Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Workshop: Complex Molecules

Therapeutic Equivalence of Complex Molecules and Formulations

Two-Day Workshop: September 10-11, 2018, Sir Frederick Banting Centre, Ottawa, ON


Presentations

Opening Remarks
Presented by Kendal Weber, Associate Assistant Deputy Minister, Health Products and Food Branch (HPFB), Health Canad
[no slides]

Introduction: Setting the Stage
Presented by Fakhreddin Jamali, University of Alberta

 

SESSION 1: BIOSIMILAR MOLECULES

From Generics to Biosimilars: Clinical and Scientific Considerations
Presented by Jian Wang, Health Canada

A ‘Global Reference’ Comparator for Biosimilar Development
Presented by Gillian Woollett, Senior Vice President, Avalere Health

The Path Forward in Biosimilar Development
Presented by Martin Schiestl, Chief Science Officer, Sandoz

Biosimilars: Opportunities and Challenges for Health Care Professionals and Patients
Presented by Scott Edwards, Dr. H. Bliss Murphy Cancer Centre

 

SESSION 2: PEPTIDES

Current Thinking on Synthetic Peptides in Abbreviated New Drug Applications
Presented by Xiaohui (Jeff) Jiang, Deputy Division Director, FDA
[Presentation not available]

Regulatory Considerations for Complex and Synthetic Peptides – Not Just Another Generic
Presented by Karen Hauda, Sr. Director Regulatory Policy, Novo Nordisk Inc.

Recombinant and Synthetic Peptide Drugs – A Generic Pathway is There
Presented by Klaus Martin, President, Apobiologix

 

SESSION 3: COMPLEX FORMULATION: CONTROLLED-RELEASE NARROW THERAPEUTIC INDEX DRUGS

Modified Release Products – A Health Canada Perspective
Presented by Susan Lum, Manager, Generic Drugs Quality Division, Therapeutic Products Directorate, Health Canada

Consideration for Interchangeability of Controlled Release Formulations of Narrow Therapeutic Index Medications
Presented by Nas Undre, Sr. Director, Basic Science, Astellas Pharma Europe

Clinical Perspective of Drugs with Narrow Therapeutic Window: The Case of Tacrolimus in Kidney Transplantation
Presented by S. Joseph Kim, Department of Medicine (Nephrology), University of Toronto; Kidney Transplant Program, University Health Network

 

SESSION 4: ORALLY INHALED DRUG PRODUCTS

Regulatory Approaches to Demonstrate Equivalence of Orally Inhaled Drug Products
Presented by Paul Wielowieyski, Senior Drug Evaluator, Division of Biopharmaceutics Evaluation, Therapeutic Products Directorate, Health Canada

Health Canada’s Regulatory Approaches to Demonstrating Equivalence of Subsequent Entry Orally Inhaled Products – Clinical Perspective
Presented by Violina Thomas, Assessment Officer, Therapeutic Products Directorate, Health Canada

Clinical Development of Generic Versions of Inhaled Long Acting Bronchodilators
Presented by Richard Allan, Senior Director, Clinical Scientist, Mylan Global Respiratory Group, Mylan Pharma UK

Weight of Evidence Approach (in vitro, PK, PD & Human Factor Studies) for Establishing Therapeutic Equivalence of Orally Inhaled Drug Products in Patients
Presented by Ashish Sharma, Executive Director, Clinical PK/PD group, Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim Pharmaceuticals

 

SESSION 5: COMPLEX FORMULATION: LONG ACTING DRUGS WITH MULTIPHASIC PROFILES

Bioequivalence Standards for Multiphasic Modified-Release Drug Products
Presented by Bruce Randall, Director, Bureau of Pharmaceutical Sciences, TPD, Health Canada

Need for Bioequivalence Standards that Reflect the Clinical Importance of the Complex Pharmacokinetics (PK) of Paliperidone Palmitate Long-acting Injectable Suspension
Presented by Stephen Sherman, Director, Risk Management, Janssen Inc.

Long Acting Injectables: Generic Development Complexity and Regulatory Landscape
Presented by Mihir Shanbhag, Director, Co-Development, Apotex Inc.
[Presentation not available]

Bioequivalence and Interchangeability for Modified-Release Formulations with Multiphasic Concentration Profiles
Presented by Laszlo Endrenyi, Professor Emeritus, University of Toronto

Concluding Remarks
Presented by Patrick Stewart, Director General, Therapeutic Products Directorate, Health Canada
[no slides]

 

Note: Presentations are available to CSPS members only; they are not to be copied, distributed, or for general release.