Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.

Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.

Explore how AI can transform your pharmacovigilance efforts and enhance patient safety by leveraging the insights and decision framework outlined here.

Tune in as experts discuss how biopharma companies can effectively engage healthcare decision-makers in the evolving digital landscape.

Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.

Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.

Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.

In this podcast episode, Michael Braun-Boghos and Cheryl James share their expertise and perspectives on leveraging innovative approaches to enhance patient safety initiatives.

Explore the strategic considerations for successfully navigating the regulatory complexities of targeted medicines. Learn about the challenges in translational medicine and key clinical development considerations.

Explore how statistical science and computational biology can accelerate drug development. Learn how innovative trial designs and Bayesian statistics can lead to more efficient and successful clinical trials.

How can integrated development planning reduce development timelines and increase your chances of commercialization success? Industry experts reveal how this approach helps avoid common pitfalls.

Discover the evolving landscape of AOMs as a value and access expert shares the latest payer coverage trends, concerns, and strategies. Learn how payers are making critical coverage decisions.

Streamline complex cell and gene therapy logistics with an integrated platform that connects manufacturers with vital services, providing full visibility and control for a more efficient and successful patient journey.

Emily Whitehead’s CAR-T cell therapy journey highlights the power of patient engagement in cell and gene therapies. Discover how her story and advocacy drive a patient-centric approach in innovative treatments.

Cell and gene therapies (CGTs) have the potential to revolutionize medicine. However, achieving therapeutic success requires advanced logistical consideration to ensure product safety and efficacy

Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.