Mid-Atlantic - Russia Business Council (MARBC)

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1 MARBC Mid-Atlantic - Russia Business Council (MARBC) 16 th Semi-Annual Russian-American Innovation Technology Weeks (RANIT-BIO) Agenda June 14-21, 2012 Philadelphia, PA Boston, MA

2 The 16 th Semi-Annual Russian-American Innovation Technology Week (RANIT BIO) Welcoming Ceremony June 14, 2012 Organized by: Philadelphia City Hall Mayor s Reception Room Broad Street and Market Street Philadelphia, PA The Mid-Atlantic - Russia Business Council Supported by The City of Philadelphia, State of Pennsylvania, State of New Jersey, State of Delaware, Pennsylvania Bio, Bio New Jersey, Delaware Bio, Virginia Bio, Philadelphia U.S. Export Assistance Center of the U.S. Commercial Service, World Trade Center of Greater Philadelphia, World Trade Center of Central Pennsylvania, World Trade Center Delaware, Pennsylvania Chamber of Business and Industry, University City Science Center, Select Greater Philadelphia, Entrepreneurs' Forum of Greater Philadelphia, Greater Philadelphia Life Sciences Congress, Ben Franklin Technology Partners, Pharmaceutical Research and Manufacturers of America, National Association of Seed and Venture Funds, Innovation America, U.S. Chamber of Commerce, American Chamber of Commerce in Russia, Association of the Russian Pharmaceutical Manufactures, Society of Professional Pharmaceutical Organizations, Russian Union of Industrialists and Entrepreneurs, Chamber of Commerce and Industry of the Russian Federation, Moscow Entrepreneurs Association 2:00 Welcoming Val Kogan, President, Mid-Atlantic - Russia Business Council Alan Greenberger, Deputy Mayor for Economic Development, City of Philadelphia Peter O Neill, Executive Director, Center for Trade Development, Pennsylvania Department of Community & Economic Development Patricia Cannon, Economic Development Office, State of Delaware Eddy Mayen, Director, Office of International Business Development and Protocol, State of New Jersey Debbie Hart, President, BioNJ Alex Halper, Manager, Government Affairs, Pennsylvania Chamber of Business and Industry Dino Ramos, Senior Vice President, World Trade Center of Greater Philadelphia Jeanne Nevelos, Vice President & Chief Business Development Officer, Select Greater Philadelphia Jonathan Kimball, Deputy Vice President - Europe, the Middle East, and Africa, Pharmaceutical Research and Manufacturers of America Russian Government Official (TBD) Networking with Members of the Russian Delegation

3 3:00 Session 1 Innovation Development in Russian Regions Establishing and Developing Pharmaceutical and Bio Industry Clusters in Russia Senior representatives of the local governments will present local clusters development, regional policies on attracting investments and discuss current pharmaceutical projects development. Development of a Bio clusters and pharmaceutical clusters in Russian Regions. Gennady Shirshov, Executive Director, Union of Professional Pharmaceutical Organizations Valeriy Turulo, General Director, Non-Commercial Partnership Biotechnological cluster of the Kirov region 3:30 Announcement of the First Russian Company s Opening of an Office at the Science Center in Philadelphia Saul Behar, Vice President and General Counsel, University City Science Center Vladimir Kanin, President, Optiflame 3:45 Session 2 Russian-American Innovation Cooperation Russian-American Innovation Cooperation Antonio Ceballos, Director, U.S. Export Assistance Center Philadelphia James Jaffe, President and CEO, National Association of Seed and Venture Funds Richard Bendis, President and CEO, Innovation America James Balaschak, Principal, Deloitte Phil Hopkins, Vice President, Select Greater Philadelphia Andrey Gidaspov, Sr. Manager, Strategic Development, American Councils for International Education Igor Pivovarov, CEO, Member of Board, HemaСore LLC Michael Egorov, Director of CRMP, MESI University

4 June, 14 th 10:00 am 12:00 pm Roundtable at the University City Science Center 3711 Market Street, Philadelphia, PA Russian Delegation at the International House of Philadelphia June, 14 th 12:30 pm 1: Chestnut Street, Philadelphia, PA June, 15 th 5:00 pm 7:00 pm Reception at Morgan Lewis & Bockius LLP 1701 Market Street, Philadelphia, PA

5 Russian-American Life Sciences Conference June 15, 2012 Co-organized by: Morgan, Lewis & Bockius LLP 1701 Market Street, Philadelphia, PA the Mid-Atlantic - Russia Business Council and Pharmaceutical Research and Manufacturers of America, sponsored by Novartis, Amgen and Morgan, Lewis & Bockius LLP Description: As Russia and the U.S. look to reset economic relations, one of the most innovative and fastgrowing sectors are pharmaceuticals, biotechnology and life sciences. Business models are changing rapidly as emerging markets like Russia develop the resources and expertise to make the transition from manufacturing to all stages of the innovation cycle. Major projects in chemical drugs, biologicals, vaccines, nanotechnology, and medical device design are underway or are planned for the mid-term. This conference will look at the policies that enable innovation in Russia and the U.S. It will then focus on several practitioners of innovation to find best practices in Russian-US partnership and cooperation. 9:00 Welcoming Remarks Val Kogan, President, Mid-Atlantic - Russia Business Council Jonathan Kimball, Deputy Vice President - Europe, the Middle East, and Africa, Pharmaceutical Research and Manufacturers of America Stephen Goodman, Partner, Morgan, Lewis & Bockius LLP Fahd Riaz, Head of Biotech Practice in Philadelphia, Morgan, Lewis & Bockius LLP Carol Brooks-Bryant, Manager of International Trade and Diplomatic Liaison, City of Philadelphia Department of Commerce David Briel, Executive Director, Center for Direct Investment, Pennsylvania Department of Community & Economic Development Bonnie Grant, Executive Director, Greater Philadelphia Life Sciences Congress Christopher Molineaux, President, Pennsylvania Biotechnology Association Bob Dayton, President, Delaware Bio 9:45 Session 1-2 Market Regulation and Government Intentions Picture Overview of the recent regulatory reform. Implementation of the BIO-2020 program and the Pharma 2020 Strategy: major objectives, challenges and progress. An update on the status of ongoing activities in the Working Groups, including plans for enhancing collaboration between the United States and Russia in the areas of public health and biomedical research, and the policy priorities in these areas. How will WTO accession impact upon the industry? What are the possible threats and benefits for local and international pharmaceutical companies? How will the BIO-2020 program affect the development of biotech products in Russia? What senior leaders from the international and local pharmas, potential investors and sectors associations think about the current regulatory environment?

6 Moderator: Jonathan Kimball, Deputy Vice President - Europe, the Middle East, and Africa, Pharmaceutical Research and Manufacturers of America Government and Industry Views Antonio Ceballos, Director, U.S. Export Assistance Center Philadelphia Yelena Shnayder, Office of Global Health Affairs, Department of Health and Human Services Russian Government Official (TBD) Elena Barmanova, Director, Federal Service on Surveillance in Healthcare and Social Development of Russian Federation Jonathan Kimball, Deputy Vice President - Europe, the Middle East, and Africa, Pharmaceutical Research and Manufacturers of America Gennady Shirshov, Executive Director, Union of Professional Pharmaceutical Organizations Stanley Satz, Chairman and Chief Scientific Officer, Bio-Nucleonics Discussion 11:15 Break 11:30 Session 3 Industry-Sponsored Clinical Research in Russia: Challenges and Opportunities (organized with Novartis) An overview on the unique advantages Russia brings to the table of the global BioPharma drug development strategy. Are there niche areas where Russia can play a bigger or differentiating role? An analysis on the challenges and opportunities for global BioPharma to increase the amount of clinical trial activity in Russia. What support or changes would be required to increase the scale and scope of clinical research in Russia? An overview on the status of the regulatory environment and a discussion on the opportunities for improvement (e.g. scientific advice, dialogue on development program, lengthy approval process for CTAs and NDAs). Moderator: John Orloff, Chief Medical Officer, Novartis Pharma Agustin (Tino) Melina, Head of Emerging Markets Clinical Development, Merck Michele Mercuri, Vice President, Daiichi-Sankyo Gennady Shirshov, Executive Director, Union of Professional Pharmaceutical Organizations Elena Barmanova, Department Director, Federal Service on Surveillance in Healthcare and Social Development of Russian Federation 12:30 Lunch 1:15 Session 4 Innovation, Cost of Innovation, Licensing Opportunities. Accessing Innovation in Life Sciences in Russia and Emerging Markets Discussion on commercializing research in the US and Russia. Panelists will discuss the Bayh-Dole Act, which legalized tech transfer in the US in the 1970 s, and best practices since then, and Russian panelists will talk about the recent legalization of tech transfer in Russia, and their successes and challenges.

7 John Steele, Director, International Government Affairs, Eli Lilly Jit Patel, Business Development Director (IMED), pre-clinical licensing in CNS/Neuroscience, AstraZeneca Marya Levintova, International Health Program Officer for Russia, Eurasia and Arctic Affairs, National Institutes of Health (NIH) Lyuba Varticovski, (NIH/NCI) Andrey Gidaspov, Sr. Manager, Strategic Development, American Councils for International Education 2:00 Session 5 New Areas for Partnership Moderator: Fahd Riaz, Head of Biotech Practice in Philadelphia, Morgan, Lewis & Bockius LLP Stanley Satz, Chairman and Chief Scientific Officer, Bio-Nucleonics Vidadi Yusibov, Executive Director, Fraunhofer USA Center for Molecular Biotechnology 2:30 Break 2:45 Session 6 Venture Investments Across the Ocean Investments in Russian Pharma Market Key aspects of the pharmaceutical industry development and analysing how transparency, access to medicines and pricing influence business and investment environment of the sector. Moderator: Fahd Riaz, Head of Biotech Practice in Philadelphia, Morgan, Lewis & Bockius LLP Patrick Keenan, Chief Counsel and Strategist, Numoda Capital Innovations Boris Foxman, President, National Business & Accounting Consultants (NBAC) Corporation Tatiana Nikolenko, Director, Programs in Life Sciences, RUSNANO Russian-Israel-American Cooperation in Innovations 3:15 3:30 Closing Remarks 3:30 5:00 Reception at Morgan Lewis & Bockius LLP 1701 Market Street, Philadelphia, PA

8 2012 BIO International Convention June 18-21, 2012 Boston Convention & Exhibition Center, 415 Summer Street Boston Description: The BIO Convention is the world s largest and most impressive exhibition and conference in the field of biotechnology. It is the most important venue to meet and exchange high-level dialogue with industry stakeholders, members of the U.S. Administration and industry participants from over 60 countries. Russia-Related Sessions 2:00 pm June 18, 2012 Global Innovations & Markets Session Innovative Transformation of the Russian Healthcare Industry and Regulatory Systems Is 2020 the Limit? (Organized by Biopharmcluster Northern) 2:00 pm June 19, 2012 Russia Country Session - International Case Studies Russia: Models and Frameworks for Biotech Commercialization in Russia (Organized by the Mid-Atlantic - Russia Business Council) This panel will review opportunities for Biotech commercialization in Russian, as well as the latest policy and activity developments in the Russian innovative life sciences sector. Through the national program: Comprehensive Program of Biotechnology Development in Russia to 2020, Russia hopes to cultivate coordination between the public and private sectors in developing biotech products. It will also discuss US perspectives on future opportunities for cooperation and collaboration with Russian institutions. Panel includes top leaders of Russian and multinational biotechnology companies, as well as influential government officials.

9 Welcoming: Val Kogan, President, Mid-Atlantic - Russia Business Council Valery Chereshnev, Chairman, Committee on Science and Innovations, Russian State Duma Moderator: Jonathan Kimball, Deputy Vice President - Europe, the Middle East, and Africa, Pharmaceutical Research and Manufacturers of America Key Panelists: Oleg Fomichev, Deputy Minister of Economic Development of Russian Federation Nikolay Gerasimenko, First Deputy Chairman, Committee on Science and Innovations, Russian State Duma Raif Vasilov, President & CEO of the Russian Biotechnology Society Victoria Anashkina, Country Director - Russian Federation, Amgen June 21, 2012 Closing of the 16 th Russian-American Innovation Technology Week (RANIT)

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