Episodes
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Forging Smarter Clinical CRO Partnerships - Fairooz Kabbinavar, REV Clinical
Trial design, recruitment, and supply chains represent pain points that routinely derail timelines and budgets for sponsors. There are, however, ways that emerging biotechs can get more speed, rigor, and strategic value from their relationships with clinical contract research organizations. REV...
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CRL - Every Moment Matters: Developing an N-of-1 ASO for a Child with an Ultra-Rare Disease
Advances in sequencing, the emergence of antisense oligonucleotide therapies, and the advent of induced pluripotent stem cell technology are among the combination of factors that have made bespoke medicines for individual patients scientifically feasible. In the case of ultra-rare, genetic...
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CRL - Every Moment Matters: A Case for Adaptive Immunogenicity Testing
Immunogenicity testing helps establish the safety of experimental therapies by ensuring drugs don’t trigger a potentially dangerous immune response. While regulators had long relied on a fixed, three-tier immunogenicity testing model, the industry is now shifting to a flexible, risk-based…
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CRL - Every Moment Matters: The Power of Study Director–Advisor Partnerships
At Charles River Laboratories, scientific advisors and study directors have complementary roles in nonclinical drug development. Scientific advisors bring years of scientific and regulatory experience to program-level strategy, while study directors act as operational captains who execute...
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CRL - Every Moment Matters: Getting Better Insights on Target and off Target Biology
Biologic drug development increasingly relies on sensitive, human relevant platforms capable of detecting both intended and unintended target engagement well before first in human studies. Charles River Laboratories is leveraging its Retrogenix cell microarray platform alongside traditional…
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CRL - Every Moment Matters: How Integrated Teams De-Risk the Path from Discovery to IND
The journey from discovery to IND is rarely linear. It demands rigorous target validation, continuous regulatory engagement, and the use of translationally relevant models to effectively de risk programs before they advance. In this installment of Big4Bio’s ongoing series with Charles River...
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CRL - Every Moment Matters: DMPK’s Role in Making Better Drugs and Better Decisions
Drug metabolism and pharmacokinetics, often referred to as DMPK, is not just a box to check on the way to advancing an experimental therapy into the clinic. In reality, it is an essential part of determining whether a program can result in a safe, effective, and commercially viable medicine. We...
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Biotech Showcase Readies as Biotech Stocks and Deals Pick Up - Sara Demy, Demy-Colton
As the biotech industry shows renewed strength with rising stock prices and growing deal values, thousands of biotech industry leaders, investors, and innovators will gather in San Francisco in January for the annual Biotech Showcase. The event, which runs concurrently with the J.P. Morgan...
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CRL - Every Moment Matters: Integrating AI into Drug Discovery
Charles River Laboratories is leveraging its deep discovery sciences expertise with advanced computational tools to accelerate drug development, improve safety, and reduce animal use. In this episode of our continuing series on discovery sciences with Charles River Labs, we explore the company’s...
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CRL - Every Moment Matters: Transforming Discovery with Organoids
Organoids¬—miniaturized, three-dimensional, lab-grown, tissue cultures that mimic organs¬—can be used to improve drug discovery and safety testing by providing more predictive human biology models than traditional 2D cultures or animal testing. In this episode in our continuing series on…
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CRL - Every Moment Matters: How NAMs Are Rewriting the Rules of Antibody Discovery
As we continue our Big4Bio occasional series on discovery and safety assessment with Charles River Labs, we explore new approach methodologies, or NAMs, and their integration with antibody discovery and development. We spoke to Charles River Laboratories’ Senior Principal Scientific Advisor Sarah...
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What It Takes for Life Science Innovation to Thrive - Tim Scott, Biocom
California research institutes, universities, and biopharmaceutical companies are a critical source of innovation, contributing to the development of approximately a quarter of new drugs that the U.S. Food and Drug Administration approved last year. But despite the breakthroughs, more mundane...
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CRL - Every Moment Matters: Navigating the Complexities of Drug Discovery
Discovery is a complex and high-risk process in drug development, as researchers strive to identify and advance promising therapeutic candidates. It requires scientific prowess, advanced technologies, and strategic vision to navigate through potential obstacles with agility. With this episode,...
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A Moment of Opportunity for European Biotech - EBD Group
With government funding cuts to research in the United States and an uncertain and erratic policy environment, stability is emerging as a strength Europe is seeking to leverage to attract scientific investment and talent. As the industry readies to gather in Vienna for Bio-Europe 2025, we spoke…
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Surviving and Thriving in the Long Biotech Winter - Kevin Sarney, Charles River CFO
The IPO market remains unwelcoming to biotechs and venture investors are reticent to back younger companies. In the absence of reliable funding sources, many biotechs are trying to advance their most promising programs while keeping their operations lean until they can get to a fundable…
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Leveraging Synergies: How a Merger Provides Speed, Flexibility, and a Unified Offering for Customers
In 2022, Charles River Laboratories acquired the vivarium operation services provider Explora BioLabs. The acquisition both complemented and expanded the operations of CRADL (Charles River Accelerator and Development Lab), which is part of Charles River’s Insourcing Solutions business. Now, three...
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Understanding the True Risk of Biotech Shareholder Lawsuits - Mike Milligan, C3 Risk & Insurance
Biotech companies are more prone than most to shareholder lawsuits because single events can often cause sharp and sudden price drops in their shares. While they buy insurance to protect their officers and directors from financial exposure, companies often do poorly to understand their actual...
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Why Biotech CEOs Should Prepare Now for All Opportunities - Gregg Beloff, Danforth Advisors
With the JPMorgan Healthcare Conference on the horizon, biotech CEOs are wondering whether the new year will bring a more welcoming IPO market. But Gregg Beloff, co-founder and managing director of Danforth Advisors, said rather than focus on an IPO, companies should prepare themselves to...
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Charles River Labs - ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?
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...
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Setting the Stage for Productive Partnering Talks During JPM Week
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...
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Innovating the Development of Therapies for N-of-1 Patients - Roxana Redis, Charles River LAbs
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…
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Overcoming Neuroscience Challenges Using Complex Cell Models - Malika Bsibsi, Charles River Labs
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…
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Gazing into the Future of Biotechnology - Sara Demy, Demy-Colton
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...
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Augmented Science: AI’s Place in Drug Discovery - David Clark, Charles River Labs
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…
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Confessions of a Hit Man: Matching Target Strategies to the Need - Rob Howes, Charles River Labs
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...
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Why Failure Can Be a Faster Path to Success - Sarah Gould, Charles River Labs
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…
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Driving Deeper Insights into Structure-Based Drug Design with Cryo-EM - Charles River Labs
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...
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Solving Major Bottlenecks in Genetic Medicine and SynBio - Matt Hill, Elegen
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...
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Using Early Biomarker Discovery to Secure Clinical Success - Stefan Kostense, Charles River Labs
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...
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Rethinking Mass Spectrometry for Drug Discovery - Zack Gurard-Levin, Charles River Labs
Earlier this year, Charles River Laboratories acquired SAMDI Tech, a provider of proprietary mass spectrometry technology that enables label-free, high-throughput screening for drug discovery. The technology cuts cost and accelerates the time it takes to identify a lead drug candidate, enabling...
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Navigating the Growing Challenges for Biotech CFOs - - Kevin Sarney, Charles River CFO
Chief Financial Officers in the biotech industry operate in a complex and ever-changing financial landscape. In addition to being charged with traditional financial duties, they must navigate regulatory uncertainties, manage risks, and adjust to evolving market dynamics. We spoke to Kevin Sarney,...
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De-Risking Therapeutic Candidates with Off-Target Screening - Mark Aspinall-O’Dea, CRL
The high cost of drug development is linked to the high rate of therapies that fail in the clinic. Safety concern relating to the ability for an experimental therapy to bind to more than a target of interest is one major reason drugs fail in development. Charles River Labs is working with its...
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Rapid Diagnostic Test Innovators Look to the Future - DCN Dx
Lateral flow diagnostics, those rapid tests that can be performed virtually anywhere without the need for specialized skills or equipment, have been an area of growth and innovation. The Advanced Lateral Flow Conference 2024 will bring together professionals who develop, manufacture, and...
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Leveraging Technology to Avoid Costly Clinical Trial Delays - Arthur D. Little
Drug developers face great pressures to complete clinical trials on time and on budget, but challenges like patient recruitment, patient retention, and site selection can cause unexpected delays with significant economic consequences. This is particularly true in the area of rare disease drug...
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Investors and Innovators Gear Up for Biotech Showcase - Tina Elder, EBD Group
The Biotech Showcase has grown into an essential part of the start to the new year in biotech as investors and industry executives gather in San Francisco to meet each January. This year’s event offers a dazzling array of content and opportunities for interaction. We spoke to Tina Elder, Global...
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Remaining Capital-Efficient While Accessing Seasoned Talent - Ramani Varanasi, Danforth Advisors
For emerging biotechs, an experienced chief medical officer can provide invaluable guidance, but with limited resources many may feel they can’t afford to bring someone in-house full time. Danforth Advisors has assembled highly-qualified, industry-proven talent to help companies access…
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Delivering Research-Ready Vivaria with Speed, Scalability, Flexibility - Julie Freebersyser, CRADL
Conducting preclinical animal studies pose a number of challenges for biopharmaceutical companies including the need for costly vivarium space, having the necessary expertise, and ensuring regulatory compliance. Charles River Labs’ CRADL, the Charles River Accelerator and Development Lab, offers...
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Keeping Employees Engaged and Productive During Difficult Financial Times - Ann Darda, Danforth
The financial pressures on biotechs these days are forcing companies to shelve programs, slash their burn rates, and cut employees. In addition to the challenges companies face keeping their teams motivated in the face of adversity, they may find the tight labor market is making it difficult find...
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Envisioning the Future of Healthcare - Sara Demy, Demy-Colton
The emergence of genetic medicines, the convergence of information technology and biotechnology, and the growing ubiquity of artificial intelligence represents some of the transformative forces reshaping healthcare in the years ahead. The BioFuture conference, which will be held in New York City...
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Biotech in the City that Never Sleeps
New York City, in addition to being a financial capital of the world, is also a major center for biotech. The New York/New Jersey region has long had the presence of top academic research institutions and a large number of top pharmaceutical companies, but it is also the top region for funding…
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A Region Where Biotech is a Capital Idea
The Capital Region, which includes Maryland/Virgina/and Washington, D.C., is home to the federal government, including the National Institutes of Health and the U.S. Food and Drug Administration. The region is fourth largest in terms of biotech jobs and sixth in venture capital funding. We spoke…
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A Home to Amazon, Starbucks, and Biotech Too
Seattle’s life sciences sector has long boasted top-tier research institutions like the University of Washington and the Fred Hutchinson Cancer Center. The region ranks fourth in venture capital funding for biotech. The decision by Pfizer to acquire Seattle Genetics for $43 billion reflects the...
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A Look at a Star-Studded Biotech Region
The Los Angeles/Orange County region leads the nation in life sciences jobs. It’s sixth in venture capital, and seventh in National Institutes of Health Funding. As Big4Bio expands with a new edition to cover the life sciences community in the greater Los Angeles area, we spoke to David Whelan…
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Addressing Drug Developer Challenges with Decentralized Clinical Trials
The COVID-19 pandemic disrupted the traditional clinical trial model and accelerated the adoption of decentralized clinical trials. Trial sponsors are embracing these new approaches as a way to improve recruitment and retention of patients, relieve the travel burden on participants, and remove...
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Pioneering Fully Programmable Medicines
While the development of genetic therapies promises to revolutionize medicine, many challenges remain before this emerging area of therapeutics can be fully realized. Senda Biosciences is tapping into a world of naturally-existing nanoparticles to address these challenges. It is creating new...
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Recruiting in a Competitive Market for Life Sciences Talent
Despite a growing number of layoffs in the healthcare and life sciences sectors, the demand for C-Suite and senior executive talent remains high and companies are having to compete for key hires. They are finding that they need to do more than just pay up for talent to attract the employees they...
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How Biotechs Can Best Navigate through Tough Financial Times
As economic pressures weigh on the ability of life sciences companies to raise capital, there is pressure on them to do more with less. With investors growing more risk averse, companies are taking steps to cut expenses without jeopardizing the pace at which they can advances their work to the…
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Delivering Efficient and Flexible Infrastructure to Life Sciences Companies
The pace of science is accelerating, but it can still take years to deploy lab and manufacturing space. This requires large upfront capital expenditures, long-term financial commitments, and often results in rigid facilities that are designed for a single purpose. SmartLabs enables life sciences...
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The Biotech Showcase Readies for a Big Year
Biotech investors and executives are expected to flock to San Francisco for a set of annual conferences in January. The Biotech Showcase has grown into a critical meeting to start the new year. With concerns about the pandemic receding, it is already attracting a large number of registrations.…
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Life Sciences Executives Learn to Give Until It Hurts
Award-winning life sciences journalist and mountaineer Luke Timmerman is once again leading The Timmerman Traverse, a three-day, 23-mile hike across New Hampshire’s Presidential Traverse to raise money for the non-profit Life Science Cares. Timmerman has assembled a team of venture capitalists…
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About this show
The Big4Bio Podcast shares podcasts that give insight and information about/from biotech and life science leaders and organizations within the Big4Bio regions. Check out our Playlists to hear podcasts by region.
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