| IVD Conference Maps Business Strategies in a World of Change By: Norbert Sparrow The $43-billon in vitro diagnostics industry has always been, well, a complicated sector, and it is getting more so every year. Faced with the uncertainty of rapidly evolving national and international regulatory and reimbursement requirements to paradigm-shifting partnerships, industry is looking for answers. It will find many of them at the IVD Business Strategy Conference scheduled for November 7 and 8, 2013, in San Diego, CA. Sponsored by IVD Technology, the two-day conference, supplemented by a half-day workshop on November 6, is articulated around the theme of developing commercially viable strategies for global markets and generating new revenue streams. Global regulatory issues will be at the forefront of conversations on November 7. Recent developments at FDA, including an update on laboratory-developed test regulations, clarifications on the 510(k) and de novo classification processes, and regulatory considerations related to drug and diagnostic company partnerships, will be explored by industry luminaries. In particular, Julio Reategui, who is responsible for international regulatory affairs at Ventana Medical Systems, part of the Roche Group, will speak to the challenges and opportunities of emerging markets, while co-presenter Chang-Hong Whitney, president of Whitney Consulting, will focus on China. Many industry analysts predict that China will surpass the United States to become the world’s largest IVD market within the next 10 to 15 years. Featured topics on day one also include the business and regulatory imperatives of the companion diagnostics market and the use of cross-industry partnerships to develop innovative IVD products while reining in costs. The second day of the conference will focus on successful commercial strategies for launching companion diagnostics and point-of-care products. An IVD company that has successfully navigated the choppy commercialization waters will share best practices for compiling clinical evidence, winning over investors and overcoming barriers to market entry. A panel discussion on emerging technologies that may shake up the status quo in clinical labs and the short and long-term impact of healthcare reform, among other hot-button issues, will wrap up the event. A half-day workshop, scheduled for November 6, aims to bring clarity to the Byzantine world of domestic and global reimbursement practices. The conference will be held at the Hilton San Diego Bayfront hotel. |
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