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LIFE SCIENCES

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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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution
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Building a “Lightspeed” Culture: How a Global Pandemic Transformed Manufacturing and Distribution

November 23, 2022

Bolstering our supply chain: Strengthening relationships with industry partners to overcome a global health crisis Making the impossible possible: “Project Lightspeed” and the development, manufacture, and distribution of the COVID-19 vaccine Where do we go from here? Ensuring this experience is a catalyst for change for our industry Key takeaways: upending our conventional ways of working and the resilience of our amazing colleagues — Mike McDermott Chief Global Supply Officer, EVP Pfizer As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities. Mike and the Pfizer Global Supply (PGS) team…

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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence
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Delivering the Pipeline of the Future with a Commitment to Radical Simplification and Pioneering for Excellence

November 23, 2022

Being part of the solution: Launching two medicines in record time during the pandemic Meeting growing complexity head-on Establishing communities of practitioners to re-imagine manufacturing and process development Re-thinking how we collaborate across boundaries — Susanne Hundsbaek-Pedersen Global Head Pharma of Technical Operations Roche Susanne serves as the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries. Pharma Technical Operations spans the world with sites on four continents and covers the value chain from Technical development, CMC to Commercial supplies. She is…

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Fireside Chat: Building the Future from a Distinguished Tenure in CMC
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Fireside Chat: Building the Future from a Distinguished Tenure in CMC

November 23, 2022

Introducing Prime Medicine and its vision for the future of medicine How are we thinking about the inclusion of novel types of automation into molecular medicine workflows? Examining how we view Talent in the emergent technology space, and how do we best deploy remote and hybrid work? Historically, pharmaceutical manufacturing leaders were predominantly men; however, many important CMC leadership positions are now held by women. Why is this the case, and how do we sustain this pattern? What are the most significant learnings from having achieved success in licensing autologous cell therapies? — Ann Lee Chief Technical Officer Prime Medicine…

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Unlocking the Promise of Gene Therapy
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Unlocking the Promise of Gene Therapy

November 28, 2022

Review the current state of gene therapy Discuss overcoming barriers to product development Make the case for global regulatory convergence Describe FDA actions facilitating gene therapy development — Peter Marks Director – Center for Biologics Evaluation and Research (CBER) FDA Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy…

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Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

November 28, 2022

The past few years has seen a migration of talent and technology from traditional biopharmaceutical manufacturing to ATMP manufacturing: How has this changed the CMC ecosystem, and are we overbuilding capacity again? Avoiding the dangers of fragmentation. How should we better communicate, collaborate, and consolidate our best ideas so we all succeed? Discussing the reasons to set up a new company today, and imagining how our business ecosystem will continue to grow and evolve Debating which production platforms will best suit the newer modalities Exploring the next steps for existing platforms like mAbs: How do we efficiently serve giant markets…

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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes
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Revolutionizing The Manufacturing Landscape to Optimize Patient Outcomes

November 23, 2022

How the pandemic has impacted innovation, technology, people and our ways of working and thinking How is Amgen transforming biomanufacturing for a faster, more data-savvy future and strengthening the balance of resiliency and efficiency Addressing unmet patient needs and establishing new markets through connected technology and other manufacturing innovations (smart materials, process automation and more) Why building integrated, collaborative, agile, high performance teams are at the heart of revolutionary manufacturing Amgen Ecovation™ – creating value through innovative and sustainable manufacturing operations — Arleen Paulino SVP Global Manufacturing Amgen Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization where…

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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy
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Fireside Chat: Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing Strategy

November 29, 2022

How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space? Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards including image selection, and packaging network design Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market considerations changing the way we traditionally work? Talking about access issues including regionalization and localization, IP considerations, and how higher order BSL…

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TCR² and the Path to Registration: The Road in Scaling a TCR Platform and Organization to Un-Lock a Therapy for Solid Tumors
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TCR² and the Path to Registration: The Road in Scaling a TCR Platform and Organization to Un-Lock a Therapy for Solid Tumors

November 23, 2022

Walking through how we built our Cell Therapy unit. What did we duplicate? What did we innovate? What did we adapt from others, and how did we make it our own? How are we building a sustainable pipeline, managing complexity, and keeping our focus? What are the “must haves”? What are the learnings on common threats of significant transformations? Lessons learned from the TCR² journey to provide innovative therapies for patients in need — Peter Olagunju Chief Technical Officer TCR² Therapeutics Peter Olagunju serves as the Chief Technical Officer of TCR².  He brings over 20 years of experience in cell…

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Technical Operations Strategies in an Uncertain Market

November 30, 2022

 State of the current market and impact on manufacturing cell and gene therapies Key factors to consider when scaling up a facility for advanced medicines Make vs. Buy and the advantages and challenges of both solutions given the current market Moderator: Adam Pfeiffer VP of Strategy Project Farma Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies…

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Moderna: The Rise of mRNA Vaccines – CMC Operations During a Once-in-a-Lifetime Pandemic
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Moderna: The Rise of mRNA Vaccines – CMC Operations During a Once-in-a-Lifetime Pandemic

November 23, 2022

Our journey from a “platform” to a “multi-product” company How we achieved the seemingly impossible What we learned along the way Where we are today and where the journey takes us next — Tara Jones SVP, North America Operations Moderna Tara is responsible for end-to-end operations for DNA, Drug Substance, and Drug Product for global clinical trial materials and commercial product for the North America region.  Prior to joining Moderna she was at Amgen where she led drug substance operations at Amgen Puerto Rico and was responsible for both the mammalian and bacterial drug substance manufacturing operations for multiple commercial…

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