Policy & Regulation: Page 16
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PharmaVoice Team/PharmaVoice
Change Agents
Alison Little Title: Principal, Advisory Industry Leader for Life Sciences Company: KPMG LLP Education: BS, Materials Science & Engineering, Johns Hopkins University Family: Parents; husband; two children Hobbies: Cooking, yoga, spending time with family and friends Bucket List: Travel with f...
By PharmaVoice Team • Aug. 1, 2016 -
PharmaVoice Team/PharmaVoice
The Patient Advocates
Lise J. Hall Title: Associate Director of Consumer Marketing, Lung Cancer Franchise Company: AstraZeneca Education: MBA, Ross School of Business, University of Michigan Family: Dad, mom, sister, Angélique, brother, Daniel Hobbies: Home renovation, cooking and eating, discovering new cultures Buck...
By PharmaVoice Team • Aug. 1, 2016 -
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
Red Jacket Awards
2016 Red Jacket Honorees Inspired leaders for today and tomorrow In 2014, to mark the milestone of the 10th anniversary of the PharmaVOICE 100, we initiated our version of a “hall of fame" — the Red Jacket Awards. One of the criteria for being named a Red Jacket is having been recognized as a Pha...
By PharmaVoice Team • Aug. 1, 2016 -
PharmaVoice Team/PharmaVoice
The Changing Clinical Landscape
Clinical operations — the department that manages the operational aspects of clinical studies — is facing increased challenges: compressed timelines; increased competition for sites and patients; more complex study protocols; increased regulatory expectations; and new technologies and industry st...
By PharmaVoice Team • June 1, 2016 -
PharmaVoice Team/PharmaVoice
HBA Rising Stars: Healthcare Vision 2020
PharmaVOICE has exclusive access to nearly 100 women leaders, who are providing their take on the trends that are expected to shape the healthcare industry in the next four years. Identified by their companies as HBA Rising Stars and Luminaries, these industry executives talk about everything fro...
By PharmaVoice Team • May 1, 2016 -
PharmaVoice Team/PharmaVoice
Pharma Trax
Adverse Drug Event Reporting in U.S. Plagued by Incompleteness and Inaccuracy Trending now: A high proportion of healthcare professionals have no ADE reporting experience. Voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient, which could den...
By PharmaVoice Team • Jan. 1, 2016 -
PharmaVoice Team/PharmaVoice
Tools of the Trade
PerkinElmer Launches Signals for Translational Trending Now: New cloud-based informatics platform supports complete precision medicine workflow. PerkinElmer has launched PerkinElmer Signals for Translational, a cloud-based data management, aggregation, and analysis platform for pharmaceutical...
By PharmaVoice Team • Jan. 1, 2016 -
PharmaVoice Team/PharmaVoice
21st Century Cures Act
The 21st Century Cure Act, if passed, promises to promote the development and hasten the approval of new drugs and devices, especially treatments for cancer and rare diseases. It puts the view of the patient in the center of drug discovery, development, and delivery, balanced by insights derived ...
By Robin Robinson • Nov. 15, 2015 -
PharmaVoice Team/PharmaVoice
Precision Medicine: Patient-Centric R&D
President Obama unveiled early in 2015 the Precision Medicine Initiative, an effort to revolutionize medicine and generate the scientific evidence needed to move the concept of precision medicine into everyday clinical practice. With a $215 million investment in the President’s 2016 budget, the P...
By Denise Myshko • Nov. 15, 2015 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Celebrating Inspiration When we first conceptualized this special issue 11 years ago, the idea was that it would be nice to showcase the people who are having a positive impact on the industry. We didn’t know then that this issue would come to mean so much more than a metaphoric high five. Over t...
By Taren Grom • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Who's on the list by Company
AbelsonTaylor Inc. Keith Stenlund Achillion Pharmaceuticals Kevin Kucharski Advanced Clinical LLC Leo Sheridan Alcobra Pharma David Baker Altasciences Chris Perkin AmerisourceBergen Corp. Marc Kikuchi Artcraft Health Marc Sirockman Astellas Pharma US Inc. Jim Robinson Astr...
By PharmaVoice Team • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Tools of the Trade
TGaS Advisors Launches Emerging Life Sciences Network Trending Now: The network provides peer support, data, and insights for accelerating commercial success. TGaS Advisors, a benchmarking and advisory services firm for life-sciences commercial organizations, has launched the Emerging Life Scien...
By PharmaVoice Team • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Talent Pool
Pharma Pool Marcello Agosti Takeda Names Head of New Global Commercial Organization Takeda has named Marcello Agosti head of global commercial, based in Zurich. The company established the global commercial organization as part of its plans to structure operations to become more agile and custome...
By PharmaVoice Team • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Who's On The List by Section
Commanders & Chiefs Dr. Michelle Berrey Chimerix Rob Cosinuke athenahealth and Epocrates Jim Curtis Remedy Health Media Dr. Bruce Feinberg Cardinal Health Specialty Solutions Lisa Giles Giles & Associates Consultancy Inc. and Optivara Inc. Peter Goldschmidt Sandoz Inc. D...
By PharmaVoice Team • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Regulators
Dr. Lisa Jenkins Title: VP, Regulatory Strategy and Content Development Company: Virtual Regulatory Solutions Inc. Education: Post-doctoral fellow, Washington University; M.S. and Ph.D., Syracuse University; B.A., Juniata College Family: Fiancée Ken VanLuvanee, four children, one dog Hobbies: Ski...
By PharmaVoice Team • Aug. 1, 2015 -
PharmaVoice Team/PharmaVoice
Fun Facts About the PharmaVOICE 100
Where they were born? The PharmaVOICE 100 may come from all over, but what they have in common is a sincere desire to improve the lives of patients everywhere. What was their first job? We thought it would be fun to know how these highly successful executives earned their first paychecks. As it t...
By PharmaVoice Team • Aug. 1, 2015 -
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 -
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
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