Policy & Regulation: Page 10
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Permission granted by Sanjeev Luther.
Q&AClearing 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 -
Image courtesy of Ultragenyx.
Q&AUltragenyx'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 -
Explore the Trendline➔
Stock via Getty Images
TrendlineEmerging biotech
After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.
By PharmaVoice staff -
Permission granted by Russell Potterfield.
ProfileFrom 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 -
Stock via Getty Images
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 -
Diego Camargo/PharmaVoice
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 -
Dan Kitwood via Getty Images
5 trends shaping clinical trial regulations in 2022
As agencies respond to innovations in pharma, notable shifts in 2022 are on the way.
By Meagan Parrish • Jan. 11, 2022 -
PharmaVoice Team/PharmaVoice
ProfileRegulators
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
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 -
PharmaVoice Team/PharmaVoice
Change Agents
These forward-thinking individuals are disrupting the status quo and setting the strategic direction for their companies to capitalize on the opportunities that will shape the future of the healthcare ecosystem. Answering the Innovator’s Dilemma Raising the bar… by knowing what is achievable Crai...
By PharmaVoice Team • Aug. 1, 2020 -
PharmaVoice Team/PharmaVoice
Patient Champions
These patient-focused leaders are re-imagining what patient engagement is and what it can be for their organizations and the industry at large. Going the Extra Mile for Rare Disease Patients Raising the bar… to be better than the day before Mary Frances Harmon Title: Senior VP, Corporate and Pati...
By PharmaVoice Team • Aug. 1, 2020 -
PharmaVoice Team/PharmaVoice
Mentors
These champions of diversity and inclusion are dedicated to developing the next generation of leaders and setting an example for others to follow. An Ally for All Raising the bar… by bringing people together Peter Anastasiou Title: Executive VP & Head of North America Company: Lundbeck Indust...
By PharmaVoice Team • Aug. 1, 2020 -
PharmaVoice Team/PharmaVoice
A New Era of Clinical Trials
The future is now, and how the industry responds to the COVID-19 pandemic will set the course for drug development for years to come. The COVID-19 pandemic has created disruption across every aspect of the world. The clinical trial ecosystem is no exception — from drug discovery through to regula...
By PharmaVoice Team • June 1, 2020 -
PharmaVoice Team/PharmaVoice
Age of the Machine: Using Algorithms to Advance Outcomes
Machine learning is being applied across the industry to support decision-making in clinical trials, R&D, regulatory, and commercial processes. What’s the difference between machine learning and artificial intelligence? The answer lies in the word intelligence, since AI is about enabling mach...
By Kim Ribbink • June 1, 2020 -
PharmaVoice Team/PharmaVoice
Clinical Experts
These clinical development experts are redefining clinical operations to increase efficiencies, reduce costs and timelines, and improve the safety profiles of bringing new medicines to patients. A Rare Passion for Patients Energetic. Unrelenting. L. Mary Smith, Ph.D. Title: Senior VP, Clinical R&...
By PharmaVoice Team • Aug. 1, 2019 -
PharmaVoice Team/PharmaVoice
Brand Bonds
Trust is the glue of agency/client relationships, and communication is the foundation. Browse a few pharma marketing agency websites and you can learn about the number of awards won, the big name clients, the years in business, the expertise; but where is the link for “Good at Relationships?" One...
By PharmaVoice Team • May 1, 2019 -
PharmaVoice Team/PharmaVoice
Patient-Based Culture
Companies need to cultivate patient-centricity from the inside out. Not much more than five years ago, UCB was one of the first pharma companies to bring patient centeredness deep into its culture, moving away from the traditional product-based model driven by revenue growth and sales toward the ...
By PharmaVoice Team • April 1, 2019 -
PharmaVoice Team/PharmaVoice
The Evolving Role of Patient Advocates
Patient advocacy groups have long had relationships with pharma, and now, individual patients are also sharing their voices and their power. While pharma has long had relationships with advocacy organizations, there is a growing wave of individual patients who are willing to speak up, be engaged,...
By PharmaVoice Team • April 1, 2019 -
PharmaVoice Team/PharmaVoice
Patient-Focused Drug Development
Biopharma companies and regulators are working to put the patient truly at the center of drug research and development. Empowered patients are redefining the healthcare environment on their own terms. Today, patients and advocates are playing a more central and proactive role in managing their ow...
By PharmaVoice Team • April 1, 2019 -
PharmaVoice Team/PharmaVoice
Patients and Regulatory Support
Regulators are working to make sure patients have a seat at the clinical trial table. The Food and Drug Administration has been instrumental in the movement toward patient-centric clinical trial initiatives and driving these initiatives forward is the future of trial development. In recent years,...
By Denise Myshko • April 1, 2019 -
PharmaVoice Team/PharmaVoice
Clinical Experts
Nariman Nasser For Creating Opportunities for Sites Title: VP, Site Engagement Company: Continuum Clinical Education: BS Microbiology, Arizona State University Hobbies: Swimming, biking, snowboarding, and anything outdoors that provides an adrenaline rush Associations: SoCRA, DIA, ACRP Social Med...
By PharmaVoice Team • Aug. 1, 2018 -
PharmaVoice Team/PharmaVoice
Regulators
Dr. Joanne Palmisano For Advancing Regulatory Affairs Title: VP, Regulatory Affairs Company: Boehringer Ingelheim Pharmaceuticals Inc. Education: MD, Columbia University, College of Physicians & Surgeons Family: Husband Russ; sons Robert and Michael — without their patience and support she wo...
By PharmaVoice Team • Aug. 1, 2018
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