In this episode, Parexel’s Mwango Kashoki, a former FDA regulator, and Richard Macaulay, who specializes in market access challenges, join Alberto Grignolo to discuss expedited regulatory pathways and how they can impact payer evaluation. In particular, the discussion focuses on how the gap between regulatory approval and reimbursement can affect patient access to new therapies and how new models are being developed to address this dilemma.
Most Recent Articles
Episode 15: Pandemic Preparedness: Investing in the future of infectious disease vaccine development
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...
Episode 14: Why Parents and Children Join Research Studies: CISCRP’s 2020 Pediatric Perceptions & Insights Survey Reveals Critical Insights
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...
Episode 13: The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
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...
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,...
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...
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)....
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...
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...
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...
Podcast: Opportunities for biotechs in precision medicine, driving value and bringing important new therapies to patients
Parexel precision medicine experts Angela Qu and Arlene Hughes join host Alberto Grignolo to discuss how biotech companies can incorporate precision medicine into their development plans.
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...
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...
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...
Episode 1: International Women's Day
In our inaugural podcast, Siri Chilazi, a gender equality expert and Harvard Kennedy School Research Fellow, speaks with female leaders from PAREXEL - Dr. Kemi Olugemo, Dr. Ubavka DeNoble, Aida...