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BioPharm Peer Exchange

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Pharmaceutical packaging must advance to adapt to new, complex modalities

Out-of-the-Box Packaging Advancements

From Theory to Reality: Automating Process Development

Drug Digest: 

The Importance of Appropriate Supplier Oversight

Ask the Expert

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

INTERPHEX 2025: Automation for Protein Manufacturing

Biomanufacturing involves complex operations and thousands of skilled workers, says Kerry Love, co-founder and CEO of Sunflower Therapeutics, a biotech company specializing in continuous and fully integrated equipment for the production of proteins. Automation can be a way to build quality and reduce human errors, while also allowing workers who might not be as skilled to participate in high-value manufacturing.

“When you use automation in general, you kind of make something that's usually highly complex, with a lot of handoffs and transitions, much less complicated, particularly in continuous bioprocessing," Love says in the interview. "That's actually a great place for automation, because already you're simplifying unit operations and making interfaces between unit operations that oftentimes haven't been there in the past. That's a great way to then layer automation on top of that and ultimately get to walk away solutions like those that we build at Sunflower.”

® Group spoke with Love at INTERPHEX 2025, being held April 1–3 in New York City. Sunflower Therapeutics can be found at Stand 1273.

Kerry Love, co-founder and CEO of Sunflower Therapeutics

Kerry Love, PhD, is the co-founder and CEO of Sunflower Therapeutics, a women-owned and led biotechnology company delivering next-generation protein manufacturing solutions that anyone can use to create innovative new medicines, vaccines, foods, and other bio-produced materials. Love is an organic chemist by training, performing her doctoral studies at MIT, and a biotech entrepreneur at heart, having founded two companies and contributed to the starting of many more over the past 20 years.Love has authored more than 40 scientific papers and patents.

Videos

The Pharmaceutical Technology® Group spoke with Kerry Love, co-founder and CEO of Sunflower Therapeutics at INTERPHEX 2025, to find out how automation enhances the manufacture of proteins.

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FDA announced on April 1, 2025 that Martin A. Makary, MD, has been sworn in as the agency’s new commission after a bipartisan confirmation by the US Senate. Makary, a graduate of Bucknell University, Thomas Jefferson University, and the Harvard School of Public Health, completed his residency at Georgetown University and surgical oncology fellowship at Johns Hopkins.

He founded the Johns Hopkins Center for Surgical Trials and Outcomes Research and led cross-disciplinary research on cancer, obesity, Alzheimer’s, adverse event monitoring, and antimicrobial resistance. He is a member of the National Academy of Medicine and co-developer of the Surgery Checklist.

“I am honored and humbled to assume this role at the FDA under the leadership of President Trump and Secretary Kennedy,” said FDA Commissioner Martin A. Makary, in the press release (1). “I look forward to working with this Administration and the FDA workforce to advance our shared goals in meeting the agency’s public health mission. As Commissioner, I hope to ensure that the FDA holds to the gold standard of trusted science, transparency, and common sense so that we can Make America Healthy Again.”

“I am pleased to welcome Dr. Makary to the U.S. Department of Health and Human Services and the Food and Drug Administration,” said HHS Secretary Robert F. Kennedy, Jr., in the release. “He is a national leader in medicine with impeccable credentials. His extensive research, clinical experience, and national leadership make him uniquely qualified to lead the FDA as we work together to Make America Healthy Again.”

Back in January 2025, FDA leaders, Commissioner Robert Califf and the Director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, resigned their posts (2–4). And in March 2025, Peter Marks, director of the Center for Biologics Evaluation and Research resigned (5).

Califf warned of misinformation on his way out of office. "We are currently losing the battle due to the intersection of social media and cultural changes, which threatens the foundation of public health," Califf said. “A lot of people died who would not have died if they had gotten a free vaccine and not been misled [about the safety of vaccines]” (3).

The concern over misinformation was also on the mind of Marks, who stated the following in his resignation letter (6):

“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. “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.”

1. FDA. Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner. Press Release. April 1, 2025.
2. Herper, M. Leaving FDA, Califf is Unapologetic—and Warns of Staff Departures. 

. Jan. 8, 2025.
3. Eglovitch, J. S. Goodbye Message: Califf Says FDA Needs Help in Battling Misinformation, Has Deep Talent Pool to Mitigate Departures. 

. Jan. 17, 2025.
4. Haigney, S. Cavazzoni Retires as CDER Director. 

https://www.pharmtech.com/view/cavazzoni-retires-as-cder-director


5. Haigney, S. FDA CBER Director Peter Marks Resigns. 

. March 31, 2025.
6. 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 

Articles

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Martin A. Makary Becomes New FDA Commissioner

Feliza Mirasol is the science editor for 

INTERPHEX 2025 video interview with Iwata Label USA discussing practical security benefits of functional labels for parenteral drugs.

INTERPHEX 2025: How Functional Labeling Can Protect Parentals in Vials and Syringes

Sitting down with the PharmTech Group at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, a division of Japan-based IL Group, highlights the need for improved protection of pharmaceutical vials and syringes, particularly through functional labels. Previously, vials were not sufficiently protected due to cost considerations, but after conducting recent studies, the company began to understand the financial and human costs of breakage. Instead of overhauling packaging, however, Wainwright asserts that functional labels can reinforce existing vial infrastructure by preventing breakage, cracks, and leaks.

“We traditionally have not protected the vials as stringently as we should and could, just simply for cost reasons. It's just now that we've done more studies on the costs associated with broken vials, or even the human cost of negative effects to healthcare workers, [that] the need for heightened protection on vials has increased,” Wainwright says in the interview. “And then with functional labels, what they can do is, instead of reimagining the whole packaging system, you can use existing packaging infrastructure, [such as] the traditional vials, but then add on a specialty label that helps protect the vial from breakage, cracks, or seepage of the internal contents.”

He goes on to explain that, for syringes, the primary concern is material-induced drug migration, which can alter the chemical composition of highly potent medications. Preventing migration is critical to maintaining drug integrity. Another key function of these labels is shielding vial and syringe contents from light exposure, which can degrade pharmaceutical compounds. Functional labels, therefore, serve a dual purpose: physical protection and preservation of drug stability.

Wainwright also expresses enthusiasm for engaging with industry leaders at INTERPHEX 2025 to encourage broader adoption of these specialized labeling solutions within the pharmaceutical sector.

Attendees can visit Iwata Label USA at Booth #1362 at INTERPHEX, which is being held on April 1–3 in New York City.

William Wainwright, Business Development Manager, Iwata Label USA, a division of IL Group

William Wainwright is business development manager for Iwata Label USA, a division of IL Group, and a provider of precision labeling solutions for global pharmaceutical and healthcare companies. The company’s portfolio includes good manufacturing practice-compliant roll-on and shrink-tack labels featuring value-added benefits, such as tamper evidence, protection against breakage, and light-shielding properties, as well as specialty constructions whose functions range from reliable adhesion in cryogenic applications to detachable elements for ease of medical recordkeeping.

William Wainwright, business development manager at Iwata Label USA, discusses the practical security benefits of functional labels at INTERPHEX 2025.

AES Clean Technology (AES), a provider of modular cleanroom solutions, announced on April 1, 2025 that it has officially launched Omni ASCENT, a next-generation off-site manufactured (OSM) vertical utility solution that is designed to optimize the flexibility and efficiency of cleanrooms, at INTERPHEX 2025. The company said in a press release that the launch of this OSM solution is a significant advancement toward cleanroom utility integration (1). INTERPHEX is being held on April 1–3 in New York City.

Omni ASCENT is built on the foundation of AES’s Omni utility raceway, which is a system that integrates critical cleanroom utilities into a modular, adaptable framework. Omni ASCENT enables strategic placement of utilities anywhere on the cleanroom floor. In comparison, traditional systems limit layout options and pose challenges to accessibility, according to AES in the press release. Omni ASCENT enables greater flexibility, efficiency, and safety, and allows pharmaceutical and biotech facilities to optimize space and workflow without having to compromise compliance, according to the company.

“Omni ASCENT is a direct response to the evolving needs of modern cleanroom environments,” said Shawn Reniker, senior vice-president of Operations, AES Clean Technology, in the release (1). “By eliminating the need for wall or ceiling-mounted utilities, we are giving manufacturers the freedom to configure layouts more efficiently, enhance accessibility for maintenance and operations, and accelerate deployment—all while maintaining the highest industry standards.”

Omni ASCENT is designed for rapid deployment; it arrives fully assembled and ready for installation, which can be done in under half a day. This shortened deployment significantly reduces downtime. Meanwhile, its strategic utility placement enhances ergonomics while creating a safer workspace by eliminating unnecessary ladder use and tripping hazards. In addition, the new system can be easily integrated with existing Omni raceway solutions. This compatibility facilitates a streamlined transition for both new cleanroom builds and facility retrofits, according to the press release.

“Last year, the CleanLock Module reinforced the demand for smarter, more flexible cleanroom solutions. Omni ASCENT builds on that momentum, providing even greater adaptability in utility integration and ensuring that facilities can scale efficiently without redesigning their infrastructure,” said Chris Miller, chief executive officer, AES Clean Technology, in the release.

 the CleanLock Module, which is an airlock solution for cleanrooms that has been engineered to minimize the risk of contamination. The module minimizes contamination risk by integrating AES’ proprietary cleanroom finishes, patented lighting, predictable airflow patterns, and advanced door controls. These features offer the advantage of being integrated into any facility without delay. The module allows for secure transition of people and materials entering and exiting cleanrooms.

"We are thrilled to introduce the CleanLock Module airlock to the market," said Grant Merrill, AES chief commercial officer, in a press release at the time of the CleanLock Module launch in 2024 (2). "This product addresses the critical need for maintaining ultra-clean environments in industries such as pharmaceuticals, biotechnology, and medical device manufacturing. With its state-of-the-art technology and precision engineering, the CleanLock Module will set a new standard for contamination control and efficiency in design and construction execution."

Attendees can visit AES at Booth #2509 at INTERPHEX 2025.

1. AES Clean Technology. AES Cleanroom Technology Introduces Omni ASCENT: A Breakthrough in Cleanroom Utility Integration at INTERPHEX 2025. 

. April 1, 2025.
2. AES Clean Technology. AES Clean Technology Sets New Standards for Cleanliness and Efficiency in Cleanrooms with the Launch of Its CleanLock Module. Press Release. April 16, 2024.

The Omni ASCENT, officially launched at INTERPHEX 2025, is a next-generation off-site manufactured vertical utility solution aimed at optimizing the flexibility and efficiency of cleanrooms.

AES Clean Technology Introduces OSM Cleanroom Utility Solution at INTERPHEX 2025

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Culture Biosciences, headquartered in South San Francisco, Calif., is announcing the launch of Stratyx 250, which the company said in a press release is the first mobile, cloud-integrated bioreactor that is designed to provide biotech companies with simultaneous flexibility, automation, and remote process control (1).

The launch coincides with the start of the 2025 INTERPHEX conference in New York City, which runs from April 1–3, 2025.

Culture Biosciences defines cloud-based bioprocessing as the integration of physical bioreactors with remote data monitoring, automation, and artificial intelligence (AI)-driven optimization (1). The company has designed Stratyx 250 to allow researchers to leverage its Culture Console software for remote tracking and adjusting of parameters in real time.

The end results, according to Culture Biosciences in the press release, include reduction of errors, improved reproducibility, and greater precision and efficiency (1). This is especially important, the company said, considering that biotech companies are generating massive amounts of process data given the rise in high-throughput experimental methods, but may lack the ability to efficiently derive actionable insights from that data.

“The biotech and biopharmaceutical market segments are experiencing a major shift toward cloud-powered, modular bioprocessing, and these companies need hardware and software that can keep up,” said Chris Williams, CEO of Culture Biosciences, in the release (1). “With a five-month ROI [return on investment] timeline and a plug-and-play scalable architecture, our platform offers a cost-effective, flexible alternative to traditional bioreactors—helping companies accelerate development and reduce costs without compromising on quality.”

According to the press release, Stratyx 250 affords users a 16% lower total cost per run versus traditional benchtop bioreactors, development timelines that are faster by up to 25%, and a 30% improvement in scale-up success (1).

In discussing its offering of an “early adopter” program for select customers, Culture Biosciences provided the perspective of Jondavid De Jong, PhD, vice president of Scientific Operations for Virica Biotech.

“Stratyx 250 is already reshaping how we approach process development,” De Jong said (1). “The ability to remotely monitor and adjust experiments in real time is streamlining our workflows and improving reproducibility across runs. The combination of cloud integration, automation, and mobility makes it a game-changer for modern bioprocessing.”

®, Anthony Christopher, commercial manager of bioprocessing at Kent Elastomer Products, said that 

automation has been playing a larger role

 in advancing equipment that supports bioprocessing, highlighting digital twin technology, integrated control systems, automated sampling and analysis, and smart bioreactors as some of the developments being witnessed in the biomanufacturing space—including at the commercial level (2).

“From what our team has seen, most commercial biomanufacturing processes are partially automated, with automation implemented in upstream (e.g., bioreactors, feeding systems) and downstream (e.g., chromatography, filtration) steps,” Christopher said, qualifying that manual intervention is needed for setup, troubleshooting, and quality control, but that many facilities now use automated systems for data collection, process monitoring, and quality assurance (2).

Culture Biosciences said Stratyx 250 is currently being demonstrated at its South San Francisco facility (1). The company can also be found at Booth #3417 at INTERPHEX, being held at the Javits Center in New York City.

1. Culture Biosciences. Culture Biosciences Unveils Stratyx 250, the First Cloud-Integrated, Mobile Bioreactor for Cell Culture Process Development. Press Release. April 1, 2025.
2. Mirasol, F. Accelerating Adoption of Smart Tools to Advance Manufacturing. 

The company said the Stratyx 250 is the first bioreactor of its kind to offer biotech companies a combination of automation, remote process control, and flexibility.

Culture Biosciences Opens INTERPHEX 2025 with Launch of Cloud-Integrated Mobile Bioreactor

On April 1, 2025, BioPure, a provider of single-use solutions and part of Watson-Marlow Fluid Technology Solutions (WMFTS), announced that it has refined the manufacturing of its single-use sanitary connector, BioClamp, to offer sustainability benefits to users. The company will showcase the connector at INTERPHEX 2025, occurring April 1–3 in New York City.

BioPure, which introduced the first single-use sanitary bioclamp for bioprocessing in 1998, according to a company press release (1), has optimized BioClamp in terms of its design and its manufacturing process. Under the new manufacturing process and new design, the connector is 13% lighter in weight compared to the previous BioClamp model. The adoption of advanced automated assembly has also resulted in 26% less carbon dioxide emissions during manufacturing across the full lifecycle of the product (1). BioClamp securely attaches sanitary fittings and plays a crucial role in single-use critical fluid transfer lines.

“From enhanced production to shipment, use in a bioprocess and end-of-life disposal, BioClamp is designed for sustainability while maintaining the highest quality standards,” said Mark Lovallo, product manager for WMFTS, in the press release (1). “BioClamp is efficiently manufactured, pre-assembled, and packaged at our global network of state-of-the-art Class 7 cleanrooms, which gives users of our sanitary bioclamp confidence in quality and sustainability as they scale up their production. These facilities are ISO14001 certified and powered by renewable energy.”

An additional upgrade to the bioclamp is an advanced ergonomic hinge that makes it easier to close and simplifies the set-up of an assembly process, allowing for quick changeovers. Other features and benefits include:

reduced distortion on polymeric fittings when subjected to heat

suitability for sterilization using autoclave and gamma irradiation

suitability for either single-use or multiple-use applications

reliable availability of global manufacturing and supply network.

WMFTS has the goal of reaching net-zero for its scope 1 and 2 emissions (i.e., emissions that are in its direct control) and reducing scope 3 emissions (i.e., those emissions that the company is indirectly responsible for, up and down its value chain) by 2030. Optimizing the manufacturing process for the BioClamp connector is a significant step toward that goal.

Speaking with Nicole Hunter, head of Global WMArchitect at WMFTS last year at 

 the PharmTech Group discussed the importance of optimizing fluid-handling workflows in the bioprocessing space and the efficiencies that single-use technologies (SUTs) can offer for biomanufacturing (2).

“One of the main reasons to have really good workflows is to reduce the risk in your process. You want to … safeguard your therapeutic during the process and expedite getting that drug product to the patient,” Hunter said in the interview (2).

Hunter noted that the big advantages SUTs bring are flexibility and adaptability to bioprocessing. “What [SUTs] have been able to do—in moving away from stainless-steel systems—is to allow for quick changeover between drug products. One facility can make multiple drug products really easily; the manufacturing systems can be quickly assembled for the different drug products and changed out as, and when, needed. [SUT] also reduces risk of cross contamination because you're literally using that assembly for that drug product and then changing to another one,” she explained in the interview (2).

Attendees can visit WMFTS at Booth #2753 at INTERPHEX 2025.

1. Watson-Marlow Fluid Technology Solutions. 

BioPure Advances Manufacturing of BioClamp to Bring Significant Sustainability Benefits to Its Users

. Press Release. April 1, 2025.
2. Mirasol, F. 

Single-Use Technologies Reinforce Fluid-Handling Workflows (INTERPHEX 2024)

With advanced manufacturing, BioPure’s BioClamp connector is manufactured to be 13% lighter than the previous model, resulting in a 26% reduction in carbon dioxide emissions across the full lifecycle of the product.

WMFTS’ BioPure to Showcase Single-Use Bioclamp with Refined Manufacturing at INTERPHEX 2025

Mike Hennessy Jr. is the President and CEO of 

High Angle Shot of a Working Desk of an Successful Person in Office with Cityscape Window View. | Image credit: © Gorodenkoff - stock.adobe.com

The bio/pharma industry is not unfamiliar with “patent cliffs”; however, the current one being faced is notably steep and, in combination with other factors, is set to negatively impact revenues significantly in the near future. A similarly steep patent cliff was experienced by the bio/pharma industry during the 2000s, but at that time industry had the benefit of pricing tailwinds in the United States, helping industry to overcome the related revenue slump (1).

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players and potentially leading the industry to lose up to $400 billion (2). For example, Merck’s humanized antibody therapy, pembrolizumab (Keytruda), is scheduled to lose its patent in 2028; Regeneron/Bayer’s anti-vascular endothelial growth factor therapy, aflibercept (Eylea), is expected to lose its patent either in 2025 or 2026; and Eli Lilly’s glucagon-like peptide-1 receptor agonist, dulaglutide (Trulicity), is set to lose patent protection in 2027 (3).

Furthermore, while this hefty patent cliff is ongoing, industry is also facing a raft of other issues that are straining profit margins. Issues such as newer and more complex therapeutic modalities are trending, which are more expensive for companies to develop and are targeted at smaller patient populations; various geopolitical tensions are causing supply chain concerns; new legislation is shortening the exclusivity period for drugs; and investment being heavily placed on trending disease areas and specific technologies (1).

However, while the patent cliff will need companies to strategically pivot to negate revenue losses, potential opportunities may open up for other companies seeking to develop a generic or biosimilar form of the blockbuster drugs. According to research, many of the biologic therapies that are set to lose their patent exclusivity in the coming years have no biosimilars in development (4). Such a gap in the market could be a lucrative opportunity indeed.

Möller, C.; Kristic, S.; Walker, G.-C.; Aguilar, J.; Chandran, P. Biopharma’s Patent Cliff Puts Costs Front and Center. BCG, Article, Feb. 18, 2025.

DeAngelis, A.; Feuerstein, A. With a Major Patent Cliff Coming, Will JPM Play Host to Some Serious Deal-Making? STAT, Jan. 8, 2025.

Burke, H. Top 10 Drugs with Patents Due to Expire in the Next Five Years. Proclinical, Feb. 16, 2024.

Jeremias, S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. AJMC, Feb. 5, 2025.

Mike Hennessy Jr is President and CEO of MJH Life Sciences®.

When referring to this article, please cite it as Hennessy, M. Facing the Latest Patent Cliff. 

Over the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.

Facing the Latest Patent Cliff

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Industry Outlook 2025: Political Impacts on Supply Chains

Diversifying where a company sources ingredients and products is an important part of keeping the supply chain robust, says Will Gordon, senior vice president of Product Management, ArisGlobal, and companies must be able to adapt to geopolitical instability to continue to secure the supply chain.

“If something happens in X country, are you able to quickly shift capacity to develop whatever it is to another country or another area? And if we look at what's happening in the United States, there's this BIOSECURE Act, and that's kind of similar, right? So, the US government could, at any point say, ‘Okay, this company is associated to this government, and they're a non-friendly government, and so we're no longer going to allow you to source products from that if you have any federal funds.’ Well, most pharmaceutical companies receive federal funds because government is a large purchaser of pharmaceutical product, right? So, you have to be able to say, okay, how can we shift capacity? How can we shift our supply chains? And I think the pharmaceutical companies of the world have done a really good job at creating that robustness across the supply chain, from sourcing all the way to delivery, and they just have to continue to be nimble and shift as political changes come up,” says Gordon.

Click the video above to watch the full interview.

Will Gordon, senior vice president of Product Management, ArisGlobal.

Will Gordon is senior vice president of Product Management, ArisGlobal.

Pharmaceutical Technology® spoke with Will Gordon, senior vice president of Product Management, ArisGlobal, about how the geopolitical instabilities might impact the bio/pharmaceutical industry. 

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

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

Industry Outlook 2025: Business Viability and Global Collaboration

Being realistic about the viability of business, finances, technology, and the success of drug products, as well as getting back to the basics, are trends from 2024 that have impacted the bio/pharmaceutical industry, according to Alexander Seyf, CEO and Co-Founder of Autolomous. “We're seeing people going back to the drawing board and thinking at the same time [not just the] science, but also the viability of having it as a business,” says Seyf. “I think that's a very positive [trend], because sometimes we need little bit of nudge in the in the shoulder to really guide us forward.”

Seyf also stresses that the industry needs to break out of a “siloed” mentality and embrace working together. Part of making business viable is harmonization and thinking globally. “And one of the key elements, I would say, is we need support from governments. We need support from policy makers,” Seyf says. “And right now, I've seen a good trend in the United States this year that they begin to realize that this is an industry to invest in, and we need to think a little bit differently than we do for pharma. However, I also see the whole kind of healthcare situation in US can be little bit difficult to move it to a more rational change, or to more radical change. However, in Europe, we have the benefit of national health services, and … politicians start realizing the new modality of medicine. There have been a number of talks, and, also, I believe it was mentioned in the parliament. So, we see good trends, both from a Europe perspective, but also a UK [United Kingdom] perspective.”

Alexander Seyf, CEO and Co-Founder of Autolomous

Alexander Seyf is CEO and Co-Founder of Autolomous.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about which trends from 2024 he expects to impact the bio/pharmaceutical industry in 2025.

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