New & Noteworthy

Pharm Exec's 11th Annual Press Audit

The results of this year’s survey indicate that the media’s scrutiny of pharma increased in 2014,with drug safety again again sitting atop of the list of hot button issues.

Can Payers and Drug Industry Agree on Real Value?

Recent developments give the strong impression that both payers and industry are struggling to understand what represents “value” to customers, writes Ed Schoonveld.

CMOs, Meet CIOs

Digital advances, new expectations from HCPs and patients, and an outcomes-based reimbursement environment is creating a need for CMOs and CIOs to collaborate to better meet customer expectations, writes David Logue.

Personalized Medicine at a Crossroads

Personalized medicine has reached a crossroads where fundamental change is not only appealing but essential, write Klarissa Hoday, Francesca Boggio, and Aleksander Ruzicic.

A Patient Perspective on Patient Engagement

Research advocate and "cancer warrior" Jack Whelan talks to Pharm Exec about how pharma could improve its patient engagement activities.

Europe

Europe: Putting Off Off-label Decisions

The EU’s proposed new study on off-label prescribing is just another way of kicking the issue into the long grass, writes Reflector.

Precision or Personalized Medicine: What's in a Name?

President Obama's January announcement of an initiative in precision medicine has set Europe a-flutter over the term 'personalized medicine', writes Peter O'Donnell.

Stamping on MAPPs: Is Europe Trapped Again by Division?

Will the EU's proposed STAMP halt its progress on MAPPs (medicine adaptive pathways to patients)? Reflector reports.

Global

Ebola Vaccines, Treatments Ramp Up for Clinical Trials

Several vaccine candidates are moving into larger clinical trials, supported by government and industry efforts to address manufacturing and research challenges. Jill Wechsler reports.

VC Optimism to China: Leading Biologics Company Raises $100m C Round

2014 was a banner year for investment in biotech, and there is little sign of decline. With an unprecedented $100m Series C round of financing, Innovent has demonstrated this optimism extends as far as China.

Got Ideas? Go North!

The Canadian R&D industry, which boasts a rich history of drug innovation, celebrates a series of anniversaries.

Strategy

Behind the Boom in Biotech

Pharm Exec recently convened a roundtable discussion with nine company aspirants for leadership in the hard science of small biotech.

Regulatory Information Management as a Strategic Asset

Adam Sherlock looks at why pharma companies have started taking regulatory information management (RIM) more seriously.

Pharma 2015: Industry in Flux

What's hot and what's not this year? Is pharma still a 21st century growth industry? See our 2015 Strategic Outlook.

PEspeaks

Drug Makers Back Alternative to FDA Labeling Update Rule

A controversial FDA proposal to alter the process for making changes to approved drug labels has drawn opposition and support in equal measure, writes Jill Wechsler.

Drug Shortages: Not Going Away Anytime Soon

Albert Wertheimer, PhD, MBA, Professor of Pharmaceutical Economics at Temple University and a member of Pharm Exec's Editorial Advisory Board, shows how the simple matter of a drug shortage is not a simple matter at all.

Democratizing Access to Healthcare with Technology

PharmExec talks to babylon founder and CEO Ali Parsa on how technology will deliver healthcare services to patients globally.

Patients, Physicians, and Payers… How Can Pharma Do it All?

The word ‘centric’ by definition means one, as in focused on a single entity. Yet, in today’s life sciences industry, companies are customer-centric and patient-centric and physician-centric — combined. It's counterintuitive…if not overwhelming, writes Lisa Barbadora

Pharma Company Disclosures Draw SEC Scrutiny

The Securities and Exchange Commission (SEC) is focusing more on the accuracy and timeliness of biopharma company financial filings, particularly those related to regulatory actions involving FDA, writes Jill Wechsler.

News Update

CMOs, Meet CIOs

Digital advances, new expectations from HCPs and patients, and an outcomes-based reimbursement environment is creating a need for CMOs and CIOs to collaborate to better meet customer expectations, writes David Logue.

Regulatory

Accelerated Change: Understanding the FDA’s Expedited Pathways

Jamie Gault outlines the key differentiators between each of FDA's programs to facilitate and expedite drug development and review of new drugs.

Pharma Company Disclosures Draw SEC Scrutiny

The Securities and Exchange Commission (SEC) is focusing more on the accuracy and timeliness of biopharma company financial filings, particularly those related to regulatory actions involving FDA, writes Jill Wechsler.

Manufacturers Weigh Strategies to Prevent Drug Shortages

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers and biopharma manufacturers, writes Jill Wechsler.

We Need New Financial Models for Biomedical Innovation

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high U.S. revenues to fund biopharmaceutical R&D, writes Jill Wechsler.

Sales & Marketing

Patients, Physicians, and Payers… How Can Pharma Do it All?

The word ‘centric’ by definition means one, as in focused on a single entity. Yet, in today’s life sciences industry, companies are customer-centric and patient-centric and physician-centric — combined. It's counterintuitive…if not overwhelming, writes Lisa Barbadora

So What is Pharma’s Ideal Role in Social?

Advertorial: Ashfield Commercial & Medical Services believes that Pharma can use social media to play an important role in educating the healthcare professional (HCP) and the patient

What's Wrong with the Annual Sales Kickoff: And How to Fix it

New ways for pharma to make sure its sales reps stay sharp amid a flood of new information and a more complex selling climate. By Duncan Lennox.

Digital's Place in the Pharma Marketing Mix

The rush to digital will continue at a fast clip, but marketers need to reacquaint themselves with their brands' audiences.