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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.

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.

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, – some are making the leap into the digital world.

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

In a world of regulatory rigor and complex supply chains, product recalls are becoming increasingly challenging.

Business & Regulation Standards & Regulation

Adapting to the Future of Licensing

| Lynn Baird

With an EMA pilot scheme underway 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