Chad Briscoe - https://www.linkedin.com/in/chadbriscoe/
To see Gregory Austin’s book, “Stellar Resume Writing: Secrets From a Corporate Recruiter”, visit Amazon: https://www.amazon.com/dp/B07NTK6RG2

#biotechnology #pharmaceutical #science #drugdevelopment #drugdiscovery

#research

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe continue their conversation with Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. They discuss the challenges and opportunities presented by new technologies, particularly in drug development and patient engagement. The conversation highlights the evolution of pharmaceuticals, and the potential of virtual clinical trials. In this conversation, Nathan Teuscher discusses the importance of optimizing drug dosages in oncology, the challenges faced in cell therapy, and the complexities of treating immunocompromised patients. He emphasizes the need for collaboration in the scientific community and shares his perspective on measuring success in life and career. Additionally, Nathan talks about his podcast, Clinical Pharmacology (https://creators.spotify.com/pod/show/clinical-pharmacology), which aims to educate listeners on clinical pharmacology and related topics.

Chapters

00:51 The Changing Landscape of Pharmaceuticals

03:49 Virtual Clinical Trials and Patient Engagement

08:06 Optimizing Drug Dosage in Oncology

10:55 New News! - FDA Approvals (Mesoblast) and Challenges in Cell Therapy

14:26 The Complexities of Cell Therapy

17:33 Navigating Immunocompromised States in Treatment

20:09 Advice to Young Scientists in Biopharma 

23:04 Defining Success in Life and Career

24:47 The Purpose and Impact of Nathan's Podcast, Clinical Pharmacology

HOW TO REACH US:

Nathan Teuscher

https://www.linkedin.com/in/nathanteuscher/ 

Aplos Analytics - https://aplosanalytics.com/ 

Email: nathan@aplosanalytics.com

Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast

https://teuschersolutions.com/ 

Collaboration with BioTalk Unzipped (Ep. 40)

https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 

Podcast (on Spotify): https://creators.spotify.com/pod/show/clinical-pharmacology

Podcast (on Apple): https://podcasts.apple.com/us/podcast/clinical-pharmacology-podcast-with-nathan-teuscher/id1695617234

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Takeaways

Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics.

Virtual clinical trials can enhance patient engagement and diversity in research.

Finding the right dosage is a critical challenge in drug development.

Project Optimus aims to redefine oncology drug development practices.

AI and data analysis can help identify ideal candidates for clinical trials.

Ethical considerations are paramount in the use of patient data for research. The right dose for each patient varies significantly.

Understanding individual immune system capacities is crucial in treatment.

Collaboration is key to success in the scientific community.

Success is measured by the happiness of loved ones.

Finding joy in helping others is essential for career fulfillment.

Podcasts serve as valuable educational resources.

Engaging with diverse disciplines enhances scientific understanding.

Sound Bites

“If you want to be successful, seek first to understand, then be understood.”

“If you’re looking to help people and in collaboration, you’ll be successful.”

“Success in life is the happiness of loved ones around you.”

New News Story: 

After two rejections, FDA approves Mesoblast's first-of-its-kind cell therapy

https://www.fiercepharma.com/pharma/fda-nod-gvhd-cell-therapy-gives-australian-biotech-mesoblast

keywords

BioTalk, pharmacology, AI in pharma, drug development, Nathan Teuscher, pharmacometrics, virtual clinical trials, clinical research, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

In this episode of BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe welcome Dr. Nathan Teuscher, a seasoned expert in clinical pharmacology and pharmacometrics. The conversation explores Nathan's career journey, the innovative charity Light the World, and the transformative role of AI in drug development. They discuss the challenges and opportunities presented by AI, particularly in automating data analysis and rethinking traditional reporting methods in the pharmaceutical industry. The episode emphasizes the potential for small companies to leverage cloud-based tools and APIs to enhance efficiency and drive innovation in drug development. In this conversation, the speakers explore the intersection of data analysis, AI tools, and advancements in gene editing with organ transplants.

Chapters

00:00 Episode Preview

00:55 Introduction to BioTalk Unzipped

02:06 Charity Spotlight: Light of the World

04:51 Nathan Teuscher's Career Journey

07:34 Differentiating AI Types in Life Science

12:41 Challenges with Large Language Models

15:39 Rethinking Reporting in Pharma

17:56 The Future of AI and Analytics in Pharma?

18:52 Leveraging APIs (Application Programming Interfaces) for Small Companies

23:05 Leveraging Data, AI, and APIs in 3 Dimensions

26:22 NEW NEWS! - Gene Editing Breakthroughs in Medicine

How to reach us:

Light the World Charity - Church of Jesus Christ Latter Day Saints

https://www.churchofjesuschrist.org/comeuntochrist/light-the-world 

Nathan Teuscher

https://www.linkedin.com/in/nathanteuscher/ 

Aplos Analytics - https://aplosanalytics.com/ 

Nathan Teuscher’s Podcast: Clinical Pharmacology Podcast

https://teuschersolutions.com/ 

Collaboration with BioTalk Unzipped (Ep. 40)

https://podcasts.apple.com/us/podcast/collaboration-with-biotalk-unzipped-ep-40/id1695617234?i=1000682122951 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Sound Bites

"We don't need to write reports anymore."

Takeaways

• Nathan Teuscher has over 20 years of experience in clinical pharmacology and pharmacometrics.
• 
  
• Light the World charity offers unique giving machines for donations.
• 
  
• AI can automate repetitive tasks in drug development, freeing up human capital for innovation.
• 
  
• There are two types of AI: large language models and automated data analysis.
• 
  
• Large language models can be unreliable in scientific contexts.
• 
  
• Pharmaceutical companies spend significant resources on report writing, which may not add value.
• 
  
• Small companies can leverage APIs to access standardized calculations and data analysis.
• 
  
• The pharmaceutical industry is often insular, limiting the potential of AI.
• 
  
• AI could potentially eliminate the need for extensive written reports in drug development.
• 
  
• Collaboration and data sharing are crucial for advancing AI in the pharmaceutical industry. Leveraging data effectively requires combining various data sets and tools.
• 
  
• The evolution of AI tools is crucial for navigating new technologies.
• 
  
• Gene editing represents a significant breakthrough in organ transplantation.
• 
  
• 
  

New News Story: 

• A woman in the US is the third person to receive a gene-edited pig kidney
• 
  
• 
  
• https://www.technologyreview.com/2024/12/17/1108905/a-woman-in-the-us-is-the-third-person-to-receive-a-gene-edited-pig-kidney/
• 
  
• 
  
• 
  

Image Credits

• Pig Kidney, https://ny1.com/nyc/all-boroughs/news/2023/08/16/pig-kidney-works-in-a-donated-body-for-over-a-month--a-step-toward-animal-human-transplants 
• 
  
• 
  

Keywords

BioTalk, pharmacology, AI in pharma, drug development, pharmacometrics, software development, clinical research, Light the World, charity, data analysis, AI tools, gene editing, kidney transplant, pharmaceuticals, virtual trials, healthcare innovation, drug development, patient engagement, medical technology, drug dosage, oncology, FDA approval, cell therapy, immunocompromised, collaboration, success, clinical pharmacology, podcast, healthcare

In this episode of BioTalk Unzipped, host Gregory Austin and co-host Chad Briscoe engage with Dr. Mark Arnold, a distinguished bioanalytical thought leader. They discuss the impact of recent FDA regulations on drug development, the importance of community support through the Samaritan Purse charity, especially on recent hurricane victims, and the exciting advancements in RNA editing technologies. The conversation highlights the collaborative nature of the pharmaceutical industry and the drive behind bioanalytical work, emphasizing the ultimate goal of delivering effective therapies to patients. 

Chapters

00:00 Introduction to BioTalk Unzipped at AAPS PharmSci 360

03:45 Samaritan's Purse Charity and Community Impact

05:16 Most impactful talk at AAPS?

11:50 Comparative Analysis of FDA and EU Regulations

17:37 The Drive Behind Bioanalytical Work

22:24 NEW NEWS! - Innovations in RNA Editing and Bioanalysis

Takeaways

• ​The FDA's new rules on lab-developed tests could delay biomarker utilization in clinical trials.
• ​Community support through charities like Samaritan's Purse is crucial during crises.
• ​The importance of collaboration in advancing drug development and bioanalytical methods.
• ​Innovations in RNA editing present new bioanalytical challenges.
• ​The drive to help patients is a key motivator for professionals in the field.
• ​

Sound Bites

• ​"I worked on that drug and there's a clear benefit."
• ​"It's getting that new therapy to a patient."
• ​"This is going to change and potentially delay biomarkers."
• ​

New News Story: 

• ​Wave sees RNA editing validation in early trial results

◦https://www.biopharmadive.com/news/wave-rna-editing-aatd-first-trial-data/729981/ 

How to reach us:

Please donate to: Samaritan’s Purse

https://www.samaritanspurse.org/ 

Mark Arnold

https://www.linkedin.com/in/markearnoldphd/ 

Blog - https://bioanalysisandbiomarkers.blogspot.com/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Image Credits

• ​AAPS

BioTalk Unzipped, hosts Gregory Austin and Chad Briscoe engage with Dr. Tomas Helikar in an exciting discussion on the future of AI, digital twins, and personalized medicine. From mathematical models and immune system simulations to groundbreaking collaborations with the Department of Defense, this episode uncovers how digital twins have the potential to transform drug discovery and clinical trials. Don’t miss insights on the ethical challenges of data privacy, the promise of animal digital twins, and the latest AI breakthroughs like MIT’s Sparrow algorithm!

Chapters

01:00 How the mathematical models work. Normalization and Scaling in Computational Biology

07:55 Focus on the Immune System and Organ Models

09:05 Collaboration with the Department of Defense

11:03 Drug Discovery and Digital Twins

13:43 NEW NEWS! - AI in Drug Discovery: The MIT Sparrow Algorithm

17:51 Future of Digital Twins in Clinical Trials

18:59 Personalized Medicine and Individualized Treatments

23:33 The Potential of Animal Digital Twins

24:59 Building a Research Infrastructure for Digital Twins

26:03 Privacy and Ownership of Digital Twin Data

30:14 Encouraging Publication and Literature Engagement

How to reach us:

Tomas Helikar

 https://www.linkedin.com/in/tomashelikar/ 

X - https://x.com/tomashelikar 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Sound Bites

"Publications are the currency in academia."

New News Story: 

• MIT’s SPARROW Redefines Drug Discovery With Smart Synthesis

• https://scitechdaily.com/mits-sparrow-redefines-drug-discovery-with-smart-synthesis/
  

Image Credits

• MIT Molecule, https://news.mit.edu/topic/algorithms?page=2 

Dr. Tomas Helikar, a leading researcher in bioinformatics and systems biology, delves into groundbreaking work on developing a personalized immune digital twin, which aims to revolutionize the understanding and treatment of immune-related diseases. 

Chapters

00:00 Introduction to BioTalk Unzipped

01:50 Meet Dr. Tomas Helikar

04:34 The Journey into Systems Biology

10:03 Understanding Digital Twins in Immunology

14:19 The Importance of Personalized Medicine

17:20 Digital Twin Research Funding and Its Impact

18:38 The Role of Digital Twins in Disease Management

21:11 Digital Twin Efforts for Organ Transplants

24:05 Computational Challenges in Modeling

26:36 Mathematical Models in Biological Research

28:11 - NEW NEWS! - Twist Joins Absci in AI Antibody Collaboration

How to reach us:

Tomas Helikar

 https://www.linkedin.com/in/tomashelikar/ 

X - https://x.com/tomashelikar 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

Charity Mentioned: https://saintpeterlincoln.com/school 

FOLLOW ►

LinkedIn: https://www.linkedin.com/company/biotalk-unzipped

Twitter: https://x.com/BiotalkUnzipped

Instagram: https://www.instagram.com/biotalkunzipped/ 

Takeaways

• Dr. Helikar's research focuses on the immune system's network and disease.
• Systems biology integrates computer science and biology for better understanding.
• Digital twins can provide personalized models for immune system analysis.
• Your digital twin model could tell you how you might respond to a particular disease and if you really need to go to the hospital.
• The immune digital twin reflects an individual's unique immune baseline.
• Research funding is crucial for advancing innovative medical technologies.
• Personalized medicine can improve public health outcomes significantly.
• Computational power is essential for processing complex biological data.
• Mathematical models are vital for simulating biological processes.
• Digital twins can enhance drug discovery and clinical trial efficiency.

Sound Bites

"The immune system is a network of networks."

“Each of our immune system baselines are different.”

"We need to build out this multi-scale model."

New News Story: 

• Supplier-Turned-Partner: Twist Joins Absci in AI Antibody Collaboration

• https://www.genengnews.com/topics/drug-discovery/supplier-turned-partner-twist-joins-absci-in-ai-antibody-collaboration/

  
  

Image Credits

• Signal Transduction, www.scientificanimations.com - http://www.scientificanimations.com/wiki-images/

• Computational Model, https://computationstructures.org/notes/models/notes.html 

• Holland computer center, https://newsroom.unl.edu/announce/cse/16380/90600 

• https://news.unl.edu/article/husker-football-game-day-information-announced-for-2023

• https://hcc.unl.edu/office-locations

Dr. Mark Arnold, a distinguished bioanalytical thought leader with an impressive track record in supporting drug development programs. Mark is the Owner and Principal at Bioanalytical Solution Integration, where he provides strategic counsel on complex bioanalytical assays and regulatory compliance. With over 35  years of experience, including leadership roles at BMS and Labcorp, Mark has become a key figure in the biotech and pharma industries. He is also an AAPS Fellow and a founder of the Global Bioanalysis Consortium. 

01:05 - Career Reflections and Contributions to Drug Development

05:28 - Understanding the Integration of Drug Development

09:30 - What Would You Change? Embracing Career Risks in Pharma

11:32 - Navigating Career Paths: Small vs. Large Companies

16:09 - NEW NEWS! - Can Electrical Fields Disrupt Cancer?

23:28 - The Role of AI in Drug Development

31:13 - Encouraging Innovation in a Regulated Industry

Follow Mark, Chad and Gregory:

Please donate to: Samaritan’s Purse

https://www.samaritanspurse.org/ 

Mark Arnold - https://www.linkedin.com/in/markearnoldphd/ 

Blog - https://bioanalysisandbiomarkers.blogspot.com/ 

Dr. Chad Briscoe - https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin - https://www.linkedin.com/in/gregoryaustin1/ 

ECI - https://eci-rx.com / 

BioTalk Unzipped on LinkedIn - https://www.linkedin.com/company/biotalk-unzipped/ 

New News Story: 

• Novocure wins FDA approval for electric field device in lung cancer

• https://www.biopharmadive.com/news/novocure-fda-lung-cancer-approval-optune-lua-tumor-treating-field/729997

  
  

Two articles on finding 1000’s of dark matter RNA viruses:  

• https://www.fiercebiotech.com/research/deep-learning-ai-model-scans-dark-matter-genomic-data-and-finds-70000-never-seen-rna

• https://www.nature.com/articles/d41586-024-03320-6

  
  

Image Credits

• Novocure images courtesy of Novocure: www.novocure.com 

In this powerful episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Katrina Rogers, a 25-year life sciences veteran, biotech equity advocate, and founder of Evergreen Bioscience Innovation and Katrina Rogers Consulting. Katrina shares her compelling journey from Pfizer to pioneering innovation ecosystems and mentoring underrepresented biotech founders. They unpack the role of board governance, the funding gap for female founders, and how "showing your science" is critical for regulatory success. Katrina also warns of dangerous gaps in understanding between regulators and innovators and why we must protect our basic science infrastructure. If you've ever dreamed of launching a breakthrough therapy, leading a biotech, or making your idea count, this episode is for you.

00:00 Episode Preview & BioTalk Unzipped Introduction

03:09 Katrina’s Charity Highlight: 2nd Harvest (link below)

04:04 Defining Moment in Life Science

05:35 Launching a Consultancy: Overcoming Fears

07:12 Leadership Lessons

09:30 The Importance of Board Composition

13:08 NEW NEWS: The Case for Female Founders

18:04 Knowledge Gaps Between Founders and Regulators

20:23 The Impact of Regulatory Changes

21:32 The Direct Attack on Basic Scientific Infrastructure

25:57 Understanding Market Needs

29:36 The Role of Founders in Leadership and Navigating Leadership Challenges

34:00 The Most Common Mistake by Biotech Founders & What To Do

35:27 Katrina’s Scope & Delivering Unpleasant News

36:51 NEW NEWS: Understanding Tariffs and Drug Pricing

42:23 Empowering Big Ideas

45:26 Overcoming Systemic Barriers

47:24 Advice to My Younger Self

49:38 Proposing Changes to FDA Innovation Pathways

54:54 The Future of Innovation in Biotechnology

Katrina Rogers

https://www.linkedin.com/in/katrinarogers/ 

https://krogersconsulting.com/ 

Katrina’s Favorite Charity: 2nd Harvest (Food Bank) - https://2-harvest.org/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

NEW NEWS

Biotech a Bright Spot for Female Founders Amid DEI Pullback, https://www.biospace.com/business/biotech-a-bright-spot-for-female-founders-amid-dei-pullback?utm_source=chatgpt.com 

Trump signals shift in drug import tariff policy

https://www.techtarget.com/pharmalifesciences/news/366622459/Trump-signals-shift-in-drug-import-tariff-policy 

Quotables

"The world needs your big idea."

"Build trust and that will engender loyalty."

"You need to have a board already established."

"Show them your science."

"Be Specific and people can be incredibly generous with their time."

"Tariffs are incredibly blunt economic instruments."

"You should at least try to get it out there."

"Our culture has expectations that limit us."

"You have to drive that vision."

“Stop playing small - you’re meant for more.”

“Put the Visionaries with the Doers and you’re unstoppable!” 

• Founders should evaluate their board members early in the process.
• Female founders are underrepresented but show higher returns on investment.
• Understanding customer needs is crucial for product development.
• Regulatory changes can create knowledge gaps for founders.
• Basic science is essential for innovation in drug development.
• Leadership challenges often stem from board dynamics.
• Problem-solving tools can help founders navigate challenges. The most common mistake is not doing enough discovery research.
• Building a network is crucial for early-stage entrepreneurs.
• People are generous with their time if you’re super specific about your need!
• Delivering unpleasant news is part of being a problem solver.
• Tariffs can disrupt supply chains and raise drug prices.
• Leadership roles require proactive vision and engagement.
• Cultural expectations can limit innovation and self-worth.
• Anyone can be an innovator with the right support.
• The skilled technical workforce is vital for future innovation.
• Passion drives significant advancements in biotechnology.

In this special episode (#34) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin and Dr. Chad Briscoe sit down with AAPS President Dr. Russ Weiner for an unfiltered look inside AAPS NBC, at the state of rare disease research, the evolution of therapeutic modalities, and the human stories that drive scientific innovation.

From navigating the emotional weight of personal loss to watching his son experience the field firsthand, Russ shares not only his scientific insights but the heart behind his leadership. The conversation spans topics like the rising promise of AI diagnostics, challenges with biomarker sampling logistics, the role of CROs in rare disease trials, and the future of autologous vs. allogeneic therapies.

Dr. Weiner also offers an inspiring vision of industry collaboration, sharing how organizations like AAPS are becoming conduits for progress across low- and middle-income countries, underrepresented diseases, and emerging biotechnologies. Whether you're in the lab, the boardroom, or on the frontlines of clinical trials, this episode will reignite your sense of purpose in this field.

00:00 Preview & Intro

01:22 What is conference life like as AAPS President

02:27 Mentoring & Fatherhood at AAPS

03:54 Setting up the Meeting Season for AAPS

05:43 Life back in the Rare Disease Space - a Passion

10:58 The different costs of pharmaceutical & biotech research

12:59 The generosity of Rare Disease Patients

14:41 Dr. Chad Briscoe asks Russ what can we do to help advance Rare Disease efforts

19:57 Rare Disease conversations happening at AAPS and global reach

22:37 Broad use of new technologies, including Olink

24:10 Biggest change expected in Pharma in 10 years

Dr. Russ Weiner

https://www.linkedin.com/in/russellweiner/ 

AAPS - https://www.aaps.org/home 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

Takeaways:

• Treating rare diseases early is not only life-saving—it’s economically sound. Gene and cell therapies may carry high price tags, but they dramatically reduce long-term costs.
• The diagnostic delay for rare diseases—often 4 to 7 years—remains one of the biggest barriers to treatment. AI-powered diagnostics and data integration could change that.
• Dr. Russ Weiner shares how personal loss fueled his career in science and how mentoring the next generation, including his son, brings it full circle.
• The shift toward allogeneic cell therapies and in vivo CAR-T treatments will be key to driving down costs and increasing global accessibility.
• CROs must evolve: future-ready organizations will localize biomarker analysis and forge relationships with rare disease investigators to improve site performance.
• Technologies like Olink are revolutionizing biomarker discovery, enabling cost-effective, high-resolution multiplexing that was previously out of reach.
• Spatial imaging, AI pathology, and facial-recognition-based diagnosis are the next wave of precision medicine.

Quotes

“Treating rare disease isn’t just compassionate—it’s a smart investment. Do the math, and curing someone can be far cheaper than managing chronic care for a lifetime.”

“You can’t say it’s not in your backyard when that backyard becomes yours the moment you're on the same plane.”

(on global health and infectious disease risk)

“Some of the most generous people in clinical research are rare disease patients. They fight so no one else has to.”

“It took me six months to even scratch the surface of this portfolio—rare disease isn’t just rare, it’s overwhelmingly complex.”

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Binodh DeSilva, Senior Vice President of Bioanalysis at Ultragenyx Pharmaceutical, to explore the science and soul behind rare-disease drug development.

From her early days studying electrochemistry at the University of Kansas to leading cutting-edge bioanalytical programs at Ultragenyx, Dr. DeSilva shares how curiosity and community shaped her four-decade career. She discusses the profound responsibility of working with limited, often irreplaceable patient samples with care.

A special thanks to AAPS (https://www.aaps.org/) for their help and support of this episode.

The conversation dives into:

• Balancing rigor and agility in small-population clinical studies
• Leveraging entrepreneurial mindsets from biotech within big pharma frameworks
• The promise of dried blood spots (DBS) and patient-centric sampling
• Mentorship, curiosity, and the future of scientific leadership
• Her return to Sri Lanka with KU faculty to recruit the next generation of scientists

Throughout the discussion, DeSilva underscores a recurring theme: science thrives when curiosity meets compassion. This episode is a masterclass in both.

Guest Links

Dr. Binodh DeSilva

https://www.linkedin.com/in/binodh-desilva/

Ultragenyx Pharmaceuticals - https://www.ultragenyx.com/ 

Hosts

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

Keywords: BioTalk Unzipped, Binodh DeSilva, Ultragenyx, rare disease research, bioanalysis, dynamic drug development, dried blood spots, DBS sampling, biologics, AAPS NBC 2025, Gregory Austin, Chad Briscoe, Celerion, scientific leadership, mentorship in science, biopharma innovation, curiosity in research, Sri Lanka scientists, analytical chemistry, pharma innovation, drug development ethics.

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe interview Asst. Professor Pin-Kuang Lai from Stevens Institute of Technology about his keynote speech at AAPS NBC 2025 and the intersection of AI and molecular engineering, particularly in predicting the viscosity of monoclonal antibodies. They discuss the challenges of high concentration formulations, the importance of AI validation, and the future of formulation development. Lai shares insights from his international research journey and collaborations with pharmaceutical companies, as well as opportunities for students interested in this field.

00:00 Preview & Intro

01:58 Deep Viscosity and AI in Antibody Development

04:39 AI Validation and Model Reliability

07:12 International Journey and Collaborative Research

08:42 Future of Formulation Development

10:30 AAPS NBC Experience

11:30 Academic vs. Industry Career Paths

12:31 Collaboration with Pharmaceutical Companies

13:59 Modeling Protein Aggregation Challenges

14:43 Student Engagement and Research Opportunities

15:45 Expanding Applications of Machine Learning

Dr. Pin-Kuang Lai

https://www.linkedin.com/in/pin-kuang-lai/

Stevens Institute of Technology - https://www.stevens.edu/

Dr. Lai’s Publications - https://www.linkedin.com/in/pin-kuang-lai/details/publications/

The DeepViscosity Model - https://devpred.onrender.com/DeepViscosity

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Celerion - https://www.celerion.com/

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

Celerion - https://www.celerion.com/

In this powerful episode (#35) of BioTalk Unzipped, recorded live at the AAPS NBC conference in Boston, Gregory Austin engages in a deep conversation with a leading Neuroscientist, Dr. Robert Thorne, Denali Fellow at Denali Therapeutics, for an intimate and scientific deep dive into the evolving world of brain cancer treatment and CNS drug delivery. Both Gregory and Dr. Thorne share personal stories of losing family members to brain metastases, weaving in the emotional 'why' behind their professional paths.

Dr. Thorne highlights the complexities of the blood-brain barrier, the heterogeneity of brain metastases, and cutting-edge delivery technologies—including focused ultrasound and molecular engineering approaches. The conversation also touches on pediatric brain tumors like diffuse midline glioma (DIPG), emerging research in lysosomal storage diseases, and the collaborative spirit driving innovation in neuroscience today.

This is more than a technical discussion—it’s a human story about grief, hope, and the relentless pursuit of better outcomes for patients with brain diseases.

00:00 Preview & Intro

01:10 Robert Thorne’s Reflections on the AAPS NBC conference

03:14 The Professional Biotech and Pharma League

05:09 A Personal Story Shared: Family Loss to Brain Cancer

07:57 My Reason for Optimism Treating Brain Cancer

08:50 Why Brain Metastases Remain Hard to Treat

11:10 Scientific Advances in Drug Delivery for Brain Cancer

12:30 Seed and Soil Concept in Oncology

15:18 Pediatric Brain Tumors: DNET, DIPG, and Beyond

16:49 Looking Ahead: Hope for Future Therapies

21:32 Closing Gratitude

Dr. Robert Thorne

https://www.linkedin.com/in/robert-g-thorne/

Denali Therapeutics - https://www.denalitherapeutics.com/ 

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/ 

Celerion - https://www.celerion.com/  

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/ 

Celerion - https://www.celerion.com/  

• Personal Connection Fuels Professional Passion: Both Gregory and Dr. Thorne were driven into the life sciences field by family experiences with brain tumors.

• The Blood-Brain Barrier (BBB) Remains a Major Challenge: Brain metastases from cancers like melanoma, lung, and breast cancer still present difficult delivery barriers for therapies.

• Heterogeneity in Brain Mets: Different metastases within the same patient can have vastly different BBB permeability, requiring multifaceted delivery strategies.

• Emerging Drug Delivery Innovations: Focused ultrasound, engineered biologics, and Denali’s own delivery platforms are all promising ways to improve CNS drug penetration.

• Pediatric Brain Cancers Present a Unique Set of Challenges: Diseases like diffuse midline glioma (DIPG) remain largely untreatable, but learnings from lysosomal storage disorders may translate in the future.

• The Power of Community in Science: The conference setting highlights how collaboration and diverse perspectives drive breakthroughs in bioanalysis and drug development.

In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe sit down with Glafabra CEO: Dr. Chris Hopkins, geneticist, biochemist, and biotech entrepreneur, to explore the science and strategy behind next generation cell-based gene therapies for rare diseases.

With more than 25 years of experience spanning gene augmentation, rare disease biology, CRISPR licensing, and biotech formation, Dr. Hopkins shares how autologous, ex vivo engineered cell therapies may overcome key limitations of current enzyme replacement and viral gene therapies, particularly for Fabry disease.

The conversation dives deep into:

• How lentiviral gene augmentation in patient derived cells enables sustained enzyme production

• Why redosing matters and where one time AAV therapies fall short

• The scientific rationale for early intervention, including potential newborn treatment

• Differences between autologous and emerging allogeneic approaches

• Regulatory pathways for rare disease therapies and recent FDA developments

• The role of non animal models in translational research

• Montana’s early access therapy law and its broader implications

• Building biotech platforms amid a challenging funding environment

Topics include cell based gene therapy, Fabry disease, lentiviral vectors, stem cell engineering, rare disease drug development, regulatory science, and translational medicine.

Subscribe to BioTalk Unzipped for in depth conversations with the scientists and leaders shaping the future of biomedical innovation.

00:00 - Intro

00:53 – Welcome to BioTalk Unzipped, Guest intro: Dr. Chris Hopkins

02:10 – Guest charity: Environmental Defense Fund

03:12 – His journey into rare-disease therapeutics and Glafabra

05:58 – Discovering a new enzyme-deficiency therapy

06:39 – Current standard of care

07:42 – How the new autologous cell therapy works

09:40 – Treating patients earlier (even newborns)

10:33 – Emerging therapies - AAV gene therapy vs. cell-based therapy

12:16 – Long-term results & repeat dosing

14:30 – Future plans: T-cells & allogeneic approaches

18:08 – New News: FDA resubmission for rare disease

20:00 – Navigating FDA pathways

22:06 – Non-animal testing & alternative models

25:50 – Montana’s early-access therapy law & medical tourism

29:03 – Could other states follow?

31:31 – Biotech’s current funding challenges

33:46 – New News: Gene therapy trial saves 4-year-old

37:09 – Long-term vision for expanding therapies

39:53 – Personal segment: outdoor life & skiing

44:43 – Guest question on international trade

Dr. Christopher Hopkins

https://www.linkedin.com/in/christopherehopkins/

Glafabra - https://www.glafabra.com/

Environmental Defense Fund - https://www.edf.org/

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Celerion - https://www.celerion.com/

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

Celerion - https://www.celerion.com/

New News Articles:

US FDA asks Stealth BioTherapeutics to resubmit application for rare genetic condition therapy

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-asks-stealth-biotherapeutics-resubmit-application-rare-genetic-condition-2025-05-29/

Gene therapy trial saves boy, 4, from 'death sentence'

https://www.thetimes.com/uk/healthcare/article/gene-therapy-trial-great-ormond-street-70l2sgqw

Montana, revolutionary law passed: unlimited research for longevity

https://en.ilsole24ore.com/art/montana-approved-revolutionary-law-researching-longevity-without-limits-AHmDI7BB?refresh_ce=1

#CellBasedGeneTherapy #RareDisease #FabryDisease #GeneAugmentation #LentiviralVectors #Biotech #TranslationalScience #GeneticMedicine #BioTalkUnzipped

https://youtu.be/VcPXZmK-XU8

Recorded October 31, 2025

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Kate Neville, immunologist turned seasoned biotech patent attorney at Marshall, Gerstein & Borun, to unpack one of the most misunderstood and mission-critical areas of life sciences: intellectual property.

If you are a biotech founder, scientist, executive, or investor, this conversation is essential listening.

We explore what patent prosecution really means, when startups should begin thinking about IP protection, how “freedom to operate” can determine commercial viability, and how emerging AI tools are reshaping the patent landscape.

Dr. Neville brings 25+ years of experience guiding university spin-outs, biotech startups, and global pharmaceutical companies through complex patent strategy. She has helped secure patents for FDA-approved drugs and offers a rare dual perspective as both scientist and attorney.

• The difference between patent prosecution and patent litigation

• Why it is never too early for biotech startups to think about IP

• The U.S. one-year grace period vs. Europe’s stricter disclosure rules

• What “Freedom to Operate” really means for commercialization

• Antibody patents, CDR regions, and the doctrine of equivalents

• How premature disclosure can impact global patent strategy

• The real-world back-and-forth of patent office “office actions”

• AI-assisted prior art search at the USPTO — opportunity or risk?

• How funding cycles influence patent filing decisions

• Women in biotech leadership and venture funding disparities

• The most rewarding part of protecting life-changing therapies

We also break down the USPTO’s new AI pilot programs designed to modernize patent examination and discuss how artificial intelligence may impact biotech patenting over the next several years.

Intellectual property is often the single most valuable asset in a biotech company.

Strong IP strategy can unlock funding, partnerships, and market exclusivity.

Weak or mistimed IP decisions can permanently limit global opportunity.

For founders and scientists: timing, geography, and disclosure discipline matter more than most people realize.

Dr. Kate Neville

Partner, Marshall, Gerstein & Borun

PhD in Immunology, JD

LinkedIn: https://www.linkedin.com/in/kate-neville-phd/

Firm Bio: https://www.marshallip.com/katherine-l-neville-ph-d/

Charity Highlight: Girls on the Run Chicago

An organization building confidence and resilience in young girls through mentorship and athletic achievement.

https://www.girlsontherun.org/

Dr. Chad Briscoe

Bioanalytical Scientific Leader

https://www.linkedin.com/in/chadbriscoe/

Gregory Austin

Director, Business Development | Bioanalysis

https://www.linkedin.com/in/gregoryaustin1/

If you enjoyed this episode, subscribe to BioTalk Unzipped on Apple Podcasts, Spotify, or your preferred platform and share with a colleague in biotech, pharma, or life sciences innovation.

Can artificial intelligence help make cancer therapies safer, more targeted, and more effective?

In this episode of BioTalk Unzipped, Gregory Austin sits down with Dr. Daniel Reker, Assistant Professor at Duke University, for a wide-ranging conversation on active machine learning, nanomedicine, drug delivery, and the future of AI in biomedical research.

This episode is brought to you by Leucentra.

Inspired by Science Empowered by IT

https://leucentra.com/

Dr. Reker works at the intersection of AI, chemistry, biomedical engineering, pharmacology, and molecular medicine. His lab develops computational and experimental approaches to better understand small molecules, nanoformulations, and drug delivery systems.

The conversation explores how machine learning can support drug discovery and development, especially in areas where datasets are small and the biology is complex. Dr. Reker explains why nanoformulations may be able to improve targeted drug delivery, reduce toxicity, and potentially revive therapeutic agents that previously failed because of safety or tolerability issues.

Gregory and Dr. Reker also discuss explainable AI, the risks of black box thinking, AI bias, predictive modeling, FDA considerations, non-animal models, and the responsible use of AI in education and science.

Topics include:

• Active machine learning in drug discovery

• AI and nanomedicine

• Cancer therapy and targeted drug delivery

• How nanoformulations may reduce toxicity

• Small datasets in biomedical AI

• Explainable AI and scientific trust

• AI bias and model limitations

• Regulatory implications for predictive models

• The role of AI in education and cognitive development

• The future of integrated data in drug development

Guest bio:

Dr. Daniel Reker is an Assistant Professor at Duke University. His research focuses on computational and experimental approaches to molecular medicine, including active machine learning, drug delivery, nanoformulations, small molecules, and translational pharmacology. He was named to Forbes 30 Under 30 Europe in Science and Healthcare.

Guest contact:

Dr. Daniel Reker

Email: daniel.reker@duke.edu

LinkedIn: https://www.linkedin.com/in/danielreker/

Duke website: https://rekerlab.pratt.duke.edu/

Connect with BioTalk Unzipped:

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

BioTalk Unzipped uncovers the stories behind medical progress through conversations with innovators across biotech, pharma, medtech, bioanalysis, clinical research, regulatory science, and drug development.

Why haven’t we cured cancer yet? A Genentech scientist explains the real reason.

In this episode of BioTalk Unzipped, Gregory Austin and Dr. Chad Briscoe sit down with Dr. Bob Liu, Senior Principal Scientist at Genentech Roche, to unpack one of the most important and misunderstood questions in modern medicine.

This is a rigorous, scientifically grounded conversation on cancer biology, immunotherapy, and the real constraints shaping oncology drug development today.

Dr. Liu brings over a decade of experience across antibody drug conjugates (ADCs), bispecific antibodies, and CAR-T therapies, offering a rare, insider perspective on why a universal cure remains elusive and where meaningful progress is actually being made.

Thanks to our Founding Sponsor:

LEUCENTRA: Helping teams evaluate, implement, and get real value from IT solutions that support innovation, not slow it down. https://leucentra.com/

1. Why cancer is not one disease, but more than 200 biologically distinct conditions
2. What “curing cancer” actually means in clinical oncology
3. How immunotherapies like checkpoint inhibitors and CAR-T are changing outcomes
4. The biological limits of eliminating every cancer cell
5. How tumors evade immune detection and adapt over time
6. Why only about 20% of patients respond to immuno-oncology therapies
7. The role of biomarkers, molecular profiling, and precision medicine
8. Why early detection remains one of the biggest unsolved challenges
9. The economic and regulatory pressures shaping next-generation therapies

Cancer is not simply something to eliminate.

It is a dynamic, adaptive system evolving within the human body. The future of oncology is not just eradication, but control, personalization, and intelligent engagement of the immune system.

“Cancer is a collection of more than 200 diseases, each requiring its own specific approach.”

“The cure for some cancers is within reach, but for many others, early detection remains the critical challenge.”

“Our immune system is constantly surveilling. The key is learning how to harness it effectively.”

00:00 – Introduction

02:42 – Bob’s passion - AACR

04:28 – Why we haven’t cured cancer

07:09 – Defining a cancer cure

10:26 – Cancer classification and molecular signatures

14:16 – Methylation profiling in diagnosis

17:22 – Patient resources and navigation

21:14 – FDA shifts toward randomized trials for CAR-T

24:15 – Cost and access challenges

26:33 – Cancer vs cardiovascular disease progress

33:39 – The challenge of early detection

37:48 – Biomarker limitations

39:14 – Immune system dynamics in cancer

45:19 – Bioanalytical challenges in modern therapies

51:08 – Progress and future outlook

Dr. Bob Liu is a Senior Principal Scientist at Genentech Roche specializing in bioanalytical sciences and immunogenicity assessment for advanced oncology therapies, including T-cell bispecifics and CAR-T.

FDA to tighten approval requirements for CAR-T therapies

https://www.raps.org/news-and-articles/news-articles/2025/12/fda-to-tighten-approval-requirements-for-car-t-cel

American Association for Cancer Research (AACR)

https://www.aacr.org/

National Cancer Institute – Molecular diagnostics and biomarkers

https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis

Pattern recognition technologies in diagnostics

https://toby.health

Dr. Bob Liu

https://www.linkedin.com/in/bob-liu-42b8b278/

Dr. Chad Briscoe

https://www.linkedin.com/in/chadbriscoe/

Gregory Austin

https://www.linkedin.com/in/gregoryaustin1/

The path to curing cancer is not a single breakthrough. It is a long, complex progression of scientific advances, better diagnostics, and deeper biological understanding.

The progress is real.

But the work is far from finished.