Agenda

• ISPE members are encouraged to contact staff if interested in attending the Board meeting

Almut Winterstein, FISPE, University of Florida College of Pharmacy:  Cohort Studies

Anton Pottegård, Clinical Pharmacology and Pharmacy, University of Southern Denmark:   Case-Control

Tobias Gerhard, FISPE, Ernest Mario School of Pharmacy, Rutgers University: Bias & Confounding

Miriam Sturkenboom, FISPE, University Medical Center Utrecht
Innovative Approaches in Vaccine Post-Marketing Surveillance

Stephen Evans, FISPE, London School of Hygiene and Tropical Medicine
Signal detection: where do we stand?

Nicholas Tatonetti, Institute for Genomic Medicine, Columbia University
Observational Data for Biomedical Discovery

Samy Suissa, McGill University
The Prevalent New-User Design in Pharmacoepidemiology

Alison Bourke, FISPE, ISPE President
Gianluca Trifirò, Co-Chair, ISPE 2019 Mid-Year Planning Committee
Ursula Kirchmayer, Co-Chair, ISPE 2019 Mid-Year Planning Committee

Welcome address
Italian Ministry of Health
Director, Italian Medicines Agency
President of the Italian Society of Pharmacology
President of the Italian Association of Epidemiology

Moderators: 

Patrizia Popoli, President of the Scientific Committee of the Italian Medicines Agency, Italian National Health Institute

June Raine, Medicines and Healthcare Products Regulatory Agency, UK

9:15 am – 9:45 am  European Regulatory Perspective    
                                 Thijs Giezen, European Medicines Agency, Biosimilar Medicinal Products Working Party
                                     

9:45 am – 10:15 am  US Regulatory Perspective
                                   Gerald Dal Pan, US Food & Drug Administration

10:15 am – 10:45 am  The Industry’s perspective
                                     Uwe Gudat, Fresenius Kabi SwissBioSim, on
                                      behalf of Biosimilar Medicines Group
                                     Annalisa lezzi, Abbvie, on behalf of Assobiotec

10:45 am – 11:00 am  Discussion

     Moderators:

     Alessandro Mugelli, University of Florence
     Sebastian Schneeweiss, FISPE, Harvard Medical School/Brigham & Women’s Hospital

11:30 am – 12:00 pm      The Perspective of the European Crohn's and Colitis Organization (ECCO)
                                          Gionata Fiorino, European Crohn's and Colitis Organization
                                        (ECCO)

12:00 pm – 12:30 pm     The Perspective of the American Society of Clinical Oncology (ASCO)
                                         R. Donald Harvey, American Society of Clinical Oncology (ASCO)

12:30 pm – 1:00 pm        The Perspective of the European League Against Rhuematism (EULAR)
                                          Tore K. Kvien, University of Oslo, European League Against
                                         Rheumatism (EULAR)

1:00 pm – 1:15 pm          Discussion

Moderators:  

Lindsay Wong, Chair, ISPE Student Council, University of Toronto

Ursula Kirchmayer, Department of Epidemiology, Lazio Region

___________________________________________________

Incretin-based drugs and the risk of lung cancer in patients with type 2 diabetes
Julie Rouette, Centre for Clinical Epidemiology, Montreal, Canada

New Potentially Inappropriate Medications Prescribed at Hospital Discharge are Associated with Increased Risk of Adverse Events in 30-days Post Hospitalization: A Prospective Cohort Study of Hospitalized Medical and Surgical Patients
Daniala Weir, McGill University, Montreal, Canada

Risk of adverse cardiovascular events following a myocardial infarction in patients receiving combined clopidogrel and proton pump inhibitor treatment
Nawal Farhat, University of Ottawa, Ottawa, Canada

In search of predictors of switching between biosimilar and originator epoetins in clinical practice: a multi-Regional cohort study
Ylenia Ingrasciotta, Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy

Reporting of quality attributes in similarity assessments of recombinant therapeutic proteins in scientific publications: a systematic review     
Ali Alsamil, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, Netherlands

Did the warnings on the safety of antipsychotic use in older people lead to a change in the risk of stroke? A nationwide cohort study in the U.K. and Italy
Janet Sultana, University of Messina, Messina, Italy

Moderators:

Caroline Walsh, Co-Chair, ISPE Student Council, Royal College of Surgeons in Ireland

Gianluca Trifiro, University of Messina

__________________________________________________

Association Between Fluoroquinolone Use and Achilles Tendon Pathology: Active Comparator New User Investigation.
Mackenzie Herzog, University of North Carolina at Chapel Hill, Chapel Hill, USA

Concomitant anticoagulant and antidepressant therapy in atrial fibrillation patients and risk of stroke and bleeding: a population-based cohort study.
Joris Komen, Utrecht University, Utrecht, Netherlands

Myopathy with oral antidiabetics and statins: an additive model approach to test drug-drug interaction in the FDA Adverse Event Reporting System
Ippazio Cosimo  Antonazzo, University of Bologna, Bologna, Italy

Choosing appropriate machine learning algorithms for estimating propensity scores in different scenarios of complexity and exposure (treatment) prevalence: a simulation study.
Thomas Hadfield, University of Oxford, Oxford, United Kingdom

Machine Learning to Identify Trends in Hemoglobin Evolution Over a 6-Month Period in Chronic Kidney Disease (CKD) Patients Initiating a Treatment with C.E.R.A.
David Pau, Roche, Boulogne-Billancourt, France.

Assessing the risk of birth defects associated with exposure to macrolides during the first trimester of pregnancy: a study with two complementary approaches using the EFEMERIS database    .
Agnes Sommet, Service de Pharmacologie Médicale et Clinique, Centre hospitalier universitaire de Toulouse, Toulouse, France.

Radisson Lobby

     Moderators:

     Jaclyn Bosco, IQVIA
     Giuseppe Traversa, Italian National Health Institute

9:00 am – 9:30 am      Armando Genazzani, University of Eastern Piedmont:
                                     Interchangeability of reference product and biosimilars: where do we stand?  

9:30 am – 10:00 am    Bente Glintborg, DANBIO:  Disease Registries

10:00 am – 10:30 am  Antonio Addis,  Department of Epidemiology, Lazio Region:
                                    The Role of Observational Studies:
                                    An Example from the Italian Bio-Network

10:30 am – 10:40 am Discussion

     Moderators:

     Marina Davoli, Department of Epidemiology, Lazio Region,                     

    Susana Perez-Gutthann, FISPE, RTI-HS Barcelona

11:15 am – 11:45 am  Jeffrey Brown, Harvard Medical School/Harvard Pilgrim
                                    Health Institute:   Experiences from Networks in the US

11:45 am – 12:15 pm  Andrew Bate, Pfizer:   Global Real-World Data-Based
                                    Strategies for Biologics/Biosimilar postmarketing surveillance?

12.15 pm - 12:45 pm   Nello Martini, Drugs&Health:  Real World Data on Biologics and
                                     Biosimilars for Informed Regulatory Decision Making

12:45 pm - 1:15 pm    Discussion

Gianluca Trifirò, Co-Chair, ISPE 2019 Mid-Year Meeting Planning Committee

Ursula Kirchmayer, Co-Chair, ISPE 2019 Mid-Year Meeting Planning Committee