Palestrantes Internacionais Confirmados
Palestrantes Internacionais Confirmados
Hillel P. Cohen, Ph.D., Executive Director, Scientific Affairs, Sandoz, Inc., is a leading industry voice on biosimilars and biosimilar policy. With nearly two decades of experience working in biosimilars and “follow-on protein products,” Hillel has been instrumental in propelling the U.S. biosimilars industry forward. In particular, Hillel’s thought leadership on naming, interchangeability and broader biosimilars regulatory policy has helped position biosimilars as a solution for U.S. patients.
Background
Hillel’s extensive experience spans the U.S. biosimilars market lifetime. In 2002, he was one of three individuals in a Novartis delegation to the Follow-on Protein Products (FOPPs) Key Issue Team, helping PhRMA develop an initial position on behalf of the U.S. originator industry for the precursor to biosimilars. For the next 12 years, he remained engaged on PhRMA and BIO scientific committees as a Novartis representative, helping shape biosimilars positioning. Now as the executive director of Scientific Affairs in the Sandoz division of Novartis, Hillel is focused on science policy related to biosimilar development.
Hillel has held numerous high-profile industry roles focused on creating a robust biosimilars market for patients, including as a member of the Biosimilars Council Education Committee. In 2015, Hillel led the efforts for the first-ever presentation of a biosimilar to a U.S. advisory committee, following Sandoz submitting a Biologics License Application for Zarxio (filgrastim-sndz). The Oncology Advisory Committee voted 14-0 to recommend approval of Zarxio for all indications. In 2016 Hillel was among the industry negotiators who met with FDA to assess and recommend updates when the Biosimilar User Fee Act was reauthorized by Congress (BsUFA2).
The Biosimilars Council is fortunate to have Hillel as a Sandoz representative to the Council Education Committee. His robust biosimilars background is crucial as we continue to advocate and educate on the promise of biosimilars for American patients.
Hillel P. Cohen, Ph.D., Executive Director, Scientific Affairs, Sandoz, Inc., is a leading industry voice on biosimilars and biosimilar policy. With nearly two decades of experience working in biosimilars and “follow-on protein products,” Hillel has been instrumental in propelling the U.S. biosimilars industry forward. In particular, Hillel’s thought leadership on naming, interchangeability and broader biosimilars regulatory policy has helped position biosimilars as a solution for U.S. patients.
Background
Hillel’s extensive experience spans the U.S. biosimilars market lifetime. In 2002, he was one of three individuals in a Novartis delegation to the Follow-on Protein Products (FOPPs) Key Issue Team, helping PhRMA develop an initial position on behalf of the U.S. originator industry for the precursor to biosimilars. For the next 12 years, he remained engaged on PhRMA and BIO scientific committees as a Novartis representative, helping shape biosimilars positioning. Now as the executive director of Scientific Affairs in the Sandoz division of Novartis, Hillel is focused on science policy related to biosimilar development.
Hillel has held numerous high-profile industry roles focused on creating a robust biosimilars market for patients, including as a member of the Biosimilars Council Education Committee. In 2015, Hillel led the efforts for the first-ever presentation of a biosimilar to a U.S. advisory committee, following Sandoz submitting a Biologics License Application for Zarxio (filgrastim-sndz). The Oncology Advisory Committee voted 14-0 to recommend approval of Zarxio for all indications. In 2016 Hillel was among the industry negotiators who met with FDA to assess and recommend updates when the Biosimilar User Fee Act was reauthorized by Congress (BsUFA2).
The Biosimilars Council is fortunate to have Hillel as a Sandoz representative to the Council Education Committee. His robust biosimilars background is crucial as we continue to advocate and educate on the promise of biosimilars for American patients.
Gilberto Castañeda-Hernández is a Principal Investigator in the Department of Pharmacology of the Center for Research and Advanced Studies of the National Polytechnic Institute in Mexico City. He has been a member of the Mexican Association of Pharmacology since 1984 (President 1998–2000), a member of the Western Pharmacology Society since 1991 (President 1997–1998), a member of the National Academy of Sciences of Mexico since 1994 and a member of the Mexican Association of Pharmacovigilance since 2008. He was a member of the Council of Clinical Pharmacology of the International Union of Basic and Clinical Pharmacology between 2004 and 2014. Additionally, he has been a member of the Review Committees of the National Council of Science and Technology of Mexico, of the Italian Medicines Agency, of the National Research System of Panama and the National Science Centre of Poland.
Professor Castañeda-Hernández has published 190 articles in international journals in the area of Pharmacology and has supervised several 29 doctoral and 61 master's theses in this discipline. He was a member of the editorial board of the Annals of Hepatology from 2010 to 2016 and of the Journal of Pharmacological and Toxicological Methods between 1998 and 2000. At present, he is editor-in-chief of the Latin American Journal of Clinical Sciences and Medical Technology.
Gilberto Castañeda-Hernández is a Principal Investigator in the Department of Pharmacology of the Center for Research and Advanced Studies of the National Polytechnic Institute in Mexico City. He has been a member of the Mexican Association of Pharmacology since 1984 (President 1998–2000), a member of the Western Pharmacology Society since 1991 (President 1997–1998), a member of the National Academy of Sciences of Mexico since 1994 and a member of the Mexican Association of Pharmacovigilance since 2008. He was a member of the Council of Clinical Pharmacology of the International Union of Basic and Clinical Pharmacology between 2004 and 2014. Additionally, he has been a member of the Review Committees of the National Council of Science and Technology of Mexico, of the Italian Medicines Agency, of the National Research System of Panama and the National Science Centre of Poland.
Professor Castañeda-Hernández has published 190 articles in international journals in the area of Pharmacology and has supervised several 29 doctoral and 61 master's theses in this discipline. He was a member of the editorial board of the Annals of Hepatology from 2010 to 2016 and of the Journal of Pharmacological and Toxicological Methods between 1998 and 2000. At present, he is editor-in-chief of the Latin American Journal of Clinical Sciences and Medical Technology.
Doctor en Bioquímica (Universidad Nacional de Rosario, Argentina), Postdoctorado en Oncología Molecular (Barcelona, España). Investigador del Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET). Docente de Genética y Oncología de la Facultad de Ciencias Médicas y Profesor invitado en la carrera del Doctorado en Ciencias Biomédicas, Universidad Nacional de Rosario. Dirección de proyectos de Investigación en Oncología e Inmunología, en temas de Inmunoterapia del Cáncer, Terapias dirigidas a blancos moleculares e identificación de Biomarcadores. Inmunoterapias Combinadas. Investigación Traslacional. Publicaciones en revistas internacionales con referato, libros y presentaciones en Congresos Internacionales. Experto y Asesor externo de la Industria Farmacéutica en Biotecnología y Medicamentos Biotecnológicos. Organización y Exposición en Programas de Formación Profesional Médica continua dirigida a Médicos especialistas en Oncología, Reumatologia, Hematología y Neurología. Planificación, Organización y Exposición en Jornadas, Cursos, Simposios y Foros Científicos en temas de Biotecnología, Medicamentos Biotecnológicos y Medicina Personalizada. Asesoramiento de Agencias Regulatorias de Latinoamérica sobre Medicamentos Biotecnológicos. Ex-becario de la American Association for Cancer Research, Fundación Carolina y Agencia Española de Cooperación Internacional, y Liga Argentina de Lucha contra el Cáncer (LALCEC).
Doctor en Bioquímica (Universidad Nacional de Rosario, Argentina), Postdoctorado en Oncología Molecular (Barcelona, España). Investigador del Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET). Docente de Genética y Oncología de la Facultad de Ciencias Médicas y Profesor invitado en la carrera del Doctorado en Ciencias Biomédicas, Universidad Nacional de Rosario. Dirección de proyectos de Investigación en Oncología e Inmunología, en temas de Inmunoterapia del Cáncer, Terapias dirigidas a blancos moleculares e identificación de Biomarcadores. Inmunoterapias Combinadas. Investigación Traslacional. Publicaciones en revistas internacionales con referato, libros y presentaciones en Congresos Internacionales. Experto y Asesor externo de la Industria Farmacéutica en Biotecnología y Medicamentos Biotecnológicos. Organización y Exposición en Programas de Formación Profesional Médica continua dirigida a Médicos especialistas en Oncología, Reumatologia, Hematología y Neurología. Planificación, Organización y Exposición en Jornadas, Cursos, Simposios y Foros Científicos en temas de Biotecnología, Medicamentos Biotecnológicos y Medicina Personalizada. Asesoramiento de Agencias Regulatorias de Latinoamérica sobre Medicamentos Biotecnológicos. Ex-becario de la American Association for Cancer Research, Fundación Carolina y Agencia Española de Cooperación Internacional, y Liga Argentina de Lucha contra el Cáncer (LALCEC).
Dr. Thomas Kirchlechner holds a Master's degree in chemistry from the University of Munich, Germany, and a PhD in chemistry, specializing in marine analytics, from Otago University in Dunedin, New Zealand. In total, he has accumulated 20 years of vast experience in the pharmaceutical industry, including Global Biopharmaceutical Regulatory Affairs at Sandoz in Austria for the last 15 years. His current role is in Biosimilars Regulatory Policy & Intelligence.
Dr. Thomas Kirchlechner holds a Master's degree in chemistry from the University of Munich, Germany, and a PhD in chemistry, specializing in marine analytics, from Otago University in Dunedin, New Zealand. In total, he has accumulated 20 years of vast experience in the pharmaceutical industry, including Global Biopharmaceutical Regulatory Affairs at Sandoz in Austria for the last 15 years. His current role is in Biosimilars Regulatory Policy & Intelligence.