Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Workshop: Therapeutic Equivalence of Complex Molecules and Formulations

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
10:00Welcome

Committee Chair, CSPS, and Health Canada

Opening Remarks:

   Kendal Weber, Associate Assistant Deputy Minister, Health Products and Food Branch (HPFB),
Health Canada

Introduction: Complex Molecules and Formulations

   Fakhreddin Jamali, University of Alberta

10:45SESSION 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

13:00Lunch & Networking
14:00SESSION 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

17:00Day Concludes
DAY 2 – September 11, 2018
8:30SESSION 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

11:00SESSION 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
Products Directorate, Health Canada

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

13:00Lunch & Networking
14:00SESSION 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

16:30Concluding Remarks:

–  Patrick Stewart, Director General, Therapeutic Products Directorate (TPD), Health Canada