In, “The Outsourcing Balancing Act,” Leona Fitzgerald and Denise Moody from PPD talk about achieving the right blend of oversight and involvement as more and more clients become interested in outsourcing. The authors discuss different models for a client’s situation, such as insourced work with their internal staff, full-service outsourcing, functional service partnerships, or hybrid approaches and the best ways to provide oversight.
On the regulatory front, Walter Matzmorr from Tunnell Consulting says that being ready for a pre-approval inspection (PAI) is a key milestone for the successful approval of a new product and can significantly influence the approval timeline and the time to market for a new product. However, he says small companies and biotech startups who want to bring their first product to the market often struggle to determine if they are ready for a PAI. Mr. Matzmorr takes us through this cross-functional process that includes several phases and covers elements of technical and regulatory compliance, organizational aspects, process validation and training.
When it comes to drug delivery, Louise Righton of 3M Drug Delivery Systems, says pharma needs to adopt a more “up-front” approach, rather than the “add-it-on” at the end attitude that is too prevalent across today’s pharma landscape. She says that by bringing drug development and drug delivery closer together, what we’re really bringing closer together are drug acceptance and effective treatment, and that’s a win for all involved.
Discussing the Regenerative Medicine Advanced Therapy (RMAT) market for this issue is Mark Sawicki from Cryoport. He says the RMAT market presents a major opportunity—the market generated $17.03 billion in revenue in 2016 and is expected to reach $50.55 billion by 2025. But there is a great deal at stake for the companies that are racing to develop these revolutionary therapies. The author addresses challenges that range from integrating new manufacturing techniques, answering bioethics questions, to ensuring product safety, product efficacy, and more.
Lastly, there has been a growing fervor among regulators, equipment suppliers, research institutions and consulting houses that pharmaceutical companies should use continuous processing for the manufacture of drugs. In, “The Good, The Bad, and The Ugly Complexities of Pharma Manufacturing,” Girish Malhotra of EPCOT International says that the use of continuous processes where relevant is not a bad idea. In fact, it is a great idea. However, the author argues that such processes MUST be authenticated according to established definitions.
As in each issue of Contract Pharma, we cover a wide range of topics related to pharma drug development, manufacturing and outsourced services. If there is a topic you’d like to see covered or are interested in writing about, please feel free to send me an email with your thoughts and/or ideas. Hope you enjoy!
Tim Wright, Editor