Biologics at Scale: Navigating Development & Manufacturing Challenges in an Uncertain World

The biologics external manufacturing panel at CDMO Live 2025, sponsored by BSP Pharmaceuticals, brought together industry leaders to tackle the key challenges in scaling biological manufacturing amid geopolitical tensions, capacity constraints and evolving partnership models.The panel featured Olaf Birkenmeier, Head of External Manufacturing at Polpharma Biologics; Julien Laizé, Director of External Manufacturing CTM at Valneva; Catherine Seigneur, Senior Director of External Manufacturing Business Lead at UCB; and Giorgio Salciarini, Head of Sales - Technical Business Development at BSP Pharmaceuticals.Download the full CDMO Live Report

Joshi Venugopal, SVP and Head of Region for Novartis Gene Therapies, outlined three critical inflection points that will determine whether cell and gene therapy reaches its full potential at CDMO Live 2025The cell and gene therapy industry finds itself squarely in the middle of a classic Gartner hype cycle, according to Novartis gene therapy chief Joshi Venugopal. Speaking at CDMO Live 2025, Venugopal drew on Novartis's experience with the first two FDA-approved gene therapies to map where the industry stands today — and what it will take to reach the "plateau of productivity.""We had the opportunity to be the pioneers in introducing these innovative medicines in several countries, and sense the opportunities and challenges first hand," Venugopal told delegates in Rotterdam.Download the full CDMO Live report

At CDMO Live 2025, industry leaders Elisabeth Stampa (Medicines for Europe), Elena Barboni (Flamma) and Agneta Larhed (RegSmart Life Science) discussed how Europe's stringent new regulations could reshape the continent's pharmaceutical manufacturing landscape.Europe's pharmaceutical manufacturing sector faces an unprecedented challenge as new environmental regulations threaten to drive production offshore, whilst the Critical Medicines Act attempts to bring it back home. Industry leaders warn that razor-thin margins on generic medicines could lead to widespread product withdrawals if costs aren't carefully managed.Download the full CDMO Live report

“When you’re building something at the edge of science, it’s crucial to start with the problem, not the solution. My team has created 15 pharma startups using this approach, and 14 are still alive.” – Kerstin Papenfuss, Director of Pharma at Deep Science VenturesKerstin Papenfuss serves as the Director of Pharma at Deep Science Ventures, where she leads the creation and development of novel therapeutics for unmet medical needs. With a PhD in Tumour Immunology from Imperial College London and an MBA from Bayes Business School, Kerstin brings over a decade of experience in oncology, signal transduction, and pharmaceutical markets to her role building science-based startups from scratch.Kerstin explains why traditional approaches to biotech startup creation often fail and how working from first principles can lead to more successful, impactful ventures. Her experience spans working with entrepreneurs, academics, pharmaceutical companies, and disease charities to build companies that solve fundamental challenges in healthcare.Read the full article:https://pharmasource.global/content/podcast/building-biotechs-from-first-principles-deep-science-ventures-formula-for-science-based-innovation/

The COVID-19 pandemic demonstrated how pharmaceutical manufacturing timelines can be dramatically compressed while maintaining quality. At CDMO Live 2025, Fabrice Le Garrec shared lessons from the Lonza-Moderna vaccine scale-up, where "timeline meant lives."Here are his "10 Commandments" for fast-tracking emergency drug manufacturing.Dpwnload the full CDMO Live 2025 Report

Simon Kucher opened CDMO Live 2025 in Rotterdam by unveiling brand new research developed in partnership with PharmaSource.The comprehensive study, presented by Kaan-Fabian Kekec and Clarita Simon, mapped the evolving landscape of CDMO-sponsor partnerships based on insights from over 100 industry experts.Read more

CDMO Live 2025, a panel sponsored by Lifecore Biomedical brought together industry quality leaders to discuss how quality management can become a strategic enabler rather than a compliance burden. The panel featured Jackie Klecker (EVP Quality & Development Services, Lifecore Biomedical), Liesbeth Foesters (VP Head of External & Clinical Supply Quality, UCB), Stefan Bouckaert (Vice President External Supply Integration Quality, Johnson & Johnson), and Gwladys Mabonzo (Associate Director External Manufacturing Vaccines, MSD).Download the full 50 page report

“We invest to meet the needs of the customer. What’s driving these investments are really the customer partnerships that we’re building to make these happen,” explains Arul Ramadurai, Chief Commercial Officer at Axplora.Axplora, a global leader in API small molecule and ADC manufacturing, was formed through the merger of Farmabios, Novasep, and PharmaZell. With 2,400 employees across ten API manufacturing sites in Europe, India and the US, the company has recently accelerated its growth strategy with major investments in high-growth areas like GLP-1 peptides and antibody-drug conjugates (ADCs).In a strategic leadership move to drive this expansion, the company appointed Martin Meeson as its new Chief Executive Officer in April 2024, succeeding Sylke Hassel.In the latest episode of the PharmaSource podcast we interview Arul Ramadurai about the company strategy.Full interview

At CDMO Live 2025, a panel sponsored by Aizon explored how pharma companies are transforming external manufacturing operations through digital integration, with experts from sharing practical approaches to implementation.The Digital Divide: Big Pharma vs Mid-Size PlayersThe panellists painted a stark contrast in digital maturity across the pharmaceutical manufacturing landscape. Dave O'Gara, pharmaceutical business consultant at Aizon with over 30 years experience at Novartis, outlined the current state of play."When you move into pharma and segregate into big pharma, they have digital strategies... When you move into the mid-range CDMOs and smaller CMOs, it's not so active," O'Gara explained, highlighting what he termed a "massive opportunity" for mid-size players.Franziskus Kath, founder of Kath-Consulting and former VP of Emerging Technology for QA at Johnson & Johnson, confirmed this assessment: "The larger the companies, the more digital is already there... Most of them have been for the past eight to 10 years really tackling the topic."From the CDMO perspective, Vishnu Dwadasi, Director of Life Sciences at West Monroe, described significant implementation challenges: "A lot of these companies are still very manual, so they have to move from paper to digital and then digital to eventually leveraging analytics and AI."Download the full report

“Know your supply chain. Make sure you have it well mapped. The biggest thing that we’ve seen coming out of COVID was investments in technology – that’s what’s helping manufacturers respond to the unexpected.”Ryan Kelly, Senior Director of Supply Chain Security and Brand Protection at Rx-360, delivered this stark assessment of pharmaceutical supply chain management during a live podcast recording at CDMO Live 2025 in Rotterdam.Ryan brings extensive experience in pharmaceutical supply chain security from his role at Rx-360, a nonprofit consortium representing approximately 130 manufacturers, suppliers, distributors and contract logistics providers. His organisation focuses on safeguarding the quality and security of pharmaceutical supply chains through information sharing and collaborative risk management.In this episode Ryan explains how pharmaceutical companies can build resilience against increasingly frequent supply chain disruptions whilst maintaining patient access to critical medications.Read more