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PMWS23

Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine
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Operational Excellence, Innovation & Teamwork as Enablers for Reimagining Medicine

As President, Operations, Steffen Lang leads a team of 35,000 associates dedicated to manufacturing and supplying high-quality medicines to patients, and providing operational support to the entire Novartis enterprise. Novartis Operations incorporates the company’s manufacturing, quality, and supply organization, as well as information technology, data and digital, procurement, environmental sustainability, facility services, and other global services.

Prior to taking on this role, Steffen was Global Head of Novartis Technical Operations (NTO). Under his leadership, NTO underwent a transformation to become one of the leading manufacturing and supply organizations in the industry, providing agile, efficient support to the business, and reliably delivering life-changing medicines to patients around the world. During this time, the unit adapted its manufacturing capacity and capabilities to the changing needs of the Novartis strategy and product portfolio, maximizing the potential of its assets and expertise. As well as delivering technological innovation to enable the production of advanced therapeutic platforms, the unit collaborated with industry partners to support global demand for COVID-19 vaccines and therapies.

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Our Journey in Next Generation Manufacturing: What We Can Achieve Together
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Our Journey in Next Generation Manufacturing: What We Can Achieve Together

Jim Cafone has been with Pifzer since 2010.  In his current role as Senior Vice President, Global Supply Chain, Jim oversees global demand forecasting, demand and supply planning, worldwide logistics, and inventory management for Pfizer.

In his previous role, as Vice President, Network Design & Performance, Jim was responsible for business development, supply chain network design, Pfizer’s lean production system, all performance reporting and analytics, innovation, and recognition programs.

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Quality and Compliance from the Regulators’ Perspective
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Quality and Compliance from the Regulators’ Perspective

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 Center Director for CBER and became Center Director in January 2016.

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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?
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Panel: ‘Next’ Generation Manufacturing: What Did We Learn and Where Are We Going?

At PMWS23 we recorded a panel on ‘Next’ Generation Manufacturing that looks at where the industry has come from, and where it’s going in the future.

From discussing how today’s pipeline and technologies are reshaping biomanufacturing, to looking at the technologies that enable next generation manufacturing processes, give this one a listen!

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Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply
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Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply

Karin Shanahan oversees worldwide product development, manufacturing and supply for Bristol Myers Squibb as executive vice president, Global Product Development & Supply (GPS). GPS develops and produces active ingredients and drug products and delivers the company’s medicines throughout the world. The GPS team achieves this mission through a relentless focus on innovation, quality, safety and agility.

“I’m excited to return to Bristol Myers Squibb, where I began my career in the pharmaceutical industry. Though I’ve worn many hats in the industry since then, I was drawn back to Bristol Myers Squibb because of its unwavering dedication to quality and delivering innovative medicines to patients in need,” says Karin. “I am honored to help lead the integral GPS team as we navigate an everchanging landscape.”

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Fireside Chat: The New Normal and Beyond: How to Design the Fit for Purpose Technical Operations Organization of the Future
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Fireside Chat: The New Normal and Beyond: How to Design the Fit for Purpose Technical Operations Organization of the Future

An international operations executive with global technical, operational, and P&L experience, Carlo has deep expertise in designing and operating global supply chains in complex regulatory environments, leading accretive M&A activity and devising and executing value-creating strategies in global markets.

Since May 2020, Carlo has been the lead advisor for Manufacturing and Supply Chain to Operation Warp Speed/Federal Covid Response, the US government initiative to support the acceleration of development and supply of Covid-19 vaccines and therapeutics. He has collaborated with the sponsors, suppliers and CDMOs to ensure the fast scale-up of manufacturing and distribution for the entire US.

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Managing Innovation and Variability in a Growth Environment
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Managing Innovation and Variability in a Growth Environment

Andrew (Andy) Wirths is a senior pharmaceutical operations leader with over 30 years’ experience in the industry spanning small and large molecule manufacturing.

Andy joined AstraZeneca in 2015 and is currently Senior Vice President, Americas Supply, where he is responsible for overseeing the manufacturing operations of 8 sites in North and South America.

Previously Andy held various senior positions at Merck where he was fundamental to the development of their manufacturing strategy and its execution at multiple sites.

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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics
LIFE SCIENCES

Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics

Spencer has more than 30 years of experience in Manufacturing and CMC product development. While at Rubius, Spencer built the technical functions to design and deliver the RED™M manufacturing platform, including clearance of 4 IND’s over 4 years.

He also led the acquisition and re-fit of their Red Cell Therapeutics manufacturing site in Smithfield Rhode Island, where the team transferred and delivered clinical supplies for their 3 oncology programs. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where he led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led technical development teams across the Novartis Biologics portfolio in support of the commercialization of Cosentyx® and the registration and approval of Erelzi™M? and Rixathon®.

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Transforming a Global Development & Product Supply Network for Delivering a Multi-Modal Portfolio – It’s More than Flexible Facilities
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Transforming a Global Development & Product Supply Network for Delivering a Multi-Modal Portfolio – It’s More than Flexible Facilities

Dr. Jens Vogel rejoined Bayer in March of 2020 as Global Head of Biotech for the Bayer Pharmaceuticals Product Supply organization. He has more than 20 years of professional and leadership experience in the area of biologics operations, development and technology management. From 2012 until 2020, he held positions of increasing responsibility at Boehringer Ingelheim (BI), including as President and CEO of BI Fremont Inc and member of BI’s Biopharma Executive Committee. Prior to his years at BI, Dr. Vogel was a member of the Biologics Development Leadership team at Bayer in Berkeley. Jens holds a PhD in Biotechnology from University of Braunschweig, Institute of Technology, Germany.

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The Vertex Story: Serial Innovation in Manufacturing
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The Vertex Story: Serial Innovation in Manufacturing

As SVP and Head of Commercial Manufacturing & Supply Chain, Morrey’s current responsibilities include defining the commercial manufacturing and supply chain strategy needs, as well as, designing and building a global organization and supply network. In addition, Morrey is responsible for assuring reliable supply of Vertex’s transformative medicines.

Morrey is a trained laboratory scientist who brings more than 25 years of experience leading the development and commercial manufacturing of multiple products at organizations like Eli Lilly and Bristol Myers Squibb. An accomplished leader and builder of strong scientific, engineering, and operations teams, Morrey also has prior experience in process development for cell and gene therapies, including the development and manufacturing of one of the first gene therapy candidates for cystic fibrosis.

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A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients
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A Look into the Future: How Pharmaceutical Manufacturing Is Transforming to Bring Hope to Patients

Jennifer Baxter has over 20 years of experience in pharmaceutical development and manufacturing activities. During her tenure at Merck, Jennifer has worked in research & development, technical support, and strategic planning of small molecules in roles across the human health, animal health, research and manufacturing divisions. Jennifer is currently the Vice President of Small Molecule Science and Technology, leading a group of approx. 800 scientists and engineers located worldwide. The group is responsible for the late-stage development of Merck’s small molecule pipeline across drug substance, drug product and packaging for both worldwide and regional products as well as all technical support for in-line small molecule products and lifecycle management activities. The group also manages manufacture and supply of late-stage clinical materials, technology development of new and innovative manufacturing technologies and provides site based technical support to all of Merck’s small molecule sites. Jennifer holds BS, MS and PhD degrees in Chemical Engineering from Rutgers University.

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Designing the Next-Generation Advanced Therapeutics Manufacturing Process
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Designing the Next-Generation Advanced Therapeutics Manufacturing Process

Dr. Richard D. Braatz is the Edwin R. Gilliland Professor of Chemical Engineering at MIT, where he conducts research into advanced biopharmaceutical manufacturing systems. In this role, he leads process data analytics, mechanistic modeling, and control systems for several projects on campus, including those focused on monoclonal antibody, viral vaccine, and gene therapy manufacturing. Dr. Braatz received an M.S. and Ph.D. from the California Institute of Technology and was the Millennium Chair and Professor at the University of Illinois at Urbana-Champaign and a Visiting Scholar at Harvard University before moving to MIT.

Dr. Braatz has collaborated with more than 20 companies including Novartis, Pfizer, Merck, Bristol-Myers Squibb, Biogen, Amgen, Takeda, and Abbott Labs. Honors include the AIChE PD2M Award for Outstanding Contribution to QbD for Drug Substance, the AIChE Excellence in Process Development Research Award, the Technical Innovation Award from the International Society of Automation, and the IEEE Control Systems Society Transition to Practice Award. He has published over 200 papers and three books, including Fault Detection and Diagnosis in Industrial Systems. Dr. Braatz is a Fellow of IEEE, IFAC, AIChE, and AAAS and a member of the U.S. National Academy of Engineering.

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Why Your Digital Strategy May Be Incomplete: How Legacy Models Prevent End-To-End Digital Manufacturing
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Why Your Digital Strategy May Be Incomplete: How Legacy Models Prevent End-To-End Digital Manufacturing

As the senior vice president of go-to-market strategy, Marty Smyth is responsible market intelligence, product strategy, and bringing MasterControl quality and manufacturing products to market globally. He brings 20 years of technology strategy, marketing, sales, and support experience across high-growth private SaaS companies as well as Fortune 500 companies.

In previous roles, Marty has driven strategic planning, customer experience, and go-to-market for technology leaders like Cisco, Panasonic, Verizon, and AT&T. He is a University of Notre Dame alumnus.

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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

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?

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

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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