Editorial Podcasts

With so many new solutions and other technologies appearing in the clinical trials space, how are stakeholders choosing which ones are best for them and how are these advancements translating to the actual clinic?

While clinical research in rare diseases has many unique operational challenges, there is plenty of work being done to advance it and bring effective therapies to patients.

With the recent boom in artificial intelligence (AI), industry is finding ways to best utilize it in advancing the development of potential therapies.

New models such as IROs are changing the way industry views the current site landscape and addressing challenges.

Innovative pharma companies are stepping up to integrate digital health technology to advance pharmaceutical drug and medical device development, in both the healthcare and research worlds, to achieve better measurements and outcomes.

The evolution of data and digital health uses in both the healthcare and research worlds is bringing the two closer together for the good of patients.

Integrated research organizations (IROs) are creating a shift in the way clinical trials are operated, bringing new methods for enrollment and building patient-physician relationships.

From startups to major research organizations, early-phase research can be managed in different ways depending on the company.

The many sources of data source in clinical trials can be overwhelming, but the data itself can be used positively to guide clinical operations decision-making.

Chris Learn, PhD, PMP, Vice President, Cell and Gene Therapy Center of Excellence, Parexel describes highlights of his career, what originally spurred his interest in clinical research, the current landscape of CGTs and much more.

Doug Warner, MD and CMO for eFFECTOR Therapeutics, discusses the complexities of oncology clinical trials, the important relationship medical directors should have with their clinical study teams, and more.

Peter Benton, President and CO-CEO for Worldwide Clinical Trials, speaks about his unconventional entrance into the industry, advice for clinops professionals, and much more.

Sindhu Ramchandren, MD, Director, Clinical Leader, Neuroscience at Janssen, discusses the importance of having physicians involved in clinical trials, walks us through her career path and more.

Gabriele Brambilla, CEO of Alira Health, discusses the ever-evolving landscape of real-world data.

Rose Blackburne, MD, MBA, Vice President, Global Head, General Medicine, PPD Clinical Research, Thermo Fisher and Margarita Nunez, MD, Principal Investigator, Synexus NY / Accelerated Enrollment Solutions New York discuss their panel at the recent Health Equity in Clinical Trials Congress in Boston last month; share insights into how diversity can be improved at the site and CRO; and the hope that clinical trial awareness and diversity can be discussed with all levels of stakeholders in healthcare to improve drug development worldwide.

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.