Registration and Light Breakfast (8:00 a.m. 8:30 a.m.)

Transcription

1 Overcoming Export Challenges in the Medical Device and Bioscience Industry Thursday, March 6 th, :00 a.m. 7:00 p.m. Anschutz Medical Campus University of Colorado Denver Health Sciences Library Reading Room, Aurora, CO Registration and Light Breakfast (8:00 a.m. 8:30 a.m.) Welcome (8:30 a.m. 9:00 a.m.) Karen Gerwitz, World Trade Center Denver Sandi Moilanen, Office of Economic Development & International Trade Eloise Hirsch State s Bioscience Industry Lead, OEDIT Introduction of the World Trade Center Denver Promote in-person and online classes (for the fundamentals of exporting) Discuss Advanced Industries Export Acceleration Act and the other pieces of the program Overview of today s program Global Overview of the Bioscience Industry & Reimbursement Process (9:00 a.m. 10:30 a.m.) Ed Rozynski, Chairman, International Working Group, Medical Device Manufacturer s Association Broad overview of the Bioscience industry and global device markets Emerging market review for Bioscience opportunities Focus on opportunities, processes and reimbursement in China, Brazil, India, the EU, Japan, and other opportunistic markets Strategies for Growing Bioscience Exports (10:30 a.m. 11:15 a.m.) Jodi Scott, Partner, Hogan Lovells Outline of the strategies for growing abroad o Obtaining premarket notification (510(k)) and/or premarket approval (PMA) prior to growing internationally vs. o Seeking export markets prior to FDA approval (leveraging the CE Mark, etc.) Fundamentals of navigating the FDA overcoming hurdles Explanation of FDA memorandums of understanding Marketing Strategies & Finding Buyers (11:15 a.m. 12:15 p.m.) Selina Marquez, U.S. Export Assistance Center, U.S. Commercial Service Carl Craig, 1stWEST Mergers & Acquisitions LLC Market research techniques Finding qualified buyers and distributors distributor application process Bioscience trade shows working the floor Trade publications for the bioscience industry Networking Lunch (12:15 p.m. 1:00 p.m.) Obtaining the CE Mark (1:00 p.m. 1:45 p.m.) Clay Anselmo. CEO, Reglera Overview of the three directives standard devices, active implantables, in-vitro diagnostics

2 Medical Device Classification Class I, Class IIa, Class IIb, Class III Selecting an appropriate notifying body Role of ISO in conformity assessment Costs of obtaining and maintaining a CE Mark Logistics & Supply Chain Management (2:00 p.m. 2:45 p.m.) Suzy Canon, Senior Manager of Global Logistics, Terumo BCT What is it like to manage a global supply chain? focus on additional considerations for Bioscience companies Selecting and interfacing with a freight forwarder The importance of understanding Incoterms Common export documents in which you need to be familiar Considerations for Global Supply Chain Security Tips and tricks for logistics Protecting Bioscience Intellectual Property in the Global Marketplace (3:00 p.m. 3:45 p.m.) Kyle Siegal, Associate, Lewis Roca Rothgerber Tam Pham, Of Counsel, Lewis Roca Rothgerber Best practices for managing patent/copyright/trademarks globally Export-related intellectual property issues Strategies for wisely allocating resources for intellectual property protection Market-Specific Corporate Panel Discussion (4:00 p.m. 4:45 p.m.) A focus will be placed on the key markets in which the state of Colorado has consultants (Brazil, Canada, Mexico, France, Germany, Scandinavia, United Kingdom, China, Japan) Moderator John Eckstein, Director, Fairfield and Woods P.C. The Export Ready Reception (5:00 p.m. 7:00 p.m.) Tailored for companies that are new to exporting OEDIT staff, USEAC staff, any OEDIT regional consultants that are available, CO Bioscience Association staff and/or representatives, and other resources are invited with a booth opportunity Topic-Specific Webinars Based on feedback from the training, we will select three topics that stood out and feature them in short, one hour, topic-specific webinars to address anything that wasn t covered (i.e. overcoming challenges with the reimbursement process for medical devices in Italy).

3 Speaker Profiles Ed Rozynski Chairman, International Working Group, Medical Device Manufacturer s Association As MDMA s Senior International Advisor, Ed Rozynski enjoys introducing medical device executives to health and hospital leaders in key markets, such as China, India, Brazil, Japan, Europe and U.S. Ed has served as a former U.S. trade negotiator and, also, has been a student of international health care systems for the past 30 years. Ed likes to use his knowledge and experience to help medical device companies, especially start-ups with their global pre-market strategy, including how to navigate regulatory, payment and purchaser system in key global markets. Immediately prior to working with MDMA, Ed launched Stryker's Corp.'s global government affairs program and worked on U.S. health reform legislation. He has appeared before the U.S. Senate and House testifying in favor of pediatric device legislation. In addition to various other industry positions, Ed's served in the Office of the U.S. Trade Representative and negotiated U.S. investment treaties with foreign governments which have been approved by the U.S. Senate. Ed earned B.S. and M.A. degrees in Economics from The University of North Carolina at Greensboro. UNCG's Business School awarded Ed Rozynski their Distinguished Alumni Award in Jodi Scott Partner, Hogan Lovells Denver Jodi Scott focuses her practice on assisting the medical device industry in navigating the complex requirements for achieving U.S. marketing authorization and maintaining compliance to the U.S. Food and Drug Administration's (FDA) quality system and other postmarket regulatory requirements. She has also spent considerable time developing and implementing strategies to manage FDA-initiated enforcement actions, such as the issuance of FDA Form 483s, untitled letters, Warning Letters, and consent degrees of permanent injunction. Additionally, Jodi assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; in addressing regulatory due diligence issues; and with FDA training programs. Having been in industry, she counsels clients on risk management techniques for running a medtech business in today s heavily regulated environment. Prior to joining Hogan Lovells, Jodi served for four years as senior FDA legal counsel and, subsequently, four years as principal FDA legal counsel for Medtronic, Inc., where she was instrumental in growing the company's corporate FDA legal practice to meet the needs of their business in an increasingly enforcement-minded environment. Selina Marquez Senior International Trade Specialist, United States Export Assistance Center Carl Craig 1stWEST Mergers & Acquisitions LLC Clay Anselmo CEO, Reglara Sandi Moilanen International Division Director, CO Office of Economic Development & International Trade Sandi Moilanen serves as the International Division Director at the Colorado Office of

4 Economic Development and International Trade (OEDIT). OEDIT promotes the creation and retention of jobs and economic prosperity of the State by assisting Colorado companies in exporting manufactured goods and services and attract foreign direct investment. As the International Division Director, Sandi is responsible for managing the overall strategic direction of the international division, which includes promoting the State of Colorado and its companies in the global marketplace, introducing Colorado companies to foreign buyers and investors, building diplomatic relationships with international delegations and managing a staff of international representatives. Sandi brings eight years of experience in international business development, manufacturing and international finance to the position. Prior to joining the OEDIT, Sandi managed international financial transactions and overseas production planning for London Fog-Pacific Trail, an apparel manufacturer. She helped develop European distribution and managed a network of international dealers. She has experience as a Customs Broker and an international logistics agent. Suzy Canon Senior Manager of Global Logistics, Terumo BCT Kyle Siegal Associate, Lewis Roca Rothegerber Kyle is an associate in the firm s Intellectual Property group. He leverages his technical background in biomedical engineering and biotechnology to help clients obtain and defend patents. He also assists with other intellectual property matters including trademark prosecution and litigation. Kyle is registered to practice before the United States Patent and Trademark Office. Before joining Lewis Roca Rothgerber, Kyle worked as an international regulatory affairs specialist for a leading medical device manufacturer. Tam Pham Of Counsel, Lewis Roca Rothgerber Ms. Pham is a patent attorney in the firm s Silicon Valley office. Representing clients at all stages of development from start-ups to public companies, she crafts and implements intellectual property strategies aligned to the particular business goals of each client. She also helps defend innovators from opportunists, competitors, and/or the insidious efforts of patent trolls that seek to claim others innovations as their own. Ms. Pham counsels clients on strategies for acquisition, acceleration, enforcement, and defense of domestic and foreign patents. She has represented clients in every phase of patent preparation and prosecution, including reissue, reexamination, and appeals to the Patent Trial and Appeal Board (PTAB) and the United States Court of Appeals for the Federal Circuit. Her practice also includes developing and implementing litigation strategies for U.S. District Court and International Trade Commission (ITC) patent proceedings, preparation of opinion letters regarding non-infringement and invalidity, and due diligence related to venture capital financing and acquisitions. John Eckstein Director, Fairfield and Woods P.C. John A. Eckstein focuses on the general representation of technology-based companies and venture capital funds, investors, investment bankers, financial advisors and financial institutions. He works often with complex legal structures in entity and project financings. As a securities lawyer active in corporate finance, John has been involved in a range of offerings in the U. S. capital markets, including initial public offerings; other primary and secondary offerings of securities; exchange offers; tender offers; and private and limited

5 offerings. He also has assisted clients in preparing and reviewing all types of disclosure reports for businesses regulated under federal and state securities laws. John provides advice regarding integrated legal strategies for board-level challenges faced by all kinds of companies. He is interested in the application of technology to the business of energy and is actively involved in legal and public policy aspects of energy, biomedical and IT/software.