Strategic partnerships are becoming more important in development and deployment of biotechnology solutions. Today's panel discusses the way partnerships are formed, some of the important considerations with IP and licensing, and how relationships are managed. 

The news reports say that scientists have found "high levels" of herbicide in human sperm, and suggest it is a cause of infertility. But what do the data really say? Dr. Andrea Love and I discuss the paper. A report by Vasseur et al., in the June 2024 Ecotoxicology and Environmental Safety entitled Glyphosate presence in human sperm: First report and positive correlation with oxidative stress in an infertile French population strongly implies a tight connection between the herbicide glyphosate and world population decline.  However, it is a classical case of overstepping the data. This group studied 128 men in a French infertility clinic and quantified glyphosate in in their blood and seminal fluids. Amazingly, they found parts per trillion, very low levels. They also never measured levels in sperm. They did measure sperm quantity and quality and they are just fine in individuals with glyphosate levels and those below detection. So there is no effect on sperm, consistent with previous studies. They do identify a correlation between glyphosate presence and two oxidative stress markers, but it is unclear what the "normal" range is, and it is very difficult to connect parts per trillion of a benign herbicide and meaningful physiological response. However, this was enough to ignite the media into connecting this trace of herbicide to crashing world populations, when people are most likely simply having smaller families. Dr. Andrea Love @Dr_AndreaLove and immunologic.org

Where many therapeutic compounds are raised in bacteria or fungi, plants sometimes offer many advantages as bioreactors. Capital and production costs are lower, and products may be edible instead of injectable. The problem tends to be standardization, and conditions that ensure that the desired proteins are produced This episode features Jim Wilson from Zea Biologics, where cleanrooms, precise regulation of all aspects of the plant growth environment, and massive data collection, allow for the production of biological compounds to treat everything from hemophilia to influenza. The compounds are bio-encapsulated, a patented process that allows oral delivery instead of injection. Using precision "pharming" drugs and be produced at a lower cost in less time, and the products are temperature stable, allowing wider distribution at lower cost, with a lower carbon footprint. www.zeabio.com

Jennifer Hubert, Executive Director of Biotechnology at Crop Life Canada, discusses Canada's unique regulatory approach to gene editing, focusing on risk assessment of final products. The podcast explores the challenges and opportunities of gene editing technology, acceptance, and regulations in Canada, emphasizing the need for updated policies based on current scientific knowledge and global biotechnology frameworks.

Immunotherapy is weaponizing the body's immune system against cancer or other disease. One of the most promising approaches is CAR-T cell therapy, yet as this technology has been implemented, it's limitations have been identified. Dr. Andy Scharenberg described the current drawbacks of CAR-T cells and how his company, Umoja, is re-engineering CAR-T cells in vivo to create more effective therapies, including approaches that can address solid tumors. Co-hosted by Donald Coon. www.umoja-biopharma.com

How do new drug applications move forward to approval?  Four experts discuss the partnership between the FDA, the drug developer, and the data needed to move a product forward. It is a surprising discussion that reveals the depth of the FDA process.  Joined by Dr. Debra Webster, Dr. Julia Marre, Dr. Michael Matthews and Dr. Jonathan Helfgott. 

We live in amazing times of technological advance, but how are the real benefits of new tech lost to an inflated sense of risk?  Dr. Felicia Wu from Michigan State University shares her expertise in describing the psychological basis of risk and applying it to questions like glyphosate and aspartame. 

This is an update on the American Chestnut Restoration Project, as discussed previously on the podcast. The American Chestnut dominated the forests of Appalachia until an imported fungus destroyed the entire range. Efforts to restore the chestnut and its ecology have employed a biotechnology approach, integrating a gene from wheat that limits the mechanism the fungus uses to attack the tree. Dr. Andy Newhouse and Erik Carlson join the podcast to discuss progress in the project.  

Despite being over half of the population women's health care lags behind other areas of drug development. The problem is caused by many facets, but is augmented by the fact that many of the conditions are not life threatening or are functions of aging. Sabrina Johnson, CEO of Daré Bioscience, discusses how the disparity exists, the pipeline of drugs that seek to mitigate female-specific conditions, and how smaller, leaner businesses can have significant impacts in this space. 

The podcast discusses biotechnology innovations, collaborations with pharmaceutical data management software companies, panel discussions on business dynamics, debunking anti-GMO claims, advancements in gene therapy, and technological solutions in the citrus industry.