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LIFE SCIENCES

Enhancing the Timely Introduction of Novel Therapies
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Enhancing the Timely Introduction of Novel Therapies

John Pinion has over 30 years of global biotech leadership experience across multiple modalities, including gene therapy, and spanning multiple functions across CMC and translational sciences.

John joined Ultragenyx in July 2015 and provides leadership for Quality, Compliance and Translational Sciences to include Pharmacology, Toxicology, Research and Bioanalytical Development. As an executive leader, he contributes to corporate strategy and portfolio management.

Prior to joining Ultragenyx, Mr. Pinion held senior leadership roles at Roche and Genentech departing the organization as Senior Vice President, Global Head of Quality and Compliance. Prior to Genentech, Mr. Pinion spent 17 years in operational and global senior leadership roles at Baxter International.

In addition to his position at Ultragenyx, John is currently COO of Amlogenyx, a subsidiary of Ultragenyx and is a member of the Board of Directors of Aroa Biosurgery Ltd.

He holds a B.S. in Mechanical Engineering from West Virginia University.

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How to Reset the Pharma Trajectory: From Profit to Patient-Centric
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How to Reset the Pharma Trajectory: From Profit to Patient-Centric

Andrew “Andy” Ramelmeier, Ph.D. is Adverum’s chief technology officer responsible for leading the company’s technology and operations organization, including process development and manufacturing. Dr. Ramelmeier has more than 30 years of experience in the development and manufacturing of biopharmaceuticals, including monoclonal antibodies, vaccines, gene and cell therapy products and therapeutic proteins. Most recently, Dr. Ramelmeier served as executive vice president, head of technical operations at Sangamo Therapeutics, where he was responsible for quality, process and analytical development, manufacturing and supply chain of viral vector and cell therapy pipeline products, as well as the oversight of two internal GMP facilities and multiple contract manufacturing organizations (CMOs)/contract research organizations (CROs) for manufacturing and quality control (QC) activities. Prior to Sangamo, Dr. Ramelmeier served as senior vice president, technical operations at Portola Pharmaceuticals, responsible for the process development, technology transfer, manufacturing, and supply chain of small and large molecule pipeline products. Before that, Dr. Ramelmeier held positions of increasing responsibility at several companies, including BioMarin Pharmaceuticals, Johnson & Johnson and Merck Research Laboratories.

Dr. Ramelmeier earned his B.E.S. in Chemical Engineering from Johns Hopkins University and a Ph.D. in Chemical Engineering from University of California, Berkeley. He conducted post-doctoral work at The Institute of Enzyme Technology affiliated with the Heinrich-Heine-University of Dusseldorf.

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Building a Leading Quality Management Framework
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Building a Leading Quality Management Framework

Karin Ann Payne is the Vice President of Corporate Quality in BMS.

In this role, Karin provides strategic quality and compliance leadership in the GxP development and implementation of an integrated QMS across the Enterprise including Research and Early development, Global Drug Development, Global Product and Supply and Medical Affairs and in support of the product lifecycle.

Prior to joining BMS she was the VP of NA Quality for Bayer where she was responsible for ensuring that Bayer remained committed to the highest standards of quality, which is paramount to the patients and customers it serves every day. She joins Bayer from Reckitt Benckiser, where she most recently held the role of Head of Global Corporate Quality Compliance. In this role, she was responsible for managing the company’s Global Quality Management System, Corporate Quality audits, and its Global metrics and Computer System Validations teams. She also managed the Europe and North America Commercial Quality teams, responsible for managing market quality. Prior to that, she held a variety of roles in Quality Assurance and Compliance including positions at Actavis and Pfizer, managing the unique challenges and opportunities of both the consumer health and pharmaceutical industries.

She holds an MLS in Pharmaceutical law (High Honors) from Seton Hall, MBA in Financial Management (High Honors) with a Certificate in International Finance from Iona University and a Bachelor’s in Biological Sciences from Rutgers University.

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Sanofi Manufacturing Modernization – The Best in Class Ambition
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Sanofi Manufacturing Modernization – The Best in Class Ambition

Koustuv Chatterjee is the Senior Vice President of External Manufacturing & Supply, in the Manufacturing & Supply division of Sanofi. Prior to joining Sanofi in 2023, Koustuv has held several leadership positions in Merck & Co, Teva Biopharmaceuticals USA, and Amgen Inc. Koustuv’s career started in process development and has spanned across manufacturing operations, network strategy, product and device development, Manufacturing Science & Technology, internal and external manufacturing operations. Koustuv obtained his Bachelor’s degree in Pharmaceutical Technology from Jadavpur University, Kolkata, India, Masters. in Industrial Pharmacy from University of Toledo Ohio, and Ph.D. in Pharmaceutics from University of Minnesota.

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Data Doesn’t Lie – Digital Manufacturing ROI
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Data Doesn’t Lie – Digital Manufacturing ROI

Matt Lowe has served MasterControl for nearly two decades across several different executive leadership roles including product, engineering, sales, and marketing, and now as Chief Strategy Officer. In this role, Lowe brings vast institutional knowledge of the market, MasterControl’s products, and customers to identify growth strategies and expansion opportunities for the company. He also serves on the MasterControl Board of Directors.

Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices. He has five patents issued and one pending. His regulatory experience includes writing a 510(k) that was cleared by the FDA and managing a multi-site, multi-year postmarket clinical study for orthopedic devices.Lowe has a bachelor’s degree in mechanical engineering from the University of Utah and an MBA from Indiana University.

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Speed to Market: The Power of Centralized Data and the Promise of AI
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Speed to Market: The Power of Centralized Data and the Promise of AI

Ken has spent over 30 years in product, project and IT operations leadership focused in the software and life science industries. Prior to joining IDBS where he focuses on software to manage biopharma manufacturing process data, Ken served as Director, Project Management at BIOVIA. Previously, he was Director of Commercial Operations at Fischer Imaging and Director of IT at Allos Therapeutics and Genomica.

Ken holds a BSc in Computer Science from Cal Poly and an MBA from the University of Colorado, Denver.

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Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility
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Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility

Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with gene and cell therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our gene and cell therapy clients include early stage startups, establish cell and gene therapy companies and CMOs / CROs. We are committed to helping advance cutting-edge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges.

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Revolutionizing RNAi Therapeutics Manufacturing with Enzymes
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Revolutionizing RNAi Therapeutics Manufacturing with Enzymes

Stefan Lutz joined Codexis in 2020 as Senior Vice President of Research to lead the company’s research team advancing the discovery of proteins. Previously, he was a Professor and Chair of the Chemistry Department at Emory University, joining the university in 2002 and ascending to Department Chair in 2014. Stefan has co-authored over 65 peer-reviewed articles and six technical books and journals, holds six patents and is a frequent industry speaker. Dr. Lutz received a B.Sc. in chemistry/chemical engineering from Zurich University of Applied Sciences, an M.Sc. in Biotechnology from the University of Teesside and a Ph.D. in chemistry from the University of Florida.

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KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation
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KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation

John Stewart, Vice President KojoX Strategy, serves as part of the Global Strategic Business Services group at FUJIFILM Diosynth Biotechnologies. His responsibilities include the execution of the Company’s novel KojoXTM Strategy. John is an executive with 30 years tenure in the pharmaceuticals industry with a background in international multi-site leadership of both small molecule and biologics manufacture and supply networks and with responsibility for internal and external manufacturing of clinical and commercial stage biologics.

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The Coming Patient Treatment Crisis
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The Coming Patient Treatment Crisis

Fabian Gerlinghaus is Co-Founder and Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about meeting total patient demand for cell therapies globally. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honors degree in technology management from the Center for Digital Technology and Management, Munich.

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Panel: Digital Change for Future-Proof Biomanufacturing: How Biopharmas and CDMOs Redefine Operations
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Panel: Digital Change for Future-Proof Biomanufacturing: How Biopharmas and CDMOs Redefine Operations

Data Ecosystem for the Future: We’ll look at how AI and data-centric architectures are setting the stage for future innovations and predictive capabilities
Scale Out and Up Across Manufacturing Networks: We’ll discuss strategies for standardizing and integrating digital processes across multi-site and decentralized networks
Accelerate Technology Transfers and New Product Introductions: We’ll examine how digital solutions are transforming tech transfer and expediting the launch of new products, including how global contract development manufacturing organizations (CDMOs), are accelerating knowledge transfer and reducing time-to-market by up to 40%
Enable Composable Architectures: We will discuss how composable architecture addresses the limitations of monolithic systems, ensuring flexibility, scalability, and better data-driven decision-making

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Using Innovation to Accelerate and Optimize Your Drug Manufacturing Scale-Up Strategy
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Using Innovation to Accelerate and Optimize Your Drug Manufacturing Scale-Up Strategy

Joe Goodman is the Global Vice President of Customer Transformation at Honeywell Life Sciences where he leads efforts to strategically partner with global clients and prospects to achieve their business goals. Joe is recognized as a thought leader in the fields of life sciences quality and manufacturing. Prior to joining Sparta Systems which subsequently became Honeywell Life Sciences through acquisition, Joe spent more than 7 years at Merrill Lynch as a Six Sigma Black Belt. He owes much of his penchant for process and solution design to his time spent in that role. Joe also speaks internationally at Compliance and Manufacturing events.

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Addressing Cell Therapy Challenges for Rare Diseases
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Addressing Cell Therapy Challenges for Rare Diseases

Robert W. Beall -Vice President, ProPharma Group has 35+ years of industry experience. Robert has supported the development and commercialization of multiple cell therapy products and processes including decentralization of CD19+ CAR T therapies, development of hospital cellular therapy labs, including expansion of the NIH Center for Cellular Engineering, as well as the expansion of the first commercialized CAR-T therapy process capabilities. Other Cell therapy programs included remediation support for cellular and media manufacturing programs, and guidance for multiple CAR-T manufacturing automation advancements. Robert supported the COVID-19 response by establishing global safety systems for three major vaccines. He has led hundreds of international product transfers utilizing both internal transfers and CMO’s at multiple top 10 Pharmaceutical companies. He is a graduate of the Rochester Institute of Technology (RIT) with a BS in Engineering and has completed advanced degree studies as well as completing his PMP certification. He is an international speaker and author.

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The TechOps Leadership Accelerator Program — A Conversation with Pascal Bécotte and Laurent Rossi
LIFE SCIENCES, VIDEO, LIFE SCIENCES, PODCAST

The TechOps Leadership Accelerator Program — A Conversation with Pascal Bécotte and Laurent Rossi

The TechOps Leadership Accelerator Program — A Conversation with Pascal Bécotte and Laurent Rossi

Description
At the 2024 edition of the Biomanufacturing World Summit series Pascal Bécotte of Russell Reynolds and Laurent Rossi, the former CEO of the F1 team Alpine and a former Google Executive, spoke about Peak Performance Leadership. In this follow-up interview they explain some of the origins and themes behind that presentation, and then launched into details of the TechOps Leadership Accelerator Program first outlined in an interview at PMWS23. How can biopharmaceutical manufacturers address the generational gap in leadership for technical operations roles that will need to be filled as Advanced Therapy Medicinal Products (ATMPs) begin to commercialize and scale? For updates on how the industry collectively is working to address this critical bottleneck to growth, give this episode a listen!

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John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers
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John H. Adams, Jr. of Spark Therapeutics — Computer Software Assurance for Biopharmaceutical Manufacturers

At the 2024 edition of the Biomanufacturing World Summit series we sat down with John H. Adams, Jr., Spark Therapeutics’ Senior Director, Validation, to talk about Computer Software Assurance in the Life Sciences. John has been doing Computer Systems Validation (CSV) for decades as a regulatory requirement, so when talk of a risk-based Computer Software Assurance (CSA) requirement started making the rounds, he was interested to understand the differences so he could best stay ahead of the compliance curve and ensure his best practices were not out of step with expectations. In this episode, John walks us through where the conversation between industry and regulators currently stands, what validation professionals should already be doing, what they should continue to do, what they should confirm they are doing correctly, and what they should prepare themselves for if and when current guidance becomes new regulations. For everyone in the Life Sciences who cares about the compliance of manufacturing systems, give this episode a listen!

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‘First in Human’ Continuous Manufacturing in Biopharmaceuticals — A Conversation with Magnus Schroeder of Just – Evotec Biologics
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‘First in Human’ Continuous Manufacturing in Biopharmaceuticals — A Conversation with Magnus Schroeder of Just – Evotec Biologics

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Magnus Schroeder, the VP, Process & Product Design for Just – Evotec Biologics, to talk about some of the advantages of continuous manufacturing in biopharmaceutical manufacturing, especially for companies whose products are approaching the First in Human (FIH) stage. It is never too early to think about process optimization, scalability, and controlling costs, but there is an understandable position where companies focused on the medicine and the science believe that can be sorted out later. Just – Evotec Biologics is a passionate advocate for taking lessons from other industries that build their businesses’ success into the R&D stage of their products’ development. So what does that look like in the Life Sciences? What role do CDMOs need to play to help the industry succeed at this, especially at the crucial FIH stage? For all this and more, give this episode a listen!

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