Feliza Mirasol

In this Q&A interview with the PharmTech Group, 

, PhD, vice president of regulatory strategy at Abzena, and 

, MS, director of regulatory affairs at Cellares, explore the implementation of risk-based strategies to navigate 

, adaptive clinical trial designs, and data integrity are transforming the drug development lifecycle. They note how, by embedding quality risk management into initial process designs and leveraging prior knowledge from contract development and manufacturing organizations (CDMOs), the industry can achieve greater manufacturing efficiency, faster innovation, and improved patient outcomes.

: How are evolving global regulations shaping biopharma quality standards?

Mocny (Abzena): There is a shift toward risk-based thinking and leveraging prior knowledge as often as possible. As drug developers, we need to understand the products we manufacture and maintain control over the manufacturing process, materials, and analytical aspects to demonstrate the molecule meets requirements. As regulators adopt this risk-based thinking, leveraging the prior knowledge held by CDMOs offers opportunities to use existing tools in new ways to allow for faster innovation. This reduces development time and allows developers, sponsors, and CDMOs to focus on better patient outcomes and faster-to-market strategies. 

Implementing a robust risk-based quality framework requires integrating risk management into design, not just operations. A common mistake is treating quality risk management as something that kicks in during manufacturing or post approval; instead, it should be embedded into process design and development from the start.

Mocny (Abzena): Safety and risk-based thinking are at the core of these trial models. Trial designs have evolved to improve efficiency and ethical standards by enabling real-time data and informed decision-making. This allows us to leverage prior knowledge and data from other sources to foster faster development and reach go/no-go decisions more quickly. Because clinical trial activities, monitoring, and safety drive the largest portion of drug development costs, economized thinking in these trials is key. Incorporating real-world evidence makes trials stronger and tells a more complete story regarding safety, efficacy, and mechanism of action. This allows products to move through trials quickly based on milestones and an understanding of how the product works.

Mocny (Abzena): Recent FDA guidance and changes in thinking will change the landscape. Placebo-controlled mandates are beneficial for understanding drug performance, and returning to these clinical trial basics is helpful. Reduced animal testing and the incorporation of real-world evidence offer better chances for novel strategies to reach the market and affect positive health outcomes. From a CDMO perspective, this introduces aspects of supply chain and strategic compliance, such as the BIOSECURE Act.

 This has caused intensified oversight of local US-based manufacturing operations, which benefits the market by driving the development of high-quality, patient-centric medicines. It also offers CDMOs an opportunity to modernize approaches, be more competitive on the global market, and offer higher-quality materials at lower prices.

What strategies can biopharma companies use to implement risk-based quality frameworks?

McMahon (Cellares): Implementing a robust risk-based quality framework requires integrating risk management into design, not just operations. A common mistake is treating quality risk management as something that kicks in during manufacturing or post approval; instead, it should be embedded into process design and development from the start. For example, automated cell therapy manufacturing platforms build risk considerations into the engineering requirements of the system to reduce operator intervention and standardize workflows. It is also essential to foster a risk-aware quality culture where personnel are trained on why procedures exist and are empowered to escalate emerging risks. Practically, this means building cross-functional quality review boards where manufacturing, regulatory, and clinical teams collaborate.

Mocny (Abzena): CDMOs have the luxury of leveraging prior knowledge gained from developing multiple products over many years. For instance, IgG1 [immunoglobulin G1] manufacturing platforms have been used since the 1980s and are well understood, allowing for predictable and fast-moving strategies. Risk-based thinking involves carefully considering whether a platform strategy is best for phase 1 clinical trials while understanding critical quality attributes and manufacturing design considerations. Implementing these frameworks relies on data integrity and control over the processes within the facility. While the expectation of data integrity and control is always present, the level of detail and understanding of the product evolves at each phase of development.

How are regulatory shifts influencing manufacturing and clinical development workflows?

Mocny (Abzena): ICH [International Council for Harmonisation] Q14 and Q2(R2) have changed the approach to analytical methods, moving away from rigid thinking toward a risk-based understanding of method design and function. Analytical development is now viewed as a continuum that evolves with the product, allowing developers to leverage prior knowledge to streamline validation. Additionally, the FDA has moved away from the need for clinical trials for biosimilars, emphasizing robust analytical development programs to demonstrate biosimilarity. This [move] reduces financial barriers and allows products to move to market more quickly.

McMahon (Cellares): FDA-accelerated approval modernization and the FDORA [Food and Drug Omnibus Reform Act]

 provisions strengthen the authority to require postapproval confirmatory trials. This leads companies to build commercial-scale manufacturing readiness in parallel with development, rather than sequentially. The agency has also announced more flexible development strategies for cell and gene therapies in areas like clinical development, commercial specifications, and process validation. In Europe, the EU HTA [European Union Health Technology Assessment]

 regulation requires evidence that goes beyond traditional end points like overall survival. This means phase 2 protocols must be designed with joint clinical assessment requirements in mind from the outset, requiring early collaboration between regulatory, medical affairs, and market access functions.

What challenges do companies face when aligning evidence generation with modern FDA guidances?

Mocny (Abzena): A primary challenge is data integrity, as evidence is presented based on collected data. There is a shift toward structured data submissions to regulators, moving away from the written word toward data and numbers. This change offers an opportunity to judge a product’s analytical performance against the field and understand how manufacturing fits with clinical activities. Establishing a clear link between manufacturing unit operations and clinical performance demonstrates an understanding of the molecule and consistent manufacturing. As regulators modernize, the shift toward structured data elements and understanding interrelationships will become more prevalent. While AI tools are being developed to help manage these data, the FDA still emphasizes the importance of having a human in the mix.

How can quality and compliance strategies improve biopharma development efficiency?

Mocny (Abzena): Quality is a scientist’s best friend. Scientists must understand why they follow specific [guidelines] and how those actions affect the product and the patients. A renewed focus on the purpose behind development activities leads to enhanced efficiency. When an organization understands that everything is done with purpose, it is easier to translate the “why” and “how” of meeting regulatory requirements. Compliance is one thing, but making material with a purpose and maintaining that cultural mindset within an organization is the essence of a successful quality strategy.

BIOSECURE Act of 2025, S 3469, 119th Cong (2025). Accessed May 11, 2026. 

https://www.congress.gov/bill/119th-congress/senate-bill/3469

Food and Drug Omnibus Reform Act (FDORA) of 2022. FDA. December 5, 2025. Accessed May 11, 2026. 

https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-omnibus-reform-act-fdora-2022

New EU rules on health technology assessment open up a new era for patient access to innovation. News release. European Commission. January 9, 2025. Accessed May 11, 2026. 

https://ec.europa.eu/commission/presscorner/detail/en/ip_25_226

Articles

Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.

Using Risk-Based Quality Frameworks to Fast-Track Biopharma Development: A Q&A with Abzena’s Jeffrey C. Mocny and Cellares’ Anna McMahon

MilliporeSigma's Sebastián Arana breaks down CGT manufacturing's biggest scale-up gaps and why supply chain collaboration is now essential.

MilliporeSigma's Arana Maps the Gaps Holding Back CGT Manufacturing

Cell and gene therapy manufacturing is roughly where monoclonal antibody production stood a quarter-century ago, according to Sebastián Arana, global head of Process Solutions at MilliporeSigma, the life science business of Merck KGaA, and that comparison says a lot about how much ground is left to cover.

In the second installment of his conversation with our sister publication 

, Arana, turns to the unresolved manufacturing problems in CGT, the biggest themes coming out of the 2026 BIO International Convention (BIO 2026, June 22–25 in San Diego), and why collaboration across the supply chain is becoming non-negotiable.

Check out Part 1 of the interview, in which Arana discusses why modular, digital, platform-based manufacturing, not raw capacity, will define biomanufacturing's next decade.

CGT manufacturing, Arana says, still leans heavily on manual, customized processes. Getting to reproducible, scalable production will take real advances in automation, process optimization, advanced analytics, and real-time monitoring, but the field isn't there yet.

Asked where the biggest unresolved problems sit in CGT scale-up, Arana points to three:

Process characterization gaps remain one of the most consistent issues developers run into. 

Technology transfer has grown more delicate as biological systems get involved, especially when a therapy made at one site has to be reliably reproduced at another. 

Analytical readiness keeps lagging behind manufacturing ambitions, a gap Arana argues companies need to close proactively, before scale becomes the immediate problem rather than the long-term goal.

"If you cannot manufacture it, produce it, and scale it up at the end, it's just a good idea," he says.

Supply chain resilience is the other thread running through Arana's comments. Lessons from the pandemic, he says, have made interdependency and coordination across CGT manufacturing networks more important than ever. Zooming out to BIO 2026 more broadly, Arana describes the conference as confirming rather than revealing a familiar tension: the science keeps outpacing the manufacturing infrastructure built to support it. Flexible manufacturing, digital tools, and collaboration spanning large pharma, biotech, suppliers, and CDMOs came up again and again as the priorities the industry keeps circling back to.

Videos

Industry experts from Sanofi, GxP Frame, and Open Biopharma outline how AI is transforming drug discovery, manufacturing, and workforce strategy through biopharma partnerships in the latest episode of Drug Digest.

Drug Digest: How Advanced Analytics Partnerships Enhance the Biopharma Value Chain

, global head of Computational and AI Strategy for R&D at Sanofi, 

, founder and principal consultant of GxP Frame, and 

, senior director of Education, Outreach, and Digital Experience at Open Biopharma Research and Training Institute, discuss artificial intelligence (AI) integration across drug discovery, 

, supply chain operations, and workforce development in this special combined episode of 

Truppo describes AI's primary value as connecting signals across previously siloed data types, including molecular structure, biological assay results, patient demographics, and clinical site performance, to improve scientific decision quality rather than generate autonomous answers. At Sanofi, for example, disease-specific target identification engines integrate genetics, proteomics, transcriptomics, and single-cell data to help researchers determine target druggability, tissue expression, and optimal therapeutic modality, he explains. 

All three experts emphasize that human oversight must be structurally embedded in AI workflows, not applied as an afterthought. 

How should biopharma companies govern AI tools to maintain data integrity and regulatory compliance?

, Drapeau emphasizes that the most valuable AI applications are not headline-grabbing but operational, such as deviation management, batch record review, predictive maintenance, and supply and demand forecasting. In cell and gene therapy (CGT), specifically, he notes that supply chain is patient-specific, making chain of identity and chain of custody the true measures of AI's value. He also notes that no single manufacturer owns the full CGT supply chain, making cross-company partnerships essential.

Drapeau adds that effective partnerships between biopharma and AI tech and/or advanced analytics companies require a partner capable of integrating across multiple domains while maintaining strict data governance. "Completion is not competency," he stresses, cautioning against operators who can execute AI-assisted tasks but lack the independent judgment to troubleshoot or critically evaluate model outputs.

All three experts emphasize that human oversight must be structurally embedded in AI workflows, not applied as an afterthought. Jaenisch states that explainability is non-negotiable, cautioning that AI outputs used in regulated environments must be traceable and defensible to inspectors.

“There are [many] pieces that an explainable AI system is able to retrieve and provide with every output, and if you do not have that, then you are probably not going to have a good time when an audit comes,” he explains.

Truppo adds that data governance, source traceability, and clearly stated model uncertainty are prerequisites for trustworthy AI integration across biopharma R&D and manufacturing operations when dealing with a strategic partner.

Matt Truppo, Global Head of Computational & AI Strategy, R&D, Sanofi

As the global head of Computational and AI Strategy at Sanofi, Dr Truppo oversees platform capabilities across all therapeutic areas and modalities to advance the company’s drug discovery ambitions. He focuses on embedding AI and predictive technologies throughout R&D to accelerate timelines and enable the development of first-in-class therapies. Prior to Sanofi, he led Protein Therapeutics API Development and Biologics Discovery at Johnson & Johnson and spent more than a decade at Merck working across both small- and large-molecule discovery and development. He holds a PhD in Chemistry from the University of Manchester and undergraduate degrees in Chemical Engineering and Engineering Biology from Princeton University. Over a 20+ year career, Truppo has contributed to bringing 13 medicines to market and advanced many more into the clinic, a quest driven by his commitment to improve global health through innovative science.

Richard Jaenisch, Senior Director of Education, Outreach, and Digital Experience, Open Biopharma Research and Training Institute

Jaenisch has spent the past 15 years in patient advocacy since he began and fought off end stage liver disease and more than 15 years in STEM education, marketing, and consulting. Among his duties at Open Biopharma, he is leading several data projects regarding generative AI integration and exploring generative AI in biomanufacturing training. At Prompting Integration and Consulting LLC, he develops training courses and works alongside his brother, a seasoned AI/ML engineer to develop bespoke generative AI integrations for business in life sciences and healthcare and deliver educational programming on generative AI.

Brian Drapeau, Founder and Principal Consultant, GxP Frame

A private consultant to some of the largest biotech companies in the industry, Drapeau brings more than 5 years of experience in workforce development and training across the biotechnology and pharmaceutical sectors. His expertise includes new hire training, instructional program development, contract development and manufacturing organization (CDMO) training requirements, and high-volume ramp-ups. Drapeau also authors 

, a newsletter covering FDA enforcement trends, CDMO training failures, and pharmaceutical manufacturing operations.

® Group editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

In this episode of Drug Digest, experts from Sanofi, GxP Frame, and Open Biopharma explain how AI is transforming drug discovery, manufacturing, and workforce strategy and how strategic partnerships play a role.

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.

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.

Industry collaboration remains critical to addressing the challenges of modern drug manufacturing, regulation, and global supply resilience as bio/pharmaceutical development increasingly becomes complex. Informa Markets' announced agenda and speaker lineup for 

 reflects this need as the company launches a new Leadership Summit designed to unite decision-makers from across the global bio/pharmaceutical value chain (1).

Taking place Oct. 28–30, 2025, at Messe Frankfurt, the event will feature more than 260 expert speakers from regulatory bodies, biotech startups, manufacturing organizations, and supply chain leaders. The program will focus on the future of drug development, artificial intelligence (AI), digital transformation, and sustainability—key themes shaping how bio/pharmaceutical technologies are developed, scaled, and delivered worldwide (1–4).

“The 2025 event reflects not only the scale of innovation across pharma but also the sector’s need for connected leadership and diverse perspectives,” said Tara Dougal, event director for Informa Markets, in a press release (1). “Our speaker line-up represents a balance of experience and forward thinking, tackling the core challenges and opportunities facing pharma today.”

What key industry issues will the leadership summit address?

The Leadership Summit, sponsored by Ensera (formerly SteriPack), is a major addition to this year’s event. The summit will serve as a strategic forum for executive dialogue on topics such as pharmaceutical resilience, mergers and acquisitions, access to medicines, and the impact of geopolitical shifts on global supply chains.

These discussions are expected to resonate across the bio/pharmaceutical industry, for which managing risk and maintaining manufacturing continuity are central concerns. By emphasizing long-term strategy and policy alignment, the summit aims to bridge the gap between regulatory goals, commercial strategy, and the operational realities of global drug production.

What hot topics will the specialized tracks explore?

The conference’s seven content tracks will explore specialized areas critical to the evolution of pharmaceutical manufacturing and development and will include:

Packaging and Device Innovation (Hall 8.0): Patient-centric packaging, connected devices, and regulatory strategies for combination products

Future of Pharma and Ingredients (Hall 8.0): Advances in API design, digital chemistry, and modernization of regulatory pathways

Next-Gen Bio (Hall 4.1): Challenges and solutions in scaling up biologics, cell and gene therapies, and messenger RNA platforms

Clinical Innovation (Hall 6.1): Use of AI, digital endpoints, and decentralized trial models to improve patient recruitment and data reliability

Manufacturing 5.0 (Hall 4.1): Smart factories, machine learning integration, and operational excellence in production

Sustainable Futures (Hall 4.0): Strategies for low-emission manufacturing, circular pharma, and responsible sourcing

Spotlight Stage (Hall 4.0): Focused updates on cleanroom technologies and sustainability in production.

According to Informa, each track was developed in collaboration with global partners, including IQVIA, Medicines for Europe, CEPI, Environmental Financial Consulting Group, and PSCI. The collaboration aims to ensure that the content reflects the latest data-driven insights and industry priorities (1).

The diversity of speakers includes subject matter experts from government, academia, and multinational biopharma enterprises and underscores CPHI Frankfurt’s role as a global forum for advancing bio/pharmaceutical technology. Through technical sessions and leadership discussions, the event aims to shape the dialogue around efficiency, sustainability, and digitalization across the full drug development lifecycle (1).

CPHI Frankfurt 2025 Unveils Dynamic Speaker Line-Up and Launches New Leadership Summit

. Press Release. Oct. 21, 2025.
2. Fu, C.; Chen, Q. The Future of Pharmaceuticals: Artificial Intelligence in Drug Discovery and Development. 


3. Mustoe, C. L.; Turner, A. J.; Urwin, S. J.; et al. Quality by Digital Design to Accelerate Sustainable Medicines Development. 

The Rise of AI in Biopharmaceuticals: Uncovering the Environmental Cost and the Promise of Sustainable AI

The upcoming CPHI Frankfurt 2025 event will address the complexities of modern drug manufacturing, regulation, and global supply resilience through a new Leadership Summit. This summit will unite decision-makers from the bio/pharmaceutical value chain to discuss key industry issues such as pharmaceutical resilience, mergers and acquisitions, and geopolitical impacts on supply chains. The event will feature over 260 expert speakers and seven specialized content tracks focusing on themes like AI, digital transformation, and sustainability. The goal is to align regulatory goals with commercial strategies and operational realities in global drug production.

Spotlighting global biopharma innovation, the event will unite leaders to discuss digitalization, sustainable manufacturing, and future-ready development.

CPHI Frankfurt 2025 to Showcase Advances in Biopharma Manufacturing, Digital Transformation, and Global Industry Collaboration

Sherwin-Williams Protective & Marine (Sherwin-Williams), a supplier of high-performance flooring, wall systems, and coatings for pharmaceutical, life sciences, and biotech facilities, will showcase its latest pharmaceutical cleanroom innovations at INTERPHEX 2025, occurring April 1–3 in New York City. In particular, the company will highlight its new high-performance coating systems at the conference, according to a March 20, 2025 company press release (1).

The company’s high-performance coating systems are designed to ensure safe, sterile, and efficient pharmaceutical manufacturing environments. The systems contain solutions that are tailored to meet the specialized needs of cleanrooms and critical production spaces. The company’s advanced coatings portfolio includes coatings for floors, walls, ceilings, and other surfaces, all of which are designed to minimize downtime while maximizing protection against contamination and wear (1).

By design and through engineering, these advanced coating systems are geared toward supporting the rigorous demands of pharmaceutical manufacturing facilities. Features of the advanced coating systems include:

durability, with high resistance to harsh chemicals, abrasion, and heavy wear for long-term reliability

sterility, by offering seamless, durable surfaces that minimize cracks, with the aim of reducing contamination risks in sterile environments

efficiency, such as fast-curing systems that reduce installation time and downtime to ensure continuous production and development

sustainability, including solutions that are free of Red List chemicals (2) and that are designed to meet Leadership in Energy and Environmental Design compliance (3).

“This industry is a constant balance of compliance and innovation,” said Michael Durbin, market segment manager for Pharmaceutical at Sherwin-Williams Protective & Marine, in the press release (1). “Our precision-engineered coating solutions empower manufacturers to maintain that balance while creating environments critical to life-saving advancements. INTERPHEX is a great opportunity for us to continue to connect with industry leaders and showcase how our coatings contribute to the next generation of pharmaceutical manufacturing.”

At the conference, Sherwin-Williams will also highlight innovative solutions aimed at enhancing efficiency, safety, and compliance in pharmaceutical environments, including:

A floor visualizer tool: the company will exhibit an interactive touchscreen floor visualizer with which attendees can engage; this tool will allow users to explore and customize flooring solutions in real time and helps pharmaceutical manufacturers select the ideal flooring system based on their facility’s unique requirements.

A grout and topcoat technology (Accelera One): this technology offers rapid cure times, chemical resistance, and cost-saving efficiency to help facility owners protect their investments as well as maintain safe and sterile manufacturing environments.

Thermal insulative coating solutions (Heat-Flex): These coating solutions are designed to be used with coolers, freezers, and high-temperature equipment to aid in the prevention of condensation buildup, reduction of thermal losses and enhancement of site safety; these solutions also offer protection to personnel by reducing the risk of burns and injuries, in compliance with Occupational Safety and Health Administration regulations concerning thermal insulation on metallic equipment.

Attendees can visit Sherwin-Williams at booth #2569 at INTERPHEX.

1. Sherwin-Williams Protective & Marine. 

Raising the Bar: Sherwin-Williams Highlights Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025

. Press Release. March 20, 2025.
2. Green Building Alliance. Product and Building Materials Red List. 

 (accessed March 28, 2025).
3. US Green Building Council. LEED Rating System. 

Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments. 