ARTICLES BY TRISHA GLADD
Federal Ruling Offers Some Regulatory Clarity For Biosimilars
On July 21, 2015, the Federal Circuit reached a momentous decision in the case of Amgen vs. Sandoz. The significance of this ruling goes well beyond the rights of these particular manufacturers, as the decision marks the first step toward clarifying the regulatory path for U.S. biosimilar manufacturers.
Advances In Science Could Give Way To Limited NIH Funding
Funding allocated to the National Institute of Health (NIH) has declined considerably over the last decade, particularly the last five years, despite the fact that the cost of conducting biomedical research has gone up. Without budget predictability, the NIH is now forced to be very conservative with grants. This is where we could see a significant impact to both the pharmaceutical industry and patients.
First Commercial-Scale ADC Facility Launches In North America
As of last month, there are a total of 264 antibody drug conjugates (ADCs) in pharma’s pipeline. 161 of those are being developed in North America, making it the continent with the highest number of ADCs in development. Despite this, there is not a company currently offering ADC manufacturing capacity through commercial scale in North America. However, this will no longer be the case by the end of this year.
3 Critical Considerations For Cell Therapy Manufacturing
While autologous cell therapies offer promise in the way of patient treatment, manufacturing them is a complex process requiring thorough understanding of the cell type(s) that a company will be providing as therapy. When it comes to ensuring the successful manufacturing of a cell therapy drug, Ross Tubo, chief scientific officer at Vericel Corporation, says there are three critical areas where particular attention should be paid.
Are Your Single-Use Sensor Tests Set Up To Fail?
When it comes to testing methods, experts warn that the same testing methods used on stainless-steel sensors should not be used for single-use sensors. If an attempt is being made to recreate results achieved with a traditional sensor, it’s very possible for those results to appear unfavorable with a single-use sensor.
DARPA’s Challenge: Manufacture A Biopharmaceutical In Less Than 24 Hours
In order to ensure American soldiers fighting in remote locations overseas can receive the biopharmaceuticals they need on time, Defense Advanced Research Projects Agency (DARPA) created a program called Biologically-derived Medicines on Demand (Bio-MOD). The goal of Bio-MOD is to build a system that has the ability to create an on-demand biopharmaceutical in less than 24 hours. I spoke with one of the teams working on this effort about how they intend to accomplish this and what it could mean to the future of the industry.
Is Your Supply Chain Ready For the Biopharma Tidal Wave?
In order to manage risk in your supply chain, you have to know where it exists. The same logic is applied when quantifying risks during a process change. Just as a lack of quality affects the patient, so does a lack of supply. So what can you do to ensure your supply chain provides a safe and efficient delivery of your product?
Academia Is Pivotal To The Future Of Pharma Innovation
We all know that biosimilars have been driving several recent M&As (e.g., Hospira) across the industry. And yes, biosimilars, generics, and second-generation drugs all can keep pipelines and pockets full. But you know what they don’t do — offer new treatments or cures for diseases. That requires innovative R&D and drug development, and that’s why I believe academia is even more important to the industry than ever before.
Genzyme Pioneering Continuous Manufacturing In Biotech
One company that has made significant progress in the development of a continuous manufacturing platform for large molecule drugs is Genzyme. I recently spoke with Jason Walther, a staff scientist at Genzyme, about the impact of continuous manufacturing on the industry as well as its potential.
Drug Shortages Highlight Quality Problems
On the same day the Wall Street Journal published an article highlighting the issue of drug shortages in the US, CDER Director, Dr Janet Woodcock, delivered a keynote at the ISPE Quality Manufacturing Conference. Dr. Woodcock discussed initiatives by the FDA to overcome issues with manufacturing quality, a leading reason for drug shortages in the US.