Cliff Mintz

After almost a decade of debate, there is now a generally agreed upon definition for biosimilar molecules: a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference product) that demonstrates similarity to the reference product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exercise.

The current U.S. legal/regulatory landscape has given rise to two distinct types of companies that are attempting to commercialize cannabis products. The first of these is commonly referred to as medical marijuana companies, or as Steven Schultz, VP of investor relations at GW Pharma suggested, “nutraceutical or herbal remedy companies that promote the medicinal properties of cannabis.”

Biotechnology is one of the newest entrants to India’s life sciences sector and is expected to drive future growth of its burgeoning pharmaceutical industry. The company largely responsible for jumpstarting India’s biotechnology is Biocon Limited, a 35-year-old company founded and operated by Kiran Mazumdar-Shaw. Mazumdar-Shaw is one of India’s most influential women. Biocon currently employs 7,000 people and is one of the world’s top 20 biotechnology companies.

With increasing globalization of the pharmaceutical industry in emerging markets there is a need to standardize or “harmonize” regulations and requirements. By Cliff Mintz, Ph.D., contributing editor

Stuart Peltz founded Post-Transcriptional Control Therapeutics (PTC) to identify and commercialize small molecule drugs that work at the post-transcriptional level to modify protein production in therapeutics. By Cliff Mintz, Ph.D., Contributing Editor

Thinning drug pipelines, burgeoning development costs, and a lack of innovation suggest that the traditional pharmaceutical drug development process is too costly and inefficient to survive in its current format. Many pharmaceutical company executives blame these problems on increased regulatory scrutiny, escalating labor costs, and downward drug pricing pressures as the generic drug market continues to grow.

To bolster its therapeutic MAb (monoclonal antibody) development pipeline, in 2006, AstraZeneca purchased United Kingdom-based Cambridge Antibody Technology, and shortly thereafter, in 2007, acquired MedImmune for $15.6B. By Cliff Mintz Ph.D., Life Science Leader magazine

There is a growing realization among many American life sciences graduate students and postdoctoral fellows that a job as a tenure-track assistant professor at an academic institution or a research scientist at a pharma or biotech may no longer be viable options. 

Unlike a majority of academicians, Dartmouth’s Tillman Gerngross’ approach to biological research has always been extremely focused and, most importantly, practical.

A Q&A With Dr. Steven Projan, VP and head of global infectious diseases at the Novartis Institute for Biomedical Research (NIBR)