Pharmaceutical Development & Manufacturing

1. Biopharma Public Opinion, Pricing, Politics 12/1/2022

   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.

2. Building New Solutions For 2023 In Manufacturing And Supply Chain 12/1/2022

   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.

3. The Product Launch: When Slower Is Faster 3/1/2022

   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

4. A New Era of Biopharma Advanced & Continuous Manufacturing? 3/1/2022

   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.

5. To Ace Your Product Launch, Don’t Fail At Market Access 3/1/2022

   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.

6. How To Begin A Manufacturing Data Hub Initiative 3/1/2022

   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.

7. Reducing Human Error In GMP Operations With Defined Work Environments 1/4/2022

   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.

8. Overcoming Roadblocks Along The Cell Therapy Product Pathway 1/4/2022

   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.

9. The Main Obstacles To A Pharma 4.0 Program And How To Deal With Them 5/1/2019

   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.

10. The Worldwide War On Counterfeit Medicines 4/7/2017

    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?