Tuesday, February 21, 2023
9:00 am Workshop A: Outlining Progress From Within the Oligonucleotide Conjugate World & Discussing Unique Challenges With Their Development
- Sukumar Sakamuri Chief Technology Officer, Aro Biotherapeutics
- Niels Svenstrup Senior Vice President, Chemistry & Manufacturing, PepGen
- Fuan Kang Vice President - Research, MiRecule Inc.
Although the first wave of next-generation conjugates was primarily immunestimulating orientated, there is a growing abundance of oligonucleotide conjugate drugs in development. Conjugating oligonucleotide payloads helps overcome traditional oligonucleotide delivery challenges, but with only a handful of these drugs so far entering the clinic there still is work to do to progress this modality forward.
Through a series of presentations followed by interactive panel and roundtable discussions, gain a comprehensive overview of where the oligonucleotide-conjugate field is now and where it is going.
- Centyrin-targeted siRNA Conjugates: A Novel Therapeutic Modality for the Treatment of Rare Diseases
- Developing PepGen’s Enhanced Delivery Oligonucleotide (EDO) Platform
Followed by discussions focusing on:
- What therapeutic opportunity do oligonucleotides offer?
- What challenges still exist in taking these conjugates forward?
- Outlining conjugation, manufacturing and scale-up challenges
9:00 am Workshop C: From Pre-IND to IND – Overcoming Important Regulatory Hurdles to Get into the Clinic
- Richard Markus Chief Executive Officer, Dantari, Inc.
- Michael Chansler Vice President, Business Development, Savid Therapeutics Inc.
- Omid Soltani Senior Director - Chemical Development, Vincerx Pharma
Although traditional ADCs now have a developed regulatory framework, the regulatory pathway for next-generation conjugates is still developing. As more next-generation conjugates are being developed this will begin to become clearer, however, there still remains questions around the pre-IND and IND path, as well as core clinical and manufacturing regulatory challenges. This workshop will offer a deep dive to enable you to have a greater understanding of the regulatory framework for next-generation conjugates, and enable you to more proactively think about all things regulation, including:
- What are the important pre-IND questions to think about?
- What does the IND path look like for next-generation conjugates?
- How similar is the pathway compared to traditional conjugate drugs?
- How do you approach working with novel formats or novel payloads?
1:00 pm Workshop B: Overcoming Challenges with Nonclinical Models to Accelerate into the Clinic Quicker
- Gregory adams CSO, Elucida Oncology
As many next-generation conjugate companies are driving to enter the clinic there still remains fundamental challenges in understanding what nonclinical models you should be conducting your studies in to see accurate translational into the clinic and pass through the important regulatory checkpoints.
This workshop will provide an overview of the key considerations when choosing your nonclinical models to ensure a rapid, successful and smooth translation into clinic studies.
Join this workshop to:
- Discuss what lessons can be pulled across from ADCs or other modalities when developing next-generation conjugates
- Understand how novel payloads impact toxicity studies non-clinically especially when not directly killing
- Examine what are the best models to be using for your next-generation ADC and how do you match your mouse model with the type of study
1:00 pm Workshop D: Understanding How to Take a Next-Generation Conjugate Through Lead Candidate Selection & Technical Development
- Juan Carlos Cordova Senior Director, Process Development, Abzena
- Nicolas Camper Senior Director - Chemistry, Abzena
Selecting the right candidate and progressing it is a challenge for all drugs, and specifically next-generation conjugates.
This workshop is an opportunity to learn and discuss the important aspects of developability assessment and the interface between research and CMC for successful lead selection, development and manufacture of novel format conjugates. The workshop will be of interest to Research and CMC leads new to the conjugate field or with experience developing traditional antibody-drug conjugates and will enable you to think more holistically about the key aspects of next-generation conjugate lead selection and development and to better understand similarities and differences between traditional and next-generation conjugates development programs.
Join this workshop to learn about:
- Developability assessment study design for novel format conjugate selection
- Analytical approaches in developability assessment
- Program integration for developability assessment at the interface between research and CMC