In the United States, the FDA and CDC recently granted emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine for 5–11-year-olds, making it the first COVID-19 vaccine available for younger children and arriving nearly one year after Pfizer’s COVID-19 vaccine received EUA for adults. If the adult vaccine was authorized for this long, why did it take so long to make one available for younger children?

In today’s episode, Nathalie Sohier, Global Head of Infectious Disease and Vaccines, and Shipra Patel, Global Head of Pediatrics explain the clinical trial process for vaccines, the nuances in this process for children, and the facts parents should know now that the vaccine is available for younger children.

Viral infections continue to emerge and represent a serious threat to global public health, from SARS to H1N1 influenza to MERS. Yet none has caused the level of global devastation levied by the coronavirus. In fact, the long-term complications of COVID-19 on our healthcare system are just beginning to come into focus. Managing these complications will increase the demand for healthcare resources in the years to come and will elevate the need for novel therapies to manage them. This episode features Sy Pretorius, Parexel’s President, Clinical Development & Chief Medical Officer; Paul Bridges, Senior Vice President, Regulatory and Access at Parexel; and Ruggero Rossi, Vice President, Health Advances on how biopharmaceutical companies are preparing for COVID-19-related complications, the development of novel treatments to manage them, and future investments in vaccine development for infectious diseases so that we are better prepared for future pandemics.

Pediatric participation in clinical trials is essential to understanding how drugs perform in children, whose side effects and responses to medications are often very different from adults. Yet the vast majority of medications are only evaluated in adults, and pediatric participation in clinical trials remains exceedingly low worldwide. In this podcast, experts discuss critical insights gleaned from a survey of 500 parents and children about their perceptions and experiences of clinical research. Hear from Sarah Glass, Global Head of Rare Diseases at Parexel; Shipra Patel, Senior Medical Director at Parexel and a pediatric endocrinologist at UNC-Chapel Hill; Annick de Bruin, Senior Director, Research Services at CISCRP; and parent advocate Rachel Daley about how to incorporate learnings from the pediatric survey — sponsored by Parexel and conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) — into designing more child-friendly and family-friendly trials.

Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief Commercial and Strategy Officer, talks with Paul Bridges, Worldwide Head of Regulatory and Access, and Sheela Hegde, a Partner with Parexel’s Health Advances subsidiary, about the regulatory, investing and clinical development changes that are most likely here to stay – The New Pragmatism. After listening, you can read more about Paul and Sheela’s perspective in this article: https://regulatory-access.parexel.com/parexels-covid-19-expert-content/covid-19-and-the-new-pragmatism

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.

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.

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.

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.

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?

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.