PharmaSource Podcast

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

Joerg Ahlgrimm brings over two decades of experience in pharmaceutical manufacturing and operations to his role as Chief Executive Officer at SK pharmteco. His distinguished career includes leadership positions at Schering, Baxter, and Lonza, where he managed 35 facilities during a period of unprecedented growth. He was one of the founding members of the Center for Breakthrough Medicines (CBM), where he served as employee number four and helped build the operation from scratch before the CDMO was acquired by SK pharmteco. In this exclusive interview, Joerg shares insights into SK pharmteco’s strategic vision, the future of pharmaceutical outsourcing, and why making outsourcing “easy” is crucial for success in the evolving CDMO landscape. His unique perspective comes from having experienced both sides of a major acquisition, overseeing the integration of CDM into SK pharmteco. Joerg Ahlgrimm, CEO of SK pharmteco, believes the CDMO industry is heading for significant consolidation: “If you fast forward 10 years, there will probably be 10-15 large, multi-modality CDMOs, with many smaller and specialised ones being bought.” Read the full article on PharmaSource

"In underserved markets, there's always a challenge of reaching patients due to political and economic pressures. Through smart packaging, logistics, and distribution, we're committed to providing healthcare solutions across our network of more than 100 distributors," says Samir El Nasharty, Chief Operations Officer at Acino. Samir El Nasharty leads an experienced global team of over 1,000 Tech Ops professionals at Acino, a Swiss pharmaceutical company established in 1836. As part of the Arcera Life Science platform, established by ADQ, an Abu Dhabi-based investment and holding company, Acino focuses on delivering high-quality pharmaceutical products to emerging markets across the Middle East, Africa, Ukraine, CIS, and Latin America. Speaking to the PharmaSource podcast at CPHI Milan, Samir provides detailed insights into managing complex manufacturing networks, implementing digital transformation initiatives, and steering the company's strategy through challenging market conditions while ensuring consistent medical supply to underserved regions. Read the full article

“The GLP-1 agonist market is seeing unprecedented growth, and we’re investing €900 million to capture a fair amount of that business,” says Dr Mimoun Ayoub, Senior VP and Global Head of Sales at CordenPharma, outlining the CDMO’s most ambitious expansion plan to date in response to surging demand for peptide manufacturing. Dr Mimoun Ayoub serves as Senior VP and Global Head of Sales and Key Account Management at CordenPharma, a full-service CDMO operating an extensive network of 11 cGMP facilities across Europe and the US. With decades of experience in pharmaceutical manufacturing and a deep understanding of the CDMO landscape, he oversees the company’s global sales strategy and manages relationships with key pharmaceutical and biotech partners. Speaking to the PharmaSource podcast at CPHI Milan, Dr Ayoub provided detailed insights into CordenPharma’s expansion plans, particularly in the rapidly growing GLP-1 market, and discussed how the CDMO is positioning itself to support pharmaceutical companies’ evolving needs across multiple technology platforms. Read the full article on PharmaSource

“The industry is back, and we’re uniquely positioned to provide end-to-end services, including clinical trials. That’s what we mean by CDMO plus CRO – it’s a complete 360-degree set of operations,” says Dr. Anil Kane, Executive Director and Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific. Dr. Kane leads Thermo Fisher’s technical and scientific initiatives, bringing extensive experience in pharmaceutical development and manufacturing. His expertise spans multiple modalities, from small molecules to advanced therapies, positioning him at the forefront of innovative drug development solutions. Speaking to the PharmaSource podcast at CPHI Milan, Dr. Kane explained Thermo Fisher’s latest initiative, Accelerator™ Drug Development, which combines their Contract Development and Manufacturing Organisation (CDMO) capabilities with Contract Research Organisation (CRO) services from their PPD acquisition. This integrated approach aims to streamline the complex journey from pre-clinical development to commercialisation, offering a truly connected and customisable suite of services. The 2021 acquisition of PPD marked a pivotal moment in Thermo Fisher’s evolution, enabling the creation of a comprehensive service offering that spans the entire drug development spectrum. This integration brings together: Drug substance development Drug product development Clinical trial packaging and labeling services Full clinical trial management Specialised GMP laboratory testing Regulatory documentation support “This combination of services brings efficiency, reducing cost and time for our partners to run drug development from very early stage, through clinical phases, to approval and bringing medicines to patients faster,” explains Kane. “We help our clients even put documentations together for IND, NDA, and other regulatory submissions.” Read the full interview on PharmaSource

“Customer centricity is something that is lacking in our industry, and we knew we could do it differently,” says Adragos Pharma CCO Henny Zijlstra, discussing the company’s mission to transform pharmaceutical contract manufacturing. Henny Zijlstra serves as Chief Commercial Officer at Adragos Pharma, a rapidly expanding contract development and manufacturing organisation (CDMO) headquartered in Munich. Since its founding in 2020, the company has grown to encompass five manufacturing sites across Europe and Asia, focusing on small molecule drug products. In this exclusive interview from the showfloor at CPHI Milan, Henny shares insights into Adragos Pharma’s ambitious growth strategy, their customer-centric approach, and how digital transformation is reshaping traditional CDMO services. Read the full article here

“Building relationships and transparent communication are key to successful outsourcing in cell therapy manufacturing,” says Jessica Brantley, Senior Manager of External Manufacturing at Sonoma Biotherapeutics. Jessica Brantley, Senior Manager of External Manufacturing at Sonoma Biotherapeutics, brings a wealth of experience from her roles at Novartis and a decade at Fujifilm Diosynth. Her expertise spans both sides of the outsourcing equation, having worked as a programme manager for a CDMO and now managing external partnerships for a cell therapy innovator. Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. In the latest PharmaSource podcast episode, Jessica explains why getting supplier relationship management right is a crucial strategy for driving down costs and improving efficiency in the fast-moving cell therapy space. Read the interview

Quality, Integration, and Culture: Key Lessons in CDMO Selection from Firelli Alonso Firelli Alonso, former Senior Director of External Manufacturing at Pfizer, brings over two decades of experience in the pharmaceutical industry. With a PhD in molecular virology, she has spearheaded viral vaccine development and headed Pfizer’s pre-commercial outsourcing group, focusing on biologics manufacturing. In the latest PharmaSource podcast episode, Firelli explains how she supports biotechs in finding quality outsourcing partners they can trust to deliver. She shares invaluable insights on selecting and managing Contract Development and Manufacturing Organisations (CDMOs), drawing from her extensive experience with complex biologics, including monoclonal antibodies, vaccines, and antibody-drug conjugates (ADCs). Read more

“Our job is to add value, rather than sell stuff and make money.” – David Anchell, Co-Founder and Managing Director of Camida Camida are a specialist supplier of pharmaceutical raw materials, fine chemicals and intermediates to the life sciences industry, founded in 1988. In the latest PharmaSource podcast episode, David Anchell shares his journey and insights on the challenges and opportunities in pharmaceutical raw material sourcing, emphasising Camida’s problem-solving approach and customer-centric focus. David explains how the pharmaceutical industry has shifted from traditional chemical synthesis to biopharmaceutical production methods. This change has created new challenges in raw material sourcing: “Biopharmaceutical production uses products that weren’t traditionally used in pharmaceuticals, like buffers, cleaning solutions, minerals, sugars. These were previously used as commodities, but now they’re critically needed for pharmaceutical production, which upgraded the quality needs.” He further elaborates on the pain points this creates: “Whereas the pharmaceutical raw material needs are USP, GMP, EP, etc., these products were made in hundreds of tons. I’m talking about things like phosphoric acid and sodium hydroxide, some of the phosphates. They were manufactured in huge quantities by commodity producers, and this industry suddenly needed this high quality. I don’t think that has been solved yet.” Read the full article

“We hide behind that hubris of science, but we still have a lot of operational challenges to really impact the lives of our patients,” warns Sanjay Srivastava, Managing Director of Accenture’s Centre of Excellence for Cell & Gene Therapy.  This sobering assessment cuts through the hype surrounding cell and gene therapies, highlighting the critical need to address practical hurdles in bringing these revolutionary treatments to patients at scale. Sanjay Srivastava blends academic rigour with consulting acumen. With over a decade focused exclusively on cell and gene therapy, including involvement in launching the first CAR-T therapies, Sanjay’s insights stem from hands-on experience in navigating the complex landscape of this evolving sector. In this PharmaSource podcast episode, Sanjay unpacks the intricacies of cell and gene therapy manufacturing, offering practical solutions to key challenges in scaling production, implementing automation, and balancing innovation with regulatory requirements.  His analysis provides a roadmap for companies striving to translate scientific breakthroughs into operational success. Read the full interview

“Quality oversight isn’t just about compliance – it’s about building successful partnerships and driving down costs,” asserts Stephanie Gaulding, Managing Director at Pharmatech Associates. Stephanie Gaulding, Managing Director at Pharmatech Associates, brings over 30 years of experience in quality management within the life sciences industry. Her expertise in quality systems, regulatory compliance, and supplier relationship management provides valuable insights into effective quality oversight practices. In a recent ⁠PharmaSource podcast episode⁠, Stephanie explains why robust quality oversight is crucial for successful supplier relationships and cost reduction in pharmaceutical manufacturing. For more insights from Stephanie Gaudling, take ⁠Outsourcing Fundamentals⁠ – a foundational eLearning course on how to master biopharma outsourcing. Use the code POD100 for a discount

“What’s in it for the CDMO? That’s the crucial question. We’re not buying a service; we’re establishing a partnership. There has to be interest for both partners.” says Eduardo da Fonseca. Eduardo da Fonseca, Head of Supply Chain at Bioeq, brings over five years of experience in building a virtual manufacturing operation from scratch. With a background in global companies like Nestlé, Roche, and Acino, Eduardo now leads Bioeq’s innovative approach to supply chain management. Bioeq is a new Biosimilars company with a clear vision focused on launching specific products in key markets, utilising an out-licensing strategy for commercial distribution and an outsourcing strategy for manufacturing and supply. In the latest PharmaSource podcast episode, Eduardo explains how he’s built up their value chain from raw materials to delivery of finished products, building a network of external partners and internal teams, to get them to where they are now. Read the full interview on PharmaSource --- Learn the essentials of successful biopharma outsourcing. Outsourcing Fundamentals is a new eLearning course that consolidates best practices from 100+ expert interviews into 10 engaging modules. Podcast subscribers can use the discount code POD100 to get money off. Sign up here

“Sustainability is not just a trend; it’s integral to our DNA,” says Teva’s Global Head of Sustainability Amalia Adler-Waxman, SVP, Global Head of Sustainability and ESG and head of Corporate Affairs of International Markets at Teva Pharmaceuticals Industries, brings a wealth of experience from her roles in government, international affairs organisations, and the pharmaceutical industry. Her unique perspective bridges the gap between public and private sectors, offering invaluable insights into the evolving landscape of corporate sustainability. Amalia Adler-Waxman’s journey with Teva began in 2016 as a consultant. Since then, she has led the company’s transformation into one of the ‘World’s Most Sustainable Companies’, as recognised by Time magazine. In the latest PharmaSource podcast episode, Amalia explains how Teva’s commitment to sustainability has become a key strategy for driving positive impact and improving business performance.