Policy & Regulation: Page 13
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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 -
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
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 -
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 -
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
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