BIO INTERNATIONAL CONVENTION
Schedule of Brazil and Latin America Programming & Events
Prepared for:
BIO International Advocacy Steering Committee, Brazil / L.A. Working Group
Programming and Events listed by country, then by order of day & time.
BRAZIL
World Cup Viewing Party (By Invitation Only)
Date: Monday, June 23rd
Time: 12:00PM – 4:00PM
Location: Hennessey’s Tavern
Address: 708 4th Ave, San Diego
Thank you to EMD Serono for their support of this event.
Biosimilars Regulations: A Perspective from Influential Global Regulators
Forum: Emerging Opportunities in Global Markets
http://mybio.zerista.com/event/member/103914
Date: Tuesday, June 24th
Time: 1:30PM – 3:30PM
Location: Room 4
Translation is available in English/Portuguese/Spanish
Description: Regulatory agency officials from around the world will be moderated by an industry representative to discuss scientific and regulatory issues for biosimilars, including specific requirements for approval of biosimilars, interchangeability and implications for substitution. Discussion of approval requirements will address, among other topics, clinical trials, extrapolation of data and immunogenicity. Naming, labeling, and pharmacovigilance issues will also be addressed. How are global health authorities approaching these issues and what are the main challenges and concerns.
Confirmed
MEXICO
Biosimilars Regulations: A Perspective from Influential Global Regulators
Track: Emerging Opportunities in Global Markets
http://mybio.zerista.com/event/member/103914
Date: Tuesday, June 24th
Time: 1:30PM – 3:30PM
Location: Room 4
Translation is available in English/Portuguese/Spanish
Description: Regulatory agency officials from around the world will be moderated by an industry representative to discuss scientific and regulatory issues for biosimilars, including specific requirements for approval of biosimilars, interchangeability and implications for substitution. Discussion of approval requirements will address, among other topics, clinical trials, extrapolation of data and immunogenicity. Naming, labeling, and pharmacovigilance issues will also be addressed. How are global health authorities approaching these issues and what are the main challenges and concerns.
Confirmed
CHILE
Pursuing Biotechnology Patent Protection in the U.S. and Latin America
Track: Intellectual Property
http://mybio.zerista.com/event/member/103946
Date: Tuesday, June 24th
Time: 3:00PM – 4:00PM
Location: Room 23ABC
Description: The panelists include the Heads of the Intellectual Property (IP) offices of Mexico and Chile, and the Chief Judge of the U.S. Court of Appeals for the Federal Circuit. These panelists will bring three different perspectives to a discussion of various hot topics in biotechnology patent protection in the U.S. and Latin America. Topics will include: patent filing trends, unique and common challenges in patent examination, scope of subject matter eligible for patent protection, and recent legal and legislative developments impacting biotechnology patent protection in the three countries. This panel discussion will provide an overview of patent protection of biotechnology inventions and current issues facing each country. The panel will be moderated by a former U.S. Patent and Trademark Office official who oversaw the agency’s international policies and activities.
Confirmed
COLOMBIA
Inter-Institutional Agreement of Cooperation Between Health Agencies of the Pacific Alliance: Future Expectations for Biologics Regulations
http://mybio.zerista.com/event/member/103966
Forum: Emerging Opportunities in Global Markets
Date: Thursday, June 26th
Time: 9:15AM – 10:45AM
Room 5A
Translation is available in English/Spanish
Special thanks to Baker & McKenzie for their support of this panel.
Description: The signing of the Inter-Institutional Agreement of Cooperation between health agencies of the Pacific Alliance took place with the participation of the Mexican Undersecretary for Foreign Trade at the Ministry of the Economy, Francisco de Rosenzweig and COFEPRIS Commissioner Mikel Arriola, along with their counterparts from Chile, Colombia and Peru. Certain biologics regulatory issues are important for these countries and impact the region. These important issues will be examined in the session.
Confirmed
REGIONAL INTEREST, NOT LISTED ELSEWHERE
Opening Plenary
Forum: Emerging Opportunities in Global Markets
http://mybio.zerista.com/event/member/104558
Date: Tuesday, June 24th
Time: 10:30AM – 12:00PM
Location: Room 4
Description: This session will provide an overview of global issues confronting the biotech sector by bringing together prominent policy and business officials, and setting the stage for the next three days of panel sessions.
Confirmed
BRAZIL
World Cup Viewing Party (By Invitation Only)
Date: Monday, June 23rd
Time: 12:00PM – 4:00PM
Location: Hennessey’s Tavern
Address: 708 4th Ave, San Diego
Thank you to EMD Serono for their support of this event.
Biosimilars Regulations: A Perspective from Influential Global Regulators
Forum: Emerging Opportunities in Global Markets
http://mybio.zerista.com/event/member/103914
Date: Tuesday, June 24th
Time: 1:30PM – 3:30PM
Location: Room 4
Translation is available in English/Portuguese/Spanish
Description: Regulatory agency officials from around the world will be moderated by an industry representative to discuss scientific and regulatory issues for biosimilars, including specific requirements for approval of biosimilars, interchangeability and implications for substitution. Discussion of approval requirements will address, among other topics, clinical trials, extrapolation of data and immunogenicity. Naming, labeling, and pharmacovigilance issues will also be addressed. How are global health authorities approaching these issues and what are the main challenges and concerns.
Confirmed
- Jay Siegel, Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson, U.S.A. (Moderator)
- Lic. Mikel Arriola, Commissioner, COFEPRIS (Mexico)
- Dirceu Barbano, President, ANVISA; Member, Brazilian National Biotechnology Committee (Brazil)
- Ian Hudson, Chief Executive, MHRA (U.K.)
- Anthony Ridgway, Senior Regulatory Scientist, Office of the Director, Health Canada (Canada)
- Jasemine Chambers, Of Counsel, Wilson Sonsini Goodrich & Rosati, P.C., U.S.A. (Moderator)
- Miguel Ángel Margáin, Director, Instituto Mexicano de la Propiedad Industrial (Mexico)
- Randall Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit (U.S.A.)
- Maximiliano Santa Cruz, Director, Instituto Nacional de Propiedad Industrial (Chile)
Time: 3:45PM – 5:00PM
Location: Room 4 Translation is available in English/Portuguese/Spanish Special thanks to Kira Alvarez of AbbVie for organizing this session. Description: Pharmacovigilance regimes are an important part of the risk management plans required by the new biologics and biosimilars regulations being implemented throughout the region and play a key role in ensuring patient safety. Panel will provide a perspective on how patient groups and the stakeholders interacting with them view the importance of pharmacovigilance, as well as a candid assessment of the challenges in the region with suggested next steps and calls to action. Confirmed- Dr. Freddy J Faccin L, Associate Medical Director – Biotherapeutics, GMA – GPRD, AbbVie (Moderator)
- Dr. Inés Bignone, Director of Evaluation of Medicines, ANMAT (Argentina)
- Gustavo Campinos, Presidente, Fundación Red De Apoyo Social de Antioquia; RASA (Colombia)
- Dr. Eduardo Mysler, Director, OMI (Argentina)
- Eva Maria Ruiz de Castilla, Board Member, IAPO (United Kingdom)
- Dr. Francisco Zaragozá García, Chair, Pharmacology at the University of Alcalá; Member, Scientific Committee for the National Research Promotion Plan, Ministry of Industry (Spain)
- Laura Hamill, Vice President LACAN, Amgen (Moderator)
- Prof. Jorge Almeida Guimarães, President, CAPES (Brazil)
- Rogerio Ribeiro, SVP & Area Head Emerging Markets and Asia Pacific, GlaxoSmithKline
- Reginald Seeto, VP Partnering & Strategy, MedImmune (U.S.A.)
- Dr. Glaucius Oliva, Presidente, CNPq (Brazil)
- Eric Walczykowski, Vice President, Life Sciences, Thompson Reuters, U.S.A. (Moderator)
- Lic. Mikel Arriola, Commissioner, COFEPRIS (Mexico)
- Dirceu Barbano, President, ANVISA (Brazil)
- Cláudia Simone Costa de Cunha, Advisor on Research and Innovation, EBESERH (Brazil)
- Jorge Otero, Executive Medical Director LACAN, Amgen
- Vonnie Estes, Managing Director, GranBio (Brazil)
- Jonathan Wolfson, Chief Executive Officer, Solazyme, Inc (U.S.A.)
- Nelson A. Fujimoto, Secretary of Innovation, Ministry of Development, Industry and Foreign Trade (MDIC), Brazil (Moderator)
- Otávio Brandelli – President, National Institute of Industrial Property (INPI) (Brazil)
- Pedro Lins Palmeira Filho, Head of Pharmaceutical and Biotech Department, Brazilian Development Bank (BNDES) (Brazil)
- Maria Sueli Felipe – Innovation Coordinator, Brazilian Agency for Industrial Development (ABDI) (Brazil)
- McLean Sibanda, Chief Executive Officer, The Innovation Hub (South Africa)
- Eduardo Emrich Soares, President, Biominas (Brazil)
- Peter Khoury, Senior Program Officer, Life Sciences Partnership, Bill & Melinda Gates Foundation, U.S.A. (Moderator)
- Mahima Datla, Managing Director, Biological E. Limited (India)
- Suresh Jadhav, Executive Director-Quality Assurance and Regulator, Serum Institute of India Ltd. (India)
- Dr. Luciana Leite, Director Biotechnology, Instituto Butantan (Brazil)
MEXICO
Biosimilars Regulations: A Perspective from Influential Global Regulators
Track: Emerging Opportunities in Global Markets
http://mybio.zerista.com/event/member/103914
Date: Tuesday, June 24th
Time: 1:30PM – 3:30PM
Location: Room 4
Translation is available in English/Portuguese/Spanish
Description: Regulatory agency officials from around the world will be moderated by an industry representative to discuss scientific and regulatory issues for biosimilars, including specific requirements for approval of biosimilars, interchangeability and implications for substitution. Discussion of approval requirements will address, among other topics, clinical trials, extrapolation of data and immunogenicity. Naming, labeling, and pharmacovigilance issues will also be addressed. How are global health authorities approaching these issues and what are the main challenges and concerns.
Confirmed
- Jay Siegel, Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson, U.S.A. (Moderator)
- Lic. Mikel Arriola, Commissioner, COFEPRIS (Mexico)
- Dirceu Barbano, President, ANVISA; Member, Brazilian National Biotechnology Committee (Brazil)
- Ian Hudson, Chief Executive, MHRA (U.K.)
- Anthony Ridgway, Senior Regulatory Scientist, Office of the Director, Health Canada (Canada)
- Dr. Freddy J Faccin L, Associate Medical Director – Biotherapeutics, GMA – GPRD, AbbVie (Moderator)
- Dr. Inés Bignone, Director of Evaluation of Medicines, ANMAT (Argentina)
- Gustavo Campinos, Presidente, Fundación Red De Apoyo Social de Antioquia; RASA (Colombia)
- Dr. Eduardo Mysler, Director, OMI (Argentina)
- Eva Maria Ruiz de Castilla, Board Member, IAPO (United Kingdom)
- Dr. Francisco Zaragozá García, Chair, Pharmacology at the University of Alcalá; Member, Scientific Committee for the National Research Promotion Plan, Ministry of Industry (Spain)
- Jasemine Chambers, Of Counsel, Wilson Sonsini Goodrich & Rosati, P.C., U.S.A. (Moderator)
- Miguel Ángel Margáin, Director, Instituto Mexicano de la Propiedad Industrial (Mexico)
- Randall Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit (U.S.A.)
- Maximiliano Santa Cruz, Director, Instituto Nacional de Propiedad Industrial (Chile)
Time: 4:30PM – 5:45PM
Location: Room 5A Description: The TPP negotiations, now in their fourth year, bring together the United States, Japan, and 10 other Asia Pacific economies to lower barriers to commerce, improve intellectual property rights, and expand cross-border collaboration. This session will review the negotiations and its broad-ranging implications. In particular the panel will discuss aspects of the agreement which are mission critical for the biotech industry, including changes to Intellectual Property regimes, regulatory harmonization (or the opposite) and market access issues, particularly for new and innovative therapies. Invariably this will traverse hot topics such as biosimilars, gene patenting, data protection, ever-greening and government policies which denude patents of a substantial portion of their value. Accepted- Brian Pomper, Partner, Akin Gump Strauss Hauer & Feld LLP, U.S.A. (Moderator)
- Juan Antonio Dorantes, Director General of International Trade Rules, Ministry of Economy (Mexico)
- Mark Elliot, Executive Vice President, U.S. Chamber of Commerce, Global IP Center (U.S.A.)
- Declan Hamill, Chief of Staff & Vice President, Legal Affairs, R&D, Canada’s Research-Based Pharmaceutical Company (Canada)
- Paul Neureiter, Executive Director, Amgen (U.S.A.)
- Probir Mehta, Acting Assistant USTR for Intellectual Property (U.S.A.)
- Dr. Christian Lopez-Silva, Partner (Local), Head of Pharmaceuticals & Life Sciences, Baker & McKenzie, S.C., Mexico (Moderator)
- Señora Midori de Habich Rospigliosi, Ministra de Estado en el Despacho de Salud, Ministerio de Salud (Peru)
- Dr. Alejandro Gaviria Uribe, Ministro, Ministerio de Salud y Protección Social (Colombia)
- Fabiola Munoz Espinoza, Jefa de Subdepartamento de Registros, ANAMED Agencia Nacional de Medicamentos (ANAMED)and Instituto de Salud Publica (ISP)(Chile)
- Fernando Quezada, Executive Director, Biotechnology Center of Excellence Corporation, U.S.A. (Moderator)
- Jesus Paniagua, Senior Researcher, Ctr. Scientific Research Ensenada (Mexico)
- Roberto Trujillo, President and CEO, TruBios (U.S.A.)
- Mary Walshok, Associate Vice Chancellor for Public Programs, UCLA (U.S.A.)
CHILE
Pursuing Biotechnology Patent Protection in the U.S. and Latin America
Track: Intellectual Property
http://mybio.zerista.com/event/member/103946
Date: Tuesday, June 24th
Time: 3:00PM – 4:00PM
Location: Room 23ABC
Description: The panelists include the Heads of the Intellectual Property (IP) offices of Mexico and Chile, and the Chief Judge of the U.S. Court of Appeals for the Federal Circuit. These panelists will bring three different perspectives to a discussion of various hot topics in biotechnology patent protection in the U.S. and Latin America. Topics will include: patent filing trends, unique and common challenges in patent examination, scope of subject matter eligible for patent protection, and recent legal and legislative developments impacting biotechnology patent protection in the three countries. This panel discussion will provide an overview of patent protection of biotechnology inventions and current issues facing each country. The panel will be moderated by a former U.S. Patent and Trademark Office official who oversaw the agency’s international policies and activities.
Confirmed
- Jasemine Chambers, Of Counsel, Wilson Sonsini Goodrich & Rosati, P.C., U.S.A. (Moderator)
- Miguel Ángel Margáin, Director, Instituto Mexicano de la Propiedad Industrial (Mexico)
- Randall Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit (U.S.A.)
- Maximiliano Santa Cruz, Director, Instituto Nacional de Propiedad Industrial (Chile)
- Insights related to designing public policies through private-public partnership in a developing country
- Main challenges and value drivers for a second generation bio-renewable industry and the justification for government involvement
- Key initiatives that are requires for the creation of a bio renewable industry and how it affects the different actors of the value chain
- Gabriela Gerbin Cezar, Head External R&D Innovation South America, Pfizer (Brazil)
- Sebastián Flores, Project Director, Chile Bio Renovables (Chile)
- Jose Nunez, Environmental Senior Manager, LATAM Airlines Group (Chile)
- Katia Trusich, Undersecretary of Economy, Ministry of the Economy, Government of Chile
COLOMBIA
Inter-Institutional Agreement of Cooperation Between Health Agencies of the Pacific Alliance: Future Expectations for Biologics Regulations
http://mybio.zerista.com/event/member/103966
Forum: Emerging Opportunities in Global Markets
Date: Thursday, June 26th
Time: 9:15AM – 10:45AM
Room 5A
Translation is available in English/Spanish
Special thanks to Baker & McKenzie for their support of this panel.
Description: The signing of the Inter-Institutional Agreement of Cooperation between health agencies of the Pacific Alliance took place with the participation of the Mexican Undersecretary for Foreign Trade at the Ministry of the Economy, Francisco de Rosenzweig and COFEPRIS Commissioner Mikel Arriola, along with their counterparts from Chile, Colombia and Peru. Certain biologics regulatory issues are important for these countries and impact the region. These important issues will be examined in the session.
Confirmed
- Dr. Christian Lopez-Silva, Partner (Local), Head of Pharmaceuticals & Life Sciences, Baker & McKenzie, S.C., Mexico (Moderator)
- Señora Midori de Habich Rospigliosi, Ministra de Estado en el Despacho de Salud, Ministerio de Salud (Peru)
- Dr. Alejandro Gaviria Uribe, Ministro, Ministerio de Salud y Protección Social (Colombia)
- Fabiola Munoz Espinoza, Jefa de Subdepartamento de Registros, ANAMED Agencia Nacional de Medicamentos (ANAMED)and Instituto de Salud Publica (ISP)(Chile)
REGIONAL INTEREST, NOT LISTED ELSEWHERE
Opening Plenary
Forum: Emerging Opportunities in Global Markets
http://mybio.zerista.com/event/member/104558
Date: Tuesday, June 24th
Time: 10:30AM – 12:00PM
Location: Room 4
Description: This session will provide an overview of global issues confronting the biotech sector by bringing together prominent policy and business officials, and setting the stage for the next three days of panel sessions.
Confirmed
- David Brancaccio, Host, American Public Media’s Marketplace Morning Report, U.S.A. (Moderator)
- Yali Friedman, PhD, Chief Editor, Journal of Commercial Biotechnology, thinkBiotech (U.S.A.)
- Mike May, Editorial Director, Scientific American (U.S.A.)
- David Brancaccio, Host, American Public Media’s Marketplace Morning Report, U.S.A. (Moderator)
- Francis Gurry, Director General, World Intellectual Property Organization (WIPO) (Switzerland)
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