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기조 세션

Muthiah (Mano) Manoharan, PhD

RNAi 치료제 전달:siRNA의 약리학적 특성 개선

Alnylam Pharmaceuticals, Inc.

Jesper Lau, PhD

Semaglutide의 Drug Discovery - Ala 스캔으로부터 GLP-1 유사체의 구조 설계까지의 과정

Novo Nordisk A/S

Thazha P. Prakash, Ph.D.

올리고뉴클레오티드 치료제 개발의 새로운 전략과 기술

Ionis Pharmaceuticals

Hiroaki Suga, Ph.D.

모조 천연 펩티드의 리보솜형 생체외 발현에 관한 최근 연구 성과

University of Tokyo, Japan

2월 26일
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12:45pm - 1:55pm

점심식사

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3:30pm - 4:00pm

네트워킹 브레이크

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6:00pm - 7:00pm

네트워킹 디너

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9:00am - 12:45pm 225 mins
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워크샵
  • Co-Moderator Marc Lemaitre, 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
워크샵 #2:펩티드 치료제 개발 입문:임상 개발, CMC 및 이후 단계로 진행시키기 위한 전략
워크샵
  • 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
워크샵 #2:펩티드 치료제 개발 입문:임상 개발, CMC 및 이후 단계로 진행시키기 위한 전략
펩티드 원료의약품 합성에서의 문제
  • 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
워크샵 #2:펩티드 치료제 개발 입문:임상 개발, CMC 및 이후 단계로 진행시키기 위한 전략
개발 조기 단계용 분석법, 예비 처방, 처방
  • 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
워크샵 #2:펩티드 치료제 개발 입문:임상 개발, CMC 및 이후 단계로 진행시키기 위한 전략
네트워킹 브레이크
11:15am - 12:00pm 45 mins
Info
워크샵 #2:펩티드 치료제 개발 입문:임상 개발, CMC 및 이후 단계로 진행시키기 위한 전략
펩티드의 IND 신청, 비임상 안전성 시험:약물동태, 생물학적 분석, 독성학
  • 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
워크샵 #2:펩티드 치료제 개발 입문:임상 개발, CMC 및 이후 단계로 진행시키기 위한 전략
미국 펩티드약과 펩티드 생물제제 제품 개발의 유사점과 차이점
  • 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
점심식사
1:55pm - 2:00pm 5 mins
기조 연설
의장 인사
2:00pm - 2:30pm 30 mins
Info
기조 연설
RNAi 치료제 전달:siRNA의 약리학적 특성 개선
  • 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
기조 연설
Semaglutide의 Drug Discovery - Ala 스캔으로부터 GLP-1 유사체의 구조 설계까지의 과정
  • Jesper Lau, PhD - Vice President, Protein and Peptide Chemistry, Novo Nordisk A/S
3:00pm - 3:30pm 30 mins
Info
기조 연설
올리고뉴클레오티드 치료제 개발의 새로운 전략과 기술
  • 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
네트워킹 브레이크
4:00pm - 4:30pm 30 mins
Info
기조 연설
모조 천연 펩티드의 리보솜형 생체외 발현에 관한 최근 연구 성과
  • 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
네트워킹 디너

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