Shows
Conversations in Clinical Trial ReadinessPandemic Impact on Clinical Trial Recruitment with Atul Mahableshwarkar, M.D., DFAPAAtul MahableshwarkarDr. 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...2021-12-0934 minConversations in Clinical Trial ReadinessAre Virtual SIVs the Future?: Interview with Jennifer BrandlJennifer 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 HighlightsThe elem...2021-10-2824 minConversations in Clinical Trial ReadinessWhy every clinical trial needs to consider Middle East and African sites: Interview with Ahmed HamoudaAhmed HamoudaAhmed 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 n...2021-08-2525 minConversations in Clinical Trial ReadinessIncreasing Access to People of African Descent in Pharma: Interview with Peju OshisanyaPeju OshisanyaPeju 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...2021-07-2144 minConversations in Clinical Trial ReadinessHow Can We Manage the Increasing Complexity of Clinical Trial Protocols? Interview with Ken Getz of Tufts Center for the Study of Drug DevelopmentKen 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 s...2021-06-0239 minConversations in Clinical Trial ReadinessStruggling with the Silent Killer: An Honest Look at How Demanding Oncology Trials Have Become with Rebecca SettaRebecca 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...2021-04-2028 minConversations in Clinical Trial ReadinessWhat Do You Do When You Don't Have Enough Trial Locations? with Krystyna KowalczykTopics covered and questions you’ll uncover during this episode:The three tenets of OncoBay’s approach to cutting-edge cancer researchHow to prepare staff for the complexities of a 21st-century oncology trialWhy 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 researchHow the just-in-time model can help address diversity challenges in enrollmentWhy new technologies and methodologies often create discomfort, and what leaders can do about itHow you can make 1 + 1 equal 3 when you combine tools effectivelyWhy putting tog...2021-03-1829 minConversations in Clinical Trial ReadinessHelping Sites and Teams Make the Shift to Decentralized Trials with Paul EvansTopics 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 fro...2021-02-1724 minConversations in Clinical Trial ReadinessThe Evolving Role of Sites in Decentralized & Virtual Trials with Mary CostelloTopics 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...2021-01-2039 min
Clinical Trial Podcast | Conversations with Clinical Research ExpertsClinical Trial Readiness with Joel SelzerOne of the biggest challenges in clinical study start-up and conduct is “training.” A few factors that impact training include the clinical site personnel’s ability to retain and understand key study information, staff turnover at the site, individual learning style and preferences and much more. With many clinical research and trial activities going virtual, having an online platform to train research staff on the protocol and trial operations is useful and necessary. In this podcast interview, I speak with Joel Selzer, CEO & co-founder of ArcheMedx. Joel shares with us how the Arc...2021-01-011h 00Conversations in Clinical Trial ReadinessDemystifying Decentralized Clinical Trials with R'Kes StarlingEpisode 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...2020-12-1432 minConversations in Clinical Trial ReadinessWhat We Learned from the Clin Ops Nightmares of 2020 with Kunal Sampat of CeribellEpisode 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 video is the best tool for training and communication, and how to leverage it.What the future of...2020-11-1730 minConversations in Clinical Trial ReadinessWelcome to Conversations in Clinical Trial ReadinessWelcome 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.
2020-11-1700 min