Devyn Smith, CEO of Arbor Biotechnologies and Chairman of the Alliance for Regenerative Medicine, brings a wealth of experience to the cell and gene therapy ecosystem. With a PhD in developmental biology and eight years in strategy consulting, Devyn’s journey led him to Pfizer, where he served as COO of their cell therapy group in Cambridge, UK, before a series of board roles at various biotechs.

In the latest PharmaSource podcast episode, he shares insights on the promise of cell and gene therapy to transform lives and the operational challenges the industry must overcome to realise this potential.

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.

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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

As part of Wacker Chemie, a century-old German chemical company, the biotech division leverages over 20 years of experience in advanced therapy manufacturing for contract development and manufacturing.

Speaking to the PharmaSource podcast ahead of CDMO Live 2025, John shares best practices for successful partnerships and explains how Wacker Biotech is positioning itself for growth in the evolving contract manufacturing landscape.

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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.

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David Caron, Senior Vice-President of CMC, AL102 at Immunome, shares why choosing the right CDMO partner can make or break a biotech’s development timeline: “For biotechs, the main business challenge is to do right the first time. To do this, we need to look at the risks related to each activity.”

David Caron brings over three decades of pharmaceutical industry experience across multiple biotechs, with expertise spanning from bench formulation to senior leadership roles. His background includes extensive work with various dosage forms and regulatory requirements across EU and US markets.

In this latest episode of the PharmaSource podcast David shares crucial insights on how emerging biotechs can optimize their CDMO partnerships, manage costs effectively, and align CMC strategy with business objectives.

David Caron will be sharing advice about how to overcome biotech CMC challenges at CDMO Live 2025. Book your ticket here

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.”

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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.

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