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December, 6 - 7, 2023 | Boston, MA
BEFORE

WELCOME
www.mRNA-assaydevelopment.com OCTOBER 6

Creating Better mRNA Drugs with Validated, Reliable & Reproducible Assays

SPEAKERS
Developing Sensitive & Robust
Bioanalytical, Analytical & Potency
Assays to Accurately Measure Quality,

AGENDA
Expression & Efficacy for Accelerated
mRNA Drug Development

Expert Speakers Include:

PARTNER WITH US
Hui Wang
Harkewal Singh
Senior Scientist, Taesun Eom
Director, Head
Bioanalytical/DMPK, Director in mRNA
of Bioanalytics –
mRNA Center of Science
Nonclinical Sciences
Excellence Beam Therapeutics
Moderna
Sanofi

Rebecca Malott Benjamin Hall Cristian Del Campo

Senior Scientist Associate Director
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Senior Scientist
Providence Tessera RNA Analytics
Therapeutics Therapeutics BioNTech SE

+1 617 455 4188 @ info@hansonwade.com

www.mrna-assaydevelopment.com RNA Therapeutics & Vaccines
 Welcome to the mRNA Assay December, 6-7, 2023

Development Summit Boston, MA

WELCOME
What our speakers
Despite a huge boom in interest in mRNA therapeutics and vaccines to treat have to say:
infectious diseases, and more recently for oncology indications, assays to
assess potency, integrity and mRNA expression are currently plagued by low
specificity, sensitivity and leading to slower translation into the clinic and scale-up As novel mRNA therapies
manufacturing of these drugs. become more available, it’s
important to collaborate and
The inaugural mRNA Assay Development Summit is the first and only industry
dedicated meeting to address the specific technical challenges of analytical, have an open dialogue with
bioanalytical and potency assay development to accelerate mRNA therapeutics developers and regulators to
and vaccines from early discovery into the clinic to reach patients in need. discuss innovative approaches
to mRNA analytics so that

SPEAKERS
This technical 3-day meeting will allow you to: these transformative therapies
Investigate new technologies with higher sensitivity to accurately determine can get to the patients that
drug efficacy for safer and more effective drugs to fast-track into the clinic
Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

need them.
Improve reliability and reproducibility of a plethora of assays to better Senior Scientist, Tessera
quantitate mRNA drugs and allow for more accurate investigation
Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

Therapeutics
Increase mRNA integrity, expression and quality of circular and linear mRNA
with robust analytical and potency assays to get better drugs to patients
Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

This meeting will address

faster very key technical questions
 educe variability and standardise new methods to create a robust assay
R in the field of mRNA
roadmap for accelerated research and development
Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

therapeutics. Robust and

reproducible assays will help
 tay on track and in harmonization with regulatory expectations early to
S
ensure on time approvals
Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays the field move forward to
make mRNA drugs which will
Join 60+ technical scientists and strategic leaders from assay development, be beneficial to patients.

AGENDA
analytical and bioanalytical teams to ensure your assay strategy is robust
and reproducible to achieve regulatory compliance and ultimately fast-track Associate Director in mRNA
transformative mRNA therapeutics and vaccines into the clinic towards approval Science, Beam Therapeutics
and scale-up manufacturing for the unmet global need.

KEY BENEFITS OF ATTENDING

Learn how to Deep dive into Improve purity of Leverage new Evaluate functional PARTNER WITH US
navigate complex characterization mRNA therapeutics assays for the assays to build more
regulatory assays to assess by delving into analysis of circular robust and sensitive
expectations of mRNA drug new bioanalytical mRNA and methods for better
potency assays products and drug strategies comparing with drug efficacy
and exploring new substance for better for detecting methods for linear with Providence
methods to improve investigation of contaminants mRNA to accurately Therapeutics
understanding quality to improve and combatting understand integrity & University of
of mechanism of drug efficacy with the presence of and quantity for Massachusetts
action and fast- Sanofi & University dsRNA to reduce better quality drug Chan Medical
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track mRNA-based of Massachusetts immunogenic substances with School

therapeutics through Amherst side effects with GeneLeap Biotech
the clinic with Beam Moderna & Senda & Laronde
Therapeutics Biosciences
& Tessera
Therapeutics

+1 617 455 4188 @ info@hansonwade.com

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Your Expert Speakers December, 6-7, 2023
Boston, MA

WELCOME
Harkewal Singh Hui Wang Taesun Eom
Director, Head Senior Scientist, Director in mRNA
of Bioanalytics – Bioanalytical/DMPK, Science
Nonclinical Sciences mRNA Center of Beam Therapeutics
Moderna Excellence
Sanofi

SPEAKERS
Dinesh Manvar Benjamin Hall Alisa Zhilin-Roth
Associate Director Senior Scientist Scientist, Discovery
of Analytical Tessera Biology, In-Vitro and
Development Therapeutics Mechanism of Action,
Laronde mRNA Center of
Excellence
Sanofi

David Liston Shilpi Mahajan Rebecca Malott

Principal Scientist Associate Director, Senior Scientist
Recode Therapeutics Head of Bioanalytics Providence
Switch Therapeutics Therapeutics

AGENDA
Craig Martin Corey Perez Lusheng Fan
Professor Principal Scientist in Investigator
University of Discovery GeneLeap Biotech
Massachusetts Senda Biosciences
Amherst

Poulami Talukder Li Li Ryan Sowell

Principal Scientist Assistant Professor Directory,
Tiba Biotech University of Translational Biology
Massachusetts Chan Strand Therapeutics

PARTNER WITH US
Medical School

Krishna Sapkota Bethany Zhao Cristian Del Campo

Scientist II Senior Scientist, Associate Director
Beam Therapeutics Respiratory Delivery RNA Analytics
in Drug Product BioNTech SE
Development
Moderna

This meeting will be a great place to share and learn strategies

to overcome some of the technical challenges found in developing
REGISTER YOUR PLACE

assays for mRNA vaccine development

Senior Scientist, Bioanalytical/DMPK, mRNA Center of
Excellence, Sanofi
+1 617 455 4188 @ info@hansonwade.com
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Conference Day One Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

December, 6-7, 2023

Wednesday December 6, 2023 Boston, MA

WELCOME
8.00 Registration & Morning Coffee

Shilpi Mahajan
Associate Director, 8.50 Chair’s Opening Remarks
Head of Bioanalytics
Switch Therapeutucs

Examining Potency Assays to Accurately Interpret Biological Activity for Better

SPEAKERS
Understanding of mRNA Drugs

9.00 Considerations for mRNA Potency Assay Development for Gene Editing
Products
Benjamin Hall • Overview of matrix approach for potency assay development
Senior Scientist • Review of available regulatory guidances and expectations for phased-based approach
Tessera Therapeutics to potency assay development
• Tools and considerations when measuring biological cascade of mRNA delivery in-vitro
• Challenges associated with potency assay development for gene editing products

9.30 Panel Discussion: Trailblazing Potency Assays for a Fine-Tuned Approach to Meeting Specifications &
Ensuring the Correct Response is Elicited
• How is the field aligning potency assays which are used to show that mRNA expresses the protein?

AGENDA
• Assessing which assays can be used to show whether the drug product elicits the correct response
• What is the most reliable combination of potency assays to carry out?
• Are robust potency assays needed for both drug substances and drug products?
Moderator:
Poulami Talukder Benjamin Hall Taesun Eom
Principal Scientist Senior Scientist Director in mRNA Science
Tiba Biotech Tessera Therapeutics Beam Therapeutics

10.30 Morning Break & Speed Networking

As the mRNA assay development community comes together, this valuable session
will ensure you can reconnect with your peers in the room to make new and lasting
connections. All attendees will have the opportunity to meet and network with their

PARTNER WITH US
academic and industry colleagues!
Optimizing Bioanalytical Methods to Investigate Mechanism of Action & Determine
Quantitation for Robust Translation

Harkewal Singh 11.30 Bioanalytical Strategies for Advancing mRNA Therapeutics

Director, Head
of Bioanalytics – • Lipid Nanoparticle quantitation
Nonclinical Sciences • RT-qPCR vs bDNA for mRNA quantitation
Moderna • Approaches for protein and Anti-Protein Antibody quantitation

12.00 Illuminating the Mechanism of Action for LNP/mRNA-Based Vaccines by

Alisa Zhilin-Roth
Scientist, Discovery Employing Fluorescent Based Assays
Biology, In-Vitro and • Fluorescent-based assays to explore the Mechanism of Action for LNP/mRNA-Based
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Mechanism of Action, Vaccines

mRNA Center of • Determining cellular LNP internalization, trafficking, and RNA cargo release by High
Excellence content confocal microscopy
Sanofi • Assess the translation of released mRNAs by fluorescent microscopy assays

12.30 Networking Lunch Break

+1 617 455 4188 @ info@hansonwade.com

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Conference Day One Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

December, 6-7, 2023

Wednesday December 6, 2023 Boston, MA

WELCOME
Shining a Spotlight on Advances in mRNA Quality Assessment Tools
to Improve Drug Efficacy

Cristian Del Campo 1.30 Digital PCR for Analysis of RNA Quality Parameters
Associate Director RNA • Introducing dPCR technology for quality control analytics
Analytics • Analysis of identity and ratio of RNA mixtures
BioNTech SE • Correlation of dPCR RNA quality data with classic capillary electrophoresis method

SPEAKERS
2.00 Comparing Assays used to Determine the Integrity of Circular vs Linear
mRNA for Better Characterization
Lusheng Fan
Investigator • Do new assays need to be developed for new types of mRNA or can existing ones be
Geneleap adapted?
• What are reliable assays for assessing the quality and quantity of circular RNA?
• How is the field approaching discriminating between circular and linear RNA?

Dinesh Manvar 2.30 The Development of Analytical Methods for Circular RNA & Differences
Associate Director of from mRNA
Analytical Development
Laronde • Details to be revealed

AGENDA
3.00 Afternoon Networking Break

Increasing Assay Sensitivity to Accurately Assess mRNA Expression for

Improved Safety & Efficacy
4.00 Roundtable: Evaluating Reliable Potency Assays to Improve the Investigation of Toxicity for Safer Drugs
• How to reduce variability in cell-based assays?
• What parameters and specifications should be considered?
• How to build robust assays for investigating toxicity?
• What are the main challenges the field faces when developing potency assays?

PARTNER WITH US
• How to improve sensitivity of potency assays?

Moderator:
Rebecca Malott
Senior Scientist
Providence Therapeutics

5.00 Methods to Assess Functional Protein Expression & Biodistribution for

David Liston
Principal Scientist
Recode Therapeutics
Development of Inhaled mRNA Therapeutics
• What methods can you use to ensure that functional protein is being expressed in vitro
and in vivo preclinical models?
• Methods to confirm expression of your protein in the desired target cells/tissues
• Sensitive tools to look for expression of your protein in non-target organs
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Shilpi Mahajan
Associate Director, 5.30 Chairs Closing Remarks & End of Conference Day One
Head of Bioanalytics
Switch Therapeutucs

+1 617 455 4188 @ info@hansonwade.com

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Conference Day Two Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

December, 6-7, 2023

Thursday December 7, 2023 Boston, MA

WELCOME
8.00 Morning Networking Coffee

8.50 Chair’s Opening Remarks

Leveraging Assays to Better Investigate Protein Expression & Function for Improve

SPEAKERS
Therapeutics Effect

Rebecca Malott 9.00 Assay Development for Monitoring mRNA Functionality

Senior Scientist • Overview of methods used to confirm that the target protein is functional.
Providence • Exploring the relationship between mRNA integrity and functionality.
Therapeutics • Cell-based potency assay development for both DS and DP samples – case studie

Hui Wang 9.30 LC-MS Based Assay Development for Absolute Quantification of Protein
Senior Scientist, Expression from mRNA Vaccine Candidates
Bioanalytical/DMPK,
mRNA Center of • Overview of assays used for measuring protein expression from mRNA vaccines
Excellence • A robust and sensitive assay for mRNA expression using targeted proteomics
Sanofi • Case study of determining mRNA expression from mRNA vaccines

AGENDA
10.00 Morning Networking Break & Scientific Poster Session

Assessing Bioanalytical Tools to Evaluate the Purity of mRNA Drug Substances for Reduced
Immunogenic Side Effects
11.00 Evaluate mRNA Immunogenicity Using Macrophage/Monocyte Cell Lines
Li Li with CRISPR-Mediated Gene Knockout

PARTNER WITH US
Assistant Professor • Immune cells provide a more sensitive readout of immunogenic side products in mRNA
University of preps than non-immune cells
Massachusetts Chan • CRISPR knockout of key innate immune sensors in immune cell lines
Medical School • Detect source of contaminants and their immune sensing pathways using such immune
cell lines

11.30 Roundtable: Reviewing Assays to Determine the Presence of dsRNA & Reduce Undesired
Immunogenicity
• Which methods are currently used by the field to measure the presence of dsRNA?
• What types of controls and standards are being used in these assays to facilitate accurate and reliable quantitation?
• What approaches are being employed by the field to translate in vitro to in vivo response? Which biomarkers are most
useful?
• What novel/next-generation methods are being developed to address existing challenges?
• What characteristics would define an ideal assay to measure immunogenicity?
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• How is the field approaching the definition of impurity limits? Does this approach differ based on therapeutic area?
Moderator:
Corey Perez
Principal Scientist in Discovery
Senda Biosciences

12.30 Networking Lunch Break

+1 617 455 4188 @ info@hansonwade.com

6
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Conference Day Two Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

December, 6-7, 2023

Thursday December 7, 2023 Boston, MA

WELCOME
Evaluating In Vitro Tools to Accurately Assess mRNA Drug Products for Improved Quality &
Activity

1.30 Improving Analysis of LNP Encapsulated Drug Products to Achieve

Bethany Zhao Reliable Results for Better Efficiency & Quality
Senior Scientist, • How is dynamic light scattering used in the characterization of LNP encapsulated
Respiratory Delivery mRNA?
in Drug Product • Evaluating separation techniques, such as asymmetric flow field flow fractionation, to

SPEAKERS
Development measure LNP efficiency and quality.
Moderna • How to approach running assays when facing issues of LNP sensitivity?
• How to quantify delivery of LNP encapsulated drug product?

2.00 Microphysiological Systems for the Assessment of Activity of mRNA

Ryan Sowell Therapeutics
Director of Translational
Biology • Overview of the current state of microphysiological systems (MPS)
Strand Therapeutics • Opportunities for the use of MPS in drug development
• Challenges with the use of MPS in mRNA therapeutics

2.30 Afternoon Networking Break

AGENDA
Optimize Manufacturing with Robust & Reproducible Assays to Enable Successful Scale-Up

3.00 Quantitatively Distinguishing Full (Correct) Length mRNA From Truncated

Craig Martin or (Self-)Extended mRNAs
Professor
University of • Degradation, truncation, and self-primed extension occur during manufacturing
Massachusetts • Evaluation of these behaviors is critical to optimizing manufacturing approaches/
Amherst conditions
• New approach allows relatively easy assays

PARTNER WITH US
Krishna Sapkota 3.30 Developing Assays for Process Development to Accurately Up-Scale
Scientist II Production for Better Manufacturing of mRNA Therapeutics
Beam Therapeutics • Details to be revealed

4.00 Chairs Closing Remarks

4.15 End of mRNA Assay Development Summit 2023

REGISTER YOUR PLACE

Register Before October 6 to Save $500!

+1 617 455 4188 @ info@hansonwade.com

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Partner With Us Developing Better mRNA Drugs with Validated, Reliable & Reproducible Assays

December, 6-7, 2023

Boston, MA

WELCOME
Are you committed to overcoming challenges in the world of mRNA assay
development?
Are you able to overcome some of the biggest challenges facing the field today with the commitment to
quality and scientific excellence?
If so, the mRNA Assay Development Summit is your premium opportunity to showcase your expertise, advance
your organization’s brand and benchmark yourself as a key thought leader and solutions provider in front of leading
biopharma companies.
The mRNA field is rapidly evolving with drug developers around the world racing to make mRNA-based therapeutics
and vaccines. To achieve this, leading experts are looking for solutions to overcome the challenge of a lack of
commercially available antibodies and learn about new analytical and bioanalytical tools to fast-track their R&D.

SPEAKERS
This summit can provide you with a platform to communicate your exciting progress to the decision-makers in the field,
generate leads, and understand what tools and services the market wants and needs to ultimately deliver on your
business development goals. You can rely on our ability to advise and deliver the right opportunities for you.

Developing Better mRNA Drugs with Validated,

Developing
Reliable
Better
& Reproducible
mRNA DrugsAssays
with Validated,
Developing
Reliable
Better
& Reproducible
mRNA DrugsAssays
with Validated,
Developing
ReliableBette
& Re

Benefit From Market
Intelligence
Hear how and where
pharmaceutical companies
Meet & Network In-Person Position Yourself as an Raise Brand Awareness
with Industry Pioneers Industry Expert & Generate Commercial
With a room full of drug With the growing landscape Collaborations
developers, meet prospective of mRNA-based biotech Benefit from pre and post

are looking for services and
solutions to facilitate their
R&D to match your solutions
accordingly
clients during speed
networking breaks and informal
networking receptions to fuel
commercial opportunities
companies, this meeting a
dedicated platform to put your
independent expertise in front
of the key decision-makers in
the field
AGENDA
conference exposure to our
key opinion leaders and make
sure you connect with the
hottest prospects

SENIORITY OF ATTENDEES* TYPES OF COMPANIES ATTENDING*

C Level/VP/Directors – 28% 20% 70%

PARTNER WITH US
Large Pharma &
Biotech
Head/Manager – 19%
Research &
Academia
10%
Solution
Scientist/Project/Team – 33%
Provider
Developing Better mRNA Drugs with Validated, R

Professor/Other – 20%
* Statistics taken from other events in the Hanson Wade mRNA series of conferences.
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George Shrimpton
Partnerships Director

GET INVOLVED Tel: (+1) 6174554188

Email: sponsor@hansonwade.com

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Ready to Register?
DISCOVER how leading companies are creating
a robust assay roadmap to unleash the potential
of next-generation mRNA therapeutics/vaccines.

WELCOME
DEVELOP your understanding of the current
3 Easy Ways to Book challenges, strategies and solutions to
successfully build reliable and sensitive mRNA
assays.
www.mrna-assaydevelopment.com/take-
ENGAGE with your community and peers from
part/register leading pharma and biotech companies in order
to build complementary collaborations and
Tel: +1 617 455 4188 partnerships.

Email: info@hansonwade.com

Register & Pay by Friday, October 6 &

Drug Developer Pricing* On the Door

SPEAKERS
Save $500

Conference Only $2,499 $2,999

Academic & Research Register & Pay by Friday, October 6 &

On the Door
Institutes Pricing** Save $500

Conference Only $2,099 $2,599

Solution & Service Register & Pay by Friday, October 6 &

On the Door
Provider Pricing Save $500

AGENDA
Conference Only $3,199 $3,699

All prices shown in US dollars. Please visit the website for full pricing options or email info@hansonwade.com

*To be eligible for this price, the group or individual must be from a biotech or pharma company that has a publicly available pipeline, and does not offer pay for services.

**To be eligible for this price, the group or individual must be full-time academic(s).

Team Discounts*** ***Please note that discounts are only valid when three or more

PARTNER WITH US
delegates from one company book and pay at the same time.
• 10% discount – 3 Attendees Discounts cannot be used in conjunction with any other offer or
discount. Only one discount offer may be applied to the current
• 15% discount – 4 Attendees pricing rate.
Contact: info@hansonwade.com
• 20% discount – 5+ Attendees

Venue
Embassy Suites by Hilton at Boston Logan Airport
207 Porter St, Boston, MA 02128, United States
https://www.hilton.com/en/hotels/bosapes-embassy-suites-boston-at-logan-airport/
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TERMS & CONDITIONS

Full payment is due on registration. Cancellation and Substitution Policy:
Cancellations must be received in writing. If the cancellation is received more
than 14 days before the conference attendees will receive a full credit to a
future conference. Cancellations received 14 days or less (including the four-
teenth day) prior to the conference will be liable for the full fee. A substitution
from the same organization can be made at any time.
Changes to Conference & Agenda: Every reasonable effort will be made to
adhere to the event programme as advertised. However, it may be necessary
to alter the advertised content, speakers, date, timing, format and/or location
of the event. We reserve the right to amend or cancel any event at any time.
Hanson Wade is not responsible for any loss or damage or costs incurred as
a result of substitution, alteration, postponement or cancellation of an event for
any reason and including causes beyond its control including without limitation,
acts of God, natural disasters, sabotage, accident, trade or industrial disputes,
terrorism or hostilities.
Data Protection: The personal information shown and/or provided by you will be
held in a database. It may be used to keep you up to date with developments
in your industry. Sometimes your details may be obtained or made available to
third parties for marketing purposes. If you do not wish your details to be used
for this purpose, please write to: Database Manager, Hanson Wade, Eastcastle
House, 27/28 Eastcastle Street, London, W1W 8DH

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