Policy & Regulation: Page 18


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    UpFront

    INDUSTRY at Large Kowa and Football Player Help those with High Cholesterol Kowa Pharmaceuticals America has announced a partnership with Kurt Warner, Super Bowl winner and two-time NFL MVP, and his wife Brenda, to launch First and Goal, a national education initiative to help people prioritize h...

    By Denise Myshko • July 28, 2014
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    Letter from the Editor

    The 2014 PharmaVOICE 100 The PharmaVOICE 100 Turns 10! It’s hard to believe that 10 years after the vision for this issue was captured on the back of a napkin during a long flight delay, we have now profiled 1,000 of the industry’s most inspirational and motivational individuals making this issue...

    By Taren Grom • July 28, 2014
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    Trendline

    Rare diseases

    As drug developers find promise in the rare diseases, deals and treatments are on the rise

    By PharmaVoice staff
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    Thailand Makes Great Strides in Healthcare

    With a growing pharmaceutical market, renowned biotechnology research programs, and strong government support for the industry, Thailand has much to recommend it to the global pharma industry. The Kingdom of Thailand, a country with a population of 70 million people, is regarded as newly industri...

    By Kim Ribbink • May 29, 2014
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    New FDA Guidelines Gateway to Social Interaction

    New FDA?Guidelines Gateway to Social Interaction With the final ruling approaching next month, experts outline what has changed and what hasn’t under the new FDA draft guidelines. As the industry settles into a wary comfort zone with the draft guidelines around social media issued in January, we ...

    By Robin Robinson • May 29, 2014
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    Personalized Medicine: From Bench To Bedside

    Pharmaceutical companies are embracing the concept of personalized medicine from research and development to commercialization. Personalized medicine is the future of medicine. It will become standard in every hospital, clinic, and medical practice, supported by electronic records, decision suppo...

    By PharmaVoice Team • May 29, 2014
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    Talent Pool

    Talent Pool executive appointments and promotions in the healthcare industry Pharma Pool DR. UDIT BATRA EMD Millipore Introduces CEO and President EMD Millipore, the life-sciences division of Merck KGaA, has appointed Udit Batra, Ph.D., as president and CEO, responsible for the organization’s str...

    By Ann Grey • May 29, 2014
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    Malaysia Focuses on Growth with Healthcare a Top Priority

    Malaysia presents an attractive market to pharmaceutical companies thanks to growing government support, good infrastructure, and a trusted manufacturing environment. Malaysia is a federal constitutional monarchy with a population of about 29 million and an open and growing economy. According to ...

    By Kim Ribbink • April 28, 2014
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    EHRs: Full of Promise But Can Pharma Play?

    The opportunities within the electronic health record channel to reach physicians and patients come with many challenges for the industry. EHRs could be the promise land for the industry: a direct channel of engagement with physicians, an avenue for providing patient education, and a space to col...

    By PharmaVoice Team • April 28, 2014
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    On the Calendar

    The Calendar Industry Events and Conferences, including SPECIAL DISCOUNTS Coming Attractions ATA 2014, May 17-20, in Baltimore, brings together healthcare professionals and leading telemedicine programs to share new clinical research, best practices, and innovative business models. It is the prem...

    By PharmaVoice Team • April 28, 2014
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    Creating Positive Communications with the FDA

    Creating Positive Communications with the FDA By Denise Myshko A critical success factor in the regulatory review process is clear and frequent communications to ensure a smooth and efficient review of an application. Navigating the regulatory review process can be challenging. Industry experts s...

    By Denise Myshko • March 27, 2014
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    Public-Private Partners For Innovation

    Public-Private Partners For Innovation By Denise Myshko Partnerships with academics and the public sector have always played a significant role in research. In fact, successful private-public partnerships have led to private sector growth and innovation, job creation, and a strengthened national ...

    By Denise Myshko • March 27, 2014
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    The Patient Experience: Keeping It Real

    The Patient Experience: Keeping It Real By Robin Robinson Sidebars: The Pharmaceutical Industry Needs Emotional Insights Personal Connected Health Alliance ePUBLication Personal Connected Health: Becoming A Reality For The Life Sciences Provided by: PCHA http://bit.ly/PersonalConnectedHealth A de...

    By Robin Robinson • March 27, 2014
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    Last Word

    Last Word Educating The Next Generation John Castellani, president and CEO of Pharmaceutical ­Research and Manufacturers of America (PhRMA), talks about the imperative for improved science, technology, ­engineering, and math (STEM) education. PV: Why is STEM education so important? Castellani: Th...

    By John Castellani • March 27, 2014
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    Talent Pool

    pharma Pool Dr. John ORLOFF Merck Serono Names Head of Global Clinical Development Merck Serono has named John Orloff, M.D., as head of global clinical development. Dr. Orloff leads the design and execution of Merck Serono’s global clinical development programs and projects, driving quality execu...

    By Ann Grey • March 27, 2014
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    Regulating in the Connected Health World

    Regulating in the Connected Health World U.S. regulators have issued guidances to help bring clarity to companies considering mHealth. By Denise Myshko Regulation, by its nature, hinders some activity, says Napoleon Monroe, managing director, New Directions. “But regulation is also necessary to e...

    By Denise Myshko • Feb. 25, 2014
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    On the Calendar

    On the Calendar The Calendar Industry Events and Conferences, including special discounts Coming Attractions In May 2014, the Healthcare Businesswomen’s Association is celebrating the 25th anniversary of its prestigious Woman of the Year (WOTY) award. The HBA is proud to announce that three vis...

    By Heather Hummel • Feb. 25, 2014
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    Singapore a Pharma Hub for Asia

    Singapore a Pharma Hub for Asia By Kim Ribbink The pharma industry is increasingly drawn to Singapore, thanks to its commitment to research and innovation, good talent base, and trusted regulatory and IP environment. Singapore is fast becoming a leading regional and even global center for the lif...

    By Kim Ribbink • Jan. 28, 2014
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    Global Regulations Becoming More Uniform

    Pharmaceutical companies must navigate a changing regulatory environment both here and abroad. As the digital age brings the clinical world closer together and research and development become more global, the industry needs to find a way to address regulatory requirements across myriad regions. T...

    By Denise Myshko • Jan. 28, 2014
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    Preparing for a Successful FDA Inspection

    Pharmaceutical manufacturers need to be inspection ready, aligning their organization with the expectations of regulators. Preparing for successful inspections is not a one-time event. Being inspection ready means that pharmaceutical leaders are committed to managing compliance as part of their c...

    By Denise Myshko • Jan. 28, 2014
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    Breakthrough Therapies: Become A Priority

    Denise Myshko The FDA’s new breakthrough therapy designation pathway, which was launched in 2012, aims to streamline and speed development of products for life-threatening diseases. Many people with life-threatening diseases often have little options for treatment. Now the FDA is working with bio...

    By Denise Myshko • Dec. 28, 2013
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    ACA: A Data Sharing Imperative

    Denise Myshko The sharing of data has become a critical success factor in the healthcare market under the Affordable Care Act The Affordable Care Act changes how healthcare data need to be collected, managed, and analyzed. Accountable care organizations, providers, and payers will require connect...

    By Denise Myshko • Dec. 28, 2013
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    Last Word

    Building an Innovation Supply Chain Dr. Noubar Afeyan, managing partner and CEO of Flagship Ventures, discusses his thoughts on how ­pharmaceutical companies can create an “innovation pipeline." PV: What is an innovation supply chain? Afeyan: What I anticipate happening is a professionalization o...

    By Dr. Noubar Afeyan • Dec. 28, 2013
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    R&D Collaboration: Thriving in an Era of R&D Collaboration

    Thriving in a Era of R&D Collaboration Year in Preview: R&D collaboration Greater cooperation with academic and government researchers, as well as with other companies, is needed to create collaborations that push innovation forward. There is a growing consensus that the industry must tea...

    By PharmaVoice Team • Nov. 13, 2013
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    Corporate Crystal Ball: Trends From the Top

    Trends From the Top From the ACA to a value-based system, executives representing all aspects of the life-sciences industry name the top trends they believe will impact near- and long-term success. Phil Birch Senior VP, Global Strategic Marketing Aptiv Solutions 1. Value-Based System. The evolvin...

    By Taren Grom • Nov. 12, 2013
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    On the Calendar

    The Calendar MHealthSummit — where technology, business, research, and policy connect. The largest event of its kind, the fifth annual mHealth Summit, December 8-11, 2013, Gaylord National Resort and Convention Center, Washington, D.C., brings together leaders in government, the private sector, i...

    By Heather Hummel • Nov. 12, 2013