As the evolution of the global pharmaceutical industry continues to drive the need for more flexibility and lower costs, continuous manufacturing becomes an even more appealing and sensible option. However, despite the tremendous promise of its economic and quality control benefits, there are still many concerns about the regulatory landscape for continuous manufacturing. Dr. Christine Moore, executive director and global head of chemistry, manufacturing and control (CMC) policy at Merck, recently discussed the company’s pursuit of worldwide approval of continuous manufacturing for solid oral dosage products and what regulatory risks it sees as potential roadblocks.
John Crowley, chairman and CEO of Amicus Therapeutics discusses why biotechs in the rare disease space face particularly unique and fundamental challenges.
From global macro trends to a discussion of which trends from other industries will leak into life sciences, these top-level experts offer in-depth insights for the coming year.
Dr. Ray Kurzweil, a futurist, inventor, pioneering computer scientist, and director of engineering at Google, believes that in the next 10 years 3D printers will be able to print human organs using modified stem cells derived from a patient’s own DNA, thereby providing an inexhaustible supply of organs with no rejection issues.
Although the pharma industry will see continued refinements to global biosimilar regulations and more biosimilars entering the fledging U.S. market, experts say the biosimilar space will be evolving slowly through 2016.
As the patient-consumer becomes more educated and savvy, they will inevitably start to push back concerning the discrepancies in U.S.- versus international-branded drug pricing.
The changes in technologies, processes, and relationships you can expect in 2016 to support the expected dramatic increase in the use of biologics.
Early integration of delivery device expertise and methodologies – to create a true combination product team — will emerge as best practice in biopharma companies that succeed.
Given the choice, I would choose the combination of a mediocre asset and a great management team over a great asset and a mediocre management team. Simply put, management teams can create or destroy value.
Eileen Daniel, executive director of clinical operations at Nektar Therapeutics, always felt there were ways the clinical trial planning process could be improved.
In December 2014, Biogen got some huge news that sent its stock up nearly $19 — in just one day! The company had achieved positive Phase 1b clinical trial results for its experimental Alzheimer’s drug, BIIB037 (aducanumab). The data looked so good, in fact, that Biogen announced it would be fast-tracking the drug straight to Phase 3 clinical trials.
Some biomanufacturing experts have recently begun referring to the expected growth of biologic therapeutics as an oncoming tidal wave or tsunami. Like the natural disasters these terms describe, there can be harmful repercussions — both to the industry’s reputation and the patients in need — if companies are not adequately prepared for the impending biologic manufacturing capacity crunch.
One egg per person. That is what it takes to produce a flu vaccine. The standard, predominant method has not changed in more than 70 years.
In 2014, the FDA’s Center for Drug Evaluation and Research (CDER) approved 41 new molecular entities (NMEs) and new therapeutic biological products; it was an exciting year for the biopharmaceutical industry. These approvals set a record not seen since 1996, when 53 new NMEs were passed.