Using Real-World Evidence for U.S. Regulatory Decision-Making: What Pharma Needs to Know

Advanced therapy medicinal products (ATMPs) comprise a category of innovative and complex biological products and hold one of the keys to personalised treatment. It holds promises as treatments for untreatable and high burden diseases.

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.

During direct compression tablets are manufactured without pre-granulation. Excipients therefore need to be highly effective, controllable and free-flowing.

When it comes to the Pharma supply chain, problems can occur at any part of the process, including non-standardized bills of material, translation mistakes, typos and poor proofreading, missed annotations, unclear briefs, artwork problems, expired digital assets, third-party artwork suppliers and printing shops. Consumer and pharma companies must also deal with a very strict regulatory environment. Each time there is a problem, the manufacturer risks having to issue a (potentially major) recall.