Parexel Regulatory & Access Hub
Welcome to the Parexel Regulatory & Access Hub
Register now for full access to all the content
2:29It is essential to address the payer landscape very early in development for a product administered once with a lifelong effect, such as a gene therapy. The one-time, front-loaded costs of these treat
2:28Learn how Parexel brings the principles and energy from face-to-face investigator meetings to an interactive and engaging virtual environment.
3:29Dr. Scott Gottlieb, Former Commissioner of the Food and Drug Administration speaks with Parexel’s Peyton Howell, Executive Vice President, Chief Commercial & Strategy Officer and Sy Pretorius, Executi
3:18RWE experts Leanne Larson, Senior Vice President and Worldwide Head, Real-World Evidence and Access and Amy McKee, Vice President, Regulatory and Access dig deeper into the evolving role of RWE.
Recommendations for navigating the "new normal" and how to prepare for the future.
A lay summary for patients participating in clinical trials
The COVID-19 pandemic has brought many negative feelings to the forefront of our everyday lives, including anxiety, fear and social division, but what if we explored the new positive relationships...
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....
The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...
If regulatory and payer landscapes are so different, then why bring the two worlds together?
A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...
Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the...
Use Real-World Evidence to Navigate From Regulatory Approval to Reimbursement Success
The value strategy (also termed value story) for your product should act as the cornerstone for all market access activities. The value strategy drives your market access planning, which...
Health Technology Assessment (HTA) agencies are increasingly demanding the inclusion of patient-relevant data in submission dossiers. It is evident that there is an effort to ensure...
Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities. Designing a facility or finding a contract manufacturer to meet the...
Patients have unique perspectives on their conditions that, when incorporated into value communications, can provide an authenticity and salience which would otherwise be lacking. Who knows...
Find out how to plan evidence generation for your value story!
