Policy & Regulation: Page 14
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PharmaVoice Team/PharmaVoice
Overcoming the Challenges that Hinder Innovation
PharmaVOICE 100 honorees discuss the challenges that the industry needs to overcome to support future innovation. Between 2009 and 2014, the annual growth rate for the top 25 life-sciences companies slowed from the prior decade’s double-digit average to only 1% annually, according to a recent rep...
By PharmaVoice Team • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Innovation In a Patient-Centric World
From healthcare reform to the push for value in medicines to personalized healthcare, the patient is now at the center of, well, everything. This means that pharmaceutical companies are now required to create a new paradigm, with the patient at the center. An initiative that began last year withi...
By PharmaVoice Team • Aug. 1, 2015 -
Explore the Trendline➔
Stock via Getty Images
TrendlineCommercialization, 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 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
In the rare disease community there is saying: Alone we are rare, together we are strong. Wendy White, senior VP, for rare diseases, at Dohmen Life Science Services, a board member of Global Genes, and the president of the Heathcare Businesswomen’s Association (HBA), shared her personal rare dis...
By Taren Grom • June 1, 2015 -
PharmaVoice Team/PharmaVoice
2015 DIA Preview
The DIA Annual Meeting brings together key thought leaders and innovators from industry, academia, government and regulatory agencies, health, patient, and philanthropic organizations from around the globe and across all disciplines involved in the discovery, development, and life-cycle managemen...
By PharmaVoice Team • June 1, 2015 -
PharmaVoice Team/PharmaVoice
SHOWCASE FEATURE: Clinical Solutions: Clinical Services Market Poised For Growth
According to a recent report from JZ Med, the global clinical trial service market is expected to reach more than $64 billion by 2020, up from $38.4 billion at present, representing a CAGR of 9% between 2015 and 2020. By 2020 the average clinical trial outsourcing penetration will likely reach ar...
By PharmaVoice Team • June 1, 2015 -
PharmaVoice Team/PharmaVoice
How Do iComply? A Look at Regulatory Topics Surrounding the use of Mhealth Technology in Clinical Trials
The U.S. National Institutes of Health (NIH) Consensus Group has defined mHealth as “the use of mobile and wireless devices to improve health outcomes, health care services and health research." The mHealth landscape is expanding with over 97,000 apps (mobile applications) as of 2013. Yet the vas...
By Philip Coran • June 1, 2015 -
PharmaVoice Team/PharmaVoice
Extracting Maximum Value From Electronic Data Capture
Electronic data capture (EDC) has been employed for clinical trial data for many years and is encouraged by the FDA because it provides significant benefits to sponsors, investigators, and patients, including more accurate data that can be more easily shared and monitored, increased compliance wi...
By Zaher El-Assi • June 1, 2015 -
PharmaVoice Team/PharmaVoice
MHRA Guidelines on TMFs: Where Are We One Year Later?
On April 2014, the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) updated its definition of a critical GCP inspection finding to include trial master files (TMFs) that were “not readily available or accessible." The agency asserted the change was partly driven by the fact that ...
By Jennifer Goldsmith • June 1, 2015 -
PharmaVoice Team/PharmaVoice
2015 HBA Luminaries
The Importance of Mentoring and Sponsorship Emily Lightfoot. AmerisourceBergen. Relationships with mentors have been the key to my career success. Having an advocate and coach to help me plan my career, discover my strengths, and identify opportunities has helped me develop confidence to take on ...
By Taren Grom • May 1, 2015 -
PharmaVoice Team/PharmaVoice
Innovations: Apps and Websites
App Screens for Early Vision Loss GoCheckKids Screens Children Younger than 5 Years Pediatricians now have a new way to screen for amblyopia, a leading cause of vision loss in children. Gobiquity Mobile Health’s GoCheck Kids is the first pediatric vision screener app designed to facilitate early ...
By PharmaVoice Team • April 1, 2015 -
PharmaVoice Team/PharmaVoice
Innovations: Drug Therapies
First and Only Vaccine Approved for Meningitis Pfizer’s Trumenba a Key Public Health Advance A serious and life-threatening disease can now be prevented with the first and only FDA-approved vaccine in its class. Pfizer’s Trumenba Meningococcal Group B Vaccine was granted accelerated approval by ...
By PharmaVoice Team • April 1, 2015 -
PharmaVoice Team/PharmaVoice
UpFront
Film to Shed Light on Neurological Condition The film crew chats with Kirk J., a young stroke victim currently coping with PBA. Avanir Pharmaceuticals has begun production of The PBA Film Project, a documentary to provide an intimate look at six real people living with a little-known neuro...
By PharmaVoice Team • Feb. 1, 2015 -
PharmaVoice Team/PharmaVoice
Innovator's Corner
The Next-Generation Artificial Lung Patients with acute respiratory failure have a new treatment option beyond ventilation. ALung Technologies has developed a next-generation device that could minimize or even replace mechanical ventilation. It is a simple, minimally invasive device that could be...
By Peter DeComo • Feb. 1, 2015 -
PharmaVoice Team/PharmaVoice
Tools of the Trade
Veeva Brings User-Guided Detailing to the Cloud Trending Now: New remote detailing solution expands life-sciences companies’ multichannel capabilities for improved customer engagement. Veeva CRM CoBrowse is a new remote detailing solution that enables real-time, interactive engagement and collabo...
By PharmaVoice Team • Feb. 1, 2015 -
PharmaVoice Team/PharmaVoice
Last Word
Guiding Regulators About Patient Safety Volker Knappertz, M.D., VP and Head of Global Clinical Development for MS at Teva Pharmaceuticals, provides a clinician’s view on patient safety, in particular, how the industry might help educate regulators in the development of new regulations for follow-...
By Volker Knappertz • Dec. 31, 2014 -
PharmaVoice Team/PharmaVoice
Payers: Addressing the Needs of Payers
Helping payers contain costs and improve outcomes becomes paramount for pharma in the healthcare reform future. According to an EY report, the majority of payers in the United States and Europe believe that drug adherence solutions and data that pharma companies possess are vital to lowering heal...
By PharmaVoice Team • Nov. 15, 2014 -
PharmaVoice Team/PharmaVoice
R&D Crowdsourcing: Crowdsourcing in Pharma
Companies are looking at nontraditional ways of collaborating to access new insights that could lead to innovative therapies. There is a growing movement within the industry toward open access and crowdsourcing scientific information to accelerate research and development. This open environment r...
By Denise Myshko • Nov. 15, 2014 -
PharmaVoice Team/PharmaVoice
Year in Preview: On the Horizon: Looking Ahead…
Experts from across all sectors of the industry provide their input on the trends in 2015 that will have the biggest impact on the industry, and how they will shape the future of healthcare. For this year’s special Year in Preview issue we took a slightly different tact than in years past. We are...
By Taren Grom • Nov. 15, 2014 -
PharmaVoice Team/PharmaVoice
On the Calendar
The Calendar Industry Events and Conferences, including SPECIAL DISCOUNTS Coming ATTRACTIONS The mHealth Summit, Dec. 7-11, convenes an array of healthcare stakeholders focused on the integration of mHealth and wireless solutions to improve systemic healthcare systems, patient outcomes, and acces...
By PharmaVoice Team • Nov. 15, 2014 -
PharmaVoice Team/PharmaVoice
The Researchers & Scientists
Dr. Rob Kotin Seeing the Big Picture in Gene Therapy Driven to innovate by Curiosity One of the most influential thought leaders in gene therapy today, Rob Kotin, Ph.D.’s work has the potential to make a lasting impact on the lives of patients suffering from debilitating diseases of the central n...
By PharmaVoice Team • Nov. 6, 2014 -
PharmaVoice Team/PharmaVoice
A New Era of Collaboration: Knowledge Sharing
To innovate in an efficient, cost-effective, and timely manner in today’s drug development environment, companies won’t be able to go it alone; they will need to share data and collaborate in new ways. There was a time when a drugmaker would own and guard every aspect of its research and developm...
By PharmaVoice Team • Sept. 27, 2014 -
PharmaVoice Team/PharmaVoice
On the Calendar
The Calendar Industry Events and Conferences, including special discounts Coming Attractions The Healthcare Businesswomen’s Assocation is holding its annual conference at the Chicago Hilton, Nov. 12-14, 2014. The conference ‚- Inspired Leaders. Powering Innovation. ‚- is expected draw more than 1...
By PharmaVoice Team • Sept. 27, 2014 -
PharmaVoice Team/PharmaVoice
ACA Expands Pharma Market
Prescription drug coverage through the ACA’s health exchanges includes 8 million patients. While this is an opportunity for the pharmaceutical industry, it also puts more focus on value, costs, and outcomes. Pharmaceutical companies are finding a changed market for prescription drugs now that con...
By PharmaVoice Team • Aug. 28, 2014 -
PharmaVoice Team/PharmaVoice
Talent Pool
Pharma Pool DR. JOHN ORLOFF Baxter Appoints VP of BioScience R&D Baxter International has appointed John Orloff, M.D., as VP and global head of research and development for Baxter BioScience. Dr. Orloff joins Baxter from Merck Serono Pharmaceuticals, where he served as global head of clinical...
By Ann Grey • Aug. 28, 2014 -
PharmaVoice Team/PharmaVoice
Social Buzz
A collection of social media news, events, and strategies. Trending now: Mobile technology improves patient outcomes. A randomized control trial conducted through the Montefiore Medical Center earlier this year found a significant improvement in a number of key patient engagement metrics when car...
By Taren Grom • Aug. 28, 2014
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