This series highlights how Charles River Laboratories partners with biotech and pharmaceutical companies to accelerate research, focusing on modern challenges like personalized medicine, AI, and regulatory changes.

Every Moment Matters: Charles River Series

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 from the National Institutes of Health and third in terms of biotech jobs. We spoke to Nancy Kelley, president and CEO of Nancy J. Kelley and Associates and founding member of Builds Bio+, about the New York/New Jersey region for biotech, its  strengths, and what’s ahead for the sector there.

Biotech in the City that Never Sleeps

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 companies an alternative to building and staffing their own vivaria with state-of-the-art facilities located in major biotech centers. CRADL provides scalable and flexible solutions that can save young companies the need for substantial capital expenditures on space, equipment, and staff. We spoke to Julie Freebersyser, senior director of CRADL, about the company’s offerings, its expansion through its 2022 acquisition of Explora BioLabs, and how companies working with CRADL are able to leverage the greater expertise and services within Charles River.

Delivering Research-Ready Vivaria with Speed, Scalability, and Flexibility

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 clients to detect off-target binding early in the drug development process using its Retrogenix platform, cell microarray technology that can identify potential safety problems of an experimental therapy (https://www2.criver.com/l/60962/2024-01-31/n4wrxz). We spoke to Mark Aspinall-O’Dea, associate director of U.K. advanced modalities for Charles River Labs, about the risks of off-target binding, how its Retrogenix platform technology works to detect potential problems, and its ability to work across therapeutic modalities.

De-Risking Therapeutic Candidates with Off-Target Screening

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 commercialize these diagnostics February 13 and 14 in San Diego to learn from each other, network, and provide visibility into the future of the industry. We spoke to Giles Hamilton, investor and advisor to life sciences companies and Mitzi Rettinger, chief revenue officer for DCN Dx, about the evolution of the diagnostics industry, what’s ahead at the ALFC 2024 conference.

Rapid Diagnostic Test Innovators Look to the Future

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, Life Sciences Practice Leader for Charles River CFO, about the current financial environment for biotech companies seeking to raise money, how CRCFO works with biotech clients, and how the use of an outsourced CFO can allow younger biotechs to cost-effectively tap deep industry experience.

Navigating the Growing Challenges for Biotech CFOs

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 drug developers to make critical go-no-go decisions earlier. We spoke to Zack Gurard-Levin, science director in discovery for Charles River Laboratories about the advantages SAMDI’s mass spectrometry offers over alternative technologies, how it enables the study of a broad range of modalities, and how it fits into a comprehensive set of Charles River offerings.

Rethinking Mass Spectrometry for Drug Discovery

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.

Driving Deeper Insights into Structure-Based Drug Design with Cryo-EM

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.

Augmented Science: AI’s Place in Drug Discovery

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.

Gazing into the Future of Biotechnology

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.

Overcoming Neuroscience Challenges Using Complex Cell Models

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.

Innovating the Development of Therapies for N-of-1 Patients

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.

Setting the Stage for Productive Partnering Talks During JPM Week

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

ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?

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 capitalize on a range of financing options that may present themselves. We spoke to Beloff about what CEOs should do now to get their companies positioned for different financing options, how they can de-risk themselves, and the things it is never too early to do so they can capitalize on opportunities when they arise.

Why Biotech CEOs Should Prepare Now for All Opportunities

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 risks. C3 Risk & Insurance Services has created “The Answer,” a proprietary database of 13,000 shareholder suits with 80 data points around each to guide companies in their coverage decisions. We spoke to Mike Milligan, managing director at C3 Risk & Insurance Services, about its shareholder lawsuit database, the insights it provides, and why who owns a stock is a much better indicator of a company’s risk of being sued than the size of a price drop.

Understanding the True Risk of Biotech Shareholder Lawsuits

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 years later, the company has built a consistent brand, set of services, and unified offering across its North American locations based on the best of both companies. And, Explora BioLabs clients now have direct access to Charles River’s other products and services. We spoke to Charlie Cook, Senior Director of Operations for Charles River Labs, and Julie Freebersyser, Executive Director NA Insourcing Solutions for Charles River Labs, about the merger, the benefits it has brought, and the greater flexibility it provides its clients.

Leveraging Synergies: How a Merger Provides Speed, Flexibility, and a Unified Offering for Customers


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 milestone. We spoke to Kevin Sarney, Life Sciences Practice Leader for Charles River CFO, about the current uncertainty biotechs face, the need for capital efficiency, and how companies can best prepare for future opportunities.

Surviving and Thriving in the Long Biotech Winter

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 to Director of the European Portfolio for EBD Group Claire Macht and BioXconomy Partnering and Investment Editor Millie Nelson, about the state of the European biotech industry, the landscape for finance and dealmaking, and what to expect when 5,700 investors and biotech executives gather for 30,000 meetings Vienna.

A Moment of Opportunity for European Biotech

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, Big4Bio is kicking off an occasional series on discovery sciences with Charles River Labs, which, over the past five years, has contributed to more than 80 percent of novel FDA-approved drugs. We spoke with Charles River Labs' chief scientific officer of discovery Justin Bryans, and Charles River Labs' vice president and chief scientific officer for discovery and safety assessments, Steve Bulera, about the challenges of drug discovery, why every moment matters, and the benefits of the collaborative approach Charles River takes in working with its partners.

Every Moment Matters: Navigating the Complexities of Drug Discovery

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 issues of tariffs, drug pricing, and access to funding continue to weigh on leaders within the sector. We spoke to Tim Scott, president and CEO of Biocom California, about the current state of the biotech industry, a surge in mergers and acquisitions driven by the looming patent cliff, and what Biocom is doing to support companies through partnerships, advocacy, and policy reform.

What It Takes for Life Science Innovation to Thrive

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 Gould and Charles River Laboratories’ Scientific Business Director Omar Aziz about the evolving landscape of predictive toxicology, regulatory efforts to advance alternatives to animal testing, and the role of collaboration and strategy in accelerating therapeutic programs from concept to the clinic.

Every Moment Matters: How NAMs Are Rewriting the Rules of Antibody Discovery

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 discovery sciences with Charles River Laboratories, we explore the use organoids as powerful tools within the arsenal of New Approach Methodologies. We spoke to Charles River Labs Senior Research Leader Ludovico Buti, and Charles River Labs Chief Technology Officer for Discovery David Fischer, about the use of organoids, how Charles River is integrating these powerful tools into its work, and their potential to transform early discovery.

Every Moment Matters: Transforming Discovery with Organoids

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 use of the Logica AI platform and virtual control groups. We spoke to Charles River Labs Senior Science Director Alison Jones and Director of Digital Product Management, Discovery, and Safety Assessment Laura Lotfi, about how AI is accelerating the discovery process, how data is a differentiator, and the enduring role of human scientific judgment in therapeutic innovation.

Every Moment Matters: Integrating AI into Drug Discovery

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 spoke to Michael Templin, director of scientific advisory services at Charles River Laboratories, about how a thoughtful DMPK strategy can identify liabilities early, how emerging tools like AI-driven prediction and organoid systems are reshaping the DMPK toolkit, and its role in influencing business decisions such as program prioritization and competitive differentiation. 

Every Moment Matters: DMPK’s Role in Making Better Drugs and Better Decisions

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 Laboratories, we look at how the company’s One Step approach guides sponsors from discovery concept to IND-ready clinical candidate. We spoke to Manu Kohli, principal scientific advisor for Charles River Labs, about how the company’s integrated development model works, the benefits of having an end-to-end drug development solution under one roof, and how this approach helps deliver submission-ready assets on time and on budget.

Every Moment Matters: How Integrated Teams De-Risk the Path from Discovery to IND

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 tissue cross-reactivity studies to gain a more comprehensive view of target and off-target biology. We spoke with Charles River Labs  Associate Director of Advanced Modalities Mark Aspinall O’Dea and Charles River Labs Senior Scientific Director James Raymond, about how combining these two approaches helps sponsors select better leads, design safer studies, and meet regulatory expectations for complex modalities.

Every Moment Matters: Getting Better Insights on Target and off Target Biology

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 individual studies under good laboratory practice. Close collaboration between the two plays a critical role in helping clients build coherent, IND-enabling safety packages. We spoke to Pramila Singh, senior principal scientific advisor at Charles River Laboratories, about how scientific advisor–study director collaborations are crucial for creating robust, regulatory-ready study designs, how they help prevent costly errors, and how they can accelerate development timelines.

Every Moment Matters: The Power of Study Director–Advisor Partnerships

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 Healthcare Conference, has become an essential gathering place for emerging companies seeking visibility, funding, and deals. In addition to a packed agenda over three days, the conference will host 7,000 meetings between biotech companies and potential investors and partners. We spoke to Sara Demy, founder and CEO of Demy-Colton — which co-produces the Biotech Showcase with the EBD Group — about what’s in store at this year’s event, the large number of partnering meetings that are scheduled, and what participants can do to get the most out of the conference.

Biotech Showcase Readies as Biotech Stocks and Deals Pick Up

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 approach that continues to meet regulatory requirements and ensure patient safety. We spoke to Katie Sime, principal research scientist at Charles River Laboratories, about when reduced-tier approaches make sense, what regulators want to see; and why adaptive strategies can particularly benefit resource-constrained biotechs by balancing scientific rigor, patient safety, and budget constraints.

Every Moment Matters: A Case for Adaptive Immunogenicity Testing

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 diseases, a child may face a progressive, life-threatening condition with no available treatments. As we continue our series on discovery with Charles River Laboratories, we take a look at how the organization partnered with global collaborators and a patient’s family to design, screen, and advance a highly selective antisense oligonucleotide therapy targeting a pathogenic allele underlying a child’s ultra-rare epileptic encephalopathy. We spoke to Charles River Lab’s Associate Research Leader Blanca Torroba and Group Leader of Neuropharmacology Johanna Uhari Väänänen about how they moved from concept to a candidate for a custom ASO therapy, steps they took to accelerate the process, and the challenges of advancing N of 1 medicines to an IND.nbRb

Every Moment Matters: Developing an N-of-1 ASO for a Child with an Ultra-Rare Disease

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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