Talking Biotech with Dr. Kevin Folta

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.

After a three month hiatus the Talking Biotech Podcast is back. Today's episode is a visit with Colarbra CEO Aoi Senju about his view for the podcast, followed by synopsis of three major news stories that broke since the last Talking Biotech Podcast. The new format includes a video component, and I'll be speaking with panels and also discussing recent news stories. It is an exciting opportunity to capture a new audience, expand listenership, and provide new levels of programming to the popular format. Thank you for your patience and I hope you enjoy the new episodes. Kevin

After 8.5 years of weekly podcasts I'm going to take a 5 week break and plan new episodes for 2024. I'm going through a medical glitch that has me unable to do my normal work. On top of this we're going to switch to an audio plus video format to find a wider audience. So check back in 2024 for the next episode. Have a great rest of 2023, thank you for listening, and looking forward to better times.

Even under the best conditions, crops need our assistance to survive the numerous threats that limit production. Classically, synthetic and natural compounds have been used to control insects, fungi and weeds, sometimes with negative collateral effects or fostering resistance of genetically tolerant genotypes. Todd Hauser from Trillium Ag describes his company's novel RNAi approach. RNAi can be used to target specific insect species, and his company's design and particle-based technology appears to offer safety, effectiveness, and specificity. We discuss the use of RNAi and how it may be a key point of crop protection strategies, along with its inherent challenges.

There is tremendous variation in the plant kingdom, as plants have adapted to many ecological niches with discrete challenges. Part of adaptation is production of novel secondary metabolites, compounds not required for central metabolism that serve a role in the plant, such as defense or attraction of pollinators. The rainforest is replete with unusual plants and their resident metabolites. Indigenous peoples have identified therapeutic qualities of specific plants. How can this knowledge be transferred to aid those suffering beyond the rainforest? Lisa Conte is the CEO, President and Founder of Jaguar Health, a subsidiary of Napo Pharmaceuticals. We discuss process of working with indigenous peoples to learn from their findings, then test and validate them in ways to identify novel mechanisms of action for use in modern medicine.

Gene editing is a powerful and specific technique that allows customized changes to DNA. Because there are no additional sequences transferred, and alternations match what could happen naturally over time, the technology is considered less invasive and less prone to regulatory oversight. That's true in the USA, Canada, China and other nations. However, the European Court of Justice determined that these techniques should be regulated in a manner identical to transgenics, where the EU has not approved such innovations in over two decades. EU scientists see how the EU is falling behind and after long may never catch up. The rejection of technology leads to a tremendous economic loss. Dr. Emma Kovak of the Breakthrough Institute discusses the current regulations, the proposed changes, and the dynamics of opposition to a good technology that could have profoundly positive impacts for people and the planet.

Information has been weaponized, and the ability to create false information to achieve an ideological goal has never been more easy. Political polarization, science denial, and a shining, effective conduit of dissemination (the internet) allows anyone with an agenda to recruit the like minded, and produce compelling media to reinforce bankrupt ideas. Where did information warfare originate, what are its effects, and how do we fix it? This week's podcast discusses the book, On Disinformation: How to Fight for Truth and Protect Democracy with author Dr. Lee McIntyre. The book presents a chilling description of who creates disinformation, how subscribes to it, and its long term effect on free society. Fortunately, solutions are proposed that can help curb the penetration of disinformation, particularly as it becomes more effective through artificial intelligence.

While DNA captures most of the fanfare, proteins are the catalytic and structural superstars of the cell. However, they can also become problematic. Cells have intricate mechanisms to remove damaged or mis-expressed proteins that could be deleterious to cellular function. This process is mediated by a process called ubiquitination, mediated by a special class of proteins called E3 ligases. Ubiquitin is the tag that's added that signals that a protein should be moved to the biochemical garbage can. Dr. Juliet WIlliams of Kymera describes how their company has used modeling and A.I. to design molecular linkers that connect a protein that needs to be degraded with the machinery to tag it for destruction. The goal of this line of therapeutics is to target a suite of proteins that need to be degraded for normal health and development. Their pipeline contains multiple clinical and pre-clinical trials, and the approach is an exciting complement to other drug discovery methods.

Recombinant DNA technologies once confined to the laboratory are now available to just about anyone. Is this a good thing or an extreme risk? David Ishee is self-described biohacker, dog breeder and mad scientist, and merges these passions in cutting edge DIY projects and educational tools. We discuss the opportunities and risks in DIY molecular biology, biohacking and democratization of modern genetic plant, animal and microbial genetic tools.

We're surrounded by microbes, many that are the basis of disease. Others have evolved resistance to our best antibiotics. Others may be weaponized for bioterrorism. Because microbial threats can evolve rapidly and grow quickly, early detection of a microbial threat is essential. Dr. Brad Perkins of Karius describes the threats of microbes, his company's novel approach to fast and easy test that can detect evidence of thousands of putative pathogens in a small blood sample, essentially overnight. We discuss the technology and its applications. The technology stands to be an important tool to ensure a lower-risk pathogen environment in medical facilities, as well as detect putative pathogens before they become major problems for a patient or broader population.

The Pawpaw (Asimina triloba) is the largest native North American fruit, and grows wild throughout most temperate forests of the eastern United States and Canada, from southern Ontario to the Florida border. Several breeding efforts have sought to improve this tree crop, seeking mostly to improve fruit quality, especially post-harvest. The fruits feature a tropical flavor, a flesh that has been described as everything from marshmallow to banana, in a custard-like texture. Despite its flavorful appeal, few have experienced this fruit, mainly because of its perishable nature, and the fact that wildlife appreciate the fruit before humans ever get to it. However, a new initiative called Project Pawpaw seeks to improve the species for fruit production. Director Adam D'Angelo speaks about fundraising efforts to grow breeding populations, and utilize modern approaches to hasten development of improved pawpaws. Project Pawpaw website Follow on Instagram

In today's episode I cover two topics with Cameron English, science journalist and podcast host. We discuss the current status of citrus greening disease in the USA, a disease that has ravaged the Florida juice industry. We also discuss the copious disinformation around seed oils, which many internet sources claim to be dangerous.

The connection between tobacco smoke, cancer and heart disease has been well established since the 1800's, with irrefutable medical evidence presented since the 1950s. There is no question that smoking has significant public health impacts. The effects of second hand smoke were examined in various studies and also claimed negative effects. But these reports has some significant limitations, and larger studies later showed no significant risk. One of the authors, cancer epidemiologist Dr. Geoffrey Kabat, recounts the publication, the fallout, the lack of defense from the scientific community, and later independent reports that would reinforce their findings of no association with lung cancer and heart disease. While predating social media, the findings that did not fit a public health narrative where harshly criticized, using arguments that failed to address the evidence. This example is a precursor to understanding the modern-day discussions about issues like vaccination, COVID19, glyphosate, and other topics where the evidence is strong, but public opinion often fails to accept it. Dr. Kabat's accompanying article on Quillette.

This episode has two parts. The first part discusses how Odylia Therapeutics is addressing rare disease, using a novel non-profit model. The second half address two rare genetic eye diseases and the approaches being designed to address them. Dr. Ashley Winslow, CEO/CSO of Odylia, describes how a non-profit is well suited to address these rare diseases, using strategies that leverage capacities in rare disease patient communities coupled to their expertise in drug discovery.

The more information you know about your genetics the better, right? This is the idea behind companies like 23andMe, which offer platforms to understand your potential genetic predisposition toward a specific disease. The concept thrives on massive collection of public genetic data, coupled to extensive questionnaires that en masse, generate statistical associations between different genetic variants and various disorders, diseases, behaviors or drug sensitivities. These powerful tools are shaping our understanding of genes and genetic variants that contribute to our physiology, metabolism and psychology, and even aiding in drug discovery. Dr. Joyce Tung, Vice President of Research at 23andMe describes the technology, the evolution of the business, racial disparities, and what the future looks like for public genetic services.

DNA has been an invaluable tool to make certain matches between a suspect and a crime. Since its early use in the 1980s, we have seen an explosion in DNA sequence availability, allowing forensic scientists to identify hypervariable regions of the genome that can assist in confirming a person's identity. However, there are many ethical issues surrounding its implementation, such as use of public and private databases (like 23 and Me) to identify a suspect. The discussion covers a breadth of forensic applications with Brian Hoey, Director of the Missouri State Police Crime Lab.

If you've ever publicly communicated enthusiasm for a new product or technology, you inevitably have been accused to being a shill for the company that produced it. It is a normal part of human psychology to assume there is an undisclosed motivation for someone's excitement, and it is based on legitimate concerns about how conflicts of interest can shape one's perceptions of associated science. We discuss the topic with Dr. Chris MacDonald from Toronto Metropolitan University.