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Public-Private collaboration for accessible infectious disease mAbs in LMICs
There are significant gaps in monoclonal antibodies (mAbs) access and availability in low- and middle-income countries (LMICs). The highest burden populations for a growing number of licensed mAbs are not benefiting from this class of innovations. Prophylactic, long acting mAbs offer a viable alternative and complementary approach to vaccines in protecting against infections of critical importance in LMICs, but the impact of this established modality may not be realized. Viable business models, commercial incentives and pathways to afford access are currently not in place. Public-Private collaboration will likely be needed to bridge this gap.
Co-organized by: IAVI, Medicines Patent Pool (MPP), Unitaid and Wellcome
Goal of session: To foster mAb developer engagement to understand the barriers and define the incentives and enablers that would facilitate affordable access to mAbs in LMICs.
Target audience: Participants in the World Vaccine Congress, in particular industry stakeholders working in the mAbs field and broader stakeholders with expertise or interest in various aspects related to the development, manufacturing, supply, regulation, and procurement of monoclonal antibodies.
10:00 Introduction
Shelly Malhotra, Executive Director, Global Access, IAVI
10:20 Panel: Challenges and opportunities: What are the barriers and unique considerations for mAbs accessibility/availability in LMICs? What advancements have recently been achieved and how can they be further leveraged for infectious disease mAbs?
Moderator: Carmen Pérez Casas, Strategy Senior Lead/PPPR Head, Unitaid
11:20 Panel: Industry perspectives on a path towards access and the role of global health stakeholders
Moderator: Esteban Burrone, MPP
12:20 Wrap up/Closing remarks
Pete Gardner, Wellcome
Co-organized by: SAVAC
Objectives: Bring together vaccine developers to seek alignment and investment in Strep A vaccine development.
What is the progress on new technologies in medical product development?
How our governments are incentivizing (portfolio approach), especially with biotech? What International collaborations are being facilitated?
Cutting-edge technologies shaping the future of vaccine development.
10:00 Workshop Leader Opening RemarksDr Wolfgang Leitner, Chief, Innate Immunity Section, NIH
10:10 Innovating Vaccine Development: The Role of VaxArray in SolaVAX, a novel photochemical inactivation vaccine platformDr. Izabela Ragan DVM, Director of Research and Development, Solaris Vaccines
10:30 Revolutionizing mRNA Production: the paradigm-breaking Nfinty™ continuous RNA systemPatrick Thiaville, Chief Technologies Officer, Nucleic Acids, Exothera
10:45 A Novel Intranasal Adjuvant Show to be Safe and Immunogenic in HumansDr Chad Costley, CEO & President, Blue Willow Biologics
11:00 Use of adjuvants to enhance mucosal immunity after vaccinationDr Lisa Morici, Professor, Tulane University School of Medicine
11:15MF59 Adjuvant Mimic: yeast derived squalene and alternative sourcesChase Kempinski, CEO, Enepret
11:30 Alternative uses for adjuvants & cross-over immunotherapy technologies Dr Jay Evans, Chief Scientific and Strategy Officer, Inimmune & Director of the Center for Translational Medicine at the University of Montana
11:45 New developments in vaccine adjuvant research: How has the pandemic changed the field?Dr Wolfgang Leitner, Chief, Innate Immunity Section, NIH
12:00 Utilizing AI in Adjuvant Discovery – Title TBCDr David Dowling, Scientist, Professor, Division of Infectious Diseases, Instructor in Pediatrics, Boston Children's Hospital & Harvard Medical School
12:15 Fine-Tuning Immunity, AI-Driven Adjuvant Discovery, Sustainable Formulations, and Novel Vaccine Delivery Strategies – Title TBCDr Aaron Esser-Kahn, Professor of Molecular Engineering, University of Chicago
12:30 Fireside Chat: Emerging discovery tools and technologiesModerator: Dr Jay Evans, Chief Scientific and Strategy Officer, Inimmune & Director of the Center for Translational Medicine, University of MontanaDr David Dowling, Scientist, Professor, Division of Infectious Diseases, Instructor in Pediatrics, Boston Children's Hospital & Harvard Medical SchoolDr Wolfgang Leitner, Chief, Innate Immunity Section, NIHDr Aaron Esser-Kahn, Professor of Molecular Engineering, University of Chicago
A holistic approach will be integral to tackling the AMR pandemic – how is industry ensuring the development of new tools & which interventions are best suited to our priority pathogens?
10:00 Chair opening remarks
Dr Anna Jacobs, Biologist, Antimicrobials Division, BARDA
10:10 Accelerating the Development of Novel Tools against AMR
Dr Richard Alm, Chief Scientist, CARB-X
10:40 The application of phages to treat bacterial infections
Dr Steven Theriault, CEO & CSO, Cytophage
11:10 The role of diagnostics in AMR
Claire Wingfield, Director, Partnerships and Advocacy, FIND
11:35 The Significance of Robust Health and Economic Data in Tackling Antimicrobial Resistance
Latifat Okara, Principal, Health Policy and Insights, The Economist Impact
Jennifer Young, VP, Global Policy & Public Affairs – Specialty Care, Pfizer
Melissa Mitchell, Secretariat Lead, AMR Industry Alliance
12:00-1:00 Panel: What is our AMR strategy: ESKAPE and Priority Pathogens?
Moderator: Dr Kimberly Taylor, Senior Scientific Officer, Biodefense Vaccines, NIH
Dr Tim Cooke, CEO, Omniose
Dr Bret Sellman, Executive Director, Vaccine and Immune Therapies and Head of Bacteriology and Vaccines Discovery, Astrazeneca
Dr Francesca Micoli, Director GVGH Innovation Academy and Senior Project Leader, GSK Vaccine Institute for Global Health
1:00 - 2:00 Lunch Break
2:00 Combination vaccines to combat AMR
Dr William Hausdorff, Public Health Value Proposition Lead, PATH
2:30 Shigella and ETEC vaccines
Dr Chad Porter, Department Head Translational and ClinicalResearch Defense Infectious Diseases Directorate, Naval Medical Research Center
3:00 Serotype Independent Pneumococcal Vaccine
Dr Tim Hirst, CEO, GPN Vaccines
3:30 Developing Pseudomonas and Klebsiella vaccines using a reverse vaccinology approach
Dr Rebecca Ingram, Senior Lecturer, Queens University Belfast
3:45 Update on C. diff vaccine development
Dr Erik Lamberth, Senior Director, Vaccine Clinical Research and Development, Pfizer
4:00-5:00 Panel: Defining the value of vaccines against AMR
Moderator: Dr Jomana Musmar, Executive Director, PACCARB
Dr Jessica Pickett, Director, US Vaccines Health Economics and Outcomes Research, GSK
Dr Fadi Makki, Partner and Director, BCG
Dr John Jernigan, Chief, Epidemiology Research and Innovations Branch Division of Healthcare Quality Promotion, CDC
Dr Yewande Alimi,One Health Unit Lead,Africa CDC
How are we improving our understanding of RNA technology for next generation vaccines? How will RNA transform therapeutics and cancer treatment?
10:00 Chair opening remarks
Prof Jeffrey Coller, Bloomberg Distinguished Professor of RNA Biology and Therapeutics Professor of Molecular Biology and Genetics, Johns Hopkins University
10:10 mRNA vaccines of the future: Bridging the Knowledge Gaps
Dr Sudha Chivukula, AVP, Head of Discovery Biology, mRNA Centre of Excellence, Sanofi
10:25 Beyond respiratory vaccines
Dr Jacqueline Miller, SVP, Therapeutic Area Head - Infectious Disease Development, Moderna
10:45Individualized mRNA vaccines
Ruben Rizzi, Senior Vice President Global Regulatory Affairs, BioNtech
11:00 Accessing vast design space with modular high throughput platform for RNA therapeutics and vaccines
Dr Sarit Schwartz, Head of RNA, Business Development Gingko Bioworks
11:15 Analytical challenges in characterization of multivalent mRNA vaccines
Dr Gautam Sanyal, Principal Consultant and Founder, Vaccine Analytics, LLC
11:30 RNABL: A Novel RNA Delivery Platform for Therapeutic Applications
Dr Micheal Breen, Scientist, Tiba Biotech
11:45 From a preventive vaccine to a therapeutic vaccine
Dr Jason Zhang, CEO and Co-Founder, ZipCode Bio
12:00 – 1:00 Panel: Beyond prophylactic vaccines: the future of RNA therapeutics
Moderator: Anna Rose Welch, Editorial and Community Director, Advancing RNA, Life Science Connect
Dr Gilles Besin, Chief Scientific Officer, Orbital Therapeutics
Dr Gopi Shanker, Chief Scientific Officer, Beam Therapeutics
Dr Andrew Geall, Chief Development Officer, Replicate Bioscience
Dr Kate Zhang, Chief Scientific Officer, Hopewell Therapeutics
Africa CDC, in collaboration with partners such as Mastercard Foundation, Institut Pasteur de Dakar and other key stakeholders have been working on potential solutions with propositions of establishing the Vaccine Research and Development Centres and a Research and Development Coordinating Platform. This program envisages the establishment of a system of regional R&D centres connected by a single continental R&D coordinating platform. R&D centres will consolidate infrastructure, assets, and expertise (virtually or physically) in each region to deliver meaningfully on at least one stage of the R&D value chain.
Objectives:
The first 90 minutes will made of a round questions aimed at the panellists, followed by Q&As from participants. An opportunity to discuss Vaccine R&D Talent, R&D in general in Africa and perspectives from the continental body (Africa CDC) and active engagements with participants. The final 30 min will be the time for participants to engage with Panellists and networking opportunities
This session explores solutions that can reshape adult vaccination through policy and system level change (e.g., closing coverage gaps, timeliness of coverage, data systems, equity considerations, alternative administration sites), provider level (e.g., simplification and standardization of recommendations, system prompts), and consumer level (e.g., healthy aging, empowerment and education).
Advanced vaccine delivery methods: novel routes and technologies to optimize administration, efficacy, and accessibility.
2:00 Workshop Leader Opening Remarks:David Hoey, President & CEO, Vaxxas
2:10 Microneedle Patches for Measles-Rubella Vaccine Delivery: Gamechangers for Measles and Rubella Elimination:Dr Stephen Crooke, Vaccine Immunology Lead, Viral Vaccine Preventable Diseases, Center for Disease Control and Prevention
2:30 Redefining Access: Prefilled Injectables for Safe and Efficient Vaccinations.:Dr Edward Kelley, Chief Global Health Officer, Apiject
3:00 RNA & MAP - Combining Breakthrough Innovations:Dr Markus Winterberg, Head of Analytical Development, Microbiology, and Quality Control, LTS Lohmann
3:15 Formulate the future: cutting-edge technologies for manufacturing of sustainable components of vaccine delivery systems:Dr Dennis Christensen, Global Head of R&D, Adjuvant Systems, CRODA
3:30 CeraMAPs(tm), the next generation Micro-needle Array Patches:Mike G.W. de Leeuw, CEO, Mylife Technologies
3:45 Improving the performance of vaccines with precision-delivery technologies:Dr Carmen Ledesma-Feliciano, Scientific Affairs Manager, Pharmajet
4:15 Consumer Preference for High-Density Microarray Patch to Enable Skin Delivery of Vaccines:Dr Rochelle Chaiken, Chief Medical Officer, Vaxxas
4:30 HalDisc®: A Fast-Delivery Investigational Microneedle TechnologyMariacristina Castelli, Chief Clinical and Regulatory Affairs Officer,on behalf ofHisamitsu Pharmaceuticals
BEYOND EFFICACY [PM3]: Innovating vaccine development and implementation for impact
Room 207A
Vaccine efficacy is only one determinant of vaccine impact. This workshop will explore innovations throughout the development of a novel vaccine which may ensure better access and equity.Whichever the theme each year, it will challenge our thinking, our dogmas and perhaps reveal new horizons. It honoursDr Mike Watson, a true vaccinologist and original thinker.
2pm Workshop leader opening remarks:Dr Angus Thomson,Principal,Irimi Company,Bruce Gellin, MD, MPH, Chief, Global Public Health Strategy, Senior Vice President, Health, The Rockefeller Foundation
2:10pm Presentation 1:Program implementation – Electronic Immunization Records are foundational for equitable vaccination (and PHC)
EIRs can reduce HCW workload,track the un- and under-vaccinated and be leveraged in many ways to build vaccine demand and uptake. They can facilitate a switch from input-based financing to results-based financing, a transformational shift which can drive vaccine uptake and may be a scaffold for many other PHC services.
Rustam Nabiev, Director,Shifo Foundation
2:40pm Presentation 2:Outracing the Outbreak: CEPI’s Mission to Develop Vaccines in 100 Days
To meet its vision of developing a pandemic vaccine within 100 days, CEPI identified a number of transformational innovations in technologies, processes and partnerships that will be required. What are these necessary shifts in what we do and in how we think and act? And how can they inform the development and delivery of routine vaccines as well?
Dr Rebecca Farkas, Director of Dept of R&D Innovations,CEPI
3:10pm Presentation 3:Beyond the infodemic: Building a foundation for infodemiology within public health systems
Public health programs across the world struggled with an infodemic of disinformation through the COVID-19 pandemic. However our understanding of how to more systematically track and respond to disinformation, and how to proactively create healthier health nformation ecosystems moved ahead in leaps and bounds. Infodemiology is a new public health discipline that studies the spread of information with the goal of improving health. Infodemiology.com, which launched this week, provides live dashboards that track trending online health conversations, practical trainings that will help integrate infodemiology into daily practice, and the latest resources from across the field. It aims to support public health professionals and health care providers to practice effective infodemiology in routine practice, and is already being used by leading public health institutions and healthcare associations in the US.
Joe Smyser, CEO, The Public Good Projects
3:40pm Presentation 4:How do we make sure that the vaccines we develop are what countries want?
Recent new vaccine technologies such as mRNA, peptides or VLPs allow for rapid, flexible and scalable development and production of new vaccine candidates. But these innovations mean little if they aren’t translated into vaccines that used. How can we mapthe potential public health, economic and societal value and the realities of vaccination programs when selecting candidate vaccines.
Dr William Hausdorff,Public Health Value Proposition Lead,PATH
4.10pm Panel Discussion with all speakers.
Identifying innovative and collaborative solutions throughout the development pathway to advance NTD vaccine candidates beyond historical roadblocks.
2:00 Workshop Leader Opening Remarks
Dr Simona Rondini, Head Bacterial Projects and Senior Project Leader, GSK Vaccines Institute for Global Health
2:20 Panel: Optimizing pre-clinical frameworks to maximize successful transition of NTD vaccines into the critical path
Moderator: Dr Maria Elena Bottazzi, Co-Director of Texas Children’s Hospital for Vaccine Development, Baylor College of Medicine
Dr Phillip Felgner, Director, UCI Vaccine Research & Development Center & Protein Microarray Laboratory and Training Facility, University of California IrvineDr Simona Rondini, Head Bacterial Projects and Senior Project Leader, GSK Vaccines Institute for Global Health
Dr Jeffrey Bethony, Professor & Vice Chair for Translational Research, Department of Microbiology, Immunology & Tropical Medicine, The George Washington University
Dr Jay Evans, Chief Scientific and Strategy Officer, Inimmune & Director of the Center for Translational Medicine at the University of Montana
3:20 Panel: Navigating the Critical Path: Advancing NTD Vaccines Beyond Phase II
Moderator: Dr Orin Levine, Non-Resident Fellow, Center for Global Development
Dr David Diemert, Professor & Clinical Director, GW Vaccine Research Unit, The George Washington University
Amy Finan, CEO, Sabin Vaccine Institute
Dr Milagritos Tapia, Professor of Pediatrics, University of Maryland
4:15 Transnational & Regional Approaches to Pandemic PreparednessDr Jerome Kim, Director General, IVI
Prof Leo Poon, Chair of Public Health Virology, The University of Hong Kong
Dr Gaurav Pandey, Head of Vaccine Process Development, IVI
In 2020, the World Health Organization (WHO) set out to achieve Cervical Cancer Elimination by 2030. While countries across the globe are making progress towards the WHO 90-70-90 targets for vaccination, screening, and treatment, more must be done to meet these important milestones. This session will highlight the importance of multi-sectoral partnerships (both in the US and globally) in driving progress towards the WHO elimination targets in pursuit of a world free of cervical cancer.
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In many developing countries, social media usage is growing at a rate of 50% per year and disinformation is increasing. In some African countries, a majority of adults did not have sufficient trust to accept a Covid vaccination. The response from governments to misinformation and trust deficits often uses 19th century rather than 21st century technology.
This roundtable discussion is focused on sharing ideas to help change that, covering topics such as:
Transforming data-use in demand work through rapid surveys and pulse checks Achieving a step-change in the use of social media to combat misinformation
Utilizing 21st century approaches to understand and respond to vaccine hesitancy
Strengthening government capacity to rapidly and proactively respond to rumors and misinformation
Lessons learned from the private sector in approaching demand and communications
In this roundtable scientific experts will discuss the importance of accurate and precise viral titers both as analytical assays and real-time process analytical technology (PAT). From raw material characterization to the measurement of precise infectious titer during process development, manufacturing, and QC the measurement of viral infectivity is a critical parameter for consistent quality assurance throughout vaccine development and production workflows.
Please choose another roundtable
In many developing countries, social media usage is growing at a rate of 50% per year and disinformation is increasing. In some African countries, a majority of adults did not have sufficient trust to accept a Covid vaccination. The response from governments to misinformation and trust deficits often uses 19th century rather than 21st century technology.
This roundtable discussion is focused on sharing ideas to help change that, covering topics such as:
Transforming data-use in demand work through rapid surveys and pulse checks Achieving a step-change in the use of social media to combat misinformation
Utilizing 21st century approaches to understand and respond to vaccine hesitancy
Strengthening government capacity to rapidly and proactively respond to rumors and misinformation
Lessons learned from the private sector in approaching demand and communications
In this roundtable scientific experts will discuss the importance of accurate and precise viral titers both as analytical assays and real-time process analytical technology (PAT). From raw material characterization to the measurement of precise infectious titer during process development, manufacturing, and QC the measurement of viral infectivity is a critical parameter for consistent quality assurance throughout vaccine development and production workflows.
Please choose another roundtable
Join us in the exhibition hall (level 3) for:
1:10 – 2:30 1-2-1 Partnering
1:30 – 2:20 Start-up pitches
2:00 – 2:30 Poster Presentations
Sponsored by Tekton Research.
Only those who have paid for the ViE admission can attend. If you do not have the official awards ticket you will not be allowed entry to the drinks reception or awards
ViE Award & Pre-Drinks Reception attendance is by strict RSVP which is now CLOSED.
For those who had previously RSVP on the website your confirmation email / code will be required on entry to pick up your wrist band. If you didn't RSVP previously and/or don't have the confirmation email then please do not turn up as we have only allocated seats for those who have.
Only those who have paid for the ViE admission can attend. If you do not have the official awards ticket you will not be allowed entry to the drinks reception or awards
ViE Award & Pre-Drinks Reception attendance is by strict RSVP which is now CLOSED.
For those who had previously RSVP on the website your confirmation email / code will be required on entry to pick up your wrist band. If you didn't RSVP previously and/or don't have the confirmation email then please do not turn up as we have only allocated seats for those who have.
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-Global infectious disease surveillance
-Epidemic and pandemic preparedness
Tired of chasing data queries and spending hours correcting errors? In vaccine trials, where speed is crucial, clean data matters. This session dives into how electronic systems can revolutionize your workflow, reducing data entry errors and streamlining analysis using practical examples and case studies.
Eliminate double data entry: Put an end to double data entry and say goodbye to redundant queries with a single point of data capture.Edit-proof your data: Experience the power of automated validation and reduced manual edits, leading to cleaner, more reliable datasets.Faster analysis, faster results: Spend less time cleaning and more time analyzing, accelerating your journey to vaccine submission.
Enhance data integrity: Secure audit trails prevent unauthorized changes.
Boost your vaccine impact: Discover how clean data empowers faster development, ultimately saving lives and improving public health.
Key takeaways:
Time is of the essence in vaccine trials. This session will demonstrate how cleaner data translates to faster results, ultimately contributing to the effectiveness and broader availability of life-saving vaccines using practical case studies and real-world data.
The WHO declared the end of COVID-19 as apublic health emergencyin May 2023. Since then, the number of COVID-19 metrics easily available has declined drastically across the world. Alternative data sources are therefore needed to continue to track and analyse COVID-19 trends in a post-pandemic world.Airfinity will be presenting never before seen analyses showing how wastewater data has closelyfollowed COVID-19 cases, hospitalisation and deaths, and how it can beused as a relative indicator of disease levels to inform vaccination timelines.
1. Intent for Vaccination and Public Health Strategy
2. Equity in Vaccine Access and Distribution
3. Pharmacy Access, Scope of Practice for Healthcare Providers
4. Coverage, and Payment Challenges
5. Preparing for the Next Season: Lessons Learned and Future Strategies
Reserved for Dr Wassana Wijagkanalan, Scientific Advisor, BioNet
Senior representative Vaxess
Domestic manufacturing in the U.S. healthcare supply chain is essential for ensuring a resilient and responsive system, especially in times of crisis. Supporting local or regionalized production reduces sourcing risks, ensuring timely and reliable access to critical healthcare supplies, and an economically sound medical/pharmaceutical industrial base. This session provides an opportunity for interactive dialogue with federal partners on long term solutions.
Sponsored by Cerba Research
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-Do we need multi-stage vaccine vs multi target vaccines?
-Elimination vs Eradication
-What are the biggest hurdles to enable malaria vaccine eradication?
· Engaging with diverse partners to encourage vaccination in underserved communities
· Innovative initiatives with trusted partners
· Addressing emerging needs and changing demographics
· Overcoming challenges in your own communities