Policy & Regulation: Page 15
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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 -
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
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 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Storied Careers This is my favorite issue of the year — nothing against the other great issues we put out every month. But there is something particularly special about showcasing 100 men and women who have dedicated their lives to the life-sciences industry. They could be using their talents in ...
By Taren Grom • Aug. 1, 2017 -
PharmaVoice Team/PharmaVoice
Who's On The List by Section
This article contains the list of 100 honorees. If you want to read the article featuring a particular person, please view the Section in which he/she is featured. Change Agents Danielle Bedard inVentiv Health Kathy Biberstein Alkermes Kim Carpenter HCB Health Dr. Ryan Cohlhepp Takeda Oncology Su...
By PharmaVoice Team • Aug. 1, 2017 -
PharmaVoice Team/PharmaVoice
The Researchers & Scientists
Dr. Daniel Auclair Bridging the Cancer Gaps Title: Senior VP, Research Company: Multiple Myeloma Research Foundation Education: BS, Biochemistry, MSc, Biochemistry, University of Montreal; PhD, Nutrition/Biochemistry, Dana-Farber Cancer Institute/Harvard Cancer Center Family: Father — lost to an ...
By PharmaVoice Team • Aug. 1, 2017 -
PharmaVoice Team/PharmaVoice
The Technologists
Steve Powell Tackling Technology Innovation with a Patient-Focus Title: Executive VP of Trial Oversight Company: ERT Education: BSc (Hons), Mathematics, University of Wales, Cardiff Family: Lori, his wife who supports him in the career decisions and the changes he makes; Betty and Eddie, his mot...
By PharmaVoice Team • Aug. 1, 2017 -
PharmaVoice Team/PharmaVoice
Responding to Increased FDA Focus on Data Integrity
As clinical trials grow in complexity and new technologies emerge for capturing clinical data, the need to improve sustainability of data integrity throughout study conduct has heightened. Over the past five years, the volume of data integrity-related CGMP violations have grown in prevalence. In ...
By Don Zinn • June 1, 2017 -
PharmaVoice Team/PharmaVoice
C-Suite Outlook: Leading Through Extraordinary Change
Sustaining Value According to Deloitte, life-sciences companies are evolving their business models from product development through manufacturing and distribution, to move “beyond the pill" and to engage more fully with providers and patients throughout the product lifecycle and “transform what ...
By PharmaVoice Team • Feb. 1, 2017 -
PharmaVoice Team/PharmaVoice
Global Expedited Review
Following the implementation of the Food and Drug Administration’s Breakthrough Therapy Designation in 2012, both the European Union’s and Japan’s regulatory agencies began the process of determining how to provide an expedited review for therapies for serious diseases with unmet needs. The resu...
By Denise Myshko • Jan. 1, 2017 -
PharmaVoice Team/PharmaVoice
What's New
FDA Issues Guidance on Registering Clinical Trials Trending now: A new rule takes steps to provide more information about clinical trials to the public. In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services in Sept...
By PharmaVoice Team • Nov. 21, 2016 -
PharmaVoice Team/PharmaVoice
Trending 2017: The Cancer Moonshot
Launched in January 2016, the White House’s Cancer Moonshot is a $1 billion initiative to jump-start the effort to eliminate cancer. A large part of this initiative is the development of cancer immunotherapies. In October 2016, Vice President Joe Biden delivered the Cancer Moonshot report that la...
By PharmaVoice Team • Nov. 21, 2016
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