American Biomanufacturing Summit Gathers Executives to Discuss the Right Tools, Mindset and Culture Needed to Drive Productivity and Ingenuity • Generis

From June 18-19, biopharmaceutical executives and cutting-edge technology providers are meeting in San Fransisco to discuss industry challenges and opportunities, quality as a culture, supply chain management, and new technologies.

The biopharmaceutical industry continues to grow and change rapidly. Patient-specific biologics, such as cell and gene therapies, are emerging as the next frontier of medicine, and new technologies, such as gene editing tools, are leading to the development of even more advanced, targeted therapeutics. Additionally, the application of Artificial Intelligence and Machine Learning into manufacturing processes is helping reduce risks and improve productivity outcomes. As the biopharmaceutical industry continues to evolve, executives face unique challenges in manufacturing processes, supply chain needs, and capacity planning.

The American Biomanufacturing Summit is a meticulously curated forum for leading biopharmaceutical executives and technology providers to collaborate and discuss current trends, strategic insights, case studies, and best practices in manufacturing, outsourcing, capacity management, quality assurance, quality control, regulatory compliance, operational performance, supply chain, and logistics.

Leaders discussing solutions on the horizon for cell and gene therapy manufacturing at this year’s meeting in San Fransisco include:

Tim Moore, EVP, Technical Operations, Kite Pharma, a Gilead Company
“Attributes Of Great Leaders To Create A Game-Changing Culture”

Raj K. Puri, M.D., Ph.D., Director, Division of Cellular And Gene Therapies Office of Tissues and Advanced Therapies, FDA, Center for Biologics Evaluation and Research (CBER)
“Advancing Manufacturing for Advanced Therapies”

Joanne Beck, Ph.D., EVP, Global Pharmaceutical Development and Operations, Celgene
“Evolving External Collaboration Models: How Our Industry’s Business Partnerships Have Changed Over Time and How Trends Will Continue in the Future”

Andy Ramelmeier, Ph.D., SVP, Chief Manufacturing and Quality Officer, Sangamo Therapeutics, Inc.
“Navigating the Unique Manufacturing Challenges in Cell and Gene Therapy and What We Can Learn from Our Past Experiences

Diane Blumenthal, Head, Technical Operations, Spark Therapeutics
“Making Gene Therapy a Reality – CMC Considerations for Fast-paced Product Development and Speed-to-Market

Ensuring manufacturing compliance with rigorous quality, safety, and environmental standards is also a focal point of the event. Leading quality executives will ask critical questions, such as: What are we trying to achieve with Quality Metrics? What do we want Quality Culture in our industry to look like? How effective is your process capability program in driving product quality?

Some of the quality executives speaking at the American Biomanufacturing Summit 2019 include:

Rohin Mhatre, Ph.D., SVP, Pharmaceutical Development, Engineering and Technology, Biogen
“Continuous Process Verification of Next Generation Processes Utilizing Advanced Process Control”

Anders Vinther, Ph.D., VP, Global Quality and Engagement, Intarcia Therapeutics, Inc.
“Quality Culture and Quality Leadership: Where Are We Now and Where Are We Headed in the Next 5 Years?”

Ron Branning, SVP, Quality, Dermira
“Building a Quality Culture: Key Elements in Identifying Gaps and Building a Platform for Continuous Improvement”

Tina Self, VP, Quality, Supply Center Berkeley, Bayer U.S. LLC
“Driving Modern Day Quality Thinking And Operational Approaches”

Other core learning objectives:

• Discover how to create flexible, state-of-the-art, multi-product manufacturing facilities
• Explore new production technologies to improve costs and efficiency
• Identify the tools to find, retain, grow, and mentor talent
• Examine methods to mitigate risk and avoid product shortages
• Enhance visibility and security with IT, Big Data, and ERP tools
• Achieve clarity on global capacity in an evolving picture
• Establish an effective quality culture in your organization
• Navigate supply chain complexity for inventory build and planning

This year, the American Biomanufacturing Summit will lead conversations around the pressing issue of gender diversity in the workforce. Despite accounting for almost half of the American working population, women still remain underrepresented in biotech C-suites and on boards. Women hold just 20% of leadership roles and 10% of board of director seats. The American Biomanufacturing Summit is proud to address this through our Women in Leadership Roundtable.

Led by inspirational female leaders specializing in supply chain, procurement, biologics, compliance, and technology, this year’s roundtable will feature top executives from Bayer, Takeda, Merck, Akorn Pharmaceuticals, Spark Therapeutics, and Orchard Therapeutics.

Interested in attending?

Network with peers, connect with exhibitors and hear from the top industry influencers as we explore strategies to maximize efficiency while remaining compliant in an ever-evolving environment. This invitation-only summit provides a unique opportunity to explore innovation in production methods and evolving technologies.

Join us to:

• Engage in peer-to-peer conversations and pre-scheduled networking
• Hear from the industry’s top biopharmaceutical executives in an intimate, exclusive environment
• Discover the tools necessary to maximize efficiency and remain compliant in an ever-evolving environment

If you are interested in attending, sponsoring or speaking at the American Biomanufacturing Summit, applications are open now. Please submit your request here.

Highlights from previous events and this year’s agenda can be found on the American Biomanufacturing Summit website.