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PMWS25

Resilient Operations in a Changing World: Innovation with Purpose
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Resilient Operations in a Changing World: Innovation with Purpose

Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization. Prior to this role, Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing from 2016 to 2018, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant.

Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials.

She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing and technology transfer, as well as plant manager for the cell culture facility.

Paulino holds a Bachelor of Science degree in Biochemistry from Marquette University.

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From Platform Excellence to Personalized Oncology: Shaping the Next Era of mRNA Science and Manufacturing at Moderna
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From Platform Excellence to Personalized Oncology: Shaping the Next Era of mRNA Science and Manufacturing at Moderna

As Chief Technical Operations and Quality Officer, Dr. Collins is responsible for the technical development, quality, and supply of preclinical, clinical and commercial programs within Moderna’s portfolio.

Dr. Collins joined Moderna from Novartis, where he held roles of increasing responsibility over the last nearly 30 years, focused on pharmaceutical production and manufacturing, including roles serving as Head of Global Chemical Operations and Anti-Infectives and as Head of Global Chemical Operations.

Dr. Collins received his Bachelor of Science in Chemistry and his Ph.D. in Organic Chemistry from University College Cork, Ireland. He also conducted post-doctoral cancer research at Arizona State University.

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Regulatory Instability’s Impact on Drug and Biologics Manufacturing

Alexander Gaffney is a regulatory and media executive responsible for founding and leading the research division of AgencyIQ, the regulatory analysis division of the media company POLITICO. As the Vice President of Regulatory Policy and Intelligence, Alexander directs the division’s analysis of regulatory issues affecting pharmaceutical, biotechnology, medical device, chemical and food companies.

Before joining AgencyIQ, Alexander analyzed life sciences regulations as part of PricewaterhouseCoopers’s Health Research Institute and was the Manager of Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS), where he also served as Managing Editor for the company’s flagship publication, Regulatory Focus.

Alexander is regularly asked to speak to executive audiences about life science regulatory policy developments and his analysis and work (including his daily newsletter, FDA Today) is relied upon by many of the country’s top life sciences companies, law firms, trade associations, regulatory professionals, legislative staffers and public health officials. He has a master’s degree in Regulatory Science from the University of Maryland and his Regulatory Affairs Certification (RAC) in US regulation. He also serves as the co-chair of the Drug Information Association’s (DIA) Regulatory Policy and Intelligence Community and the Chair of RAPS’ Regulatory Intelligence Conference.

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Bold and Unafraid: Lessons in Leadership and the Value of Manufacturing in Building the Next Great Biotech
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Bold and Unafraid: Lessons in Leadership and the Value of Manufacturing in Building the Next Great Biotech

Tim Maines joined Alnylam in August 2017 as the Global Head of Quality Assurance and Quality Control and was promoted to Chief Technical Operations and Quality Officer in April of 2023, holding over 35 years of experience. Prior to joining Alnylam, Tim was a member of the senior leadership teams at Ariad Pharmaceuticals, Omthera Pharmaceuticals, Astra Zeneca/MedImmune, GTC Biotherapeutics (formerly Genzyme Transgenics) and Stryker Biotech where he provided strategic input and independent quality and technical oversight of each company’s global GxP operations. In total, these experiences resulted with the commercialization and market expansion of thirteen novel medicines, including four FDA-approved therapies at Alnylam.

Tim holds a Bachelor of Science in Biology/Microbiology from Gannon University.

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Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine
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Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine

Evaluating which production platforms will be most effective for emerging modalities, such as rAAV gene therapies
Considering the next steps for established platforms like mAbs, ADCs, and mRNA: How can we efficiently address significant markets, such as treatments for Alzheimer’s
Examining the changes within the CMC ecosystem and assessing whether we are once again overextending our capacity
Addressing the risks of fragmentation: How can we improve communication, collaboration, and the consolidation of our best ideas to ensure collective success?
Discussing the motivations for launching new companies today and envisioning the future growth and evolution of our business ecosystem

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Fireside Chat: Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership and Cell Therapy Success
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Fireside Chat: Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership and Cell Therapy Success

Dr. Joanne Beck is currently Chief Technology Officer at Abata Therapeutics. Prior to this, she served as Chief Technology Officer at Aerium Therapeutics and COO at Boston Pharmaceuticals, a private company developing candidates across multiple indications in cardiometabolic, oncology, and immune/inflammatory diseases. Prior to joining Boston Pharmaceuticals, she was Executive Vice President of Global Pharmaceutical Development and Operations at Celgene where she oversaw the company’s Product Development, Global Manufacturing Operations, Supply Chain, Engineering and Quality. Prior to Celgene, she was SVP of Pharmaceutical Development at Shire. Prior to Shire she held roles of increasing responsibility in Process Development at Genentech and Amgen and in Operations at Abbott’s Pharmaceutical and Vascular Divisions. Beck holds a BA in Chemistry from Lewis and Clark College, a Ph.D. in Biochemistry and Molecular Biology from University of Oregon Medical School and completed a postdoctoral fellowship in the department of Pharmaceutical Chemistry at the University of California, San Francisco. Dr. Beck serves on the board of directors for Orchard Therapeutics and Astria Therapeutics.

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Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing

Dr. Jack Prior leads MSAT Process Monitoring & Data Science/AI Strategy at Sanofi, where he spearheads global initiatives in process monitoring and AI-driven yield improvement for biologics manufacturing. Previously as Head of MSAT Digital, he led teams working to develop global process data analytics systems and to digitize laboratory operations for Industrial Affairs Specialty Care drug substance and drug product manufacturing.

His leadership spans nearly three decades at Sanofi-Genzyme, where he has led manufacturing science organizations supporting process characterization, modeling, technology transfer, and manufacturing operations for critical therapies treating rare genetic disorders. Throughout his career, he has focused on integrating process modeling and advanced analytics with manufacturing science to enhance biologics production across US and European operations. He has led manufacturing science teams supporting multiple tech transfers across the Sanofi network, including the team supporting transfer to a new continuous single-use digital facility, while advancing approaches to process modeling and scale-up.

Dr. Prior holds a Doctor of Science in Chemical Engineering from MIT, where his research in data reconciliation for bioprocess development laid the foundation for his work in process monitoring and control. His current work continues to advance manufacturing science through the integration of digital technologies, process modeling, and AI in biologics manufacturing.

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

Joe Goodman is the General Manager of the Americas region for Honeywell Life Sciences, where his team partners strategically with the company’s global clients and prospects, identifying the quality and manufacturing system solutions that best fits their needs. Joe is recognized as a thought leader in the fields of quality systems, regulatory compliance, and the implementation of enterprise software within the Life Sciences manufacturing industry. Before joining Honeywell, 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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Building Audit-Ready Facilities: Quality Leadership from Design to Commercial Launch
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Building Audit-Ready Facilities: Quality Leadership from Design to Commercial Launch

LeeAnn Chrisco is an accomplished Quality Assurance executive with over 20 years of leadership in GMP manufacturing and compliance. As Director of Quality Assurance at INCOG Biopharma Services, she provides strategic QA oversight across manufacturing, packaging, and quality control, ensuring global regulatory compliance. LeeAnn has led audit readiness, regulatory agency interactions, and facility startups for clinical and commercial operations. Her expertise spans technical transfer, aseptic processing, and quality systems innovation. A contributing author to ISPE and BioPhorum publications, LeeAnn brings deep industry insight and a passion for building high-performing quality cultures in fast-paced, regulated environments.

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