BIO From The Editor and Guest Columns

1. Recommendations For Managing Complexity In Pharmaceutical Operations 1/21/2020

   There is an inherent tendency in pharmaceutical operations to make things much more complex than they need to be. “More” is considered to be better, what regulators want to see. However, more content in an SOP, additional signatures, and new forms and control loops do not necessarily equate with “better.”

2. CAR T-Cell Therapy In Non-Hodgkin’s Lymphoma: Where Do We Go From Here? 1/16/2020

   Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, many key players are now pursuing development of therapies in earlier treatment settings and in other non-Hodgkin’s lymphoma subtypes, such as mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.

3. Are You Prepared For Impending Changes To U.S. Biologics & Biosimilars Law? 1/16/2020

   Sponsors for insulins and other protein products originally submitted for premarket review under an NDA may be anticipating the arrival of March 23, 2020 with trepidation. On that date, the BPCIA requires that those NDA-approved products will be deemed to have a BLA approval instead of an NDA approval.

4. CDER-ETP: A Resource For Innovative Biopharma Firms 1/15/2020

   The FDA’s Center for Drug Evaluation and Research’s Emerging Technology Program (CDER-ETP), is yet another step toward removing slow-moving bureaucracy and red tape that stands in the way of innovative new technologies that drive drug development. 

5. Why You Need A World-Class Quality Culture — And How To Build One 1/13/2020

   The quality culture of the organization has a clear and direct impact on the ultimate quality of the product, where either the quality is built into the product or is tested against the product for acceptance. This article discusses several ideas for implementing a quality culture that is based on innovation while ensuring compliance with regulations.

6. An Introduction To Forced Degradation Studies For Drug Substance & Drug Product 1/9/2020

   The forced degradation study is a vital analytical aspect of the drug development program for small molecules. Commonly known as stress testing, it is carried out to demonstrate as specificity to developed a stability-indicating analytical method, using high-performance liquid chromatography (HPLC). As per ICH Q1A, stability studies must be performed to propose the shelf life of new drug substances and/or drug products.

7. FDA FY2019 Human Tissue And Cell Therapy Observations And Trends 1/9/2020

   Very soon after publication of the FY2018 data on human tissue and cell therapy products, the FDA released the data from FY2019, which we address here. We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area. The regulations that govern this area, 21 CFR 1271, are the same regulations that govern segments of human cell therapy and gene therapy products. Human cell and gene therapy products are part of FDA’s Regenerative Medicine framework.

8. A Disruptive Approach To Oncology Therapy Development 1/9/2020

   CureLab Oncology CEO Alex Shneider’s lament is a biopharma industry that exhibits little appetite for those discoveries made while coloring outside the lines. We caught up with him for an update on the maverick path of lead candidate Elenagen.

9. Biosimilar Industry Advancements To Watch In 2020 1/8/2020

   Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

10. Packaging Good Manufacturing Practices (GMPs) For Medicinal Products 1/6/2020

    Has your supplier of primary packaging materials for medicinal products established and implemented — and continued to maintain — an adequate quality management system (QMS)? Generally, most suppliers of packaging materials maintain an ISO 9001 QMS. However, the requirements of ISO 9001 may not provide the necessary levels of good manufacturing practices (GMPs) and rigor to ensure the packaging materials are adequate for their intended use.