Zachary Zubulake

Bristol Myers Squibb Anthropic Collaboration

Bristol Myers Squibb (BMS) has announced a strategic agreement with Anthropic to deploy Claude, in what the company describes as a shared intelligence platform across its global operations.

 The deal represents one of the more substantive AI commitments made by a major pharmaceutical company to date, extending well beyond the general-purpose chat tools that have dominated enterprise adoption. The agreement gives BMS employees access to Claude's capabilities, with the deployment prioritizing three areas: accelerating software engineering through Claude Code, embedding AI agents into core workflows, and connecting the model to the institutional knowledge spread across the company's systems and data repositories.

The key aspects of the agreement involve quality systems and production operations.

 BMS intends to apply the technology to root-cause investigations, corrective and preventive action documentation, and data-driven batch release decisions. The ambition is to accelerate decision-making without compromising the compliance standards that regulated manufacturing demands.

The company is also targeting the documentation-heavy arc of clinical trial work, including drafting clinical study reports, patient safety narratives, and regulatory submissions.

 If the technology performs as intended, it could meaningfully compress the time between data lock and regulatory filing.

Underpinning these ambitions is a significant data integration challenge.

 Pharmaceutical organizations accumulate decades of scientific, regulatory, manufacturing, and commercial information across systems that rarely communicate well with one another. The agreement explicitly focuses on connecting Claude to those repositories in a way that preserves enterprise governance and audit controls.

Can AI Agents Deliver on the Promise of Interconnected Pharmaceutical Data?

The company frames this as a continuation of more than three years of internal investment in frontier model access, suggesting the organization has already built some of the change management and governance infrastructure that agentic deployment requires.

 That foundation matters, because the technical capability of the AI is only one part of the equation. How it integrates with validated systems, how outputs are reviewed, and how the technology is governed under existing regulatory frameworks will determine whether the productivity gains translate to real-world impact.

How Else Is BMS Strengthening its Platform Through Collaboration?

Separately, BMS has announced a global licensing and research agreement with China-based Hengrui Pharma.

 This deal reflects a growing trend among large pharmaceutical companies, using regional partners to accelerate early clinical decision-making. The deal includes $600 million upfront and spans 13 early-stage programs across oncology, hematology, and immunology, with total potential value reaching $15.2 billion.

Taken together with the Anthropic agreement, these two announcements suggest a company deliberately restructuring how it generates and uses knowledge, whether that means deploying artificial intelligence agents to surface insights from decades of internal data, or distributing early clinical work across global partners to reach human evidence sooner.

 Both strategies point in the same direction: reducing the time and uncertainty that define pharmaceutical development, and doing so at a scale that individual programs or technologies alone cannot achieve.

Bristol Myers Squibb. Bristol Myers Squibb Announces Strategic Agreement with Anthropic to Position Claude Enterprise as the Shared Intelligence Platform Across Its Global Operations. Published May 20, 2026. Accessed May 21, 2026. 

https://news.bms.com/news/details/2026/Bristol-Myers-Squibb-Announces-Strategic-Agreement-with-Anthropic-to-Position-Claude-Enterprise-as-the-Shared-Intelligence-Platform-Across-Its-Global-Operations/default.aspx

Bristol Myers Squibb. Bristol Myers Squibb and Hengrui Pharma announce strategic agreements to advance innovative medicines across oncology, hematology, and immunology. Press release. May 12, 2026. 

https://news.bms.com/news/details/2026/Bristol-Myers-Squibb-and-Hengrui-Pharma-Announce-Strategic-Agreements-to-Advance-Innovative-Medicines-Across-Oncology-Hematology-and-Immunology-2026-EbQpaI6Zdc/default.aspx

Articles

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

BMS-Anthropic Signals AI Move in Drug Manufacturing Quality Systems

Sandra Coufal, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

 How Toragen Is Fast-Tracking TGN-S15 to IND

Sandra Coufal, MD, CEO of Toragen, discusses the strategic approach to drug development, intellectual property, and regulatory advancement for the company’s lead compound, TGNS15.

Dr. Coufal explains why Toragen chose to advance TGNS15 over TGNS11. Since TGNS11 is a racemic compound tied to a generic, it offers limited IP protection. TGNS15, however, was an undifferentiated enantiomer before Toragen began its work, giving the company a stronger patent position. As Dr. Coufal notes, "Since it was an undifferentiated or a non-differentiated enantiomer prior to Toragen working on it, we actually have patents that are composition of matter patents, not just method of use patents." With those patents filed and method of use patents already granted, TGNS15 is the clear path forward.

Dr. Coufal also highlights a key formulation decision that the drug is available in liquid form, specifically designed to serve patients who cannot swallow pills. This method was developed for patients with head and neck cancers who have undergone disfiguring resections. "We wanted to be certain to have a liquid form available," she explains, adding that patients in this population "may have special tubes that they eat from."

On the chemistry, manufacturing, and controls front, Dr. Coufal shares that Toragen has successfully identified and crystallized its preferred salt form. The company is now focused on scaling up production to good manufacturing practice standards for human use.

Perhaps most significantly, Dr. Coufal explains that because TGNS15 derives from a compound with decades of human safety data, Toragen anticipates the FDA will require only a fraction of the standard investigational new drug-enabling studies that are typically required, which could save the company millions of dollars and considerable time on its path toward Phase II trials across multiple HPV-positive cancer indications.

Videos

Sandra Coufal, MD, Toragen, discusses advancing TGNS15 with strong IP, liquid formulation, and an accelerated FDA pathway, potentially saving millions on IND-enabling studies.

How Toragen Is Fast-Tracking TGN-S15 to IND

Lilly Acquires Engage Bio Accelerate Development of Non-Viral Genetic Medicines

May 20, 2026, Eli Lilly acquired Engage Biologics, a preclinical biotechnology company developing a non-viral DNA delivery platform, in a transaction valued at up to $202 million, including upfront and milestone-based payments.¹ The deal places Engage’s Tethosome platform inside Lilly’s broader genetic medicines organization.

“With a lean organization and modest seed funding, I am incredibly proud of the rapid progress Engage has made toward a new class of genetic medicines. This is a testament to what a nimble, passionate team can achieve with the tools of synthetic biology,” said Will Olsen, CEO, Engage, in a press release.¹ “We are excited to begin our next chapter with Lilly, which has demonstrated unmatched speed and a uniquely forward-thinking approach to genetic medicine. We believe that the combination of Engage’s platform with Lilly’s significant capabilities will meaningfully accelerate development of new genetic therapies.”

What Did Lilly Acquire in Non-Viral Genetic Medicines?

Engage has focused on non-viral DNA delivery systems intended to address two technical barriers cited in the announcement: nuclear localization and innate immune sensing.¹ The company’s Tethosome platform is described as combining engineered DNA payloads with lipid nanoparticle delivery and an messenger RNA (mRNA)-encoded proprietary technology intended to improve localization and expression.

Non-viral gene delivery has long been investigated as an alternative to viral vectors, with potential advantages related to design flexibility and manufacturing scalability, but delivery efficiency, tissue targeting, and immune activation remain central technical constraints.²

How Could Non-Viral DNA Delivery Affect Genetic Medicines?

The transaction reflects continued interest in platforms that may allow genetic medicines to be engineered, manufactured, and modified using modular components.¹ Engage’s approach uses lipid nanoparticles, a delivery modality with an established role in nucleic acid delivery, particularly for mRNA-based products.³ However, translating lipid nanoparticle experience from mRNA to DNA payloads is not a simple substitution. DNA payloads introduce distinct requirements, including intracellular trafficking and nuclear access.¹ Engage states that its DNA payloads are engineered to improve tolerability while preserving attributes associated with DNA-based therapies, including durability and programmability.

What is Known About the Tethosome Platform?

Engage is a preclinical company, and the announcement did not identify clinical candidates, active investigational new drug applications, trial designs, or regulatory filings.¹ As a result, the immediate development implications are primarily strategic and technical. Lilly gains access to a delivery system intended to improve potency, tolerability, and redosability in non-viral DNA medicines, while Engage’s programs move into a larger genetic medicines infrastructure.

From a regulatory perspective, genetic medicine programs typically require detailed characterization of product design, delivery system performance, biodistribution, immune response, and long-term follow-up considerations, particularly when durable expression is anticipated.⁴ These expectations are likely to shape any future clinical translation of a DNA-based platform, regardless of whether the delivery system is viral or non-viral.

Engage Bio acquired by Lilly to accelerate development of non-viral genetic medicines. Business Wire. News release. May 20, 2026. Accessed May 20, 2026. 

https://www.businesswire.com/news/home/20260520932076/en/Engage-Bio-Acquired-by-Lilly-to-Accelerate-Development-of-Non-Viral-Genetic-Medicines

Yin H, Kanasty RL, Eltoukhy AA, Vegas AJ, Dorkin JR, Anderson DG. Non-viral vectors for gene-based therapy. 

. 2014;15(8):541-555. doi:10.1038/nrg3763  

Hou X, Zaks T, Langer R, Dong Y. Lipid nanoparticles for mRNA delivery. 

 2021;6(12):1078-1094. doi:10.1038/s41578-021-00358-0  

Long Term Follow-Up After Administration of Human Gene Therapy Products: Guidance for Industry

Eli Lilly agreed to acquire Engage Biologics for up to $202 million (upfront plus milestones), integrating the preclinical Tethosome platform into its genetic medicines organization. The program targets persistent bottlenecks in non-viral DNA therapeutics—nuclear entry and innate immune sensing—using engineered DNA payloads delivered via lipid nanoparticles and an mRNA-encoded proprietary component intended to enhance localization and expression. No clinical assets, INDs, or regulatory filings were disclosed, making near-term impact primarily platform-driven, with eventual translation shaped by biodistribution, immunogenicity, and long-term follow-up expectations.

Lilly’s Engage Bio acquisition adds a preclinical non-viral DNA delivery platform to its genetic medicines development portfolio.

Lilly Acquires Preclinical Non-Viral DNA Delivery Platform for $202M

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher

connected with Stuart Tindal, portfolio manager, Intensified Downstream Systems, Sartorius; and David Chau, global technical product specialist, Thermo Fisher—both Bio-Process Systems Alliance committee leaders—discuss automation, single-use technology challenges, and smarter process control in bioprocessing.

Watch the 2-part video interview with Tindal and Chau:
Part 1: 

How Predictive Control Is Reshaping Continuous Bioprocessing

Stuart Tindal and David Chau on Sensors, Standards, and Shared Progress

PT: How Should Companies Think About Integrating Automation into Continuous Bioprocessing?

 Automation isn't optional anymore, it's an integral part of any continuous or advanced bioprocessing operation. The industry has moved decisively away from purely manual operations. As processes have become more data-driven and connectivity has increased, the need for robust control and automation has become paramount. It's no longer a nice-to-have; it's a must-have for maintaining consistency and productivity.

 The foundation must be process understanding. Before you can automate anything, you need to know what you're trying to make continuous. You must consider what the inputs and outputs are, what parameters matter, how you'll measure them through sensors or equipment. People entering continuous bioprocessing right now can feel overwhelmed, whether they're building a process from scratch or retrofitting an existing one. Going back to the fundamentals of your process is often the most valuable first step.

How Do Single-Use Technologies Fit in with the Demands of Continuous Manufacturing?

 It's a real tension. Single-use technology has earned its place in the industry with faster turnaround times, flexibility, speed at the R&D and pilot scale. But those same benefits can become concerns when you're talking about commercial-scale continuous manufacturing, where processes run for weeks or even months. Single-use was designed to be limited. As an industry, vendors and end users must come together to honestly assess the limitations and innovate around them.

 It comes down to the materials of construction. When something is designed for a single day of use and you're asking it to perform for weeks, critical failure points emerge. Are the sensors drifting over time? Are the actuators, the pumps and valves moving plastic components, going to withstand prolonged friction and wear? The work being done now is about understanding how far these materials can be pushed and what alternatives or design changes can support longer continuous runs.

What Does the Future of Process Control Look Like in Continuous Bioprocessing?

 We're moving beyond conventional PID controllers toward predictive and model-based control. In a continuous process, your operating window becomes more of a tunnel, you need to steer the process along that tunnel in real time, being adaptive and anticipatory. That requires a very fast control and response loop. For more complex or labile molecules with tighter critical quality attributes, advanced predictive control isn't a luxury, it's what enables you to maintain the process trajectory from start to finish.

 Continuous manufacturing generates enormous amounts of data, and the question becomes what we do with it. Model-based approaches make a lot of sense in this context; with enough data, you can build predictive models that guide processes rather than simply hold set points. The shift is from reactive control to genuinely steering and predicting where your process is headed. That's where the industry is going, and it's an exciting direction.

Automation is now foundational to continuous and advanced bioprocessing, driven by increased connectivity and data-centric operations requiring robust control to maintain consistency and productivity. Effective implementation starts with deep process understanding—defining critical inputs, outputs, and measurable parameters—especially when retrofitting legacy operations. Single-use systems offer flexibility and rapid changeover, yet commercial continuous runs expose durability limits in materials, sensors, pumps, and valves. Process control is shifting from PID to predictive, model-based strategies that use high-frequency feedback and large datasets to steer processes within tight operating windows.

Stuart Tindal, Sartorius, and David Chau, Thermo Fisher, discuss automation, single-use technology limits, and predictive control shaping continuous bioprocessing's future.

Q&A: How Continuous Bioprocessing Is Evolving With Smarter Automation

Sandra Coufal, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of a safer, cheaper oral cancer drug.

From Bench to Pill Enantiomer Science and Oral Delivery

, Sandra Coufal, MD, CEO, Toragen, walks through the preclinical research that validated her team's preferred enantiomer compound for TGN-S11, Toragen’s small molecule inhibitor of the E5 oncogene protein, in patients with cancers associated with HPV.

Dr. Coufal describes two key rodent studies that shaped the direction of TGN-S11’s development program. The first was a neurotoxicity assessment, in which the non-preferred enantiomer triggered seizures in half of the test animals, while the preferred enantiomer showed no such effect. The second was a tumor model study using HPV-positive cancer cells, for which animals were treated for 69 days across three drug variants. The preferred enantiomer outperformed both the racemic compound and the non-preferred enantiomer in reducing tumor growth. As Dr. Coufal explains, "We were able to confirm the efficacy and also confirm the absence of neurotoxicity in the preferred enantiomer, and that's what gave us confidence to go forward."

From there, Dr. Coufal discusses the intellectual property strategy her team has pursued, focusing on patenting GRAS-designated salt forms of the preferred enantiomer. One salt form stood out for its pharmacokinetic profile, specifically a blunted peak drug concentration after ingestion. "That high Cmax in your bloodstream after taking a small molecule is what's really most associated with toxicity," Dr. Coufal notes.

Sandra Coufal, MD, Toragen, discusses how TGN-S15's preferred enantiomer showed no neurotoxicity and reduced tumor growth, supporting development of the oral cancer drug.

From Bench to Pill: Enantiomer Science and Oral Delivery

FDA headquarters at White Oak Campus in Silver Spring, Maryland, USA - January 13, 2020. The United States Food and Drug Administration (FDA) is a federal agency. | © JHVEPhoto - stock.adobe.com (330225712)

Following the resignation of FDA Commissioner Marty Makary, the FDA has replaced the acting heads of its two primary product review centers, continuing a pattern of leadership instability that has characterized the agency under the second Trump administration.

 The changes affect the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The turnover raises practical questions about regulatory continuity and the pace of decision-making during what is already a complex period for the industry.

Tracy Beth Høeg, who had been serving as acting director of CDER, 

stated on social media that she was fired.

 Katherine Szarama, acting director of CBER, will depart her leadership role but remain at the agency. Michael Davis steps in to lead the drug evaluation center, while Karim Mikhail takes over the biologics division. Lowell Zeta has also been named acting chief of staff. The agency's official organizational chart was updated within days of the announcement.

FDA Overview Organization Chart, Content Current as of 05/18/2026 | Image Credit: FDA

What Does Repeated Leadership Turnover Mean for Regulatory Timelines?

The leadership changes are not occurring in isolation.

 They follow the resignation of commissioner Marty Makary, who departed after reports emerged that President Trump sought to remove him from the position. A senior administration official has indicated that a new permanent commissioner nominee could be named within weeks, though that individual would still require Senate confirmation, which adds further uncertainty to the timeline. CDER has now seen several acting directors since January of last year, a level of churn that is unusual by historical standards.

How Stable Is the Broader Public Health Leadership Environment?

The situation at the drug and biologics centers reflects a wider vacancy problem across federal health agencies.

 The administration is simultaneously working to fill the director position at the CDC and the office of the surgeon general, suggesting that the leadership gaps extend well beyond the FDA's immediate remit.

Within CBER specifically, the past year has seen multiple individuals rotate through leadership, including Vinay Prasad, who left, returned, and ultimately departed again following a series of public controversies.

 That kind of instability in the division responsible for vaccine regulation creates difficulties for manufacturers navigating complex biologics pipelines, where long-term regulatory relationships and scientific consistency are closely tied to development strategy and investment planning.

The pharmaceutical industry's ability to plan around regulatory interactions depends heavily on predictable institutional structures.

 While the FDA's career staff provides a degree of continuity that political appointees do not, senior leadership sets the tone for enforcement priorities, review standards, and external engagement. Until a confirmed commissioner is in place and both centers have settled leadership, manufacturers and developers will need to be on top of the continuous rotation of the staff at the FDA, as the choices for those roles carry massive repercussions for the entire pharmaceutical industry.

Peebles A. FDA shuffles top drug, biologics leaders in latest shakeup. CNBC. May 15, 2026. 

https://www.cnbc.com/2026/05/15/fda-shuffles-top-drug-biologics-leaders-in-latest-leadership-shakeup.html

FDA overview organization chart. U.S. Food and Drug Administration. May 18, 2026. 

https://www.fda.gov/about-fda/fda-organization-charts/fda-overview-organization-chart

Peebles A. FDA vaccine head will step down in April after string of controversial decisions. CNBC. March 6, 2026. 

https://www.cnbc.com/2026/03/06/fda-vaccine-head-prasad-step-down.html

Repeated leadership turnover is reshaping oversight at CDER and CBER, with acting directors replaced shortly after the commissioner’s departure. Tracy Beth Høeg reported being fired as acting CDER head, while Katherine Szarama is leaving the acting CBER role but staying at FDA. Michael Davis and Karim Mikhail will lead the drug and biologics centers, respectively, alongside a new acting chief of staff. The churn extends across federal health agencies and heightens uncertainty for sponsors reliant on stable review expectations, engagement norms, and timing predictability.

The FDA replaced acting heads of its drug and biologics centers, deepening leadership instability that raises concerns for pharmaceutical developers.