How Takeda Drives Quality Excellence Across External Manufacturing Networks

“The idea is to get the information in real time. And for that, you would go and see what systems you have at hand, what system your CMO is using, and find a joint, so called ‘Safe Space’, which serves both sides.” – Ingrid LuxIngrid Lux serves as Lead Quality Disposition in Oncology & Small Molecule External Supply Europe at Takeda, bringing extensive experience from her previous 16 years at Sandoz. Her expertise spans pharmaceutical quality management, with a particular focus on cross-functional collaboration and external manufacturing partnerships.In the latest PharmaSource podcast episode, Ingrid shares valuable insights on managing quality across external manufacturing networks, creating effective partnerships with CDMOs, and navigating the evolving landscape of pharmaceutical quality oversight in an increasingly complex global environment.Full article here

"Sustainability isn't just about doing the right thing. It's about making smarter, more cost effective decisions that are really building stronger, more reliable supply chains."Christiane Walker, Product Development Team Lead at Intelsius, believes the pharmaceutical industry stands at a critical juncture where environmental responsibility and operational excellence must converge.Christiane Walker leads the product development team at Intelsius, managing cross-functional teams that design innovative and sustainable packaging solutions. With four years at the company, she brings deep expertise in temperature-controlled transport packaging, working with pharmaceutical clients across global markets to optimise their cold chain operations.In the latest PharmaSource podcast episode, Christiane explains how pharmaceutical companies can simultaneously reduce their carbon footprint, cut operational costs, and improve supply chain resilience through strategic adoption of sustainable packaging technologies and connected digital systems.

Link to the CDMO News Analysis download:CDMO News Analysis Tracker“CMC topics are often taken a bit late in development. The biggest pitfall is not only it’s going to cost you more, but it’s going to cause delays to your programme. The more you push it, the bigger are the costs and potentially the delays.”Marine Joly-Battaglini, CMC consultant and founder of PharmDev, specialises in CMC regulatory strategy for pharmaceutical companies at all stages of development. With a decade of experience in CMC development at Galderma and a master’s degree in regulatory affairs, she has built her career around preventing the costly mistakes that derail pharmaceutical development programmes.In the latest PharmaSource podcast episode, Marine reveals the strategic framework that successful biotechs use to navigate manufacturing partnerships, avoid development pitfalls, and position their products for commercial success. Her approach challenges conventional wisdom about when to engage with CMC planning and demonstrates how early strategic thinking prevents expensive delays down the development pathway.Full article

“The greatest opportunity at Teva is our innovative pipeline. We’re really leaning in on our innovative pipeline as an integral part of our pivot to growth strategy.”This is the ambitious vision of Dr Eric Hughes, Executive Vice President of Global R&D and Chief Medical Officer at Teva Pharmaceuticals.He speaks about the company’s strategic transformation from generics powerhouse to innovative biopharmaceutical leader - including how strategic partnerships and a matrix organisational approach are driving Teva’s remarkable 10 consecutive quarters of growth. He shares best practices on leveraging generics expertise for innovation, building successful partnerships across multiple therapeutic areas, and creating synergies between different business portfolios.Full article here

“We need to strive to be an easy client. Being an easy client with clear goals and internal alignment is key for successful long-term relationships with CMOs. Equally important is how we manage internally – how we align internally and bring that one message to the CMOs.”Felipe Furiati, Senior Director External Supply Operations at Grünenthal, manages external supply operations across a €2 billion portfolio whilst leading crisis management and M&A integration activities.Felipe brings a distinctive background to external manufacturing, having started as a pharmacist in QA at Johnson & Johnson, spent time in management consulting at Bain & Company, and returned to pharmaceutical operations with experience spanning both technical and strategic functions.In the latest PharmaSource podcast episode, Felipe shares practical insights on building strategic partnerships without volume leverage, implementing product-centric supply chain management, and using digital tools for supplier selection – approaches that are particularly relevant for mid-sized pharmaceutical companies navigating complex supplier networks and geopolitical uncertainty.

"We are seeing a doubling or tripling of applications from the United States. You can really feel that shift already. People have been offered jobs and professorships and are already here in Heidelberg."Dr. Julia Schaft, Managing Director at BioRN Cluster Management GmbH, reveals the significant increase in American scientists exploring opportunities in Germany's Rhine-Neckar biotech hub as researchers seek new environments that support their work.Julia brings over a decade of international experience, including 11 years in Australia working with human embryonic stem cells, before returning to Germany to drive innovation at the intersection of industry and academia. She also serves as spokesperson for bioDeutschland's Working Group of BioRegions.In the latest PharmaSource podcast episode, Julia explains how changing dynamics are creating new opportunities for European life science clusters and what this means for the global biotech landscape.https://pharmasource.global/content/podcast/the-heidelberg-advantage-biorn/

HHS Secretary’s unprecedented move to terminate 22 federal mRNA contracts sends shockwaves through biotech sector and raises critical questions about U.S. pandemic preparednessThe pharmaceutical industry woke up to a fundamentally altered landscape this week as Health and Human Services Secretary Robert F. Kennedy Jr. announced the termination of $500 million in federal funding for mRNA vaccine development. The decision, which affects 22 active projects across major pharmaceutical companies including Pfizer, Moderna, and Sanofi, represents the most significant policy reversal in vaccine development funding in recent memory.In this episode, we speak to Ben Locwin Vice President at Reliant Life Sciences, about what why mRNA therapeutics are so an important - not just to vaccines but also to cancer, genetic disorders and other therapeutic areas.Read the article

"When you are seeing great results in your research lab, you think that everything has been done. But then when you try to humanise your drug, a new adventure starts, because the CMC process is very difficult. In my opinion, it's as difficult as demonstrating efficacy." - Mari Carmen ÁlvarezMari Carmen Álvarez PhD. is the Managing Director of Tetraneuron, a pioneering Spanish biotech developing novel gene therapies for neurodegenerative diseases. With nearly two decades in biotech leadership, she founded Valencia University's first biotech spin-off and brings expertise spanning innovation management, business development, and fundraising from seed to Series A.In the latest PharmaSource podcast episode, Mari Carmen explains why scaling gene therapy development requires more than strong science, how to navigate the complex CDMO ecosystem, and what she learned from a previous biotech failure that shaped her approach to leadership and patient impact.Full interview: https://pharmasource.global/content/podcast/from-lab-to-patient-how-tetraneurons-gene-therapy-approach-is-tackling-alzheimers-disease/

“From Tokyo to Boston, we knew people had to see and feel the future we were building together. That is how you create lasting change.”Amber Meriwether, Director of Corporate Strategy at Astellas Pharma, has orchestrated one of the industry’s most dramatic supplier rationalisations whilst navigating complex cultural dynamics across seven global locations.In the latest PharmaSource podcast episode, Amber reveals how effective supplier rationalisation transcends traditional cost-cutting approaches, requiring sophisticated change management, cultural intelligence, and the ability to forge consensus amongst diverse scientific teams spanning multiple continents and research modalities.https://pharmasource.global/content/podcast/how-astellas-procurement-cut-their-supplier-base-by-95-while-building-global-consensus/

"Current revenue scale is $1.3 billion. We anticipate it will grow to $5 billion, just in five years' time. We've committed to invest about two-thirds of Fujifilm's entire annual capex in this business."Toshihisa “Toshi” Iida, Chairman of FUJIFILM Biotechnologies Group and Board Director at FUJIFILM Corporation, reveals how 89 years of healthcare heritage drives the company's ambitious CDMO expansion strategy.Toshihisa brings 34 years of experience at Fujifilm, having witnessed the company's transformation from the golden age of photographic film through the digital revolution to its current position as a major biotechnology manufacturer. His journey spans international marketing, European operations, and now leading the Life Sciences strategy for the 91-year-old corporation.In this exclusive podcast interview, Toshihisa explains how Fujifilm's unique modular manufacturing approach and zero-defect philosophy position the company to achieve unprecedented growth whilst delivering scalability, speed and resilience to pharmaceutical partners worldwide.Full article: https://pharmasource.global/content/podcast/from-film-to-pharma-inside-fujifilm-biotechnologies-5-billion-growth-strategy/