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Key Sessions

Junichi Koga, PhD

Transforming Daiichi Sankyo into a Global Pharma Innovator: Updated Directions and Future Vision of R&D

Daiichi Sankyo Co., Ltd.

Keiichi Masuya, PhD

Recent Progress in the Discovery and Development of Macrocyclic Peptides

PeptiDream, Inc.

Yasuhiro Takeshima, MD, PhD

Stunning Clinical Effectiveness of RNA/ENA Chimera Antisense Oligonucleotide (AO85) against Dystrophin Exon 45 in DMD Patient

Hyogo College of Medicine

Ekkehard Leberer, PhD

Delivering Oligonucleotides, Peptides and Other Biopharmaceuticals across Biobarriers: Opportunities and Challenges in Drug Development

Sanofi

Showing of Streams
Showing of Streams
5:30pm - 5:35pm
Close of Day One

Close of Day One

6:00pm - 8:00pm

Networking Dinner in Kyoto

Ticket cost = $120 USD

Network with fellow AsiaTIDES attendees from around the world by attending this Networking Dinner event at Ganko Takasegawa Nijoen, a high-class kaiseki cuisine restaurant in a historic building with an impressive and spacious Japanese garden.

Your ticket includes access to an 11 course dinner with free flowing of drinks, including tempura and higher-quality sushi and sashimi and the presence of a Maiko (apprentice geisha).

Round-trip transportation from the conference venue will be provided.  To purchase a ticket, simply select the 'Tuesday Evening Networking Dinner' option during online registration.  

Spaces for the dinner are limited and reservations will close on Friday 23rd February.

more
9:00am - 9:15am 15 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Accelerating Oligonucleotides to IND and Beyond
  • Workshop Moderator Marc Lemaître, PhD - Principal, ML Consult
more
9:00am - 9:15am 15 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
An Introduction to Peptide Therapeutic Development
  • Workshop Moderator Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts
  • Workshop Moderator Bruce Morimoto, PhD - Vice President, Scientific Affairs, Celerion, Inc.
more
9:15am - 10:00am 45 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Making Drugs out of Oligonucleotides: Role of Chemical Modifications
  • Workshop Speaker Muthiah (Mano) Manoharan, PhD - Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals, Inc.
more
9:15am - 9:45am 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Formulation Considerations for Peptide Therapeutics
  • Workshop Moderator Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts
more
9:45am - 10:15am 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Overview of Cell-penetrating Peptides and Delivery Strategies for Peptides
  • Ikuhiko Nakase, PhD - Special Lecturer (Tenure Track Lecturer), Nanoscience and Nanotechnology Research Center, Osaka Prefecture University
more
10:00am - 10:45am 45 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Process Development, Early Stage Development and Delivery - Lessons Learned from a Few Cases Studies
  • Workshop Moderator Marc Lemaître, PhD - Principal, ML Consult
more

Companies moving to clinic for the first time with oligonucleotides usually face a lot of questions. In this presentation, we will address those questions with respect to the CMC parts of an IND/IMPD for drug substance and drug product, based on recent experiences.

10:15am - 10:45am 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Bioanalytical Strategies for Peptides
  • Workshop Speaker Rafiq Islam - Senior Director, Bioanalytical Services, Celerion, Inc.
more
10:45am - 11:15am 30 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Networking Refreshment Break
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
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Bioanalysis of Oligonucleotides- Challenges and Solutions
  • Rafiq Islam - Senior Director, Bioanalytical Services, Celerion, Inc.
more
11:15am - 11:45am 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Nonclinical Toxicology and Pharmacokinetic Considerations for Peptides
  • Bruce Morimoto, PhD - Vice President, Scientific Affairs, Celerion, Inc.
more
11:45am - 12:15pm 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Successful Characterization of Peptide APIs and Setting the Specifications Optimally
  • Jean-Marc Poudrel, PhD - Program Manager, PolyPeptide Group
more
12:00pm - 12:45pm 45 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Regulatory Considerations for Oligonucleotide Therapeutics
  • Workshop Speaker David Lin, Ph.D. - Senior Consultant, Biologics Consulting (Former Chemistry Team Leader and Former Acting Division Director, Division of New Drug Chemistry, CDER, FDA)
more
12:15pm - 12:45pm 30 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Regulatory Considerations for Peptide Therapeutics
  • Workshop Speaker Duu-Gong Wu, PhD - Senior Director, Regulatory Consulting, PPD
more
12:45pm - 1:00pm 15 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Closing Remarks
12:45pm - 1:00pm 15 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Closing Remarks
1:55pm - 2:00pm 5 mins
Keynote Presentations
Chairperson’s Remarks
  • Chairperson Osamu "Sam" Sato, PhD - Executive Director, R&D Planning Department, Daiichi Sankyo Co., Ltd.
more
2:00pm - 2:30pm 30 mins
Keynote Presentations
Transforming Daiichi Sankyo into a Global Pharma Innovator: Updated Directions and Future Vision of R&D
  • Keynote Speaker Junichi Koga, PhD - Executive Officer, Head of R&D Division, Daiichi Sankyo Co., Ltd.
more
2:30pm - 3:00pm 30 mins
Keynote Presentations
Recent Progress in the Discovery and Development of Macrocyclic Peptides
  • Keynote Speaker Keiichi Masuya, PhD - Chief Operating Officer, PeptiDream, Inc.
more

PeptiDream will present some of its recent progress in the discovery and development of therapeutics arising from its PDPS technology. PDPS technology has proven to be a powerful hit finding platform effective against almost any target. PeptiDream has evolved to turn those initial constrained peptide hit candidates into peptide therapeutics, small molecule therapeutics, and peptide-drug conjugates.

3:00pm - 3:30pm 30 mins
Keynote Presentations
Stunning Clinical Effectiveness of RNA/ENA Chimera Antisense Oligonucleotide (AO85) against Dystrophin Exon 45 in DMD Patient
  • Keynote Speaker Yasuhiro Takeshima, MD, PhD - Professor, Department of Pediatrics, Hyogo College of Medicine
more

A modified nucleotide of 2′-O, 4′-C-ethylene-bridged nucleic acid (ENA) has been shown to have high binding affinity for the complementary RNA strand and nuclease resistance. We have identified an 18-mer antisense RNA/ENA chimera against dystrophin exon 45 (AO85) that is able to induce skipping of dystrophin exon 45. Here, we report the clinical effectiveness of AO85 which was administered intravenously in DMD patient.

3:30pm - 4:00pm 30 mins
Keynote Presentations
Networking Refreshment Break
4:00pm - 4:30pm 30 mins
Keynote Presentations
Oligonucleotide Manufacturing Capacity – A Shortage May Soon Turn into an Excess
  • Detlef Rethage - President, Nitto Denko Avecia, Inc.
more

In 2015/2016, oligonucleotide “oligo” customers experienced capacity constraints resulting in longer lead times.  Nitto Avecia was the first to respond to meet its customer and industry needs by opening a new manufacturing facility with up to 1800mmol additional capacity in August, 2017, while other CMO and biotech organizations followed, adding capacity to be operational in the 2018 to 2020 timeframe.  However, due to disappointing results of some late stage clinical trials within the last 12 months have drastically reduced the demand for oligo manufacturing capacity for the next few years.  It is quite possible that the oligo market may soon be faced with excess manufacturing capacity.

4:30pm - 5:00pm 30 mins
Keynote Presentations
Cyclisation of Analgesic Conotoxins as a Tool to Modulate Folding, Potency and Biopharmaceutical Properties
  • David Craik, PhD - Professor of Biomolecular Structure, Institute for Molecular Bioscience, University of Queensland
more

Conotoxins from the venoms of marine cone snails have attracted considerable attention as leads for the development of novel analgesics, following the registration of Prialt (ziconotide) a decade ago. This presentation will describe the use of synthetic cyclisation to enhance the biopharmaceutical properties of several classes of conotoxins with the potential for orally delivered analgesic activity.

5:00pm - 5:30pm 30 mins
Keynote Presentations
Delivering Oligonucleotides, Peptides and Other Biopharmaceuticals across Biobarriers: Opportunities and Challenges in Drug Development
  • Keynote Speaker Ekkehard Leberer, PhD - Senior Director, R&D Alliance Management, Sanofi
more

Biologics such as proteins, peptides and oligonucleotides have a huge pharmacological potential but their widespread therapeutic application has been very limited due to pharmacokinetic and drug disposition limitations at both the tissue and cellular level. The presentation will address these delivery limitations and summarize the work of a European consortium of pharma companies and academic partners to improve nanocarrier-based delivery technologies that can overcome these limitations.

5:30pm - 5:35pm 5 mins
Close of Day One
6:00pm - 8:00pm 120 mins
Networking Dinner in Kyoto
more

Ticket cost = $120 USD

Network with fellow AsiaTIDES attendees from around the world by attending this Networking Dinner event at Ganko Takasegawa Nijoen, a high-class kaiseki cuisine restaurant in a historic building with an impressive and spacious Japanese garden.

Your ticket includes access to an 11 course dinner with free flowing of drinks, including tempura and higher-quality sushi and sashimi and the presence of a Maiko (apprentice geisha).

Round-trip transportation from the conference venue will be provided.  To purchase a ticket, simply select the 'Tuesday Evening Networking Dinner' option during online registration.  

Spaces for the dinner are limited and reservations will close on Friday 23rd February.