Conversations in Clinical Trial Readiness – Détails, épisodes et analyse

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Conversations in Clinical Trial Readiness

ArcheMedx Inc.

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Business & Entrepreneuriat

Éducation

Fréquence : 1 épisode/35j. Total Éps: 12

Welcome to Conversations in Clinical Trial Readiness, a series featuring life science executives who share their stories and insights related to clinical operations, and clinical trial readiness.

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Données mises à jour le 04/07/2026

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https://emalexbiosciences.com/
2 partages
https://isctm.org
2 partages
https://cnssummit.org
2 partages

https://www.linkedin.com/in/atul-mahableshwarkar-07772338/
2 partages
https://www.linkedin.com/company/oncobay-clinical/
2 partages
https://www.linkedin.com/company/oncosec-medical-inc/
2 partages

https://www.archemedx.com/corp-blog/conversations-clinical-trial-readiness-interview-kunal-sampat/
7 partages
http://www.archemedx.com
3 partages
https://twitter.com/OncoBay
2 partages

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Pandemic Impact on Clinical Trial Recruitment with Atul Mahableshwarkar, M.D., DFAPA

Épisode 11

jeudi 9 décembre 2021 • Durée 34:47

Atul Mahableshwarkar

Dr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes.

Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years.

Episode Highlights

The pivotal role of strong methodology in allowing good products to succeed
Atul’s advice for others beginning to design clinical trials
What he sees as the greatest challenges clinical trials have in common
How teams can help motivate clinical trial participation
Where standard concepts of patient-centricity may be lacking
How collaboration can help minimize mistakes
The Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug status
How the pandemic nearly tripled Emalex’s enrollment
The importance of supporting sites that may feel threatened by decentralized clinical trials
The pandemic-enforced recruitment practices he plans to continue
Key considerations in choosing a preferred ratings scale, and what his is
Rater training as a misnomer that needs revising
How to assess and manage raters appropriately
The value of monitoring data and communicating insights to stakeholders in real time

Links

https://www.linkedin.com/in/atul-mahableshwarkar-07772338/

https://emalexbiosciences.com/

https://isctm.org

https://cnssummit.org

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Are Virtual SIVs the Future?: Interview with Jennifer Brandl

Épisode 10

jeudi 28 octobre 2021 • Durée 24:17

Jennifer Brandl is the Associate Director of Clinical Operations at Kezar Life Sciences. She has 15 years of experience as a researcher and clinical operations specialist, and she is currently pursuing a Master’s degree in Data Science from the University of Wisconsin.

Jennifer credits her prior experience at a smaller biotech company with giving her a critical foundation in clinical conduct and study execution. At Kezar, she leverages this expertise and her passion for research to support the company’s development of pioneering therapies and to change the lives of patients.

Episode Highlights

The elements of Jennifer’s expertise that have especially helped her drive success in the trials she manages
The benefits of functional service provider outsourcing models
How Kezar’s patient-centric nature had the company well prepared to navigate the COVID-19 pandemic
The greatest challenges Jennifer and Kezar experienced due to the pandemic, and some positive outcomes
Important considerations for organizations exploring home health options
How communication and relationship-building form the foundation of clinical trial work
The challenges and benefits she’s experienced conducting site initiation visits virtually
How best to prepare before updating or transforming site initiation processes
What she believes is next for decentralized clinical trials
How automation and tech adoption can help extract more insight from data

Resources:

Kezar Life Sciences
Jennifer Brandl on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

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Why every clinical trial needs to consider Middle East and African sites: Interview with Ahmed Hamouda

Épisode 9

mercredi 25 août 2021 • Durée 25:57

Ahmed Hamouda

Ahmed Hamouda is the Head of Clinical Operations in the Middle East and Africa at RAY. In more than 10 years in the clinical research field, Ahmed has worked on both the CRO side and the pharmaceutical side in Europe, the Middle East, the Far East, and Africa.

Ahmed brings the full range of his experience to bear at RAY, which provides outsourcing and consulting services to support pharmaceutical and biotech companies through the clinical trial development process. With RAY, Ahmed leverages his expertise to bring hope and opportunity to patient populations who would not otherwise be reached.

Episode Highlights

Why Africa and Middle Eastern markets represent a major opportunity for sponsors
What regulations and unique requirements sponsors need to understand before moving into these markets
How the site selection and preparation process is different in these markets as opposed to in the U.S.
The importance of partnering with qualified regional experts
The challenges involved in driving patient participation in these regions
How one rare disease clinical trial was saved by a move from the U.S. to the Middle East, and how that move paid off in terms of recruitment
Potential logistical issues with global trials and how RAY manages them
Why continuous education is so important for sites
How Ahmed and RAY estimate the timeframe for study startup in a new region
The unexpected positive regional outcomes of the pandemic

Resources:

Ray-CRO
Ahmed Hamouda on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

Increasing Access to People of African Descent in Pharma: Interview with Peju Oshisanya

Épisode 8

mercredi 21 juillet 2021 • Durée 44:12

Peju Oshisanya

Peju Oshisanya is a Director and Clinical Program Leader at BenevolentAI. With more than 20 years in the drug research industry, Peju is an expert in pharmaceutical organization. Her career has run the gamut from early roles as a clinical trial associate to extensive experience running a wide range of global clinical research programs. In her role at BenevolentAI, she pairs her biomedical science background with further perspective from the tech side.

Peju is a passionate proponent of diversity in data and inclusion in clinical trial research. She believes that problems of diversity and inclusion are fixable, and she has determined to become a champion of that change, working to raise awareness and dedicating her own career to upend the status quo.

Episode Highlights

Peju’s “aha” moment that drove home the magnitude of inequity in biopharma, health, and clinical trials
Why it’s crucial to really understand the communities that we want to include in research
How decision-makers’ personal perspectives influence which diseases are prioritized and which treatments are funded
Why representation needs to extend to the experts rather than stopping with the patient population
Why it’s misleading and counter-productive to frame populations using the term “minority”
How helping patients understand the importance of research in informing treatments can help motivate participation
The huge potential opportunity Africa represents for clinical trials
The problem of perception when it comes to African institutions’ preparedness
How mining past data can create a self-perpetuating cycle that prevents capable sites from becoming experienced sites
What we can do to help ameliorate diverse patient populations’ trust in the healthcare industry
How anyone, regardless of their role within a company, can take steps to influence diversity in research
How the pandemic has signaled hope for diversity and inclusion going forward

Resources:

Peju Oshisanya on LinkedIn
BenevolentAI

How Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug Development

Épisode 7

mercredi 2 juin 2021 • Durée 39:42

Ken Getz is the Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. Ken is an expert in drug development management and practices who has dedicated much of his career to raising awareness of clinical research enterprise.

In addition to frequently speaking at industry events and publishing in peer-reviewed journals, Ken is the founder of several organizations, including the non-profit CISCRP and the publisher CenterWatch. His career is a true testament to his belief in the importance of transparency and keeping all clinical research stakeholders well-informed.

Episode Highlights

The takeaways, both expected and surprising, from 2020 protocol performance data
The factors that are contributing to increased complexity in clinical trial protocols
Why simplifying the design of a study is not the right goal
The inherent benefits in complexity, and how we can reap them through proper management
What drives regulatory agencies to seek to quell rising complexity in clinical trial protocols
Why more data isn’t necessarily better
The importance of investigating underlying causes of problems rather than defaulting to solving them with volume
What happened to feasibility committees and what should replace them
Why it’s critical to incorporate patient input into study design
The consistent positive impact of patient advisory boards
How taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later on

Resources:

Tufts Center for the Study of Drug Development
Ken Getz on LinkedIn
CISCRP
CenterWatch
Conversations in Clinical Trial Readiness Interview Series

Struggling with the Silent Killer: An Honest Look at How Demanding Oncology Trials Have Become with Rebecca Setta

Épisode 6

mardi 20 avril 2021 • Durée 28:54

Rebecca Setta is an Associate Director at OncoSec whose 13 years of experience in clinical trials have given her the benefit of several different perspectives. Rebecca began her career on the vendor side, and her continuous pursuit of development and higher-level understanding led her to transition to the CRO space in 2015. Her role at OncoSec represents the natural evolution of a career shaped around an inherent desire for growth through further immersion in clinical trials.

In Rebecca’s years of experience at the project level, she consistently found building effective teams to be among the most rewarding elements of her work. She now brings that expertise to bear at the department level, where she can act as a mentor, shaping a team to build on her knowledge and experience.

Episode Highlights

How Rebecca helps her team avoid burnout in a grueling field
The common characteristics she saw across the sites that adapted best at the start of the pandemic
The crucial change in mindset that she’s encouraged in her CRAs
The COVID-inflicted adaptations she expects to persist post-pandemic
Why it’s important to partner with sites
The unexpected upside to the pandemic adjustments her sites have made
What really impresses her about the industry
How remote work and limited face time can impact morale, and one way she compensates for that
How the weighty context of oncology research can also translate to motivation
Why she is so excited about the future of the industry

Resources

https://oncosec.com

https://www.linkedin.com/company/oncosec-medical-inc/

https://twitter.com/oncosec

What Do You Do When You Don't Have Enough Trial Locations? with Krystyna Kowalczyk

Épisode 5

jeudi 18 mars 2021 • Durée 29:42

Topics covered and questions you’ll uncover during this episode:

The three tenets of OncoBay’s approach to cutting-edge cancer research
How to prepare staff for the complexities of a 21st-century oncology trial
Why we need to evolve from serial to real-time data assessment
OncoBay’s “just-in-time” enrollment model (and a touching success story)
Why investing up-front in site preparedness is critical to maximizing impact in research
How the just-in-time model can help address diversity challenges in enrollment
Why new technologies and methodologies often create discomfort, and what leaders can do about it
How you can make 1 + 1 equal 3 when you combine tools effectively
Why putting together the right team is both more challenging and more critical than putting together the technology
What Krystyna looks for when assessing potential team members
Why she’s excited for the next generation of industry employees

Resources mentioned within the episode:

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Helping Sites and Teams Make the Shift to Decentralized Trials with Paul Evans

Épisode 4

mercredi 17 février 2021 • Durée 24:28

Topics covered and questions you’ll uncover during this episode:

Why brick-and-mortar and virtual constitute a continuum, not a dichotomy.
What teams need to do to be successful transitioning to virtual.
Why remote monitoring still poses a challenge.
Why tech isn’t always optimized for the site side.
How remote improves patient engagement and retention.
Why the clinical research coordinator role is changing, right down to the essential skillsets.
What we need to do to make sure site coordinators are comfortable enough to be effective with the tech they need to adopt.
Why we’re probably a long way from seeing virtual as a money-saver, and what will need to change to make it cost-effective.
How lessons learned in the late 90’s can be an instructive cautionary tale today.

Resources mentioned within episode:

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The Evolving Role of Sites in Decentralized & Virtual Trials with Mary Costello

Épisode 3

mercredi 20 janvier 2021 • Durée 39:18

Topics covered and questions you’ll uncover during this episode:

How excellence in site management has changed since the pandemic.
Why the sites are still the lynchpin.
Why anxiety around decentralized clinical trials is misplaced.
How a marketing perspective can serve clinical operations and site management.
What sets sites apart that will succeed and sites that will struggle in this new landscape.
Why it’s important to assess a site’s tech-readiness and physical situation before handing down directions on how a study will be run.
Simply providing a site with technology isn’t enough, so what else needs to be done?
Why prevention and preparation beat correction and remediation.
How to maximize collected data through follow-up and implementation.

Resources mentioned within episode:

Medable
ArcheMedX
Kelly Ritch on LinkedIn
Mary Costello on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

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Demystifying Decentralized Clinical Trials with R'Kes Starling

Épisode 2

lundi 14 décembre 2020 • Durée 32:07

Episode Highlights:

The industry and operational challenges facing DCT adoption.
How inconsistent nomenclature has contributed to widespread misunderstanding of DCT, and how misnomers have slowed adoption.
The challenge of change management and how clarity and infrastructure can be an antidote.
How DCT can help boost minority representation in clinical trial research, and why shifting those numbers requires time.
How sponsors can get started with DCT and what they need to consider.
Why organizational fit is critical and how to assess it.
Why it’s so important to talk with the patients and understand the challenges they face.
Why DCT and patient-centric approaches so often go hand-in-hand.
How patient engagement is changing, and why clinical trials need to adapt to that.
How sites have been forgotten as stakeholders and why they’re still central to clinical development.

Resources:

www.archemedx.com
Conversations in Clinical Trial Readiness series
www.revelesclinical.com
www.linkedin.com/in/klritch
www.linkedin.com/in/r-kes-starling-rph-mba-9996214/
www.clinicaltrialpodcast.com
Reveles’ Decentralized Clinical Trial Grader: https://form.typeform.com/to/RhOpipVQ
https://www.linkedin.com/company/reveles-clinical-services

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Conversations in Clinical Trial Readiness – Détails, épisodes et analyse

Détails du podcast

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Liens partagés entre épisodes et podcasts

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Podcasts Similaires Basées sur le Contenu

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