Rx for Biotech

OncoOne is a biotech company developing novel therapeutics for patients with solid tumors and autoimmune diseases. In this podcast episode, Brent Meadows, Chief Business Officer and US General Manager, discusses the role of oxMIF in innate and adaptive immunity and outlines the company's development approach and plan for entering the clinic.

In this podcast episode, our guest, Karoline Eastman, SVP of Customer Experience and Strategy Lead at Pixacore, discusses new digital trends for pharma in 2023 and how to improve HCP and patient customer engagement.

Our guest in this episode is Cove Therapeutics CEO, Niren Shah, who discusses the pitfalls of current viral vector based gene therapies and shares how Cove's next generation non-viral gene delivery platform overcomes many of the challenges of viral vectors.

There are many hurdles to streamlined, cost-effective manufacturing of cell and gene therapy products. To help address this, the Alliance for Regenerative Medicine published A-Cell, a case-based guidebook to help drug developers incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs. A-Cell builds on previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene), bringing best practices in CMC to a case study of a CAR-T therapy manufacturing.

This is the second of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. This episode covers key questions around conducting a risk assessment and best practices for product and process characterization for cell therapies.

There are many hurdles to streamlined, cost-effective manufacturing of cell and gene therapy products. To help address this, the Alliance for Regenerative Medicine published A-Cell, a case-based guidebook to help drug developers incorporate Quality by Design (QbD) principles into cell-based therapy CMC programs. A-Cell builds on previous QbD efforts that were applied to the manufacturing of monoclonal antibodies (A-Mab), vaccines (A-Vax), and more recently, gene therapies (A-Gene), bringing best practices in CMC to a case study of a CAR-T therapy manufacturing.

This is the first of a two-part deep dive into the A-Cell document as part of a round table conducted during Meeting on the Mesa. The first podcast episode explores quality by design principles and the importance of the quality target product profile.

The Inflation Reduction Act was signed into law in August 2022 and is one of the most significant pieces of healthcare reform since the Affordable Care Act. In this episode, learn more about how the new policy will impact R&D portfolio decision making and new product development strategies.

The FDA’s Office of Tissues and Advanced Therapies hosted their first virtual town hall to answer industry questions related to gene therapy chemistry, manufacturing, and controls. In this episode, we unpack what happened at the town hall and provide a brief overview of the key insights and guidance from the agency for those developing gene therapies.

Twice a year, the Alliance for Regenerative Medicine (ARM) surveys the cell and gene therapy landscape to advance the field and provide an update to their members, stakeholders, and the public.

In this podcast, Stephen Majors, Senior Director of Public Affairs, reviews key insights from ARM's updated cell and gene therapy sector report for the first half of 2022.

ARM is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies.

In this episode, Jan Hannon and Lisa Hefner from BluPrint Oncology dig deeper into scientific and medical communications and how health care provider education has evolved in the post-COVID pandemic era.

In this episode, Paul Callahan, President and Founder of CDT Pharma Strategies discusses market access, trade and distribution best practices for novel therapeutics.