Summary:
In this podcast from the 2024 CRAACO: Clinical Research as a Care Option conference, Dr Meredith Zozus, UT Health San Antonio, walks through several studies illustrating differences in data quality and scalability using EHRs in the conduct of structured protoocls versus retrospective studies using EHR. The results highlight the important methods and approaches for using EHR data in clinicla studies, which is a key component of integrating care and research. 

For more information, go to CRAACOevent.com.

Summary:
This podcast delves into the critical challenges of scalability in T-cell therapies (including CAR-T, TILs, and TCR-T). The panelists discuss the primary obstacles hindering the increased availability of T-cell therapies to patients, the most promising upcoming approaches to enhance access, the greatest opportunities to improve efficiencies and scalability, and the developments in the near future that could help meet growing demand. 

For more information, go to IO360summit.com. 

This podcast features a panel discussion from the 2024 PODD Conference with pharma and biotech leaders about the technical innovation in the vaccine space within R&D over the past several years as well as the challenges and opportunities around the uptake and implementation of these technologies. Specifically:

• Barriers to implementation of technological advancements
• How the vaccine marketplace differs from other therapeutic marketplaces and the drivers of meaningful innovation in the space
• How to best develop and position innovative vaccine technologies for success
• Unmet needs and opportunities for vaccine technologies
• Exciting emerging technologies

To learn more about the PODD conference, please visit Drug-Delivery.org.

Moderated by: Axel Hoos, MD, PhD, CEO, Scorpion Therapeutics Panelists: Jonathan Fassberg, Vice Chairman of Healthcare Investment Banking, OppenheimerIrina Margine, PhD, Principal, Biotech Private Equity, Wellington ManagementAsthika Goonewardene, MBA, Managing Director, Senior Biotech Analyst, Truist SecuritiesGraig Suvannavejh, PhD, Managing Director, Equity Research Biopharmaceuticals & Biotechnology, Mizuho Securities USA Learn more about the IO360° Summit at www.io360summit.com

This panel, first recorded at the 2022 IO360° Summit addressed: What are the risks and implications of investing in cell/gene therapy companies who have no clinical data from programs available?Venture company perspectives on what they are investing in and why? • What science needs to be seen in order to invest in either a startup or IPO?What are investors/pharma partners looking for and how does that inform what people should be doing?How do we think about partnerships between organizations? Moderated by: Michael Polansky, CEO, Parker Group Panelists: Mark Bonyhadi, PhD, Senior Advisor, Qiming Venture PartnersElaine Cheung, SVP, Corporate Strategy & Business Development, Lyell ImmunopharmaArjun Goyal, MD, MPhil, MBA, Co-founder and Managing Director, Vida Ventures Learn more about the IO360° Summit at www.io360summit.com

In this session, first recorded at the 2022 IO360° Summit, Dr Semenza will talk about how his work is impacting cancer immunotherapy. Dr Semenza’s groundbreaking discovery of hypoxia-inducible factors paves the way for the development of drugs that could kill cancer cells by cutting off the oxygen supply tumors need to grow and improve the response to immunotherapies. Key areas addressed include: Regions of intratumoral hypoxia are a common feature of advanced cancersHypoxia-inducible factors increase the expression of multiple proteins that mediate immune evasionHIF inhibitors stimulate anti-tumor immunity and improve the response to immune checkpoint blockade Gregg Semenza, MD, PhD, Director, Vascular Program, Institute for Cell Engineering and Professor of Genetic Medicine, Johns Hopkins University School of Medicine Learn more about the IO360° Summit at www.io360summit.com

Neoadjuvant (pre-surgical) immune checkpoint blockade may prevent cancer relapse and progression.This treatment approach is now FDA-approved for resectable triple-negative breast cancer, and hundreds of clinical trials in other cancers are ongoing.Surgical resection specimens collected after several weeks of neoadjuvant ICB offer vast opportunities for predictive biomarker discovery and understanding ICB response/resistance. Suzanne Topalian, MD, Associate Director / Professor of Surgery, Bloomberg~Kimmel Institute for Cancer Immunotherapy / Johns Hopkins University Learn more about the IO360° Summit at www.io360summit.com

Nouhad Husseini, MBA, SVP, Business Development and Corporate Strategy, Regeneron Pharmaceuticals with Allan Shaw, CFO / Founder & Senior Managing Director, Portage Biotech / Shaw Strategic Capital, LLC Learn more about the IO360 Summit at www.io360summit.com

What is the impact of targeted radiotherapy on the immune system?What are the implications for combination IO?Current approaches and future direction Moderated by: Michael Groaning, PhD, Global Medical Affairs Lead, Genitourinary, Amgen Panelists: Charles Glaus, PhD, Sr Director, Radiomics & Radiology Biomarkers, Bayer US-PharmaceuticalsJeff Legos, PhD, MBA, EVP, Global Head of Oncology & Hematology Development , NovartisMatthew Silva, PhD, CEO , InvicroOhad Ilovich, PhD, Senior Director, Translational Sciences, Curie Therapeutics Learn more about the IO360° Summit at www.io360summit.com

Learn more about the IO360° Summit at www.io360summit.com

In this podcast, you will hear a keynote fireside discussion with Dr Robert Langer, MIT, and Dr Ester Caffarel-Salvador, Chiesi USA, from the 2022 PODD Conference regarding current projects in the Langer Lab, how COVID affected the lab’s dynamics and collaborations, challenges in the drug delivery space, and exciting technologies in the pipeline,  To learn more about the PODD Conference, please visit PODDConference.com.  

This panel, first recorded at the 2021 Immuno-Oncology 360° Summit, will bring together chinese biotechs to share how they are partnering with additional IO companies to advance cancer treatments for patients. This will include partnering strategies and decision making. To learn more about the IO360° Summit visit, www.io360summit.com

In this session, GSK shares how they delivered on patient and caregiver engagements, especially with communities experiencing the highest COVID burden. They gained insights on study designs, educational pieces and captured patient experiences to enhance HCP/public COVID awareness. GSK will discuss: Value of COVID engagements Novel approaches and mechanisms for finding patients who don’t belong to an organized patient community Overcoming challenges How this initiative could be modeled to help find future patients when the pathway is not clear Patient Perspectives-In their own words Susan Burriss, Patient Engagement Lead, GSK Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

Summary:
In this podcast, PALADIN Consortium Committee Co-Chairs, Deirdre BeVard of CSL and Dr Len Valentino of World Federation of Hemophilia USA, discuss how the pre-competitive group is creating resources aimed at enhancing and speeding up industry-patient advocacy collaborations. 

For more information on PharmaTalk Radio podcasts, you can go to theconferenceforum.org. For more information on patient engagement in clinical research, visit patientsaspartners.org. 

In this session, Janssen shares how they are collaboratively working with patients and sites to advance DCTs and will share engagement methodologies, what they have learned from the perspective of participants and sites, and the direction this has taken them in DCTs. Alyson Gregg, Director Patient Insights, GMA Commercial Operations, Janssen Morgan Wooten, Investigator & Patient Engagement Program Team Leader, Janssen Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

Merck’s iLab53 (a modular 39-foot mobile unit) was used to bring clinical research into community settings as an effort to increase clinical trial awareness and engagement. More specifically: How the iLab53 was created and implemented How Merck is continuing to work to help build trust within communities, and provide increased access to clinical research Challenges, learnings and successes to date How this initiative can be scaled and adapted Susan Manoff, MD, MPH, Executive Director, Office of the Chief Patient Officer, Merck Kai Bode, Director, Digital Innovation and Patient Strategy, Global Digital Analytics & Technologies Team, Merck Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this session, Sanofi shares how they created and implemented an end-to-end fully integrated patient informed R&D organization that works directly with patients as advisors in 100% of development staged programs from discovery and supporting research pipeline prioritization to registration. Key topics include: Aligning with the patient community’s most pressing needs Gaining insights that established clinical programs and studies and reshaped clinical trial designs and logistics Prioritizing early diversity & inclusion planning Generating patient relevant data that supports improved patient experience Victoria DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi R&D Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

In this podcast, you will hear a keynote presentation from Dr John Maraganore from the 2022 PODD Conference regarding lessons learned from his 19 years as CEO of Alnylam Pharmaceuticals, leading a team that conquered some very difficult drug delivery challenges.  To learn more about the PODD Conference, please visit PODDConference.com.  

Legal barriers exist for many good reasons, but can block our pathway in making the changes needed to help patients in the current climate. The panel addresses: Protocols that require approval from legal and complianceR&D and compliance, breaking down the silos and working jointly for patient needsHow to bring the patient voice to legal and compliance initiatives that impact patients?What are the next steps? What initiatives could legal/compliance be a part of with patient engagement to gain an understanding of the impact and urgency of their approvals? Led by: Marilyn Metcalf, PhD, Senior Director, Patient-Focused Development, Global Medical, GSK Panelists: Roslyn Schneider MD, VP, Scientific, Medical and Patient Affairs, Theravance Biopharma USParthena Psyllos, Senior Corporate Counsel, Clinical Development Legal, PfizerSue Gregory, Former Managing Counsel/Executive Director, GSKCandace Lerman, Patient Advocate and AttorneyKate Harr-Sponsler, Associate General Counsel – Global Commercial, Spark Therapeutics Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

Learn more about the IO360° Summit at www.io360summit.com

In this session recorded at DPHARM 2021, Merck shares about their proprietary Site Monitoring and Reporting Tool (SMART), an iOS Apple iPad technology that enables “monitoring and deviation management” before, during and after COVID-19. Merck talks about how they got SMART. Merck developed a real-time “scorecard” for sites called Site Health Check, which allows them to see how they are performing in absolute and relative terms compared to other sites. Merck addresses how this really helped in COVID-19. Merck has engaged in project RESTART to help sites and to lock databases (~300 locked in 2020 and none missed in 2020 and 2021). Merck shares with the DPHARM audience how this worked.  Speakers Andrew Onikepe, Director, Monitoring Excellence – North America, Global Clinical Trial Operations (GCTO), MerckMerle Schneider, Director, Monitoring Excellence Innovation, MerckKatherine Taylor, MBA, Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck

In this session from DPHARM 2021, Gilead shares how they designed, developed and obtained Emergency Use Authorization and Full Approval for Remdesivir for the treatment of COVID-19 in record time. Key topics: How they built new capabilities at an extremely accelerated pace to design and execute the remdesivir trialsThe role of Real World Data (RWD) in remdesivir trials to understand the natural history of the disease, to inform study design and conduct, and support real world effectivenessManaging compassionate use programs and communicating with regulators at the peak of the global pandemicLessons learned and the impact on other therapeutic areas Speakers: Matthew Bryant, MBA, Head of Technology & Innovation Global Development and Clinical Operations, Gilead SciencesAnand Chokkalingam, PhD, Senior Director, Clinical Research, Gilead SciencesHassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

In this podcast, you will hear a presentation with Peter Skutnik, BD Medical-Pharmaceutical Systems and Wendy D Woodley, BD Technologies & Innovation, from the 2022 PODD Conference regarding challenges in combination product development, patient-centric device development considerations, as well as case studies in large volume subcutaneous formulations. To learn more about the PODD Conference, please visit PODDConference.com.  

In this session from DPHARM 2021, Regeneron's Bari Kowal sits down with Craig Lipset to discuss: Driving greater efficiencies in a pandemicA fresh look at solving problemsPrioritizing priorities Speakers: Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management, RegeneronCraig Lipset, Advisor and Founder, Clinical Innovation Partners

CMOs play a critical role in ensuring activities prior to approval lead to a successful launch. In this podcast, originally recorded as a session at the 2024 CMO Summit 360°, panelists discuss the role of the CMO in preparing for a new product launch, including planning, timing, activities and hiring prior to PDUFA, including:

• The timing and strategy of building out medical affairs
• Strategic imperatives to achieve launch readiness
• Collaborating with your Chief Commercial Officer leading up to and after drug approval
• Managing the transition from development to commercial organization

To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

In this session recorded at DPHARM 2022, Memorial Sloan Kettering Cancer Center shares about their Connected Care protocol. Digital monitoring of patients has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimized engagement across the cancer continuum. Remote monitoring is especially crucial when patients are at high risk for experiencing symptoms or toxicities from treatment. During these episodes, patients and clinicians benefit from routine assessments of electronic patient-reported outcomes (ePROs) to identify symptoms early and prevent adverse outcomes. The Connected Care protocol provides remote monitoring to medical oncology patients for 10-days post hospital discharge as this is a high-risk period for patients due to a lingering symptom burden and a need for enhanced patient-clinician communication as symptom management shifts from the inpatient to outpatient team. Specifically, Dr. Daly will discuss: The feasibility and acceptability of remote monitoring in the post discharge setting for patients with cancerPatient perspectives for remote monitoring post hospital dischargeePRO versus device and challenges with implementationThoughts on the right data to collect and at what intervals Speaker: Robert Daly, MD, MBA, Assistant Attending Medical Oncologist, Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center

In this session recorded at DPHARM 2022, panelists from Pfizer discuss: Understanding the key steps Pfizer is taking to make remote clinical trials a reality for patientsExploring the cross functional team approach to scaling remote clinical trials across all therapeutic areasExamining the impact of adopting the light speed mindsetReviewing the key learnings and what the voice of the patient data reveals to date Speakers: Tim Joy, Executive Director, Head of Strategic Solutions, PfizerDaniela Graham, Clinician, Pfizer

This session was recorded at DPHARM 2022. As the life sciences industry’s focus on digital transformation advances at a rapid pace, the opportunity to understand how well your organization stacks up to the rest of the industry around digital maturity in clinical operations can be highly valuable. This session examines a new benchmarking effort to help pharmaceutical companies rank their digital capabilities in clinical operations, codify specific terms that are used readily and leverage insights to drive strategic priorities. Specifically, this session will: Discuss the study purpose, methodology and areas being ranked for digital readinessExamine the value for companies participatingConsider how the study with greater industry participation could evolve into an innovation index and generate industry digital maturity metrics Moderated by: Craig Lipset, MBA, Founder, Clinical Innovation Partners Speakers: Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMSTim Joy Executive Director, Head of Strategic Solutions, PfizerAman Thukral, Head of Digital Operations and Clinical Systems, AbbVieBrandon Maggio, Director, Digital & Process Optimization, GSK

This is a session recorded from DPHARM 2022. As the competition to recruit patients for clinical trials increases and sites are burdened by staffing shortages, technology shifts and more, how can innovative trial designs reduce patient, site and investigator burden? Designing for patient centricity – reducing the burden for patients, sites and investigatorsAddressing organizational implementation challengesEngaging in collaborative partnerships and innovation to operationalize and deliver innovative trials designs Speakers: Victoria L. Chiou, MD, Head of Clinical Excellence and Innovation, AstraZenecaSheryl Jacobs, VP, Global Development Operations, AmgenCamilla Richmond, MD, MA, Medical Director, Translational Medicine, TakedaDaniel Millar, MBA, Senior Director, Strategic Business Transformation, Janssen Research & Development, LLC

In this session recorded at DPHARM 2022, moderated by Pfizer's Amy Cramer, the panelists discuss patient data. Often the elephant in the room that hinders the advancement of innovation in clinical trials for the benefit of patients in the lack of structured, clean patient data. R&D executives know the ability to garner greater data value from all data sources [clinical trials, EHRs, claims data, etc] is critical to supporting the future of drug development. The continued conundrum is that data is too often unstructured, incompatible, incomplete and unreliable and leads to an output of a research-intensive, operational bottlenecks. We have a unique group of panelists who will prioritize the critical issues first, provide potential solutions and address what to do about pending issues to be resolved. Speakers: Amy Cramer, Global Product Development Strategic Partnerships, PfizerXiaoying Wu, MD, MS, VP, Data Science Data Platform & Privacy, The Janssen Pharmaceutical Companies of Johnson & JohnsonPaul Bleicher, MD, PhD, Executive Partner, Arden EquityLekan Wang, Head, Machine Learning Services, Parexel

In this session recorded at DPHARM 2022, Pfizer's Judy Sewards is joined by Patient Advocate Barry Nelson. Judy Sewards was one of the top 30 leaders who played a critical role in the success of Pfizer’s Covid-19 vaccine clinical trial program. In her role, she led patient and site communications and engagement. She was responsible for Pfizer’s relationships with the over 150 trial sites who conducted the Covid-19 vaccine clinical trials. She also helped create awareness about the clinical trials and worked with community, and government partners to elevate the importance of participation in the trial by diverse communities and organized services to make clinical trial participation more convenient and sustainable for patients. In this fireside keynote chat, Judy will discuss leadership lessons needed to drive innovation and specifically, how to better support patients and sites. Speakers: Judy Sewards, VP, Head of Clinical Trial Experience, PfizerBarry Nelson, Patient Advocate

About The Episode When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data? Join Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel, to discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision. About the Speakers:  Sangeeta Budhia is VP and Global Head, Pricing and Market Access, at Parexel. Her role is to ensure that global strategies including pivotal clinical trials, long-term data collection studies, real world evidence generation plans and HEOR strategies are prepared for the reimbursement challenges that each product will face.  Wyatt Gotbetter is SVP & WW Head of Access Consulting, leading all facets of Parexel's Access Consulting business with a focus on helping customers position products for market success.  With more than 25 years of industry experience, he brings unique insights to guide Parexel's strategy as we invest in this segment of the business to further our patients-first focus. Sangeeta and Wyatt can be contacted at Sangeeta.Budhia@parexel.com & Wyatt.Gotbetter@parexel.com.

In this podcast, you will hear a presentation from Dr Liping Zhou, AstraZeneca, from the 2022 PODD Conference regarding formulation techniques and developability considerations for LAI peptide delivery, with a case study example. To learn more about the PODD Conference, please visit PODDConference.com.  

In this session recorded at DPHARM 2022, Moderna discusses its recent partnership with CVS Health to bring its clinical trial closer to patients and expand patient access into more communities. Review the complexities of forming a new partnership and developing a model for implementation and executionExamine the model in terms of investigator strategy, shipping and logistics approach and overall quality & monitoringOperationalizing each part of the model – key considerations, digital platforms, possibilities for scalingLessons learned moving forward Speakers: Jessica Perry, Director, Patient Centricity, Clinical Innovation, ModernaJosh Rose, VP, Head of Decentralized Trials, Site Solutions and Strategy, CVS Health

In this session recorded at DPHARM 2022, Bari Kowal, SVP & Head, Development Operations and Portfolio Management, Regeneron, moderates a panel discussion on: Examining how modernizations like the implementation of AI/ML, RWE, DE&I, DCTs impact the need for more flexibility clinical trial designBuilding protocols in tandem with study design and re-envisioning methods to execute trials Panelists include: Henry Wei, MD, Head of Development Innovation, RegeneronRinol Alaj, MBA, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, RegeneronBill Illis, Global Head, Collaboration and Technology Strategy, Clinical Development & Analytics, Novartis 

Valerie Bowling, Executive Director of Patients as Partners Europe conference, discusses what attendees can expect at the 9th annual conference, including key topic areas, session highlights, presenting companies and more.

For more information about the upcoming event, full agenda and speakers, visit https://patientsaspartnerseu.com/

In this podcast, you will hear a keynote presentation from Dr Peter Cullis, UBC, from the 2021 PODD Conference regarding the path of discovery and innovation that led to the lipid nanoparticle delivery system driving one of the most successful vaccines against COVID-19. To learn more about the PODD Conference, please visit PODDConference.com.  

Learn more about the IO360° Summit at www.io360summit.com

Evaluating single cell omics to understand the heterogeneity in immune and tumor cellsMulti-omic biomarkers for patient selection in solid tumor IO: is there a path to more personalized therapy?In an era of ‘targeted’ therapies against cell-intrinsic mechanisms (e.g. PARP, NTRK, BRAF) and surface molecules (Nectin-4, HER2), is there a path forward for pan-tumor biomarkers, or is multi-tumor more likely to be the dominant development mechanism? Moderated by: Theresa LaVallee, PhD, VP, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy Panelists: Jared Lunceford, PhD, Distinguished Scientist, Biostatistics and Research Decision Sciences, Merck Research LaboratoriesAngel A Rodriguez, MD, Oncology Medical Director, NateraSamik Upadhaya, PhD, Research Analyst, Anna-Maria Kellen Clinical Accelerator and Venture Fund, Cancer Research Institute (CRI) Learn more about the IO360° Summit at www.io360summit.com

In this podcast, you will hear a presentation from Dr Barbara Lueckel, Roche Pharma Partnering, from the 2021 PODD Conference summarizing trends, approvals and pipelines within the drug delivery space. To learn more about the PODD Conference, please visit PODDConference.com.    

Dan Chen, MD, PhD, Founder, Engenuity Life Sciences Learn more about the IO360° Summit at www.io360summit.com

This panel, first recorded at the 2022 IO360° Summit, reported on advances in achieving more diversity and inclusion in oncology clinical trials. Moderated by: Adrelia Allen, PharmD, Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Labs Panelists: Chétna Rao, PhD, Head of Site Strategy and Operations, BMSRobert Vonderheide, MD, DPhil, Director, Abramson Cancer Center, Perelman School of Medicine, University of PennsylvaniaKaren Peterson, Patient Advocate and Founder, Karen’s ClubMichel Reid, Sr. Director and Head, Global Demographics & Diversity, Global Clinical, Delivery, Global Clinical Operations, R&D, GSK Learn more about the IO360° Summit at www.io360summit.com

About The Episode With pharma’s focus on the extension of drug release windows, new technologies are needed that can lengthen that duration. Today, Zach Fletcher of Trelleborg Healthcare & Medical provides an insight into how the emerging field of long-acting implantables & polymeric drug delivery can address that need. He will be addressing: current applications of implantables and likely future applications, top concerns from pharma and assessing your portfolio for lifecycle applications, manufacturing and scalability challenges, likely conversations around reimbursement from payers. About the Speaker:  Zach Fletcher, Business Development Manager - Implantable Drug Delivery & Combo Products at Trelleborg Healthcare & Medical Zach Fletcher is the Business Development Manager - Implantable Drug Delivery & Combo Products at Trelleborg Healthcare & Medical. In this role, he identifies, establishes and develops relationships with device organizations and pharmaceutical companies to deliver unique solutions and therapies to patients. Trelleborg is a world leader in engineered polymer solutions that seal, damp and protect critical applications in demanding environments.   For more information on drug delivery news and partnership opportunities, click here.

CAR T cells for solid tumors: Lessons learned from on-going clinical trials in glioblastoma.Interplay between CAR T cells and the endogenous immune systemNext-generation CAR designs to overcome barriers for solid tumor CAR therapy Christine Brown, PhD, Deputy Director, T Cell Therapeutics Research Laboratory, Beckman Research Institute, City of Hope Learn more about the IO360° Summit at www.io360summit.com

When Claas Röhl’s 12-year old daughter was an infant, she was diagnosed with Neurofibromatosis Type 1 (NF), a rare genetic disorder that causes tumors to form along nerves. With no prior background in research, Claas founded NF Kinder and became an advocate for his daughter and patients impacted by this rare disorder. Claas will discuss his involvement in research, how he helped set up the first pediatric department for NF at a major medical University in Austria, and his efforts to create a national registry of NF patients. He will share lessons learned and offer insights on how best to engage carers to impact clinical research. Claas Röhl, Chairman, NF Kinder, EUPATI Austria, NF PatientsUnited  with: Renata Lazarova, MD, VP Development, Pediatric Programs, Noema Pharma Learn more about the Patients as Partners EU conference at www.patientsaspartners.org

Where have we come over the past 5 yearsWhat are the approvals and approval activity over the past year?What are the challenges and issues?What have we learned?What are the real important technologies that are being developed that might help transform the cell and gene therapy spaceWhat are the key things we need to think about moving forward? Michael Kalos, PhD, Managing Director, Next Pillar Consulting Learn more about the IO360° Summit at www.io360summit.com

Summary:
In this podcast, recorded at the 2024 Clinical Research as a Care Option (CRAACO) event, Donna O'Brien, Manatt Health, Trevan Locke, Duke-Margolis, and Denise Snyder, Duke University School of Medicine, discuss the financial barriers to getting coverage for clinical trials, coverage by sponsors vs standard of care and new developments for the audience to be aware of. 

They also cover: 

• What policy approaches can empower hospitals, trial sponsors, providers, and other stakeholders to manage change with their own organizations and engage with payers to foster broader coverage of trial-related activities
• How we can improve evidence generation processes within our own organizations for both healthcare systems and pharma
• How can we effectively communicate steps that Federal agencies can take to encourage stakeholder collaboration to align on incentives for improving coverage of clinical trials for patients

For more information, go to CRAACOevent.com. 

Kate Woda, IO360° Conference Director, gives a 6 minute overview on what you can expect at the 9th annual IO360° Summit taking place February 7-10 in Brooklyn, NY. Keynotes Include: Dr Carolyn Bertozzi, Stanford University on Bioorthogonal and Click Chemistries Impact on Advancing Cancer ImmunotherapyDr Marcela Maus, Massachusetts General Hospital on Mechanisms Driving CAR T CellsDr Isabelle Rivière, Memorial Sloan Kettering Cancer Center on Cell Therapy Manufacturing Progress Report and Novel Manufacturing ParadigmsDr Axel Hoos, Scorpion Therapeutics on Transformational Medicines & The Next Wave of IODr Andrew Baum, Citi on What’s Next on the IO Radar? Top 10 RecommendationsDr Arjun Goyal, Vida Ventures on Investor Perspective on the State of the Current Market and Impact on the IO Cell Therapy FieldOswald Peterson, Stage IV Lung Cancer Survivor who will share his extraordinary story from diagnosis through to immunotherapy treatments that saved his life Plenary Topics: Biomarkers / Assay DevelopmentDiscovery / PreclinicalImaging AdvancementsClinical OperationsBusiness DevelopmentsTranslational ScienceCell TherapyRNA TherapeuticsClinical Developments Learn more about the upcoming IO360° Summit at www.io360summit.com

There are many reasons why patients don’t trust or feel comfortable using a digital/mobile device. Implementing mobile technologies in clinical trials can sometimes create barriers to participation amongst patients who struggle to access them, are digitally challenged and/or do not have the bandwidth to support the utilization. This session addresses the digital divide, the challenges of accessing and using mobile technologies and solutions to reduce these barriers. Patient and site perspectives on utilizing mobile/digital technologies in clinical trialsHow pharma is addressing access and equity from a digital perspectiveEducating, communicating and supporting patients through the use of digital/mobile technologies, reducing anxiety and building trustHow do we think about trial design to accommodate patients using digital/mobile technologiesHow are we addressing and tackling WiFI/Bandwidth connectivity challenges that are required with these technologies such as patient access? Speakers: Adama Ibrahim, VP, Digital Strategy and Change Management, Novo NordiskTina Aswani-Omprakash, Patient AdvocateMarieElena Cordisco MA, NP-C, APRN, AVP Clinical Trials, Research and Innovation, Nuvance HealthTimothy Joy, Head, Clinical Operations Strategic Solutions, PfizerJoan Severson, Chief Innovation Officer, Clinical InkAsh Rishi, CEO, COUCH Health

Moderna shares how they created and implemented their digital-first organizational infrastructure that has transformed the way clinical research is getting done. They will discuss their approach to agility, delivering value early and often. They will also specifically discuss the example of their COVID-19 vaccine trial.  Key topics include: About Moderna’s Digital-first infrastructure that allows for rapid adoptionHow they built the infrastructure to support one of the biggest infectious disease trialsHow they built their medical information, safety capabilities to support adverse events, surveillance and capabilities to support launchAI as a major component in their safety organization and driving recruitment for clinical trialsBest practices for the industry to move the needle forward without innovation labs or huge transformations Speaker: Jean-Remy Behaeghel, VP, Digital, Moderna Therapeutics