Industry Insights

1. Advanced Therapies In The UK: A Recipe For Success? 10/7/2022

   This article discusses the current landscape for advanced medicinal therapies (ATMPs), explains the benefits and challenges of developing and adopting them, and outlines best practice resources and schemes developed in the U.K. that are supporting and accelerating the delivery of new, cutting-edge medicines to patients.

2. Tips For Your Virtual Meetings With The FDA 10/7/2022

   It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

3. FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner 10/6/2022

   Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

4. Allogeneic Cell Therapy Results: Delving A Little Deeper 10/3/2022

   Poseida's CEO explains that the allogeneic cell therapy data we have seen from others has been uninspiring, but the natural follow up question is, “What about those data has fallen short, and what are the likely causes for those results?” The answer is multi-faceted.

5. Manufacturing CGTs: Should I Use A CDMO? 9/30/2022

   Given the current regulatory framework, manufacturing issues are a major challenge for sponsors of cell and gene therapies. This article shares some key questions and considerations you should ask yourself in order to make the decision whether or not you should use a CDMO.

6. Life Sciences RIM: Modernization & Moving Ahead 9/28/2022

   Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

7. Effective Medical Communications During CGT Clinical Trials 9/27/2022

   Medical communications help crystalize the nuances of cell and gene therapies for patients and healthcare providers. For a successful cell or gene therapy launch, you'll need to draw attention to stakeholders early in clinical trials to effectively inform them of the value of the therapy in development. This article shares key tips for an effective strategy.

8. 6 Best Practices For Biopharma Talent Management In 2023 9/23/2022

   The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.

9. Overcoming 4 Challenges In Orphan Disease Clinical Trials 9/22/2022

   Developing innovative treatments for patients with orphan and rare diseases offers substantial challenges. This article shares the author's tips for recruiting from small patient populations, collaborating with the FDA, choosing to work with a CRO or not, and determining a patient-centric approach.

10. Securing Cell and Gene Therapies Access for Patients 9/21/2022

    CGT manufacturers should be focused on the resiliency of processes, systems, and data within their vein-to-vein value chain in order to protect against cyber-attacks. CGT manufacturers that deprioritize cybersecurity efforts risk their ecosystem being vulnerable to cyber-attacks that can adversely impact their business and the patients they serve.