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Biotherapeutics (Duke-NUS)



APEC RHSC Centre of Excellence Pilot Workshop
Biotherapeutics

29 - 30 October 2018 Lead on 3, Level 3 Duke-NUS Medical School
-Day 1- APEC Biotherapeutics Centers of Excellence Pilot Training
Day 1
time Topic Speaker / Organisation
8.30am Registration
9:00am Welcome Prof John Lim
Executive Director
Centre of Regulatory Excellence
Duke-NUS Medical School
9:10am Congratulatory Remarks Dr Sun Hee Lee
Director
APEC Harmonization Center (AHC)
Director General
National INstitute of Food and Drug Safety Evlauation
Ministry of Food and Drug Safety Korea
9:15am
  • Workshop Briefing
      • - Objectives and conduct of workshop

        - Define Biotherapeutics and Biosimilars

Ms Lavanya Balan
Associate, CoRE
Duke-NUS Medical School
Session 1 – Regulatory Requirements for Biotherapeutics
9.30am
  • Key learnings from existing guidelines governing the regulation of biotherapeutics
      • - Overview of the major global guidelines

        - Key principles in regulation of biotherapeutics

        - Highlight some best practices within the major regulatory authorities

Dr Sannie Chong
Head
APAC Technical Regulatory Policy

Roche 

10.00am Break and Photograph Taking
Session 2 – Quality Requirements for Biotherapeutics
10.30am
  • Quality evaluation for biotherapeutics
      • - Overview of CMC requirements and scope for biotherapeutics

        - Key components in characterisation and comparability of biotherapeutics

Dr Anne Cook
Biologicals Quality Assessor
Licensing Division
Medicines and Healthcare products Regulatory Agency (MHRA)
11.10am

Role of Compedial Standards

- Pharmacopeia standards for biotherapeutics

- Performance standards: From product-specific to general requirements

Dr Fouad Atouf
Vice President
Science - Global Biologics
United States Pharmcopeial Convention (USP)
11.30am
  • Case example and team-based exercise
      • - CMC assessment of biotherapeutics

      •   Viral safety evaluation
      •   Control of process- and product-related impurities
      •   Choice of container closure system

Dr Anne Cook
MHRA

 

Dr Lim Sok Bee
Senior Associate, CoRE
Duke-NUS Medical School 

12.30pm Lunch
Session 3 – Non-Clinical and Clinical Considerations for Biotherapeutics
1.30pm
  • Non-clinical studies for biotherapeutics
      • - Overview of non-clinical considerations when evaluating biotherapeutics

        - Key non-clinical aspect: Pharmacokinetics/ pharmacodynamics

        - Sharing of Case Examples

A/Prof Cynthia Sung
Adjunct Faculty, CoRE
Duke-NUS Medical School
2.30pm
  • Clinical studies of biotherapeutics
      • - Overview of clinical considerations when evaluating biotherapeutics

        - Overview of clinical study design

        - Key clinical aspect: Immunogenicity

        - Case examples sharing

Dr Julia Katharina Maier
Clinical Assessor
Paul-Ehrlich-Institut (PEI)

Federal Institute for Vaccines and Biomedicines Langen, Germany 

3.45pm Break
4.15pm
  • Panel Discussion
    • - Current landscape for biotherapeutics in the region

      - Opportunities for better regulation of biotherapeutics

      •   Policies, frameworks and guidelines
      •   Submission and review processes
      •   Finding the balance between physicochemical versus biolofical assay in analysing biotherapeutics
      •   Comparability and post-approval changes
      •   Product life cycle management

 

Moderator:

Dr Anne Cook
MHRA

 

Panelist:

Dr Sannie Chong

Roche

Dr Fouad Atouf

USP

A/Prof Cynthia Sung

CoRE

Dr Isabelle Colmagne-Poulard

Senior Director

Regulatory CMC

Global Regulatory Affairs & Quality Assurance

IFPMA (Merck) 

5.15pm Conclusion for Day 1

 

Asst Prof James Leong

Head

Pharmaceutical Regulatory Science Programme, CoRE

Duke-NUS Medical School
 

5.30pm End
-Day 2- APEC Biotherapeutics Centers of Excellence Pilot Training
Day 2
time Topic Speaker / Organisation
8.30am Registration
Session 4 – Regulatory Requirements for Biosimilars
9:00am
  • Key learnings from existing guidelines governing the regulation of biosimilars
    • - Overview of the major global guidelines

      - Key principles in regulation of biosimilars

      - Highlight some best practices within the major regulatory authorities

      •   EMA’s product specific biosimilar guidelines

Ms Inger Mollerup

Regulatory Consultant

Novo Nordisk

Session 5 – Quality Requirements for Biosimilars
9.30am
  • Quality evaluation for biosimilars
    • - Key components in characterisation and comparability of biosimilars – ICH Q5E

      •   Biosimilar product development
      •   Reference medicinal product
      •   Assessment of similarities and differences in biosimilar product and RMP
      •   Shift in QTPP during product lifecycle

Dr Anne Cook

MHRA

10.00am Break
10.30am
  • Case example and team-based exercise
      • - CMC assessment of biosimilars

      •   Consideration in the choice of a reference medicinal product
      •   Comparison of the critical quality attribute between the biosimilar product and the reference product


Dr Anne Cook

MHRA


Dr Lim Sok Bee

CoRE

Session 6 – Clinical Considerations for Biosimilars
11.45pm
  • Clinical safety studies of biosimilars
    • - Key clinical considerations when evaluating biosimilars

      - Clinical comparability of biosimilars

      •   Study designs and approaches – Stepwise and Totality-of-evidence
      •   Justification of endpoints
      •   Requirements for interchangeability, substitution and switching

Dr Julia Katharina Maier 

PEI

12.30pm Lunch
1.30am

Deficing and handling non-comparable ciologics

- Highlight definitive differences between NCBs and biosimilars - WHO guidelines

- Implications of NCBs in current regulatory processes for biotherapeutics, including post-approval monitoring 

- Example of products approved in specific regions or countries (e.g., Korea, India, etc)

Dr Inger Mollerup

Novo Nordisk

Session 7 – Post Market Activities for Biotherapeutics and Biosimilars
2.30pm
  • Pharmacovigilance for strengthening approaches to regulation
    • - Overview of PV framework

      - Specific safety considerations for biotherapetuics and biosimilars

      - Risk Management Plan components

      - Product lifecycle approach for biotherapeutics and biosimilars

Ms Christine Ho 

Regulatory Consultant

Vigilance and Compliance Branch

Health Sciences Authority (HSA)

3.00pm Break
3.15pm
  • Group activity
    • - Brief RMP review to ensure that PV requirements are met

    •   Addressing safety cnocerns

Ms Christine Ho 

HSA

4.15pm
  • Panel Discussion
    • - Current landscape for biosimilars in the region

      •   Accessibility – Does biosimilar reduce cost and increase accessibility to patients?

      - Opportunities for better regulation of biotherapeutics and biosimilars

      •   Policies, frameworks and guidelines
      •   Submission and review processes
      •     - NRA competency

      •   Product life cycle management
      • - Managing safety with post market activities

Moderator:

Dr Inger Mollerup

Novo Nordisk 

 

Panelist:

Dr Anne Cook

MHRA

Dr Fouad Atouf

USP

Ms Christine Ho

HSA

A/Prof Cynthia Sung

CoRE

Dr Sreedhar Sagi

Head

Medical Affairs

Sandoz Asia-Pacific Middle East and Africa (APMA)

Novartis Asia Pacific Pharmaceuticals Pte. Ltd Singapore

3.00pm Conclusion of Workshop

A/Prof Silke Vogel

Deputy Director, CoRE

Duke-NUS Medical School

 

Ms Su Kyoung Seong

APEC Harmonization Center (AHC)

5.15pm End