Transforming Global Operations: Accelerating Production and Innovation at BMS
LIFE SCIENCES, VIDEO, LIFE SCIENCES

Transforming Global Operations: Accelerating Production and Innovation at BMS

Catalina Vargas is Senior Vice President and Global Supply Chain (GSC) Lead at Bristol Myers Squibb (BMS). A global pharmaceutical executive with more than 20 years of experience, Catalina currently leads a talented team, working to seamlessly deliver medicines to patients in more than 50 countries around the world. Under her leadership, Catalina has built a highly synchronized, transparent and sustainable supply chain organization.

Catalina joined BMS in 2018 as Vice President, Strategic Sourcing and Procurement, Global Product Development and Supply, where she managed a complex supply chain to bring critical medicines to patients. During her time in this role, BMS acquired Celgene, which at the time was the largest deal in biopharma history, and Catalina successfully integrated the Celgene and BMS sourcing and procurement groups.

Immediately prior to her current role leading GSC, Catalina was Chief of Staff to the CEO of BMS where she led strategic enterprise-wide initiatives and advanced the leadership team’s governance and decision-making model. With an exceptional record of building high performing and agile global teams, Catalina is a passionate advocate for inclusion.

Prior to joining BMS, Catalina was with Pfizer for 17 years, where she was tapped for leadership positions across strategic sourcing, operations, and external manufacturing.

Catalina has a bachelor’s degree in industrial engineering and a graduate degree in finance and capital markets.

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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
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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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Reimagining Toyota’s Customer Centered Supply Chain
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Reimagining Toyota’s Customer Centered Supply Chain

Manny Bansi is Vice President of Toyota Logistics Services (TLS). He is responsible for finished vehicle logistics for North American operations that includes managing Marshalling Yards and Ports Operations.

Manny started his career at NUMMI (Joint Venture Between Toyota & General Motors) back in 1992. He then went on to hold positions in various areas including Corporate Strategy, Production Planning, Human Resources, including two-year assignment at Toyota Motor Corporation in Japan.

Manny is also involved in many Business Partnering Groups (BPG) at Toyota Headquarters, such as Young Professionals, AAC, Spectrum, TODOS, TAASiA, and WIIT. He currently serves as Executive Advisor for TAAiSA BPG and believes in the growth of all of his team members through Toyota principles.

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Safety as a Competitive Advantage: How to Build Safety Into Your Culture and Drive Productivity
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Safety as a Competitive Advantage: How to Build Safety Into Your Culture and Drive Productivity

Peter Gibbons joined 3M in November 2021 as group president of Enterprise Supply Chain, which includes planning, procurement, internal and external manufacturing, logistics, quality, engineering, and business supply chain.

Prior to 3M, Peter served as chief executive officer of TireHub, a joint venture last mile distributor between Bridgestone and Goodyear. Possessing a wealth of experience in manufacturing and supply chain operations, Peter previously held senior-level executive positions at Mattel, Starbucks and ICI Paints. His growth mindset, inclusive leadership, and orientation toward developing talent and culture has helped him lead highly successful complex changes and significant transformation.

“I believe that building confidence and removing the fear of failure are key components of leadership,” says Peter. “People achieve great things when they are embraced and valued; when they are connected, not isolated; and when their intelligence and imagination are unleashed.”

Outside of work, Peter enjoys hiking, reading, and supporting the Glasgow Celtic soccer club and serves on the board of the Jesuit School of Theology of Santa Clara University. He holds a bachelor’s degree in Physics from University of Edinburgh and a master’s degree in Business Administration from Strathclyde Business School in Glasgow, Scotland.

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Factory Fast-Forward: How Smart Manufacturing is Empowering the New Workforce Demographic Summary
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Factory Fast-Forward: How Smart Manufacturing is Empowering the New Workforce Demographic Summary

Christina Upah is the vice president of Attack Helicopter Programs for Boeing Defense, Space & Security and the senior site executive in Mesa, Ariz. In this role, Upah leads more than 4,600 employees supporting the design, production and delivery of the AH-64 Apache and AH-6 Little Bird helicopters for the U.S. Army and allied defense forces around the globe.

Prior to this role, Upah was director of Mesa Site and Attack Operations. In this position, she was responsible for overall production of the Apache and Little Bird for global customers.

Upah has previously served as the director of International Apache Programs, where she led the program execution of foreign military sales and direct commercial sales supporting customers worldwide. Additionally, she served as the director for Apache India and Supplier Transitions Programs and as the director of Domestic Apache Programs.

First joining Boeing in 1997, Upah has held positions within production operations, fabrication, human resources, supplier transitions and program management. Most notably, she progressed through program management positions of increasing responsibility, having led the successful program start-up of the Little Bird and Apache international and development programs, with a core emphasis on contracts, estimating/pricing, cost management and scheduling.

Upah holds a bachelor’s degree in human resources and psychology from Ottawa University. She is an Arizona native and serves on the board of directors for the Mesa Chamber of Commerce.

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Panel: Shopfloor Safety Advancements/Avoidances – A Strategic Report Reviewing Plant Level Operations
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Panel: Shopfloor Safety Advancements/Avoidances – A Strategic Report Reviewing Plant Level Operations

Safety in manufacturing touches nearly every aspect of the business. Despite its costs, it must remain a priority. Join our panel of leading manufacturers to hear their report from the shopfloor and how they are developing and advancing their safety procedures and policies.

Achieving a single source of truth and increased visibility into everyday operations in order to:
Monitor real-time processes
Document procedure and policies
Use these aids in traceability and accountability
Provide actionable reporting and analytics

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Panel: New Technology on the Shop Floor, How to Onboard and Maintain: Driving Efficiency, Training and Long-Term Success in Manufacturing
MANUFACTURING, VIDEO, MANUFACTURING

Panel: New Technology on the Shop Floor, How to Onboard and Maintain: Driving Efficiency, Training and Long-Term Success in Manufacturing

Empowering Employee Engagement: Effective engagement is more than just morale; it’s about creating an environment where employees take ownership of their roles. We’ll discuss strategies for fostering open communication, recognizing contributions, and aligning individual goals with organizational success. Key challenges like overcoming resistance to change and bridging generational workforce gaps will be addressed.
Securing Buy-In for Digital Tools: Implementing new technologies often meets resistance on the shop floor. This session will explore how to present digital tools as enablers, not threats, by involving employees early, addressing fears of job displacement, and emphasizing practical benefits like improved safety, efficiency, and productivity. Training programs and peer advocacy will also be covered to ensure seamless adoption.
Building Skills for Tomorrow: Upskilling is critical to prepare your workforce for industry 4.0 and beyond. We’ll identify the technical and soft skills most in demand for 2025, strategies for integrating ongoing learning into daily operations, and how to overcome the challenge of knowledge gaps in a fast-evolving landscape.
Driving Continuous Improvement: In an era of fluctuating customer demands and supply chain complexities, continuous improvement remains a cornerstone. The discussion will focus on integrating real-time data analytics, fostering a culture of problem-solving, and balancing agility with consistency to optimize performance across the production line.

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