June 27, 2023
Welcome to hubXchange’s Oligonucleotide Therapeutics Europe 2023, bringing together executives from pharma and biotech to address and find solutions to the key issues faced in oligonucleotide therapeutics.
Discussion topics will cover New Modalities, Oligonucleotide Discovery, Manufacturing and Drug Delivery.
Take advantage of this unique highly interactive meeting format designed for maximum engagement, collaboration and networking with your peers.
Venue: DoubleTree by Hilton Brussels City, Ginestestraat 3 Rue Gineste, 1210 Brussels, Belgium
SNAPSHOTS OF DISCUSSION TOPICS
- Recent advances in oligonucleotide therapeutics development
- Target selection for oligonucleotide therapeutics
- Best practice for the oligonucleotide therapeutics hit-to-lead process
- Targeted delivery of RNA using viral biologya
- Regulatory CMC challenges
- Challenges in drug substance and drug product manufacturing
- New receptors for targeted delivery of oligonucleotides
- Reviewing lipid-encapsulation and nanostructures/ polymers with focus on LNP delivery technology for nucleic acid Tx
Full Xchange Agenda
Click on each track for detailed agenda
Opening Address & Keynote Presentation
(Presented by ChemGenes)
Target selection for oligonucleotide
- When to use oligonucleotide-based therapeutics approach?
- ASOs vs SiRNA to address specific needs?
- CRISPR-CAS9 technology for gene editing
- How is specificity addressed at the design phase of the drug?
- How can specificity be improved for oligonucleotide based drugs?
Senior Scientist, Clinical Pharmacology and Quantitative Pharmacology, AstraZeneca
Shilpi Mahajan is a Senior Scientist at AstraZeneca in the Bioanalysis group. She is a Molecular Biologist and her current focus is on new drug modality areas including mRNA-LNP, Antisense Oligonucleotides (ASO) and Cell therapy (CAR-T). She has been the lead scientist for the strategy design and development of a number of assays in new drug modality. She has developed droplet digital PCR (ddPCR) and qPCR based assays for CAR-T programs. Prior to joining AstraZeneca she worked at Genentech in the oncology biomarker development group and contributed to the strategy design and development of assays for both small and large molecules. She has also worked on liquid biopsy and extracellular vesicles.
Shilpi received her PhD from the International Center for Genetic Engineering & Biotechnology (ICGEB), New Delhi and did her postdoctoral studies at UCSF. Her career interests include molecular biology, immuno-oncology and biomarker development.
n-of-1 batches from the perspective of a CMO
Working with the n-of-1 sponsors
Lessons learned based on n-of-1 projects to date
What does the future landscape look like in this area
Director of Custom Oligonucleotides, ChemGenes
Jeremy Little is currently the director of custom oligonucleotides at ChemGenes Corporation in Wilmington, MA, and is responsible for the company’s custom oligonucleotide manufacturing group. He joined the team at ChemGenes in early 2019, having more than 10 years of experience in the field of nucleic acid drug discovery and oligonucleotide manufacturing. Prior to joining ChemGenes, Jeremy held positions at AnaSpec, BioSpring GmbH, and Pfizer. While at Pfizer, he established and managed on-site oligomer production laboratories to support Pfizer’s internal efforts in the field of oligonucleotide drug discovery. Before his transition into the world of oligonucleotides, Jeremy spent the first 7 years of his career as a medicinal chemist at Pfizer and Millenium Pharmaceuticals. He received his Ph.D. from the University of Wisconsin-Madison in 2001 where he developed a novel route into the ring system of a class of compounds termed aziridinomitosenes and related to Mitomycin-C.
13:20 – 13:50
Ensuring therapeutic efficacy and safety: analytical considerations to characterize and monitor nucleic acids API, lipid nanoparticles and associated impurities
Americas Biopharmaceutical Market Development Manager, Waters Corporation
Ann Gray has held a number of positions including sales and business development. Prior to joining Waters she learned her analytical instrumentation analyzing tobacco and purifying proteins at United States Department of Agriculture. She has a Masters degree in biology from New Mexico State University and a bachelor of science degree from Juniata College.
Recent advances in oligonucleotide therapeutics development
- Review of the recent successes in oligonucleotide therapeutics. What can we learn from these successes?
- Discussion of novel targets, mechanisms, pathways and therapeutic indications. Oligo therapeutics in non-orphan indications?
- Personalized medicine and the possible role for oligonucleotide therapies.
Vice President Drug Development, Alto Neuroscience
Bruce Morimoto has over 25 years of industry experience in leading project teams in the development of innovative medicines, providing guidance in the design and execution of preclinical, clinical and regulatory strategies with a therapeutic focus in Parkinson’s, Alzheimer’s and frontotemporal dementias. Previously, Bruce held leadership roles at Alkahest, Celerion, Cerecin and Allon Therapeutics, and works closely with the Michael J Fox Foundation, chairing one of their scientific review panels. He is an advisor to several biotech companies helping to move their programs through clinical development and drug registration. Bruce started his career on the faculty in the Chemistry Department at Purdue University where his independent research focused on neuronal signal transduction.
Bruce earned his doctorate in biochemistry from UCLA and completed a postdoctoral fellowship at the University of California Berkeley.