Season 1 Episode Guide
Episode 1: De-Risking Therapeutic Candidates with Off-Target Screening
Episode 2: Rethinking Mass Spectrometry for Drug Discovery
Episode 3: Using Early Biomarker Discovery to Secure Clinical Success
Episode 4: Driving Deeper Insights into Structure-Based Drug Design with Cryo-EM
Episode 5: Why Failure Can Be a Faster Path to Success
Episode 6: Confessions of a Hit Man: Matching Target Strategies to the Need
Episode 7: Augmented Science: AI's Place in Drug Discovery
Episode 8: Overcoming Neuroscience Challenges Using Complex Cell Models
Episode 9: Innovating the Development of Therapies for N-of-1 Patients
Episode 10: ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?
Episode 10
ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?
Guest experts: Michael Templin | Director, Senior Principle Scientific Advisor, Charles River, and Marko Andrić | Senior Business Development Director, Late Discovery, Charles River
Drug-drug interaction (DDI) data is crucial to building a successful IND package and, ultimately, creating therapies that are effective and safe for patients. New guidelines, aimed at harmonizing drug-drug interaction requirements across regulatory bodies globally, will require drug developers to evolve their approach to DDI studies.
In this episode, we talk to Michael Templin, Director and Senior Scientific Advisor, and Marko Andrić, Senior Business Development Director in Late-Stage Discovery, about the ICH M12 guidelines, and how they provide a framework for considering and addressing drug-drug interaction risk at earlier development stages. We dig into the details including scope, research implications, opportunities, benefits to patients, and the immediate impact on in-flight preclinical drug development projects.
Learn more about applying new ICH M12 Guidelines in this on-demand webinar
Episode 9
Innovating the Development of Therapies for N-of-1 Patients
Guest expert: Roxana Redis | Associate Science Director, Advanced Modalities, Charles River
Ultra-rare diseases are often without treatment options. Even if a biopharmaceutical company decides to pursue one of these conditions, it is challenging to produce a treatment quickly enough. Charles River has embarked on a three-pronged approach to N-of-1 drug discovery, designed to accelerate therapeutic development so that patients with rare and orphan conditions can receive the treatment they need in an impactful timeframe.
In this episode, we talk to Roxana Redis, Associate Science Director of Advanced Modalities, about how the simultaneous pursuit of drug repurposing, antisense oligonucleotides, and gene therapies could revolutionize the treatment of orphan and rare conditions, and how this approach is designed to meet the urgency of these patients.
Episode 8
Overcoming Neuroscience Challenges Using Complex Cell Models
Guest expert: Malika Bsibsi | Research Leader, Cell Biology, Charles River
The vast majority of drug candidates for neurodegenerative diseases fail before reaching clinical trials, resulting in a lack of disease-modifying therapies. One of the reasons for this slow progress is the quality of models that are available to study disease processes and for use in early stages of drug development. Commonly used mono-culture cells models, with neurons or microglia, fail to recapitulate the complex communication and interactions that occur between different cell types in the brain.
In this episode we talk to Malika Bsibsi, Research Leader at Charles River, about how human iPSC-derived cells provide an alternative to primary mouse or human cells for in vitro pharmacology assays, and how innovative multi-cell culture models can advance neuroscience drug discovery.
Episode 7
Augmented Science: AI's Place in Drug Discovery
Guest expert: David Clark | Senior Research Leader, UK Small Molecule Drug Discovery, Charles River
Does AI belong in drug discovery? Where does it fit? Machine learning and artificial intelligence are already broadly used across the scope of drug discovery, from helping us explore virtual chemical space to more accurate, faster data analysis, and even integrated candidate development.
In this pragmatic assessment of the current and future roles of artificial intelligence, we talk to David Clark, Senior Research Leader at Charles River, about how the application of AI is likely to shape and change the way we conduct drug discovery, and how researchers can leverage this virtual lab assistant to develop better drugs, in faster timeframes.
Episode 6
Confessions of a Hit Man: Matching Target Strategies to the Need
Guest expert: Rob Howes | Senior Director Hit ID, Small Molecule Drug Discovery, Charles River
In the current funding environment, it has never been more important to pair the right hit identification strategy with your target. As funding activity increases, hit identification is gaining greater importance with the widespread need to rebuild early-stage pipelines, and to build compelling data packages to attract fresh capital.
In this episode, we talk to Rob Howes, Senior Director of Hit ID, Small Molecule Drug Discovery. Learn about how the landscape of hit identification is changing, how drug developers can think innovatively to increase investor confidence in their candidates, how to strategically leverage a broad portfolio of technologies, and how to get started with novel or undruggable targets.
Episode 5
Why Failure Can Be a Faster Path to Success
Guest expert: Sarah Gould | Director, Senior Principal Scientific Advisor, Charles River
How can capitalizing on earlier in vitro methods and innovative technology increase investor confidence and support clinical success in a challenging R&D environment? 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 with risks that outweigh their benefits as quickly as possible.
In this episode, we talk to Sarah Gould, Director and Senior Principal Scientific Advisor at Charles River, about how we can reposition the way we think, plan, and strategize around de-risking therapeutic candidates and drug discovery programs.
Episode 4
Driving Deeper Insights into Structure-Based Drug Design with Cryo-EM
Guest experts: Karl Bertram | Managing Director, ATEM Structural Discovery and Tim O'Bryan | Director of Discovery Partnerships and Commercial Integration, Charles River Discovery
Cryo-EM is rapidly becoming an essential component of a comprehensive structure-based drug design portfolio. Often a more ideal solution for large and challenging complexes and structures which are difficult to crystallize, cryo-EM works by flash freezing samples for analysis.
In this episode, we talk to Dr. Karl Bertram from Charles River partner ATEM Structural Discovery about how the integration of AI with Cryo-EM can empower structure-based drug design, and specifically how their proprietary software can be leveraged for advanced automated characterization of lipid nanoparticles. Joining Karl is Tim O'Bryan, who will discuss how Charles River works collaboratively with research partners to provide a heightened user experience for drug discovery clients.
Episode 3
Using Early Biomarker Discovery to Secure Clinical Success
Guest expert: Stefan Kostense | Director of Biology, Discovery
More and more drug developers are choosing to begin their biomarker research early in the discovery pipeline. Biomarkers can provide insights into experimental therapies, identify patients who are likely to benefit from them, and improve chances for clinical success. Charles River Laboratories offers a range of early biomarker discovery services, leveraging the expertise of its scientists to identify biomarkers in the early stages of drug development programs.
In this episode, we talk to Stefan Kostense, director of biology at Charles River Laboratories, about the benefits of conducting biomarker discovery early in the drug development process, how it can drive development decisions and success in the preclinical phase and beyond, and how it benefits patients.
Episode 2
Rethinking Mass Spectrometry for Drug Discovery
Guest expert: Zack Gurard-Levin, | Science Director, Discovery
The SAMDI platform provides an innovative approach to high-throughput mass spectrometry, successfully navigating the optical interference challenges associated with many conventional high-volume screening approaches. In this episode, Science Director Zack Gurard-Levin and Daniel Levine discuss how the technology works to accelerate drug discovery and how "losing the label" can open new avenues for researchers to rapidly execute hit identification campaigns.
Episode 1
De-Risking Therapeutic Candidates with Off-Target Screening
Guest expert: Mark Aspinall-O’Dea | Associate Director of Advanced Modalities, Discovery
The high cost of drug development is linked to the high rate of therapies that fail in the clinic. Safety concerns relating to the ability of an experimental therapy to bind to more than the target of interest is one common reason for failures in development.
The Retrogenix® cell microarray is a unique innovative technology that enables researchers to detect off-target binding early in the drug development process. This identifies potential safety problems of an experimental therapy and generates data widely accepted by global regulators to support IND submissions and drive confidence in therapeutic candidates.
In this episode, Mark Aspinall-O’Dea, Associate Director Advanced Modalities in Discovery, talks to us about the risks of off-target binding and how this novel platform works to detect potential problems in a translatable in vitro setting across therapeutic modalities.
This podcast series was made in collaboration with Big4Bio and presented by Daniel Levine of Levine Media Group.