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ATMPs

Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances
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Navigating the Modalities Landscape: Adapting Manufacturing Strategies for Future Therapeutic Advances

November 27, 2024

Sanat Chattopadhyay is responsible for the company’s (approx. $64 billion revenue) worldwide manufacturing and supply operations across a global network of sites for pharmaceuticals, vaccines, biologics and animal health products. Merck is known as MSD outside of the U.S. and Canada.

Sanat joined Merck in 2009 as Senior Vice President of Global Vaccines & Sterile Manufacturing Operations, spearheading the transformation of manufacturing and supply chain to grow and globalize its Vaccine business. Under Sanat’s leadership, Merck is currently executing a significant expansion of its biologics and vaccines manufacturing capacity with planned capital investments of more than $20 billion from 2020 through the end of 2024, to reach more patients around the globe.

Before joining Merck, he served as Senior Vice President, Technical Operations & Product Supply, for Wyeth Pharmaceuticals. Previously, he worked at Aventis and its predecessor companies as Senior Vice President, Industrial Operations, having served in many positions with increasing responsibilities for global supply chain, technology and manufacturing sites across North America, Europe and Asia Pacific. Sanat started his career with Hoechst Pharmaceuticals in 1983 and worked in many senior leadership assignments.

Sanat is a graduate in Chemical Engineering and holds a post-graduate degree in Industrial Engineering from India.

Outside of Merck, Sanat is a member of the Board of Directors of Ashland Inc.

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Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing
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Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

December 2, 2024

Assessing Changes in the CMC Ecosystem: Are We Overbuilding Capacity Again?
Uniting for Success: Strategies to Prevent Fragmentation and Foster Collaboration in Biomanufacturing
Pioneering New Ventures: Reasons to Establish a New Company Today and Anticipating Future Growth in the Business Ecosystem
Evaluating Production Platforms for Emerging Modalities: Which Platforms Will Best Serve the Future of Medicine?
Navigating the Future of Existing Platforms: Efficiently Addressing Market Needs for Established Therapies such as mAbs, ADCs, and mRNA-based Treatments

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Advancing Cell Therapy Industrialization: Key Focus Areas
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Advancing Cell Therapy Industrialization: Key Focus Areas

December 2, 2024

Thomas has been serving as the Senior Vice President of Cell Therapy Development and Operations at BMS since August 2023. Before joining BMS, he held multiple roles with Merck & Co, where he gained experience in basic research, early and late-stage process development, capital project management, site-based technical operations, commercialization, manufacturing science and technology, and supply chain. Before that, Thomas worked for startup, GlycoFi, founded at Dartmouth College, where he conducted post-doctoral research after receiving his PhD in Bioprocess Engineering from the University of Cape Town in South Africa.

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

December 2, 2024

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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The Coming Patient Treatment Crisis
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The Coming Patient Treatment Crisis

December 2, 2024

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

December 2, 2024

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 Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services
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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services

May 30, 2024

JR Humbert is currently the VP, Quality at INCOG BioPharma Services, and created and implemented the quality system at INCOG, which in three years went from company creation through successful FDA inspection in 3 years.

JR has over 20 years of pharmaceutical and biotechnology industry experience in validation, quality, technology transfer, process engineering, and program management. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica.

JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.

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Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects
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Issues, Trends, Excitement, and Great News for Pharmaceutical Manufacturers — A Conversation with Teresa Gorecki of Compliance Architects

May 22, 2024

At the 2024 edition of the Pharma Manufacturing World Summit we sat down with Teresa Gorecki of Compliance Architects to speak with enthusiasm and optimism about the future of medicine, the most recent developments and what they mean for patients, but especially the most recent ideas and information pharmaceutical manufacturers and other senior leaders in the Life Sciences need to know as the industry moves forward together into a very exciting time. What are some of the top-of-mind challenges and opportunities pharma manufacturers are dealing with right now, and how are the early adaptors already addressing those issues? How are regulators working with industry to improve end results for patients? How is commercialization of ATMPs progressing, and what can we all learn from the first examples coming online now? For all this and more, give this episode a listen!

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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity
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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity

November 21, 2023

Ralf Altenburger joined the Technical Operations Leadership Team at Roche/Genentech in July 2015 as Head of Pharma Technical Regulatory. Additionally, in Oct. 2021 he assumed the role of Global Head Cell and Gene Therapy. Ralf has more than 20 years of experience in the pharmaceutical industry and joined Roche in 2009 leading global functions in Technical Development.

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Towards Industrialization of Cell Therapy
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Towards Industrialization of Cell Therapy

November 22, 2023

Dr. Jens Vogel is SVP & Global Head of Biotech, Bayer Pharmaceuticals Product Supply, leading biologics operations, development and strategy across five sites, including cell & gene therapy industrialization. Jens has more than 20 years of professional and leadership experience in biologics development, operations, program management and regulatory affairs.

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Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics
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Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics

November 22, 2023

Katarina works for Cytiva in the Manufacturing capacity solutions business unit. She has worked over 20 years in the industry and has extensive expertise in developing end-to-end manufacturing solutions that includes process workflows, process equipment, automation, consumables, and facilities. Her focus over the last few years has been developing and designing solutions for the manufacture of new product modalities such as viral vectors, plasmids, and mRNA therapies.

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The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing
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The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing

November 22, 2023

John Tomtishen is Vice President of Operations at Cellares Corporation. At Cellares, John is responsible for Cellares’ IDMO business, supporting partnership activities, and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm and address industry bottlenecks to accelerate access to life saving cell therapies. John has extensive experience in cell and gene therapies, biologics, and vaccines with diverse roles in Business Operations, CMC/Technical Operations, R&D, Supply Chain, Engineering/Facilities, and Operational Excellence. While at Novartis Pharmaceuticals, John had an integral role in the filing and approval of the first CAR T-cell BLA, Kymriah™ (tisagenlecleucel) for pALL (pediatric acute lymphoblastic leukemia) and DLBCL (diffuse large B-cell lymphoma).

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Michael Kamarck & Pascal Bécotte — Global Talent Trends in Pharma and Biotech Technical Operations: A Perfect Storm
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Michael Kamarck & Pascal Bécotte — Global Talent Trends in Pharma and Biotech Technical Operations: A Perfect Storm

June 20, 2023

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Michael Kamarck, a senior industry executive, and Pascal Bécotte, the Managing Director of Russell Reynolds Associates, about the most serious challenge threatening to bottleneck the otherwise very bright future of medicine. For a number of reasons explored in both this interview and in this recent blog post, there are not enough qualified people to fill all the top jobs that need to be done, and this is not something that is going to be fixed in a day or even a few years without the industry working together in a decisive and unprecedented way to collectively develop its rising Top Talent in the technical operations space into the senior leaders that Small Molecule, Large Molecule, and especially the emerging Advanced Therapy Medicinal Products sectors cannot do without.

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