Conversations in Clinical Trial Readiness
12 episodes - English - Latest episode: over 2 years ago - ★★★★★ - 2 ratingsWelcome 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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Episodes
Pandemic Impact on Clinical Trial Recruitment with Atul Mahableshwarkar, M.D., DFAPA
December 09, 2021 14:36 - 34 minutes - 31.9 MBAtul 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 t...
Are Virtual SIVs the Future?: Interview with Jennifer Brandl
October 28, 2021 15:00 - 24 minutes - 22.2 MBJennifer 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 ...
Why every clinical trial needs to consider Middle East and African sites: Interview with Ahmed Hamouda
August 25, 2021 20:43 - 25 minutes - 23.8 MBAhmed 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,...
Increasing Access to People of African Descent in Pharma: Interview with Peju Oshisanya
July 21, 2021 20:35 - 44 minutes - 40.5 MBPeju 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 pr...
How Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug Development
June 02, 2021 16:56 - 39 minutes - 36.3 MBKen 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 Cen...
Struggling with the Silent Killer: An Honest Look at How Demanding Oncology Trials Have Become with Rebecca Setta
April 20, 2021 19:50 - 28 minutes - 26.5 MBRebecca 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 y...
What Do You Do When You Don't Have Enough Trial Locations? with Krystyna Kowalczyk
March 18, 2021 13:48 - 29 minutes - 27.2 MBTopics 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...
Helping Sites and Teams Make the Shift to Decentralized Trials with Paul Evans
February 17, 2021 20:17 - 24 minutes - 22.6 MBTopics 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 ...
The Evolving Role of Sites in Decentralized & Virtual Trials with Mary Costello
January 20, 2021 16:20 - 39 minutes - 36.2 MBTopics 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 hand...
Demystifying Decentralized Clinical Trials with R'Kes Starling
December 14, 2020 13:00 - 32 minutes - 29.6 MBEpisode 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. Wh...
What We Learned from the Clin Ops Nightmares of 2020 with Kunal Sampat of Ceribell
November 17, 2020 20:48 - 30 minutes - 28.5 MBEpisode Highlights: Why it’s vital to adapt—during the pandemic and always. Why clarity around workflow is critical to adaptation. What sponsors and CROs can do to reduce the burden on their sites, and why it’s their responsibility. How “making the sites our heroes” can help with patient recruitment. The importance of creating ways for your sites to exchange information with each other. How the CRA role is evolving. How tech vendors can address the biggest obstacle to adoption. Why v...
Welcome to Conversations in Clinical Trial Readiness
November 17, 2020 20:33 - 53 seconds - 1.02 MBWelcome 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 t...