Vaccines Bioprocess Development & Commercialization Workshop

This two-day virtual workshop will explore the critical issues at the various stages of vaccine development. International experts with over 10 years’ experience in their field will lead delegates in developing their understanding in the research, operational, and regulatory challenges of the vaccine market.

 This workshop is suitable for:

scientists new to the vaccines sector (recent graduates / research scientists)

scientists and technical managers looking to broaden their knowledge in various vaccine technologies and platforms

project managers, funders and policy-makers wanting to gain an understanding in vaccines

PROGRAM

Click HERE for a downloadable version of the course agenda and HERE for a list of course participants!

Welcome, Introduction, and Framing of the Workshop

A welcome to the 2021 MIT-CBI | UCL Vaccines Bioprocess Development & Commercialization Course.

30 minutes

Stacy Springs

Dr. Stacy Springs serves as Senior Director of Programs at MIT’s Center for Biomedical Innovation (CBI) and Executive Director of CBI’s Biomanufacturing Initiatives, which include the BioMANufacturing Consortium (BioMAN), its Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), and its BioACCESS initiative. The objective of the BioMANufacturing Consortium is to develop new knowledge, science, technologies […]

Responding to the Covid Pandemic – Advancing Global Supply

This presentation will discuss the challenges of responding to the pandemic within the context of the vaccines eco-system and highlight the limitations and opportunities therein. It will also discuss Merck’s response to the pandemic, highlighting the different vaccine approaches, as well as the company’s response with antivirals and therapeutic treatments. With the success of new technologies, most notably mRNA, alternate approaches to pandemic response will also be discussed as well as its long-term impact on the vaccines market.

45 minutes

Tarit Mukhopadhyay

Tarit is the Head of Vaccine Process R&D at Merck. He is based in West Point, PA and overseas the development all pipeline projects, technologies, and collaborations within the vaccines area. Before joining Merck, he was a professor at University College London, and chaired the working group for the UK Vaccine Network for epidemic/outbreak preparedness.

Introduction to Vaccine Development with Case Studies on Rotavirus, HPV, COVID-19, and Influenza

The development of successful vaccines has been accomplished using a great variety of different technologies and a summary of these will be described.  Case studies will be presented for vaccines effective against Rotavirus, COVID, HPV and Influenza and some of the major challenges highlighted for integration of process development, analytics, clinical evaluation and transfer to routine manufacturing.

45 minutes

Barry Buckland

Barry Buckland obtained a PhD in Biochemical Engineering from University College London. During his 28 years at Merck Research Laboratories, he led the process development and transfer of technology to manufacturing for many key new vaccines including Hepatitis A, Rotavirus, HPV, Shingles, Chicken Pox, and pneumonia. Since leaving Merck 12 years ago Barry has worked […]

Lunch Break

30 minutes

Established and emerging science of Vaccine Adjuvants

Adjuvants are vaccine components that enhance the magnitude, breadth, and durability of the immune response. Since its introduction in the 1920s, insoluble Alum remained the only adjuvant licensed for human use for the next 70 years. However, since the 1990s, a further five adjuvants have been included in licensed vaccines. Yet, the molecular mechanisms by which adjuvants work remains only partially understood. A revolution in our understanding of the molecular pathways of activation of the innate immune system through pattern recognition receptors (PRRs) has allowed a mechanistic understanding of adjuvants, and resulted in the development of adjuvants containing TLR ligands. I will reviewed progress in adjuvant biology, including the notion that tissue damage, different forms of cell death, and metabolic regulators and nutrient sensors, can all profoundly activate the innate immune system and adaptive immunity. Also, recent advances in the use of systems biology to probe the molecular networks driving immune response to vaccines in humans is revealing new mechanistic insights and providing a new paradigm for the vaccine discovery-development process.

45 minutes

Derek O’Hagan

Dr. O’Hagan currently serves as Senior Advisor in R&D in GSK Vaccines, since 2018, and a GSK Fellow, since 2019. Prior to this Dr. O’Hagan was the Global Head of Discovery Support and New Technology in GSK Vaccines. Until 2015, her served as  the Global Head of Vaccine Chemistry and Formulation Research for Novartis Vaccines. […]

Quality Control of Human Viral Vaccines

Ensuring the biosafety and quality of human vaccines is achieved through a multi-tiered approach that examines several factors to establish product safety and manufacturing consistency.  The manufacture of vaccines can be both complex and challenging.  There are a number of key process goals which are maintained to achieve scalable processes to ensure reproducibility of product.  We provide an analysis of the current regulatory requirements for cell substrate testing and characterization of vaccines .  Current testing methods are reviewed and presented to ensure understanding of methods to provide assurance of viral safety.  The use of  state of the art techniques to improve and expand existing testing processes to examine process product related impurities, identity and viral safety provides a level of both safety and quality assurance which address  current  regulatory expectations will also be presented.  

45 minutes

Alison Armstrong

Alison Armstrong serves as the Global Head Field Technology Management and Technical services leading a team of scientific and regulatory experts within the Merck BioReliance® testing services business.  Alison holds a PhD in Molecular Virology from the University of Glasgow and she has a certificate in Advanced Management from Cranfield University School of Management. Throughout […]

Lessons from the CAACB on the Prevention and Control of Adventitious Agent Contamination

Abstract: Adventitious agent contamination of cell culture-based biomanufacturing operations for the production of protein and monoclonal antibody biotherapeutics are infrequent, but when they do occur, they are very costly, impact manufacturing operations, and can potentially impact patient safety and product supply. In response to this need, the MIT Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) began the confidential collection and analysis of industry-wide viral contamination data with an emphasis on “lessons learned”. The mission of the CAACB is to pool and to share knowledge, experience and practices in the area of adventitious agent contamination in biomanufacturing.  The Consortium is providing a safe and collaborative environment for networking and information exchange focused on identifying best industry practices in contamination response, corrective and preventive actions, and promoting the development of new technologies to detect adventitious agents and mitigate risk of contamination. This presentation will cover the learnings from this study, including identified industry risks and best practices to mitigate those risks. This talk will discuss some of the lessons learned from the collaborative work done by the CAACB and their implications for vaccine manufacture.

45 minutes

Paul W. Barone

Paul W. Barone has been at the Massachusetts Institute of Technology’s Center for Biomedical Innovation (CBI) since 2010 where he is currently the Director of the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) a pre-competitive biopharmaceutical industry consortium focused on identifying and sharing best practices to mitigate the risk of adventitious agent contamination in […]

Vaccine Product Development – The View from the Post-Approval Side

This session will provide an industry perspective on how post-approval CMC changes impact global supply.  Case studies will be presented to illustrate how increased product characterization during early and late development can improve this picture and consequently improve patient access.

45 minutes

Kimberly Duffy

Kimberly Duffy has been with Merck since 1988, her entire career in the vaccine manufacturing field.  Kim has held positions in Vaccine Manufacturing, Quality Control, Laboratory Operations, and Regulatory Affairs.  Kim joined the Regulatory CMC group in 2007 and has led the organization responsible for global registrations and post-approval changes for a variety of vaccines; […]

Day 1 Closing Remarks

10 minutes

Advancing SARS-CoV-2 Subunit Vaccine Candidates with Improved Immunogenicity and Manufacturability

Abstract: Access to current authorized and licensed vaccines for SARS-CoV-2 remains limited in many low- and middle-income countries. Storage requirements and costs are two factors that impact the distribution. New vaccines using safe and proven adjuvants like alum and protein subunits amenable to large-scale, low-cost production in existing manufacturing facilities could further enhance global access and immunity. This talk will describe a series of pandemic-driven collaborations to advance a modular vaccine candidate based on SARS-CoV-2 Receptor Binding Domain (RBD) presented on a Hepatitis B Antigen virus-like particle. Improvements in the molecular design of the RBD for immunogenicity and expression, engineering of strains of Komagaetalla phaffii  to allow scale-up in a methanol-free process, and non-clinical data to support demonstrations of protective immunity will be discussed. Considerations for future readiness for pandemics will be discussed.   Biography: J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering at the Koch Institute of MIT, and the Director of the AltHost Consortium—an MIT-Industry research collaboration on advancing next-generation manufacturing hosts. His research lab focuses on advancing technologies for improving the design and production of recombinant biopharmaceuticals and vaccines. He has authored more than 100 peer-reviewed papers and advises a number of companies, including ones he has helped found (Honeycomb Bio, OneCyte Bio, Sunflower Therapeutics).

45 minutes

J. Christopher Love

J. Christopher Love is the Raymond A. (1921) and Helen E. St. Laurent Professor of Chemical Engineering at the Koch Institute of MIT, and the Director of the AltHost Consortium—an MIT-Industry research collaboration on advancing next-generation manufacturing hosts. His research lab focuses on advancing technologies for improving the design and production of recombinant biopharmaceuticals and […]

Process Intensification for Scalable & Cost-Effective Vaccine Manufacture in Response to New Disease Outbreaks

The global COVID-19 pandemic has highlighted the important role that scalable and flexible manufacturing solutions in enabling rapid response to new disease outbreaks. The pandemic has led the biotech industry to join forces to rapidly develop different vaccine candidates (e.g. mRNA, vector vaccines, protein subunits etc.). Given the scale of the immunization campaigns needed, reaching the correct manufacturing capacity is paramount, hence the scalable and flexible technologies are needed in order to accommodate different process designs while enabling wide access to these vaccines. This presentation will demonstrate how process intensification is used to provide scalable and flexible solutions for cost-effective vaccine manufacture.

45 minutes

Tania Pereira-Chilima

Tania D. Pereira Chilima is the Chief Technology Officer at Univercells Technologies where she focuses driving innovation to execute our mission of making biologics globally available and affordable. She also oversees the direction of the technology portfolio and is responsible for continuously identifying new technologies that could complement our portfolio as well as the application […]

Advancing Global Health: The Role of Vaccine Bioprocessing and Commercialization

The introduction of vaccines ranks as one of the greatest healthcare achievements in modern history. Through the global efforts of the vaccine community, small pox has been eradicated worldwide and the eradication of polio nears. Other infectious diseases such as measles have been eliminated from large regions of the world. All of these advances have contributed to increases in health around the globe. The ongoing COVID 19 pandemic has demonstrated the value of vaccination and we’ve all witnessed the rapid development of new vaccines. However, vaccine distribution is subject to a high degree of inequity that correlates with national income levels, as well as with access to vaccine manufacturing facilities. New advances in vaccine manufacturing and delivery, such as highly intensified small-foot print manufacturing processes and improved vaccine delivery, may help to address these inequities. The speaker will touch upon each of these topics during the presentation.

45 minutes

David Robinson

As Deputy Director, CMC Vaccines Development and Surveillance, David and his team work with internal and external partners to develop manufacturing technologies and execute CMC strategies to advance the foundation’s goal to save lives and reduce healthcare inequities. Specifically for COVID, David is a co-chair of the COVAX Vaccine Manufacturing SWAT team and a member […]

Lunch Break

30 minutes

Transforming the Production of Tailor-Made Glycoconjugate Vaccines

The Future Vaccine Manufacturing Research Hub (Vax-Hub) is a partnership between academia, industry and non-government organizations aimed at the development, scale up and manufacture of vaccines for LMIC. In this talk an overview of the Hub mechanism, outcomes and research activities will be presented, as well as a case study focusing on a promising Protein-Glycan Coupling technology (PGCT) and the science-based approach used to speed up the process development of a new vaccine.

45 minutes

Martina Micheletti

Martina Micheletti is a Professor of Bioprocess fluid Dynamics from the department of Biochemical Engineering at UCL. She is co-Director of the Future Vaccine Manufacturing Research Hub.

Conjugate Vaccine Structure, Development, and Manufacture

The manufacture of conjugate vaccines is very complex.   Carrier proteins and capsular polysaccharides are produced by fermentation processes, while capsular polysaccharide activation and conjugation to the carrier protein are chemically mediated.  Process development requires a cross-discipline team of scientists with backgrounds in analytical chemistry, biochemistry, bioprocess, chemistry, engineering, statistics, and vaccines research.  Throughout the development process, care must be taken to ensure that the physicochemical, biochemical, and immunogenic properties of the conjugate are consistently maintained across production scales.  This talk will highlight some of the manufacturing and development challenges encountered with conjugate vaccines and potential mitigations.

45 minutes

Stephen A. Kolodziej

Steve has been an Associate Research Fellow in the Bioprocess R&D group at the Pfizer-St. Louis site since 2010, where his team has focused on process development of protein conjugates as biotherapeutic drug candidates for vaccine (prophylactic and therapeutic), oncology and cardiovascular indications.  Prior to this position, he spent 16 years in the Discovery Medicinal […]

Broadly Neutralizing Antibodies Against HIV and Novel Vaccine Approaches to Generate Them

A large and diverse body of evidence indicates that vaccine-mediated protection against HIV infection will require the induction, in vaccinated individuals, of antibody responses that are able to potently neutralize the ability of diverse genetic variants of HIV to establish infection in host target cells. Such broadly neutralizing monoclonal antibodies (HIV bnAbs) have been isolated from HIV infected individuals and their interactions with specific regions of the HIV Envelope glycoprotein (EnV) mapped in exquisite detail. In addition, the unusual structural features of the HIV bnAbs themselves are now well understood. Further, the pathways of evolution of HIV bnAbs within infected individuals over the course of their infections has been described for a number of HIV bnAb families. Collectively, these data have provided detailed insights into why induction of HIV bnAbs by a wide range of HIV vaccine candidates represents an unprecedentedly complex challenge and why it has not been achieved by any HIV vaccine candidates evaluated in clinical trials to date. A recent clinical trial (the “AMP study”) has provided direct evidence that a HIV bnAb can protect individuals at high risk of HIV infection from becoming infected, and also helped define a potential threshold for bnAb potency, breadth of recognition and in vivo levels needed to confer protection. Despite the biological challenges in inducing HIV bnAb responses by vaccination, the combination of contemporary structural and computational biology approaches, combined with high resolution immunologic analyses have helped frame a rational hypothesis for how HIV bnAbs may be generated by vaccination, and an initial experimental medicine trial (IAVI G001) has provided important foundational evidence to support this concept. This presentation will summarize progress made to date in HIV bnAb-focused vaccine efforts and describe ongoing work to further accelerate progress to achieve this long-elusive goal.

45 minutes

Mark Feinberg

Mark Feinberg is President and CEO of the International AIDS Vaccine Initiative (IAVI) where he leads a global team working to advance the development of vaccines and other biomedical innovations to protect against infection with HIV, TB and other infectious diseases that disproportionately impact low income countries. Prior to joining IAVI in late 2015, Mark […]

Day 2 Closing Remarks

15:10

Facilitating the Development of COVID-19 Vaccines

Emerging infectious diseases can cause epidemics or pandemics, as the current global COVID-19 outbreak has well demonstrated. Rapidly responding to such outbreaks requires adequate public health capabilities including the ability to rapidly develop, evaluate, manufacture, and deploy adequate supplies of preventative vaccines. Early on during the pandemic, the Food and Drug Administration issued guidance to help expedite the development of COVID-19 vaccines. In the United States there are three vaccines now authorized or approved for use. These include one of the vaccines that is available for use in individuals at least 5 years of age. Additional primary vaccine doses have also been authorized for certain immunocompromised individuals and boosters have been authorized for all adults. The development of COVID-19 vaccines for the youngest children is currently ongoing.

45 minutes

Peter Marks

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development.  He joined the […]

Vaxzevria: The Journey to Develop and Commercialize a COVID-19 Vaccine for the World

Over the past 18 months, AstraZeneca, Oxford University and its partners and suppliers have been on an incredible journey of developing and commercializing Vaxzevria, the AstraZeneca COVID-19 vaccine. In little over 6 months, AstraZeneca developed the commercial process, analytics as well as scaled up the process to enable the emergency use authorization of Vaxzevria. This presentation outlines the process development and analytical development strategy as well as the technology transfer efforts needed to successfully establish the manufacturing network required for worldwide supply of Vaxzevria. The presentation will also discuss the analytical comparability strategy that was successfully employed to enable licensure of greater than thirty five drug substance and drug product manufacturing sites that were needed to supply the vaccine to the world. These efforts were foundational to the efforts of AZ and its partners who have thus far supplied over 2 Billion doses of COVID-19 Vaccine to the world.

1 hour

Raghavan Venkat

Raghavan Venkat (Venkat in short) leads the Cell Culture and Fermentation Sciences team, Bioprocess technologies and engineering team, as well as the Flu MS&T team within Biopharmaceutical Development (BPD) at AstraZeneca.  Venkat obtained his B. Tech. degree in Chemical Engineering at Anna University, Chennai, India and his M.S. and Ph.D. degrees in Chemical Engineering at […]

Sir Adrian Hill

Adrian V.S. Hill is Professor of Vaccinology and Director of the Jenner Institute at Oxford University. In 2005 he founded the Jenner Institute at Oxford, which is now one of the largest academic vaccine centres globally with clinical-stage vaccine programmes against fifteen diseases. His malaria vaccine has shown high efficacy in clinical trials in the […]

COVID-19: Developing a Vaccine During a Pandemic

45 minutes

Dan H. Barouch

Dr. Dan Barouch received his Ph.D. in immunology from Oxford University and his M.D. from Harvard Medical School. He is currently the William Bosworth Castle Professor of Medicine and Professor of Immunology at Harvard Medical School, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, a member of the […]

Supplying a CVD 19 Vaccine at Unprecedented Pace and Scale

This presentation will explore how Pfizer and BioNtech developed, scaled, and overcame numerous challenges to supply approximately 3B doses of our mRNA vaccine to the world during 2021.

45 minutes

David Sullivan

David is currently the Vice President of Large Molecule Technology and a member of the PGS Global Technology & Engineering leadership team.  In this role, David and his team are responsible for providing technical leadership and support for all new and marketed vaccine/biological products.  This scope includes 2nd generation process development, technology transfer, supply robustness, […]

Lunch Break

30 minutes

Cambridge Marriott Ballroom

mRNA Vaccines for Rapid and Adaptable Pandemic Response

The recent emergence of the Omicron variant highlights the necessity of pandemic responses which can be rapidly adapted to changing needs. mRNA technology is uniquely suited to meet this urgent need both by virtue of the high degree of characterization attainable and the potential for sequence-agnostic manufacturing. Moderna has established a vaccine technology platform by combining established methods for vaccine process development based on Quality by Design (QbD) with advanced process control strategy and analytical characterization methods. Once a product is initially developed, the technology can be readily adapted to respond to variants. The strategy will be illustrated with examples from the development of mRNA-1273 and follow-on products addressing variants.

45 minutes

Don Parsons

Don Parsons leads process development activities for lipid nanoparticles for Moderna as a member of the Technical Development Leadership Team. He also coordinates CMC activities for Moderna’s early clinical development portfolio. He has over 25 years of experience in the pharmaceutical and biotechnology industry, leading process development and analytical development functions for both large and […]

Julia O’Neill

Julia O’Neill leads CMC Modeling and Statistics for Moderna as a member of the Technical Development Leadership Team. She is a Fellow of the American Society for Quality and has consulted supporting approval of multiple accelerated products including gene therapy, microbiome, and regenerative medicine. O’Neill worked at Merck (MSD) as Senior Scientific Fellow – Statistics […]

Lessons Learned from COVID-19 and How to Prepare for the Future: a Panel Discussion

45 minutes

Raghavan Venkat

Raghavan Venkat (Venkat in short) leads the Cell Culture and Fermentation Sciences team, Bioprocess technologies and engineering team, as well as the Flu MS&T team within Biopharmaceutical Development (BPD) at AstraZeneca.  Venkat obtained his B. Tech. degree in Chemical Engineering at Anna University, Chennai, India and his M.S. and Ph.D. degrees in Chemical Engineering at […]

David Sullivan

David is currently the Vice President of Large Molecule Technology and a member of the PGS Global Technology & Engineering leadership team.  In this role, David and his team are responsible for providing technical leadership and support for all new and marketed vaccine/biological products.  This scope includes 2nd generation process development, technology transfer, supply robustness, […]

Don Parsons

Don Parsons leads process development activities for lipid nanoparticles for Moderna as a member of the Technical Development Leadership Team. He also coordinates CMC activities for Moderna’s early clinical development portfolio. He has over 25 years of experience in the pharmaceutical and biotechnology industry, leading process development and analytical development functions for both large and […]

Julia O’Neill

Julia O’Neill leads CMC Modeling and Statistics for Moderna as a member of the Technical Development Leadership Team. She is a Fellow of the American Society for Quality and has consulted supporting approval of multiple accelerated products including gene therapy, microbiome, and regenerative medicine. O’Neill worked at Merck (MSD) as Senior Scientific Fellow – Statistics […]

Peter Marks

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development.  He joined the […]

Day 3 Closing Remarks

10 minutes

Stacy Springs

Dr. Stacy Springs serves as Senior Director of Programs at MIT’s Center for Biomedical Innovation (CBI) and Executive Director of CBI’s Biomanufacturing Initiatives, which include the BioMANufacturing Consortium (BioMAN), its Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), and its BioACCESS initiative. The objective of the BioMANufacturing Consortium is to develop new knowledge, science, technologies […]

SPEAKERS

Alison Armstrong
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Alison Armstrong

Merck Group

Paul W. Barone
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Paul W. Barone

MIT

Dan H. Barouch
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Dan H. Barouch

Harvard Medical School

Barry Buckland
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Barry Buckland

University College London

Kimberly Duffy
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Kimberly Duffy

Merck & Co, Inc.

Mark Feinberg
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Mark Feinberg

International AIDS Vaccine Initiative

Stefanie Frank
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Stefanie Frank

University College London

Sir Adrian Hill
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Sir Adrian Hill

University of Oxford

Stephen A. Kolodziej
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Stephen A. Kolodziej

Pfizer

J. Christopher Love
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J. Christopher Love

MIT

Peter Marks
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Peter Marks

USFDA

Martina Micheletti
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Martina Micheletti

University College London

Tarit Mukhopadhyay
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Tarit Mukhopadhyay

Merck & Co, Inc.

Derek O’Hagan
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Derek O’Hagan

GlaxoSmithKline

Julia O’Neill
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Julia O’Neill

Moderna

Don Parsons
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Don Parsons

Moderna

Tania Pereira-Chilima
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Tania Pereira-Chilima

Univercells

David Robinson
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David Robinson

Gates Foundation

Stacy Springs
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Stacy Springs

MIT

David Sullivan
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David Sullivan

Pfizer

Raghavan Venkat
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Raghavan Venkat

AstraZeneca

Jacqueline Wolfrum
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Jacqueline Wolfrum

MIT

VENUE

All attendees have been sent an email containing Zoom webinar log on details.  Please contact Marisia Ketchum (mketchum@mit.edu) if you have yet to receive your log-on credentials!

REGISTER

Registration for the 2021 Vaccines Workshop is now closed!

Contact Marisia Ketchum (mketchum@mit.edu) if you would like to join the event.

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