8:00am | Registration & Welcome Coffee

9:20 am Chair’s Opening Remarks

  • Tim Turner Senior Manager, Synthetic Process Development , Alexion Pharmaceuticals

Looking into CMC & Regulatory Compliance

9:30 am CMC for cGMP Manufacturing of Oligonucleotides

Synopsis

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

10:00 am Outlining Oligo Drug Delivery & LNP Platform at WuXi STA

  • Lu Tian Director, CMC Project Management, STA Pharmaceutical

Synopsis

  • Understanding that LNP for oligo drug delivery comes from efficient process technologies
  • Using innovative active excipients for better therapeutic index
  • Exploring STA’s end-to-end enabling service to help develop oligo therapeutics for patients

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

Defining a Winning Formula for Your Next Generation Oligos & Peptides

11:15 am The industrial Design, Translation, & Development Strategies for Long-Acting Peptide Delivery

Synopsis

  • Bring the patient and disease perspective early into development of LAI peptide products
  • Current landscape of the LAI formulations and future perspectives
  • Stage appropriate considerations and strategies to bring LAI peptide from bench to bedside

11:45 am 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?

12:30pm | Networking Lunch

1:30 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

2:00 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

2:30 pm Exploring the Challenges of Oligonucleotide Chemistry

Synopsis

REMOTE PRESENTATION

3:00pm | Afternoon Break & Poster Session

3:30 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

4:00 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

4:30pm | Chair’s Closing Remarks & End of Day One
We look forward to welcoming you back for Day Two!

  • Tim Turner Senior Manager, Synthetic Process Development , Alexion Pharmaceuticals