Policy & Regulation: Page 16
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PharmaVoice Team/PharmaVoice
Singapore a Pharma Hub for Asia
Singapore a Pharma Hub for Asia By Kim Ribbink The pharma industry is increasingly drawn to Singapore, thanks to its commitment to research and innovation, good talent base, and trusted regulatory and IP environment. Singapore is fast becoming a leading regional and even global center for the lif...
By Kim Ribbink • Jan. 28, 2014 -
PharmaVoice Team/PharmaVoice
Global Regulations Becoming More Uniform
Pharmaceutical companies must navigate a changing regulatory environment both here and abroad. As the digital age brings the clinical world closer together and research and development become more global, the industry needs to find a way to address regulatory requirements across myriad regions. T...
By Denise Myshko • Jan. 28, 2014 -
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
Preparing for a Successful FDA Inspection
Pharmaceutical manufacturers need to be inspection ready, aligning their organization with the expectations of regulators. Preparing for successful inspections is not a one-time event. Being inspection ready means that pharmaceutical leaders are committed to managing compliance as part of their c...
By Denise Myshko • Jan. 28, 2014 -
PharmaVoice Team/PharmaVoice
Breakthrough Therapies: Become A Priority
Denise Myshko The FDA’s new breakthrough therapy designation pathway, which was launched in 2012, aims to streamline and speed development of products for life-threatening diseases. Many people with life-threatening diseases often have little options for treatment. Now the FDA is working with bio...
By Denise Myshko • Dec. 28, 2013 -
PharmaVoice Team/PharmaVoice
ACA: A Data Sharing Imperative
Denise Myshko The sharing of data has become a critical success factor in the healthcare market under the Affordable Care Act The Affordable Care Act changes how healthcare data need to be collected, managed, and analyzed. Accountable care organizations, providers, and payers will require connect...
By Denise Myshko • Dec. 28, 2013 -
PharmaVoice Team/PharmaVoice
Last Word
Building an Innovation Supply Chain Dr. Noubar Afeyan, managing partner and CEO of Flagship Ventures, discusses his thoughts on how pharmaceutical companies can create an “innovation pipeline." PV: What is an innovation supply chain? Afeyan: What I anticipate happening is a professionalization o...
By Dr. Noubar Afeyan • Dec. 28, 2013 -
PharmaVoice Team/PharmaVoice
R&D Collaboration: Thriving in an Era of R&D Collaboration
Thriving in a Era of R&D Collaboration Year in Preview: R&D collaboration Greater cooperation with academic and government researchers, as well as with other companies, is needed to create collaborations that push innovation forward. There is a growing consensus that the industry must tea...
By PharmaVoice Team • Nov. 13, 2013 -
PharmaVoice Team/PharmaVoice
Corporate Crystal Ball: Trends From the Top
Trends From the Top From the ACA to a value-based system, executives representing all aspects of the life-sciences industry name the top trends they believe will impact near- and long-term success. Phil Birch Senior VP, Global Strategic Marketing Aptiv Solutions 1. Value-Based System. The evolvin...
By Taren Grom • Nov. 12, 2013 -
PharmaVoice Team/PharmaVoice
On the Calendar
The Calendar MHealthSummit — where technology, business, research, and policy connect. The largest event of its kind, the fifth annual mHealth Summit, December 8-11, 2013, Gaylord National Resort and Convention Center, Washington, D.C., brings together leaders in government, the private sector, i...
By Heather Hummel • Nov. 12, 2013 -
PharmaVoice Team/PharmaVoice
The Physician Payments Sunshine Act: Leveraging Reporting to Build Engagement, Relationships, Trust, and Transparency
As we all know, the life sciences industry is under increased scrutiny for the money paid to physicians and other covered recipients for any marketing, consulting, speaking, and educational spend. The Physician Payments Sunshine Act, which is a part of the Patient Protection and Affordable Care A...
By Mike Haley • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Play Like a Team
Play Like a Team Why effective Talent Supply Chain Management is essential for the pharma company of the future Glenn Edward “Bo" Schembechler was the head football coach at the University of Michigan for 20 years, winning 13 Big Ten conference titles during his wildly successful career. Not surp...
By Mark. A Lanfear • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Showcase Feature: Regulatory Affairs: Regulatory Science & Regulatory Affairs
Showcase Feature: Regulatory Affairs Regulatory Science & Regulatory Affairs Regulatory affairs groups play a pivotal and ever-expanding strategic role in the success of compounds, brands, and companies, according to a report from Cutting Edge Information (CE). Regulatory teams enable organiz...
By Taren Grom • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Talent Pool
BIOTECH POOL Kelly BLACKBURN aTyr Pharma Expands Leadership Team aTyr Pharma has expanded its executive leadership team. Kelly Blackburn joins aTyr as VP, clinical affairs. Ms. Blackburn was formerly VP, clinical development operations, at Vertex Pharmaceuticals, where she was responsible for the...
By Ann Grey • Sept. 27, 2013 -
PharmaVoice Team/PharmaVoice
Evolving Regulations in a Globalized Industry
Evolving Regulations in a Globalized Industry Global production of FDA-regulated products has quadrupled over the last decade. Regulators and companies have to keep pace with a changing global industry. Pharmaceutical development and manufacturing have become global industries. But globalization ...
By Denise Myshko • Aug. 23, 2013 -
PharmaVoice Team/PharmaVoice
Closing the Loop on Pharma Marketing
The emergence of the iPad and similar tablets has paved the way for increasing use of closed loop marketing (CLM) throughout the pharma industry. These nimble, real-time devices enable the industry to tailor presentations, gather feedback, analyze data, and reconfigure approaches on the fly. The ...
By PharmaVoice Team • Aug. 23, 2013 -
PharmaVoice Team/PharmaVoice
The Technologists
The Technologists Brian Longo CRM Trailblazer A true trailblazer in developing flexible, customizable customer relationship marketing, Brian Longo is one of the key individuals behind Veeva’s commercial suite for the life sciences, including Veeva CRM, the multitenant cloud technology solution th...
By PharmaVoice Team • July 29, 2013 -
PharmaVoice Team/PharmaVoice
PharmaVOICE 100 - Who's on the List by Section
The Commanders & Chiefs David Berry Pronutria Damian Braga Sanofi Pasteur David Bruggeman Clinical Research Advantage Walter Capone The Multiple Myeloma Research Foundation Steve Collis AmerisourceBergen Corp. Nick Colucci Publicis Healthcare Communications Group Jim Curtis Remedy Health Medi...
By Taren Grom • July 29, 2013 -
PharmaVoice Team/PharmaVoice
2013 PharmaVOICE 100 - Who's on the List by Company
2013 PharmaVOICE 100 – Who’s on the List by Company Indexed by Company Affiliation Accelrys Ken Rapp Acorda Therapeutics Denise Duca Acurian Kristin Gross Addgene Dr. Joanne Kamens Advanced Clinical Concepts David Rear Agano Solutions and Auditgraph Mauricha Marcussen AmerisourceBergen Corp. Stev...
By Taren Grom • July 29, 2013 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Letter from the Editor By Taren Grom The 2013 PharmaVOICE 100 Each year we have the privilege of showcasing 100 of the most inspiring and motivational individuals throughout the life-sciences industry. This special issue, now in its ninth year, once again showcases the individuals as identified b...
By Taren Grom • July 29, 2013 -
PharmaVoice Team/PharmaVoice
Count Down to the Sunshine Act
Count Down to Sunshine Act The final rule for tracking physician payments under the Sunshine Act has provided needed clarity, but questions remain about data accuracy and the public’s ability to interpret the information. The pharmaceutical industry now has some guidance on how to report payments...
By Denise Myshko • May 29, 2013 -
PharmaVoice Team/PharmaVoice
2013 DIA Preview
2013 DIA Preview This year’s theme: Advancing Therapeutic Innovation and Regulatory Science. The Drug Information Association’s 49th Annual Meeting will be held June 23 to 27 at the Boston Convention & Exhibition Center. There will be more than 250 sessions covering 22 tracks on hot topics fr...
By Taren Grom • May 29, 2013 -
PharmaVoice Team/PharmaVoice
On the Calendar
June 17-18 Gross to Net Accounting Forum for Pharmaceutical Manufacturers Hyatt Harbor Side, Boston Institute for International Research, iirusa.comJune 17-19 Next-Gen Kinase Inhibitors The Revere Hotel, Boston Cambridge Healthtech Institute, healthtech.com/kin/ June 18 5th Annual Cloud Slam 2013...
By Heather Hummel • May 29, 2013 -
PharmaVoice Team/PharmaVoice
Advancing Innovation with Better Regulatory Science
Advancing Innovation with Better Regulatory Science By Denise Myshko The FDA is in the middle of an effort to improve regulatory science and how new medicines are approved. The Food and Drug Administration is in the midst of a huge undertaking to transform the way medical products are developed, ...
By Denise Myshko • April 26, 2013 -
PharmaVoice Team/PharmaVoice
Radical Collaboration: Pharma's New Players
Radical Collaboration: Pharma’s New Players Pharma companies are taking advantage of the benefits of playing well with others. The once guarded and uber competitive pharmaceutical industry is now collaborating and sharing information with partners — both inside and outside of the industry — to sp...
By PharmaVoice Team • April 26, 2013 -
PharmaVoice Team/PharmaVoice
On the Calendar
May 16-17 Thought Leader Engagement, the Role of Medical Affairs and Medical Science Liaisons in the Era of Healthcare Reform Hyatt at the Bellevue, Philadelphia World Congress, worldcongress.com May 20-21 2nd Annual Quality Assurance in Pharmaceutical Manufacturing Conference Alexandria, Va. Q1...
By Heather Hummel • April 26, 2013
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