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November 2014 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

Big Bad Pharma?

| Charlotte Barker

The Ebola media frenzy has reminded the public how selfish our industry is. But, somehow, that doesn’t sound quite right...

Manufacture Small Molecules

The Final Frontier?

| Stephanie Sutton

The Galactic Grant Competition encourages companies to use the International Space Station for pharmaceutical R&D

Business & Regulation Business Practice

Access All Areas

| Stephanie Sutton

The 2014 Access to Medicine index shows progress – but companies remain “conservative”

Business & Regulation

Battle of the Superbugs

| Stephanie Sutton

Can phage endolysins revolutionize the way bacterial infections are treated – and prevent drug resistance?

Business & Regulation

Endolysins Vs MRSA

| Stephanie Sutton

Micreos, a biotech based in the Netherlands, has launched the first endolysin registered for human use against methicillin-resistant Staphylococcus aureus. What is an endolysin? Micreos describes it as a “bacteria-killing enzyme” that originates from bacteriophages. We spoke with Bjorn Herpers from the Regional Public Health Laboratory Kennemerland, Haarlem, in the Netherlands to find out more.

Business & Regulation Business Practice

Care to ‘Patent Dance’?

| Stephanie Sutton

Amgen accuses Sandoz of snubbing its advances in a complex biosimilar dispute

Business & Regulation Standards & Regulation

Regulators Target Ebola

| Stephanie Sutton

Will FDA fast review and voucher incentives make a difference?

Discovery & Development Drug Delivery

Dosing to Circadian Rhythm

| Stephanie Sutton

Could medicines be made more effective with better timing?

Business & Regulation Standards & Regulation

Making European Regulations Work

| Stephanie Sutton

Pathways designed to bring medicines to market faster in Europe are not delivering the goods

Manufacture Small Molecules

Side Effects and Supercomputers

| Stephanie Sutton

A group of researchers have used supercomputers to link proteins to drug side effects (1). Could this computational model be more predictive than current statistical methods?

Manufacture Biosimilars

The Monoclonal Milestone

| Carsten Brockmeyer

The launch of the world’s first biosimilar monoclonal antibody was a big step forward from a regulatory and scientific standpoint. Will there be enough room at the table?

Manufacture Small Molecules

Calculate – Don’t Estimate – Drug Development Costs

| Ayman Chit

Researchers estimate the cost of drug development at over $1 billion, while others say it’s less than $100 million. Who’s right? And how can we accurately determine the true costs?

Business & Regulation Business Practice

Sharing Data – and Knowledge

| Steve Thomas

How to use a knowledge repository that doesn’t retire or leave you for a competitor.

Discovery & Development Formulation

What About the Kids?

| Jenny Walsh

Making medicines for pediatrics adds a whole new dimension to the challenges of formulation and drug delivery

Manufacture Bioprocessing - Upstream & Downstream

Pass Me a Bottle Opener

| Jaime Marach

Upstream processes in biopharma manufacturing are growing ever more efficient; conversely, downstream processing is increasingly a bottleneck. Can a new generation of chromatography techniques and technologies get things moving again?

Manufacture Standards & Regulation

Safety First - Sizing Up Biologics Side Effects

| Catherine Akers

Biologic medicines present unique challenges for pharmacovigilance. And with biosimilars hitting the market, life just got more complicated – especially when products share the same name.

Discovery & Development Small Molecules

Electrifying R&D Acceleration

| Mark R. Taylor, Susana Da Silva Torres

Electrochemical reaction cells are finding new applications in the pharma R&D lab that could offer big time and cost savings. Here, we share our experiences using electrochemistry with on-line mass spectrometry to study pharmaceutical stability and oxidation products – and explain why we’re electrochemistry converts.

Business & Regulation Business Practice

Our Unholy Alliance

| Lee DesRosiers

Science and business: tenacious partners in a shaky marriage or eternally bound nonidentical twins?

Business & Regulation Small Molecules

United Science Stands

Sitting Down With… William Chin, Executive Vice President, Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA).

Discovery & Development Drug Delivery

Connecting the Dots in Drug Delivery

| Sponsored by Catalent

The days of “low-hanging fruit” in drug discovery are a thing of the past. Drug candidates are increasingly made up of complex, poorly soluble molecules – and that poses a big challenge: how can we continue to produce effective medicines that meet patient needs?

Other issues of 2014