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

United Health To Congress: Let Cancer Patients Eat Gauze (Op-Ed in The Hill)

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Jonathan Wilcox’s op-ed in The Hill today highlights the growing challenge of insurance company tactics that contribute to increased costs to the health care system and restricted patient access to life-saving medicines. While UnitedHealth Group just reported increased revenues for first quarter 2015, patients are shouldering the burden with rising copays and restricted coverage, asserts the author. As Wilcox writes, ‘That’s why cancer advocacy organizations are taking action, pressing Congress and state legislatures to cap co-pays on specialty Read More >

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BIO Principles on Expanded Access to Investigational, Unapproved Medicines

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Seriously ill patients with limited or no alternative therapies, and who are ineligible or unable to participate in the clinical trials, may desire access to investigational, unapproved medicines.  Such access outside of the clinical trial setting, or “expanded access,” may be sought through a company’s expanded access program, or through individual patient expanded access, if available. We believe that the best way to make innovative biotechnology medicines available to patients is through the efficient development of approved, safe Read More >

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Dr. Petra Kaufmann Video Interview: Clinical and Translational Science Awards Program

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Petra Kaufmann, MD, MSc, Director of the Division of Clinical Innovation at the National Institutes of Health, recently joined us in the BIO Buzz Center to discuss streamlining clinical trials through the Clinical and Translational Science Awards (CTSA) Program. As part of NIH’s National Center for Advancing Translational Sciences (NCATS), the CTSA program is designed to address the development and implementation of national standards and best practices for the full range of translation, from basic Read More >

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The Value of Innovation to Save and Transform Lives

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Patients have greater hope for cures to today’s most complex and challenging diseases thanks to modern specialty medicines, which allow doctors and patients to focus on prevention and avoid hospital care altogether. With the potential to save countless lives and improve so many more, today’s innovative life-enhancing medicines and therapies provide economic value far beyond their cost. The debate surrounding the value of modern specialty medicines focuses narrowly on one aspect – cost – while Read More >

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We Need Your Input: BIO Survey on Effective FDA-Sponsor Communication

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BIO is surveying members and non-members on their interactions with the FDA during the various stages of drug development prior to submitting an NDA/BLA. The survey can be accessed here. Why is it important for you to share your feedback? In an increasingly competitive and fiscally-constrained environment, it is more important than ever for all stakeholders to work together to promote effective R&D for innovative medicines. In this BIO BuzzCenter video, Alnylam’s Dr. John Maraganore Read More >

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