Industry Insights

1. Decoding The Immune Synapse To Create Novel Immunotherapies 8/2/2021

   The potential of T cell therapies to be curative by harnessing our own immune repertoire has exciting implications for cancer and many other immune-mediated disorders.

2. These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. 7/30/2021

   Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.

3. Shaping A System That Enables Patients To Access High-Cost Cell & Gene Therapies 7/28/2021

   The health and life sciences industry needs to create an effective financial system to support the complex new payment structures being adopted for cell and gene therapies.

4. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

   Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

5. Rare Diseases: How To Leverage Social Media For Patient Analysis 7/15/2021

   Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.

6. FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products 7/14/2021

   At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.

7. Designing A Patient-Centric Digital Ecosystem: Strategies For Cell And Gene Therapy CxOs 7/12/2021

   Cell and gene therapy (CGT) production is costly, complex, and high-risk; in part, because most supply chain and manufacturing processes involve multiple stakeholders and facilities. In the first article of this series we discussed how CGT adoption and success hinges on early planning to scale manufacturing and supply. This article describes strategies to enable a patient-centric digital ecosystem and capabilities to support CGTs before, during, and after the order life cycle.

8. How To Enhance “Operational Learning” In Biopharma 7/9/2021

   According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.

9. The Cumulative Risk Of Multiple CT Scans on Blood Cancer Patients Enrolled In Clinical Trials 7/6/2021

   Bob Levis, Director of CLL Society, proposes alternatives to CT scans for the FDA's consideration.

10. Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances 7/5/2021

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.