Susan Haigney

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In a letter to Sara Brenner, FDA’s acting commissioner of Food and Drugs, Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research (CBER), resigned his post. Marks pointed to an “unprecedented assault on scientific truth” that “adversely impacted public health” and the current administration’s concerns over vaccine safety (1) in his resignation.

“Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health,” Marks said in the letter. “As you are aware, I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

In a statement released by the Biotechnology Innovation Organization (BIO), John Crowley, BIO director and CEO, praised Marks for shepherding a “new era of scientific breakthroughs” such as vaccines and cell and gene therapies, and he voiced his concern that the “loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people.”

“It is imperative that we retain and recruit scientific expertise and strong leadership at our health agencies and that the high standards that are the hallmark of these health institutions are upheld and advanced. We are committed to working with the new Commissioner and the Administration to support and enable a strengthened and modernized FDA,” Crowley said (2).

According to NPR, an official at the Department of Health and Human Services (HHS) stated (3), “if Marks ‘does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.’"

NPR also cited a comment by Dr. Paul Offit of the University of Pennsylvania, who referred to HHS Secretary Robert F. Kennedy, Jr. as a “wolf guarding the hen house” (3). 

 for use in humans, including vaccines. Marks joined FDA as deputy center director of CBER in 2012 and became the center’s director in 2016. He was a part of Operation Warp Speed, which was instrumental in the development of COVID-19 vaccines. He has also put forth several initiatives to advance cell and gene therapies (4). His resignation is effective April 5, 2025.

“I leave behind a staff of professionals who are undoubtedly the most devoted to protecting and promoting the public health of any group of people that I have encountered during my four decades working in the public and private sectors,” Marks said of his staff in the letter. “I have always done my best to advocate for their well-being and I would ask that you do the same during this very difficult time during which their critical importance to the safety and security of our nation may be underappreciated.”

Reuters reported that pharmaceutical company stocks fell on Monday after Marks’ resignation. Shares in vaccine companies such as Moderna fell between 6% and 12% (5). 

HHS announced a restructure of the organization

 in response to a Trump Administration Executive Order, which will include the reduction of its workforce by 10,000 full-time employees. Cuts to FDA’s staff include the reduction of approximately 3500 full-time employees. HHS stated the reduction will not impact drug, device, or food reviewers or inspectors and will streamline operations and centralize administration functions (6, 7).

Marks, P. Letter to Sara Brenner, MD, MPH Acting Commissioner of Food and Drugs U.S. Food and Drug Administration. March 28, 2025. Posted by 

https://static01.nyt.com/newsgraphics/documenttools/c946b864e1dc08f9/05e7e4f0-full.pdf

BIO. BIO Statement on Resignation of Peter Marks from the FDA. March 29, 2025. 

https://www.bio.org/press-release/bio-statement-resignation-peter-marks-fda

Stein, R. The Top FDA Vaccine Official is Forced Out, Cites RFK Jr.'s 'Misinformation and Lies'. 

Marks, P. Updates on the FDA’s Efforts to Accelerate Advances in Cell and Gene Therapy. ARM Cell & Gene State of the Industry Briefing. Jan. 13, 2025. https://alliancerm.org/wp-content/uploads/2025/01/ARM-Marks-011325.pdf

Mishra, M. Pharma Stocks Sink after Ouster of Top FDA Vaccine Regulator. 

https://www.reuters.com/business/healthcare-pharmaceuticals/biotech-stocks-tumble-reports-fdas-top-vaccine-regulator-leave-2025-03-31/

HHS. HHS Announces Transformation to Make America Healthy Again. Press Release. March 27, 2025.

HHS. Fact Sheet: HHS’ Transformation to Make America Healthy Again. HHS.gov (accessed March 27, 2025). 

https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html

Articles

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

FDA CBER Director Peter Marks Resigns

The US Department of Health and Human Services (HHS) announced on March 27, 2025 that it is restructuring the organization in response to a Trump Administration Executive Order. HHS states the restructuring will include the reduction of its workforce by 10,000 full-time employees; however, the total amount of workforce reduction will be closer to 20,000 when combined with other agency efforts such as early retirement and Fork in the Road (1).

The restructure plans are to streamline functions and remove redundant units. These areas will be consolidated into 15 new divisions, such as a new Administration for a Healthy America (AHA), and core functions will be centralized. HHS will reduce regional offices in half from 10 to 5. “The restructuring will improve Americans’ experience with HHS by making the agency more responsive and efficient, while ensuring that Medicare, Medicaid, and other essential health services remain intact,” the agency stated in a press release.

As part of the restructuring, FDA’s staff will be reduced by approximately 3500 full-time employees, with a HHS fact sheet stating the reduction will not impact drug, device, or food reviewers or inspectors (2). Instead, HHS states the changes will streamline operations and centralize administration functions. In addition, the staff of the National Institutes of Health will be reduced by approximately 1200 employees.

The new AHA will combine the Office of the Assistant Secretary for Health (OASH), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Toxic Substances and Disease Registry (ATSDR), and National Institute for Occupational Safety and Health (NIOSH). “Transferring SAMHSA to AHA will increase operational efficiency and assure programs are carried out because it will break down artificial divisions between similar programs,” the agency stated in the release.

TheAdministration for Strategic Preparedness and Response (ASPR), which is responsible for national disaster and public health emergency response, will transfer to the Centers for Disease Control and Prevention (CDC), and the Assistant Secretary for Planning and Evaluation (ASPE) will merge with the Agency for Healthcare Research and Quality (AHRQ) to create the Office of Strategy.

“We aren't just reducing bureaucratic sprawl. We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic,” HHS Secretary Robert F. Kennedy, Jr., stated in the press release (1). “This Department will do more—a lot more—at a lower cost to the taxpayer. Over time, bureaucracies like HHS become wasteful and inefficient even when most of their staff are dedicated and competent civil servants. This overhaul will be a win-win for taxpayers and for those that HHS serves. That’s the entire American public, because our goal is to Make America Healthy Again.”

HHS. Fact Sheet: HHS’ Transformation to Make America Healthy Again. HHS.gov (accessed March 27, 2025).

 https://www.hhs.gov/about/news/hhs-restructuring-doge-fact-sheet.html

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

HHS Announces Restructuring

Ask the Expert: Product Inspection, Part Two

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses the benefits of automating visual inspection, which include increased efficiency and accuracy, and what goes into the cost versus benefit of automating inspection of small batches.

“[T] he decision to continue manual inspection for small batch sizes involves several considerations,” says Margosch. “So, costs versus benefit, automated inspection systems can still have high upfront costs for small batch sizes. The return on investment maps may still not justify the expenses if the volume does not vary in automation. [One should] evaluate the cost effectiveness of automating small batches versus manual inspection, [and] if possible, conduct a pilot test for automated inspection on the product to evaluate its principal effectiveness and efficiency before fully committing to automation.”

In this episode, Margosch also discusses how cold chain requirements can be maintained during visual inspection. “Maintaining the cold chain for parameters is critical to ensure product stability, especially when visual inspections [that are] typically performed at room temperature,” says Margosch. “Several strategies are available to assure that the cold chain is maintained during inspection, so [one should] develop comprehensive standard operation procedures that outline the processes for handling, storing, transport, and visual inspection that all require cold chain management, include specific protocols for the transfer of products from cold storage to room temperature. [One should] ensure that these procedures are followed and documented. [One should] consistently implement a robust temperature monitoring and alert system for the entire cold chain, that means for both refrigerated transport and cold storage itself, but ensure also a temperature-controlled and monitored transport from cold storage to room temperature all the way … inside the inspection rooms and back, and very important, limit the duration that products are exposed to room temperature during the inspection processes.”

Click the video above to watch Dr. Margosch answer the following questions:

“My company is looking to move from a manual to a fully automated final product inspection method. However, although we manufacture mostly large batch sizes of product, some of our clients require small batch size production for some of their products. Should we continue to inspect those products manually?”

“My company is looking to develop a product that needs to be stored at a cool temperature. How can we assure the regulators that the cold chain is maintained during visual inspection?”

Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG. Since joining Vetter in 2008 as head of automated visual inspection, Margosch has promoted to managing the visual inspection department and, from 2021, overseeing all non-aseptic production, including assembly and secondary packaging.

Margosch joined Vetter in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Videos

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection. 

Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations

DCAT Week 2025: Enzymatic RNA Synthesis

Understanding the critical quality attributes of a whole cell is challenging, remarks Alison Moore, chief technical officer, Codexis, and companies are working on manipulating transcription or translation more directly. 

 spoke with Moore ahead of Drug, Chemical & Associated Technologies Association Week (DCAT Week) 2025 to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.

“What we've seen is amazing strides by amazing companies in gene therapy,” says Moore. “For example, I think manipulations directly of DNA, where necessary, you know, can create curative outcomes, whether those will be really large, ever really large population size medicines, perhaps not. And that brings me to the RNA space, where manipulating RNA and just the beauty of having very specific transcriptional or translational control is really a lovely concept that is being worked on so actively across many companies, then double clicking a little more into RNA in general. So obviously, the public has seen the utility of mRNA in vaccine development, which remains revolutionary, and we'll see where that goes in the future.”

DCAT Week is happening March 17–20, 2025 in New York City.

Click the video above to watch the full interview.

PharmTech Group spoke with Alison Moore, chief technical officer, Codexis to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.


DCAT Week 2025: Impact of Geopolitical Climate on Biopharma

® spoke with Joseph Principe, chief commercial officer at Abzena about how current events around the world are impacting the bio/pharmaceutical industry, especially the supply chain and drug shortages.

According to Principe, the current geopolitical climate is creating uncertainty in the bio/pharmaceutical industry. “The industry doesn't really like uncertainty. I think the circumstances around [the] BIOSECURE [Act] or potential tariffs, all sort of create this uncertainty,” he says. “I think that is creating some tailwinds for Western suppliers, particularly those in the [United States]. But again, lots of uncertainty. I think we see that depending on the type of customer that we're talking to, some of the early developers have a little bit less concern about the geopolitical situation, and people who have supply chains embedded in the regions and in many cases, they're looking for alternatives to avoid some of the uncertainty.”

Abzena will be attending DCAT Week 2025, which is happening in New York City from March 17–20, 2025.

Click on the video above to watch the full interview.

PharmTech sat down with Joseph Principe, chief commercial officer at Abzena ahead of DCAT Week 2025 to get his perspective on how the geopolitical climate is impacting the industry.

DCAT Week 2025: Packaging Innovations

The evolution of personalized medicine and their complexity, such as temperature-sensitive therapies and customized packaging configurations, is impacting the biopharmaceutical packaging market, according to Peter Belden, president of Tjoapack US. 

 spoke to Belden ahead of DCAT Week 2025, which is being held March 17–20 in New York City, to get perspective on how recent innovations in biopharmaceutical manufacturing are impacting the pharma packaging market.

“We've been investing heavily in expanding our cold chain capabilities, in expanding our capability and capacity to package unique configuration for injectable products, whether that is a product that comes to us in a syringe format, a vial format, or an auto injector format,” Belden says. “[We have] the ability to either automate or semi-automate, label, and then finish [to] pack those products while maintaining tight control of time [and] temperature to allow for packaging, and then getting those materials and finished goods back into cold storage. [We also serve] as a potential logistics hub for several of our clients to manage the supply complexity, then shipping those time- and temperature-sensitive medicines to the many markets around the world that our client base is serving.”

Click the video above to watch the interview.

Peter Belden is president of Tjoapack US.

Pharmaceutical Technology® spoke with Peter Belden, president of Tjoapack US, ahead of DCAT Week 2025 to discuss recent innovations in bio/pharmaceutical packaging.