Top BP Videos of 2025: An Intersection of AI, Innovation, and Compliance

The top 10 BioPharm International videos of 2025 demonstrate a strong industry focus on advanced technology (especially AI), regulatory modernization, and the evolution of drug development modalities. A major theme is the pervasive integration of AI and predictive analytics across the biopharma lifecycle, including evaluating clinical trial sites for risk factors, designing novel mRNA molecules to bind difficult proteins, aiding regulatory compliance for new manufacturing techniques, and improving the efficiency of development strategies through real-world data integration. Concurrently, the industry is navigating crucial operational challenges, such as adopting sustainable practices in infrastructure like cleanrooms by measuring embedded carbon using Environmental Product Declarations (EPDs), and ensuring quality and compliance in complex areas like sterile injectable manufacturing and FDA regulations. Market dynamics are addressed through discussions of major mergers and acquisitions (like Waters-BD and Merck-Verona) and shifts in investment frontiers, while therapeutic innovation centers on emerging cancer treatments like CAR T-cell therapy.

Let’s take a closer look back at our top 10 videos of 2025:

1. Ask the Expert: Key Considerations for Building Sustainable Cleanrooms

Steve Griffiths, Global VP of Business Development at GCS, outlines the essential environmental decisions involved in sustainable cleanroom construction. He highlights two main considerations: operational carbon, which is significant due to high energy usage from air changes, and embedded carbon within the construction materials themselves. Griffiths stresses the importance of sustainable sourcing, challenging manufacturers to use recycled and renewable materials, and minimizing carbon-heavy products like concrete and steel. The universally accepted tool for measuring the embedded carbon across a product’s lifecycle is the environmental product declaration, which is publicly registered and assessed by third parties, he notes.

2. Aikium's AI-Driven mRNA Engine Looks to Address Undruggable Disordered Proteins

Eswar Iyer, MS, PhD, CEO and co-founder of Aikium Inc., describes his company's AI-driven mRNA engine aimed at addressing the challenge of "undruggable disordered proteins." Iyer explains that protein predictions often fail because they don't account for the conformational flexibility of proteins and because roughly half of the proteome is disordered and lacks stable structures. To solve the issue of sparse paired binding interfaces and interaction data, Aikium employs an experimental approach in which an AI algorithm precisely designs the binding protein, such as an antibody, to interact with the disordered target.

3. DCAT Week 2025: Maintaining Aseptic Integrity and Stability in Sterile Injectable Manufacturing

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the main challenges in aseptic processing for sterile injectable pharmaceuticals. Key hurdles include maintaining aseptic conditions during complex, multi-hour manufacturing processes, ensuring stability for sensitive molecules like antibody-drug conjugates (ADCs), upholding cold chain logistics throughout global supply chains, and adhering to strict safety standards for highly potent and cytotoxic molecules, she explains. Simtra is addressing these issues by implementing advanced automation, digitalization, lean manufacturing practices, and robust technology transfer protocols to maintain molecule stability from transfer onto filling lines until shipment to the patient.

4. Ask the Expert: Complying with 21 CFR 211.110

Susan J. Schniepp and Siegfried Schmitt, PhD, discuss the implications of the FDA's draft guidance released in January 2025 concerning compliance with 21 Code of Federal Regulations (CFR) 211.110. This specific section focuses on production and process controls for testing and sampling in-process materials and drug products, applying to human drug products and biologics, but not to the manufacture of APIs. Schniepp suggests the guidance targets new manufacturing techniques, offering flexibility for biopharmaceuticals, personalized medicines, continuous manufacturing, and the use of AI to identify key process parameters. Schmitt adds that the guidance addresses continuous manufacturing, although this process is currently rare, with most processes still running batch by batch.

5. Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers

This Behind the Headlines panel discussion analyzes major deals and trends that were reshaping the life sciences landscape in early summer 2025. The discussion includes analysis of the $17.5 billion Waters and BD Biosciences merger, which aimed to create a more vertically integrated life sciences leader focused on diagnostics, instrumentation, and biologics-enabling technologies. Attention also centers on Merck's strategic $10 billion acquisition of Verona Pharma, securing the COPD drug Ohtuvayre as a hedge against the upcoming Keytruda patent expiry. The panelists additionally assess external pressures like pharma tariffs and the practical deployment of AI across development and operational pipelines.

6. Industry Outlook 2025: The Rising Prominence of AI in Pharma

Ben Sidders, Chief Scientific Officer for Biorelate, discusses the projected continuing dominance of AI in the pharma industry, noting that 2024 was marked by the rise of AI-first companies and its increasing use across traditional pharma processes. Sidders predicted that the rise of AI in 2025 would be driven by three major areas: the increased availability and maturation of pharma's data strategies; the development of models that embed underlying causality; and a cultural shift within pharma companies toward a top-down mandate placing AI at the center of research programs and organizational design. He suggested that if these developments occur, the evolutionary process of adopting AI would begin to fulfill its promise.

7. ASGCT 2025: Emerging Modalities for Cancer Treatments

Ryan Larson, PhD, SVP, head of Research at Umoja BioPharma, discusses how emerging modalities, including cell therapies, are transforming cancer treatments. Larson notes that oncology treatments are rapidly advancing, encompassing areas like T cell engagers, antibody drug conjugates, immune checkpoint inhibitors, and in vivo chimeric antigen receptor, or CAR, T-cell therapy. While cell therapies have demonstrated a transformative nature, particularly in hematologic malignancies like multiple myeloma and diffuse large B-cell lymphoma, achieving deep and durable responses, access to ex vivo autologous cell therapies remains a significant challenge for a large fraction of eligible patients.

8. Industry Outlook for 2025—Real-World Data

Sujay Jadhav, CEO of Verana Health, provides insight into trends concerning real-world data (RWD) and real-world evidence, which have become a major focus for pharmaceutical regulators like FDA and the European Medicines Agency. Jadhav notes that exponential changes are occurring in RWD components, including the mainstreaming of external control arms in clinical research, facilitated by recent FDA guidance. He also highlights the trend of predictive analytics and AI helping to predict disease progression, assisting with early detection, and supporting patient recruitment and retention. This leverage of AI and technology leads to informed decisions across the entire drug life cycle, he says.

9. Biopharmaceutical Development: Innovations Impacting Development

Oury Chetboun, CEO of Seekyo Therapeutics, provides his perspective on how new modalities and technological innovations are influencing biopharmaceutical development. Chetboun notes that the biopharma industry is experiencing growth in innovation, specifically in specialized medicines and new treatments for autoimmune diseases and cancer. He cautions that a key trend advancing the industry is continuous manufacturing, which helps reduce time to market, addressing the challenge that a fantastic drug developed in the lab might cost too much to be scaled up or produced at a reasonable cost for large-scale production.

10. AAPS National Biotechnology Conference 2025: AI’s Role in Clinical Study Site Evaluation

This video features Jerry Chapman of Redica Systems discussing the application of AI in evaluating clinical sites to identify and predict risk factors. Chapman emphasizes that for AI to be successful, it must be applied to a "foundation of facts," requiring data that has been cleaned, labeled, enriched, categorized, and scored beforehand. Once this clean data foundation is established, AI can be used to look for semantic matches and matches that have led to further compliance actions, he adds. AI ranks the language used in FDA observations based on severity by comparing it against similar language found in FDA warning letters.