SSM4 (4th Summer School on Medicines) 2 July 2-13, 2012 – Montréal (Québec) CANADA www.ssm4.org SSM4, the Fourth Summer School on Medicines offers a unique 70--hour training program under a multicultural sponsorship in the wonderful setting of Montreal, Quebec. Make plans now for two full weeks of lively presentations and direct interactions with the Faculty, including two Case Studies and Workshops with Industry, covering the whole value chain of medicines, from “idea to market”. The Faculty members are leaders in their field and contribute to create one of the most innovative and focused programs in drug discovery and development currently offered. Scientific committee Denis deBlois, U de Montréal (www.umontreal.ca) Brian White-Guay, U de Montréal (www.umontreal.ca) Michelle Savoie, U de Montréal et Montreal-InVivo (www.montreal-invivo.com) Roland Bugat, Institut Claudius Regaud (http://eng.claudiusregaud.fr/) Christophe Cazaux, U de Toulouse III, Oncopole (www.oncopole-toulouse.com) Pierre Cordelier U de Toulouse III, Oncopole (www.oncopole-toulouse.com) Jordi Quintana, Parc Cientific de Barcelona (www.pcb.ub.edu) Marta Princep, Biocat (www.biocat.ca) Organizing committee: Francis Beaulieu, Montreal-InVivo (www.montreal-invivo.com) Brian White-Guay (U de Montréal (www.umontreal.ca) Lionel Havion, Fondation InNaBio Santé (www.innabiosante.fr) Jean-Louis Molina, , Institut Claudius Regaud (http://eng.claudiusregaud.fr/) Nerea Alonso, Biocat (www.biocat.ca) MONDAY, July 2nd 08:30 – 09:00 Registration OFFICIAL OPENING – 4th Summer School on Medicines (SSM4) 09:00 – 09:15 Denis deBlois, Chairman, SSM4 Scientific Committee Pierre Moreau, Dean, Faculty of Pharmacy Université de Montréal Michelle Savoie, Director, Montréal in Vivo Pierre Cordelier, Université Paul-Sabatier/ Oncopole, Toulouse SESSION 1 : NEW MEDICINES: AN OVERVIEW FROM IDEA TO MARKET Chairperson: Denis deBlois, Université de Montreal 09:15 – 10:15 Drug discovery Denis de Blois, Université de Montréal, Québec 10:15 – 10:45 Health Break 10:45 – 11:45 Translational medicine Denis de Blois, Université de Montréal, Québec Brian White-Guay, Université de Montreal, Québec 11:45 – 13:15 Lunch 13:15 – 14:30 Clinical development Brian White-Guay, Université de Montreal, Québec 14:30 – 15:30 Molecules and Money Jeffery Elliott, Sectoral Asset Management, Montreal 15:30 – 16:00 Health Break 16:00 – 17:00 Evolving models of pharma R&D: Introductory remarks & panel Philippe Walker, V-P Astra Zeneca R&D 17:00 – 19:00 Welcome Reception in Montreal TUESDAY, July 3rd SESSION 2 : DRUG DISCOVERY Chairperson: Denis de Blois, Université de Montreal 08:30 – 9:15 Target identification and validation Marc Servant, Université de Montreal 9:15 – 10:00 Assessing target function Michael A Adams, Queen’s University, Kingston, ON 10:00 – 10:30 Health break 10:30 – 11:15 The medicinal chemistry of small molecules Eric Marsault, Université de Sherbrooke 11:15 – 12:00 Case example: Preclinical development of a molecule with an original mechanism of action against leukemia Christian Recher, Toulouse 12:00 – 13:30 Lunch 13:30 – 14:15 Biologicals: discovery and development Jean-François Gauchat, Université de Montréal 14:15 – 15:00 Targeting shifting targets: constraints in the area of antibacterials Karine Auclair, McGill University 15:00 – 15:30 Health break 15:30 – 16:15 Gene therapy: from preclinical to phase I clinical trials Pierre Cordelier, Toulouse 16:15 – 17:00 Panel Discussion WEDNESDAY, July 4th SESSION 3: NONCLINICAL DEVELOPMENT Session Chairperson: Brian White-Guay, Université de Montreal 8:30 – 9:15 The absorption, distribution, metabolism and excretion of drugs Véronique Michaud, Université de Montréal 9:15 – 10:00 Current Trends in Non-Clinical Safety Testing Simon Authier, CiToxLAB 10:00 – 10:30 Health break 10.30 – 11:15 Unexpected & Unusual Adventures in Chemistry, Manufacturing & Controls Patrick Colin, Chief Development Officer, GiCare Pharma 11:15 – 12:00 Panel Discussion 12:00 – 13:30 Lunch SESSION 4: CASE STUDY IN DRUG DISCOVERY AND DEVELOPMENT (I) Development of GIC-1101: A novel analgesic with dual mechanisms of action Case Study presented by: Patrick Colin, Chief Development Officer, GiCare Pharma 13:30 – 14:00 Case presentation and outline of challenges 14:00 – 15:00 Group session: Students work in small teams to tackle the challenges 15:00 – 15:30 Health break 15:30 – 17:00 Each team reports / General discussion THURSDAY, July 5th SESSION 5 : CLINICAL DEVELOPMENT Chairperson: Brian White-Guay, Université de Montreal 08:30 – 9:15 ADME in humans : Issues and challenges Jacques Turgeon, Université de Montreal 9:15 – 10:00 Learning trials : exposure – response and dose selection Richard Lalonde, Pfizer, USA 10:00 – 10:30 Health break 10:30 – 11:15 Biomarkers in drug development Patrice Hugo, Senior Global Director, LabCorp Clinical Trials 11:15 – 12:00 Panel Discussion 12:00 – 13:30 Lunch 13:30 – 14:15 Regulatory strategy and interactions: early development Patrick Colin, GiCare Pharma, Canada 14:15 – 15:00 Regulatory strategy and interactions : late development Brian White-Guay, Université de Montréal 15:00 – 15:30 Health break 15:30 – 16:15 From discovery to life cycle management: an integrated view of drug development Robin Godlstein, consultant, Boston 16:15 – 17:00 Panel Discussion FRIDAY, July 6th SESSION 6: CLINICAL TRIALS Session Chairperson: Denis Querleu, Université Paul-Sabatier, McGill University 8:30 – 9:15 Late development design, analysis & interpretation of clinical trials Raymond Bain, Merck USA 9:15 – 10:00 Late clinical development issues and challenges Ted Reiss, Vanderbilt University, Nashville, USA 10:00 – 10:30 Health break 10.30 – 11:15 Value vigilance: What should we be looking for ? Pierre Anhoury, Accenture, Toulouse 11:15 – 12:00 Panel Discussion 12:00 – 13:30 Lunch SESSION 7: CASE STUDY IN DRUG DISCOVERY AND DEVELOPMENT (II) Discovery of Montelukast: Endpoint / comparator selection; target product profile Case Study presented by: Ted Reiss, Vanderbilt University, Nashville, USA 13:30 – 14:00 Case presentation and outline of challenges 14:00 – 15:00 Group session: Students work in small teams to tackle the challenges 15:00 – 15:30 Health break 15:30 – 16:15 Each team reports 16:15 – 17:00 How it really happened SUNDAY, July 8th 9:00 Bus departure for Quebec City 12:00 – Free Visit (PM) 19:00 – Dinner in Old Quebec MONDAY, July 9th SESSION 8: MOLECULAR BIOMARKERS AND DEVELOPMENT OF POINT OF CARE DIAGNOSTICS FOR INFECTIOUS DISEASES Session Chairperson: Michel G Bergeron, Université Laval 9:00 – 12:00 A medical practice revolution : molecular diagnosis of infectious diseases Michel G Bergeron, Director and Founder, Centre de Recherche en Infectiologie 12:00 – 13:30 Lunch SESSION 9: INNOVATIVE VACCINE DEVELOPMENT PLATFORM Session Chairperson: TBA 13:30 – 17:00 Medicago Research Center Louis-Philippe Vézina, Medicago Inc. 17:00 – Departure for Montreal (bus) TUESDAY, July 10th SESSION 10 : PHARMACOGIVILANCE AND RISK MANAGEMENT Chairperson: Sylvie Perrault, Université de Montréal 08:30 – 9:15 Benefit-risk assessment in clinical decision making James Brophy, McGill University 9:15 – 10:00 Pharmacovigilance and risk management considerations in Canada Ariel E. Arias, Ctr for Blood and Tissues Evaluation, Health Canada 10:00 – 10:30 Health break 10:30 – 11:15 Global implementation of pharmacovigilance plans Gervais Tougas, Novartis , Bâle 11:15 – 12:00 Panel Discussion 12:00 – 13:30 Lunch SESSION 11 : MARKET ACCESS AND HEALTH TECHNOLOGY ASSESSMENT (HTA) Chairperson: Jean Lachaine, Université de Montreal 13:30 – 14:15 The path towards reimbursement of pharmaceutical innovations in Canada Frédéric Lavoie, Pfizer 14:15 – 15:00 Market Access – Third Payer Perspective Reiner Banken, INESS 15:00 – 15:30 Health break 15:30 – 16:15 HTA methodologies Jean-Eric Tarride, McMaster University 16:15 – 17:00 Panel Discussion WEDNESDAY, July 11th SESSION 12: FINANCING THE VALUE CHAIN Chairperson: (TBA) 08:30 – 9:15 From innovation to value Anne-Marie Larose, Hema-Quebec 9:15 – 10:00 New trends in financing opportunities, models for start-ups Elizabeth Douville, Amorchem 10:00 – 10:30 Health break 10:30 – 11:15 Global financing and partnerships Elizabeth Stoner, MPM Capital, New-York 11:15 – 12:00 Panel Discussion 12:00 – 13:30 Lunch SESSION 13: BUSINESS DEVELOPMENT Chairperson: (TBA) 13:30 – 14:15 Stakeholders Michelle Savoie, Université de Montréal, 14:15 – 15:00 Pharma vs. Biotech
Luc Vachon, 15:30 – 16:15 Panel Discussion 16:15 – 17:00 Poster session THURSDAY, July 12th SYMPOSIUM : Facing the current innovation challenge Chairperson: Jean-Pierre Moreau, CytoxLab, Montreal 09:00 – 12:00 Networking Session Speakers: TBA Keynote speaker: Times of Change in Drug Discovery and Chemical Biology: Hard Lessons from the Last Decades Dr. Chris Lipinski Scientific Advisor Melior Discovery Waterford, CT 12:00 – 13:30 Lunch 13:30 – 17:00 Scientific Session Speakers: TBA Keynote speaker: Discovery of Telaprevir: A novel protease inhibitor for the treatment of Hepatitis C virus infection Ann Kwong, Vertex, Poster session for SSM4 participants 17:00 – 19:00 Cocktail FRIDAY, July 13th SESSION 14: NEW STRATEGIES Session Chairperson: Jordi Quintana, Parc Científic de Barcelona 8:30 – 9:15 Genomics: present and future impact Ivo Gut, Director, Natl Ctr for Genomic Analysis, Barcelona 9:15 – 10:00 Public –Private partnerships (PCB-Chembiobank) Jordi Quintana, Parc Científic de Barcelona 10:00 – 10:30 Health break 10.30 – 11:15 Pre-competitive research / Open Innovation Max Fehlmann, CQDM 11:15 – 12:00 Panel Discussion 12:00 – 13:30 Lunch SESSION 15: CAREER PLANNING Chairperson: Michelle Savoie, Université de Montréal et Montréal InVivo 13:30 – 14:15 Career profiles in life sciences. What are the opportunities? Patrick Colin, Chief Development Officer, GiCare Pharma 14:15 – 15:00 Career development: what does it take? Luc Vachon 15:00 – 16:00 Panel Discussion 16:00 – 16:15 SSM4 Closing comments and overture towards SSM5 Denis deBlois