Payer insights for cell and gene therapies
It 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
Maximizing your virtual investigator meeting results
Learn how Parexel brings the principles and energy from face-to-face investigator meetings to an interactive and engaging virtual environment.
CAR-T: A patient’s cell therapy success story
Clinical trials of (CAR) T-cell therapies can present unprecedented enrolment challenges. How can we encourage participation in these trials? Doug Olson, one of the first CAR-T patients treated on a
Parexel on the pulse
Parexel regulatory expert, Mark Birse, gives an update on BREXIT.
Impact of Real-World Evidence on Payers & Patients
Dr. 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
Real-World Evidence: The Feedback Loop
RWE 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.
Accelerated Pathways – Alberto Grignolo
FDA Quality Management Maturity Pilot Programs
Parexel’s Paul Bridges, SVP Regulatory & Access and Lynne Ensor, Head of Global Compliance outline the benefits for drug manufacturers in participating in two new FDA pilot programs. These include API
Parexel on the Pulse
Paul Bridges on the EU Clinical Trial Regulation (CTR)
Genomics & biomarkers: Answers in the blood
Parexel’s Anita Nelsen, SVP, Translational Medicine and Michelle Hoiseth, Chief Data Officer, Corporate VP speak with Ashley Druckenmiller about caring with her two sons with hemophilia and the benefi
Patient registries: Defining the patient
Parexel’s Leanne Larson, Corporate VP and WW Head, Real-world Evidence speaks with Deborah Collyar, cancer survivor and President of Advocates in Research about the importance of Real-world Evidence (
Innovation: Today’s patients, tomorrow’s medicines.
Sy Pretorius, EVP and Chief Medical & Scientific Officer, Parexel and Gadi Saarony, CEO, Advarra discuss how industry-leading innovations help to reduce the time and cost of development, minimize the
Leveraging Real-World Evidence in a Rare Disease Oncology Drug Approval
Parexel experts discuss a recent project involving a Rare Disease Oncology therapeutic, in which our experts leveraged Real-World Evidence and FDA/Regulatory expertise to develop and execute a Synthet
Parexel Patient Advisory Council: EU Meeting
Rare Diseases: Aligning Expertise
See how Parexel are bringing together regulatory and market access experts to help companies developing rare and orphan disease products. Learn more about our Regulatory & Access Consulting Group: htt
Parexel Biotech: The value of patient-centric approaches - escaping the clinic
Parexel’s Rosamund Round, Director, Patient Innovation Center and Amy McKee, Vice President, Regulatory Consulting Services sit down with Monica Theis, a breast cancer survivor and two-time clinical t
Parexel Biotech – designed with biotech’s unique way of working in mind
James Anthony, SVP, Global Head Biotech and Graciela Rácaro, SVP, Global Head, Biotech Operations, both from Parexel, discuss how Parexel Biotech has been built to meet customer and the patient needs
Parexel dares to do its part #WithHeart
Navigating Global Regulatory Submissions
Parexel® Regulatory Consulting Services
An overview of Parexel’s Regulatory Consulting services.