The Big4Bio Podcast

The recently released update to the International Council for Harmonisation M12 guidelines provides a consistent approach to drug-drug interaction studies across different regulatory agencies. The new guidelines replace regional and local ones and set a global standard for addressing drug-drug interactions. We spoke to Michael Templin, Senior Principal Scientific Advisor for Charles River Laboratories; and Marko Andric, Senior Business Development Director, Late Discovery, for Charles River Laboratories; about the new guidelines, changes drug developers will need to make in their approach to pre-clinical development, and the tools and technologies that might help them comply. A related webinar on the guidelines can be found at www2.criver.com/l/60962/2024-11-05/n5wj6y

Partnering has long been a critical engine to drive companies’ success in the life sciences. In the current difficult financing environment, executives and business development leaders need to take advantage of opportunities to meet with organizations around the world to ensure they have the capital, resources, and expertise they need to achieve their goals. We spoke to Patrik Frei, CEO and founder of Venture Valuation, about the role partnering plays in the life sciences, The Pre-JPM Partnering Week that will run virtually December 2 through 6, and how companies can best position themselves for a productive JPM Week.

Ultra-rare neurological diseases are often without any treatment options. Even if a biopharmaceutical company decided to pursue one of these conditions, it’s unlikely that a child already diagnosed would be able to get treatment in time to prevent irreversible damage. Charles River Laboratories has embarked on a three-pronged strategy to work with families of children with these conditions to rapidly develop customized therapies. This involves the simultaneous pursuit of drug repurposing, antisense oligonucleotides, and gene therapies customized to individual patients. The company is using induced pluripotent stem cells to create differentiated cells with a patient’s genetics to study the disease and screen treatments. We spoke to Roxana Redis, Associate Science Director of Advanced Modalities for Charles River Laboratories, about the potential to rapidly develop so-called N-of-1 therapies, how Charles River does this, and why its pursuit of multiple modalities at once is designed to meet the urgency of these patients.

One of the challenges for drug discovery for new therapies to treat neurological conditions has been the need for better models of the various cells within the human brain and the interaction between different cell types. Charles River Laboratories, through a partnership with Bit Bio, has been able to access a consistent and scalable supply of a variety of induced pluripotent stem cell-derived human brain cells that have enabled the development of multi-cell cultures that can model various neurological diseases. We spoke to Malika Bsibsi, research leader at Charles River Laboratories International, about the challenges of developing treatments for neurological diseases, the limitations of animal models and single cell type cultures, and how this new approach promises to improve drug discovery in what has been a difficult area for therapeutic developers.

The emergence of TechBio takes center stage at this year’s BioFuture conference, which will be held in New York City, one of the emerging centers of this new breed of companies. The conference will explore the transformative forces from AI to digital medicine that are reshaping healthcare. The conference, which will be held October 28 to 30, brings together innovators and investors to exchange ideas, discuss trends, and do business. We spoke to event organizer Sara Demy, co-founder and CEO of Demy-Colton, about BioFuture, how innovative technologies are transforming the healthcare landscape, and why it is unlike other biotech conferences.

AI is increasingly being integrated into the drug discovery process and promises to not only increase efficiency, but expand the chemical space for drug developers to explore. Even though it is still early days for the technology, it is already demonstrating its ability to be a powerful tool across a broad set of applications from testing molecules in silico to designing new molecular entities. We spoke to David Clark, Senior Research Leader in UK Small Molecule Drug Discovery at Charles River Laboratories, about the potential to harness the predictive powers of AI to improve drug discovery, how generative AI can get us to better drugs faster and cheaper, and how this technology is reshaping the drug discovery process.

For drug developers, hit identification is a critical part of the discovery of new medicines, but the proliferation of therapeutic modalities, new biological targets, and screening technologies has meant that there’s not a one-size-fits-all strategy for drug developers to pursue. We spoke to Rob Howes, Head of Discovery Sciences UK for Charles River Labs, about the need for pairing the right hit Identification strategy to a target, how hit identification is gaining importance as funding activity picks up and biopharmaceuticals turn their attention to rebuilding their early-stage pipelines, and why compelling hit identification data can attract fresh capital to a drug developer. You can learn more about Charles River Labs Hit Identification work at https://www.criver.com/products-services/discovery-services/integrated-drug-discovery/hit-identification?utm_source=big4bio&utm_medium=podcast®ion=3701

One of the reasons that drug development is so expensive and time consuming is the cost of clinical trial failures. A critical means of accelerating drug development and reducing its cost lies in identifying candidates during preclinical development that have risks that outweigh their benefits and eliminating them from the pipeline before they advance to the clinic. We spoke to Sarah Gould, Director and Senior Principal Scientific Advisor for Charles River Labs, about the types of risks that can be detected through preclinical testing, strategies that can be used to de-risk programs, and why doing so in the current environment can take on growing importance for companies seeking funding or licensing agreements.

Cryo electron microscopy, or Cryo-EM, enables high-resolution screening for small-molecules or biological ligands, particularly for targets that are challenging to crystallize. One area that technology is proving to be a valuable tool for is the development of lipid nanoparticles, which have emerged as important vectors for mRNA and other genetic medicines. Cryo-EM can be used to analyze the size, shape, payload characteristics and other aspects of LNPs. We spoke Tim O’Bryan, director of discovery partnerships and commercial integration for Charles River Labs; and Karl Bertram, co-founder and managing director for ATEM Structural Discovery; about ATEM’s Cryo-EM technology, its incorporation of machine learning, and how it fits in with Charles Rivers’ broader drug discovery offerings.

Despite significant advancements, the field of Synthetic Biology has yet to fully deliver on its promise of a world where we can overcome the challenges we face in human health and the environment by programming biology. Elegen has developed innovative, cell-free technologies that allow it to synthesize DNA with unprecedented speed, length, and quality. We spoke to Matt Hill, founder and CEO of Elegen, about Elegen’s ENFINIA DNA technology, the need it addresses, and how it has disrupted the status quo for DNA synthesis.