New & Noteworthy

Why CMOs and CIOs Need to Collaborate

Digital advances, new expectations from HCPs and patients, and a dominant outcomes-based reimbursement environment is creating an emerging need for CMOs and CIOs to converge and collaborate, 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.

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.

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.

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.

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 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.

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.

News Update

Why CMOs and CIOs Need to Collaborate

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

Regulatory

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.

Obama's Mixed Message for Biopharma R&D

President Obama has unveiled his $215m “Precision Medicine Initiative” to support the future biomedical research, while calling for a reduction in exclusivity on brand biologics from 12 to 7 years and a curb on "evergreen” patents on certain biologics. Jill Wechsler reports.

Does the Adaptive Pathways Debate Go Far Enough?

While such discussions have advanced in Europe, two key omissions from the dialogue may limit any real changes.

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.