Podcasts about cdmos

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Julien Laizé, Director External Manufacturing CTM at Valneva. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Julien, covering: Comparative views of being externally outsourced in large pharma's R&D vs a more action-oriented, small-med pharma company Taking us behind the scenes into in-housing vs outsourcing manufacturing decisions and CDMO identification... Why the selection process is becoming more and more challenging for buyers The importance of reputation and track record for CDMOs, and the value of being known as a specialist How do geopolitical issues and macro uncertainty play into the planning of external manufacturing?   Julien Laizé is a French/Italian executive with extensive and international experience in the vaccines and biologics industry. A Doctor of Pharmacy, Julien spent time at Siemens Healthineers, Novo Nordisk and Eli Lilly before joining Valneva, a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical needs.   Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is also sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

On this episode, host Chris Adkins speaks with Gerry Farrell, a seasoned expert with over two decades of experience in the CDMO space and current executive advisor at Kymanox. Their discussion explores three key areas of the evolving bioprocessing landscape: 1. The Evolution from Antibodies to Gene Therapy. How bioprocessing has grown increasingly complex from the relatively straightforward days of monoclonal antibody manufacturing to today's gene therapy challenges. Gerry highlights the critical importance of analytical development for early-stage companies and why having the right methods—not necessarily more methods—is crucial for success. 2. Economic Realities and CDMO Dynamics. Gerry offers perspectives on the current economic environment facing biotech, including investor sentiment and funding challenges. The discussion unpacks the paradox of some CDMOs expanding capacity while others close facilities, and explores the strategic considerations driving companies toward either in-house manufacturing or outsourcing. 3. Manufacturing Technologies and Future Trends. The episode delves into the ongoing debate between single-use and stainless steel manufacturing systems, with insights into why large-scale stainless steel facilities continue to dominate commercial antibody production. Gerry shares thoughts on emerging technologies, the potential impact of AI and machine learning on bioprocessing, and how sponsor companies can better leverage CDMO expertise to navigate these evolving landscapes. Resources and Links:Learn more about Kymanox: kymanox.comConnect with Kymanox on LinkedIn: Kymanox LinkedInAbout Kymanox:Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product's life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.Life Science Solutions is edited and produced by Walk West.

“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

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

In the latest episode of The Top Line, Chris Hayden of Fierce Pharma sits down with Mary Lou Glotzbach, senior manager of drug delivery partnerships at Grand River Aseptic Manufacturing (GRAM). They explore the evolving landscape of biologics, the increasing importance of cold chain management, and how contract development and manufacturing organizations (CDMOs) are adapting to industry shifts. Glotzbach highlights a growing trend in biotech: transitioning patient treatments from infusion centers to home delivery. This shift demands innovative drug delivery solutions, including wearable devices and auto-injectors, capable of handling high-viscosity biologics. She also emphasizes the industry's push for smaller batch sizes due to the high cost and complexity of producing biologics, which challenges traditional manufacturing processes. Another key discussion point is the rising demand for transparency and early collaboration between pharmaceutical companies, CDMOs, and device manufacturers. Glotzbach notes that CDMOs are now being brought into the development process earlier than ever, allowing for better alignment on formulation, container design, and regulatory compliance. The conversation also touches on Annex 1 compliance and the need for standardization in primary containers like syringes and cartridges. Glotzbach envisions a future where standardized components streamline production, making drug development more efficient. For anyone interested in the intersection of biologics, manufacturing, and drug delivery innovation, this episode offers valuable insights into how GRAM is helping shape the future of the industry. Tune in to learn more about the latest advancements and challenges in aseptic manufacturing.See omnystudio.com/listener for privacy information.

In this podcast Christine Furst, Senior Director Key Account Management Europe from Vetter joins host Lucy Chard to discuss the relationship between pharma companies and CDMOs and the impacts this relationship has on a business's vision for the future.Taking into consideration that although the practical and technical aspects have to line up, more and more partnerships are placing value in the corporations seeing ‘eye to eye' because they want the relationship to grow and flourish. We touch on the importance of people, sustainability and values aligning for building successful partnerships.

In this episode, we sit down with Audrey Greenberg, Founder and CEO of AG Capital Advisors, to explore her journey building and scaling the Center for Breakthrough Medicines into one of the largest advanced therapies CDMOs. Audrey shares how she fosters a strong culture in her ventures, her insights on the critical need for more women in capital allocation roles, and where she sees the cell and gene therapy field heading next – including what it will take to get there.

In this episode of SCW for Pharma, Evren Ozkaya welcomes Ongun Saracbasi, Head of Assets and Brands Supply at UCB, to explore the evolving landscape of pharmaceutical supply chains.Ongun shares insights into managing supply chains for both commercialized medicines and those in late-stage clinical trials. He explains how pharma companies increasingly rely on contract development and manufacturing organizations (CDMOs) to enhance flexibility and responsiveness. While supply chains in the consumer goods sector adapt rapidly, pharma supply chains require strategic foresight due to higher market uncertainty and longer lead times for change.The discussion highlights a crucial industry challenge: limited supply chain visibility. Ongun explains how pharma manufacturers still lag behind consumer goods companies in digital connectivity, with upstream supply chains and shop floors often lacking real-time data. Despite improvements in digitalization, the industry struggles with fragmented data and underutilized analytics. However, he emphasizes that track-and-trace regulations have created an opportunity to enhance transparency and efficiency.Evren and Ongun also examine the shift in supply chain priorities post-COVID-19. Beyond cost reduction, resilience has become a key focus. Advanced analytics and digitalization play a critical role in detecting early market signals and optimizing operations, but many pharma companies still rely on outdated ERP systems that lack granularity. Ongun stresses the importance of mapping supply chain networks to identify high-risk areas for digital investment.The conversation then shifts to the future of supply chain talent. Ongun highlights the importance of both hard and soft skills, from data analytics to storytelling and decision-making. He notes that while technical skills evolve rapidly—Python coding was once a must-have, now it's prompt engineering—the ability to adapt and continuously learn remains the most valuable trait for supply chain professionals at all levels.Reflecting on his own career, Ongun advises young professionals to take bold risks and immerse themselves in diverse experiences, as learning agility is shaped by the challenges we embrace.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Luke Bilton, Co-Founder at Life Science Networks, PharmaSource and CDMO Live. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Luke, covering: How Covid exposed the complacency of event organizers in pharma services Behind the scenes of organizing CPHI Worldwide - what's it really like - chaos or calm? How companies should be thinking about event budgeting, planning and ROI in 2025 Beware 'the HIPPO' when planning which events to attend Luke Bilton is Co-Founder of Life Science Networks, a next-generation community and events organization specializing in biopharma manufacturing. The company's growing portfolio includes the PharmaSource outsourcing podcast and online community, alongside its flagship event, CDMO Live. With over 20 years experience launching and growing digital media and events businesses at companies including Informa, Future and Innovation Enterprise, Luke partnered with Chris Kilbee, former head of CPHI global events, to establish Life Science Networks. CDMO Live (World Trade Center, Rotterdam, 7-8 May 2025) brings together biopharma's manufacturing leaders to optimize their outsourcing strategy. The event's unique PartnerMatch program facilitates curated one-to-one meetings between sponsors and over 50 leading CDMOs. To find out more, visit CDMO Live Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is also sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

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

In this episode of SCW for Pharma, host Evren Ozkaya welcomes Bryan Holmes, Vice President of Information Technology at Andelyn Biosciences, to discuss the evolving role of IT in pharmaceutical manufacturing and the transformative impact of digitalization on Contract Development and Manufacturing Organizations (CDMOs). The conversation begins with a deep dive into the fundamental differences between traditional pharmaceutical manufacturing and the rapidly growing field of cell and gene therapy, a market that exceeded $5 billion in 2024 and sustains an annual growth rate of over 25%. Bryan explains how these personalized treatments, often targeted for rare diseases and small patient populations, require an entirely new approach to manufacturing, one that prioritizes agility and responsiveness. Evren and Bryan explore how IT strategy plays a pivotal role in modern pharma operations. They discuss the challenges of digital transformation, from ensuring regulatory compliance and data security to bridging communication gaps between CDMOs and their clients. Bryan highlights the ongoing shift toward data sharing, transparency, and accountability in CDMO partnerships—critical for optimizing production processes. The discussion then shifts to the cost-benefit analysis of digitalization, weighing Software-as-a-Service (SaaS) solutions against customized approaches. Evren emphasizes that while change management is difficult, companies that invest in digital transformation today will secure a long-term competitive advantage, as the pharma shop floor is poised for dramatic evolution over the next two decades. Looking ahead, Bryan and Evren explore AI's biggest opportunities in pharma. From automating routine tasks to enhancing quality assurance, AI-driven solutions are unlocking new efficiencies. Bryan underscores that the younger workforce expects technology-driven workplaces, making digitalization not just a competitive edge but a necessity for attracting top talent. Evren and Bryan wrap up their discussion with a call to action: embracing IT and digital transformation is no longer optional but essential for pharma companies looking to stay ahead in an industry evolving at an unprecedented pace.

In this episode, we take a deep dive into the life sciences industry's most transformative trends for 2025, inspired by 2025 Life Sciences Trends: Reducing Complexity, Improving Healthcare. The healthcare landscape is evolving rapidly, with technological advancements and regulatory shifts reshaping how treatments are developed and delivered.We explore key developments such as AI-driven drug discovery, the increasing role of Contract Development and Manufacturing Organizations (CDMOs) in accelerating new therapies, and the growing demand for resilient healthcare supply chains. We also discuss the ethical considerations of personalized medicine, the promise of bioconvergence in medical innovation, and how sustainability is becoming a core pillar of life sciences.Join us as we unpack these trends and discuss how they are shaping the future of healthcare.What You'll Learn in This Episode:1. Accelerating Drug Development Through AI & Collaboration:The role of AI and generative AI in streamlining drug discovery and development.How CDMOs are helping pharma companies develop complex therapies faster.The rise of personalized medicine and its potential to transform patient care.2. Strengthening Healthcare Supply Chains & Regulatory Compliance:Why supply chain resilience is now a top priority for life sciences companies.The impact of real-time tracking, data integration, and digital tools in reducing disruptions.How stricter global regulations are reshaping pharmaceutical manufacturing and distribution.3. The Impact of Bioconvergence & Emerging Technologies:How bioconvergence is merging biology and technology to create groundbreaking treatments.The potential of 3D-printed organs, bioengineered materials, and implantable health sensors.Ethical and accessibility challenges that must be addressed.4. The Future of Healthcare Payment Models & Sustainability:The shift toward usage-based billing in healthcare and its implications for affordability.Why sustainability is becoming a competitive advantage for life sciences companies.How circular economy practices and eco-friendly manufacturing are shaping the industry.Key Takeaways:AI and CDMOs are accelerating drug development, making life-saving treatments more accessible.Supply chain resilience and compliance strategies are crucial to ensuring reliable healthcare delivery.Bioconvergence and personalized medicine are redefining how healthcare is provided.Sustainability and innovative payment models will shape the financial future of life sciences.Subscribe to our podcast for more deep dives into the latest trends in healthcare and technology. Visit The Future of Commerce for additional insights, and don't forget to share this episode with colleagues and industry professionals to keep the conversation going.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Ian Tzeng, a Managing Director and Partner in L.E.K. Consulting. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Ian, covering: Reflections on 2024's market dynamics, shifting sponsor behavior, big pharma woes, biotech rebound and segment-specific impact The outlook for 2025 across discovery, development, clinical trials, and manufacturing The uptick Ian expects and where companies should be focusing efforts Ian Tzeng, a Managing Director and Partner in L.E.K.'s Boston office, joined the company in 1998 with experience in growth strategy, regulated markets, innovation, pricing, and mergers and acquisitions. He focuses on healthcare and life sciences, including pharmaceuticals, vaccines and medical devices.    He leads L.E.K.'s Pharmaceutical Contract Services practice, including CROs, CDMOs, supply chain and distribution, commercial, medical, and market access services. Other areas of deep experience include rare diseases, biodefense, biosimilars and generics, and consumer-directed healthcare.  Additionally, Ian has extensive consulting and board experience with nonprofit organizations in education, arts, LGBT advocacy and public service. He received a Bachelor of Arts degree, magna cum laude, in chemistry from Harvard College and is a George F. Baker Scholar, Master of Business Administration with high distinction from Harvard Business School.   Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!   Molecule to Market is also sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.  

On this week's episode of Let's Talk Quality: The Podcast

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

On this week's episode of Let's Talk Quality: The Podcast

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

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

In this episode of The Factor, host, Chris Adkins interviews Bill Monteith, Kymanox Executive Advisor, to discuss the art of building successful partnerships in biopharma manufacturing. With over 40 years of experience, Bill shares how aligning operations, quality, and patient focus is essential for success.From preparing CDMOs for FDA scrutiny to designing flexible Quality Management Systems (QMS) and fostering patient-first cultures, this episode provides actionable insights for navigating the complexities of biologics and advanced therapies. If you're scaling operations or managing critical partnerships, this conversation is a must-listen.About the Factor:The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry. About Kymanox:Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management.  Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product's life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.The Factor is edited and produced by Earfluence.

"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/

Contract development and manufacturing organizations (CDMOs) are reshaping pharmaceutical production, playing a pivotal role in supply chain stability and driving innovation. In today's fast-evolving environment, CDMOs help life sciences companies enhance speed, flexibility, and efficiency, which ultimately advances access to life-saving therapies. Norstella provides tailored insights, tools, and intelligence solutions to support this progress, empowering companies to make informed decisions and optimize their manufacturing partnerships. This year at CPHI Milan, our team observed key industry trends, including innovations to strengthen supply chains and enhance sustainable practices. At Citeline's (a Norstella company) 11th Annual Global Generics & Biosimilars Awards, we also celebrated excellence in the generics sector. Following the conference, Andrea Charles, VP of custom content at Norstella, and Andrew Warmington, Citeline's manufacturing editor, joined Izabela Chmielewska, managing editor of custom content, to discuss major takeaways – from the BIOSECURE Act's influence on global operations to advancements in biomanufacturing. Together, they explored how Norstella and Citeline drive solutions to streamline the journey from pipeline to patient.

Send us a textWant to peek behind the curtain of a leading Contract Development and Manufacturing Organization (CDMO)? In this inspiring episode, KBI Biopharma's Chief Scientific Officer Sigma Mostafa reveals the intricate world of bioprocess development and manufacturing.Sigma shares game-changing insights into accelerating biologics development without compromising quality. She also unveils how KBI is leveraging AI and machine learning to revolutionize everything from protein sequence analysis to formulation development.Key Takeaways:Learn how to master the art of seamless tech transferDiscover how to slash development timelines using innovative cell line technology and parallel processingLearn how AI and machine learning are transforming CDMO operations, from predicting developability challenges to automating lab processesReady to transform your bioprocess development journey? Tune in to hear Sigma's vision for the future of CDMOs and get actionable insights for your next project.Connect with Sigma Mostafa:Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817KBI: https://www.kbibiopharma.comNext Steps:Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

Send us a textIn this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development.Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship.Key Takeaways:Why harvest steps deserve more attention in bioprocess developmentThe truth about one-stop-shop CDMOs versus specialized partnersCritical factors in cell line and media selection that impact long-term successSigma emphasizes that successful CDMO partnerships hinge on transparent communication and cultural alignment, not just technical capabilities. She reveals that while one-stop shops seem convenient, partnering with specialized CDMOs who excel in specific areas often yields better results - as long as there's strong project coordination.Whether you're a startup navigating your first CDMO relationship or an established biotech company looking to optimize your partnerships, this episode provides actionable insights for making informed decisions that will impact your project's success for years to come.Listen now to transform your approach to CDMO selection and avoid costly pitfalls in your bioprocess development journey.Connect with Sigma Mostafa:Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817KBI: https://www.kbibiopharma.comNext Steps:Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Peter Stevenson, Independent Director and Pharma industry veteran. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Peter, covering: Bringing an outsourcing model from UpjohnPharmacia into Pfizer and then driving manufacturing out of Pfizer into CDMOs without compromising on quality or IP Behind the scenes of Pfizer's mammoth acquisitions of Wyeth and Hospira The failure to spend too much time setting up a reliable, high-quality outsourcing network in China The different perspectives of being 'the mayor of one huge site' to having a diversified, helicopter view across several Switching from buy-side external outsourcing to running Pfizer's CDMO division Pfizer CentreOne Don't be penny-wise and pound-foolish when balancing the onshoring manufacturing conundrum and how price controls in the US will impact all aspects of the industry Peter Stevenson is a leader in the pharmaceutical industry with extensive manufacturing and commercial experience. He was a Pfizer's Global Manufacturing Leadership Team member, responsible for global procurement, global external supply, and a portfolio of Pfizer's internal manufacturing sites in North America, Europe, and Asia. Today, he is a Non-Executive Independent Board Member at Piramal Pharma. Later, Mr. Stevenson served as General Manager of Pfizer's contract manufacturing business and Value Stream Leader for the Injectables and Hospital Products Value Stream. Mr. Stevenson recently retired from Pfizer and serves as the Board Vice-Chair for Uniting to Combat Neglected Tropical Diseases and Chair of the Governance Committee. Earlier in his career, Mr. Stevenson held positions at Rhone Poulenc and Celanese, including a 3-year expatriate assignment in France. He has a Bachelor's degree in Arts from Gettysburg College, Pennsylvania.   This episode of Molecule to Market is sponsored by Vetter, a global leader in aseptic filling solutions for injectable products in the pharmaceutical and biotech industries. Discover more about Vetter's comprehensive services, from early-stage development to commercial production, and how they support clients in delivering high-quality therapies to the market.   Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!   Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

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

This week on Data in Biotech, we're joined by Martin Permin, the co-founder of Invert, a company that builds software that automates bioprocessing. Martin talks us through his own unique journey into biotech - starting from a role at Airbnb - through to co-founding Invert. Invert helps users grab data from their instruments, map out their individual processes, clean up the data for analysis, and look for ways to speed up the “mundane” data cleaning tasks that often take up the majority of one's time.  With our host, Ross Katz, Martin tells us the statistical problems Invert works to solve for their different types of clients: biologic development labs, full-scale manufacturers, and CDMOs. While they all approach data cleaning and analysis from different directions, Invert can see how clients use the system and look for ways to automate repeated processes to help them save time. They discuss implementing Invert into the Design, Build, Test, Learn Loop and why Invert is invested in reducing how many times one has to go around that loop. Martin explains how his company looks to reduce the risk in tech transfer in both directions, in terms of time and labor.  Then, the conversation moves to ML/AI, where Martin tells us how a lot of his customers are finding that the bottlenecks in their processes aren't where they thought they were, thanks to using Invert for process automation.  Finally, Martin gives us his opinions on the future trends around the corner for the biotech industry - and how Invert is preparing themselves and their customers.  Data in Biotech is a fortnightly podcast exploring how companies leverage data innovation in the life sciences. Chapter Markers [1:29] Introduction to Martin and his journey into biotech [4:10] Introduction to Invert - the what and why [6:47] How Invert is implemented into a customer's workflow [11:36] The problems Invert can solve [16:16] Design > build > test > learn… and how Invert facilitates that [20:00] CDMOs and contractors - how Invert works with their different customers [22:15] The use of ML/AI in bio-processing [33:40] Trends in Biotech that will influence Invert over the long-term

Welcome to episode 061 of Life Sciences 360.In this episode of Life Sciences 360, host Harsh Thakkar sits down with Kevin Sharp, Senior Vice President and Head of Global Sales at Samsung Biologics. They dive deep into the evolving CDMO industry, the importance of agility, innovation, and the strategic growth pillars that are driving success at Samsung Biologics. Kevin shares his journey from government roles to life sciences, discusses the rapid advancements in ADCs, and explores how emerging technologies like AI are reshaping the industry.Chapters:00:00 - Introduction  00:02 - Overcoming Roadblocks in the Industry  00:10 - Flexibility and Agility in Implementation  00:18 - Innovating Through Challenges  00:24 - The Mission of Life Sciences and Pharma  00:52 - The Speed Factor in Pharma Development  01:26 - Introduction to Kevin Sharp and Samsung Biologics  02:00 - Kevin Sharp's Career Journey to Life Sciences  03:29 - Transition from Pharma to CDMO Space  05:29 - The Rapid Growth of the CDMO Industry  07:14 - Key Challenges in Transitioning to a CDMO Role  09:22 - The Boom of CDMOs and Their Impact  11:32 - Regulatory Challenges and CDMO Expertise  13:48 - Strategic Partnerships with Top Pharma Companies  15:59 - The Importance of Diversification and Capability Growth  18:25 - Building Long-Term Partnerships with CDMOs  22:04 - Adapting to Roadblocks with Agility  23:59 - ADC Market Insights and Samsung Biologics' Strategy  28:24 - The Future of Life Sciences: New Modalities and Technologies  30:27 - Leveraging Emerging Technologies like AI in CDMOs  34:52 - Leadership and Operational Excellence in Life Sciences  39:20 - Working at Samsung Biologics  41:17 - Final Thoughts and How to Connect with Kevin SharpConnect with Kevin Sharp:Kevin's LinkedIn: (https://www.linkedin.com/in/kevinsharp)  Samsung Biologics: (https://www.samsungbiologics.com/)Don't forget to like, share, and subscribe for more insightful conversations on achieving success in life sciences and beyond!---Links:*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/ )*Listen to this episode on the go! 

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA). Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Gil, covering: The evolution of the PBOA over the last decade, the impact of M&A on the Association, and building a safe place where CDMOs belong How the industry has evolved over the last few years after Covid, including harder times and areas of green shoots Why Gil believes Novo's purchase of Catalent is a black swan event and not a new megatrend A deeper dive into fine details of The BIOSECURE Act, and its potential impact on the CDMO space over the next 7-8 years The need to know market headwinds and tailwinds that you simply cannot ignore Gil Roth is the Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA), a nonprofit trade group that advocates for the regulatory, legislative and general business interests of the CMO/CDMO sector. In this role, he brings CDMO perspectives and education to FDA, the US Congress, and other bodies, and brings CDMOs together to share best practices, develop policy positions, and provide briefings on government positions that impact that sector. He also organizes and hosts PBOA's annual members-only Meeting & Conference. Previously, he was the Founding Editor of Contract Pharma magazine. In his alleged free time, he produces a weekly cultural conversation podcast called the Virtual Memories Show (https://chimeraobscura.com/vm) Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

Text us your thoughts on this episodeIn this episode, Dinkar Saran, Pharma and Life Sciences Operations Partner at PwC, and Jim Cafone, SVP of Global Supply Chain at Pfizer, dive into operations transformation and its critical role in building resilient and sustainable supply chains, revenue growth and differentiation in an ever-changing world.Their discussion features insights on how to navigate the delicate balance between short-term pressures and long-term challenges, exploring strategies for improving operations, enhancing agility and leveraging technology to drive productivity and adaptability.Join us as we uncover key principles and practical approaches that can help your organization thrive in an evolving business landscape.About the podcast participantsDinkar Saran leads PwC's Pharmaceutical & Life Sciences Operations practice delivering integrated operations solutions for PwC clients.Globally he has worked across biopharmaceuticals, generics and CDMOs with the board and C-suite of multinational companies to enable quantifiable value and EBITDA improvements. He has extensive experience in mergers & acquisitions and has supported multiple corporate and private equity driven transactions on revenue and cost side diligence, integration planning, and post deal value capture.Jim Cafone is the Senior Vice President, Global Supply Chain, at Pfizer. He is responsible for global demand forecasting, demand and supply planning, worldwide logistics, and inventory management.Jim is an engineer by trade and has expertise in supply chain management and strategic sourcing. Prior to joining Pfizer, Jim spent almost two decades with Wyeth Pharmaceuticals as part of the manufacturing and operations analysis team. He held numerous positions within manufacturing, materials management, customer order management, physical distribution, and information technology functions. This included Vice President, EMEA Manufacturing and Supply and Vice President, Worldwide Logistics.For more information on this episode's speakers, and to view the full transcript, please visit pwc.com.

Are you navigating the complex world of bioprocess CMC development and manufacturing in a small biotech company?Our latest episode is a must-listen! Join us as we sit down with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, who shares invaluable insights on overcoming the unique challenges faced by small biotech firms.In this episode, we explore:The critical communication strategies needed for successful outsourcing to CDMOs.How small biotechs can leverage their agility to make fast, impactful decisions.The surprising benefits of wearing multiple hats and fostering cross-functional expertise.Tune in to discover how mastering these areas can help your small biotech thrive and stay ahead in a competitive market.Don't miss this opportunity to gain practical advice and turn your challenges into advantages!Connect with Mark Melville:LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2Next Steps:Wondering how to develop biologics with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessmentDevelop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

The biggest news of the week was the FDA approval of Eli Lilly's Kisunla (donanemab) on Tuesday. While not unexpected, it was one of the year's most highly anticipated decisions. And last week saw another big approval from the FDA—that of Verona's novel COPD drug. But the regulator has also dropped three Complete Response Letters on drugmakers in the last seven days. Two of these were directly related to issues with third-party manufacturers. Though it's unclear if those contract development and manufacturing organizations (CDMOs) were overseas, the FDA has flagged several concerns regarding manufacturers in India and China that have contributed to extreme drug shortages in the U.S. This will be particularly important in the face of a potential decoupling from Chinese CDMOs should the BIOSECURE Act become law, as India has been one country eyeing the opportunity. Meanwhile, Korean company Samsung Bio struck a $1 billion manufacturing contract with an undisclosed U.S. biopharma company. Among the many products the manufacturer makes are the piping hot antibody-drug conjugates, or ADCs. The global market has already exceeded $10 billion and is estimated to grow to nearly $30 billion by 2028. As evidence of the excitement surrounding ADCs are five major deals struck by biopharma companies this year. It's not all good news for the ADC space, though, as one of those three FDA rejections was handed to Merck and partner Daiichi Sankyo's investigational ADC for the treatment of certain non-small cell lung cancers. Meanwhile, BMS backed out of a collaboration with Eisai to develop an ADC being investigated in ovarian, peritoneal and fallopian tube cancers, as well as non-small cell lung cancer. We will continue to watch the industry's strategies unfold as biopharma firms compete for a piece of that exploding ADC market.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Andy Holt, CCO of Viralgen Vector Core. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Andy, covering: Growing a CDMO while dealmaking in a gene therapy company…at the same time Selling a revenue-generating therapy company to Bayer during the pandemic Faster failure or faster acceleration; the need to celebrate every gene therapy batch as it's going to save lives The challenges of manufacturing AAV gene therapies and why the next generation of CGT CDMOs need a voice at the table  Andy has been working on the business side of cell and gene therapy for more than 15 years, focused on creatively connecting science and solutions, whether health care for whale sharks or supporting multi-billion dollar transactions between biotech and big pharma.  Along the way, he has held positions in business development and management for several large CDMOs like Lonza and MilliporeSigma, leadership positions in Askbio, Ncardia, and Cellistic, and his current role as Chief Commercial Officer for Viralgen, a pioneering AAV-focused CDMO leveraging Askbio's manufacturing expertise for clients around the world. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital, and content agency that helps companies differentiate, get noticed, and grow in the life sciences.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Mark W. Womack, Chief Executive Officer at BioCina. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Mark, covering: How a tough upbringing in LA led him to the US Navy, and then onto a pathway into leadership Why he decided to end his own practice and jump into a senior role within a biopharma CDMO space The key factors that led him to relocate to Adelaide, Australia The reality that most biologics CDMOs frequently fail to deliver... and why winning requires operating with discipline, and consistently executing at a high level Mark W. Womack is BioCina's Chief Executive Officer. Prior to BioCina, he was CEO of KBI Biopharma and Selexis SA, and previous to that, he was CEO and Managing Director of Stelis Biopharma, leading both to significant YOY growth. Preceding Stelis, as the CBO for AGC Biologics, one of the world's leading global biopharma CDMOs, he led them to nearly a 300% increase in new sales in just two years. Prior to joining AGC Biologics, Mark served over 20 years as an international management consulting industry leader, guiding many of the world's renowned companies to achieve record highs in revenue and profit. This included a $20B post-merger integration within General Motors and numerous transformations that generated more than $100M in certified client benefits. Mark began his professional journey by leading a succession of U.S. Navy units to unprecedented results, including while serving as a combat center leader on a destroyer class ship, and he received numerous of the Navy's highest honors and awards. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.  

In this episode I speak with Alex Vidras, Executive Director and Co-Founder at Vimachem. Before founding Vimachem, Alex spent 10 years in the Data Science space working for Accenture and other data science firms in the USA. He is passionate about data and data-driven decision-making and is excited about the potential of AI in transforming pharmaceutical manufacturing. Alex is an Adjunct Professor at Columbia University where he teaches graduate-level classes in Data Science and Change Management. About Vimachem: Vimachem Pharma MES is a no-code, AI-powered MES designed by pharma end-users specifically for pharma/biopharma manufacturing. Alex co-founded Vimachem in 2015 with the mission to support pharma and biopharma manufacturers to reach the market faster with high-quality, affordable medicines.  Vimachem is currently deployed across multiple mid-sized pharma CDMOs globally and is increasingly becoming present in big pharmas in USA, Europe and APAC. Discover the Vimachem MES Platform: https://www.vimachem.com/pharma-mes-platform/ https://www.vimachem.com/pharma-mes-platform/oee-for-pharma-biopharma-manufacturing/ https://www.vimachem.com/resources/blog/how-citizen-developers-and-low-code-platforms-are-shaping-the-future-of-pharma-manufacturing/ You can find more information about Vimachem from their website: https://www.vimachem.com/ You can find more information about Manufacturing IT Recruitment from their website: https://mitrec.com/

Episode 041: J.D. Mowery, President and CEO of KBI Biopharma, discusses his career journey and the role of CDMOs in the biotech and pharma industry. He emphasizes the importance of relationships, risk-taking, and continuous learning in his career success. J.D. highlights the unique combination of expertise required to work in both biotech and CDMO companies. He explains the challenges faced by biotech and pharma companies that have led to the rise of CDMOs. Harsh asks J.D. to share the key factors to consider when selecting a CDMO. They introduce the concept of a next-generation CDMO, focusing on regulatory leadership, R&D and innovation, and risk sharing. -----Links:*J.D. Mowery LinkedIn*KBI Biopharma *Harsh Thakkar LinkedIn *Would you rather watch the episode? Click here! 

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Pfizer is planning to bring an RSV shot to adults aged 18-59, while Boehringer Ingelheim is facing staff layoffs due to biosimilar challenges. Amylyx made a rare move by pulling an ALS drug from the market. On the regulatory front, the FDA has approved CAR-T therapies from J&J and Bristol Myers for earlier use in myeloma patients. Sage's depression drugs are facing hurdles, with the first medicine approved for postpartum depression not gaining traction and challenges in launching its second drug. Real-world evidence is becoming increasingly important in comparative effectiveness research, highlighting the need for a new approach to sales team development and coaching in biopharma companies. The industry is experiencing various challenges and advancements that are shaping the future of healthcare.A new study found that GLP-1 receptor agonists like Novo Nordisk's Ozempic do not increase the risk of thyroid cancer. Another study presented at AACR suggests that drugs approved through accelerated approval may not always lead to clinical benefit. Merck and Kelun's anti-Trop2 ADC shows promise in gastric cancer, while Torl Biotherapeutics secures funding for ADC therapies. Less than half of cancer drugs approved via accelerated approval showed clinical benefit in confirmatory trials. There are also job listings and other news updates related to the pharmaceutical industry.The resurgence of a shelved radioactive cancer therapy is making a comeback after being developed abroad for decades. The radiotherapy market is growing, with estimates suggesting it could be valued at $8.8 billion by 2028. Radiotherapy is commonly used in oncology to destroy cancer cells, but it carries risks of damaging surrounding tissue. Precision medicine innovations, such as stereotactic body radiation therapy, are being developed to target tumors more accurately. There is also increasing focus on psychiatric drugs in the pharma industry, as well as challenges and opportunities in the biosimilar market. The text includes information about a survey on what emerging biotechs want from CROs and CDMOs, recent developments in the pharmaceutical industry like job cuts at Novartis and partnerships in cancer drug development, a poll about running clinical trials in Ukraine during the ongoing war, and offers links to resources on patient support hubs, emerging biotechs, and the obesity drug revolution.

This is the latest episode of the free DDW narrated podcast, titled: What trends will speed up the journey from clinic to bedside? It covers three articles written for Volume 23 – Issue 4, Fall 2022 of DDW. They are called: Sitting down with… PharmEnable, Is single-cell gene expression the next trend in next generation sequencing? and Preparing for new-era drug modalities with technology. In the first article, Reece Armstrong speaks to Natalia Mateu, Co-Founder, Jelena Aleksic, Co-Founder and Peter Curran, Chemoinformatics Scientist, about utilising 3D chemistry and AI to get small molecule therapies from the clinic to the bedside. In the second article, we hear from Dr Dina Finan, PhD, Product Manager at 10x Genomics and Dr Nick Downey, PhD, NGS Collaborations Lead at Integrated DNA Technologies.  In the third article, Samsung Biologics' Senior Vice President, James Park, explores the opportunities emerging for CDMOs to support mRNA developers as they explore new therapeutic areas for patients. You can also find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts. 

Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forging the future of pharma. During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we've chosen to profile in our March issue — ten23 health, Cellares, INCOG BioPharma Services and Matica Biotechnology. Launching a new company into a crowded contracting space isn't for the faint of heart — it demands expertise, ingenuity and a willingness to embrace risk. Fortunately, a new generation of CDMOs are boldly positioning themselves to become pillars of pharmaceutical progress.

The FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise. Discussion points include: » The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of employees—areas that are pivotal for inspection readiness and regulatory compliance. » The integral components of quality culture, including an emphasis on resolving issues constructively rather than avoiding them, the crucial role of trust, a shared commitment to quality, and holding each other accountable for outcomes. » How leadership should exemplify and consistently reinforce quality values, impacting trust and openness within the organization. » The challenges in sustaining a quality culture, which underscore the need for ongoing employee engagement and assimilating new staff into the existing culture. » The fact that quality culture isn't static and must evolve with changing internal and external business environments. Vincent is a distinguished expert in quality assurance and regulatory compliance with over 30 years of extensive experience in the life sciences industry. As the Founder and Managing Consultant of Practical Compliance Results, LLC, he specializes in inspection readiness, compliance, and quality systems, focusing particularly on medical devices and in vitro diagnostics (IVD). His expertise includes the development, management, and auditing of quality systems to ensure adherence to both domestic and international regulatory standards. Vincent is known for his skill in building and leading effective quality and regulatory compliance teams, ensuring their operational excellence and sustained inspection preparedness. With a background as an internal and supplier auditor, Vincent brings practical insights into FDA inspection techniques and a comprehensive understanding of quality system standards such as ISO 13485 and ISO 9001. His experience is extensive in the European and Global regulatory landscape, including the EU Medical Device Regulations. He also offers valuable expertise in collaborating with contract design and manufacturing organizations (CDMOs), ensuring products are designed and manufactured in compliance with global quality system requirements. His proficiency covers a wide range of areas, including FDA Regulations, Quality Assurance, Regulatory Compliance, Change Control, and FDA Readiness and Remediation. Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Kevin Bittorf, Founder and Principal Consultant of SCxCMC. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Kevin, covering: Joining a little company called Vertex Pharma when it was looking to be innovative The leap of faith required to become a consultant, and why helping smaller businesses makes a bigger difference An insight into the sentiment of virtual, small, and emerging biotechs after a brutal 12 months What the most significant factor is in CDMO selection for biotechs, as well as other critical components Why CMC is a crucial investment from pre-IND to phase 2 to get things done on time Kevin is an experienced consultant who has demonstrated success in pharmaceutical development (innovator and generics) and technical innovation. Leveraging his extensive experience in GMP, business development, contract manufacturing, and long-term strategy, Kevin partners with biopharma CEOs and executives to guide their companies through groundbreaking pharmaceutical advancements by evaluating strategy, attaining government approvals, and developing new and emerging technologies that improve the development lifecycle. He has formed multiple non-profit conferences, including the Advancing Drug Development Forum, which examines how innovations are brought from inception to regulatory approval. He has spent time at Vertex and Trek Therapeutics and advising several CDMOs. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

What constitutes a healthy, productive, and successful relationship between an emerging biopharma company and its contract develpment and manufacturing outsourcer (CDMO)?  Jenny Holt, Chief Development Officer at the biopharma company Ray Therapeutics has some opinions. So does John Maslowski, Chief Commercial Officer at the CDMO Forge Biologics. Think they align?On this episode of the Business of Biotech, we dig into the trust, technical expertise, and project timeline considerations that required of a successful partnership. We also broach the risks associated with emerging CDMOs, the right balance among cost, quality, and time, what you should ask when evaluating outsourcing partners, and a whole lot more. ***REGISTER for the first-ever, interactive Business of Biotech Live! Legal & IP Protection For New Biotechs here!Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with J.D. Mowery, President and Chief Executive Officer at KBI Biopharma. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with J.D., covering: The experience of bringing a product to market... and then many years later seeing that product used on his wife to help bring his sons into the world How bringing a commercial facility online for Genentech to impact thousands of patients compares to the ‘vain to vain', hospital-based, one-off patient CAR-T product for Juno Why the ethos of taking care of the person on your left and the person on your right helps with the scale-up of a multi-national global CDMO The emergence of a partnership-based, absorption business model between innovators and CDMOs in the wake of the shift in capital markets What the next generation CDMO will look like… J.D. is an accomplished leader with a distinguished reputation in the biopharma industry and proven expertise in guiding global innovators and contract development and manufacturing organizations (CDMOs) for nearly 25 years. Throughout his diverse career, J.D. has demonstrated strategic vision and the ability to drive all aspects of an organization, including operations, R&D, manufacturing, tech transfer, facility construction, business development, employee growth, and investor relations. He is an expert in diverse modalities, including small molecules, biologics, and cell and gene therapy. J.D. has held executive leadership positions as  Head of Operations at Lonza and Executive Vice President of U.S. Operations at AGC Biologics. He has also held influential roles at innovators, including Genentech, Celgene, and Juno, and most recently served as Chief Operating Officer at Treadwell Therapeutics. J.D. holds a Bachelor of Science from George Fox University and an MBA from Marylhurst University. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital, and content agency helping companies differentiate, get noticed, and grow in life sciences.

In this episode of Life Science Success, my guest is Hanns-Christian Mahler.  Dr. Mahler is Founder, CEO and Board Member at Ten23 health AG, the human-centric and sustainable pharmaceutical development partner.   Hanns-Christian Mahler is the Founder, CEO, and Board Member of ten23 health AG, a company specializing in sustainable pharmaceutical development. He has a background in pharmacy and has worked in various pharmaceutical companies and CDMOs (Contract Development and Manufacturing Organizations). Mahler's leadership style focuses on building organizations from the ground up, emphasizing the importance of values, purpose, and motivation. He believes in creating a work environment that fosters joy and engagement among employees. ten23 health AG differentiates itself from other CDMOs by its customer-centric approach and specialized expertise in developing difficult-to-produce products, such as high-volume blockbuster injectable products and products for subcutaneous self-administration. Mahler is deeply concerned about climate change and is inspired by young activists like Greta Thunberg. His company is committed to sustainability, even registering for B Corp pending status and implementing various eco-friendly initiatives. The best leadership advice Mahler has received emphasizes trust in employees. He believes that if you have the right people, there's no need to micromanage, and that trust fosters a more productive and engaged workforce.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Shawn Singh, Chief Executive Officer and Director at Vistagen Therapeutics. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Shawn, covering: What life is like running a public company and how that is impacted depending upon the season of the capital markets The ups, downs and pivots of a biopharmaceutical company that's led it down a mission of transforming the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders How the pandemic has magnified mental health issues and their prevalence among young people, and why finding a radically social transformative treatment is needed Why collaboration is key when developing several drug candidates and how partnerships can happen at any stage of the lifecycle His views on CROs, CDMOs, what is essential to outsource in the vendor universe... and the most critical asset to a biotech boss Shawn is an experienced public company Chief Executive Officer and Director. He has over 30 years of experience working with private and public biotechnology, medical device, and pharmaceutical companies, a venture capital firm, and a profitable contract research and development organization (CRO), serving in numerous senior management roles. He's an attorney and a member of the California State Bar with a Juris Doctor from the University of Maryland Francis King Carey School of Law. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Vishnu Dwadasi, Director of Manufacturing at Ashvattha Therapeutics Inc.   Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Vishnu, covering: Lessons learned from 15 years in CDMOs and consulting, before joining a start-up drug development company What he's learned from working with and managing CDMOs all over the world Why many CDMOs are behind the eight-ball... fancy marketing meets chaotic operations The challenge of scaling up through phases as a drug sponsor, and the evolving needs when it comes to outsourcing Major frustrations as a client in a post-covid world and the one area every CDMO needs to invest in moving forward   Vishnu Dwadasi is currently a Director of Manufacturing at a biopharmaceutical start-up company, Ashvattha Therapeutics, leading drug programs from pre-clinical to commercialization. Vishnu brings over a decade of experience in life sciences with a unique background in pharmaceutical operations, consulting, and business development. He has developed extensive experience shepherding complex drug development programs from early clinical development to full-scale commercial manufacturing and distribution. Along with his drug development experience, Vishnu has gained expertise in operations and implementing technology solutions for life sciences companies. Vishnu earned an MBA from Duke University and a B.S. in Health Sciences from Purdue University. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Will Patrick, CEO at Culture Biosciences. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Will, covering: How time at Google, MIT and Kendall Square led him to build disruptive tools and hardware for the bioprocessing sector Creating a cloud-based, real-time data alternative for companies wanting access to bioreactors... without the need for large-scale investment Why biotech and biopharma firms are embracing digitization, virtualization, and simulation... but less so at CDMOs Raising funds from VCs that understand the need for technological disruption How biotechs, biopharma companies, and CDMOs alike can leverage Culture's proprietary, integrated, and cloud-based single-use reactor platform How enhanced data-driven modeling and simulation can save a lot of time and costs in upstream bioprocess development going forward Will is an entrepreneurial engineer with a background in mechanical engineering, product design, and bioengineering. He develops hardware products at the interface of biology and digital fabrication. He holds 17 patents and has published 4 peer-reviewed journal articles. He currently runs Culture Biosciences, a company building and operating automated bioreactor infrastructure for the biotech industry. Will graduated from the MIT Media Lab in 2015 where he was a researcher in the Mediated Matter group. His research focuses on 3D printing fluidic systems and their applications in biotechnology and product design. Previously, he worked at Google[x] as a Rapid Evaluator where he developed and prototyped new projects for the organization. Will was a founding member of the Google[x] UAV delivery project, Project Wing, was an early team member of Project Loon, and also led the launch communications for Project Glass. Please subscribe, tell your industry colleagues, and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with  Ian Walters, CEO and Chairman at Portage Biotech. Your host, Raman Sehgal, discusses the pharmaceutical and biotechnology supply chain with Ian, covering: What Ian learned from his time working with a team of Nobel Prize winners at Rockefeller University Breaking the mold by launching a clinical trial in just three months versus the 12-month standard in a big pharma firm Why building relationships with big pharma is key as a small biotech company with multiple assets in the pipeline How his lean biotech is running the most rapid proof of concept studies in the market whilst conserving cash and building value Why manufacturing and reliance on CDMOs have been the biggest challenge to his business Dr Ian Walters has over 20 years of leadership and expertise in oncology/immunology drug development and specializes in the evaluation, prioritization and innovation of new therapies for the treatment of severe diseases.  Prior to Portage, Ian spent seven years at Bristol Myers Squibb, where he managed physicians overseeing the international development of more than eight oncology compounds and biomarker and companion diagnostic work. He was a core member of Bristol Myers Squibb's Strategic Transactions Group evaluating and executing licensing agreements, mergers and acquisitions, clinical collaborations and the company's immuno-oncology strategy. Prior to BMS, he held positions at PDL BioPharma, Inc., Millennium Pharmaceuticals, Inc. and Sorrento Therapeutics, Inc., leading corporate development, translational medicine, clinical development and medical affairs. Before entering the private sector, Ian was a lead investigator at the Rockefeller University and initiated advanced immunology research to understand the mechanism of action of several compounds. Ian received his M.D. from the Albert Einstein College of Medicine and an MBA from the Wharton School of The University of Pennsylvania. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating! Molecule to Market is sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.