The Parexel Podcast

Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster, MD, Head of Parexel’s Oncology Center of Excellence; Matthew Cooney, MD, co-lead of Parexel’s Cell and Gene Therapy initiative; and Keith Donovan, an expert in Early Phase Development with a focus on oncology, join Alberto Grignolo, Corporate Vice President, Regulatory and Access, to discuss the progress made in cell and gene therapy as presented at ASCO and how the industry can continue to move these developments forward today and in the future.

Episode 11: Maintaining Clinical Trial Continuity During COVID-19: The Patient Perspective

Now more than ever it's important to recognize and show our appreciation for clinical trials and the critical role that they play in advancing public health. Since the outbreak of the COVID-19 pandemic we've seen many changes that have been made to clinical trials to maintain continuity. In this podcast, we explore how clinical trials have changed and adapted, and how those changes may impact clinical trials in the future for patients. Ken Getz, professor at Tufts University School of Medicine and the Founder and Chairman of the Center for Information and Study on Clinical Research Participation (CISCRP) moderates this discussion on this most important #ICTD2020 featuring three members of Parexel's Patient Advisory Council along with Parexel’s Chief Medical & Scientific Officer, Dr. Sy Pretorius.

Episode 10: The emerging role of wearables in clinical trials

The COVID-19 pandemic has forced us to rethink just about every aspect of clinical trials. An area of significant potential is the use of wearables as part of Decentralized Clinical Trials (DCTs). Today, wearables are enabling at-home care and providing long-term monitoring of COVID-19 patients. How can wearables change the game in this most critical time for our industry? What considerations need to be kept in mind when involving wearables in a clinical trial? Julia Lakeland, solutions architect, program director, and wearables expert for Parexel joins Sheng Feng, Parexel’s head of real-world data in Asia-Pacific, in this episode hosted by Keith Wenzel, a leader of our Scientific Data Organization, discussing the role of wearables in the future of clinical trials.

Episode 9: Making the Most of Functional Service Provider (FSP) Relationships

In this episode, we discuss how Functional Service Provider or FSP partnerships have been gaining traction and increasing in relevance in today’s environment because of their potential to offer flexibility, access to expertise, and reduce costs in outsourcing without compromising quality. Parexel’s Head of Global FSP Chris Baker discusses with FSP leaders Joanne Sullivan, Alisdair Falconer and Beth Shaleesh several “tips and tricks” for making the most of FSP relationships, how Parexel has built a successful FSP culture in areas including India, and what factors contribute to a successful FSP relationship - right from the outset.

Episode 8: Performing clinical trials in a shifting development landscape

The COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leaders about the implications of this pandemic for the important work of drug developers, researchers, and regulators. How are we to cope with the new realities? What new behaviors should we adopt to sustain progress? What are the new best practices when working with regulatory authorities, with clinical sites, and with each other?

Episode 7: International Women’s Day: Insights from Ascending Davos

In this episode, Parexel Executive Vice President and Chief Commercial & Strategy Officer Peyton Howell interviews Meghan FitzGerald, Parexel Board Advisor and author of the new book Ascending Davos: A Career Journey from the Emergency Room to the Boardroom. The two healthcare leaders discuss topics including Meghan’s career pivots from nursing to the healthcare industry to private equity, why you should take your CFO to lunch, and their unexpected friendship.

Episode 6: The opportunity for biotechs in precision medicine: driving value and bringing important new therapies to patients

Within the past 20 years, the field of precision medicine has been transformed. For biotech companies, this new landscape holds tremendous promise for innovation. So, why aren’t more companies leveraging this approach? In this episode, Parexel precision medicine experts Angela Qu and Arlene Hughes join host Alberto Grignolo to discuss this conundrum, and what biotechs should be thinking about right from the start, to open up the opportunity for this approach to help bring innovation and new therapies to more patients.  

Episode 5: CAR-T: How far have we come and where are we going?

In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days. Parexel’s experts Mo Heidaran, Alexander Gee and host Alberto Grignolo, all part of our newly-integrated Regulatory & Access consulting unit, also weigh in on the current regulatory and reimbursement landscape for CAR-T and what we might look forward to in the future for this and other cell and gene therapies.

Episode 3: Bridging the Gap – How Minimizing Patient Barriers Can Improve Clinical Research

In this episode Alberto Grignolo, Corporate Vice President, Parexel, Sy Pretorius, Executive Vice President and Chief Medical and Scientific Officer, Parexel, and Roz Round, Director of Parexel's Patient Innovation Center, team up to discuss how the clinical research industry can bridge the gap between the scientific needs of research and development and the needs of patients. Stemming from feedback based on a survey looking at perceptions of clinical trials, the episode explores current barriers to clinical trial participation patients face, how we can make research more patient-centric, and techniques to adopt to increase patient-centricity. Later, Roz interviews Shannon Scarlett, a Parexel employee and cancer survivor, about her experience as a trial participant.

Episode 2: Tackling Rare Diseases & Inside the FDA

Recorded during the 2019 World Orphan Drug Congress, this episode brings together Amy McKee and Mo Heidaran who both recently joined PAREXEL from the FDA, as well as Zizi Imatorbhebhe, an expert in rare disease drug development. Amy, Mo and Zizi discuss how the industry can work to deliver more innovative treatments for rare disease patients and the reality of working with the Food and Drug Administration (FDA). In the first segment, the experts share their insights working with the rare disease/orphan drug community, including patients, physicians, regulators and patient advocacy groups. Next, they focus on FDA’s recent leadership change and tackle some common misconceptions about working with the Agency.