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Key Sessions

Muthiah (Mano) Manoharan, PhD

RNAi Therapeutics Delivered: Improving Pharmacological Properties of siRNAs

Alnylam Pharmaceuticals, Inc.

Jesper Lau, PhD

The Discovery of Semaglutide – A Journey from Ala Scan to Structural Design of GLP-1 Analogues

Novo Nordisk A/S

Thazha P. Prakash, Ph.D.

New Strategies and Technologies in Oligonucleotide Therapeutic Development

Ionis Pharmaceuticals

Hiroaki Suga, Ph.D.

Recent Progress in Ribosomal in-vitro Expression of Pseudo-natural Peptides

University of Tokyo, Japan

Feb 26
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Showing of Streams
12:45pm - 1:55pm

Lunch

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Showing of Streams
3:30pm - 4:00pm

Networking Refreshment Break

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Showing of Streams
6:00pm - 7:00pm
Info

Networking Dinner in Tokyo

Enjoy a gourmet dinner with drinks at this intimate networking dinner at a local upscale Tokyo restaurant.  By attending, you can connect with fellow attendees from AsiaTIDES, as well as attendees from the co-located BioProcess International Asia, Cell Therapy Manufacturing Asia and Antibody Engineering & Therapeutics Asia meetings. 

$130 fee to attend, sign up during conference registration.

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9:00am - 12:45pm 225 mins
Info
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Workshops
  • Co-Moderator Marc Lemaître, PhD - Chief Operating Officer / Principal, Sirnaomics, Inc. / ML Consult
  • Co-Moderator Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany

This workshop will address early drug development and CMC of oligonucleotide therapeutics. A detailed discussion of moving oligonucleotide therapeutics from discovery to clinical trials will include a description of strategies for early clinical development, including GMP synthesis, analytical controls and specifications; nonclinical, CMC, manufacturing and scale-up and the regulatory framework for preparation of IND-IMPD dossiers. Participants will also gain a basic understanding of the considerations and requirements for taking an oligonucleotide therapeutic into first-in-human clinical trials.

Speakers:

CMC Oligos - Real World Case Studies

Marc M. Lemaitre, Ph.D., Principal, ML Consult, USA

Oligo Synthesis Scale-up and Process Related Issues and Troubleshooting

Thomas Rupp, Owner & Principal, Thomas Rupp Consulting, Germany

Additional Workshop Speakers to Be Confirmed

9:00am - 9:15am 15 mins
Info
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Workshops
  • Co-Moderator Bruce Morimoto, PhD - Vice President, Scientific Affairs, Alkahest
  • Co-Moderator Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts

This practical, introductory workshop will address early drug development of peptide therapeutics. A detailed discussion of moving peptide therapeutics from discovery to clinical trials will include a description of strategies for early clinical development, including GMP synthesis, analytical controls and specifications; formulation strategies; pharmacokinetics and toxicology study designs and requirements; and the regulatory framework for preparation of IND-IMPD dossiers. Participants will gain a basic understanding of the considerations and requirements for taking a peptide therapeutic into first-in-human clinical trials.

Who should attend?

Anyone interested in preclinical/clinical development of peptide therapeutics including scientists in discovery research, manufacturing, project management, drug development, business development and regulatory affairs.

9:15am - 10:00am 45 mins
Info
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Challenges in Synthesis of the Peptide API
  • Robert Hagopian - Director Business Development, PolyPeptide Group

An overview of solid versus liquid phase peptide manufacturing approaches will be presented. This will be followed by potential challenges including aggregation, scale-up, stability, changes in manufacturing early versus late phase, and other related notes.

10:00am - 10:45am 45 mins
Info
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Analytical Methods, Pre-formulation, and Formulation for Early Phase Development
  • Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts

The discussion will focus on all aspects of drug product development. We will start with analytical methods required for drug product, including in process controls, QC release methods, and stability, and how they differ from those for drug substance. In addition, we will discuss preformulation and formulation development of peptides to support non-clinical research studies, toxicity studies, and clinical programs. A third topic area to cover will be the selection, design, and development of delivery systems for peptides.

10:45am - 11:15am 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Networking Refreshment Break
11:15am - 12:00pm 45 mins
Info
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
IND-enabling, Nonclinical Safety Studies for Peptides: Pharmacokinetics, Bioanalysis and Toxicology
  • Bruce Morimoto, PhD - Vice President, Scientific Affairs, Alkahest

Peptides bridge small molecules and biologics, not only in their size, but also in specificity and selectivity. These unique properties of peptides require specialized consideration when designing and executing the safety studies to support first-in-human clinical trials. This talk will outline and discuss the pharmacokinetics and bioanalysis of peptides and the design of toxicology studies for peptides.


12:00pm - 12:45pm 45 mins
Info
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Similarities and Differences in the Product Development between a Peptide Drug and a Peptide Biologic in the US
  • Duu-Gong Wu, PhD - Senior Director, Regulatory Consulting, PPD

With the advancement of immunotherapies, the development of peptide therapeutic cancer vaccines and preventive vaccines as biologics has entered new therapeutic areas.  The regulation and the process in FDA governing the review and approval these products as biologics under PHS Act are quite different relative to other therapeutic peptides regulated as drugs. The presentation will discuss the similarity and differences in the review process and data requirements between a peptide drug and a peptide biologic.

12:45pm - 1:55pm 70 mins
Lunch
1:55pm - 2:00pm 5 mins
Keynote Presentations
Chairperson’s Remarks
2:00pm - 2:30pm 30 mins
Info
Keynote Presentations
RNAi Therapeutics Delivered: Improving Pharmacological Properties of siRNAs
  • Muthiah (Mano) Manoharan, PhD - Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals, Inc.

This presentation will focus on key advances in these areas: 1) LNP mediated delivery and the approval of the first RNAi therapeutic; 2) Advances in GAlNAc conjugates and 3) Chemical modifications for improving the pharmacology of siRNAs.

2:30pm - 3:00pm 30 mins
Keynote Presentations
The Discovery of Semaglutide – A Journey from Ala Scan to Structural Design of GLP-1 Analogues
  • Jesper Lau, PhD - Vice President, Protein and Peptide Chemistry, Novo Nordisk A/S
3:00pm - 3:30pm 30 mins
Info
Keynote Presentations
New Strategies and Technologies in Oligonucleotide Therapeutic Development
  • Thazha P. Prakash, Ph.D. - Director, Medicinal Chemistry, Ionis Pharmaceuticals

Inability to selectively deliver antisense oligonucleotide (ASO) therapies to ß-cells is a substantial barrier to the development of treatments for ß-cell specific diseases. We show that the GLP1 receptor can be used as a targeting approach for efficient and selective delivery of ASO to pancreatic ß-cells in cells and in animals.

3:30pm - 4:00pm 30 mins
Networking Refreshment Break
4:00pm - 4:30pm 30 mins
Info
Keynote Presentations
Recent Progress in Ribosomal in-vitro Expression of Pseudo-natural Peptides
  • Hiroaki Suga, Ph.D. - Professor of Chemistry, School of Science, University of Tokyo, Japan

This lecture discusses recent progress in ribosomal in-vitro expression of pseudo-natural peptides containing D-amino acid, beta-amino acids, and other exotic amino acids. This method opens a new opportunity to explore novel sequence space of pseudo-natural peptides.

6:00pm - 7:00pm 60 mins
Info
Networking Dinner in Tokyo

Enjoy a gourmet dinner with drinks at this intimate networking dinner at a local upscale Tokyo restaurant.  By attending, you can connect with fellow attendees from AsiaTIDES, as well as attendees from the co-located BioProcess International Asia, Cell Therapy Manufacturing Asia and Antibody Engineering & Therapeutics Asia meetings. 

$130 fee to attend, sign up during conference registration.