If you are an industry expert with years of experience and would welcome the opportunity to strengthen your reputation as a thought leader, we would love to hear from you.

Our Speaker Faculty is constantly evolving, for consideration or to nominate an industry leader, please call us at 416-829-6500 or email us at info@executiveplatforms.com.

Please check back as our speaker faculty is frequently updated.

2024 Speakers

Sanat Chattopadhyay
EVP, President Merck Manufacturing Division at Merck
Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network of 50 […]
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Arleen Paulino
SVP Global Manufacturing at Amgen
Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization where she is responsible for all internal and external manufacturing operations and strategic supplier relationships to deliver reliable supply for patients across the globe. Prior […]
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Peter Marks
Director – Center for Biologics Evaluation and Research (CBER) at FDA
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 […]
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Greg Guyer
EVP and Chief Technical Officer at BioMarin Pharmaceuticals
C. Greg Guyer, Ph.D, joined BioMarin in May 2020 and currently serves as Chief Technical Officer and Executive Vice President of Global Manufacturing and Technical Operations, responsible for overseeing our manufacturing, process development, quality, supply chain, […]
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John Pinion
EVP Translational Sciences, Chief Quality Operations Officer at Ultragenyx
Mr. Pinion joined Ultragenyx in July 2015 as CQOO and EVP, where he provides leadership for the company’s translational sciences functions, including Pharmacology and Toxicology, Research and Bioanalytical Development, as well as GxP Quality and Compliance, […]
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Magaly Aham
SVP, Head Global Quality Compliance & Systems at Takeda
Magaly currently works at Takeda as a Senior Director Quality Compliance for the Global Oncology & Biologics Division. Prior to joining Takeda she worked in consulting for Pharma-BioServ US Inc., MedImmune, Pfizer, Wyeth and Schering Plough […]
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Eliana Clark
Chief Technical Officer at Intellia Therapeutics
Eliana Clark brings to Intellia more than 20 years of experience in the biopharmaceutical industry. Prior to Intellia, Eliana spent eight years in many leadership roles at Biogen, including vice president of Product Development and Portfolio […]
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Jamie Moore
SVP Global Head of Technical Development at Gilead
Jamie Moore is the Senior Vice President of Technical Development responsible for all aspects of CMC development of drug substance and drug product for Gilead’s pharmaceutical and biologic product portfolio. She has over 20 years of […]
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Koustuv Chatterjee
Senior Vice President, Head of External Manufacturing and Supply at Sanofi
Koustuv Chatterjee is the Senior Vice President of External Manufacturing at Sanofi, responsible for the global supply chain across all modalities. With extensive experience in manufacturing operations, technical operations, and product development, Koustuv leads multidisciplinary teams […]
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Alison Moore
CMC Executive, Board Member
Dr. Alison Moore is a CMC Executive who most recently served as the Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was […]
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Pat Yang
Vice Chairman & Co-Founder at Resilience, Inc.
Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry. From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company […]
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Michael Thien
Head, Pharmaceutical Sciences Takeda R&D at Takeda
Mike has 35 years of experience in the BioPharma industry, having spent 16 years in R&D and 17 years in manufacturing; retiring as a senior vice president from Merck & Co. (MSD) in March of 2022 […]
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Jack Garvey
CEO/ Managing Partner at Compliance Architects LLC
Jack Garvey, founder of Compliance Architects®, is a seasoned FDA compliance expert with nearly 30 years of leadership experience at industry giants like Johnson & Johnson and C.R. Bard. Combining his chemical engineering and law background, […]
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2023 Speakers

Per Alfredsson
SVP, Global Biologics Operations AstraZeneca and President AstraZeneca AB at AstraZeneca
As Senior Vice President, Global Biologics Operations, Per leads the global biologics operations network, which includes five internal manufacturing sites across four countries, as well as the external biologics supply network. Since April 2020, Per has […]
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Ralf Altenburger
Global Head, Cell and Gene Therapy, Genentech/Roche at Roche
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 […]
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Stacey Ma
EVP, Pharmaceutical Development and Manufacturing at Gilead
Stacey Ma, PhD, serves as Executive Vice President of Pharmaceutical Development and Manufacturing, with responsibility for all the company’s investigational compounds and marketed products. Stacey joined Gilead in 2022 after more than two decades in the […]
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Roberto Silveira
Global Technology & Engineering at Pfizer
As Senior Vice President of Global Technology & Engineering group in Pfizer Global Supply, Roberto leads a group of highly capable Subject Matter Experts and is responsible for capital projects, implementation Integrated Facility Management and Global […]
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Peter Marks
Director – Center for Biologics Evaluation and Research (CBER) at FDA
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 […]
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Chris McDonald
SVP & Global Head of Technical Operations at Kite, a Gilead Company
Chris McDonald joined Kite in 2018 and currently serves as Global Head of Technical Operations. Prior to joining Kite, Chris was with AstraZeneca, where he was VP & Site Head of Operations for their monoclonal antibody […]
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Dr. Pascal Bécotte
Managing Director at Russell Reynolds Associates
Pascal leads operations for Russell Reynolds Associates in New York and Canada. He works closely with top healthcare clients around the globe, advising them on their talent strategy, including leadership assessment, succession planning, and the recruitment […]
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Shannon Knott
Executive Director at Russell Reynolds Associates
Shannon Knott is a member of Russell Reynold’s Leadership and Succession Practice, and is based in Durham, NC. She specializes in executive transition and development, partnering with clients to build more effective and aligned leadership teams. […]
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Alison Moore
CMC Executive
Dr. Alison Moore is a CMC Executive who most recently served as the Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was […]
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Lars Petersen
President and CEO at FUJIFILM Diosynth Biotechnologies
Lars is a visionary leader with over 30 years of experience in Life Science including his tenure at FUJIFILM Diosynth Biotechnologies. In 2019 when FUJIFILM Diosynth Biotechnologies acquired the Biogen site in Hillerød, Denmark, he assumed […]
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Rahul Singhvi
Co-Founder & CEO at Resilience, Inc
Rahul Singhvi is a global leader in the Life Sciences industry and is co-founder and CEO of the biomanufacturing company, Resilience (National Resilience, Inc.). Prior to co-founding Resilience in 2020, Rahul was an Operating Partner at Flagship Pioneering, […]
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David Y. H. Chang
President and Chief Technology Officer at WuXi Advanced Therapies
Dr. David Chang has more than 30 years of industrial experience. Before his current role, he was Chief Executive Officer WuXi AppTec Advanced Therapies Unit (ATU), prior to joining WuXi he was Corporate VP and Head […]
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Wolfram Carius
EVP Pharmaceuticals at Bayer AG
Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior […]
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Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation at MIT (Massachusetts Institute of Technology)
Charles L. Cooney is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering at MIT and founding Faculty Director, Emeritus of the Deshpande Center for Technological Innovation. […]
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Sanat Chattopadhyay
EVP, President, Merck Manufacturing Division at Merck
Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network of 50 […]
Read more
Mike McDermott
EVP, Chief Global Supply Officer at Pfizer
As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities. Mike and the Pfizer Global Supply (PGS) team work to ensure uninterrupted supply for Pfizer’s entire […]
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Pat Yang
Vice Chairman & Co-Founder at Resilience, Inc.
Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry. From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company […]
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Brendan O’Callaghan
EVP, Manufacturing and Supply at Sanofi
Brendan O’Callaghan leads an international network of manufacturing and distribution sites. His ambition is to enable successful commercialization of Sanofi’s diverse pipeline, to build world-class standards of manufacturing and supply chain excellence and to future proof […]
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Aine Hanly
Chief Technology Officer at Vir Biotechnology
Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology, where she is responsible for overseeing the Company’s technical operations. Her purview includes product and process development, supply chain, manufacturing, quality and CMC strategy. Her […]
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Michael Kamarck (In Memoriam)
BioPharma Advisor & Board of Directors: Passage Bio, VaxCyte
Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global […]
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Robert Zamboldi
Site Head - US Cell & Gene Therapy, Morris Plains at Novartis
Rob Zamboldi is the Site Head and General Manager of Novartis’ flagship cell processing operation in Morris Plains, NJ providing worldwide supply of novel CAR-T therapies. Rob was instrumental in the ramp up of the first […]
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Jennifer McCafferty
SVP, CMC-Regulatory and Quality at Merck
Jennifer McCafferty is Senior Vice President, Head of Regulatory CMC and Quality Assurance at Merck Research Laboratories (MRL). In this role, Jennifer leads the global Regulatory Affairs (RA) CMC and MRL Quality Assurance organizations (900+ employees) […]
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Jens Vogel
SVP & Global Head of Biotech at Bayer Pharmaceuticals
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 […]
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Michael Thien
Head & SVP, Pharmaceutical Sciences at Takeda Pharmaceuticals
Mike has 35 years of experience in the BioPharma industry, having spent 16 years in R&D and 17 years in manufacturing; retiring as a senior vice president from Merck & Co. (MSD) in March of 2022 […]
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Federico A Feldstein, JD
VP, Global Head of Supply Chain Quality at Johnson & Johnson Innovative Medicines
Federico Feldstein is Vice President, Head of Janssen Supply Chain Quality at Johnson & Johnson. In this capacity, Federico is responsible for providing strategic direction and oversight for all areas of Quality for both Large and […]
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Heidi Zhang
EVP, Head of Technical Operations at Tune Therapeutics, Inc.
Dr. Heidi Zhang is the Executive Vice President and Head of Technical Operations at Tune Therapeutics. A seasoned scientific executive who has led global teams across a range of biotech and pharma companies, including Juno Therapeutics, […]
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Luis Mustafa Perez
VP Innovation & Operational Excellence at Moderna
As the CMC Vice President of Innovation & Operational Excellence at Moderna, Luis leads the CMC Transformation Office, integrating scalable business processes and advance technologies across functional areas to ensure successful launches and secure vaccine supply […]
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Anders Vinther
SVP Pharmaceutical Development & Manufacturing at Kronos Bio
Anders Vinther serves as VP Quality at Kronos Bio. He joined Intarcia Therapeutics in 2018 as VP Global Quality and Engagement, previous to this Anders was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP […]
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Chris Stevens
Chief Patient Supply Officer at Spark Therapeutics
As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team of dedicated professionals working together in manufacturing and technical operations, supply chain, quality and compliance to deliver transformational therapies for patients globally. Chris is […]
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Thomas Potgieter
SVP, Global Cell Therapy Development & Operations at Bristol-Myers Squibb
Thomas Potgieter is the Senior Vice President leading Cell Therapy at Bristol Myers Squibb. In his previous role he was the Vice President of the Large Molecule Manufacturing Science and Technology team within Merck’s manufacturing division. […]
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Amy Gamber
VP, Manufacturing at Atara Biotherapeutics
Amy has been at Atara Biotherapeutics for 5 years. She is currently the Vice President of Manufacturing, which includes External Manufacturing, Material Sciences, and Manufacturing Science and Technology functions. Prior to her current role, she led […]
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Amy Doucette
Head of Business Operations – Automation Product Group Pharma at Applied Materials
Amy leads the Pharma Automation Product Group Business Operations team (Business Development, Sales, Pre-Sales, Marketing, Operations and Client Success) that’s providing SmartFactory Rx® automation solutions to the Pharma Industry worldwide.  SmartFactory Rx® is developed for process […]
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Michael Kraich
VP of Global Project & Product Management at Boehringer Ingelheim Biopharmaceuticals GmbH
Dr. Michael Kraich is Vice President of Global Project & Product Management within Boehringer Ingelheim’s Biopharma Contract Development and Manufacturing Business. Michael has more than 15 years of experience in Biopharmaceutical Development, Manufacturing, Project Management and […]
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Seshu Tyagarajan
Chief Technical and Development Officer at Candel Therapeutics
Dr. Seshu Tyagarajan serves as Chief Technical and Development Officer at Candel Therapeutics. She brings over two decades of technical, manufacturing and development experience in biologics and cell and gene therapies (CGT). Before joining Candel, Dr. […]
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Dr. Larry R. Fiegland
Discoverant Product Manager at Dassault Systèmes
Larry is part of BIOVIA’s Research and Development organization responsible for product development of the BIOVIA Discoverant solution. Larry obtained his Ph.D. from Virginia Tech under the direction of Professor John R. Morris, working on ultrahigh […]
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Brad Wynja
VP of Business Development at INCOG BioPharma Services, Inc.
Serving as VP of Business Development, Brad brings 20+ years of extensive and diverse life sciences industry experience to the leadership team at INCOG BioPharma. Prior to joining, Brad served as the Chief Financial Officer at […]
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Giuseppe Mauro
VP, Head of Large Molecule Manufacturing at Incyte Biosciences Technical Operations Sarl
Giuseppe has spent 25+ years in the life sciences industry. Today, he is responsible for the overall commercial biologics manufacturing operations for Incyte, a global biopharmaceutical company headquartered in Wilmington, Delaware with more than 1,700 employees […]
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Ben Castro
SVP Manufacturing Operations at Just – Evotec Biologics
Ben brings over 25 years of biotechnology industry experience to the Just – Evotec Biologics team. As SVP of Manufacturing Operations and Site Head at Just – Evotec Biologics, Ben oversees Clinical and Commercial Manufacturing Operations, […]
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Eric Hacherl
Chief Operating Officer, Co-Lead, NIIMBL Viral Vector Program at Kyttaro Therapeutics
Eric Hacherl, Ph.D. is Managing Partner at SMART Bio Works, a consultancy established in 2020 to bring commercialization expertise and workforce development solutions to the Life Sciences industry. He is also COO of Kyttaro Therapeutics, a […]
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Kacey Fetcho-Phillips
AVP, Site Head at Merck
Kacey Fetcho-Phillips is the Associate Vice President and Site Head of MSD Biotech Dublin, Ireland, where she is responsible for growing supply toward meeting increasing KEYTRUDA demand and achieving strategic advances for the biologics facility.  Merck […]
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Heather Erickson
VP, Supply Chain Management & Business Operations at Sangamo
An accomplished Life Sciences executive, Heather Erickson has a proven record of building and scaling organizations through strategy, operations, and financial acumen. She founded, built, and led two life science startups before joining Sangamo in 2016 […]
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Mike Nuzzolo
Head of Quality Operations at Spark Therapeutics
Mike Nuzzolo is the Head of Quality Operations at Spark Therapeutics where he leads an organization responsible for assuring the consistent quality of commercial and clinical gene therapy products. With over thirty years of quality-related experience […]
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Georgeta Puscalau
Senior Vice President Quality at Tune Therapeutics, Inc.
Georgeta is an accomplished leader with extensive experience in the biotechnology and pharmaceutical industry. She has successfully combined technical, quality, regulatory and project management expertise during the drug product development lifecycle through the commercialization phase and has […]
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Greg Sukay
VP Manufacturing and Process Technologies at Arcutis Biotherapeutics
Greg Sukay serves as Arcutis Vice President of Manufacturing and Process Technologies where he leads a group of engineers and scientists in developing and manufacturing their pipeline of novel human therapeutics.  Mr. Sukay has worked in […]
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Vinod Bulusu
Executive Director, Head Global Biologics CMC Product Stewardship at AstraZeneca
As Executive Director, Head Global Biologics CMC Product Stewardship Vinod leads a team of CMC-team leads in Global Technical Operations (GTO) supporting the expanding biologics portfolio of AstraZeneca. Previous to this role, Vinod led EVUSHELD Global […]
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John Tomtishen
VP Operations at Cellares
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 […]
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Shahid Rameez
Director, Global Vaccines and Biologics Commercialization at Merck
Shahid Rameez did his doctoral and post-doctoral work at The Ohio State University and is a Chemical Engineer and a Biochemist by training. He has over 11 years of experience in the Biopharmaceutical Industry and technical skills in biologics […]
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Tariq Warsi
Sr. Executive Technical Operations
Tariq Warsi was recently the Vice President of Technical Operations at Novome Biotechnologies, where he led the company in the areas of process and analytical development, manufacturing, and quality to generate bacterial cell therapy products for […]
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Christine Sheaffer
Head of Manufacturing and Supply at Spark Therapeutics
A biotechnology leader with 25 years’ experience in developmental, clinical and commercial biologics manufacturing, Christine Sheaffer joined Spark in 2018 and now serves as the Head of Manufacturing & Supply. In this role she leads both […]
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Annette Hillebrand
Executive Director Global Regulatory Affairs CMC at Ultragenyx
As the Executive Director Global Regulatory Affairs CMC at Ultragenyx, Annette is leading the Regulatory Affairs CMC function within the Ultragenyx Brisbane/Novato unit. Her team is primarily focusing on commercial and Phase 3 biological products for […]
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Glen Campbell
Head of External Manufacturing at Vir Biotechnology
Glen is currently the head of external manufacturing at Vir Biotechnology and previously held positions at Amgen, Immunex, and Genentech. He has over 29 years of industry experience in commercial and clinical manufacturing, facility design and […]
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Tim Moore
EVP, Chief Technical Officer at Allogene
Tim Moore is Executive Vice President, Chief Technical Officer for Allogene, overseeing product sciences, supply chain, manufacturing, quality and technical operations. Tim has more than three decades of leadership experience in biopharmaceutical manufacturing and operations and […]
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Snehal Patel
SVP, Head Technical Operations at Sana Biotechnology
Snehal Patel is the Head of Technical Operations at Sana Biotechnology.  He has oversight of Manufacturing, Process and Analytical Development, Supply Chain, CMC Regulatory, and Technical Quality for Cell and Gene Therapy.  Snehal has a breadth […]
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Jack Garvey
CEO/ Managing Partner at Compliance Architects LLC
Jack Garvey, founder of Compliance Architects®, is a seasoned FDA compliance expert with nearly 30 years of leadership experience at industry giants like Johnson & Johnson and C.R. Bard. Combining his chemical engineering and law background, […]
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Judith Koliwer, PhD
Sr. Industry Advisor and Principal Consultant Advanced Therapies at Körber Business Area Pharma
After her PhD on the genetic background of autism spectrum disorders, Judith was leading an academic research group, which analyzed the physiological role of proteins associated with cancer and epilepsy by using lenti and retroviral transduction […]
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Kevin Sharp
SVP, Head of Samsung Biologics America Sales at Samsung Biologics
Kevin Sharp is the Senior Vice President and Head of Samsung Biologics America Sales. He joined the company in 2017 and has served as the Head of Global Sales and Head of Alliance Management at Samsung […]
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Katarina Stenklo
Enterprise End-to End Solutions Leader at Cytiva
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, […]
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Adam Pfeiffer
VP at Project Farma
Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships. With […]
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John Khoury
EVP at Project Farma
John Khoury is a 20+ year veteran and leader in the biotech / pharmaceutical industry. As a member of the Project Farma Leadership Committee, John has spearheaded Project Farma’s growth in the gene and cell therapy […]
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Doug Alleavitch
VP Quality at Arcellx
40 years of Operations and Quality experience in medical products. Have worked for small (early clinical stage) and large commercial medical product companies including (Baxter, Boston Scientific, Nevro and Arcellx). Currently head of Quality for a […]
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Paul Jorjorian
VP Biologics at Thermo Fischer
Paul Jorjorian is the Vice President of Biologics at Thermo Fisher Scientific and has responsibility for five drug substance manufacturing and development sites located globally. Paul has previously held roles in process development, manufacturing, and technology […]
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Sarah Stevens, Ph.D.
President of Azzur Labs & Azzur Cleanrooms on Demand™ at Azzur Group
In her role as President, Azzur Labs & Azzur Cleanrooms on Demand™ (COD), Sarah Stevens is responsible for operations and strategy across all Azzur Labs and Azzur COD locations throughout the United States. Prior to joining […]
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Brian Curran
SVP Manufacturing Excellence Success at MasterControl, Inc.
Brian Curran oversees the success of MasterControl’s Manufacturing Excellence (Mx) solution in the quest to digitize the 80% of life sciences manufacturing, large and small, that still use paper for their batch records or device history […]
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Amrit Chaudhuri
CEO/Cofounder at SmartLabs
Amrit Chaudhuri spent his first eight years in the industry working with hundreds of R&D leaders at universities, biotechs, and large pharma companies to develop commercial products from discovery to market approval. In 2007 he founded […]
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Dave Stewart
SVP, Operational and Process Technology, Large Scale Business Unit at FUJIFILM Diosynth Biotechnologies
Dave Stewart, Senior Vice President Operational and Process Technology, Large-Scale Business Unit, is a proven leader in the biologics manufacturing industry, with a focus on building diverse, multi-disciplinary teams that drive customer deliverables. He brings a […]
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Martin Rabel
Sr. Field Application Scientist at Precision NanoSystems Inc.
Martin Rabel, Dipl.-Pharm., Ph.D. currently works as a Senior Field Application Scientist for Precision NanoSystems ULC supporting clients in Central Europe, Middle East, and Africa (EMEA). He obtained his pharmaceutical license as well as a postgraduate […]
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2022 Speakers

Mike McDermott
Chief Global Supply Officer, EVP at Pfizer
As Chief Global Supply Officer, EVP, Mike McDermott leads all of Pfizer’s internal and external manufacturing and supply chain activities. Mike and the Pfizer Global Supply (PGS) team work to ensure uninterrupted supply for Pfizer’s entire […]
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Peter Marks
Director - Center for Biologics Evaluation and Research (CBER) at FDA
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 […]
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Susanne Hundsbaek-Pedersen
Global Head Pharma of Technical Operations at Roche
Susanne serves as the Global Head of Pharma Technical Operations at Roche, a global biotech company. Roche delivers long-term and sustainable healthcare solutions to serve millions of patients in 150 countries. Pharma Technical Operations spans the […]
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Patrick Yang
Vice Chairman & Co-Founder at National at Resilience, Inc.
Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry. From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company […]
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Alison Moore
Chief Technology Officer at Allogene Therapeutics
Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as Senior Vice President, Process Development, in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where […]
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Michael Kamarck
BioPharma Advisor & Board Member
Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global […]
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Ann Lee
Chief Technical Officer at Prime Medicine
Ann Lee, PhD, is the Chief Technical Officer of Prime Medicine. Ann is an accomplished biotech executive with extensive experience and accomplishments in vaccines, biologics, small molecules and cell therapy development and manufacturing. She brings a […]
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Eric Hahn
SVP, Global Cell Therapy Operations at Bristol-Myers Squibb
Eric has 25+ years in the biopharmaceutical industry and currently serves as SVP, Global Cell Therapy Operations for Bristol Myers Squibb where he has responsibility for managing a network of clinical and commercial manufacturing facilities to […]
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Cynthia Pussinen
Former Chief Technical Officer at Spark Therapeutics, Inc.
Cynthia Pussinen is the Chief Technical Officer (CTO) for Spark Therapeutics, Inc., — a member of the Roche Group which is the world’s largest biotech company. As CTO, Pussinen has overall responsibility for Spark’s technology and […]
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Arleen Paulino
SVP Global Manufacturing at Amgen
Arleen Paulino, senior vice president, Manufacturing, leads Amgen’s commercial manufacturing organization where she is responsible for all internal and external manufacturing operations and strategic supplier relationships to deliver reliable supply for patients across the globe. Prior […]
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Wolfram Carius
EVP Pharmaceuticals at Bayer AG
Prof. Wolfram Carius is the EVP Pharmaceuticals at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was a corporate senior […]
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Jerry Cacia
Chief Technical Officer at Graphite Bio
Jerry Cacia is the chief technical officer at Graphite Bio. In this role, Jerry is responsible for leading the overall manufacturing strategy and technical operations in support of Graphite Bio’s gene editing programs as they advance […]
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Jens Vogel
SVP & Global Head of Biotech at Bayer Pharmaceuticals
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 […]
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Gerard Greco
Global Quality Officer at Takeda
Jerry Greco is the Global Quality Officer of Takeda Pharmaceutical Company Ltd. Joining the company in 2014, Mr. Greco has transformed Quality by creating one Quality Management System and a Global Quality organization that establishes consistent […]
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Charlene Banard
EVP, CTO at Atara Biotherapeutics
Charlene Banard serves as Executive Vice President, Chief Technical Officer at Atara Biotherapeutics. With diverse expertise in manufacturing, quality and technical operations across multiple technologies and advanced therapies, including CAR T, Charlene leads Atara’s talented Technical […]
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Rahul Singhvi
Co-Founder & CEO at Resilience, Inc.
Rahul is a global leader in the Life Sciences industry. Most recently, he was an Operating Partner at Flagship Pioneering, where he was responsible for founding and operating companies launched from Flagship’s innovation foundry, Flagship labs. […]
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Aine Hanly
Chief Technology Officer at Vir Biotechnology
Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology, where she is responsible for overseeing the Company’s technical operations. Her purview includes product and process development, supply chain, manufacturing, quality and CMC strategy. Her […]
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Tara Jones
SVP, North America Operations at Moderna
Tara is responsible for end-to-end operations for DNA, Drug Substance, and Drug Product for global clinical trial materials and commercial product for the North America region.  Prior to joining Moderna she was at Amgen where she […]
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Ann Lee-Karlon
Chief Operating Officer at Altos Labs
Dr. Ann Lee-Karlon is Chief Operating Officer of Altos Labs and leads scientific and business operations for the company. She was previously Senior Vice President at Genentech, leading portfolio strategy and operations with oversight for over […]
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Andy Ramelmeier
EVP Technical Operations at Sangamo Therapeutics
R. Andrew “Andy” Ramelmeier, PhD, currently serves as Executive Vice President, Technical Operations and is responsible for Technical Operations at Sangamo, including manufacturing, quality supply chain, and process and analytical development. Dr. Ramelmeier has 25 years […]
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David Maraldo
SVP, Global Biologics Operations at Merck
Dave Maraldo leads Global Biologics Operations within the Merck Manufacturing Division (MMD). In this role, he oversees manufacturing and supply of Merck’s Biologic portfolio of products. Dave has been part of Merck for over 20 years. […]
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Bala Sreenivasan
SVP Global Supply Chain Management at Merck
She leads a global team with presence in 40+ markets, responsible for all aspects of Supply Chain Operations and Value Chain Management (Product and Manufacturing strategies) at Merck across Small Molecules, Biologics, and Vaccines. She has […]
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Michael Kress
SVP Development Sciences and Clinical Supply at Merck
Mike received his B.S. in Chemistry from Pennsylvania State University and his Ph D. from Harvard University. Upon graduation he accepted the position of Sr. Research Chemist within the Merck Process Research group where he focused […]
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Karen Walker
Chief Technology Officer at Kyverna Therapeutics
Karen Walker is Chief Technology Officer at Kyverna Therapeutics. Ms. Walker has broad and deep industry experience developing biopharmaceuticals and cell and gene therapy (CGT) products. She brings extensive and pioneering expertise in the product development, […]
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Stephen Hill
Chief Operating Officer at Lyell Immunopharma
Stephen Hill has served as our Chief Operating Officer since October 2021. He joined Lyell in June 2019 as our Chief Technical Operations Officer. From June 2018 to June 2019, he was Senior Vice-President, Head of […]
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Patricia Turney
SVP Operations at Arcutis Biotherapeutics
Ms. Turney has served as our senior vice president, operations since January 2020. She previously worked at Amgen, Inc. from 1996 to 2019 in roles of increasing responsibility, most recently as vice president, external supply, where […]
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Peter Olagunju
Chief Technical Officer at TCR² Therapeutics
Peter Olagunju serves as the Chief Technical Officer of TCR².  He brings over 20 years of experience in cell and gene therapy, clinical development, program management, manufacturing and technical operations. Prior to joining the Company, he […]
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Brandon Varnau
Head, Industrial Affairs Specialty Care Global Business Unit Quality Operations at Sanofi
Brandon Varnau is Head of Industrial Affairs Specialty Care Global Business Unit Quality Operations for Sanofi. He utilizes 30 years of experience in Biologics to lead all aspects of Quality Assurance, Quality Control and Compliance for […]
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RJ Doornbos
VP, Global Quality Systems at Bristol Myers Squibb
As the Head of Global Quality Systems, RJ serves as a key member of the Global Quality Leadership (GQLT) team. The primary function of this role is to ensure that an effective Quality System is in […]
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Kathleen Munster
Intercept Pharmaceuticals at Chief Quality Officer & SVP, Technical Operations
Kathleen Munster is a biopharmaceutical leader with experience in global Fortune 500 companies and biotech/start-ups covering Biologics, Cell & Gene Therapy, Solid Dosage and Drug Products.  Effective today, she is Chief Quality Officer & SVP, Technical […]
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Mark Butchko
Associate VP Global Quality Laboratories at Eli Lilly
Mark A. Butchko, Ph.D. is currently Associate Vice President for Eli Lilly and Company in Indianapolis, IN. He is responsible for leading Lilly’s Global Quality Laboratories organization to provide analytical method stewardship, specialized analytical services, and […]
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Ramji Krishnan
Head of Technical Operations at Celularity
Ramji has more than two decades of wide-ranging experience in the development and manufacturing of engineered cell therapies, AAV gene therapy products and Biologics. At Celularity he serves as the Head of Technical Operations. He is […]
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Michael Paglia
Chief Operational Officer, BaseCamp at ElevateBio
Michael has spent the last twenty years in biotechnology building, leading and motivating process development and manufacturing teams to support clinical programs from early development to late-stage clinical trials. Currently, Michael is the Chief Operating Officer […]
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Larry Pitcher
Sr. Director and General Manager, MMS, mRNA, Advanced Therapies at Thermo Fisher Scientific
Operations and business leader with experience running manufacturing sites across different geographies and regulated industries. Currently, Larry is serving as the GM for Thermo Fisher’s rapidly growing Plasmid DNA CDMO business with multi-site responsibilities. Previously, he […]
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Eric Hacherl
Head of Manufacturing at Spark Therapeutics
Eric Hacherl, Ph.D. is Managing Partner at SMART Bio Works, a consultancy established in 2020 to bring commercialization expertise and workforce development solutions to the Life Sciences industry. He is also COO of Kyttaro Therapeutics, a […]
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Jose Caraballo
VP Corporate Quality at Kite Pharma
Jose Caraballo is a Biotech/biopharma executive with extensive quality, development, and manufacturing expertise. As VP of Corporate Quality, he directs and oversees global compliance, quality systems, and quality engineering functions for Kite Pharma, a Gilead company. […]
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Pratik Ahuja
VP, Supply Chain at Urovant Sciences
Pratik Ahuja is Vice President of Supply Chain at Urovant Sciences. He is a visionary executive and leader who has successfully built, led, and transformed large teams in the biopharmaceutical industry across process development, supply chain […]
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Kumar Dhanasekharan
SVP Technical Operations at Renovacor
Dr. Kumar Dhanasekharan is SVP of Technical Operations at Renovacor Inc. and has over 20 years’ experience in biologics development and manufacturing and most recently, in AAV gene therapy process and analytical development and manufacturing in […]
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Pouria Motevalian
Director Process Development at Thermo Fisher Scientific
As Director of Process Development, Pouria Motevalian leads process characterization, optimization and scale up for viral vectors at Thermo Fisher Scientific. Additionally, he oversees process modeling/simulation and knowledge management activities. Prior to joining Thermo Fisher Scientific, […]
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Tariq Warsi
VP of Technical Operations at Novome Biotechnologies
Tariq Warsi is currently the Head of Technical Operations at Novome Biotechnologies, where he leads the company in the areas of process development, manufacturing, and quality to generate bacterial cell therapy products for numerous indications. As the […]
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Claus Weisemann
VP Quality at NGM Biopharmaceuticals
Claus Weisemann joined NGM Biopharmaceuticals in September 2019 as VP of Quality, developing and implementing  science- and risk-based Quality Systems for all GxP areas in a small clinical stage Biotech company.  He brings more than 30 […]
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Steve Goodman
Executive Director, AAV CMC at Vertex
Steve Goodman is Executive Director, AAV CMC, at Vertex Cell and Gene Therapies. In this role, Steve oversees internal and external process and analytical development, as well as manufacturing, for AAV programs. Prior to this, Steve […]
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Eric T. Blair
Chief Commercial Officer at Andelyn Biosciences
Eric Blair is the Chief Commercial Officer at Andelyn Biosciences leading the commercial function. He previously served as Chief Commercial Officer at Argonaut Manufacturing Services, Global Head of Sales at Metabolon, and held various leadership roles […]
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John Higgins
Sr. Director Global Technical Operations at AstraZeneca
John Higgins is a Director who serves as Product Champion in Global Technical Operations at AstraZeneca, and is the CMC lead for commercial biologics at AstraZeneca. John has a passion for excellence in CMC and biologics […]
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Aaron Vernon
VP, Manufacturing at TCR² Therapeutics
Aaron Vernon serves as Vice President, Manufacturing for TCR2 Therapeutics.  In this role, Aaron is responsible for Internal and External Manufacturing, Supply Chain, and Patient Operations.  Prior to joining the company, he was Vice President, Engineering […]
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Michael S. Roberts, PhD
Chief Scientific Officer at International Space Station National Laboratory
Dr. Michael Roberts is Chief Scientist of the International Space Station National Laboratory and Vice President at the Center for the Advancement of Science in Space (CASIS).  As managers of the ISS National Laboratory in partnership […]
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Dr. Behnam Ahmadian Baghbaderani
Global Head of Process Development, Cell & Gene Technologies at Lonza
Dr. Baghbaderani is the Global Head of Process Development, Cell & Gene Technologies at Lonza. He has over 15 years of experience in stem cells engineering, bioprocessing, and cell and gene therapy field. Dr. Baghbaderani holds […]
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Colette Ranucci
AVP Global Technical Operations at Merck
Dr. Colette Ranucci has over 25 years’ experience in Vaccine and Biologics process development, commercialization, and manufacturing. She is currently the head of Global Large Molecule Technical Operations responsible for technical operations across all internal and […]
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Sid Advant
VP Manufacturing Operations at GSK
Siddharth (Sid) J. Advant has 25+ years of experience in the Biopharmaceutical Industry in the area of pharmaceutical development, technical operations and CMC leadership. Sid is currently employed at GSK, leading a GMP Operations organization (Cell […]
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Dave Geoghegan
Head of Quality at Spark Therapeutics
David Geoghegan is the Head of Quality Assurance for Spark Therapeutics, Inc. He leads a team of scientists and professionals who are responsible for all aspects of Quality throughout the development lifecycle of gene therapy products, […]
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Manmohan Singh
Chief Technology Officer at Beam Therapeutics
Dr.Manmohan Singh is currently Chief Technology Officer at Beam Therapeutics in Cambridge, MA. Dr. Singh has over 28 years of R&D experience in drug product development, Cell and Gene therapies, novel delivery systems and vaccine research. […]
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Jim Weidner
Executive Director of Engineering at Amgen
Jim Weidner currently serves as the Executive Director for the Engineering Technical Authority (ETA) group. Jim has 27 years of experience with Amgen, Hoffmann-La Roche, and Biogen Idec. Jim joined the ETA in July 2020.  His […]
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Pascal Becotte
Managing Director at Russell Reynolds Associates
Dr. Pascal Bécotte leads the firm’s Canadian operations and co-leads the firm’s Global Functions group, which includes the Finance, Human Resources, Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs Practices. Pascal is also […]
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Ravi Samavedam
Chief Innovation Officer at Azzur Group
Ravi Samavedam is a Biochemical Engineer with more than 20 years of experience in the pharmaceutical and biotechnology industries. Ravi joined Azzur in 2012, and prior to his appointment as CINO of Azzur Group, Ravi was […]
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Dr. Judith Koliwer
Principal Consultant, Cell & Gene Therapy at Körber Pharma Software
After her PhD on the genetic background of autism spectrum disorders, Judith was leading an academic research group, which analyzed the physiological role of proteins associated with cancer and epilepsy by using lenti and retroviral transduction […]
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Shannon Knott
Executive Director at Russel Reynolds Associates
Shannon Knott is a member of Russell Reynold’s Leadership and Succession Practice, and is based in Durham, NC. She specializes in executive transition and development, partnering with clients to build more effective, future ready leadership teams. […]
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Vinita P. Kumar
SVP, Quality at Mirum Pharmaceuticals, Inc.
Vinita Kumar is the senior vice president of quality, where she oversees GxP quality operations within clinical, laboratory, document control, training, and IT systems. She is also responsible for creating and implementing Mirum’s global inspection readiness […]
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Courtney Breen
Executive Director, Oncology Marketing at Merck
Courtney leads a team that drives long-term strategy for Merck’s Oncology business – ensuring that we can achieve and sustain a leading Oncology business – delivering on our ambition to save and improve lives of cancer […]
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George Peters
Sr. Offering Manager, Life Sciences at Honeywell Process Solutions
George Peters has over 20 years of experience working with automation customers in batch, and continuous process industries, as well as discrete manufacturing.  He is the Sr. Offering Manager for Honeywell MES and the new Honeywell […]
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Joao Paulo Mattos
Director, Global Process Validation and CMC Lead at Thermo Fisher Scientific
Joao Paulo Mattos is Director of Global Process Validation and CMC Lead at Thermo Fisher Scientific and has responsibility for process validation and CMC strategy for late stage and commercial programs across six drug substance manufacturing […]
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Kevin Sharp
VP of Strategic Operations, Global Sales Center at Samsung Biologics
Kevin Sharp is the Vice President of Global Sales Strategic Operations at Samsung Biologics. Kevin joined the company in 2017 and has served as the Head of Global Sales and Head of Alliance Management at Samsung […]
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Tony Khoury
EVP at Project Farma
Tony Khoury is an experienced industry leader in life sciences, specifically, biologics and advanced therapies. As a member of the Project Farma leadership team, Tony has spearheaded the firm’s growth in the biologics and most recently […]
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Adam Pfeiffer
VP of Strategy at Project Farma
Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.With 16+ […]
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Marc Wolfgang
VP, Technical Operations at BioNTech
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Vishaka Rajaram
Director, Pharmaceutical and Life Sciences Practice at PwC
Vishaka is a Director in PwC’s Pharmaceutical & Life Sciences Practice where she focuses on pragmatic Quality System Transformations at Medical Device and Pharmaceutical companies. Prior to joining PwC, Vishaka worked in the Medical Device Industry with […]
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Sean Ganley
AGILE Champion III at Takeda
Sean is part of the AGILE team at Takeda’s Los Angeles plasma manufacturing facility. AGILE, in all caps, is Takeda’s methodology for transforming its manufacturing capabilities. Following his bachelor’s degree in Biology from Occidental College, Sean […]
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John Tomtishen
VP Operations at Cellares
John Tomtishen is Vice President of Operations at Cellares. At Cellares John is responsible for supporting partnership activities and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm. He […]
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Yuxian Zhang
Life Sciences Solution Consultant at Dassault Systèmes
Yuxian Zhang is a Solution Consultant in the Life Sciences team at Dassault Systèmes. She earned her M.S. in Chemical Engineering from Worcester Polytechnic Institute. She worked on the process scale-up from laboratory to production at […]
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Art Hewig
VP of Biologics Process Development at Gilead Sciences
Art Hewig is the Vice President of Biologics Process Development at Gilead Sciences in Oceanside, CA. He leads a >200-member organization of scientists and engineers to deliver early stage, late stage, and life cycle management assets […]
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Rick Johnston
Sr. Director at Applied Materials
Rick is a senior technical leader within Applied Materials’ pharmaceutical business unit. He has more than 15 years of experience in building software that solves big data, machine learning, scheduling, forecasting and advanced analytics problems in […]
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Jennifer Staffin
Director Biomanufacturing Automation at Resilience
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Parinaz Rajaii
Director, Quality Operations at Iovance Biotherapeutics
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Danielle Pund
Director of Vault Quality at Veeva Systems
Danielle is a Director of Strategy at Veeva Systems, focused on the Vault Quality Suite of applications. She has spent nearly her entire career within the QMS space and is passionate about continuous improvement and the […]
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2021 Speakers

Sanat Chattopadhyay
EVP & President, Merck Manufacturing Division at Merck
Sanat Chattopadhyay is responsible for Merck’s worldwide manufacturing and supply operations supporting annual global sales revenues exceeding $40 billion. Merck is known as MSD outside of the U.S. and Canada. Sanat oversees a network of 50 […]
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Lynn Bottone
VP Biotech Operations at Pfizer
Lynn Bottone is a proven leader with over 30 years of manufacturing and quality experience in the biotechnology, pharmaceutical and dietary supplement industries. Her vast career includes experiences in Quality Control, Quality Assurance, Compliance, Project Management, […]
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Peter Marks
Director - Center for Biologics Evaluation and Research (CBER) at FDA
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 […]
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Pam Cheng
EVP, President Global Operations & IT at AstraZeneca
Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. […]
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Esteban Santos
EVP, Operations at Amgen
Esteban Santos serves as executive vice president, Operations. Esteban is responsible for the Operations organization, which encompasses Manufacturing, Process Development, Quality, Engineering and Global Supply Chain. Prior to this role, Santos was senior vice president, Manufacturing, […]
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Patrick Yang
Vice Chairman & Co-Founder at National Resilience, Inc.
Dr. Pat Yang is one of the most accomplished biotech manufacturing executives and technical operations leaders in the industry. From 2017 to 2019, Pat was executive vice president at Juno Therapeutics, a leading CAR-T biotech company […]
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Alison Moore
Chief Technology Officer at Allogene Therapeutics
Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she […]
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Michael Kamarck
BioPharma Advisor & Board Member
Michael Kamarck was the Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global […]
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Aine Hanly
Chief Technology Officer at Vir Biotechnology
Aine Hanly, Ph.D., serves as Chief Technology Officer at Vir Biotechnology, where she is responsible for overseeing the Company’s technical operations. Her purview includes product and process development, supply chain, manufacturing, quality and CMC strategy. Her […]
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Wolfram Carius
EVP, Cell and Gene Therapy at Bayer AG
Prof. Wolfram Carius is the EVP, Cell and Gene Therapy at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer, Wolfram was […]
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Tim Moore
President & COO at PACT Pharma
Tim Moore has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Mr. Moore is current the President and Chief Operating  Officer at PACT Pharma.  Prior to joining PACT, he served as Executive […]
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Karen Walker
Chief Technology Officer at Kyverna Therapeutics
Karen Walker, Chief Technology Officer, Kyverna Therapeutics.  Karen brings >30 years’ experience in the biotech industry, holding positions in Technical Development, Regulatory Affairs and Quality. She has worked in a number of companies including Roche/Genentech, Seattle […]
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Joseph Tarnowski
SVP, Cell & Gene Therapy, R&D Medicinal Science and Technology at GSK
Prior to his current role in CGT, Joe was the Senior Vice President of Biopharm CMC R&D. Before joining GSK in June, 2010, Joe was the Senior Vice President, Biologics Manufacturing and Process Development in the […]
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Andrea Goddard
SVP, Global Head of Quality and Compliance for Pharma Technical Operations at Roche
Andrea Goddard (Andi) is currently the Senior Vice President and Global Head of Quality and Compliance for Roche/Genentech Pharma Technical Operations and is a member of Genentech Executive Committee. Pharma Technical Operations spans the world with […]
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Chris McDonald
SVP & Global Head, Manufacturing at Kite Pharma
Chris leads the Global Manufacturing Leadership Team (GMLT), which includes the Site Operational Leaders and cross-functional partners from Quality, MSAT, IT, HR and Finance.  Chris is responsible for viral vector, clinical and commercial cell therapy operations, […]
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Greg Guyer
EVP and Chief Technical Officer at BioMarin Pharmaceuticals
C. Greg Guyer, Ph.D, joined BioMarin in May 2020 and currently serves as Chief Technical Officer and Executive Vice President of Global Manufacturing and Technical Operations, responsible for overseeing our manufacturing, process development, quality, supply chain, […]
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Andy Ramelmeier
EVP Technical Operations at Sangamo Therapeutics
R. Andrew “Andy” Ramelmeier, PhD, currently serves as Executive Vice President, Technical Operations and is responsible for Technical Operations at Sangamo, including manufacturing, quality supply chain, and process and analytical development. Dr. Ramelmeier has 25 years […]
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Anders Vinther
VP Quality at Kronos Bio
Anders Vinther serves as VP Quality at Kronos Bio. He joined Intarcia Therapeutics in 2018 as VP Global Quality and Engagement, previous to this Anders was the Chief Quality Officer at Sanofi Pasteur accountable for cGMP […]
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Melissa Seymour
Chief Quality Officer at Biogen
Melissa Seymour is the Chief Quality Officer. Prior to this she was Global Head of Quality and Chief Quality Officer for Biogen Inc. where she led the PO&T organization in setting the quality compliance strategy, implementation […]
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Jerry Cacia
Chief Technology Officer at Graphite Bio
Jerry Cacia is the chief technical officer at Graphite Bio. In this role, Jerry is responsible for leading the development of the overall manufacturing strategy and CMC technical operations in support of Graphite Bio’s gene editing […]
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Mihaela Simianu
Executive Director Global Vaccines Technical Operations at Merck
Dr. Simianu is currently member of Merck’s Global Vaccines Technical Operations accountable for Global Drug Product and Analytical Technology Operations. Prior to this role she served as head of Merck’s Sterile Products Commercialization. She advanced a […]
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Dushyant Varshney
EVP & Chief Technology Officer at Arcturus Therapeutics
Dr. Dushyant B. Varshney, Ph.D., is the Executive Vice President & Chief Technology Officer at Arcturus Therapeutics. He is responsible for Global CMC, Technical Operations, Supply & Quality, including technology innovation, product development, manufacturing, technology transfer […]
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Harry Lam
Chief Technology Officer at JW Therapeutics
Dr. Harry Lam currently is Chief Technology Officer and EVP at JW Therapeutics, responsible for JW’s Technical Operations functions, including process development, clinical and commercial manufacturing, manufacturing science & technology, global supply chain, engineering, and capital […]
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Stephen Hill
Chief Technical Officer at Lyell Immunopharma
Stephen Hill is the Chief Technical Officer of Lyell Immunopharma. Prior to this role he was Head of Global Biologics Operations at AstraZeneca where he was responsible for end-to-end supply of the commercial and late-stage clinical […]
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Eric Hacherl
VP of Manufacturing at Spark Therapeutics
Eric Hacherl, Ph.D. is the VP of Manufacturing. He Holds a Ph.D. in Chemical Engineering from Rutgers University. As the Head of Manufacturing, he is responsible for Internal and External Manufacturing, Materials Management, Shipping & Receiving […]
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Som Chattopadhyay
VP Global Supply Chain at Amgen
Som Chattopadhyay serves as Vice President, Global Supply Chain Organization. Reporting to Executive Vice-President of Operations, primary responsibilities include supply of medicines to patients in a safe, compliant, and efficient manner. Activities covered included network optimization, […]
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Søren Thuesen Pedersen
Sr. Director, External Affairs Quality Intelligence and Inspection at Novo Nordisk
Søren Is Chemical Engineer by education (1994) and has been working 27 years in Novo Nordisk. During that that time he has been engaged and lead different areas within Manufacturing, QC-Laboratories and CMC Manufacturing Development. He […]
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Murali Muralidhara
Chief Manufacturing Officer at RVAC Medicines
Murali Muralidhara, PhD, Chief Manufacturing Officer at RVAC Medicines, heads up Global CMC, MSAT and SC functions based out of  Singapore-Boston & Shanghai.  He has over  20 years of technical and leadership experience  in Product Development, Manufacturing, […]
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RJ Doornbos
VP Global Quality Systems at Bristol-Myers Squibb
As the Head of Global Quality Systems, RJ serves as a key member of the Global Quality Leadership (GQLT) team. The primary function of this role is to ensure that an effective Quality System is in […]
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Nuno Fontes
SVP, Global Head of Development at Bayer
Nuno is the SVP, Head of Global Biologics Development at Bayer Pharmaceuticals, leading the group responsible for all process development and clinical manufacturing of cell therapy, gene therapy and recombinant protein therapeutics in both Berkeley, CA, […]
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Stan Russell
VP, Quality at TCR2 Therapeutics
Stan Russell is a 32+ year veteran of the Life Science Industry, with experience in Biotechnology, Pharmaceuticals, and Medical Devices.  His background spans a broad spectrum of dosage forms and therapeutic areas, as well as roles […]
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Jason Murphy
VP, Nucleic Acid Process Development and Applied Technologies at Moderna
Dr. Murphy joined Moderna in 2018 and leads Technical Development of DNA, Enzymes and mRNA related to Moderna’s mRNA platform technology.  Dr. Murphy also leads Applied Technologies which houses Moderna High Throughput Development and Automation Engineering […]
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Claus Weisemann
VP Quality at NGM Biopharmaceuticals
Claus Weisemann joined NGM Biopharmaceuticals in September 2019 as VP of Quality, developing and implementing  science- and risk-based Quality Systems for all GxP areas in a small clinical stage Biotech company.  He brings more than 30 […]
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Jeff Ranney
Executive Director, Engineering at Amgen
Jeff leads Amgen Engineering’s Process System team within the Engineering Technical Authority Department (ETA). This team provides operational engineering support for the Amgen network and leads the design for process systems and equipment for major projects […]
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Gargi Seth
Director, Global Technical Development Project and Portfolio Management at Genentech
Dr. Gargi Seth is a Director in Global Technical Development Project and Portfolio Management group. In this role, Dr. Seth and her team partner with TDTs and stakeholders to drive the progression of CMC projects to deliver […]
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Babita Parekh
VP, Analytical Sciences and Global Bioassay Steward at Eli Lilly
Currently, Babita Parekh is the Vice President of Analytical Sciences and Global Bioassay Steward at Eli Lilly & company. She has obtained an M.S and a Ph.D. in Microbiology/Biochemistry from the M. S. University of Baroda, […]
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Eileen Higham
SVP Technical Operations at Intergalactic Therapeutics
Eileen Higham, Ph.D. has more than 20 years of experience leveraging deep technical, strategic, and operational expertise to develop innovative cell therapies, gene therapies, and biologics to transform human health. Eileen is currently Senior Vice President, […]
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Ruby Casareno
SVP Technical Operations at Allakos
Ruby Casareno, Ph.D., serves as Senior Vice President, Technical Operations at Allakos Inc, leading the biologics drug substance and drug product process development and analytical development, CMC strategy & project management, quality control, and supply chain […]
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Sid Advant
VP GMP Operations at GSK
Siddharth (Sid) J. Advant has 25+ years of experience in the Biopharmaceutical Industry in the area of pharmaceutical development, technical operations and CMC leadership. Sid is currently employed at GSK, leading a GMP Operations organization (Cell […]
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2020 Speakers

Juan Andres
Chief Technical Operations and Quality Officer at Moderna
As Chief Technical Operations and Quality Officer, Juan Andres is responsible for the supply of product required for Moderna’s preclinical and clinical development programs, as well as scaling the CMC (chemistry, manufacturing and controls) processes across Moderna’s […]
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Patrick Yang
Chairman at Acepodia & Founding Board Director at Sana Biotechnology
Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech, Roche, and Juno Therapeutics. He was Executive Vice President and Global Head […]
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Lou Schmukler
EVP and President, Global Product Development & Supply at Bristol-Myers Squibb
As Executive Vice President and President of Global Product Development and Supply (GPS), Lou oversees the worldwide product development, manufacturing and supply chain arms for Bristol-Myers Squibb (BMS). His organization leads the development, launch and commercial lifecycle […]
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Michael Kamarck
Chief Technology Officer at Vir Biotechnology
Michael Kamarck is Chief Technology Officer at Vir. Previously, he was senior vice president of Global Vaccines and Biologics Manufacturing and president of Merck BioVentures where he was responsible for the establishment of Merck’s global biosimilars […]
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Alison Moore
Chief Technology Officer at Allogene Therapeutics
Dr. Alison Moore is Chief Technical Officer at Allogene Therapeutics. Prior to this role, Moore served as senior vice president, Process Development,in Amgen Operations. Moore was previously vice president, Process and Product Engineering (P&PE), where she […]
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Pam Cheng
EVP, President Global Operations & IT at AstraZeneca
Pam Cheng joined AstraZeneca in 2015 as executive vice president of Global Operations and Information Technology (IT), guiding the company’s manufacturing, supply chain, procurement, and IT across 18 countries and leading a team of over 19,000. […]
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Derek Adams
Chief Technology and Manufacturing Officer at bluebird bio
Derek Adams joined bluebird bio in March 2017 as Chief Technology and Manufacturing Officer leading all pharmaceutical sciences that includes process and analytical development, manufacturing, technical operations, and supply chain. Prior to joining bluebird, Derek was […]
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John Pinion
EVP Translational Sciences, Chief Quality Operations Officer at Ultragenyx Pharmaceutical
John Pinion has over 26 years of global experience leading biologic, small molecule pharmaceutical, gene therapy and device operations across Asia, Europe and the Americas. His expertise and leadership spans engineering, quality, manufacturing and translational sciences. […]
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Brendan O’Callaghan
SVP & Global Head of Specialty Care IA at Sanofi
Brendan O’Callaghan is responsible for over 5000 colleagues across several global manufacturing sites who are committed to bringing life-changing biologics based medicines to help improve the lives of patients everywhere. In his role, Brendan collaborates transversally […]
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Arleen Paulino
SVP Global Manufacturing at Amgen
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 […]
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Jens Vogel
SVP & Global Head of Biotech at Bayer Pharmaceuticals
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 […]
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Charlene Banard
Global Head of Technical Operations for Cell & Gene Therapy at Novartis
Charlene Banard serves as the Head of Technical Operations for the Cell & Gene Therapy platform at Novartis, a role which is accountable for the multi-national network of manufacturing facilities producing innovative CAR-T cell therapies for […]
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Craig Kennedy
SVP Global Supply Chain Management at Merck
Mr. Craig Kennedy is Senior Vice President of Transformation and Supply Chain Management.  Craig has a proven track record of driving change and operations improvement at Merck.  Craig will enable our transformational efforts focused on Fortify […]
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Stacey Ma
EVP Technical Operations at Sana Biotechnology
Stacey is currently the Executive Vice President of Technical Operations at Sana Biotechnology. In this role, she is a member of the Sana Executive Team, and oversees process, pharmaceutical and analytical development, supply chain, quality, CMC […]
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LeAnn Pipkins
VP Global Supply Chain at Gilead Sciences
LeAnn Pipkins joined Gilead in 2019 as Vice President of Global Supply Chain and has been focused on leading Gilead’s transformation in integrated planning. Before Gilead, LeAnn spent 20 years in the biopharmaceutical industry in roles […]
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Greg Russotti
Chief Technology Officer at Century Therapeutics
Greg Russotti is the Chief Technology Officer at Century Therapeutics, a company developing iPSC-derived, allogeneic immune cell therapy products for hematology/oncology indications. Before joining Century in January 2020, Greg was Vice President of Cell Therapy Development […]
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Susan Abu-Absi
SVP, Pharmaceutical Development & Technology at bluebird bio
Susan Abu-Absi, Ph.D. is Senior Vice President of Pharmaceutical Development & Technology at bluebird bio, a gene therapy company located in Cambridge, MA. The integrated product platforms at bluebird bio encompass gene therapy, cancer immunotherapy and […]
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Prentice Curry
SVP, Quality and Compliance at Kite, A Gilead Company
Prentice Curry has been a biotechnology and pharmaceutical professional for more than 30 years. He started his career at Cetus Corporation, one of the first biotechnology start-up companies in quality laboratory and manufacturing roles. He has […]
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Eric Hahn
SVP, Head Biologics Operating Unit at Takeda
Eric is the SVP & Head of Takeda’s Global Biologics Operating Unit. He joined Takeda in 2014 as Head of Global Engineering for the Vaccines Business Division and transitioned to Takeda’s Global Manufacturing and Supply Organization […]
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Hari Pujar
Operating Partner at Flagship Pioneering
Hari Pujar, Ph.D., serves as Operating Partner, at Flagship Pioneering, helping create breakthroughs in human health and build life science companies.  Previously he was Chief Technology Officer of Spark Therapeutics, a pioneer and leader in AAV […]
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Som Chattopadhyay
VP Global Supply Chain at Amgen
Som Chattopadhyay serves as Vice President, Global Supply Chain Organization. Reporting to Executive Vice-President of Operations, primary responsibilities include supply of medicines to patients in a safe, compliant, and efficient manner. Activities covered included network optimization, […]
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Kim Burson
Head of Quality Assurance and Quality Control at Denali Therapeutics
Kim K. Burson, Ph.D. is the Head of Quality Assurance and Quality Control at Denali Therapeutics which is dedicated to defeating neurodegenerative diseases. She has over 20 years of quality experience in diversified product platforms including […]
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Stephen Hardt
VP, Supply Chain and External Manufacturing at Allogene Therapeutics
Stephen Hardt is the Vice President Supply Chain and External Manufacturing for Allogene Therapeutics, overseeing a broad network of contract manufacturers and suppliers and leading Allogene’s planning, logistics and distribution functions. Stephen has over 25 years […]
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Shannon Holmes
Director, Product Development Quality at Biogen
Shannon is the Director of Product Development Quality at Biogen, based in Research Triangle Park, NC. She leads a global team responsible for quality oversight and strategy of all products and devices in clinical development as […]
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John Lunger
Chief Patient Supply Officer at Adaptimmune
John Lunger has been Adaptimmune’s Chief Patient Supply Officer since August 2019. John leads the teams responsible for producing and delivering products to patients, accelerating supply execution, and optimizing the supply chain to be ready for […]
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Professor. Mazen Hassanain
Managing Director at SaudiVax
Prof. Mazen Hassanain, King Saud University Professor of Surgery, Canadian College of Surgery Association Fellow with expertise in Transplantation, Immunology, and Oncology, has founded a number of companies in the healthcare and biotechnology sectors. SaudiVax is […]
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Shishir Gadam
VP Cell Therapy Manufacturing Science and Technology at Bristol-Myers Squibb
Shishir is currently a Vice President of Cell Therapy Global Manufacturing Science and Technology at BMS. He was previously at Genentech/Roche where he held various leadership roles: Senior Director of Biologics commercial CMC management; Head of […]
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Ezequiel Zylberberg
VP of Product Development at Akron Biotechnology
Ezequiel Zylberberg, Ph.D. is Vice President of Product Development and Planning at Akron Biotechnology, a manufacturer of cGMP-compliant ancillary materials to enable the development and commercialization of advanced therapies. Ezequiel manages Akron’s supply chain and product […]
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Derrick Fournier
Executive Director, Global Product Development and Supply Business Insights and Analytics at Bristol-Myers Squibb
Derrick is an executive focused on helping organizations drive value through the power of analytics. He currently leads the manufacturing and supply chain Business Insights and Analytics (BIA) team at Bristol-Myers Squibb (BMS). Derrick also led […]
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Sam MacHour
SVP & Chief Quality Officer at Samsung Biologics
Prior to joining Samsung Biologics in 2019, Sam spent more than 32 years supporting large MedTech, Bioscience and Biopharmaceutical companies achieve business operational excellence and gain leadership in the areas of Research & Development, Quality, Compliance, […]
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Paul Jorjorian
VP & General Manager, Biologics at Thermo Fisher Scientific
As the VP of Biologics Paul oversees a global Biologics Drug Substance manufacturing and development network for Thermo Fisher Scientific’s Pharma Services. Paul has held multiple leadership roles in process development, technology transfer and operations. In […]
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Pascal Bécotte
Co-Leader, Corporate Officers Sector (Global Functions) & Global Leader, Operations & Supply Chain Practice at Russell Reynolds Associates
Dr. Pascal Bécotte leads the firm’s Canadian operations and co-leads the firm’s Global Functions group, which includes the Finance, Human Resources, Operations & Supply Chain, Legal, Regulatory & Compliance and Corporate Affairs Practices. Pascal is also […]
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Eric Good
Director, Compliance at ProPharma Group
Dr. Eric Good is an energetic, award-winning leader with extensive U.S. and international experience in Fortune 500 companies. Dr. Good has worked in aseptic manufacturing, project management, and Quality Assurance under Consent Decree conditions. He has […]
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Daniel J. Littlefield
Principal at Modality Solutions
Daniel Littlefield has established Modality Solutions as an innovator in cold chain validation practices. Dan exemplified this leadership during Modality Solutions’ recent clinical trial operations work in the Democratic Republic of the Congo (DRC), along with […]
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Gary Hutchinson
President at Modality Solutions
Gary Hutchinson is president of Modality Solutions and has led our organization since its founding in 2011. Over the last two decades, he has designed and managed biopharmaceutical cold chains for best-in-class organizations. His professional focus […]
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Zinaid Dzinovic
Director Principal Consulting & Client Advisory at Körber Pharma Software
Zinaid Dzinovic is Director Principal Consulting & Client Advisory at Körber Pharma (formerly Werum IT Solutions). Before taking on his current position, for over 5 years Zinaid has worked at Novartis AG in Switzerland. His core […]
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Stephen McCarthy
VP, Digital Innovation at Sparta Systems
Steve McCarthy is Vice President of Digital Innovation at Sparta Systems. Steve provides domain expertise and serves as an industry evangelist and customer advocate for Sparta. In this role, Steve works closely with Sparta’s customers to […]
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Anne Marie O’Halloran
Supply Chain Global and NA Lead-Life Sciences at Accenture
Anne Marie O’Halloran is a Managing Director in Accenture’s Products Operating Group, where she leads Accenture’s Industry X.0 & Supply Chain practice for the Life Sciences sector.  This practice brings together services across innovation, product development, […]
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Barry Heavey
Life Sciences Industry X.0 Lead – Ireland at Accenture
Barry has 20 years of experience in the pharmaceutical industry, working in areas such as immunology,  bio manufacturing  and stem cell research. He has a PhD in Genetics from University of Vienna and an MBA from […]
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George Siu
Part Leader at Samsung Biologics
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