Focus Day | 3rd mRNA-Based Therapeutics Summit

7:30 am Registration & Morning Networking Coffee

8:50 am Chair Person’s Opening Remarks

Rachel Groppo Director - Replicon Team Leader, The Janssen Pharmaceutical Companies of Johnson & Johnson

9:00 am Biotechnology Leaders Fireside Chat

Shiv Krishnan Head - External Innovation; Biologics R&D, Lonza AG
Jacob Becraft Co-Founder & CEO, Strand Therapeutics
Jenny van Asbeck – van der Wijst CEO, Mercurna
Nathaniel Wang CEO & Co-Founder, Replicate Bioscience
Private: Kelly Lindert Chief Development Officer of Vaccines, Arcturus Therapeutics

Synopsis

Ask your burning questions to industry pioneers who will discuss the new frontiers in mRNA technology, the hottest indications at the forefront of scientific research and the future for the next wave of mRNA.

What does the future look like for the next generation of mRNA- based therapeutics for clinically relevant targets?
Where do we expect new innovations to come from and what challenges are ahead of us?
What limits actual development where mRNA might be leveraged to replace existing technologies?

10:00 am Navigating the IP Landscape in the mRNA Space

Daniel Shores Partner, Rothwell Figg

Synopsis

The current IP and competitive landscape for mRNA and LNP delivery technology
Strategies for freedom to operate, design-around, and licensing
IP protection strategies for new innovations

10:30 am Morning Networking Break

Track A: Analytical Development

Exploring Analytical Development for Improved mRNA-Based Therapeutics & Vaccines

Chair: Russel Johnson, VP - Formulation Research, RVAC Medicines

11.30 Challenges in Analytical Methods and Control Strategy During mRNA Vaccine Development & LCM

Phase appropriate approach for developing analytical methods in support of mRNA vaccine development
Advantages and challenges in leveraging analytical platform approach
What to consider for life cycle management

Stephanie Prizzon, Head - Analytical Sciences, mRNA Center of Excellence, Sanofi
Jianmei Kochling, Senior Director - Analytical Development, mRNA Center of Excellence, Sanofi

12.00 mRNA-LNP Nucleic Acid Stability & Purity Analysis by Capillary Gel Electrophoresis

Overview a high-throughput, kit-based workflow to analyze mRNA identity, integrity, and purity from LNPs for vaccine development
Demonstrate quantitative, high-resolution RNA size estimation of main products and product-related impurities in the range of 50 - 9,000 bases
Review a practical application of this workflow for a 92-day mRNA-LNP product stability study

Mario Pulido, Senior BioPharma Applications Scientist, SCIEX

Track B: Supply Chain & Logistics

Plan, Source, Make & Deliver - Landscaping the Challenges of Supply Chain & Logistics for mRNA-Based Drugs

Chair: Metin Kurtoglu, Chief Operating Officer, Cartesian Therapeutics

11.30 Challenges in mRNA Manufacturing & Supply Chain

Status of current mRNA manufacturing
Challenges with the COVID pandemic and impacts to supply chain
Solutions and future trends

Charles Cabral, Drug Substance Manufacturing; Technology & Tech Transfer Director, Arcturus Therapeutics

12.00 Interactive Roundtable on mRNA-Based Therapeutics & Vaccines Supply Chain & Logistics

Metin Kurtoglu, Chief Operating Officer, Cartesian Therapeutics

Harris Makatsoris, Professor of Sustainable Manufacturing Systems, King’s College London

12:30 pm Networking Lunch Break

Track A: Analytical Development

Addressing Characterization Methods for the Development of mRNA-Lipid Nanoparticles

1.30 Understanding mRNA Degradation in LNP Delivery Systems

mRNA-based vaccines at Moderna
Analytics developed for mRNA
Analysis of mechanisms for the loss of mRNA activity in lipid nanoparticle

Dipendra Gyawali, Scientist - Analytical Development, Moderna

2.00 Analytical Method Development in mRNA-Lipid Nanoparticle COVID 19 Replicon Vaccines

Challenges and overall strategy in developing and transferring analytical methods for mRNA-lipid nanoparticle COVID-19 replicon vaccines
Analytical method development for content of mRNA in mRNA-lipid nanoparticle
Analytical method development for purity of mRNA in drug substance and mRNA-lipid nanoparticle – from AGE to CE

Yurong Guo, Associate Director - Analytical Development & QC, Arcturus Therapeutics

Track B: Supply Chain & Logistics

Refining Cold Chain Technologies & Drug Stability to Overcome Supply
Chain Hurdles

1.30 Anhydrous Nucleic Acid Nanoparticles for Storage & Handling at Broad Range of Temperatures

Modular nucleic acid nanoparticles (NANPs) with tunable physicochemical properties which can match the desired biological effects, immunorecognition, provide uniformity, and regulate the delivery of multiple therapeutic nucleic acids for combinatorial therapy
Despite the major advantages offered by NANP technology, one drawback is in the structural diversity of these novel materials which leads to formidable barriers in optimizing protocols for their scaled up production and maintenance that currently relies on cold chain storage
To promote long-term storage of functional NANPs and retention of their biological activities at higher temperatures (e.g. +50 °C), several drying mechanisms have been introduced compared

Kirill Afonin, Professor of Chemistry, University of North Carolina at Charlotte

2.00 Panel Discussion: Rethinking Methods of mRNA Cold-Chain Storage to Solve Long Term Applications

Developing novel formulations to increase the shelf-life of high purity stabilizers for cold chain requirements
Advancing knowledge into force degradation and mRNA thermo-stability to preserve mRNA functionality and longevity
How to effectively overcome hurdles of storage for global distribution

Moderator: Poulami Talukder, Senior Scientist, Tiba Biotech

Kirill Afonin, Professor of Chemistry, University of North Carolina at Charlotte
Vishal Khanderia, Senior Director – Supply Chain, Beam Therapeutics
Mohamed ElSayed, Chief Technology Officer, CTO, RVAC Medicines

2:30 pm Afternoon Networking Break

Track A: Analytical Development

Next Generation Strategies for Analytical Development for mRNA-Based
Therapeutics & Vaccines

3.00 Panel Discussion: Novel Biological Analytical Tools & Technologies for Analyzing mRNA Effectivity & Quality

What are the latest development challenges of novel analytical tools to characterize mRNA?
How to develop and improve quantitative, robust, and rapid analytical testing for mRNAbased therapeutics?
Through harnessing tools permitting discovery and development of mRNA molecules, what is the future of mRNA therapies?

Moderator: Shigeki Miyake-Stoner, Director - R&D & Head - Technology, Replicate Bioscience

David Liston, Senior Scientist, ReCode Therapeutics
Darshana Jani, Senior Director - Pre-Clinical & Clinical Bioanalytical Sciences, Moderna
Mohammad Safari, Director of Analytical Biochemistry, Seqirus

3.45 Bioanalytical Strategies to Evaluate the Efficacy, Biodistribution, & Tolerability of
an Inhaled mRNA Therapy

How to characterize efficacy and cell type specific targeting in primary cell-based disease models and translation to pre-clinical animal models
Biodistribution of mRNA, LNP components, and target protein expression in preclinical models
Methods to assess tolerability of mRNA therapeutics

David Liston, Senior Scientist, ReCode Therapeutics

Track B: Supply Chain & Logistics

Supply Chain & Logistics Commercialization & Future Directions for Supply Chain & Logistics

3.00 Panel Discussion: Establishing Global Supply Chains with a Commercial Lens

What is the testing capacity and appropriate documentation required to ensure commercial preparedness?
How to manage equipment transfer from lab to commercial grade facilities and account for increased support, maintenance, and security?
What is the outlook for global technology transfer, process validation rapid commercialization, and supply strategies?

Moderator: Vishal Khanderia, Senior Director – Supply Chain, Beam Therapeutics

Charles Cabral, Drug Substance Manufacturing; Technology & Tech Transfer Director, Arcturus Therapeutics
Harris Makatsoris, Professor of Sustainable Manufacturing Systems, King’s College London
Prashant Yadav, Professor & Senior Fellow, INSEAD & Center for Global Development

3.45 Building the Supply Chain for mRNA-Based Therapeutics - The Role of Collaboration

Establishing multiple sources, material qualification, and ensuring GMP capabilities of
suppliers early in the development cycle
Faster translation of clinical supply sources into commercial
Role of partnerships across companies, academia and startups

Prashant Yadav, Professor & Senior Fellow, INSEAD & Center for Global Development

Returning July 2023 | Boston, MA

Pre-Conference Focus Day

This event has run
Register interest for 2023

7:30 am Registration & Morning Networking Coffee

8:50 am Chair Person’s Opening Remarks

9:00 am Biotechnology Leaders Fireside Chat

Synopsis

10:00 am Navigating the IP Landscape in the mRNA Space

Synopsis

10:30 am Morning Networking Break

12:30 pm Networking Lunch Break

2:30 pm Afternoon Networking Break

4:15 pm End of Pre-Conference Focus Day

OUR CONTACT DETAILS

ABOUT US

JOIN OUR TEAM

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Returning July 2023 | Boston, MA

Pre-Conference Focus Day

**This event has run** Register interest for 2023

7:30 am Registration & Morning Networking Coffee

8:50 am Chair Person’s Opening Remarks

9:00 am Biotechnology Leaders Fireside Chat

Synopsis

10:00 am Navigating the IP Landscape in the mRNA Space

Synopsis

10:30 am Morning Networking Break

12:30 pm Networking Lunch Break

2:30 pm Afternoon Networking Break

4:15 pm End of Pre-Conference Focus Day

OUR CONTACT DETAILS

ABOUT US

JOIN OUR TEAM

SEARCH

This event has run
Register interest for 2023