The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This decision follows an investigation into the new safety signal from postmarketing adverse event reports and clinical trials.
In today’s episode, Fierce Pharma’s Angus Liu talks with Parexel regulatory experts Mwango Kashoki, M.D., Senior Vice President, Global Head of Regulatory Strategy, and Steve Winitsky, M.D., Vice President, Technical - Regulatory Strategy, to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line.
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 3
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 2
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 1
Preparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 Achievements
Three trends impacting market access in the EU
How can we advance fair and ethical reimbursement for patients?
Beyond the Binary: Navigating Gender Diversity in Clinical Research
Why Rare Disease Therapeutics Need Early Market Access Planning
CROs and Their Role for Nano-rare
RBQM Podcast Series | Episode 4: Three ways to de-risk your DCT implementation
Careers at Parexel — FSP Podcast Series | Episode 2: Celebrating a 25-Year Career with Kerri McCaul-Claus
Careers at Parexel — FSP Podcast Series | Episode 1: Get Recruited to Be a Clinical Research Associate: The Benefits of Parexel’s FSP Program
The Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit
Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials
RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry
Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment
RBQM Podcast Series | Episode 2: Cultivating Risk-based Behaviors
Decentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented Communities
Episode 19: Improving Rare Disease Drug Development
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