The Big4Bio Podcast

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 Clinical uses rigorous upfront feasibility, pre qualified high performing sites, and real time data over...

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 cont...

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, pri...

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 i...

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...

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-r...

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...

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, fun...

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...

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 a...

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 landsc...

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...

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 th...

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 Investmen...

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 unce...

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 it...

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...

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 sho...

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 Laborato...

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 founde...

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 rapi...

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 hum...

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 ide...

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...

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 I...