Day One AM

7:15 am - 8:15 am

Morning Check-in & Coffee

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed et nulla sit amet justo volutpat placerat. Cras ac sapien porta, facilisis dolor aliquet, efficitur justo. Maecenas et condimentum libero, ut porttitor ligula. Nunc velit felis, imperdiet non semper eget, sagittis eget turpis. Nulla nec purus elit. Nullam finibus ipsum vel sapien bibendum, et molestie lacus…

8:15 am - 8:30 am

Chair’s Opening Remarks

Speaker

8:30 am - 9:30 am

CXOs’ Panel Discussion: Unlocking the Next Frontiers of mRNA-Based Vaccines & Therapeutics to Ensure Better Drugs Reach Patients Faster

What do you think are the top 3 opportunities/near future wins for the mRNA field? Given your role in the C-suite, what are the biggest challenges you face on a day-to-day basis and what kind of decisions do you have to make? Given your role and affiliation, how do you view the market consolidation and…

Speakers

9:30 am - 10:00 am

Clinical Safety & Impact of RNA Cell Therapy in Patients with Myasthenia Gravis

RNA cell therapy allows transient expression of chimeric antigen receptor in T cells, enabling therapies that do not require lymphodepletion and eliminate risk of cancerous transformation Expanding the potential of cell therapies to patients with autoimmunity, where the risk-benefit ratio is more stringent than in oncology Sharing our latest data from clinical trials using our…

Speaker

10:00 am - 10:30 am

mRNA Therapeutics: Riding the Next Wave in Biotech

mRNA Therapeutics: Riding the Next Wave in Biotech Eras that define the evolution of biotechnology The latest and the greatest in the world of mRNA – the next frontier in biotech The bottlenecks in clinical translation and how Resilience is striving to address those challenges

Speaker

  • Aalok Shah

    Aalok Shah
    Director of Process Development - Resilience

10:30 am

Morning Networking Break

Day One Track A, PM

Day One Track A, PM, Heading 1

2:00 pm

Session 1 Day One Track A, PM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

3:00 pm

Session 2 Day One Track A, PM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

  • Kevin Nguyen

    Kevin Nguyen
    Head of Business Development - Pacific Partnerships

Day One Track B, PM

3:00 pm

Session 2 Day One Track B, PM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

Day Two AM

Test Track

Lorem Ipsum has been the industry’s standard dummy text ever since the 1500 when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with…

Speakers

Day Two Track A, AM

Day Two Track A, AM, Heading 1

8:00 am

Session 1 Day Two Track A, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

9:00 am

Session 2 Day Two Track A, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

Day Two Track B, AM

Day Two Track B, AM, Heading 2

10:30 am

Session 3 Day Two Track B, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

11:00 am

Session 4 Day Two Track B, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

Day Two

Test Track

Lorem Ipsum has been the industry’s standard dummy text ever since the 1500 when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged. It was popularised in the 1960s with…

Speakers

Day Two Track A, AM, Heading 1

8:00 am

Session 1 Day Two Track A, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

8:00 am

Day Two Track C, AM, Heading 1

8:00 am

Session 1 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

9:00 am

Session 2 Day Two Track A, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

9:00 am

Session 2 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

Day Two Track B, AM, Heading 2

Day Two Track C, AM, Heading 2

10:30 am

Session 3 Day Two Track B, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

10:30 am

Session 3 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

11:00 am

Session 4 Day Two Track B, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

11:00 am

Session 4 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

  • Sarah Lee

    Sarah Lee
    Chief Strategy Officer - Visionary Ventures

Day One Track A - Discovery

Unlocking the Power of Next Generation Base Editors & Replicating mRNA for Pushing the Frontiers of mRNA

11:30 am - 12:00 pm

Advancing Next Generation Gene Editing with Beam Therapeutics’ Proprietary Next Generation Base Editor

Using mRNA for targeted delivery of a single nucleotide base editor to cure genetic ailments Preventing dsDNA breaks for more efficient and predictable gene editing Revealing pre-clinical data on ex vivo and in vivo p

Speaker

  • Luis Barrera

    Luis Barrera
    Senior Vice President, Data Sciences - Beam Therapeutics

12:00 pm

Multimodal Support of mRNA Therapeutic Development

Download the event guide for full session details.

Speaker

12:30 pm - 1:00 pm

Enabling Single-Dose, Multivalent Vaccination Against Pathogens of High Consequence Using a Muscle-Localizing NanocarrierFormulated Replicating mRNA

Download the event guide for full session details.

Speaker

1:00 pm - 1:10 pm

Accessing a Vast Design Space with a Modular High Throughput Platform for RNA Therapeutics & Vaccines

Download the event guide for full session details.

Speaker

Day One Track B - Translation

Widening the Scope of mRNA with circRNA Vaccines & Therapeutics to Treat Infectious & Oncological Diseases

11:30 am - 12:00 pm

Introducing Orbital’s circRNA Vaccine Platform as a Novel Alternative to a Linear Vaccine

Download the event guide for full session details.

Speaker

  • Gilles Besin

    Gilles Besin
    Chief Scientific Officer - Orbital Therapeutics

12:00 pm - 12:30 pm

Reduction of LNP-Associated Inflammation with Use of Biodegradable Lipids

Ionizable lipids are known to present varying degrees of immunotoxicity. Understanding the role of key cellular mediators such as the NLRP3 inflammasome in this context will be key to developing the next generation of safe, well tolerated non-viral delivery systems Our work on biodegradable ionizable lipids has indicated that tissue resident macrophages are key mediators…

Speaker

  • Syed Reza

    Syed Reza
    Scientific & Sales Consultant - NOF CORPORATION

12:30 pm - 1:00 pm

In vivo panCARTM Therapy Using Circular RNA for the Treatment of B Cell Malignancies in Oncology & Autoimmune Disease

Download the event guide for full session details.

Speaker

1:10 pm

Lunch Networking Break

Supercharging the Translation of Novel mRNA Therapeutics to Combat Cancer & Advance Regenerative Medicine

2:15 pm - 2:45 pm

Advancing Novel mRNA Therapeutics Through Discovery & Development Phases

Download the event guide for full session details.

Speaker

  • Sam Deutsch

    Sam Deutsch
    Chief Scientific Officer - Nutcracker Therapeutics

2:45 pm - 3:15 pm

mRNA-Based Transcription Factor Delivery to In Vivo Disease Models

Download the event guide for full session details.

Speaker

3:15 pm - 3:45 pm

Advancing Onco-Selective mRNA Therapeutics with Kernal’s KR-335 Program to Kill Tumor Cells

Download the event guide for full session details.

Speaker

  • Manfred Kraus

    Manfred Kraus
    Vice-President, Head of R&D Therapeutics - Kernal Biologics

3:45 pm

Afternoon Networking Break & Poster Session

Broadening the Horizons of mRNA Through Next Generation Replicating Vaccines & Therapeutics

4:30 pm - 5:00 pm

Improvements to the Self-AAmplifying RNA Platform for Safer & More Effective Vaccines & Therapeutics

Download the event guide for full session details.

Speaker

5:00 pm - 5:30 pm

Presenting Johnson & Johnson’s Discovery & Pre-Clinical Work with saRNA for Vaccine & Therapeutic Applications

Download the event guide for full session details.

Speaker

  • Rachel Groppo

    Rachel Groppo
    Director, Lead Self-Amplifying RNA Team - Johnson & Johnson Innovative Medicine

Day One Track C - Clinical Development

Advancing Neoantigen-Based mRNA Medicines in the Clinic to Effectively Treat Oncological Indications

11:30 am - 12:00 pm

Revealing Key Clinical Findings from Moderna’s Individualized Neoantigen Therapy Against Melanoma

Download the event guide for full session details.

Speaker

12:00 pm - 12:30 pm

Mitigating Risk Through Development & Engineering Runs When Transitioning from Preclinical to Clinical Manufacturing

Download the event guide for full session details.

Speaker

  • Evan Myers

    Evan Myers
    Associate Director, Process Development - TriLink BioTechnologies

12:30 pm - 1:00 pm

Neoantigen Immunotherapy for Solid Tumors: Molecular Responses & Clinical Benefit in Late-Stage Patients

Download the event guide for full session details.

Speaker

1:10 pm

Lunch Networking Break

Supercharging the saRNA Vaccine Platforms Against Infectious Diseases to Improve Patient Outcomes

2:15 pm - 2:45 pm

Next Generation Self-Replicating RNA (srRNA) Drives Substantial Improvement in Infectious Disease Vaccines

Download the event guide for full session details.

Speaker

2:45 pm - 3:15 pm

Strategies for Navigating the Complexity & Diversity of RNALipid Nanoparticles

Download the event guide for full session details.

Speaker

3:15 pm - 3:45 pm

Comparing a Second-Generation saRNA Flu Vaccine with a Traditional mRNA Flu Vaccine

Download the event guide for full session details.

Speaker

3:45 pm

Afternoon Networking Break & Poster Session

Revealing the Latest Next Generation Infectious Disease Vaccines to Open Up New Frontiers for mRNA

4:30 pm - 5:00 pm

Beyond Respiratory mRNA Vaccines: Moderna’s Norovirus mRNA Vaccine Candidates

Download the event guide for full session details.

Speaker

  • Till Schoofs

    Till Schoofs
    Director, Clinical Development, Infectious Diseases - Moderna

5:00 pm - 5:30 pm

Diving into the Analytical Characterization of in vitro Transcribed mRNAs

Download the event guide for full session details.

Speaker

  • Julien Camperi, Ph.D.

    Julien Camperi, Ph.D.
    Technical Development Principal Scientist - Gene & Cell Therapy - Genentech, A Member of the Roche Group

Day One Track D - CMC

Developing a Strategic Platform Approach to Ensure Robust Manufacturing Processes for mRNA-Based Drugs

11:30 am - 12:00 pm

Establishing an mRNA Vaccine Platform to Effectively Support a Broad Vaccine & Therapeutics Drug Portfolio

Download the event guide for full session details.

Speaker

12:00 pm - 12:30 pm

Trehalose & Sucrose: Essential Components of Platform Biopharma Formulations & COVID-19 Applications

Download the event guide for full session details.

Speaker

12:30 pm - 1:00 pm

Leveraging Historic Know-How to Establish a Strategic Internal End-to-End Nucleic Acid Production Platform

Download the event guide for full session details.

Speaker

  • Emily Wen

    Emily Wen
    Senior Principal Scientist - Merck & Co

1:00 pm - 1:30 pm

Quality in mRNA Therapeutics – How to Achieve this in Practice

Download the event guide for full session details.

Speaker

1:10 pm

Lunch Networking Break

Mission Possible: Showcasing Breakthrough mRNA Vaccine Initiatives to Establish Rapid Responses to Viral Pathogens

2:15 pm - 2:45 pm

RNA Vaccine Innovations for CEPI’s 100 Days Mission

Download the event guide for full session details.

Speaker

2:45 pm - 3:15 pm

Maximizing Success in mRNA Manufacturing: Key Considerations for Analytical Characterization

Download the event guide for full session details.

Speaker

  • Eunseo Ency Lee

    Eunseo Ency Lee
    Lead Scientist, mRNA Manufacturing Group - Samsung Biologics

3:15 pm - 3:45 pm

BAXERNA: On a Mission to Develop Novel Bacterial mRNA Vaccines

Download the event guide for full session details.

Speaker

3:45 pm

Afternoon Networking Break & Poster Session

Flash Poster Presentations

4:30 pm - 5:00 pm

Flash Poster Presentations

Jeffrey Ulmer, President, TechImmune LLC Rachel Young, Graduate Research Fellow, Rowan University Download the event guide for full session details.

Fine-Tuning mRNA Production with Innovative Enzymes & Raw Materials for Faster Synthesis

5:00 pm - 5:30 pm

Democratizing mRNA Therapeutics with Novel Cap Analogs & Modified NTPs

Download the event guide for full session details.

Speaker

  • May Guo

    May Guo
    Chief Commercial Officer - Areterna

Day One PM

5:30 pm

Drinks Reception Hosted by Thermo Fisher

Day One

7:15 am - 8:15 am

Morning Check-in & Coffee

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed et nulla sit amet justo volutpat placerat. Cras ac sapien porta, facilisis dolor aliquet, efficitur justo. Maecenas et condimentum libero, ut porttitor ligula. Nunc velit felis, imperdiet non semper eget, sagittis eget turpis. Nulla nec purus elit. Nullam finibus ipsum vel sapien bibendum, et molestie lacus…

8:15 am - 8:30 am

Chair’s Opening Remarks

Speaker

8:30 am - 9:30 am

CXOs’ Panel Discussion: Unlocking the Next Frontiers of mRNA-Based Vaccines & Therapeutics to Ensure Better Drugs Reach Patients Faster

What do you think are the top 3 opportunities/near future wins for the mRNA field? Given your role in the C-suite, what are the biggest challenges you face on a day-to-day basis and what kind of decisions do you have to make? Given your role and affiliation, how do you view the market consolidation and…

Speakers

9:30 am - 10:00 am

Clinical Safety & Impact of RNA Cell Therapy in Patients with Myasthenia Gravis

RNA cell therapy allows transient expression of chimeric antigen receptor in T cells, enabling therapies that do not require lymphodepletion and eliminate risk of cancerous transformation Expanding the potential of cell therapies to patients with autoimmunity, where the risk-benefit ratio is more stringent than in oncology Sharing our latest data from clinical trials using our…

Speaker

10:00 am - 10:30 am

mRNA Therapeutics: Riding the Next Wave in Biotech

mRNA Therapeutics: Riding the Next Wave in Biotech Eras that define the evolution of biotechnology The latest and the greatest in the world of mRNA – the next frontier in biotech The bottlenecks in clinical translation and how Resilience is striving to address those challenges

Speaker

  • Aalok Shah

    Aalok Shah
    Director of Process Development - Resilience

10:30 am

Morning Networking Break

Developing a Strategic Platform Approach to Ensure Robust Manufacturing Processes for mRNA-Based Drugs

Advancing Neoantigen-Based mRNA Medicines in the Clinic to Effectively Treat Oncological Indications

Widening the Scope of mRNA with circRNA Vaccines & Therapeutics to Treat Infectious & Oncological Diseases

Unlocking the Power of Next Generation Base Editors & Replicating mRNA for Pushing the Frontiers of mRNA

11:30 am - 12:00 pm

Revealing Key Clinical Findings from Moderna’s Individualized Neoantigen Therapy Against Melanoma

Download the event guide for full session details.

Speaker

Establishing an mRNA Vaccine Platform to Effectively Support a Broad Vaccine & Therapeutics Drug Portfolio

Download the event guide for full session details.

Speaker

Advancing Next Generation Gene Editing with Beam Therapeutics’ Proprietary Next Generation Base Editor

Using mRNA for targeted delivery of a single nucleotide base editor to cure genetic ailments Preventing dsDNA breaks for more efficient and predictable gene editing Revealing pre-clinical data on ex vivo and in vivo p

Speaker

  • Luis Barrera

    Luis Barrera
    Senior Vice President, Data Sciences - Beam Therapeutics

Introducing Orbital’s circRNA Vaccine Platform as a Novel Alternative to a Linear Vaccine

Download the event guide for full session details.

Speaker

  • Gilles Besin

    Gilles Besin
    Chief Scientific Officer - Orbital Therapeutics

12:00 pm - 12:30 pm

Mitigating Risk Through Development & Engineering Runs When Transitioning from Preclinical to Clinical Manufacturing

Download the event guide for full session details.

Speaker

  • Evan Myers

    Evan Myers
    Associate Director, Process Development - TriLink BioTechnologies

Reduction of LNP-Associated Inflammation with Use of Biodegradable Lipids

Ionizable lipids are known to present varying degrees of immunotoxicity. Understanding the role of key cellular mediators such as the NLRP3 inflammasome in this context will be key to developing the next generation of safe, well tolerated non-viral delivery systems Our work on biodegradable ionizable lipids has indicated that tissue resident macrophages are key mediators…

Speaker

  • Syed Reza

    Syed Reza
    Scientific & Sales Consultant - NOF CORPORATION

12:00 pm

Multimodal Support of mRNA Therapeutic Development

Download the event guide for full session details.

Speaker

12:00 pm - 12:30 pm

Trehalose & Sucrose: Essential Components of Platform Biopharma Formulations & COVID-19 Applications

Download the event guide for full session details.

Speaker

12:30 pm - 1:00 pm

Enabling Single-Dose, Multivalent Vaccination Against Pathogens of High Consequence Using a Muscle-Localizing NanocarrierFormulated Replicating mRNA

Download the event guide for full session details.

Speaker

In vivo panCARTM Therapy Using Circular RNA for the Treatment of B Cell Malignancies in Oncology & Autoimmune Disease

Download the event guide for full session details.

Speaker

Leveraging Historic Know-How to Establish a Strategic Internal End-to-End Nucleic Acid Production Platform

Download the event guide for full session details.

Speaker

  • Emily Wen

    Emily Wen
    Senior Principal Scientist - Merck & Co

Neoantigen Immunotherapy for Solid Tumors: Molecular Responses & Clinical Benefit in Late-Stage Patients

Download the event guide for full session details.

Speaker

1:00 pm - 1:10 pm

Accessing a Vast Design Space with a Modular High Throughput Platform for RNA Therapeutics & Vaccines

Download the event guide for full session details.

Speaker

1:00 pm - 1:30 pm

Quality in mRNA Therapeutics – How to Achieve this in Practice

Download the event guide for full session details.

Speaker

1:10 pm

Lunch Networking Break

Day One Track A, PM, Heading 1

2:00 pm

Session 1 Day One Track A, PM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

Supercharging the Translation of Novel mRNA Therapeutics to Combat Cancer & Advance Regenerative Medicine

Mission Possible: Showcasing Breakthrough mRNA Vaccine Initiatives to Establish Rapid Responses to Viral Pathogens

Supercharging the saRNA Vaccine Platforms Against Infectious Diseases to Improve Patient Outcomes

2:15 pm - 2:45 pm

Advancing Novel mRNA Therapeutics Through Discovery & Development Phases

Download the event guide for full session details.

Speaker

  • Sam Deutsch

    Sam Deutsch
    Chief Scientific Officer - Nutcracker Therapeutics

RNA Vaccine Innovations for CEPI’s 100 Days Mission

Download the event guide for full session details.

Speaker

Next Generation Self-Replicating RNA (srRNA) Drives Substantial Improvement in Infectious Disease Vaccines

Download the event guide for full session details.

Speaker

2:45 pm - 3:15 pm

Strategies for Navigating the Complexity & Diversity of RNALipid Nanoparticles

Download the event guide for full session details.

Speaker

Maximizing Success in mRNA Manufacturing: Key Considerations for Analytical Characterization

Download the event guide for full session details.

Speaker

  • Eunseo Ency Lee

    Eunseo Ency Lee
    Lead Scientist, mRNA Manufacturing Group - Samsung Biologics

mRNA-Based Transcription Factor Delivery to In Vivo Disease Models

Download the event guide for full session details.

Speaker

3:00 pm

Session 2 Day One Track A, PM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

  • Kevin Nguyen

    Kevin Nguyen
    Head of Business Development - Pacific Partnerships

3:00 pm

Session 2 Day One Track B, PM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

3:15 pm - 3:45 pm

Advancing Onco-Selective mRNA Therapeutics with Kernal’s KR-335 Program to Kill Tumor Cells

Download the event guide for full session details.

Speaker

  • Manfred Kraus

    Manfred Kraus
    Vice-President, Head of R&D Therapeutics - Kernal Biologics

BAXERNA: On a Mission to Develop Novel Bacterial mRNA Vaccines

Download the event guide for full session details.

Speaker

Comparing a Second-Generation saRNA Flu Vaccine with a Traditional mRNA Flu Vaccine

Download the event guide for full session details.

Speaker

3:45 pm

Afternoon Networking Break & Poster Session

Broadening the Horizons of mRNA Through Next Generation Replicating Vaccines & Therapeutics

Revealing the Latest Next Generation Infectious Disease Vaccines to Open Up New Frontiers for mRNA

Flash Poster Presentations

4:30 pm - 5:00 pm

Improvements to the Self-AAmplifying RNA Platform for Safer & More Effective Vaccines & Therapeutics

Download the event guide for full session details.

Speaker

Beyond Respiratory mRNA Vaccines: Moderna’s Norovirus mRNA Vaccine Candidates

Download the event guide for full session details.

Speaker

  • Till Schoofs

    Till Schoofs
    Director, Clinical Development, Infectious Diseases - Moderna

Flash Poster Presentations

Jeffrey Ulmer, President, TechImmune LLC Rachel Young, Graduate Research Fellow, Rowan University Download the event guide for full session details.

Fine-Tuning mRNA Production with Innovative Enzymes & Raw Materials for Faster Synthesis

5:00 pm - 5:30 pm

Diving into the Analytical Characterization of in vitro Transcribed mRNAs

Download the event guide for full session details.

Speaker

  • Julien Camperi, Ph.D.

    Julien Camperi, Ph.D.
    Technical Development Principal Scientist - Gene & Cell Therapy - Genentech, A Member of the Roche Group

Presenting Johnson & Johnson’s Discovery & Pre-Clinical Work with saRNA for Vaccine & Therapeutic Applications

Download the event guide for full session details.

Speaker

  • Rachel Groppo

    Rachel Groppo
    Director, Lead Self-Amplifying RNA Team - Johnson & Johnson Innovative Medicine

Democratizing mRNA Therapeutics with Novel Cap Analogs & Modified NTPs

Download the event guide for full session details.

Speaker

  • May Guo

    May Guo
    Chief Commercial Officer - Areterna

5:30 pm

Drinks Reception Hosted by Thermo Fisher

Day Two Track C, AM

8:00 am

Day Two Track C, AM, Heading 1

8:00 am

Session 1 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

9:00 am

Session 2 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

Day Two Track C, AM, Heading 2

10:30 am

Session 3 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

11:00 am

Session 4 Day Two Track C, AM

Lorem ipsum dolor sit amet, consectetur adipiscing elit Mauris viverra nibh sit amet consequat mattis Donec efficitur lectus eget velit molestie, et egestas tellus tempor

Speaker

  • Sarah Lee

    Sarah Lee
    Chief Strategy Officer - Visionary Ventures

Day 2 AM - SPP

8:00 am

Morning Check In & Coffee

8:20 am

Chair’s Opening Remarks

Speaker

  • Emily English

    Emily English
    Senior Vice President & Head of Manufacturing Operations - Cartesian Therapeutics

De-Risking Your Pipelines with Guidance from Regulatory Experts to Realize the Promise of mRNA

8:30 am

Discussing the Regulatory Expectations for mRNA-Based Therapeutics & Vaccines Against Infectious Diseases, Cancer & Rare Diseases

What are the regulatory differences between mRNA vaccines and therapeutics targeted to infectious, oncological, or rare indications? What can the next generation of mRNA vaccines and therapeutics expect as regulatory requirements? Are there any transferable regulatory learnings from mRNA vaccines and therapeutics for gene editing applications that use mRNA technology, including CRISPR?

Speaker

  • Peter Marks

    Peter Marks
    Director - Center for Biologics Evaluation & Research - US Food & Drug Administration (FDA)

9:00 am

TFF in RNA Workflow: Process Optimization for mRNA, saRNA, & LNP Manufacturing

Delta regenerated cellulose flat sheet membranes with 100 kDa molecular weight cutoff for TFF in RNA workflows TFF optimization for mRNA, saRNA, and LNPs where a single filter can work across modalities How process conditions can impact LNP processing time Scalability data from bench (93 cm2 ) to manufacturing-scale (2.5 m2 ) using LNPs, discussing…

Speaker

9:30 am

Panel Discussion : Uniting Regulatory Experts from Industry & Agencies to Navigate the Complex Landscape for mRNA-Based Medicines

How do the FDA, EMA and MHRA define a “platform” and what are the paths available to mRNA drug developers to utilize “platforms” as a way to expedite approvals Is it the right time to start developing mRNA specific regulatory guidance and should there be separate guidelines for each therapeutic area and/or application? What tools…

Speakers

  • Peter Marks

    Peter Marks
    Director - Center for Biologics Evaluation & Research - US Food & Drug Administration (FDA)

  • Ka-Wai Wan

    Ka-Wai Wan
    Leading Senior Pharmaceutical Assessor - Medicines & Healthcare products Regulatory Agency

  • Emily English

    Emily English
    Senior Vice President & Head of Manufacturing Operations - Cartesian Therapeutics

  • Nitisha Pyndiah

    Nitisha Pyndiah
    Director - Global Regulatory Affairs Lead - GlaxoSmithKline

  • Carla Vinals

    Carla Vinals
    Vice President, Global Regulatory Product Strategy - Moderna

  • Marco Cavaleri

    Marco Cavaleri
    Head of Anti-infectives & Vaccines - European Medicines Agency

10:15 am

Empowering the mRNA Industry with Nucleic Acid Therapeutics: Innovating for Success

Thermo Fisher Scientific’s extensive capabilities and tailored solutions in nucleic acid therapeutics, specifically for the mRNA industry Detailed overview of Thermo Fisher Scientific’s ability to deliver highly impactful and effective solutions in this rapidly evolving field An inspiring real-life example showcasing Thermo Fisher Scientific’s successful support for businesses in the mRNA industry, highlighting their reliability…

Speaker

  • Sara Henneman

    Sara Henneman
    General Manager, Nucleic Acid Therapeutics - Thermo Fisher Scientific Inc.

10:45 am

Morning Networking Break

Day 2 PM (ii) - SPP

3:00 pm

Gearing up for 2025: Licensing, Partnership & Financial Considerations in the Dynamic mRNA Landscape

3:15 pm

Wellcome Leap’s R3 Program: RNA Readiness & Response

R3: “RNA Readiness + Response” program goals and demonstrations at scale, to enable equitable access to RNA products and economically sustainable pandemic preparedness Living RNA Biofoundries based on multi-product, multi-scale, standardised manufacturing processes Demonstration on diverse RNA products and delivery systems stretch the edges of the product space Digital tools for product design and manufacturability…

Speaker

3:45 pm

Robust mRNA Production with End-to-End In-Process Analytics

Design of an efficient multi-step chromatographic process using CIMmultus re-usable columns to achieve scalable production of safe mRNA drug substance with low dsRNA, low fragments and residual DNA Deployment of fast analytical methods based on PATfix to reduce cost of drug substance production, and to optimize production and purification processes in shorter development timelines Overcoming…

Speaker

4:15 pm

Planning for the Second Half of 2024: Investments, Partnerships & De-Risking Your mRNA Pipeline for 2025

Seizing opportunities for investments and partnerships in a thriving mRNA company Overcoming challenges within a turbulent funding climate for mRNA companies to gain a scientific advantage Key recommendations to avoid risks and ensure success

Speaker

  • Gad Berdugo

    Gad Berdugo
    Managing Partner; Strategic Advisor - Explorium Capital

4:45 pm

Chair’s Closing Remarks

Speaker

5:00 pm

End of 4th mRNA-Based Therapeutics Summit 2024

Day 2 AM - Track B - Translation - SPP

Unlocking in vivo Cell Engineering Through mRNA Therapeutics Aiding the Fight Against Autoimmune & Oncological Diseases

11:15 am

Harnessing mRNA Technology to Unlock Cell Engineering Applications Against Solid Tumors

Introducing Factor’s proprietary platform applying mRNA to in vivo cell engineering therapeutics Transforming CAR-T cells in vivo to target solid tumors Expressing gene-editing proteins in vivo to turn “cold” tumors into “hot” tumors

Speaker

  • Matt Angel

    Matt Angel
    Co-Founder, Chairman & Chief Executive Officer - Factor Bioscience Inc.

11:45 am

Implementation of Phase Appropriate mRNA Analytics in a Contract Testing Environment: Balancing the Development & Qualification Approach in a mRNA Program

The analytical requirements for characterization of mRNA Drug Substance and Drug Products have been defined by the USP as well as sponsor companies participating in early phase clinical trials Balancing the effort spent on method development and qualification/validation is critical to keeping with timelines and controlling analytical costs How to utilize a suite of mRNA…

Speaker

  • Jeff Heiser

    Jeff Heiser
    Chief Scientific Officer - Microbial & Advanced Therapeutic Platforms - BA Sciences

12:15 pm

In Vivo Induction of CD19 CAR-T Cells using mRNA as a Therapeutic for Autoimmune Indications

Describing Capstan’s LNP platform capable of extra-hepatic delivery Targeting the hematopoietic system with tolerable doses of mRNA-LNP Discussing the pre-clinical CAR-T data in mouse and NHPs using Capstan’s technology

Speaker

Day 2 AM - Track A - Discovery - SPP

Accelerating the Development of mRNA-Based Vaccines & Therapeutics to Fight Infectious & Oncological Diseases

Speaker

11:15 am

Advancing Immunoinformatic Tools for Epitope Mapping to Supercharge Development of mRNA-Based Personalized Cancer Vaccines

Streamlined and automated cancer vaccine design platforms are key to develop on-demand therapeutics Enhanced antigen selection enables the removal of inhibitory sequences that curtail vaccinemediated immune responses Computational vaccinology toolkit

Speaker

  • Guilhem Richard

    Guilhem Richard
    Chief Scientific & Technology Officer, Head of Innovation & Technology - EpiVax, Inc.

11:45 am

Radar Therapeutics: Pioneering Precision-Expressed mRNA Therapeutics

Overview of Radar’s proprietary RNA sense-and-respond platform for precise expression of mRNA/gene therapeutics RADAR enables cell-type specific RNA expression by sensing intracellular RNA markers that define the cell type, disease state or cell state of interest to activate translation of a synthetic transcript RADAR enables precise, autonomous cell-selectivity that can bring specificity to broadly-targeting delivery…

Speaker

  • Sophia Lugo

    Sophia Lugo
    CEO, Chairman, and Co-Founder - Radar Therapeutics

12:15 pm

Innovac’s End-To-End Approach to Capitalize on the mRNA Revolution in the Vaccine Industry

Describing Innovac’s platform technologies and pipeline to drive the next wave of therapeutic and prophylactic mRNA vaccines Selecting and stratifying disease targets and patient populations for mRNA vaccines Revealing new pre-clinical data from multiple vaccine projects targeting infectious diseases and cancer

Speaker

Day 2 AM - Track C - Clinical Development- SPP

Key Clinical Case Studies on mRNA-Based Vaccines & Therapeutics Against Rare Diseases

11:15 am

Unveiling Moderna’s Latest Efforts to Target Rare Diseases with Protein Replacement Using mRNA Therapeutics

Introducing Moderna’s latest expansions into rare diseases with mRNA protein therapy Revealing proof of concept from early stage trials against propionic and methylmalonic acidemia, and type 1 glycogen storage disease Discussing safety data from prolonged exposure to mRNA therapeutics targeted at the above indications

Speaker

  • Kyle Holen

    Kyle Holen
    Head of Oncology & Therapeutics Development - Moderna

11:45 am

Overcoming dsRNA Challenge: Innovation in Assays & Enzymes

Optimization of IVT-PP for dsRNA is challenging Next-Generation T7: Overall performance enhanced ds-SensorTM: State-of-the-art dsRNA assay

Speaker

12:15 pm

Leveraging the LUNAR® Platform to Develop RNA Medicines for Diseases with Significant Unmet Medical Needs & Accelerated Clinical Paths

Overview of the ARCT-032 program – an mRNA replacement therapy to deliver a new copy of the CFTR mRNA into CF patients’ airways Overview of the ARCT-810 Program – an mRNA medicine that enables OTC patients to make healthy functional OTC enzymes in their liver cells ARCT-154 demonstrates non-inferiority to original strain and superior immunogenicity…

Speaker

  • Sean Sullivan

    Sean Sullivan
    Vice President, Senior Fellow & Head of Research & Technology Innovation - Arcturus Therapeutics

Day 2 AM - Track D - CMC - SPP

11:10 am

Deciphering Critical Quality Attributes & Embracing Next Generation Analytical Techniques for Enhanced mRNA Characterization

11:15 am

Understanding Critical Quality Attributes for mRNA in a Cell Therapy Setting

Review of the recent general quality guidelines for mRNA Applying the guidelines to mRNA quality in the context of a cell therapy program Strategies for analytical development, qualification and validation for mRNA in a cell therapy context

Speaker

  • Emily English

    Emily English
    Senior Vice President & Head of Manufacturing Operations - Cartesian Therapeutics

11:45 am

Comprehensive Evaluation of T7 Polymerase for Enhanced Yield & Quality in mRNA Production

A high throughput screening (HTS) workflow was established to enable comprehensive evaluation of T7 polymerase as a critical raw material in mRNA production Four commercially available wild type T7 polymerases were systematically evaluated via DOE based optimizations, subsequently lot-to-lot variations, and scalability studies A deep profile of each T7 polymerases including their performance in mRNA…

Speaker

  • Jing Zhu

    Jing Zhu
    Director- Messenger Ribonucleic Acid, Process & Analytical Development - Recipharm

12:15 pm

Process & Analytical Development Advances for eRNA Therapeutics

Introduction to Sail Biomedicines’ bioplatform for programmable medicines Overview of the differences between the techniques used for eRNA compared to mRNA How to align RNA analytical methods to streamline manufacturing

Speaker

  • Francis Poulin

    Francis Poulin
    Vice President - Analytical Sciences - Sail Biomedicines

Day 2 PM - Track C - Clinical Development- SPP

1:40 pm

Unlocking Novel Disease Areas with Disruptive Companies Using Next Generation mRNA Therapeutics

1:45 pm

Updates & Interim Data of mRNA-Based Cancer Vaccines to Treat EBV-Related Cancers

Presenting the latest clinical data for breakthroughs in the treatment of EBV-related cancers, including NPC and NKT lymphoma Highlighting safety and efficacy based on ongoing enrolment and interim data from clinical trials Demonstrating the transformative potential of mRNA therapeutics in the treatment of viralrelated malignancies

Speaker

  • Xiangrong Song

    Xiangrong Song
    Chief Executive Officer & Co-Founder - WestGene Biopharma

2:15 pm

Clinical Updates on Gene Editing Therapeutics Targeting Rare Diseases in the Liver

Introducing YolTech’s high throughput discovery platform for novel CRISPR-CAS proteins Revealing clinical trial data from the lead program targeting ATTR with a gene editing approach Revealing clinical trial data from a second program targeting PCSK9 with a gene editing approach

Speaker

Day 2 PM - Track D - CMC - SPP

Upgrading Platforms Through the Latest Digital & Technological Advancements for Faster mRNA Manufacturing

1:45 pm

Harnessing Digital Twin for mRNA Manufacturing

Mechanistic models are being constructed for all unit operations for the manufacturing of mRNA biotherapeutics The models are integrated with models for constraints, uncertainties, and disturbances to form a digital twin for integrated manufacturing The digital twin is used to analyze the comparative performance for batch and continuous manufacturing

Speaker

  • Richard Braatz

    Richard Braatz
    Professor & Associate Director - Faculty - Massachusetts Institute of Technology

2:15 pm

Evolving Self-Amplifying RNA Development by Pinpointing Influences & Tailoring Manufacturing Scale

Identifying the differences in materials and piloting the process development to optimize the results Navigating the landscape of new technologies, and how to incorporate this into your program Discussing the future of self-amplifying RNA and customized therapies, and scaling processes to meet patient needs

Speaker

Afternoon Networking Break

Day 2 PM - Track B - Translation - SPP

1:40 pm

Enabling Improved Potency Assays for Faster & Robust Efficacy Characterization

1:45 pm

Critical Quality Attributes: Development of a Potency Platform Assay for mRNA-Based Therapeutics & Vaccines

Current guidelines and ongoing discussions with health authorities regarding potency assay strategies Overview of existing technologies Introduction of a potency assay platform approach

Day 2 PM - Track A - Discovery - SPP

Elucidating the Fate of the mRNA Payload Inside the Cell for Increased Delivery Efficiency & Expression

1:45 pm

Decoding the Dance: Unravelling the Moves of LNP-mRNA-based Vaccines

Understanding the Mechanism of Action of vaccines based on LNP-mRNA technology Investigating the internalization and trafficking of cellular LNP, as well as the release of RNA cargo Unravelling the Mechanism of Endosomal Escape

Speaker

  • Alisa Zhilin-Roth

    Alisa Zhilin-Roth
    Senior Scientist. Discovery Biology- In Vitro and Mechanism of Action. Center for mRNA Excellence - Sanofi

Day 1 AM - Track B - Translation - SPP

Widening the Scope of mRNA with circRNA Vaccines & Therapeutics to Treat Infectious & Oncological Diseases

11:30 am

Introducing Orbital’s circRNA Vaccine Platform as a Novel Alternative to a Linear Vaccine

Download the event guide for full session details.

Speaker

  • Gilles besin

    Gilles besin
    Chief Scientific Officer - Orbital Therapeutics

12:00 pm

Reduction of LNP-Associated Inflammation with Use of Biodegradable Lipids

Download the event guide for full session details.

Speaker

  • Syed Reza

    Syed Reza
    Licensing & External Innovation Alliance Mangement Professional - NOF CORPORATION

12:30 pm

In vivo panCARTM Therapy Using Circular RNA for the Treatment of B Cell Malignancies in Oncology & Autoimmune Disease

Download the event guide for full session details.

Speaker

Day 1 AM - Track C - Clinical Development - SPP

Advancing Neoantigen-Based mRNA Medicines in the Clinic to Effectively Treat Oncological Indications

Speaker

11:30 am

Revealing Key Clinical Findings from Moderna’s Individualized Neoantigen Therapy Against Melanoma

Download the event guide for full session details.

12:00 pm

Mitigating Risk Through Development & Engineering Runs When Transitioning from Preclinical to Clinical Manufacturing

Download the event guide for full session details.

Speaker

  • Evan Myers

    Evan Myers
    Associate Director - Process Development - TriLink BioTechnologies

12:30 pm

Neoantigen Immunotherapy for Solid Tumors: Molecular Responses & Clinical Benefit in Late-Stage Patients

Download the event guide for full session details.

Speaker

Day 1 PM (ii) - SPP

5:30 pm

Drinks Reception Hosted by ThermoFisher Scientific

Day 1 PM (i) - Track D - CMC - SPP

Mission Possible: Showcasing Breakthrough mRNA Vaccine Initiatives to Establish Rapid Responses to Viral Pathogens

2:15 pm

RNA Vaccine Innovations for CEPI’s 100 Days Mission

Download the event guide for full session details.

Speaker

  • Dimki Patel

    Dimki Patel
    Chemistry, Manufacturing, & Controls Program Lead - CEPI

2:45 pm

Maximizing Success in mRNA Manufacturing: Key Considerations for Analytical Characterization

Download the event guide for full session details.

Speaker

3:15 pm

BAXERNA: On a Mission to Develop Novel Bacterial mRNA Vaccines

Download the event guide for full session details.

Speaker

Day 1 PM (ii) - Track B - Translation - SPP

Broadening the Horizons of mRNA Through Next Generation Replicating Vaccines & Therapeutics

Speaker

4:30 pm

Improvements to the Self-Amplifying RNA Platform for Safer & More Effective Vaccines & Therapeutics

Download the event guide for full session details.

5:00 pm

Presenting Johnson & Johnson’s Discovery & Pre-Clinical Work with saRNA for Vaccine & Therapeutic Applications

Download the event guide for full session details.

Speaker

  • Rachel Groppo

    Rachel Groppo
    Director - self amplifying Ribonucleic Acid team Lead - Johnson & Johnson

Day 1 PM (ii) - Track D - CMC - SPP

Flash Poster Presentations

4:30 pm

Flash Poster Presentations

Download the event guide for full session details.

Speakers

Fine-Tuning mRNA Production with Innovative Enzymes & Raw Materials for Faster Synthesis

5:00 pm

Democratizing mRNA Therapeutics with Novel Cap Analogs & Modified NTPs

Download the event guide for full session details.

Speaker

Day 1 PM (i) - Track A - Discovery - SPP

Advancing RNA Drug Development & Design with Next-Generation Discovery Platforms

2:15 pm

Introduction to Orna’s Proprietary IRES Discovery & Drug Design Platform for Durable & Sustainable circRNA Expression

Download the event guide for full session details.

Speaker

2:45 pm

Novel Efficient Cap Analogs Development & Application for mRNA Therapeutics

Download the event guide for full session details.

Speaker

  • Junlan Ren

    Junlan Ren
    Managing Director - Henovcom Bioscience Co.,Ltd

3:15 pm

Development of an mRNA Platform to Fight Infectious Disease

Download the event guide for full session details.

Speaker

Day 1 PM (i) - Track B - Translation - SPP

Supercharging the Translation of Novel mRNA Therapeutics to Combat Cancer & Advance Regenerative Medicine

2:15 pm

Advancing Novel mRNA Therapeutics Through Discovery & Development Phases

Download the event guide for full session details.

Speaker

2:45 pm

mRNA-Based Transcription Factor Delivery to In Vivo Disease Models

Download the event guide for full session details.

Speaker

3:15 pm

Advancing Onco-Selective mRNA Therapeutics with Kernal’s KR-335 Program to Kill Tumor Cells

Download the event guide for full session details.

Speaker

  • Manfred Kraus

    Manfred Kraus
    Vice President & Head of Research & Development Therapeutics - Kernal Biologics Inc.

Day 1 PM (i) - SPP

3:45 pm

Afternoon Networking Break & Poster Session

Day 1 AM - Track D - CMC - SPP

Developing a Strategic Platform Approach to Ensure Robust Manufacturing Processes for mRNA-Based Drugs

11:30 am

Establishing an mRNA Vaccine Platform to Effectively Support a Broad Vaccine & Therapeutics Drug Portfolio

Download the event guide for full session details.

Speaker

12:00 pm

Trehalose & Sucrose: Essential Components of Platform Biopharma Formulations & COVID-19 Applications

Download the event guide for full session details.

Speaker

12:30 pm

Leveraging Historic Know-How to Establish a Strategic Internal End-to-End Nucleic Acid Production Platform

Download the event guide for full session details.

Speaker

  • Emily Wen

    Emily Wen
    Senior Principal Scientist - Merck & Co

1:00 pm

Quality in mRNA Therapeutics – How to Achieve this in Practice

Download the event guide for full session details.

Speaker

  • Phil Challis

    Phil Challis
    Senior Vice President - etherna immunotherapies NV

Day 1 PM (ii) - Track A - Discovery - SPP

Advancing Next Generation mRNA Drug Development with Optimized mRNA-LNP Platforms to Enable Targeted Delivery

4:30 pm

Introducing ZipCode Bio’s Proprietary mRNA Medicine Platform

Download the event guide for full session details.

5:00 pm

Shedding Light on dsRNA: Specific & Sensitive Detection Using Bioluminescence

Download the event guide for full session details.

Day 1 PM (ii) - Track C - Clinical Development - SPP

Revealing the Latest Next Generation Infectious Disease Vaccines to Open Up New Frontiers for mRNA

4:30 pm

Beyond Respiratory mRNA Vaccines: Moderna’s Norovirus mRNA Vaccine Candidates

Download the event guide for full session details.

Speaker

5:00 pm

Diving into the Analytical Characterization of in vitro Transcribed mRNAs

Download the event guide for full session details.

Speaker

  • Julien Camperi

    Julien Camperi
    Senior Principal Scientist - Gene & Cell Therapy - Genentech

Day 1 PM - SPP

1:10 pm

Lunch Networking Break

Day 1 PM (i) - Track C - Clinical Development - SPP

Supercharging the saRNA Vaccine Platforms Against Infectious Diseases to Improve Patient Outcomes

2:15 pm

Next Generation Self-Replicating RNA (srRNA) Drives Substantial Improvement in Infectious Disease Vaccines

Download the event guide for full session details.

Speaker

2:45 pm

Strategies for Navigating the Complexity & Diversity of RNALipid Nanoparticles

Download the event guide for full session details.

Speaker

3:15 pm

Comparing a Second-Generation saRNA Flu Vaccine with a Traditional mRNA Flu Vaccine

Download the event guide for full session details.

Focus Day PM - SPP

3:15 pm

Afternoon Networking Break

3:45 pm

Breakthrough Innovations Workshop Save Millions of Lives, Trillions of Dollars, and Enable Real Global Equity

The R3: RNA Readiness and Response program, took a page from the semiconductor industry transformation in the 1980s, which developed multi-product foundries with standardized processes and design tools that exploded global innovation.  This session will cover R3 advances in: Manufacturing processes, with the potential for 10mg to 1kg of RNA-based product, or up to 100…

Speakers

6:45 pm

Drinks Reception hosted by Wellcome Leap

Focus Day AM - SPP

8:00 am

Morning Check In & Coffee

Next Generation mRNA Delivery Day

8:50 am

Chair’s Opening Remarks

Speaker

  • Annette Bak

    Annette Bak
    Head of Advanced Drug Delivery - AstraZeneca

Advancing Novel Lipid Discovery to Improve Nanoparticle Composition for Safe Systemic Delivery of LNP-mRNA

9:00 am

Overcoming Anti-PEG Antibody Responses to Increase Potency & Decrease Adverse Side Effects of mRNA-LNP Formulations

Speaker

9:30 am

Phospholipids in Vaccines

Speaker

10:00 am

AI-Assisted Design of IV-Administered Organ-Targeting LNPs for Effective Nucleic Acid Delivery to Extrahepatic Organs

Speaker

Innovating Nanoparticles Beyond LNPs to Access Specific Organs & Supercharge Your mRNA Delivery Chair: Annette Bak, Head of Drug Delivery, AstraZeneca

11:00 am

Crafting a Multi-Layered Nano Formulation Approach to mRNA Stabilization & Cell-Specific Delivery Using a Novel Nucleic Acid Delivery Platform

Speakers

  • Jessica Rouge

    Jessica Rouge
    Associate Professor - University of Connecticut

  • Annette Bak

    Annette Bak
    Head of Advanced Drug Delivery - AstraZeneca

11:30 am

yEVs Enabling the High-Efficiency Introduction of Diverse Cargos, Including mRNA, Functional Antibodies, & Enzymes, to a Broad Range of Cell & Tissue Types

Speaker

12:00 pm

Engineering Futuristic & Next Generation Nanoplatforms for Delivery of mRNA Therapeutics: Academia-to-Industry Innova

Speaker

  • Beata Chertok

    Beata Chertok
    Team Lead, Delivery of Intracellular Biologics - AstraZeneca

Optimizing System Design to Increase Delivery Efficiency & Unlock Novel Therapeutic Applications of mRNA

1:30 pm

Panel Discussion: Delving into the Latest Innovations in LNPs & Beyond for Effective Delivery of mRNA Therapeutics

Speakers

2:00 pm

Moving Beyond the Needle: mRNA Vaccine Delivery via Dermal, Pulmonary, & Nasal Pathways

Speaker

2:30 pm

Designing Lipid Nanoparticles for mRNA Delivery to Study & Treat Diseases in Pregnancy

Speaker

Regulatory Affairs Strategy Day

8:50 am

Chair’s Opening Remarks

Speaker

  • Nazia Noor

    Nazia Noor
    VP Global Regulatory Affairs, CMC - BioNTech

Tackling mRNA CMC Challenges Through Regulatory Engagement & Platform Strategies for Faster Manufacturing

9:00 am

Anticipating & Planning for CMC-Related Regulatory Hurdles to Advance the Manufacturing of Next Generation mRNA Vaccines

Speaker

9:30 am

Roundtable Discussion: Aligning Quality Control & Regulatory Submissions for Personalized Cancer Vaccines to Get Life-Saving Drugs to Patients Faster

Speakers

  • Nazia Noor

    Nazia Noor
    VP Global Regulatory Affairs, CMC - BioNTech

  • Hang Yuan

    Hang Yuan
    CTO - Innovac Therapeutics

  • Ka-Wai Wan

    Ka-Wai Wan
    Leading Senior Pharmaceutical Assessor - Medicines & Healthcare products Regulatory Agency

10:00 am

Discussing How to Engage with the EMA to Expedite mRNA Medicines to Patients Faster

Speaker

  • Marco Cavaleri

    Marco Cavaleri
    Head of Anti-infectives & Vaccines - European Medicines Agency

Building Pre-Clinical, Process, Analytical & Comparability Strategies to Create a Holistic Regulatory Package for Your mRNA Platform

11:30 am

Comparability – Regulatory Strategy Considerations for mRNA Product CMC Changes

Speaker

  • Nazia Noor

    Nazia Noor
    VP Global Regulatory Affairs, CMC - BioNTech

12:00 pm

Planning for Success: Creating a Regulatory Strategy for the Successful Development of a Novel mRNA Platform

Speaker

  • Nitisha Pyndiah

    Nitisha Pyndiah
    Director - Global Regulatory Affairs Lead - GlaxoSmithKline

Engaging with the Regulatory Nuances for Different Disease Areas to Create Effective mRNA Drugs Against All Indications for All Patients

1:30 pm

Evolving the Regulatory Landscape to Unlock the Potential of mRNA Platforms for Rare Diseases

Speaker

  • Carla Vinals

    Carla Vinals
    Vice President, Global Regulatory Product Strategy - Moderna

2:00 pm

Disease-Specific & Personal: mRNA Therapy Immunogenicity Risk for Rare Diseases

Speaker

  • Anne De Groot

    Anne De Groot
    Founder & chief scientific officer - EpiVax, Inc.

2:30 pm

Addressing the Differences in Regulatory Strategy for Various Batch Sizes of Personalized Cancer Vaccines

Speaker

Day 2 PM (i) - SPP

2:15 pm

Afternoon Networking Break

Day 2 PM - SPP

12:45 pm

Lunch & Networking Break

Add New Dayss

1:00 pm - 4:00 pm

Add New Seminarss

Add New Stream sss

sss Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint…

Speaker

Week 32 -2025 SSS SSS

9:00 am - 10:00 am

Seminar Week 32 -2025 SSS SSS

Stream Week 32 -2025

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat…

week 45 seminar days sss

9:00 am - 10:00 am

week 45 seminar sss

week 45 seminar Stream sss

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat…

Speaker

seminar day demo

10:00 am - 1:00 pm

seminar demos

seminar streams demo

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat…

Speaker

Track 1

9:00 am Seminar Week 32 -2025 SSS SSS

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Track 1
Track 1

Week 32 -2025 SSS SSS

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

9:00 am Seminar Week 32 -2025 SSS SSS

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Speakers
Expand/Collapse