Risk-based Approach to Biopharmaceutical Method Transfers

Pharmaceutical companies and their drugs face numerous challenges in the brief window between launch and patent expiration. This makes it extremely important to plan lifecycle management (LCM) strategies well in advance of patent expiry. One way to address this is with advanced manufacturing techniques that make it much more difficult for competitors to genericize. For pharmaceutical companies that seek market enhancement strategies beyond the capabilities of existing fast melt technologies, join Contract Pharma for this webinar as we hear from Don Wetherhold, the senior executive advisor and senior vice president of Aprecia Pharmaceuticals. He will talk about the company’s innovative ZipDose technology and why it offers an exclusive opportunity to address patient demand and create products not easily genericized.

Single cell cloning (SCC) is a critical and high-value process for an increasing number of applications including cell engineering; stable cell lines for therapeutic mAbs and biosimilars; vector production for gene therapy; and many more. During this webinar, Tom Kelly from Janssen (part of Johnson & Johnson) will talk about his use of Solentim’s VIPS™ (Verified in-situ Plate Seeding) system, the world’s first All-in-One Single Cell Cloning System. He will explain why Janssen moved away from older generation CLD technology using Clonepix, which was based on detecting and picking high-producer clones in semi-solid media.

Competency-based medical education (CBME) requires a vigorous and multidimensional assessment system. In order to successfully implement CBME, assessment processes must be continuous and frequent.

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians.