Editorial Podcasts

Ira C. Spector, PhD, MBA, CEO and Co-Founder, SFA Therapeutics discusses how his career journey has epitomized the ability to solve problems, which is essentially the role of drug development. It has also led to the formation and strategic approach to his company’s early-stage clinical trials for using the microbiome to address chronic inflammatory diseases.

Beth MacEntee Pileggi, Head of Global Case and Safety Data Management with Janssen Pharmaceuticals of Johnson & Johnson, and Co-Lead of TransCelerate’s Pharmacovigilance Agreements Optimization Initiative, discusses the importance of safety, collaboration, TransCelerate’s positive role in the pharma industry and her passion for PV.

Dr. Sean Bohen, CEO of Olema Oncology, discusses his career and significant contributions to the clinical research and development of numerous oncology drugs that received regulatory approval for various indications. Plus a look at Olema, how they operate, and challenges they face.

Dr. Harsha Rajasimha, Founder and Chairman of IndoUSrare, discusses the emotional reason behind founding the non-profit, programs they offer that are helping rare disease parents/patients, rare disease research in India, and much more.

Dan Brenner, Founder and CEO of 1nHealth, discusses his path into clinical research and patient recruitment, the Gold Eagle Next Generation Board, what millennials/next generations want from organizations they buy from or invest in, how industry can best harness patient data to accurately predict recruitment timelines, and much more.

In this podcast, Dr. Milligan makes the case for studying drugs in pregnant and lactating women on an ongoing basis to understand long-term efficacy and safety, as well as effects of concomitant medications on these women. Sandy believes that the entire ecosystem--regulators, policymakers, governments, physicians, healthcare systems, and industry, need to have a conversation around improving the under-met and unmet needs of women, which includes understanding the unique experiences of women with conditions such as pre-term labor, menopause or endometriosis.

Jane Myles, Vice President, Clinical Trial Innovation at Curebase, discusses her current role, what led her there, and challenges their clients face with DCTs.

Chief Science Officer at Unlearn.AI, Dave Miller, discusses digital twins, their pros and cons for the industry, and developments in Bayesian design and adaptive trials for CDER and CBER.

Susan Wood, president and CEO of VIDA Diagnostics, discusses her journey into healthcare from an engineering path, changes in the field of imaging, virtual control arms, and much more

Todd Luckritz, Associate Director, Patient Solutions at Myonex, recently left Mayo Clinic as the lead pharmacist for its clinical research programs. In this podcast, Luckritz discusses his journey “bringing protocols to life,” the joy of interacting with patients, and the frustrations with sourcing that led him to make a difference at Myonex.

Paula Brown Stafford, CEO of Novan, came to her role via increasing clinical development role responsibilities with Quintiles, now IQVIA. In this podcast, she reflects on her professional experiences, her achievements and her advice for clinical trials professionals.

Dr. Shalaan Beg, VP of Oncology for Science 37, discusses his approach to reducing the time to trial activation at an NCI designated cancer center, how to ensure a diverse representation in clinical trials, and his opinion on decentralized and hybrid trials.

Christine McSherry, CEO of Casimir and Mindy Leffler, President and Chairman of Casimir, now a part of CRO Emmes, discuss their path to true patient focused drug development based on their experiences raising sons with Duchenne Muscular Dystrophy (DMD). By understanding early and actual measurable endpoints that matter to DMD patients and caregivers, and providing PROs that can capture data that matters, the women hope to influence other diseases and the quality of life for people that have very little time to waste.

Dr. Ian Smith MBE MB ChB.B MedSc(Hons), Founder, Director and Chief Medical Officer of Panthera Biopartners, and Chris Dodd, the company's Chief Commercial Officer, discuss the evolution of the Site Management Organization and Panthera Biopartners, how clinical trials remain mired in underperformance and difficulties, and hybrid trial advancements.

Praduman “PJ” Jain, CEO & Founder, Vibrent Health; Principal Investigator, NIH All of Us Research Program, Participant Technology Systems Center; Principal Investigator, NIH RADx Program, discusses his involvement in the NIH All of Us program, digital health research tools, and more.

Otis Johnson, PhD, Vice President, Product Line Executive; Chief Diversity, Inclusion and Sustainability Officer, at Clario discusses key changes in the industry that have had the greatest impact, Clario’s first ESG report, and how DE&I initiatives will evolve.

Catharine Grimes, Senior Director, Bristol Myers Squibb Foundation, discusses the goal to increase diversity in clinical trials through the BMS Foundation Diversity in Clinical Trials Career Development Award Program, the Foundation's Global Cancer Disparities Initiative, and more.

Kuldeep Singh Rajput, CEO and founder of Biofourmis, with over 10 years of experience in the biomedical space continues to work alongside a previous guest of the ACT Podcast, Jyadev Thakkar, on electronic and biosensing research and products, including wearable solutions and biosignal analytics for cardiac health monitoring.

Mike Keens, VP of Operations at Anju Software, offers his insights into the current state of decentralized trials, the state of clinical trials technology and the near-future skill sets for clinical trials professionals.

Ardy Arianpour, Founder and CEO of Seqster, discusses his experience launching and establishing a company’s presence through COVID, acceptance of digital and data use in the industry, and recently joining the DTRA.

Dr. Salim Idriss, Executive co-director of the Duke Pediatric and Congenital Heart Center & director of pediatric electrophysiology at Duke University Medical Center discusses a collaboration with the Cardiac Safety Research Consortium (CSRC), the FDA, and Duke University Medical school.

Associate editor, Andy Studna, talks with Editorial Director, Lisa Henderson, about her recent travels to various industry conferences, the insights she gained from them, and a review/preview of recent issues.

Pamela B. Davis, MD, PhD, Professor of General Medical Sciences at Case Western Reserve University School of Medicine and Member of the Board of Directors for the Clinical Research Forum, discusses the clinical research industry, her own career, and the article that she and her colleague Dr. Wu wrote for Applied Clinical Trials.

Mike Rousselle, Vice President of Data Product for OptimizeRx, discusses his serendipitous career, current role, how the company ties AI and RWE together for trial recruitment, and more.

Jason Baumgartner, Founder and CEO of BEKHealth—an EMR to CTMS platform that uses EMR data to find patients and integrate them into the CTMS process—talks about EMR structured and unstructured data, his own career, and some additional background on BEKHealth.

Judy Canavan, Managing Director and Leader at BDO, Compensation and Benefits practice, discusses how BDO collects the data for its CRO Industry Global Compensation & Turnover Survey, recent calls for CROs to invest in their HR departments, and the effect of the Great Resignation on the industry.

Avi Kulkarni, Senior Vice President, Research & Development, at Cognizant, discusses the trajectory and growth of the Shared Investigator Platform; the history and impact of biomarkers in clinical trial conducts, as well as personal insights from his 30-year career.

Kimberly Gentile, Senior VP, Clinical Operations for Biohaven Pharmaceuticals, discusses her current position for a company that currently has a lot going in the Phase III space, as well as how her unique career journey lead her to this moment.

Dr. C.K. Wang, Chief Medical Officer for COTA discusses the use of real world data, the results of a recent survey by COTA, and his own career journey.

Martin Gouldstone, Chief Business Officer of Life Sciences, Sensyne, updates us on the status of AI in data used for clinical research, the difference between ethical AI vs. AI, and what Sensyne is trying to achieve in this space.