The field of gene therapy is growing exponentially, with The first gene therapy study was carried out in 1989 and since then, around 2600 clinical trials have been conducted. To help companies overcome issues surrounding the development and commercialization of gene therapies, the FDA directs considerable effort toward the development of regulatory frameworks and policies that provide necessary guidance to the industry. On January 28, 2020, the FDA issued Chemistry, Manufacturing, and Control (CMC) information for human gene therapy Investigational New Drug applications (INDs). The FDA's guidance document provides recommendations to sponsors of human gene therapy INDs on how to include sufficient CMC information to delineate the safety, quality, strength, and purity of the investigational product in an original IND application.
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In an industry as complex and highly regulated as life sciences, how does one get started on their company’s intelligent automation journey? With help from industry experts from companies like Pfizer, MilliporeSigma, and Johnson and Johnson, we put together this industry-specific, step-by-step guide for effectively:
This handbook draws on the discussions of leading experts and real-life experiences to serve as a guide to navigating the challenges of Pharma/CMO relationships and best practices for building long-lasting partnerships.
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The outsourcing biologics industry is expected to grow to $87.5 billion by 2027.
With the approval of the first recombinant DNA product, Humulin, biologics has brought great enthusiasm and excitement to doctors, patients and others in the pharma field. Utilizing human life tissues, the practice of biologics can ultimately pave the way for personalized treatments to specific cures based on your DNA and live tissues. With so much promise, small pharma companies are outsourcing R&D to CMOs, but this process continues to show some bumps in the road. For example, how do pharma companies go from clinical to commercial working in partnership with CMOs? How do they increase speed to market?
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The efficient onboarding and management of CMO networks is crucial to ensure that drugs get to market on time and within budget given the increasingly complex factors being applied by sponsors to supplier selection. If Sponsor/CMO partnerships are not managed effectively and are not mutually beneficial, drug development timelines and market access can be affected.
This report contains insights from over 50 individuals within the Pharma industry, and is accompanied by commentary from Ulrich Ruemenapp, Head of Launch Preparation at Bayer. Download now to take an in-depth look at the most important components when selecting a CMO, the greatest risks when choosing to outsource and best practises for managing CMO networks.
Given that unexpected challenges in CMO relationships can arise anywhere, it is important to devise a crisis management strategy that ensures production suffers as little interruption as possible, whilst protecting the necessary high quality levels. Ensuring that a CMO-related crisis is effectively managed can help save time and money for both parties.
This report was put together using insights from individuals working directly on Pharma/CMO relationships. In each case, we asked individuals how they would tackle a particular CMO crisis; we have compiled their insights into this handy guide.