Author Archive: Tracy Cooley

Tracy Cooley

Tracy serves as the Director of Events Communications and handles all communications for BIO’s events and emerging company policy issues. She loves blogging and podcasting on all things biotech and believes in the great potential of the industry, looking for every opportunity to spread the message far and wide. Nearly everyone in her family is a golfer, and as such, she has what many people have called a “natural” swing. Sometimes she even hits the ball. Tracy just finished her ninth marathon, and has nearly mastered the skill of one-foot-in-front-of-the-other (usually, sometimes the laces get in the way). The joy of her life is her five-year-old daughter Josephine.

Latest Posts

Reimbursement Considerations for Early Stage Companies

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Panelists at Tuesday’s breakout session – Reimbursement Considerations for Early Stage Companies – overwhelmingly agreed that emerging biotech companies must consider reimbursement at the earliest stages of development. Christopher de Wolff, MSFS, Consultant, Numerof & Associates, Inc. moderated the panel and kicked it off by pointing out that many drugs achieve regulatory approval yet fail when they reach the market because of a lack of data and evidence directed at reimbursement. He asserted that the Read More >

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Convention Attendees Make the Call on Expanded Access

Bioethics Panel

The BIO International Convention kicked off Monday with an interactive session organized by the BIO Board Standing Committee on Bioethics: The Bioethics of Drug Development—You Make the Call. Attendees engaged in a real-time polling exercise addressing the many difficult issues related to expanded access using a mock case study of a company – iCures – dealing with an expanded access request. Moderator Steve Usdin, Senior Editor, BioCentury, led the panel through challenging issues in drug Read More >

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In Memory of Sandi Dennis

inthememoryof

Last September, BIO and the industry lost a dear friend and one of the nation’s top regulatory attorneys – Sandi Dennis – after a long battle with cancer. Sandi served as the deputy general counsel for healthcare at BIO. She focused on educating biotechnology companies about emerging legal and policy issues affecting the development of ground-breaking new medicines, and advocating on their behalf with Congress and executive agencies to help expedite the approval of treatments Read More >

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New NPC Report on Comparative Effectiveness Research

Research

Advances in medical research create the potential for better health outcomes, improved treatment and even prevention of once-fatal diseases and, with these improvements, a more cost-effective healthcare system.  How we use research is the key to achieving a healthier society. That’s what makes the new publication by the National Pharmaceutical Council (NPC), “2014 Comparative Effectiveness Research and the Environment for Health Care Decision-Making” so valuable.  This is the fourth year that NPC has conducted a Read More >

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New Legislation Would Stimulate Investment in Innovation

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Today, the Coalition of Small Business Innovators (CSBI) applauds Reps. Jim Gerlach (R-PA), Richard Neal (D-MA), Mike Kelly (R-PA), and Ron Kind (D-WI) for introducing H.R. 4855, the Partnerships to Advance Revolutionary Technology and Novel Entrepreneurial Research (PARTNER) Act.  This bill would support early-stage research by incentivizing investment in R&D-focused small businesses. The PARTNER Act would allow companies to partner with their investors on a specific research project or pipeline.  Only start-up and small companies Read More >

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