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).

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“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.”

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“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.

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“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.

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“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.

“Building mutual understanding and trust is the foundation for optimising performance and driving innovation with contract manufacturing organisations (CMOs),” says Guosheng Zhao, Senior External Manufacturing Lead at LEO Pharma.

Guosheng Zhao brings years of experience in procurement, management consulting at PWC, and working with contract manufacturers at companies such as Procter and Gamble and Philips to his role.

At LEO Pharma, Guosheng is responsible for external manufacturing of dermatology and thrombosis medicines, a portfolio spanning both small molecules and biologics, with a focus on maintaining stable product supply and quality across complex global supply chains.

In the latest PharmaSource podcast episode, Guosheng explains why effective supplier relationship management is crucial for reducing costs, improving margins, and ensuring consistent medicine supply for patients.

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“Supply chain leaders make things work. They get things done, but they don’t shine,” says Knut Alicke, McKinsey Partner and co-author of ‘From Source to Sold‘.

‘From Source to Sold’ contains a series of interviews with top Supply Chain leaders, showcasing the stories of their journeys to leadership positions. Knut’s research revealed that only 11% of CEOs in the Fortune 200 had a supply chain background, highlighting the untapped potential for supply chain professionals to reach top executive positions.

• For more book recommendations, checkout the PharmaSource Book Club

In the latest episode of the PharmaSource podcast, Knut explains why recognising and developing supply chain leadership is crucial for driving strategic growth and innovation in corporates.

He explains that the ‘CHAIN’ model was developed from the interviews. It is a framework for professionals looking to enhance their supply chain management skills and advance their careers.

Read the full interview on PharmaSource