Clinical Trials Documentary

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PEOPLE INTERVIEWED

Dr. Hicks is the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). She oversees regulation and policy development for CDER and participates in cross-cutting agency initiatives.

She works closely with the Office of the Commissioner and other Centers to promote diversity and inclusion of underrepresented populations in clinical trials. Dr. Hicks came to the FDA in 2003 and previously served as a Team Leader in the Division of Cardiovascular and Renal Products and as a Deputy Director in the Division of Nonprescription Drugs II. She has led two large multi-stakeholder initiatives to standardize data collection for cardiovascular trials. Dr. Hicks received her undergraduate degree from Duke University, MS degree from Georgetown University, and MD degree from the Georgetown School of Medicine. She completed her internship and residency in Internal Medicine and fellowship in Cardiovascular Disease at Walter Reed Army Medical Center. She completed her Interventional Cardiology training at The Johns Hopkins Hospital and subsequently was Director of the Cardiac Catheterization Laboratory at Madigan Army Medical Center.

At the FDA Kevin was the lead for the CDER Center for Clinical Trial Innovation (C3TI). CDER provides scientific and regulatory advice to guide clinical trial development and implementation as a cornerstone in drug development, helping patients and consumers access the therapies they need.

As part of an ongoing effort to innovate and enhance clinical trials, CDER is establishing the CDER Center for Clinical Trial Innovation (C3TI). C3TI will foster CDER’s innovation efforts and act as a central point for coordinating, sharing knowledge, and communicating with both internal and external parties.

Bikash Chatterjee has worked in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years, guiding the successful approval of a dozen new products within the U.S. and Europe.

Chatterjee has developed and transferred products and processes to satellite operations and CMOs throughout his career, designing and implementing systems to satisfy the requirements for ICH Q8, Q9, and Q10, e-pedigree, risk-based validation, and developing a six sigma-based methodology to support the PAT initiative. He is an ISO 9000 certified lead assessor and six sigma / lean manufacturing master black belt. Chatterjee is a member of the USP national advisory board, past chairman of the Golden Gate Chapter of the American Society of Quality (ASQ.

Chatterjee is a regular editorial contributor to several industry journals, serves on the editorial advisory board for Pharmaceutical Manufacturing and Pharmaceutical Technology, and is a founding member of the CPhl expert industry advisory board. Chatterjee is the author of "Applying Lean Six Sigma in the Pharmaceutical Industry” (ISBN: 978-0-566-09204-6). He holds a B.A. in biochemistry and a B.S. in chemical engineering from the University of California at San Diego.

As the Director of Decentralized Trial Solutions, Nicole Gray is responsible for developing Direct-to-Patient solutions for decentralized clinical trials. She has been in the pharmaceutical industry for 20 years and has held multiple roles in clinical supplies project management.

Previously, she spent 6 years as the Director of Project Management for the Catalent Philadelphia, Pennsylvania site, where she was responsible for a team of project coordinators, project managers, and senior project managers. Nicole joined Catalent in 2012 as part of the acquisition of Apuit’s clinical supplies business, where she oversaw multiple project management teams. Before joining Catalent, she held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives. She is an alumna of Temple University, where she earned her Bachelor of Arts degree. Nicole is an active member of the Global Clinical Supplies Group (GCSG), having held multiple roles including Board Secretary, Presentation Coordinator, US Conference Vice-Chair and US Conference Chair. She will be the Vice-Chair again for the 2025 US Conference.

Harsha K Rajasimha, Ph.D., is a serial entrepreneur, scientist, patient advocate, and philanthropist. Harsha is Founder and CEO of Jeeva Clinical Trials Inc.(https://jeevatrials.com) a AI-driven unified platform for sponsors to execute modern clinical trials with efficiency and universal accessibility.

Harsha serves as the founder chairperson of the Indo US Organization for Rare Diseases (https://indousrare.org), where he is forging a new era of cross-border cooperation among various stakeholders of rare diseases in the US, India, and globally by convening the annual Indo US bridging RARE Summit (https://summit.indousrare.org) and the Abbey Meyers Khushi Bridging RARE Awards Gala.

Harsha’s 20 years of experience in precision medicine data research spans academia, federally funded research, healthcare and life science consulting, and multiple startups. Harsha made bold career moves after losing a newborn child to a rare congenital disease in 2012 and his younger brother with juvenile diabetes in 2017. He decided to apply his years of postdoctoral training at NIH and FDA to combat rare diseases. At Jeeva, Harsha leads the development of a unified software platform for efficient clinical trials for rare and common conditions that are universally accessible. He knew that technology is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would be critical ingredients of the continuously learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to diverse patients who need them anywhere by over 3x faster.

Harsha maintains academic affiliation at George Mason University since 2012 and has authored 17+ publications, book chapters, and patents. Harsha’s work has been recognized by Lead India Foundation 2020 Award for leadership and outstanding achievement in rare diseases, a travel award to join the NGO Committee on Rare Diseases at the United Nations headquarters, New York City in Feb 2019, NTT DATA Healthcare Life Sciences Silver award for outstanding achievement 2017, Sanofi Genzyme patient advocacy leadership award 2016, Bioscience company of the year 2014, NEI director’s innovation award 2012 for building their genomics data infrastructure. Harsha earned his M.S. in Computer Science (2004) and Ph.D. in Genetics, Bioinformatics and Computational Biology (2007) from Virginia Tech.

Sam Srivastava is the CEO of WCG. He is a transformative health care executive with a proven track record of driving growth and innovation in health care delivery. Sam has a passion to deliver better healthcare and is committed to leading with compassion. Prior to WCG, he served as the CEO of Neue Health and COO for Bright Health, leading strategy, development, integration, and operations.

Before joining Neue Health, Sam served as CEO at Magellan Healthcare, a leading behavioral, specialty and pharmacy management company serving 50 million customers worldwide. During his tenure, the company diversified, doubled in size, launched the nation’s first health plan for the seriously mentally ill, and developed digital therapeutics and advanced illness care programs.

Prior to Magellan, Sam worked at Cigna where he was president of the national employer and Medicare businesses. He also led U.S. strategy and business development, that included the strategic acquisition of HealthSpring and launch of Cigna Ventures. Sam has also held executive positions leading the Commercial, Medicare, and Medicaid businesses at UnitedHealth Group. He has also served as a management consultant in the US and Europe, developing risk-based integrated delivery systems for providers, insurers, and governments.

Sam serves as the advisory council chairman of the Yale School of Public Health, as well as board director for the Recovery Centers of America. He is a frequent national speaker and has testified to Congress regarding the opioid crisis aiding in the passage of the bipartisan SUPPORT act. Sam holds a Bachelor of Arts in medical science and humanities from Kent State University and completed graduate work at Yale University in health care management.

Silvio Galea is chief data & analytics officer at WCG, where he leads the Data integration and AI rollout to help create solutions that deliver efficient, safe, and impactful clinical research. With a career spanning over two decades, Silvio has led digital initiatives that foster competitive differentiation, enhance business agility, and streamline operational efficiency across numerous enterprises.

Prior to WCG, Silvio was the chief operating officer at Norbert Health where he oversaw regulatory and clinical affairs at a pioneering AI-driven hardware company that developed an ambient health scanner capable of non-intrusively measuring vital signs within a close range. At Cigna-Evernorth, Silvio helped modernize the company's data and analytics infrastructure through the delivery of various data-centric assets, including a data lake, data warehouse, and analytics platform, which unified and refined data across the global organization. Silvio's journey in the digital arena began with transformative roles across notable institutions and companies like Harvard Business Review, Businessweek, Bloomberg, ColeHaan, and others.