Andy Studna, Editor

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.

Micah Lieberman, Executive Director, Conferences for CHI and Co-Founder, VP, Community and Business Development of ClinEco talks about what to expect at the upcoming SCOPE conference in February, tips on how to get the most out of your experience, life during the pandemic, and much more.

Jane Parnes, Executive Medical Director, Early Development at Amgen talks about her own career path, how clinical trials are being conducted at Amgen, as well as her experience as a female leader in STEM.

Dr. Lise Lund Kjems, Chief Medical Officer at Cyclo Therapeutics, talks about Cyclo’s investigational therapy for Niemann-Pick Disease Type C and gives insight into rare disease drug development, with an emphasis on ensuring trial design includes holistic and specific patient concerns.

Bob Chaplinsky, Director Corporate Quality Compliance at UCB, discusses the trajectory of quality management systems in pharma, the importance of change management when implementing new systems, and staying on top of compliance and regulatory changes on a global scale.

Mary Costello, Head of Site and Investigator Network at Medable, and Pat Larrabee, CEO of Rochester Clinical Research, discuss their extensive careers in the clinical trials industry, as well as talk about their article in our October issue, “Why Siteless Trials Won’t Work.”

Jaydev Thakkar, COO of Biofourmis, talks about decentralized trials, clinical research as a care option, digital therapeutics, and what Biofourmis is working on.

Raj Indupuri, CEO of eClinical Solutions, talks about the build vs. buy pendulum faced by CROs, the pros and cons of each model, and more.

Brad Power, Founder of CancerHacker Lab, speaks about his innovative crowdsourcing approach to help cancer patients, his own battle with lymphoma, and the unique challenges brought to the table by clinical trials in oncology.

Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.

Dr. Peter Schueler, Senior VP Drug Development Services, Neurosciences at ICON, talks about topics discussed in a timely new book he edited titled Innovation in Clinical Trial Methodologies.

John Reites, CEO of THREAD Research, discusses how his organization is adapting to decentralized trials and efforts they're taking to increase patient recruitment.

Dr. Theodore Leng, MD, Medical Advisor to Verana Health and Director of Clinical and Translational Research at the Byers Eye Institute at Stanford, Stanford University Medical School, talks about a recent study he led and presented in early May at the Association for Research in Vision and Ophthalmology Meeting.