As the global biopharma industry gathered at BIO International in Boston, MA, key players shared their perspectives on the challenges reshaping drug development and manufacturing. From regulatory shifts to rising complexity in novel modalities, the roundtable captured strategic responses from CDMOs and suppliers pushing the boundaries of innovation.

Liza Laws, co-founder of Discover Pharma spoke with leaders from Mabion, Hongene, Tjoapack, Abzena, Quotient Sciences and Renaissance Lakewood, revealing how they’re adapting to market headwinds, embracing regulatory evolution and preparing for what’s next.

Dave Butler, chief technology officer, Hongene.

What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?

One of the biggest challenges in the pharmaceutical market, particularly in RNA therapeutics, is manufacturing complex novel modalities at scale with consistent quality. As therapeutic designs grow more sophisticated, including longer RNA strands, novel backbone modifications and multifunctional conjugates, the limitations of traditional synthesis platforms become more evident.

Our organization addresses this by integrating a chemoenzymatic ligation platform that allows for precise, modular assembly of complex nucleic acids. This platform overcomes common barriers related to yield, impurity profiles and sequence length, while offering enhanced customization. We’ve also built a true end-to-end vertically integrated CDMO infrastructure, enabling seamless raw materials manufacturing, process development, analytical development and scalable GMP services, from drug substance to drug product.

By partnering with clients early in the development cycle, we align technical execution with clinical and regulatory strategy. This proactive collaboration helps de-risk development and shorten timelines from preclinical through to commercial phases.

Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

Recent guidance from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) has added clarity and structure for nucleic acid therapeutics. In 2024, the EMA released a draft “Guideline on the Development and Manufacture of Oligonucleotides,” which emphasizes detailed characterization of sequences, conjugates and impurities, along with robust sterile manufacturing controls. These recommendations supplement existing International Council for Harmonisation (ICH) and GMP requirements.

At the same time, the FDA introduced the Platform Technology Designation Program, which enables sponsors to seek designation for reproducible manufacturing technologies, such as our chemoenzymatic ligation platform that supports multiple products. If granted, the designation allows companies to leverage existing CMC data to help expedite the IND and NDA review process. We’re applying risk-based strategies and strong science to support our clients within the context of these new guidelines.

Nigel Stapleton, vice president of business development, head of Europe, Mabion.

What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?

The primary challenge within the biotech and pharma industry over the last few years and for the next year or two, as far as I can see, is and will remain that funding is tight. The rise of multispecifics, ADCs and other new modalities has increased the complexity of the molecules, but also of the clinical trials needed to move these molecules forward. Analytics play a key role in improving success of the CMC activities, especially early phase development. In parallel, the use of AI in product and process development has increased competition amongst early phase innovative biotechs. Meanwhile regulatory expectations and complexity have increased in response to the increased complexity of these new modalities.

This has led to an interesting cocktail of rising development costs, complex regulatory pathways and increasing pressure to accelerate timelines so as to beat the competition.

As a leading CDMO, we have responded to these pressures by increasing our flexibility and streamlining our development timelines, particularly for small and mid-sized biotechs advancing novel therapeutics through early clinical stages, while continuing to ensure that we offer the best “bang for your buck” efficiency within the US and EU CDMO space.

At Mabion, we can offer a single-site, end-to-end solution from development to final product release, meaning we have full control over timelines and can support each product in a bespoke manner.

We have expanded our already formidable analytical capabilities, strengthened our project management oversight and established partnerships with technology leaders like Sartorius to enhance process robustness. As a European CDMO, located in Poland, we combine a high degree of cost-effectivity with a true client focus, ensuring responsiveness without the complexity of fragmented outsourcing.

Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

Internally, we strengthen regulatory expertise by hiring dedicated experts and maintaining certifications, such as RAPS, to monitor and comply with EMA and FDA requirements. Our filling and finishing operations have implemented improved contaminant control, real-time inspection systems and compliance innovations tailored to the evolving requirements of Annex 1. Through these measures, Mabion remains flexible and compliant with increasing regulatory complexity.

Tariffs imposed on the pharmaceutical industry by the US government can significantly increase development and manufacturing costs, similarly impacting the supply chain. Given that nearly 90% of US biotech companies rely on imports for key biological components, the threat of tariffs could undermine price competitiveness and supply security. In response, Mabion has intensified its strategic engagement in the US market by enhancing our business development capabilities and is actively pursuing partnerships spanning Europe and North America to build resilient “friend-shoring” supply chains.

Joe Compton, senior director, business development, Tjoapack.

What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?

At Tjoapack, we’re adapting to the pharmaceutical market’s increasing need for specialised solutions for temperature-sensitive treatments and custom configurations. This has driven us to expand our cold chain capabilities and scale our packaging capacity for injectables, including syringes, vials and auto-injectors.

We’re investing in building on our existing logistics hub to support pharmaceutical companies whose products have complex handling needs during multinational transit and storage. Automation of final packaging and labelling is also key, ensuring strict control over product integrity. These strategic decisions support more personalised, responsive delivery, enabling us to bring breakthrough therapies to patients faster.

Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

Regulations like the EU’s Falsified Medicines Directive (FMD) and the US’s Drug Supply Chain Security Act (DSCSA) now mandate serialisation on all drug units. This is vital for patient safety and anti-counterfeiting.

Regulatory challenges include:
● Securing material supply: Companies need to ensure alternative suppliers have the necessary qualification expertise and validation.
● Accurate information and labelling: Companies have to proactively respond to required artwork changes and have the ability to consume the remaining stock.
● Managing Qualified Person (QP) release responsibilities: QP release must be performed within a certain approved window to ensure compliance.

Expert packaging and logistics partners are here to support pharmaceutical companies in overcoming this regulatory complexity.

Dr Campbell Bunce, chief scientific officer, Abzena.

What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?

Next-generation biologics, such as bispecifics, fusion proteins and antibody-oligonucleotide conjugates (AOCs), offer transformative potential yet demand unprecedented speed. Emerging biotechs chase rapid value-inflection, big pharma need pipeline renewal, regulators are streamlining reviews and patients want faster access to more effective treatments.

Abzena meets this urgency by de-risking early and deploying proven platforms. Our AbZelectPRO cell line development platform, for example, consistently expresses “difficult” formats like bispecifics (bsAbs) and fusion proteins and shrinks DNA-to-research-cell-bank timelines by 30%. Coupled with two decades of expertise in antibody-drug conjugate (ADC) development, we adapt validated conjugation workflows to AOCs, enabling the seamless transition of complex molecules from design to GMP manufacture without reinventing the wheel.

Can you provide insights into any regulatory changes or compliance issues that are impacting your business?

The FDA’s initiative to reduce or replace animal studies is reshaping pre-clinical strategies. Anticipating this, Abzena expanded its bioassay arsenal, comprising high-content cytotoxicity, bystander, cross-reactivity and potency assays that characterize on- and off-target risks for ADCs and AOCs entirely in vitro or ex vivo.

These data-rich workflows meet evolving safety expectations, compress IND timelines and minimize in vivo work. By sharing data and insight through agency working groups, we help shape pragmatic guidance and keep our customers’ programs inspection-ready as regulations evolve.

Eric Kaneps, vice president of sales and marketing, Renaissance Lakewood.

What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?

One of the biggest challenges we’re navigating right now is the uncertainty around tariffs, which is impacting material costs and complicating long-term planning. These increased costs ultimately affect our clients, so we’re doing everything we can to minimize the impact.

We work closely with our suppliers to stay ahead of potential changes and identify cost-saving opportunities where possible. Internally, we’re building more flexibility into our sourcing strategies and timelines. We also maintain open, proactive communication with our clients — so they’re aware of potential cost shifts early and can make informed decisions.

It’s a complex issue, but transparency and collaboration go a long way in helping everyone stay on track.

Robert Cornog, senior director, product development, and Kevin Schaab, senior drug development consultant, Quotient Sciences.

How are Quotient Sciences’ capabilities helping clients navigate the current uncertainties in drug development and regulatory environments?

Robert Cornog: Like all companies, we’re continuing to monitor the impacts of recent BIOSECURE Act, FDA and NIH changes, and proposed US tariffs. We remain committed to supporting our pharma and biotech partners even in times of uncertainty, applying our expertise across drug development to save time and remove risk, particularly for rare disease and other programs seeking accelerated regulatory pathways.

Kevin Schaab: With capabilities in both the US and the UK, we feel well-positioned to serve the needs of companies seeking CDMO/CRO partners in times of global uncertainty from a drug development perspective.