8:00am | Registration & Welcome Coffee

9:20 am Chair’s Opening Remarks

Looking into CMC & Regulatory Compliance

9:30 am Regulatory Advances in Strategies to Control Impurities – Comparing Peptides & Oligos

  • Nadim Akhatar Senior Principal Scientist, New Modalities , AstraZeneca

Synopsis

  • Navigating control of impurities, the identity testing
  • Exploring how this impacts QA/QC
  • Comparing control of impurities in peptide products and control of impurities in oligonucleotide product

10:00 am CMC for cGMP Manufacturing of Oligonucleotides

Synopsis

  • Understanding and outlining early phase CMC and control strategies for therapeutic oligos

10:30am | Break & Speed Networking
Enjoy a morning coffee whilst meeting fellow industry experts

Defining a Winning Formula for Your Next Generation Oligos & Peptides

11:30 am The Next Frontier in Delivery of Oligos & Peptides to the CNS

Synopsis

  • Learn of novel solutions to BBB challenges
  • Hear how delivery can be specifically targeted
  • Understand safe, effective, non-invasive brain delivery

12:00 pm Roundtable – Role of Characterization Techniques in Formulation & Analytical Development of Small Oligonucleotides

Synopsis

  • Does physical stability of oligonucleotide conjugates impact formulation of the drug product?
  • Which characterization techniques are most impactful to support formulation and analytical development?
  • How does the type of molecule an oligonucleotide is conjugated to impact its developability?

12:45pm | Networking Lunch

1:45 pm It’s Not an Afterthought – The Role of Analytics in Formulation & Process Development

Synopsis

  • Evolution of drug delivery strategies, and how to approach pre-formulation studies
  • Characterization of primary and higher-order structure of oligonucleotides, and considerations for formulation

REMOTE

2:15 pm Selection of Isolation Process for Drug Substance for Peptides & Oligonucleotides Using a Six-Sigma Approach

  • Ashish Garg Director of Engineering , Eli Lilly & Company

Synopsis

  • Assessing current oligonucleotide and peptide DS isolation form selection strategies – based on available options at various CMOs
  • Challenges selecting fastest possible and lowest cost option during DS scale-up and DP manufacturing
  • Changes to isolation form during late stages of development leads to comparability challenges between DS forms and consequently for DP process
  • Utilizing different selection strategies through a systemic approach and phase appropriate decision making process to reduce challenges for DS scale-up, DP manufacturing and comparability risk

2:45pm | Afternoon Break

3:15 pm Panel Discussion: Understanding Conjugation Challenges

Synopsis

Delve into an interactive panel discussion with leading experts to explore:

  • The methods used in conjugation to improve site of action uptake and specificity
  • Encapsulation versus conjugation
  • How to ‘decorate’ your oligo / peptide for targeting different systems

3:45 pm Exploring the Challenges of Oligonucleotide Chemistry

4:15 pm Emerging Formulation Strategies to Improve Oligonucleotide PK & Delivery to Extra-Hepatic Tissues

Synopsis

  • Exploring bioconjugation and encapsulation impact on oligonucleotide PK
  • Strategies to improve extra-hepatic delivery and cellular uptake

4:45 pm Challenges in Early phase Analytics & Characterization of Synthetic Macromolecules

Synopsis

  • Analyzing major challenges in early phase analytics of therapeutic peptides and oligonucleotides
  • Outlining similarities and differences in peptide and oligo analytics
  • Delving into examples of value adding analytical activities in early phase projects

REMOTE

5:15pm | Chair’s Closing Remarks & End of Day One
We look forward to welcoming you back for Day Two!