Informa
Key Sessions

Junichi Koga, Ph.D.

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

Daiichi Sankyo

Patrick Reid, Ph.D.

Recent Progress in the Discovery and Development of Macrocyclic Peptides

PeptiDream, Inc.

Yasuhiro Takeshima, M.D., Ph.D.

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

Hyogo College of Medicine

Ekkehard Leberer, Ph.D.

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

Sanofi

Showing of Streams
Showing of Streams
5:00pm - 5:05pm
Close of Day One

Close of Day One

5:30pm - 7:30pm

Networking Dinner in Kyoto

Ticket cost = $120 USD

Network with fellow AsiaTIDES attendees from around the world by registering to attend this Networking Dinner event.  This will be a Japanese dinner held at a local event in Kyoto, with round trip transportation  provided from the hotel.  

To purchase a ticket, simply select the 'Tuesday Evening Networking Dinner' option during online registration.  

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9:00am - 9:20am 20 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Accelerating Oligonucleotides to IND and Beyond
  • Workshop Moderator Marc Lemaitre, PhD - Principal, ML Consult
more
9:00am - 9:20am 20 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.
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9:20am - 10:15am 55 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
9:20am - 10:15am 55 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
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10:15am - 11:10am 55 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Process Development and Early Stage Development - Lessons Learned from a Few Cases Studies
  • Workshop Moderator Marc Lemaitre, 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 - 11:10am 55 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
11:10am - 12:05pm 55 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Regulatory Considerations for Oligonucleotide Therapeutics
  • Workshop Speaker David Lin, PhD, MBA - Senior Consultant, Biologics Consulting Group, Inc.
more
11:10am - 12:05pm 55 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
12:05pm - 1:00pm 55 mins
Workshop #1: Accelerating Oligonucleotides to IND and Beyond
Delivery Strategies for Oligonucleotides
12:05pm - 1:00pm 55 mins
Workshop #2: An Introduction to Peptide Therapeutic Development: Strategies for Moving to the Clinic, CMC and Beyond
Analytical Characterization of Peptides
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.
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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 - Head of R&D Division, Executive Officer, Daiichi Sankyo
more
2:30pm - 3:00pm 30 mins
Keynote Presentations
Recent Progress in the Discovery and Development of Macrocyclic Peptides
  • Keynote Speaker Patrick Reid, PhD - Chief Scientific 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 Might Soon Turn into an Excess
  • Detlef Rethage - President, Nitto Denko Avecia, Inc.
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In 2015/16, oligonucleotide "oligo" customers experienced capacity constraints resulting in long lead times. Nitto Avecia was the first to respond to timely meet the customer's needs, by opening its new manufacturing facility with up to 1800mmol additional capacity in August 2017. Other CMO's and Biotech's also began building additional capacity which will be operational in the 2018 to 2020 timeframe. However, disappointing results of some late stage clinical trials during the previous 12 months have drastically reduced the demand for oligo manufacturing capacity for the next few years. It's quite possible the oligo market may soon be faced with excess manufacturing capacity

4:30pm - 5:00pm 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.

5:00pm - 5:05pm 5 mins
Close of Day One
5:30pm - 7:30pm 120 mins
Networking Dinner in Kyoto
more

Ticket cost = $120 USD

Network with fellow AsiaTIDES attendees from around the world by registering to attend this Networking Dinner event.  This will be a Japanese dinner held at a local event in Kyoto, with round trip transportation  provided from the hotel.  

To purchase a ticket, simply select the 'Tuesday Evening Networking Dinner' option during online registration.  

* 活动内容有可能不事先告知作更动及调整。