PHARMA DEVELOPMENT & MANUFACTURING ARTICLES

• Biopharma Public Opinion, Pricing, Politics

  Biopharma sustainability will require the industry not shy from public opinion, but meet it head on. To win short-term battles, however impressively as with creation of the COVID vaccines, may not be enough to secure total victory.

• Building New Solutions For 2023 In Manufacturing And Supply Chain

  In this Q&A, 10 executives provide their thoughts on what the future holds for biopharmaceutical manufacturing and supply chain operations, and which issues will have the most impact.

• The Product Launch: When Slower Is Faster

  For the established company, a new product launch can be pivotal, spurring new growth — or all too often, sullying a great brand. And for the startup, it is usually the difference between success and failure

• A New Era of Biopharma Advanced & Continuous Manufacturing?

  New support from Capitol Hill and the White House, combined with new FDA regulatory efforts and added external stakeholder collaboration, may mean a new pharmaceutical manufacturing model is well underway.

• To Ace Your Product Launch, Don’t Fail At Market Access

  As manufacturers work to develop lifesaving drugs, they aren’t doing their homework to ensure that patients will be able to access their drugs at launch. Instead, they’re focusing on aspects of commercialization that, while important, won’t matter much if their therapy can’t make it into the hands of patients in the first place.

• How To Begin A Manufacturing Data Hub Initiative

  New product introductions, scaling up production on existing drugs, validating production lines with newer processes and/or technology, and dealing with regulatory feedback may all eclipse any data initiatives. They’re all critical activities, but they also require bumping down investment in core capabilities, including a digital core for manufacturing data.

• Reducing Human Error In GMP Operations With Defined Work Environments

  A “human performance” approach leans on structured methods that assess a site’s processes where human error presents the most risk, then implements solutions that stop these errors at the source.

• Overcoming Roadblocks Along The Cell Therapy Product Pathway

  As more therapies receive commercial approval, biotech executives will face challenges unlike those experienced with traditional pharmaceuticals. However, biotech executives can take steps to minimize some of these challenges throughout the cell therapy product pathway and scale efficiently.

• The Main Obstacles To A Pharma 4.0 Program And How To Deal With Them

  Even with a sound strategy and the right people onboarded, there’s always something that can hold a company back from successfully implementing a Pharma 4.0 program.

• The Worldwide War On Counterfeit Medicines

  It’s a sobering trend for the pharmaceutical industry. The counterfeit medicines market is growing at twice the rate of the market for legitimate prescription drugs. So what can be done?