Biotechnology policies

Workshop on Pharmacogenetics: The Intersections between Innovation, Regulation and Health Delivery,


Rome, Italy, 17-19 October 2005

Agenda and presentations


Welcome remarks
:  Giuliano D’AGNOLO, ISS, Italy and Stefano VELLA, ISS, Italy
Introductory Remarks: Nobuo TANAKA, OECD

Keynote Address: David GOLDSTEIN, Duke University, United States
"Pharmacogenetics, pharmacogenomics and proteomics – Applications in biomedical research and human health"

Session 1: New Paradigms in Biomedical Research and Drug Discovery
  Stefano VELLA, ISS, Italy

Andrew HOPKINS, Pfizer, United Kingdom, "The druggable genome: How do we deliver on the promise of new drug targets?"
Allen ROSES, GSK, United States, "Improving translational research through pharmacogenomics: Where are we and what works?"
Rashmi SHAH, MHRA, United Kingdom, "Enhancing the benefit to risk ratio of new pharmaceuticals with pharmacogenetic approaches: Using genomic biomarkers to influence efficacy or safety"

Session 2:  Pharmacogenetics today: What do we know?
 Ismail KOLA, Merck, United States

Magnus INGELMAN-SUNDBERG, Karolinska Institutet, Sweden, "Case Study: Pharmacogenetics of cytochrome P450 and its applications and value in drug therapy: The past, present and future"
Michel EICHELBAUM, IKP, Germany, "Pharmacogenetics today: What we don’t know?"
Denis GRANT, University of Toronto, Canada, "How can pharmacogenetics be applied successfully to improving the efficacy or safe use of existing medicines?"


Session 3: Social and Public Policy Issues in Pharmacogenetic Data, Sample Collection and Storage
 Bob WILLIAMSON, University of Melbourne, Australia

Bartha KNOPPERS, Université de Montreal, Canada, "Pharmacogenetic data and sample collection and storage: Public perception, ethical issues and policy approaches to the problem"

Guilherme SUAREZ-KURTZ, Instituto Nacional do Câncer (INCA), Brazil, "Association studies to detect drug-gene interactions in large populations: Study design, informing policy action and sharing information across regions"

Howard MCLEOD, Washington University School of Medicine, United States, "Integrating pharmacogenetics into national formularies – setting an international research agenda"

Amnon SHABO(Shvo), IBM Research Lab in Haifa, Israel, "Development of international data standards to support the acquisition, exchange, submission and archiving of clinical-genomic data"


Roundtable Debate

Commentator: Abdallah DAAR, University of Toronto, Canada
In Jin JANG, Seoul National University and Hospital, KOREA
Bartha KNOPPERS, Université de Montreal, Canada
Howard MCLEOD, Washington University School of Medicine, United States
Amnon SHABO(SHVO), IBM Research Lab in Haifa, Israel
Guilherm SUAREZ KURTZ, INCA, Brazil
Bob WILLIAMSON, University of Melbourne, Australia




Policy Forum : Managing Regulatory Uncertainty in Rapidly Emerging areas such as Pharmacogenetics
Chair:  Eric ABADIE, AFSSAPS, France
Chairman’s introduction
Marisa PAPALUCA-AMATI, EMEA, United Kingdom, "EMEA Perspectives and Strategies"

Lawrence LESKO, CDER-FDA, United States, "US-FDA Perspectives and Strategies"

Yoshiaki UYAMA, PMDA, Japan, "Japan-MHLW/PMDA Perspectives and Strategies"


Roundtable Debate : Challenges to regulatory capabilities across OECD countries:  What are the solutions?
Sung Ho LEE, Korea Food and Drug Administration, Korea
Lawrence LESKO, CDER-FDA, United States
Clemens MITTMANN, Federal Institute for Drugs and Medical Devices, Germany
Isabel VIEIRA, INFARMED, Portugal
Marisa PAPALUCA-AMATI, EMEA, United Kingdom
Yoshiaki UYAMA, PMDA, Japan

Session 4: Pharmacogenetic Testing: What's different, what's not?
  Agnes KLEIN, Health Canada, Canada

Janet WARRINGTON, Affymetrix, United States, "Diagnostic platforms and approaches for pharmacogenetic testing: Meeting the predicted demands and integrating bioinformatics to facilitate test interpretation"

Ron ZIMMERN, Public Health Genetics Unit, United Kingdom, "Regulation and Evaluation of Genetic Tests"

Lou GARRISON, University of Washington, United States, "Co-development and marketing of pharmacogenetic tests and therapeutics: economic incentives and policy implications"

Case study: Eleni ZIKA, EC-Joint Research Centre-IPTS, Spain "Clinical implementation of HER-2 and TPMT testing in Europe"


Roundtable Debate
Commentator: Felix FRUEH, CDER-FDA (United States)
Lou GARRISON, University of Washington, United States
Agnes KLEIN, Health Canada, Canada
Patricia OSTROSKY, UNAM, Mexico
Janet WARRINGTON, Affymetrix, United States,
Eleni ZIKA, EC-Joint Research Centre-IPTS, Spain
Ron ZIMMERN, Public Health Genetics Unit, United Kingdom


Session 5: Impacts on Human Health and Health Care Systems
Chair:  Guiliano D’AGNOLO, ISS, Italy

Thane KREINER, Affymetrix, United States, "Challenges to widespread adoption of pharmacogenetics"

Mitchell SUGARMAN, Medtronic Vascular, United States, "Evidence-based medicine and pharmacogenetics"

Anders OLAUSON, EURORDIS, Sweden, "Patients’ perspectives"

Deven CHAUHAN, Office of Health Economics, United Kingdom, "Changing paradigms for evaluating the costs and benefits of drug treatments.

David GURWITZ, Tel-Aviv University, Israel, "Are health care systems ready to deliver pharmacogenetics as standard of care? Predicting the needs and setting the strategies"


Roundtable Debate
Commentator:  Larry BROWN, Columbia University, United States
Giuliano D’AGNOLO, ISS, Italy
David GURWITZ, Tel-Aviv University, Israel,
Thane KREINER, Affymetrix, United States
Mitchell SUGARMAN, Medtronic Vascular, United States
Deven CHAUHAN, Office of Health Economics, United Kingdom

Rapporteur's report – Celia CAULCOTT, United Kingdom


Related Documents




Countries list

  • Afghanistan
  • Albania
  • Algeria
  • Andorra
  • Angola
  • Anguilla
  • Antigua and Barbuda
  • Argentina
  • Armenia
  • Aruba
  • Australia
  • Austria
  • Azerbaijan
  • Bahamas
  • Bahrain
  • Guernsey
  • Jersey
  • Bangladesh
  • Barbados
  • Belarus
  • Belgium
  • Belize
  • Benin
  • Bermuda
  • Bhutan
  • Venezuela
  • Bosnia and Herzegovina
  • Botswana
  • Brazil
  • British Virgin Islands
  • Brunei Darussalam
  • Bulgaria
  • Burkina Faso
  • Burundi
  • Cabo Verde
  • Cambodia
  • Cameroon
  • Canada
  • Cayman Islands
  • Central African Republic
  • Chad
  • Chile
  • Chinese Taipei^Taipei
  • Colombia
  • Comoros
  • Cook Islands
  • Costa Rica
  • Côte d'Ivoire
  • Croatia
  • Cuba
  • Cyprus
  • Czech Republic
  • Democratic People's Republic of Korea
  • Democratic Republic of the Congo
  • Denmark
  • Djibouti
  • Dominica
  • Dominican Republic
  • Ecuador
  • Egypt
  • El Salvador
  • Equatorial Guinea
  • Eritrea
  • Estonia
  • Ethiopia
  • European Union
  • Faeroe Islands
  • Micronesia
  • Fiji
  • Finland
  • Former Yugoslav Republic of Macedonia
  • France
  • French Guiana
  • Gabon
  • Gambia
  • Georgia
  • Germany
  • Ghana
  • Gibraltar
  • Greece
  • Greenland
  • Grenada
  • Guatemala
  • Guinea
  • Guinea-Bissau
  • Guyana
  • Haiti
  • Honduras
  • Hong Kong (China)
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Iraq
  • Ireland
  • Iran
  • Isle of Man
  • Israel
  • Italy
  • Jamaica
  • Japan
  • Jordan
  • Kazakhstan
  • Kenya
  • Kiribati
  • Korea
  • Kuwait
  • Kyrgyzstan
  • Lao People's Democratic Republic
  • Latvia
  • Lebanon
  • Lesotho
  • Liberia
  • Libya
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Macau (China)
  • Madagascar
  • Malawi
  • Malaysia
  • Maldives
  • Mali
  • Malta
  • Marshall Islands
  • Mauritania
  • Mauritius
  • Mayotte
  • Mexico
  • Monaco
  • Mongolia
  • Montenegro
  • Montserrat
  • Morocco
  • Mozambique
  • Myanmar
  • Namibia
  • Nauru
  • Nepal
  • Netherlands
  • New Zealand
  • Nicaragua
  • Niger
  • Nigeria
  • Niue
  • Norway
  • Oman
  • Pakistan
  • Palau
  • Palestinian Authority
  • Panama
  • Papua New Guinea
  • Paraguay
  • China (People’s Republic of)
  • Peru
  • Philippines
  • Bolivia
  • Poland
  • Portugal
  • Puerto Rico
  • Qatar
  • Moldova
  • Congo
  • Romania
  • Russia
  • Rwanda
  • Saint Helena
  • Saint Kitts and Nevis
  • Saint Lucia
  • Saint Vincent and the Grenadines
  • Samoa
  • San Marino
  • Sao Tome and Principe
  • Saudi Arabia
  • Senegal
  • Serbia
  • Serbia and Montenegro (pre-June 2006)
  • Seychelles
  • Sierra Leone
  • Singapore
  • Slovak Republic
  • Slovenia
  • Solomon Islands
  • Somalia
  • South Africa
  • South Sudan
  • Spain
  • Sri Lanka
  • Sudan
  • Suriname
  • Swaziland
  • Sweden
  • Switzerland
  • Syrian Arab Republic
  • Tajikistan
  • Thailand
  • Timor-Leste
  • Togo
  • Tokelau
  • Tonga
  • Trinidad and Tobago
  • Tunisia
  • Turkey
  • Turkmenistan
  • Turks and Caicos Islands
  • Tuvalu
  • Uganda
  • Ukraine
  • United Arab Emirates
  • United Kingdom
  • Tanzania
  • United States
  • United States Virgin Islands
  • Uruguay
  • Uzbekistan
  • Vanuatu
  • Viet Nam
  • Wallis and Futuna
  • Western Sahara
  • Yemen
  • Zambia
  • Zimbabwe
  • Curaçao
  • Bonaire
  • Saba