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
Workshop Presenters: Abstracts & Bios
See Workshop Program PDF
Register Here
Sponsors of this workshop are welcome!
HOTELS:
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.
WORKSHOP PROGRAM
| DAY 1 – September 10, 2018 | |
| 10:00 | Welcome Committee Chair, CSPS, and Health Canada |
| Opening Remarks: 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 Open Discussion | |
| 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 Open Discussion | |
| 17:00 | Day Concludes |
| 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 Open Discussion | |
| 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. Open Discussion | |
| 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. Long-Acting Injectables Mihir Shanbhag, Director, Co-Development, Apotex Inc. Bioequivalence and Interchangeability for Modified-Release Formulations with Multiphasic Concentration Profiles Laszlo Endrenyi, University of Toronto Open Discussion | |
| 16:30 | Concluding Remarks: – Patrick Stewart, Director General, Therapeutic Products Directorate (TPD), Health Canada |