2025 Breakout Discussions
WEDNESDAY MARCH 12, 2025: 2:40 – 3:25 pm
Breakout discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. These will take place IN-PERSON ONLY.
IN-PERSON BREAKOUT DISCUSSION: Trending: How Companies Get Acquired
Moderator: Renee Williams, Founder and Managing Partner, Williams Biotech Consulting and Executive Director, Woodside Capital Partners; Former VP of External Strategy, Genetic Medicines, Eli Lilly
This discussion will look at the following trends as it relates to acquisitions of biotechs over the past years:
- Deal volume and size
- Preclinical vs clinical
- Stage of Financing
- Time to exit vs valuation
- Top strategic acquirers
IN-PERSON BREAKOUT DISCUSSION: Laying the Groundwork for a Successful IND or CTA
Moderator: Michael Hellerstein, Head of Operations, Vaxxinity
- Phase-appropriate development: Planning for evolution and improvement of CMC systems to meet regulatory requirements
- Planning for success: Design of process and analytical development programs to meet regulatory requirements
- How much is too much? How to balance the need for control against the need for flexibility
- The expected unexpected: Proactively dealing with gaps in the data
IN-PERSON BREAKOUT DISCUSSION: Analytical Characterisation and Quantitation of Impurities in Single and Double Stranded Oligonucleotides
Moderator: Mike Webb, PhD, Founder and CEO, Mike Webb Pharma; Former Vice President, API Chemistry & Analysis, GSK
- How to control impurity families with different 2' chemistries and limited chromtographic separation
- Orthogonal chromatographic methods versus orthogonal detection (UV and MS)
- Data requirements for controlling CQA's for batch analysis versus measuring CQA outputs during process characterisation experiments
- How to leverage prior knowledge for process characterisation
IN-PERSON BREAKOUT DISCUSSION: Tackling Challenges with mRNA Delivery
Moderators:
Charles Chen, PhD, Senior Scientist, Advanced Drug Delivery, Pharmaceutical Sciences, AstraZeneca Pharmaceuticals, R&D
Ekkehard Leberer, PhD, Professor of Biochemistry, Technical University of Munich; Senior Consultant, ELBIOCON; Advisor, Neuway Pharma
Dan Peer, PhD, Professor & Director, Laboratory of Precision Nanomedicine; Vice President for Research, Tel Aviv University
- Innovative mRNA formulations and delivery approaches
- Improving selectivity and efficiency of delivery
- Delivery across the blood-brain-barrier
- Targeting specific cell types for treating various diseases
- Low immunogenicity mRNA formulations
IN-PERSON BREAKOUT DISCUSSION: Overcoming Translational Challenges in RNA Therapeutics Development
Moderators:
Vikram Agarwal, PhD, Head of mRNA Platform Design Data Science, mRNA Center of Excellence, Sanofi
Arthur Krieg, MD, Founder, President and Acting CEO/CSO, Zola Therapeutics
- Optimizing innovative chemistries and modifications
- Strategies for regulating mRNA expression
- Addressing biodistribution and tissue specificity
- Uses and limitations of mouse models in RNA therapeutics development
- What properties are most important to optimize? Are there tradeoffs?
- Defining the safety profile
IN-PERSON BREAKOUT DISCUSSION: Designing and Optimizing New RNA Modalities as Therapeutics
Moderators:
William Kiesman, PhD, Chief Technology Officer, Alltrna
Edo Kon, PhD, Director of Business Development, RiboX Therapeutics
Li Li, PhD, Assistant Professor, RNA Therapeutics Institute, University of Massachusetts Chan Medical School
- Innovative circular RNAs and their applications
- Optimizing tRNA design and delivery
- Developing Self-amplifying and programmable RNAs
- Establishing criteria for modality selection, application and success