Conversations in Clinical Trial Readiness

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://www.linkedin.com/in/atul-mahableshwarkar-07772338/] https://emalexbiosciences.com/ [https://emalexbiosciences.com/] https://isctm.org [https://isctm.org] https://cnssummit.org [https://cnssummit.org]

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 [https://www.kezarlifesciences.com/] Jennifer Brandl on LinkedIn [https://www.linkedin.com/in/jennifer-brandl-8a919010/] Conversations in Clinical Trial Readiness Interview Series [https://www.archemedx.com/corp-blog/conversations-clinical-trial-readiness-interview-kunal-sampat/]

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 [http://ray-cro.com] Ahmed Hamouda on LinkedIn [https://www.linkedin.com/in/ahmed-hamouda-5869b660/] Conversations in Clinical Trial Readiness Interview Series [https://www.archemedx.com/corp-blog/conversations-clinical-trial-readiness-interview-kunal-sampat/]

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 [https://www.linkedin.com/in/peju-oshisanya-9b937a9/] BenevolentAI [https://www.benevolent.com/] Conversations in Clinical Trial Readiness Interview Series [https://www.archemedx.com/corp-blog/conversations-clinical-trial-readiness-interview-kunal-sampat/]

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 [https://csdd.tufts.edu/] Ken Getz on LinkedIn [https://www.linkedin.com/in/ken-getz-9a53b811/] CISCRP [http://www.ciscrp.org/] CenterWatch [https://www.centerwatch.com/] Conversations in Clinical Trial Readiness Interview Series [https://www.archemedx.com/corp-blog/conversations-clinical-trial-readiness-interview-kunal-sampat/]