Latest

Tufts to Plug China Industry Knowledge Gap with New Partnership

The Tufts Center for the Study of Drug Development aims to plug the knowledge gap at the lower end of China's trade business through a partnership with Shanghai’s Fudan University.

Stop Everything! Investigating FCPA Issues in Pharma

An internal audit of payment practices in Eastern Europe has revealed payments for elaborate travel for physicians in exchange for approval and prescription of your products. What should you do? Mara Senn offers some advice.

New & Noteworthy

eTMF Adoption a Year After the MHRA Update

Pharma has had a year to address MHRA’s update to the definition of a critical GCP inspection finding to include trial master files that are “not readily available or accessible”. How has it fared? Rik van Mol reports.

Top Trends in Biopharmaceutical Manufacturing 2015

New cell-culture techniques, biomanufacturing formats, and the expansion of single-use applications are driving rapid change in the biopharma market.

“Rx” for the Latest SCOTUS Decision on Obamacare

For the second time in three years, the Supreme Court of the United States (SCOTUS) has weighed in on key aspects of the 2010 Obamacare law. Tom Norton reports.

Emerging Pharma Leaders: Arjun Handa, Claris Lifesciences

The son also rises — how Handa is making his mark on the family company.

The Employee Profile in China R&D

Pharmaceutical companies are currently targeting the emerging markets of China and Africa for their future expansion, with the highest investment just in China alone.

Emerging Pharma Leaders: Julie Smith, CEO, Raptor

The East Coast native, now “happily and, hopefully, permanently relocated to the West Coast” is building more than a culture.

From the Editor

The Human Chain: The Emerging Pharma Leaders

Amid the release Pharm Exec's Emerging Pharma Leaders 2015, William Looney considers what will determine true leadership in big Pharma in the years ahead.

Health Innovation: Creating Next Gen Leaders

Institutionalizing the teachable moment with GENiE, a new network focused on advancing the idea that for healthcare to change, the education of its leaders must change first.

Europe

Greece: More Than Next Week's Medicine Supply At Risk

There are evident challenges for pharma in the ongoing Greek crisis. But, writes Reflector, there are some less evident challenges which may, over time, prove to be more difficult for the industry to cope with.

Europe Needs New Timeline for IDMP Implementation

All indications are that the July 2016 deadline for transition from Europe's eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to the new IDMP is not achievable. Sophie Daniels reports.

Global

Tufts to Plug China Industry Knowledge Gap with New Partnership

The Tufts Center for the Study of Drug Development aims to plug the knowledge gap at the lower end of China's trade business through a partnership with Shanghai’s Fudan University.

Globalization of Biomanufacturing Outsourcing Continues

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

PEspeaks

Mounting Attack on Drug Pricing: Will ICER Be the De Facto NICE in the U.S.?

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

Biosimilars: The Next Chapter

Amgen and Sandoz received a decision from the U.S. Court of Appeals for the Federal Circuit in Washington on Tuesday. PharmExec spoke with legal and biosimilar experts for their initial reactions.

FDA Seeks Smooth PDUFA Renewal Process

FDA has launched the process for reauthorizing the Prescription Drug User Fee Act (PDUFA), setting the stage for FDA to hear the views of patient, consumer and health professional representatives. Jill Wechsler reports.

Greece: More Than Next Week's Medicine Supply At Risk

There are evident challenges for pharma in the ongoing Greek crisis. But, writes Reflector, there are some less evident challenges which may, over time, prove to be more difficult for the industry to cope with.

Strategy

Taking Flight: Pharm Exec's Top 50 Pharma Companies

Our annual Pharma 50 listing is clear proof that once-small and midsize biopharma companies are joining the top ranks of big Pharma.

The Salix-Valeant Acquisition: "It’s Just a Game"

Sarah Chaney gives an in-depth look at the Salix-Valeant acquisition — how analysts and investors can affect decision-making and potentially drive poor behavior.

Capturing the Cloud: A Conversation with Veeva Systems Matt Wallach

Pharm Exec talks to Matt Wallach, President of upstart start-up, Veeva Systems

Regulatory

Mounting Attack on Drug Pricing: Will ICER Be the De Facto NICE in the U.S.?

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

“Rx” for the Latest SCOTUS Decision on Obamacare

For the second time in three years, the Supreme Court of the United States (SCOTUS) has weighed in on key aspects of the 2010 Obamacare law. Tom Norton reports.

Europe Needs New Timeline for IDMP Implementation

All indications are that the July 2016 deadline for transition from Europe's eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to the new IDMP is not achievable. Sophie Daniels reports.

Sales & Marketing

Beyond the Buzzword: Finding Your Patient Centricity

SPONSORED CONTENT. The term “patient centric” has become something of a catch-all term. Cheryl Lubbert looks at the broad range of its application.

When Care Models Collide

What you should know about integrated delivery networks, by Kim White and Christen Buseman.

Why the Emotional Sell is More Critical Than Ever

Whether a brand is preparing to launch a new product, or taking a reinvigorated one back to market, it is widely accepted that those who form the emotional connection with customers are most likely to succeed.

R&D

Optimizing Clinical Trials Using Electronic Measurement and Analysis of Drug Adherence

Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority