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PMWS

Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options
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Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options

May 26, 2023

Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Before he was appointed Chief Innovation Officer at Azzur Group, he was President and Chief Operating Officer of Azzur Cleanrooms on Demand™. In 2019, Ravi was the General Manager of Azzur Boston and has been with the company since 2012. Prior to Azzur, Ravi has been part of the technical operations and quality/validation departments at Baxter, Amgen, and Shire. Ravi is an expert in phase-appropriate cGMP implementation, process validation, supplier management, and technology transfer.

Chris Mansur serves as Azzur Group’s Executive Vice President of Corporate Development and specializes in providing innovative quality and compliant solutions to the life sciences industry. Throughout his career, Chris has specialized in the startup of new and renovated facilities, project management, commissioning and qualification, computer validation, quality management systems, and application of QRM principles. He is passionate about the use of phase appropriate GMPs to help companies solve problems that accelerate their product’s lifecycle or project timeline. Chris holds a Bachelor of Science degree in Mechanical Engineering from Worcester Polytechnic Institute.

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Can AI Deliver a ‘Real’ Advantage for Life Sciences Manufacturing?
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Can AI Deliver a ‘Real’ Advantage for Life Sciences Manufacturing?

May 26, 2023

Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network Operations practice. Based in New York, she has over 20 years of consulting operations experience across the pharmaceutical, biologics and medical device sectors. Having held leadership positions at Amazon and SAP, she brings smart / digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence and market entry operations strategy expertise. Her current focus at Deloitte is enabling advanced analytics across the end-to-end global supply chain.

Kim is a partner with Deloitte’s Life Sciences Supply Chain and Network Operations practice. Based in New York, she has over 20 years of consulting operations experience across the pharmaceutical, biologics and medical device sectors. Having held leadership positions at Amazon and SAP, she brings smart / digital manufacturing and plant floor operations, plant engineering, facilities management, material sourcing, distribution, performance improvement, operational excellence and market entry operations strategy expertise. Her current focus at Deloitte is enabling advanced analytics across the end-to-end global supply chain.

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The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC
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The Post-Pandemic FDA, Cell & Gene Therapy Updates, and Other Industry News — A Conversation with Teresa Gorecki of Compliance Architects LLC

June 6, 2023

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Teresa Gorecki of Compliance Architects LLC about what pharmaceutical manufacturers should expect from regulators as the pandemic winds down, where we are and where we’re going as the pipeline of Cell & Gene Therapies marches towards commercialization, and a wide range of other industry issues, challenges, and opportunities. This is a great conversation that speaks to a lot of key points of interest for pharmaceutical manufacturers of all shapes and sizes. Give it a listen!

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Michael Kamarck & Pascal Bécotte — Global Talent Trends in Pharma and Biotech Technical Operations: A Perfect Storm
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Michael Kamarck & Pascal Bécotte — Global Talent Trends in Pharma and Biotech Technical Operations: A Perfect Storm

June 20, 2023

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Michael Kamarck, a senior industry executive, and Pascal Bécotte, the Managing Director of Russell Reynolds Associates, about the most serious challenge threatening to bottleneck the otherwise very bright future of medicine. For a number of reasons explored in both this interview and in this recent blog post, there are not enough qualified people to fill all the top jobs that need to be done, and this is not something that is going to be fixed in a day or even a few years without the industry working together in a decisive and unprecedented way to collectively develop its rising Top Talent in the technical operations space into the senior leaders that Small Molecule, Large Molecule, and especially the emerging Advanced Therapy Medicinal Products sectors cannot do without.

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Cell and Gene Therapy Issues and Trends — A Conversation with Judith Koliwer, PhD, of Körber Pharma Software
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Cell and Gene Therapy Issues and Trends — A Conversation with Judith Koliwer, PhD, of Körber Pharma Software

July 31, 2023

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Judith Koliwer, PhD, the Principal Consultant Cell & Gene Therapy Software, Körber Business Area Pharma at Körber Pharma Software. Judith is one of the industry’s leading experts on Cell and Gene Therapies, as she led an academic research group on CGT processes years before these new therapies were approaching commercial manufacturing. At PMWS23 she gave a presentation entitled, “The Iterative Approach to a Digital Cell and Gene Therapy Process – an Overview & Best Practice.” In this interview we discuss what she shared with the audience, as well as her thoughts on current issues and trends pharmaceutical manufacturers need to be aware of as they forge a path into the new frontier of medicine. Give this one a listen!

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Packaging and Supply Chain for the Pharmaceutical Industry — A Conversation with Hunter Malick of Sharp Packaging Services
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Packaging and Supply Chain for the Pharmaceutical Industry — A Conversation with Hunter Malick of Sharp Packaging Services

September 5, 2023

At the most recent edition of the Pharma Manufacturing World Summit we sat down with Hunter Malick of Sharp Packaging Services to talk about how pharmaceutical manufacturers are working internally and externally to improve their capabilities and capacity when it comes to packaging, especially as it relates to changes and updates that could potentially bottleneck the industry’s supply chain. In a business landscape where the rate of innovation keeps accelerating, the product pipeline coming to market is full, and regulatory requirements are frequently adjusted in relation to packaging and labeling, it has never been more important to understand the options available to scale up packaging production and make quick adjustments as needed to make sure the flow of products to patients is not interrupted. Give this one a listen!

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AI & the Pharmaceutical Industry (Many Companies Are Closer Than They Think!) — A Conversation with Andy Alasso of Aizon
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AI & the Pharmaceutical Industry (Many Companies Are Closer Than They Think!) — A Conversation with Andy Alasso of Aizon

September 25, 2023

At the most recent edition of the Pharma Manufacturing World Summit we sat down with Andy Alasso, Aizon’s Chief Product and Customer Successor Officer, to talk about what Artificial Intelligence is going to do for Pharmaceutical Manufacturers now, in the near-future, and in the years to come. It may surprise many business leaders to learn they are closer to being ready to incorporate AI tools into their existing toolbox than they think. The very nature of pharmaceutical manufacturing, which is data-centric by nature, lends itself well to AI. What should industry leaders be thinking about and learning about when it comes to these powerful new tools? Give this episode a listen to find out!

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Global Talent Trends in Pharma Manufacturing
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Global Talent Trends in Pharma Manufacturing

April 21, 2022

Our knee-jerk leadership reaction to the pandemic: from managing change to managing burn-outs! Recovery: how to reboot culture, leading with purpose and agility Defining and adopting next-gen performance and talent management — Pascal Bécotte Managing Director Russell Reynolds Associates Pascal leads Canadian operations for Russell Reynolds Associates and is also a member of the firm’s global Executive Committee. He is a key member of the Healthcare Sector where he advises clients across the globe on their overall talent strategy, particularly with respect to leadership assessment, succession planning and the recruitment of directors, CEOs and other senior executives. More specifically Pascal…

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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning
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Avoiding the Pitfalls of Initial GMP Programming and Clinical Production Space Planning

April 8, 2022

Discussing the common pitfalls observed during establishment of initial GMP programs in the areas of quality systems, materials management, supplier qualification, etc. How are companies adopting organizational changes and leveraging digital systems to avoid these pitfalls? Important factors to consider when assessing build vs. buy for early-phase clinical production, and considerations for scaling a GMP program up and/or out Illustrating the importance of establishing clear process requirements and conducting informal and formal facility fit assessments using real-world examples — Chris Mansur President, Azzur Consulting Azzur Group Chris Mansur currently serves as the President of Azzur Group’s Consulting division, which specializes…

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Advancing Pharmaceutical Manufacturing Quality
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Advancing Pharmaceutical Manufacturing Quality

April 8, 2022

 Using innovative thinking to realize a future more “immune” to supply chain disruptions Incentivizing improvements to the pharmaceutical manufacturing infrastructure that enhance the reliability of manufacturing and supply Delivering on the promise of advanced manufacturing to provide reliable, available, high-quality drugs for patients — Michael Kopcha Director, Office of Pharmaceutical Quality, CDER FDA Michael Kopcha, Ph.D., R.Ph., Director, Office of Pharmaceutical Quality (OPQ), is a leader in the development of innovative solutions to resolve scientific, manufacturing, and commercialization issues worldwide – and in standardizing and harmonizing global processes. With more than 25 years of pharmaceutical industry experience, his areas of expertise…

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Managing Innovation and Variability in a Growth Environment
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Managing Innovation and Variability in a Growth Environment

April 8, 2022

How the pandemic impacted the structure and responsiveness of our global networks Responding to new geographic fluctuation of demand by disease states and patient delivery The challenges and opportunities posed by new product innovation and managing lifecycles — Linzell Harris SVP Global Supply Chain and Strategy AstraZeneca Linzell Harris is senior vice president of Global Supply Chain and Strategy for AstraZeneca, with overall responsibility for the development and execution of the end to end supply chain platform and product supply strategies. In addition, he is responsible for ensuring the strategic development of network designs and supply chain capabilities supporting the…

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