PharmaSource Podcast

Gil Roth, president of the Pharma and Biopharma Outsourcing Association (PBOA), delivered a stark assessment of the uncertain regulatory and trade environment facing US drug manufacturers under Donald Trump's administration at CDMO Live 2025.In a presentation characterised by its unflinching candour, Roth outlined the key challenges confronting contract manufacturers, from rapidly changing tariff policies to mass layoffs at the FDA. His central message was bracingly simple: "Nobody knows anything. You need to be focused on flexibility and optionality."Download the full CDMO Live Report

“Over 90% of people you meet in life sciences are going to be dealing with failure every day. You have to normalize failure in this industry to get the success you want,” says Beth Benatti Kennedy, discussing the unique pressures facing pharmaceutical professionals.Beth Benatti Kennedy brings more than two decades of experience as a leadership and resilience executive coach, working with major pharmaceutical companies including Takeda, Nautilus Biotechnology, and Pfizer. Beth is also the author of Career Recharge and co-author of ReThink ResilienceHer insights into preventing burnout have become increasingly relevant as the industry faces mounting pressures from accelerated development timelines and regulatory complexity. In this interview with PharmaSource, Beth shares critical strategies for building resilience.Read the full article

“The pharmaceutical industry is very good at being reactive. If something happens, they have very clear processes, but they're not so good anticipating change.”David Schneider, Founder & CEO of Qualifyze, brings more than a decade of experience working in investment banking (JP Morgan), Fortune 500 companies (BASF), and management consulting (McKinsey). He now leads Qualifyze, a company transforming supply risk management in the pharmaceutical industry.With operations across Frankfurt, Barcelona, and now Jersey City, Qualifyze serves around 1,400 pharmaceutical companies globally and has inspected over 4,000 production sites worldwide.In the latest PharmaSource podcast, David and Qualifyze's Chief Product Officer Martin Lehmann discuss how data-driven approaches can help pharmaceutical supply chains adapt to geopolitical pressures and uncertainty.Meet the Qualifyze team at CDMO Live 2025Read the full article

“In Big Pharma, innovation is often stifled because the bureaucracy and mindset completely kills creativity and intuition needed for discovery. That's why they now prefer to allocate their early-phase resources to smaller biotechs,” explains Julien Laizé, sharing candid insights about the delicate balance between innovation and compliance in vaccine manufacturingJulien Laizé serves as Director of External Manufacturing CTM at Valneva, a French-based specialty vaccine company developing and commercialising vaccines for infectious diseases. With previous roles at Novo Nordisk and Eli Lilly, Julien brings unique perspectives on managing external manufacturing across both big pharma and biotech environments, particularly in navigating the tension between innovation and regulatory compliance.Ahead of CDMO Live next week, Julien shares his experiences in fostering innovation while maintaining rigorous quality standards, and explains why the industry's greatest discoveries often come from embracing calculated risks.Listen to the full episode here and join Julien and other ExM leaders at CDMO Live 2025, 7-8 May, Rotterdam.

“We are privately owned by a Trust, which means all our profits are reinvested in the company. This translates to steady growth – maybe slower compared to other service providers, but we're quite proud of that steady growth,” explains Franciane Chevot, Senior Business Development Manager at Almac.With 55 years of industry experience, approximately 7,500 employees, and 18 facilities worldwide across Europe, North America, and Asia, Almac has established a global footprint. However, it's their ownership structure that truly differentiates them.This reinvestment approach has allowed Almac to take a long-term view of business development rather than focusing on short-term gains, creating stability that benefits both the company and its clients.Ahead of CDMO Live, Franciane shares how Almac's unique ownership structure, scientific expertise, and customer-centric approach have positioned the CDMO as a trusted partner for pharmaceutical and biotech companies across the drug development lifecycle.Read the article

“AI doesn't have to be the first port of call. Many organisations still need to focus on the paper-to-glass journey before they can think about more advanced technologies” Vishnu Dwadasi, Director of Life Sciences at West Monroe, brings extensive experience across pharmaceutical operations, consulting and business development from both the sponsor and CDMO sides. His career path through companies including Catalent, BioDuro, PII and now West Monroe has given him unique insights into the evolving pharmaceutical outsourcing landscape.In the latest PharmaSource podcast episode, Vishnu shares his perspective on how private equity investments are reshaping the CDMO landscape, post-merger integration challenges, and the realistic pace of digital transformation within pharmaceutical manufacturing organisations.Read the article

“Our goal is to be more than a service provider. We aim to be a strategic partner that grows with our clients from bench to bedside.” – Dr. Jim LiDr. Jim Li, President of CMC Solutions at BioDuro, brings extensive experience as a chemist and pharmaceutical industry veteran, having held leadership positions at global companies including Pfizer and Henkel before joining BioDuro to build up and manage the company's CMC business.In the latest PharmaSource podcast episode, Jim explains how BioDuro's integrated CRDMO model creates higher value outcomes for clients while balancing cost considerations with speed to market.Read the full article

“Managing hundreds of products across multiple species requires a different approach to network strategy than human pharma,” explains Bernhard Boehm, Head of External Manufacturing for Animal Health at Boehringer Ingelheim.Bernhard Boehm leads external manufacturing for animal health as VP of 3PM at Boehringer Ingelheim, bringing nearly 20 years of pharmaceutical experience across regulatory, quality, R&D, and site management roles before transitioning to animal health five years ago.Ahead of CDMO Live, Bernhard explains how animal health manufacturing differs fundamentally from human pharmaceuticals, requiring specific strategies to manage a complex portfolio across multiple species while facing tighter margins and diverse customer needs.Read Boehringer Ingelheim's Six Strategic Approaches to External Manufacturing Networks

Exclusive interview for PharmaSource ahead of CDMO Live“We've combined these two solid legacies into a new, agile CDMO with a unique focus on high-value small and medium-scale production,” says Bruce Vielle, CEO of the newly formed Meribel Pharma Solutions.Bruce Vielle, an experienced industrial business leader with extensive expertise in lean manufacturing and managing multi-site operations across automotive, aerospace, and pharmaceutical sectors, is spearheading the launch of Meribel Pharma Solutions. Most recently serving as President and CEO of Synerlab, Bruce now leads this ambitious new contract manufacturing venture backed by Blue Wolf Capital Partners.Ahead of CDMO Live next month, Bruce shares insights about this significant new entrant to the European pharmaceutical manufacturing sector, formed through Blue Wolf Capital Partners' strategic acquisition of Recipharm sites and Synerlab. The new venture brings together 13 sites across Sweden, France, and Spain with specialised capabilities in development, sterile multi-dose products, and lyophilisation.Meribel Pharma Solutions represents the culmination of a carefully orchestrated merger between Recipharm's carved-out sites and Synerlab, completed at the end of 2024. Bruce explains that the integration brings together complementary capabilities that create significant market synergies.“Our first challenge for 2025 is to bring the company under a single vision, building our culture, integrating systems, and aligning our operations,” Bruce says. “We're accelerating investment in high-added value processes such as sterile multi-doses and lyophilisation, expanding our development services, and reinforcing our role as a premium partner for small and medium-sized pharma and biotech companies.”The company operates across 13 sites in three countries, with three specialised in development and ten focused on manufacturing. This geographic spread provides both local expertise and international reach for clients seeking European manufacturing solutions.“There is always in such integration a strong focus on people,” Bruce emphasises. “We really want to bring everyone together around this transformation and merger.”Full interview

“Trust is what your customers need most. They take a great risk when they sign up with you to make their product. They need access within your organization to feel confident you'll get things done the way they want.” Thomas Thorpe, CEO of Afton Scientific, brings 45 years of pharmaceutical operations experience to his founder-led Contract Development and Manufacturing Organisation (CDMO), which has grown from bootstrapped beginnings to a company with close to 100 employees specialising in sterile injectable manufacturing.In the latest PharmaSource podcast episode, Tom explains how his experience working for large pharmaceutical companies shaped his approach to building a CDMO that prioritises customer relationships, regulatory compliance, and strategic growth investments—now culminating in a $200 million expansion plan.Read the full article

“What we're witnessing is the rapid dismantling of the US research infrastructure… It's also an opportunity for us here in Europe to step up” Dr. Oliver Schacht, Managing Director of Life Science NordDr. Oliver Schacht, Managing Director of Life Science Nord and Chairman of the Board for BIO Deutschland, spoke at German Biotechnology Days 2025 (DBT) in Heidelberg about the challenges and opportunities this disruption presents for Germany and the European biotech ecosystem.In an interview for the PharmaSource podcast, Dr. Schacht explains that in this rapidly evolving landscape, Europe now has a unique opportunity to strengthen its biotech position, fostering a more entrepreneurial research culture, developing strategic partnerships with China, and crafting a forward-looking regulatory framework that supports innovation and competitiveness.Read the full interview

In the latest episode, we speak to  Payal Gandhi, Management Executive – Business Growth at Blue Jet Healthcare explains how the company transformation from a family-owned business to a publicly listed global CDMO since its IPO in 2023.Today, Blue Jet Healthcare has positioned itself as a strategic partner in the pharmaceutical and healthcare arena, emphasizing their customer-first approach and technological capabilities that help bring innovations to life.Read the article here

“Europe has roughly double the population of the United States but lower pricing, so it's a balancing act between how much volume can you get and how little price discount you give.” – Joshi VenugopalJoshi Venugopal, Head of Region Europe for Novartis Gene Therapy & Rare Diseases and Senior Vice President, brings extensive experience spanning R&D, early pipeline development, and in-market commercialisation.Ahead of his keynote at CDMO Live, Joshi shares valuable insights on how to successfully commercialise gene therapies in Europe, including innovative pricing models and critical success factors. His strategic approach offers essential guidance for biotechs and pharmaceutical companies looking to navigate the complex European landscape.Read the full interview

“Being unique or special in something is crucial, a key factor in order to gain success in this field.” – Angela MolaschiAngela Molaschi, Chief Commercial Officer at Fisiopharma, and Nicola Cadei, General Manager, bring decades of pharmaceutical industry experience to their leadership roles at this Italian injectable product specialist. Together, they're expanding the company's global presence while maintaining its reputation for quality and flexibility.In the latest PharmaSource podcast episode ahead of CDMO Live 2025, Angela and Nicola explain how their medium-sized CDMO successfully navigates the competitive pharmaceutical manufacturing landscape by focusing on proactive customer service, quality excellence, and strategic capacity management.Read the full article

"Digital transformation is not about technology deployment. It's about a new way of doing business that allows you to make jumps which were not possible before, like reducing launch time from 70 weeks to 7 weeks." - Dr. Franziskus KathDr. Franziskus Kath, former J&J executive and now independent consultant, brings over 26 years of healthcare industry experience spanning API manufacturing, pharmaceuticals, consumer health, and digital transformation. He most recently orchestrated J&J's quality digital transformation strategy across all sectors.Ahead of CDMO Live 2025, Franziskus explains why becoming "bilingual" in both business and technology languages is the key to successful digital transformation in pharmaceutical manufacturing and quality operations.Full article

“What we're witnessing is a fundamental shift from globalized to decentralized pharma supply chains, yet many companies are hesitant to make the bold capacity investments needed despite recognizing the risks.” – Stephan Fath, Director at Roland BergerStephan Fath is a Director at Roland Berger where he specialises in advising global pharmaceutical, MedTech, and chemical industries. With a dual degree in Business Administration and Chemistry from the University of Dusseldorf, Stephan brings a valuable interdisciplinary perspective to network strategy challenges.In the latest PharmaSource podcast episode, Stephan shares critical insights into how pharmaceutical manufacturing networks are evolving in 2025, highlighting the delicate balance companies must strike between cost efficiency, supply chain resilience, and technological innovation in an increasingly uncertain global landscape.Read the full article

“Every CDMO is going to give you the Disney effect. I want to see what's below the street. How is that organisation humming below the surface?” says John Philips, highlighting why superficial evaluations are undermining pharmaceutical outsourcing success.John Philips, President at Innopath Consulting, brings over three decades of experience in CDMO partnerships, including leadership roles at Pii (Pharmaceutics International, Inc.), BioDuro-Sundia, Mikart, and Patheon. His focus on bridging the gap between early-stage development and commercialisation has given him unique insights into what makes CDMO partnerships succeed or fail.In the latest PharmaSource podcast episode, John explains why cultural alignment between sponsors and CDMOs has become increasingly critical as the industry has evolved, yet remains dangerously overlooked in vendor selection processes.Read the full article

“Every minute, over 1000 patients are using a product manufactured in one of our sites,” reveals Kerstin Vieluf, Head of Sales at Recipharm.Headquartered in Stockholm, Sweden, Recipharm has over 5,900 employees across 17 sites in Europe, US, India, and Israel and serves more than 400 customers globally.In this exclusive interview ahead of CDMO Live, the leadership team outlines how Recipharm is evolving its capabilities, with significant investments in digital prediction tools, expanded development services, and sustainability initiatives. Dr. Vincenza Pironti, (Head of Business Development), Dr. Uwe Hanenberg (Head of Product Development), and Dr. Kerstin Vieluf, (Head of Sales) reveal how technology investment is driving growth.Read the full article

“I believe that if a quality culture is really embedded, the quality organisation starts reducing, because the more quality is embedded in the organisation, the less you need quality to help you think.” – Liesbeth FoestersLiesbeth Foesters, Vice President and Head of External and Clinical Supply Quality at UCB, leads a multinational team of over 130 quality professionals who collaborate across various functions including CMC, supply chain, external manufacturing, and more. With a background in biochemical engineering and extensive experience across multiple quality roles, she brings a unique perspective to quality leadership.In a recent PharmaSource podcast, Liesbeth shared invaluable insights on embedding quality excellence across external manufacturing operations, building effective partnerships with over 100 contract manufacturing organisations (CMOs), and developing leadership approaches that drive engagement and performance.

Maurice van Rotterdam, Co-Founder of Netherlands-based digital marketing agency Sciential, believes many pharma suppliers and CDMOs are still missing the mark when it comes to effective digital marketing."If I look at pharma supplier or CDMO websites, they typically have a broad service portfolio and multiple target audiences that need to land on a specific webpage. You might attract a lot of leads, but customers then land on a page that is not working."In the latest episode of the PharmaSource podcast, Maurice shares his playbook for how pharma suppliers can level up their digital marketing game in 2025. He explains key strategies for developing a strong brand identity, distributing highly relevant content, and building personal connections instead of just pushing for leads. It is part of the Niche Demand Preference Model that Sciential have developed for life science companies.Read the full article

"Seven out of ten medicines dispensed in Europe are generic products. When we only look at price, we don't take into consideration all the efforts European companies make on sustainability. This is an industry we must protect," says Elisabeth Stampa, Vice President of Medicines for Europe.Elisabeth Stampa, Vice President of Medicines for Europe and Chair of the Board at Medichem, brings over two decades of pharmaceutical industry expertise. She has transformed Medichem from a pure API player into a vertically integrated B2B company and now champions sustainable pharmaceutical manufacturing across Europe.In the latest PharmaSource podcast episode, Elisabeth explains why Europe's focus on lowest-cost procurement threatens both supply chain resilience and environmental goals, calling for a fundamental shift in how we value medicine manufacturing.Read the full article

"We can cut preclinical development from five years to 18 months. Molecules which are AI-enabled in some way seem to be doing better in Phase 1 than standard molecules." - Dr. Eva-Maria Hempe, Head of Healthcare & Life Sciences EMEA at NVIDIADr. Eva-Maria Hempe leads healthcare and life sciences for NVIDIA across Europe, combining a background in physics with a PhD in healthcare services design to drive AI innovation across the pharmaceutical industry.In the latest episode of the PharmaSource podcast, Eva-Maria explains how NVIDIA's accelerated computing platforms are enabling breakthroughs in drug discovery, clinical trials, and personalised medicine through parallel processing power that's revolutionising pharmaceutical R&D.NVIDIA's Toolbox: Accelerating Every Stage of Pharmaceutical DevelopmentNVIDIA has developed a comprehensive suite of specialised tools for pharmaceutical companies, with the Clara platform encompassing multiple technologies targeting different areas of drug development:Parabricks: Software for sequencing of DNA and RNA data which accelerates genomic analysis from 30 hours to just 60 minutesMONAI Toolkit: Processes medical images for both human diagnostics and cellular analysisBioNeMo Framework: Handles biological language models for protein folding and molecule generationHoloscan: Enables real-time sensing and edge intelligence for laboratory applicationsNVIDIA has recently released EVO 2, an AI foundation model for biomolecular sciences released in February 2025, in collaboration with Arc Institute with contributions from Stanford University and UC Berkeley "It was trained on 9 trillion nucleotides from 100,000 species across the tree of life," Eva-Maria says. "It can predict with 90% accuracy whether a previously unrecognized mutation would affect gene function or not."Read the full article

“You don't just need to be good; you need to be better than others to drive your business,” warns Olaf Birkenmeier, Head of External Manufacturing at Polpharma Biologics, describing the evolutionary pressure facing Western biopharmaceutical manufacturers.Olaf Birkenmeier leads external manufacturing at Polpharma Biologics, bringing senior leadership experience from Sandoz and Novartis to bear on the challenges facing by pharma companies in an increasingly competitive global market.In a recent PharmaSource podcast interview, Olaf draws parallels between the pharmaceutical industry's competitive landscape and the Red Queen hypothesis – an evolutionary biology theory proposed in 1973 that suggests species must constantly adapt, evolve, and proliferate to survive while pitted against ever-evolving opposing species. This principle, he argues, perfectly captures the continuous innovation and improvement required for Western biopharmaceutical companies to maintain their market position.Join Olaf Birkenmeier at ⁠CDMO Live 2025⁠Read the full article on PharmaSource

“Other CDMOs couldn't handle these products, but we figured it out through technical grit and deep expertise,” explains Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical.In a CDMO Live Preview episode of the PharmaSource podcast, Jackie and Ryan shared insights into how Lifecore Biomedical has built its reputation as a contract manufacturer capable of handling the most challenging manufacturing projects, particularly as it celebrates its 60th anniversary in 2025.Jackie Klecker brings 30 years of medical device and pharmaceutical manufacturing expertise to Lifecore Biomedical, where she's spent 15 years evolving from technical operations to her current position leading quality and development services. She is joined by Ryan Swanson, Director of Process Development, who brings 11 years of industry experience, including significant CMC expertise from his time at Bristol Myers Squibb.Read the full interview with Lifecore Biomedical and meet you them at CDMO Live 2025

“Most founders dominate organisations, spending 70-hour weeks trying to control everything. But it's not about the hours you work – it's about the impact. That shift in mindset transformed how I built multiple successful businesses in pharma services,” explains Raman Sehgal, reflecting on his journey from startup founder to strategic leader.Raman Segal is the founder of ramarketing, a PE-backed life sciences marketing agency, Lead Candidate, a specialist pharma talent firm, and is host of Molecule to Market podcast. Based in Toronto as North American President, he has scaled multiple ventures in the pharmaceutical services sector while maintaining work-life balance – a feat many entrepreneurs find elusive.In this interview, Raman shares his framework for productive leadership, strategic growth, and building specialist businesses that command premium pricing in the pharmaceutical services sector.Read the full articleMolecule to Market is official media partner to CDMO Live, and Raman will be recording podcast episodes live from the event. Find out more and register here.

Francisco Blanco, founder of Conducta consulting, believes the human element in CDMO-sponsor relationships has been lost in the race for efficiency. “I feel like the human component of these relationships has been lost. When I see five-star client services from CDMOs, it's typically not because of the strength of their processes – it's the individual.”Francisco Blanco brings over 15 years of experience from leadership roles at Thermo Fisher and IQVIA to his consultancy Conducta, where he helps life sciences companies navigate complex supply chain transformations, with particular expertise in cell and gene therapy operations.In this PharmaSource podcast episode, Francisco shares crucial insights on how biopharma companies and CDMOs can redesign their customer experience approach, particularly as the cell and gene therapy sector evolves.Read the full interview

"We estimate about 8,000 metric tonnes of solvent per year are used by the industry to support solvent-based spray drying. That's a significant impact on cost, maintenance, safety and the environment," says Elizabeth Hickman, CEO of AustinPx, highlighting a critical sustainability challenge in pharmaceutical manufacturing.Elizabeth Hickman brings extensive experience in pharmaceutical contract manufacturing to her new role as CEO of AustinPx, having worked with several CDMOs and held leadership positions focused on developing innovative pharmaceutical technologies and business strategies.In a recent interview, Elizabeth discusses how AustinPx's innovative KinetiSol technology is eliminating the need for toxic solvents in pharmaceutical manufacturing while improving drug performance and reducing costs in the realm of amorphous solid dispersions (ASDs). She also shares insights on leadership and diversity in the pharmaceutical CDMO sector.Read the full article on PharmaSource

“We seek long-term partnerships where our technologies can bring genuine value-add that sustains growth. It's not about geography – it's about matching specialties and capabilities with companies who share our vision for innovation,” says Rocco Paracchini, Director of CDMO Business Unit Morpho at Alfasigma.Rocco Paracchini brings a blend of a biology background and extensive pharmaceutical manufacturing experience to his role as Director of Morpho at Alfasigma. After transitioning from biotech to CDMO operations in 2011 in different CDMOs across Europe, he joined Alfasigma in June 2024 to drive its Contract Development Manufacturing transformation and growth.In the latest episode of the PharmaSource podcast, Rocco shares insights into how Alfasigma, a global pharmaceutical company founded over 75 years ago in Italy with 4,000 people across four continents, is evolving its CDMO strategy to meet growing market demands, with particular focus on customer-centric manufacturing solutions and technological innovation.Read the full article onPharmaSource

A perfect Storm for US Drug Manufacturing as FDA Changes, Trade Wars and M&A Surge Collide "There's optimism… but the challenges aren't day to day - it can be minute to minute," warns Gil Roth, President of the Pharma and Biopharma Outsourcing Association (PBOA), describing a pharmaceutical manufacturing sector facing unprecedented change in 2025. Gil Roth brings deep expertise in pharmaceutical policy and manufacturing legislation, having launched PBOA in 2014 as an essential bridge between contract manufacturers and government stakeholders. In the latest PharmaSource podcast episode, Gil shares detailed insights into how the new administration's trade policies and leadership changes will likely create both challenges and opportunities for US pharmaceutical manufacturing. Read the full article Join Gil Roth and other industry experts at CDMO Live 2025

“The automotive industry was once in a similar setup to big pharma players, but they evolved through closer supplier collaboration and continuous improvement practices,” says Fabrice Le Garrec, drawing parallels between today's pharmaceutical manufacturing challenges and the automotive industry's transformation. “Toyota's model of developing suppliers as an extension of your company is something pharma isn't doing enough of.” Fabrice Le Garrec brings extensive pharmaceutical operations experience as former VP of Global Operations at Teva and GSK, and ex-McKinsey consultant. Through OSCIS Network, he now leads a network of over 100 pharmaceutical professionals providing performance transformation services across North America and Europe. In the latest episode of the PharmaSource podcast, Fabrice shares crucial insights about how pharmaceutical manufacturers can transform their operations by adopting Toyota's proven approaches to supplier integration, continuous improvement, and operational excellence, including lessons learned during the COVID-19 vaccine manufacturing ramp-up. Don't miss Fabrice's talk at CDMO Live 2025: 10 things I'd do differently if leading new fast-track pandemic drug launch again. Download the agenda here

Kolon Biotech's Jungjong Cho believes that the future of cell and gene therapy lies in automation, which offers unprecedented precision and cost efficiencies. "Traditional manufacturing is prone to human error and variability among operators, affecting the quality of the product," JJ explains. "To overcome these disadvantages, our robotic manipulator significantly reduces these errors and ensures batch-to-batch consistency." Kolon Biotech is pioneering the use of two innovative technologies that are reshaping manufacturing capabilities: The 2D Automated Closed Platform represents a quantum leap in manufacturing precision. The use of 3D Bioreactors further demonstrates the power of scale-up technologies. Read the full interview

“The Americans put a man on the moon in less time than it takes us to transfer a product between countries – this has to change,” says Luiz Barberini, who leads External Manufacturing for Bayer Consumer Health across Latin America. Luiz Barberini combines over three decades of pharmaceutical supply chain expertise from roles at Pfizer, Merck and now Bayer with academic positions at Brazil's leading business schools. His unique perspective spans both practical implementation and theoretical frameworks for supply chain excellence. In this exclusive interview with PharmaSource, Luiz shares why pharmaceutical companies must fundamentally transform their approach to supply chain management, offering practical insights on breaking down organisational silos, accelerating time-to-market, and building collaborative supplier relationships in an increasingly complex global landscape. Read the full article here

The Netherlands has emerged as one of Europe's most vibrant and interconnected biotech ecosystems, home to over 1,797 life science companies, world-class pharmaceutical manufacturers, and the European Medicines Agency. With its strategic location, exceptional infrastructure, and collaborative spirit, the country has become known as 'what industry leaders call 'Europe's connected life sciences & health metropolis'. Ahead of CDMO Live 2025, which takes place in Rotterdam's historic World Trade Center this May, we gathered insights from three leaders at the heart of the Netherlands' biotechnology sector. Wieteke Wouters, Program Director at hollandbio, which represents over 260 biotech companies; Esther Peters, Director of Leiden Bio Science Park, the country's largest life sciences hub; and Ellen Smit, Managing Director of Rotterdam Square, the organisation behind the emerging health tech campus in Rotterdam, shared their perspectives on what makes the Dutch biotech ecosystem uniquely successful. Read the full article

“The market for lipid nanoparticles really exploded during COVID-19,” says Alexander Aust, LNP manufacturing expert. Alexander Aust, a consultant specialising in lipid nanoparticle (LNP) manufacturing, brings years of experience from companies like Sigma-Tau Pharmaceuticals and Exelead. His expertise spans from commercial liposomal drug products to cutting-edge mRNA and gene editing technologies. In the latest PharmaSource podcast episode, Alexander explains why LNPs have become crucial in drug delivery, particularly for mRNA vaccines, and shares insights on manufacturing challenges, regulatory considerations, and future applications of this technology. Read the full article

The COVID-19 pandemic didn't just disrupt pharmaceutical manufacturing—it catalysed a fundamental shift in how we approach CDMO partnerships. Johnson & Johnson's Paolo Giudici reveals how their four-year digital transformation journey is reshaping the future of external manufacturing. Key transformations reshaping sponsor-CDMO relationships: Real-time manufacturing floor visibility enabling proactive process control Seamless ERP integration across the partner ecosystem Standardised quality data exchange and monitoring Compressed timelines from years to months The critical challenge? Standardisation. Unlike mature industries, pharma lacks unified frameworks for digital CDMO collaboration. "Currently, if a sponsor attempts to establish digital collaboration with a CMO, they essentially start from scratch," notes Giudici. Strategic implementation insights: Secure explicit partnership agreements before technical integration Focus on value creation, not job displacement Establish clear cost-sharing frameworks upfront Leverage industry collaboration networks Read the article here Paolo will be speaking about Digital Transformation of Pharma Manufacturing at CDMO Live 2025. Tickets available now

Leadership insights from our latest Women in BioPharma meetup. "I fully expect that the industry will have multiple female CEOs in the years to come," predicts Elizabeth Hickman, Chief Executive Officer of Austin Pharmaceuticals. However, the current state of the pharma industry is that while gender mix starts fairly even, by the time you get to the C-suite, the top table is still overwhelmingly male. In our most recent Women in BioPharma meetup Elizabeth Hickman was joined by Nikki Whitfield, CEO of Upperton; and Hennie Zijlstra, Chief Commercial Officer at Adragos to share their perspective. Their combined experience spans research and development, commercial operations, and executive leadership, offering a comprehensive view of how women can succeed in this traditionally male-dominated industry. Join our next meetup: 20th March 2025 Join us for an enlightening conversation with a pioneering female health startup founder, Valentina Milanova, Founder and CEO/CPO of Daye. Valentina will explain her own personal journey in creating an innovative period care and gynae health startup and discuss the systemic issues which are harming women's health. She will reveal the hidden gender biases she has encountered that are ingrained in the pharmaceutical industry, from research and testing, to investment, manufacturing and marketing. Join the conversation by signing up here

Gene editing and cell therapy, they're going to be entrenched modalities, much like small molecules and antibodies are today, that will fundamentally reshape healthcare.” says Devyn Smith. Devyn Smith, CEO of Arbor Biotechnologies and Chairman of the Alliance for Regenerative Medicine, brings a wealth of experience to the cell and gene therapy ecosystem. With a PhD in developmental biology and eight years in strategy consulting, Devyn's journey led him to Pfizer, where he served as COO of their cell therapy group in Cambridge, UK, before a series of board roles at various biotechs. In the latest PharmaSource podcast episode, he shares insights on the promise of cell and gene therapy to transform lives and the operational challenges the industry must overcome to realise this potential. Here's the full article

Stephen Sheehan of Alkermes shares their new governance framework for high-performing CDMO partnerships. As Director of External Development & Manufacturing at Alkermes, Stephen Sheehan brings over a decade of experience in pharmaceutical development, transitioning from small to large molecules, and implementing innovative CDMO management frameworks. Based in Dublin, he's responsible for managing CDMOs involved in development activities and manufacturing of Alkermes' drug development candidates. In this insightful interview, Stephen reveals how a critical batch failure led to the development of a comprehensive CDMO governance framework, and shares valuable insights on building effective CDMO relationships, establishing meaningful KPIs, and implementing sustainable practices in pharmaceutical manufacturing. Read the full interview Stephen will be hosting an Outsourcing Excellence Roundtable at CDMO Live about KPIs and governance frameworks for managing contract manufacturing networks. Join the conversation: CDMO Live 2025

For us, it's not a transaction. It really is a partnership,” says Nikki Whitfield, CEO of Upperton Pharma Solutions. Nikki Whitfield brings over three decades of pharmaceutical development experience to her role as CEO of Upperton Pharma Solutions. A chemist by background and self-described “formulator by heart,” she has significant experience developing sterile and non-sterile dosage forms for small and mid-sized pharma companies, including a tenure at Quotient Sciences, before taking the helm at Upperton in 2021. In the latest episode of the PharmaSource podcast , Nikki shared insights on how CDMOs can better serve small and emerging biotech companies, highlighting the importance of flexible partnerships and scientific expertise in driving successful drug development programmes. Her perspective, shaped by experience on both sides of the CDMO relationship, offers valuable insights for companies seeking manufacturing partnerships. Read the full article

Hanns-Christian Mahler, Chief Enablement Officer at ten23 health, is redefining leadership in pharmaceutical manufacturing: “I believe collaboration at the workplace should be primarily based on trust and motivation, not on typical carrot and stick command and control models.” Founded in 2021, ten23 health has a mission to be a human-centric and sustainable strategic partner of the pharmaceutical industry. With extensive experience at companies including Merck, Roche, and Lonza, Hanns-Christian brings a fresh perspective to the CDMO space, combining technical expertise with innovative leadership approaches. In the latest episode of the PharmaSource podcast, Hanns-Christian shared insights into how ten23 health is revolutionising the CDMO sector through three key pillars: expertise-driven services, human-centric leadership, and sustainable operations. The company's unique approach demonstrates how CDMOs can differentiate themselves in a competitive market while prioritising both people and planet. Read more Connect with ten23 health at CDMO Live 2025, 7-8th May 2025 at the World Trade Center, Rotterdam. Find out more about the event here

John Childers, Director of Business Development for Wacker Biotech's North American operations, emphasises the importance of early CDMO partnerships: “Working with an experienced CDMO partner can really help you stay on track for budget and schedule. Think long term – the investment with an external partner can substantially save you time and money.” As part of Wacker Chemie, a century-old German chemical company, the biotech division leverages over 20 years of experience in advanced therapy manufacturing for contract development and manufacturing. Speaking to the PharmaSource podcast ahead of CDMO Live 2025, John shares best practices for successful partnerships and explains how Wacker Biotech is positioning itself for growth in the evolving contract manufacturing landscape. Read the full article

The pharmaceutical industry faces a significant challenge with patent expiries threatening established revenue streams of approximately $300 Billion USD. Major brands are approaching patent expiry creating urgency for companies to identify new blockbuster opportunities. This is compounded by policy changes like the Inflation Reduction Act, which offers different exclusivity periods for biologics versus small molecules. Adam Siebert and Jeff Holder are partners at L.E.K. Consulting's life science enablers practice, specialising in biopharma manufacturing and supply chain strategy. With backgrounds spanning operations, services, and drug discovery, they help pharmaceutical companies and CDMOs navigate emerging technology trends. In the latest episode of the PharmaSource podcast, Adam and Jeff shared insights on horizon scanning – the critical practice of forecasting drug development and manufacturing trends years in advance. Their discussion revealed key strategies for pharmaceutical companies and contract manufacturers to stay ahead of industry shifts. Read the PharmaSource Interview

David Caron, Senior Vice-President of CMC, AL102 at Immunome, shares why choosing the right CDMO partner can make or break a biotech's development timeline: “For biotechs, the main business challenge is to do right the first time. To do this, we need to look at the risks related to each activity.” David Caron brings over three decades of pharmaceutical industry experience across multiple biotechs, with expertise spanning from bench formulation to senior leadership roles. His background includes extensive work with various dosage forms and regulatory requirements across EU and US markets. In this latest episode of the PharmaSource podcast David shares crucial insights on how emerging biotechs can optimize their CDMO partnerships, manage costs effectively, and align CMC strategy with business objectives. David Caron will be sharing advice about how to overcome biotech CMC challenges at CDMO Live 2025. Book your ticket here Read the interview here

Dr. Avencia Sánchez-Mejías is CEO and co-founder of Integra Therapeutics, a Barcelona-based biotech company developing next-generation gene-editing tools. With a background in molecular biology and clinical genetics, she brings over 15 years of experience in genetic therapy research across Europe, the US, and Asia. In this exclusive interview, Avencia shares insights on transitioning from academia to entrepreneurship, building a sustainable biotech company, and leveraging strategic partnerships to bring innovative gene therapy solutions to market. “Having a technology that can address genetic conditions and new diseases that today are not treatable, can have a huge impact. Not only for the patient but also for the cost of the health system.”, she says. One of Integra's most significant strategic decisions was expanding beyond being purely a platform technology company to developing their own therapeutic products. This transition required careful consideration of sustainable growth and market validation strategies. “This is probably one of the most strategic decisions that we had to take,” Avencia explains. “We think hard and long on which first indication should be to be successful. It also changed the type of company that we were. We were very technological, and now we are building therapeutic products. So the kind of talent that you need also changes.” Read full article

"The reality is, we have a lot of CDMOs don't they really know what they're getting into" says Herman Bozenhardt Herman Bozenhardt, a pharmaceutical manufacturing consultant with decades of experience in facility design and operations, brings a wealth of knowledge from his work with numerous pharmaceutical companies and contract manufacturers. His expertise spans from traditional small molecule drugs to complex biologics and potent compounds. In the latest PharmaSource podcast episode, Herman shares his candid thoughts on the challenges facing the pharmaceutical manufacturing industry, particularly in the rapidly growing field of Antibody-Drug Conjugates (ADCs). He explains why many Contract Development and Manufacturing Organizations (CDMOs) may not be adequately prepared to handle these complex and potent compounds. https://pharmasource.global/content/podcast/adc-manufacturing-why-herman-bozenhardt-believes-only-5-cdmos-are-fit-for-purpose/

GLP-1 drugs have become a game-changer in treating obesity and type 2 diabetes, forecast to reach a $100 billion market value by 2029. However, their rapid rise raises important questions about resource allocation in pharmaceutical development and manufacturing, as well as affecting the dynamics between patients, healthcare providers, and biopharma. In the latest episode of the PharmaSource podcast, Ben Locwin, Chief Scientist at Black Diamond Networks, explains that GLP-1 drugs represent a significant breakthrough in the treatment of obesity and diabetes and the unintended consequences they are bringing to the industry. Read the article here

“Treat them as a partner, not just a supplier. It's a mindset you need to get into.” – Federica Fraschetti, MSD Federica Fraschetti, Associate Director of External Manufacturing at MSD, brings years of experience in the pharmaceutical industry and a passion for optimising partnerships with contract manufacturing organisations (CMOs). In the latest PharmaSource podcast episode, Federica explains why getting supplier relationship management right is a key strategy for driving efficiency and fostering innovation in the biopharma industry. Creating an effective CMC operating model is crucial when working with external partners. Federica emphasises the importance of a clear internal structure that is visible to CMOs: “What is really key is the structure that you have internally and then externally. So what the CMO can see of your structure when dealing with partners,” she explains. MSD utilises a ‘virtual plant team' model, which includes representatives from key functions such as operations, technology, quality, supply chain, and procurement. This structure provides: Clear supporting model for day-to-day operations with the CMO Established escalation paths Defined roles and responsibilities While it's ideal to match these roles with counterparts at the CMO, Federica acknowledges that this isn't always possible. “It doesn't mean that each function needs to be one-to-one matched at the CMO, but you do need to know where it is matched, even if it is the same person or the same function,” she advises. Read the full interview

“Sustainability is no longer just a buzzword in the pharmaceutical industry. It's a critical business imperative,” says Hywel Woolf, Global Sustainability Manager at Sharp Services. “ “We're seeing it become a golden thread in who organizations are and what they intend to deliver, driven by both compliance requirements and client demand.” Hywel Woolf brings extensive experience in environmental management to his role as Global Sustainability Manager at Sharp Services, a leader in commercial packaging, clinical services, and sterile manufacturing for pharmaceuticals. With a background spanning consultancy, construction, and heavy manufacturing, Hywel now applies his expertise to drive sustainability initiatives across Sharp's global operations. In a recent interview at CPHI Milan, Hywel shared insights into Sharp' sustainability journey, highlighting the company's strategic approach to reducing environmental impact across its diverse business units. He explains how Sharp is tackling the challenges of sustainable packaging, managing scope 3 emissions, and collaborating with suppliers and industry partners to drive positive change in the pharmaceutical supply chain. Read the full article

“Manufacturing network strategy is about connecting the dots and seeing the interconnectivity between different brands,” explains Daniel Hurni, Director of Manufacturing Network Strategy and Business Intelligence at Bristol Myers Squibb (BMS). Daniel Hurni brings years of life sciences expertise to his role at BMS, where he is responsible for shaping overarching manufacturing network strategies across small molecules, biologics, and cell and gene therapy business units. His experience spans technical transfer projects, incident management, and long-term strategic planning. In a the latest episode of the PharmaSource podcast, Daniel shared invaluable insights into the complexities of developing and implementing an effective manufacturing network strategy in the pharmaceutical industry. He explains why a robust long-term manufacturing network strategy is crucial for optimizing costs, improving margins, and ensuring supply chain resilience in an increasingly complex global landscape. Read the full article

Live from CPHI Milan 2024, this episode is a roundup of conversations with a number of key exhibitors Recipharm, Tjoapack, Renaissance Lakewood, Ecolab and NovaCina. As you'll hear, it was a noisy event, so written transcripts are all available on PharmaSource. Jon Reed, Head of Strategic Business Planning at Recipharm discussed the CDMO's recent strategic moves, including Predictive Modeling and GLP-1 focus. https://pharmasource.global/content/podcast/recipharms-strategic-moves-embracing-predictive-modeling-and-glp-1-trends/ Dexter Tjoa, CEO of Tjoapack, shared insights into the company's 35 year evolution from a small Dutch contract packaging organisation (CPO) to a global player in pharmaceutical packaging. https://pharmasource.global/content/podcast/tjoapacks-global-expansion-bridging-european-and-us-pharmaceutical-packaging-markets/ Eric Kaneps, Vice President of Sales & Marketing at Renaissance Lakewood, discussed the company's expansion and focus on nasal spray technology. https://pharmasource.global/content/podcast/renaissance-lakewood-drives-cdmo-innovation-in-nasal-spray-technology/ Craig Cox, Vice President of Global Sales, Bioprocessing at Ecolab, shared insights into the company's bioprocessing solutions, and how they help support sustainability. https://pharmasource.global/content/podcast/ecolabs-bioprocessing-solutions-addressing-sustainability-and-complexity-in-drug-manufacturing/ Peter Bullard, Senior Vice President of Manufacturing at NovaCina, shared insights into the new Australian CDMO's unique position in the global pharmaceutical market and 50 year legacy. https://pharmasource.global/content/podcast/novacina-new-australian-cdmo-with-50-year-legacy-in-sterile-manufacturing/

"As Americans, we are very unaware of the value proposition of Poland," says Marty Henehan, highlighting the untapped potential of Central European biopharmaceutical manufacturing for North American biotechs. Marty Henehan, Vice President of Business Development and Head of North America at Mabion sheds light on the advantages of partnering with a Polish CDMO for drug development and manufacturing services. Speaking to the PharmaSource podcast during CPHI Milan, Marty explains how Mabion's transformation from a biosimilar company to a full-service CDMO has positioned them to offer cost-effective, high-quality solutions for biotechs worldwide, particularly those in North America. Read the full article