Nicholas Jacobus

At BIO 2026, Thermo Fisher's Anil Kane explains how AI is reshaping CDMO workflows and what biotechs should prioritize when choosing a development partner. 

Thermo Fisher's Kane Says AI Is Reshaping How CDMOs Add Value

For Anil Kane, PhD, the question facing small biotech companies isn't just which CDMO can run the work, but which one can make their asset worth more by the time it's done.

"I think creating value and enhancing the value of their assets is something that a small biotech company should be looking at while selecting a CDMO player," says Kane, global head of technical and scientific affairs within the Pharma Services Group at Thermo Fisher Scientific. He shared that view, along with a look at how the company is weaving artificial intelligence (AI) into its CDMO workflows, in a conversation with out sister publication 

 at the 2026 BIO International Convention (BIO 2026, June 22–25 in San Diego).

Thermo Fisher has built strategic partnerships to support AI integration across its service lines, Kane says, pairing outside expertise with in-house machine learning algorithms and predictive models trained on proprietary datasets the company has accumulated over years of development work. Those AI applications now touch preclinical and clinical phases, quality management systems, supply chain operations, and contract processing, essentially the full breadth of CDMO work, from early development through commercialization.

So what should a biotech actually weigh when picking a CDMO for AI-enabled drug development? Kane points to regulatory experience, a demonstrated quality track record, and scientific depth across modalities. He's particularly bullish on the advantage of working with a single organization that can carry a program across small molecules, biologics, messenger RNA, and viral vectors through the full development and commercialization spectrum, rather than stitching together multiple specialized partners.

On where AI itself stands, Kane says it's already producing measurable speed and efficiency gains at several development stages, though he's candid that some applications still need time to mature. The near-term emphasis, he says, has been on what he calls the "low-hanging fruit": more accessible use cases first, with deeper integrations to follow. For biotechs weighing out-licensing strategies in particular, he adds, a strong CDMO partner can move the needle directly on asset value.

Videos

At BIO 2026, Thermo Fisher's Anil Kane explains how AI is reshaping CDMO workflows and what biotechs should prioritize when choosing a development partner.

FDA's NAM Guidance | Image Credit: © Tada Images - stock.adobe.com.

President Donald Trump has signed off on the dismissal of FDA Commissioner Marty Makary, according to sources close to the White House, cited by the Wall Street Journal.

 Makary has served as commissioner since March 2025. His expected departure adds to an alarming rate of senior official exits across federal health agencies that experts warn is eroding institutional continuity and long-term policy stability.

According to Reuters, a source close to the White House said the FDA commissioner "is done" and that Trump had signed off on the decision.

 The White House and the Department of Health and Human Services were not immediately available for comment.

Makary, a surgical oncologist at Johns Hopkins University School of Medicine, was confirmed as FDA commissioner back in March 2025.

 During his time at FDA, he’s become a prominent figure within the Make America Healthy Again (MAHA) movement backed by Health Secretary Robert F. Kennedy Jr. and authored bestselling books on healthcare costs and what he described as systemic failures in modern medicine.

During his tenure he championed several controversial positions, including pushing for large placebo-controlled trials for 

 vaccines in lower-risk age groups and overseeing significant shifts in the agency's approach to drug approvals, 

Reports of Makary's potential exit have intensified over the past week and are tied to concerns about those controversial decisions.

 Some within the administration are said to be “uncomfortable” with the political fallout generated by his more provocative regulatory moves, particularly the scrutiny growing around FDA's direction in Congress and former agency officials.

What is the fallout of Makary’s firing?

Upon Makary’s departure, FDA would be left without a permanent commissioner at a moment when the agency is already operating with acting heads in charge of its top drug development departments, including 

The timing also raises practical concerns around FDA's ability to navigate high-stakes decisions on drug approvals, vaccine policy, and food safety without stable, confirmed leadership in place.

Senior officials have departed the CDC and other federal health bodies at an alarmaing rate in recent months, raising concerns among public health experts about institutional continuity at agencies responsible for drug safety, disease surveillance, and pandemic preparedness.

Critics are also warning that the repeated churn of leadership makes it harder for these agencies to retain experienced staff, maintain long-term policy commitments, and respond effectively to emerging health threats.

For now, the White House has yet to name a potential successor or confirm the report.

Whether Makary's replacement will continue the MAHA-aligned approach he helped advance, or chart a more conventional regulatory course, is likely to be closely watched.

Trump plans to fire FDA chief Makary, WSJ reports 

https://www.reuters.com/world/us/trump-planning-fire-fda-chief-makary-wsj-reports-2026-05-08/

https://www.fda.gov/about-fda/fda-organization/martin-makary

Articles

President Trump has reportedly approved the dismissal of FDA Commissioner Marty Makary, who has led the agency since March 2025. The move compounds escalating leadership instability across federal health agencies, heightening concerns about weakened institutional continuity and policy durability. Makary, a Johns Hopkins surgical oncologist aligned with the MAHA movement, drew scrutiny for controversial stances on Covid-19 vaccine trial expectations and shifts in drug, vaccine, and mifepristone regulatory posture. The FDA now faces potential leadership gaps amid consequential decisions spanning approvals, vaccines, and food safety.

Trump to fire FDA Commissioner Marty Makary amid controversy over vaccine and drug policy decisions, leaving the agency without confirmed leadership.