Policy & Regulation: Page 15
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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 -
Explore the Trendline➔
Stock via Getty Images
TrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
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 -
PharmaVoice Team/PharmaVoice
Transformation: Is the Industry Ready?
Although the pharma industry scored pretty low on a McKinsey scale of digital maturity, there is evidence that it is moving — perhaps only incrementally — toward a digital transformation that can streamline processes, generate collaboration, and coordinate data collection. The pharma sector, not ...
By PharmaVoice Team • June 1, 2018 -
PharmaVoice Team/PharmaVoice
Patients’ Voices
PharmaVOICE editors have been writing about patient-centricity and all this topic encompasses for what seems like a decade. Some say the term has lost meaning because of its ubiquituous use. We contend that patients are leading the way and influencing how businesses operate today. For sure, there...
By PharmaVoice Team • April 1, 2018 -
PharmaVoice Team/PharmaVoice
Technology and Patient-Centric Trials
The term patient-centric is about ensuring the needs and perspectives of the patients are taken into consideration while maintaining scientific rigor for a clinical trial. Pharmaceutical sponsors have begun engaging patients in the trial design, seeking input and acknowledging the importance of t...
By PharmaVoice Team • April 1, 2018 -
PharmaVoice Team/PharmaVoice
Patient-Centered Apps
The pharmaceutical industry is up against several challenges when it comes to developing mobile apps for its consumers. According to Deloitte, issues of consumer trust, app design, and regulatory concerns can throw up roadblocks in the very crowded and competitive field of 300,000-plus healthcare...
By PharmaVoice Team • April 1, 2018 -
PharmaVoice Team/PharmaVoice
Expanded Patient Access: Balancing Risk and Reward
Expanded access, or compassionate use as it is sometimes called, is an avenue through which dying patients can access medications that are still being tested in clinical trials by petitioning the company developing the treatment and the FDA for access. Regulators say for an individual patient to ...
By Denise Myshko • March 1, 2018 -
PharmaVoice Team/PharmaVoice
Women & Health: Lessons in Leadership
Currently, executive women hold only about 4.6% of CEO positions in S&P 500 companies. Research from McKinsey & Company reports that at the first critical step up to manager, women are 18% less likely to be promoted than their male peers. This gender disparity has a dramatic effect on the...
By PharmaVoice Team • March 1, 2018 -
PharmaVoice Team/PharmaVoice
Tackling Regulatory Challenges in a Tighter Global Marketplace
When it comes to pharmaceutical regulations, change is constant. Regulatory authorities have become more cautious with product approvals, there are increased demands for more comprehensive data, digital is creating new opportunities and challenges, and globalization of the industry means companie...
By PharmaVoice Team • Feb. 1, 2018 -
PharmaVoice Team/PharmaVoice
Gender Parity
A recent McKinsey report reveals that women remain underrepresented at every level in corporate America, despite earning more college degrees than men for 30 years and counting. There is a pressing need to do more, and most organizations realize this: McKinsey reports that company commitment to g...
By Taren Grom • Feb. 1, 2018 -
PharmaVoice Team/PharmaVoice
Disruptive Advertising
Technology disruptions in our world are becoming routine, and consumers are becoming impervious to the daily assault on their attention. In order to be effective, brand marketers need to rise above and beyond an ever-rising bar of campaign creativity, as well as use technology to break through al...
By PharmaVoice Team • Jan. 1, 2018 -
PharmaVoice Team/PharmaVoice
Industry Gears Up For Track and Trace
Counterfeit medicines have taken a huge toll, both in terms of human costs as well as financially. Interpol estimates that 1 million deaths each year can be linked to counterfeits. According to PwC, counterfeit pharmaceuticals are a $200 billion-plus annual business. The problem is most severe in...
By Kim Ribbink • Jan. 1, 2018 -
PharmaVoice Team/PharmaVoice
A Rare Journey: Managing the Regulatory Landscape
In 1983, Congress passed the Orphan Drug Act, bringing with it the opportunity to advance the development of drugs for rare diseases. Since that time, the Food and Drug Administration (FDA) has approved more than 550 products to treat rare diseases. The FDA established the Office of Orphan Produc...
By Kim Ribbink • Oct. 1, 2017 -
PharmaVoice Team/PharmaVoice
The Battle Against Infectious Disease
Epidemics of infectious diseases are a real and dangerous threat. Nowhere in the world have infectious diseases been addressed adequately to become a small portion of illness and death. The Ebola and Zika public health emergencies have brought to light that we are unprepared to detect, prevent, a...
By Denise Myshko • Oct. 1, 2017
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