Talking Biotech with Dr. Kevin Folta

Advancement of a new drug from pre-clinical trials to clinical trials is a pivotal time in validation of its therapeutic effects and safety.  A panel of experts discusses the process. 

Today's episode marks the beginning of the 10th year of the Talking Biotech Podcast.  To celebrate, Drs. Liza Dunn and Kevin Folta discuss the last decade of biotech breakthroughs and communications efforts, the fight against technology and the amazing progress in gene editing and human genetic therapies. Plus, what you can do to help the effort going forward. 

Chronic inflammation goes hand-in-hand with many diseases, complicating symptoms and affecting routes of treatment. What is the molecular basis of inflammation, and can it be targeted by new drugs? Scientists have studied the molecular basis of the inflammatory response and have identified specific proteins that complex to initiate the response. New drugs are showing promise in breaking the inflammatory cascade. Studies of genealogical records revealed additional targets that modify known genetic pathways that contribute to Alzheimer's, cancers and cardiovascular disease. Dr. David Bearss from Halia Therapeutics explains the roles of inflammation and the mechanisms behind several drug candidates that are targeting chronic inflammation. 

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

Canada has a unique approach to plant genetic improvement that follows the product, not the process. In other words, if there is potential risk from any genetic manipulation technique, from polyploidization to transgenic to gene edits, Canadian regulators assess the relative risk in the final product. But what does the regulatory climate look like going forward as gene editing becomes more routine? Today's podcast is a conversation with Jennifer Hubert, Executive Director of Biotechnology at Crop Life Canada. 

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.