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October 2014 Issue of The Medicine Maker

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Articles featured in this issue

Discovery & Development Clinical Trials

The (Un)fairer Sex?

| Charlotte Barker

Our understanding of the differences in male and female biology is constantly growing – but can we translate that knowledge into better healthcare for all?

Manufacture Business Practice

All a Big Game?

| Stephanie Sutton

“Welcome to Big Pharma, where you can make a fortune and still maintain a healthy conscience. Or can you?”

Manufacture Technology and Equipment

Game On

A business simulation video game called Big Pharma is being made by a UK game studio called Twice Circled.

Business & Regulation Business Practice

Acquisitions Assemble

| Charlotte Barker

Merck KGaA snaps up Sigma-Aldrich, Allergan fights Valeant, and Shire–Abbvie deal sours

Discovery & Development Clinical Trials

Sex Matters

| Charlotte Barker

New NIH policies aim to correct the sex bias in preclinical research

Business & Regulation Business Practice

The Harsh Economics of Ebola

| Charlotte Barker

Opportunistic investors surf the wave of experimental treatments

Business & Regulation Business Practice

Shared Risk, Shared Reward

| Charlotte Barker

New Alzheimer’s treatment gets $500 million collaborative boost

Manufacture Business Practice

Beware the Dragonfly

| Eric Byres, Joel Langill

Mysterious cyber attackers are hitting pharma manufacturing systems

Business & Regulation Standards & Regulation

EMA Pilot Project on Adaptive Licensing

Quick fire Q&A with Hans-Georg Eichler, Senior Medical Officer, EMA

Business & Regulation Small Molecules

Antibiotic Action

| Tracey Guise

Organizations all over the globe are taking action against drug resistance. Tracey Guise of the British Society for Antimicrobial Chemotherapy (BSAC) is positive about the latest developments.

Manufacture Standards & Regulation

Future Proofing Track and Trace

| Allan Coukell, Gabrielle Cosel

The US is finally introducing regulation on drug serialization and traceability, but gaps remain that could leave patients vulnerable.

Manufacture Advanced Medicine

Don’t Forget CDx Developers

| Mark J. Roberts

Many drug developers are going ‘full steam ahead’ with personalized medicine strategies. They would be wise to consider a more equitable business model for an essential partner in the process: the developer of the companion diagnostic.

Manufacture Facilities

Terminal Inertia

| Jeanne Moldenhauer

It is clear that terminal sterilization is the gold standard for sterile drug manufacture, so why are companies so reluctant to pursue it?

Business & Regulation Business Practice

Liking Social Pharma

| Stephanie Sutton, Charlotte Barker

Patients and physicians are tweeting, snapchatting, pinning and posting about healthcare, and although many pharma companies still have no idea what any of that means, some are making the leap into the digital world – and seeing results.

Discovery & Development Ingredients

The Long Road to EXCiPACT

| Iain Moore

If I knew six years ago just how much of my time EXCiPACT would take up, would I have even started?

Business & Regulation Business Practice

Global Recall

| Mike Rozembajgier

It is the nightmare scenario for any drug firm. And yet, in a world of regulatory rigor and complex supply chains, product recalls are becoming increasingly challenging. Here’s how you can protect your company and customers, should the worst happen.

Business & Regulation Standards & Regulation

Adapting to the Future of Licensing

| Lynn Baird

With an EMA pilot scheme underway, and ongoing discussion at regulatory agencies worldwide, it looks likely that adaptive licensing will feature in the future drug development landscape.

Manufacture Small Molecules

Antibiotic Apocalypse: Part II

| Stephanie Sutton

The rise of drug resistance has left us facing a future with few effective antibiotics. Do the next-generation antibiotics in the pipeline offer hope?

Business & Regulation Business Practice

The Talent Trap

| George Scott

Hiring gifted new employees is tough enough, but how do you keep them within your organization once you’ve got them?

Manufacture Biosimilars

Singular Head of Generics

| Charlotte Barker

Sitting Down With… Nick Haggar, Head of Western Europe, Middle East & Africa, Sandoz, and President of the European Generic Medicines Association (EGA).

Other issues of 2014