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BIO Is Almost Here – What To Consider Before Entering New Therapeutic Areas

June 14, 2015
Over the past decade, the biopharmaceutical industry has witnessed a shift towards specialty care. From 2008 to 2014, FDA specialty drug approvals jumped from 33 percent to over 50 percent of all approvals. In 2014, the FDA approved a record 19 specialty care medicines.

Given this new reality, companies are expanding the focus of their R&D into new therapeutic areas to address difficult-to-treat, specialty care conditions.

Building successful franchises requires a strategic approach to determine the appropriate level of risk, build an effective sales force and establish complementary partnerships. Each therapeutic area has its own distinct challenges — including pricing, market access, distribution, patient dynamics and types of specialists and referral patterns — so there is no one path to success.

At EMD Serono, we have first-hand experience with such challenges. Although we have a long history in the areas of neurology, fertility and endocrinology, today we are expanding into oncology, immuno-oncology and immunology. We have appointed an experienced leadership team in oncology, are building a dedicated oncology sales force and have an exciting pipeline in early- and late-stage development.

At the 2015 BIO International Conference, we’re excited to bring together a panel of distinguished industry experts who have helped build successful therapeutic franchises within their respective companies. The conversation promises to provide real-world experience and proven strategies to overcoming the challenges and maximizing the opportunities of entering a new therapeutic area.

The panelists joining me in this critical conversation for our industry include:

  • Paul Fonteyne, President and CEO of Boehringer Ingelheim USA Corp.,

  • William Hait, Global Head, Research & Development at Janssen Pharmaceutical Companies of Johnson & Johnson, and

  • Dave Rick, President of Lilly Bio-medicines.


We hope that you will join us at 12:00 p.m. on Thursday, June 18 in room 114 as we host the BIO Super Session titled “The Next Step: How Companies Build Successful Therapeutic Franchises from the Ground Up."