CSPS is pleased to announce the program for the two-day workshop, Therapeutic Equivalence of Complex Molecules and Formulations, presented by CSPS, in cooperation with Health Canada.
Monday & Tuesday, September 10-11, 2018
Banting Auditorium, Sir Frederick Banting Building,
Tunney’s Pasture Campus, Ottawa ON
Sponsors of this workshop are welcome!
While there are no hotels close by, and we do not have a room block, we can suggest The Albert at Bay Suite Hotel (http://www.albertatbay.com/), approximately a 10-minute drive to Banting Centre.
|DAY 1 – September 10, 2018|
Committee Chair, CSPS, and Health Canada
Kendal Weber, Associate Assistant Deputy Minister, Health Products and Food Branch (HPFB),
|Introduction: Complex Molecules and Formulations|
Fakhreddin Jamali, University of Alberta
|10:45||SESSION 1: BIOSIMILAR MOLECULES|
Chair: Raimar Loebenberg, University of Alberta
|From Generics to Biosimilars: Clinical and Scientific Considerations|
Jian Wang, Health Canada
A ‘Global Reference’ Comparator for Biosimilar Development
Gillian Woollett, Senior Vice President, Avalere Health
The Path Forward in Biosimilar Development
Martin Schiestl, Chief Science Officer, Sandoz
Biosimilars: Opportunities and Challenges for Health Care Professionals and Patients
Scott Edwards, Dr. H. Bliss Murphy Cancer Centre
|13:00||Lunch & Networking|
|14:00||SESSION 2: PEPTIDES |
Chair: Elisabeth Kovacs, Apotex
|Current Thinking on Synthetic Peptides in Abbreviated new Drug Applications|
Xiaohui (Jeff) Jiang, Deputy Division Director, FDA
Regulatory Considerations for Complex and Synthetic Peptides – Not Just Another Generic
Karen Hauda, Sr. Director Regulatory Policy, Novo Nordisk Inc.
Recombinant and Synthetic Peptide Drugs – A Generic Pathway is There
Klaus Martin, President, Apobiologix
|DAY 2 – September 11, 2018|
|8:30||SESSION 3: COMPLEX FORMULATION: CONTROLLED-RELEASE NARROW THERAPEUTIC INDEX DRUGS |
Chair: Catherine Lau, Janssen Inc.
|Health Canada Perspective: Guidance on Modified Release Formulations|
Susan Lum, Manager, Generic Drugs Quality Division, TPD, Health Canada
Consideration For Interchangeability of Controlled Release Formulations of Narrow Therapeutic Index Medications
Nas Undre, Sr. Director, Basic Science, Astellas Pharma Europe
Clinical Perspective of Drugs with Narrow Therapeutic Window: The Case of Tacrolimus in Kidney Transplantation
S. Joseph Kim, Department of Medicine (Nephrology), University of Toronto; Kidney Transplant Program, Toronto General Hospital, University Health Network
|11:00||SESSION 4: LONG ACTING BRONCHODILATORS |
Chair: Fakhreddin Jamali, University of Alberta
|Regulatory Approaches to Demonstrate Equivalence of Orally Inhaled Drug Products|
Paul Wielowieyski, Senior Drug Evaluator, Division of Biopharmaceutics Evaluation, Therapeutic
Health Canada’s Regulatory Approaches to Demonstrating Equivalence of Orally Inhaled Products (OIPs) – The Clinical Perspective
Violina Thomas, Assessment Officer, Therapeutic Products Directorate, Health Canada
Clinical Development of Generic Versions of Inhaled Long Acting Bronchodilators
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
Ashish Sharma, Executive Director, Clinical PK/PD group, Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim Pharmaceuticals, Inc.
|13:00||Lunch & Networking|
|14:00||SESSION 5: COMPLEX FORMULATION: LONG ACTING DRUGS WITH MULTIPHASIC PROFILES |
Chair: Co Pham, Health Canada
|Health Canada Perspective|
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
Stephen Sherman, Director, Janssen Inc.
Mihir Shanbhag, Director, Co-Development, Apotex Inc.
Bioequivalence and Interchangeability for Modified-Release Formulations with Multiphasic Concentration Profiles
Laszlo Endrenyi, University of Toronto
– Patrick Stewart, Director General, Therapeutic Products Directorate (TPD), Health Canada