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Agenda 2024
DAY 1: MONDAY, OCTOBER 7, 2024
0830 - 0930 REGISTRATION AND MORNING REFRESHMENTS
0930 - 0940 OPENING ADDRESS
0940 - 1005 mRNA: A NEW ERA IN IMMUNE THERAPEUTICS
- Innovations in platform technologies for developing mRNA-based therapeutics
- Diverse mRNA modalities to tackle autoimmune and inflammatory diseases
- Highlighting three autoimmune programs currently in preclinical stages
Kate Jeffrey
Moderna
Moderna
1005 - 1010 Q&A SESSION ON mRNA IN IMMUNE THERAPY ADVANCEMENTS
1010 - 1035 LEGAL/REGULATORY REGIMES FOR NEW TECHNOLOGY DEVELOPMENT AND APPROVAL
- The scope and strategic benefits of the FDA’s new "platform technology" designation
- "Advanced manufacturing technologies" designation and other development incentives
- Evaluating means to rely on external information in marketing applications
Chris Markus
King & Spalding LLP
King & Spalding LLP
1035 - 1040 Q&A SESSION ON STREAMLINING THE TECH DEVELOPMENT WITH REGULATORY AUTHORITIES
1040 - 1100 MORNING COFFEE BREAK IN THE EXHIBIT AREASPONSORED BY EMERGENT BIOSERVICES
1100 - 1130 PANEL DISCUSSION ON USING DATA FOR DESIGNING SAFE AND RELIABLE RNA THERAPEUTICS AND DELIVERY VEHICLE
- DATA-focused decisions for development stages for RNA therapeutics in personalized trials including cancer
- Early screening and surface coating of packaging devices ensure DP CQA and clinical success
- Ensuring consistent critical DATA for safety and reliability to mitigate challenges in RNA therapeutics
Melissa Taylor | Moderna | Moderator
Christina Annunziata | American Cancer Society
Anthony Vico | Stevanato Group
Yan Xia | Axelyf
Christina Annunziata | American Cancer Society
Anthony Vico | Stevanato Group
Yan Xia | Axelyf
1130 - 1155 BREAKING BARRIERS: ADVANCING MRNA LIPID NANOPARTICLE STORAGE
- Optimizing LNP through a continuous design-make-test-analyze cycle
- Enhancing extrahepatic mRNA delivery using targeted LNPs
Bei Cheng
AstraZeneca
AstraZeneca
1155 - 1200 Q&A SESSION ON ENHANCING THE mRNA DELIVERY WITH SPECIFIC LNPS
1200 - 1330 NETWORKING LUNCH & VISITING THE mRNA CONFERENCE EXHIBITION
1330 - 1355 LNP DRUG PRODUCT FORMULATION AND MANUFACTURING: CHALLENGES AND CONSIDERATIONS
- Key factors for successful LNP drug product development and application
- Impact of lipid matrix choice on biodistribution across targeted organs
- Influence of manufacturing technology on LNP's analytical properties
Amey Bandekar
Sanofi
Sanofi
1355 - 1400 Q&A SESSION ON KEY CONSIDERATIONS IN LNP DRUG PRODUCT MANUFACTURING
1400 - 1425 BIOANALYTICAL ASSAYS IN CLINICAL STUDIES OF mRNA-LNP THERAPEUTICS
- Introduction to mRNA-LNP therapeutics and associated clinical study bioassays
- Comprehensive review of methods used for PK, PD, and immunogenicity assessments
- Analysis of data from diverse assays, including btDNA, RT-qPCR, LC/MS, and more
- Exploring the technical challenges in assay methods and their implications
Melissa Taylor
Moderna
Moderna
1425 - 1430 Q&A SESSION ON EXPLORING mRNA-LNP THERAPEUTICS THROUGH CLINICAL BIOANALYTICAL ASSAYS
1430 - 1500 AFTERNOON COFFEE BREAK IN THE EXHIBIT AREASPONSORED BY ROTHWELL FIGG
1500 - 1525 A NEW PEPTIDE NANOPARTICLE PLATFORM FOR TARGETED DELIVERY OF mRNA
- The origin and design of a peptide-based mRNA delivery system for targeted therapy
- Comparing the safety of peptide-based systems with LNPs and viral vectors
- Application of the peptide system in targeting cancer and genetic disorders
Gilles Divita
Aanastra
Aanastra
1525 - 1530 Q&A SESSION ON NOVEL mRNA DELIVERY SYSTEM USING PEPTIDE NANOPARTICLE
1530 - 1555 FAST IN-PROCESS CHROMATOGRAPHY ANALYTICS TO CONTROL mRNA LNP MANUFACTURING
- Understanding of mRNA LNP synthesis and formation with rapid methods
- Orthogonal analytics to foster safer and more cost-effective manufacturing
- Novel chromatography methods for quicker, comprehensive data analysis
Ales Strancar
Sartorius BIA Separations
Sartorius BIA Separations
1555 - 1600 Q&A SESSION ON RAPID CHROMATOGRAPHY TECHNIQUE FOR mRNA LNP PRODUCTION CONTROL
1600 - 1625 NAVIGATING A NEW ERA IN THERAPEUTICS WITH mRNA AND LNP TECHNOLOGIES
- The patent landscape for mRNA and lipid nanoparticle technologies
- Patent trends and protections for mRNA and lipid nanoparticle innovations
- The strategic frameworks to navigate complex IP and litigation issues
Daniel Shores
Rothwell Figg
Rothwell Figg
1625 - 1630 Q&A SESSION ON mRNA AND LNP TECHNOLOGY IN THE NEW THERAPEUTICS ERA
1630 - 1730 NETWORKING DRINKS RECEPTION
DAY 2: TUESDAY, OCTOBER 8 , 2024
0900 - 0930 MORNING REFRESHMENTS
0930 - 0940 OPENING ADDRESS
0940 - 1005 PAST, PRESENT, AND FUTURE SCENARIO OF PATENT LITIGATION IN mRNA PLATFORM
- Review of previous litigation cases involving LNPs and mRNA therapies
- Discussion of current litigation with key industry players like Moderna and Pfizer
- Analysis of forthcoming case timings and Section 1498 applicability
Adam Brausa
Morrison Foerster
Morrison Foerster
1005 - 1010 Q&A SESSION ON PATENT LITIGATION IN mRNA AND DELIVERY TECHNOLOGY
1010 - 1035 LEVERAGING PLATFORM TECHNOLOGY DESIGNATION PROGRAM FOR mRNA VACCINES
- Platform Technology Designation program – advantages and current challenges
- Leveraging Platform Technology in the global regulatory arena
Asim Abdul
GSK
GSK
1035 - 1040 Q&A SESSION ON PLATFORM TECHNOLOGY DESIGNATION
1040 - 1100 MORNING COFFEE BREAK IN THE EXHIBIT AREASPONSORED BY SPECTRADYNE LLC
1100 - 1125 CASCADE AMPLIFYING OF THERAPEUTIC PAYLOADS IN VIVO FOR CANCER IMMUNOTHERAPY
- Screening ionizable lipids for the delivery of saRNA with large molecular sizes
- Introducing a novel approach to amplify therapeutic payloads effectively in vivo
- Demonstrating increased therapeutic efficacy using this innovative modality
Yingzhong Li
SunVax mRNA Therapeutics Inc.
SunVax mRNA Therapeutics Inc.
1125 - 1130 Q&A SESSION ON ENHANCING THE THERAPY THROUGH AMPLIFICATION TECHNIQUES
1130 - 1155 RNA PLATFORM IMPLEMENTATION IN BRAZIL: SEEDING THE INNOVATION ECOSYSTEM
- Tackling the challenges of deploying RNA technology platforms in Brazil
- Presenting the initial results from RNA product development at FIOCRUZ
- R&D enhancement to boost equity in vaccine distribution across Latin America
Patrícia Neves
Fiocruz
Fiocruz
1155 - 1200 Q&A SESSION ON RNA TECHNOLOGY IMPACT IN LATIN AMERICA
1200 - 1225 MAXIMIZING THE COMMERCIAL VALUE AND LESSONS LEARNED FROM PERSONALIZED C>s
- The financial and operational challenges that hinder the full potential of personalized therapies
- Current healthcare ecosystem's readiness for scaling mRNA-based personalized therapies
- Enhancing the future mRNA-based Individualized Neoantigen Therapies
Bernadette Bourjolly
ZS
ZS
1225 - 1230 Q&A SESSION ON OPTIMIZING COMMERCIAL STRATEGIES FOR PERSONALIZED THERAPIES
1230 - 1245 FEEDBACK & RAFFLE DRAW
1245 - 1400 NETWORKING LUNCH
Key topics for 2024:
- The future of mRNA-based therapeutics for infectious diseases and beyond
Hear about innovations, the limitless future of mRNA therapeutics as a new class of drugs. - Latest advancements in mRNA formulation and delivery technologies
Learn about technological advancements for therapeutic mRNA delivery from concept to market. - Breakthrough research in personalized mRNA treatments and immunotherapy
Understand the most recent technological advances towards personalized, tumor-specific, mRNA therapeutic, and vaccines for cancer. - AI/ML applications and data-driven approaches for mRNA therapeutics design
Advancements in AI and ML algorithms combined with advanced data analytics to speed up the therapeutic design process and uncover new insights leading to therapy development. - Challenges and bottlenecks in the global manufacturing of mRNA vaccines
Explore the latest innovative and rapid development and deployment of high‐volume vaccines for pandemic responses. - Regulatory and healthcare considerations in mRNA-based clinical development
Learn the key regulatory and commercial concerns to approve and accept mRNA-based therapeutics to treat diseases.
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