Explorez tous les épisodes du podcast Conversations in Clinical Trial Readiness
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Titre
Date
Durée
Pandemic Impact on Clinical Trial Recruitment with Atul Mahableshwarkar, M.D., DFAPA
09 Dec 2021
00:34:47
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
Are Virtual SIVs the Future?: Interview with Jennifer Brandl
28 Oct 2021
00:24:17
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
Welcome to Conversations in Clinical Trial Readiness
17 Nov 2020
00:00:53
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.
Listen in to hear how health and life science organizations can better equip teams and clinicians to accelerate the development and adoption of new clinical treatments and best practices.
Learn from our experts as they share their key learnings, obstacles, and success stories.
Join us as we talk to clinical trial executives from different corners of the industry.
Why every clinical trial needs to consider Middle East and African sites: Interview with Ahmed Hamouda
25 Aug 2021
00:25:57
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
Increasing Access to People of African Descent in Pharma: Interview with Peju Oshisanya
21 Jul 2021
00:44:12
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
How Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug Development
02 Jun 2021
00:39:42
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
Struggling with the Silent Killer: An Honest Look at How Demanding Oncology Trials Have Become with Rebecca Setta
20 Apr 2021
00:28:54
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