Policy & Regulation: Page 11


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    Profile

    Laura Randa's aim to break down mental healthcare barriers for disabled patients

    Despite the proliferation of mental health apps, many aren’t accessible for people with disabilities. The CEO of Toivoa plans to change that.

    By Alexandra Pecci • April 27, 2022
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    Q&A

    Real-world data is making drug development more true to life

    How RWD is moving from the background to the spotlight in pharma’s development process.

    By Kelly Bilodeau • April 26, 2022
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    Trendline

    Commercialization, marketing and social media

    As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical. 

    By PharmaVoice staff
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    Q&A

    The cannabis vanguard: A rare disease company looks to pioneer in the space

    Zynerba’s CEO shares his views on advances in cannabidiol treatments for neuropsychiatric illnesses and the regulatory environment for CBD-based drugs.

    By Jared Whitlock • April 21, 2022
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    Q&A

    A psychedelic pill for alcoholism? The CEO of Clearmind Medicine says 'Yes.'

    Known to provide a “euphoric” experience, MEAI started out as a recreational drug used as an alcohol substitute. Now, Adi Zuloff-Shani says it may even treat alcohol addiction.

    By Alexandra Pecci • April 21, 2022
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    A pharma mystery: Cancer-causing impurities drive joint search for answers

    Pharmaceutical industry insiders and regulators are striving to overcome the ‘blind spots’ that contribute to nitrosamine contamination.

    By April 19, 2022
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    Q&A

    How pharma can up its social media game

    Health Union’s VP of community development, Sara Hayes, discusses how pharma marketers can better reach online patient communities. 

    By Karissa Waddick • April 18, 2022
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    Sponsored by GoodRx

    Inflation is forcing prioritization of healthcare spending — are you ready?

    Inflation means your customers' money doesn't travel as far as it did a few weeks ago.

    April 18, 2022
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    What now? Alzheimer's drugmakers ponder the path to approval

    Why Medicare’s unprecedented decision to limit coverage for Aduhelm could have a chilling effect on Alzheimer’s R&D.

    By Kelly Bilodeau • April 14, 2022
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    Q&A

    Biotech goes Hollywood

    A few years ago, the biotech venture world in LA was almost ‘nonexistent’ — now Joseph Panetta, CEO of Biocom California, says the region is undergoing a major change.

    By April 13, 2022
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    How Congress could play a role in personalized medicine

    PGx — a tool to help determine proper dosing — may be poised to achieve broader use in healthcare and pharma.

    By Kelly Bilodeau • April 11, 2022
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    Q&A

    Down but not out: How AVEO's CEO steered the company past an FDA rejection

    Michael Bailey explains why focusing on the patient helped AVEO clear regulatory hurdles to bring a new cancer drug across the finish line.

    By Kim Ribbink • April 5, 2022
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    Another pandemic threat looms, and the antibacterial drug pipeline still isn't keeping up

    A recent report from BIO details challenges in the antibiotic market — and new policy measures that could help.

    By Kelly Bilodeau • March 23, 2022
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    Virpax's CEO on leveraging new formulations to move drugs toward approval

    Anthony Mack shares his lessons from getting unconventional pharma products across the finish line.

    By March 18, 2022
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    Permission granted by Sanjeev Luther.

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    Q&A

    Clearing hurdles in rare cancer drug development

    Rafael’s CEO, Sanjeev Luther, explains why flexibility and agility are keys to success in the rare cancer space.

    By Kim Ribbink • March 14, 2022
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    Q&A

    Ultragenyx's CEO on building a 'next-gen' rare disease company

    How Dr. Emil Kakkis is maintaining the soul of a startup while undergoing growth.

    By Kim Ribbink • March 9, 2022
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    From angel to operator: The unlikely journey of Endevica Bio's CEO

    Russell Potterfield is honing his new found passion for the space to guide Endevica into the clinic.

    By Jared Whitlock • March 9, 2022
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    QSAM's rare cancer treatment could be a game-changer

    For patients with osteosarcoma, amputation can be the only option — but QSAM's CEO hopes to change that.

    By Alexandra Pecci • Feb. 17, 2022
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    Welcome to the new PharmaVoice

    A similar mission, a new format, and our plans for PharmaVoice's next chapter.

    By Davide Savenije • Jan. 13, 2022
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    5 trends shaping clinical trial regulations in 2022

    As agencies respond to innovations in pharma, notable shifts in 2022 are on the way.

    By Jan. 11, 2022
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    Regulators

    Navigating the regulatory landscape, while ensuring quality and transparency, requires skillful leadership and knowledge. The rebel in the room, doesn’t stay in her lane Blazing new trails to… continue to elevate the need for equity in healthcare Amanjot Kaur Khera Title: ...

    By PharmaVoice Team • Aug. 1, 2021
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    Getting Real with RWE

    Real-world evidence, important for regulatory decision-making, is beginning to touch all areas of the healthcare value chain. Historically, real-world evidence (RWE) and real-world data (RWD) have been used for postmarket safety monitoring, but now sponsors are beginning to use these data sets to...

    By Taren Grom • Nov. 16, 2020
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    The New Virtual Engagement Reality

    COVID-19 has created a virtual environment that is here to stay, and the industry will need to begin to adjust. From remote working to patient and physician engagement, pharma marketers and sales reps have had to rethink commercial strategies in a virtual landscape. With the onset of COVID, the s...

    By Robin Robinson • Nov. 16, 2020
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    What's Next Post-COVID-19: The Next Normal

    From R&D to commercial operations, stakeholders across the healthcare ecosystem are adjusting to the next phase of the pandemic: business in a new reality. With some experts predicting that the “normalization" of business operations could be several months to a year away as the world awaits a...

    By PharmaVoice Team • Sept. 1, 2020
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    Commanders & Chiefs

    These forward-thinking leaders are strategically positioning their companies for success and inspiring their teams to achieve far-reaching goals as they navigate complex industry challenges. Dr. Reshma Kewalramani Breaking Barriers Raising the bar… by making the impossible, possible. Title: CEO a...

    By PharmaVoice Team • Aug. 1, 2020
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    Entrepreneurs

    These visionary leaders recognized an opportunity to fill an industry need and are successfully leading their companies to new heights. Game Changer Raising the bar… by proving what is possible in accelerating clinical drug development Michelle Longmire, M.D. Title: CEO and Co-Founder Company: Me...

    By PharmaVoice Team • Aug. 1, 2020