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2019 APEC Harmonization Center Biotherapeutics Workshop

Biotherapeutics Roadmap 2012-2019: Gap Analysis and Assessment of Progress Made Towards Convergence


DRAFT v. July 19, 2019

September 3-4, 2019 (COEX Conference Room 300) | Seoul, Republic of Korea

The Biotherapeutics Roadmap was developed in 2012 with a goal to bringing into convergence the regulatory systems of APEC economies in the biotherapeutics space by 2020. Over the past 7 years, the APEC RHSC at the recommendations set forth in the Roadmap, hosted several workshops to assess the biotherapeutics regulatory gaps in the region; identified guidances that if implemented, would minimize these gaps; developed a curriculum for biotherapeutics; identified a Center of Excellence to train regulators; and developed key performance indicators to assess convergence. Now, in 2019, just one year away from the target goal of 2020, the APEC RHSC will recap the region’s progress towards that goal and envision the Roadmap beyond 2020


Time Topic
[Day 0]September 2, 2019
17:00-18:00 [Closed Meeting] Pre-meeting with Program Committee Members & Speakers
[Day 1]September 3, 2019
09:00-09:35 Arrival, Registration, and Networking
Welcome and Introduction
09:35-09:40 Opening Remarks Dong-hee lee
(AHC Director)
09:40-10:00 Group Photo & Break
Introductory: APEC RHSC 2020 Vision and the Accomplishment

Overview of RHSC 2020 Vision and the Strategic Apporaches; Share the results of the joint AHC-LSIF project to track key performance indicator (KPIs) measuring progress towards regulatory convergence in APEC region.

10:00-10:30 APEC RHSC 2020 Vision and the Strategic Apporaches Eric Obscherning
(LSIF Advisor)
10:30-11:00 APEC Progress Towards Regulatory Convergence
Results from tracking the Key Performance Indicator(KPIs) and measuring progress towards regulatory convergence among APEC economies.
Yongseok Ko
Session I: APEC RHSC Biotherapeutics Roadmap

Overview of the Biotherapeutics roadmpa; Highlight major outcomes from the past 7 years' of roadmap activities including CoEs

11:00-11:30 Overview and History of the Biotherapeutic Roadmap
Roadmap Vision 2020, highlight the roadmamp activities in the past
Rominder Singh(Pfizer)
11:30-12:00 Center of Excellence (CoE)
Practical approach to build capacity in real world, sucessess and lessons learned
Jared Auclair (NEU)
12:00-13:30 Lunch
Session II: Global Impacts of the APEC RHSC Biotherapeutics Roadmap

The impact from the work of Biotherapeutics Roadmap in development and adapation of the global guidelines as well as leveraging initial concept of regulatory capacity-building

Chair: Jared Auclair (NEU)

13:30-14:15 WHO guideline of the Life Cycle Management for the Biologics Il Ung Oh (MFDS)
14:15-15:00 ICH guideline
- Industry perspectives of how convergence and alignment to
ICH guidelines has progressed in the past 10 years
Inhwa Choi (Roche)
15:00-16:00 Other global outreach efforts Jared Auclair (NEU)
16:00-16:30 Impcats on APEC regulatory system TBD
16:30-16:40 Wrap Up for Day1  
[Day 2] September 4, 2019
Session III, Part A: Evolving the APEC Biotherapeutics Roadmap

Working together with other PWAs and initiatives and navigating the synergy

Chair: Sannie Chong (Roche)

10:00-10:50 CMC & GMP Inspection
- Industry Perspective: From CMC to GMP - What lies Ahead?

- Academy (APEC CoE) Perspective
- Michie Ong Mei Kuen
- In Eui Lee
(Kobe University)
10:50-11:15 Pharmacovigilance TBD
11:15-11:40 Supply Chain US FDA / USP
(Remote speaker, TBD)
11:40-12:10 WHO Jeewon Joung(Remote speaker, TBD)
12:10-13:30 Lunch
Session III, Part B: Evolution of the APEC Biotherapeutics Roadmap

Considerations for broadening scope of work areas in Biotherapeutics and Innovated Technologies for Manufacturing Biotherapeutics

Chair: Seong Hwan Park (MFDS)

13:30-14:00 Antibody Drug Conjugate Tae Kyo Park (IntoCell)
14:00-14:30 Cancer metabolism drugs (targeting metabolism for cancer therapy) Vikram Shina
(MSD, Remote speaker)
14:30-15:00 Precision Medicine Howard Lee (SNU)
15:00-15:20 Break
Session IV: [Panel Discussion] Pre-assessment of the APEC regulatory convergence in Biotherpaeutics

Moderator: Rominder Singh (Pfizer)

15:20-16:30 [Panel Discussion] Real-time survey on Biotherapeutics regulatory status with the APEC regulatory authorities
16:30-16:50 Wrap up: Highlight of the workshop and next steps Rominder Singh(Pfizer)
16:50-17:00 Closing Remark Dong-hee Lee
(AHC Director)