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September 2016 Issue of The Medicine Maker

Welcome to the September issue. Experts give their view on Mylan and strategies for drug pricing, the importance of public relations, and the importance of placebos in lyophilization. Our cover feature looks to the upcoming US elections and asks what the potential impact could be on pharmaceutical pricing. In Nextgen, find out how hair follicles and nanoparticles can aid transdermal drug delivery. In Business, we ask if biologics litigations are about to increase. We also Sit Down With Akm Khairuzzaman from the FDA to discuss 3D printing.

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Articles featured in this issue

Business & Regulation Business Practice

Public Enemy

| Stephanie Sutton

Why is the pharma industry so despised when it has saved countless lives?

Business & Regulation Biosimilars

Walking the Biosimilar Guideline

| James Strachan

Not all successful biosimilar applications in Europe follow guidelines to the letter

Discovery & Development Clinical Trials

Breaking the Habit

| James Strachan

With illegal drug use rising, can a cancer drug be repurposed to cure cocaine addiction?

Discovery & Development Formulation

Can Slow and Steady Win the Cancer Race?

| James Strachan

Researchers say cancer should involve more frequent treatment at lower doses.

Business & Regulation Business Practice

CPhI in Numbers

| Stephanie Sutton

Our infographic looks at how the CPhI trade show has grown over the years.

Business & Regulation Business Practice

A Question of Access

| Charlotte Barker

Critics say a report from the UN on access to medicines ignores the real word industry

Business & Regulation Business Practice

End of an Era at EFPIA

| Stephanie Sutton

Richard Bergstrom has resigned from EFPIA - who will replace him?

Business & Regulation Business Practice

And a New Era at GSK

| Stephanie Sutton

Emma Walmsley is chosen as GlaxoSmithKline's new CEO.

Business & Regulation Business Practice

Imprudent Pricing

| George P. Sillup

Have Mylan been their own worst enemy with an imprudent pricing decision?

Business & Regulation Business Practice

Who Are You?

| Neil Hunter

Costs of failing to communicate can cost you collaboration and investment.

Discovery & Development Formulation

The Placebo Effect

| David Banks

David Banks offers a warning on using inappropriate lyophilization placebos.

Manufacture Bioprocessing - Upstream & Downstream

mAbs: Hybrid Style

| Laura Holtmann, Stephen Klutz, Martin Lobedann and Dr. Schembecker

Batch or continuous processing? For mAbs, a hybrid approach could be best.

Business & Regulation Business Practice

The Great American Debate

| James Strachan

It's Trump or Clinton for President. But what are the implications for pharma?

Business & Regulation Business Practice

A View from PhRMA

PhRMA explain why the US Elections are important for the pharma industry.

Business & Regulation Business Practice

Obama’s Legacy

| James Strachan

The original goal of 'Obamacare' was to increase access to health insurance, but has it worked?

Business & Regulation Business Practice

Trumponomics Explained

Steve Keen talks to us about Trump, China, free trade and globalization

Manufacture Contract Development Services

Bioprocess Knowledge Is Power

| Nick Hutchinson, Floris De Smet and Miriam Monge

A new approach to outsourcing leverages external expertise and benefits internal learning.

Manufacture Analytical Science

The Science of Sugar: Lessons Learned with Pauline Rudd

| Pauline Rudd

Pauline Rudd explains why sugars and glycosylation are important for biosimilars.

Discovery & Development Drug Delivery

Follicular Drug Delivery: a Root to Success

| Hanzey Yasar, Sarah Gordon, Brigitta Loretz, Kai Schulze, Carlos A Guzman and Claus-Michael lehr

Can hair follicles and nanotechnology help topical drugs overcome the skin barrier?

Business & Regulation Business Practice

Surveying the Biologic Patent Battleground

| Laura von Hertzen

With an approaching patent cliff in biologics, are we be about to see a rise in litigation?

Manufacture Standards & Regulation

Regulating a 3D-Printed Future

| Akm Khairuzzaman

Sitting Down With… Akm Khairuzzaman, a 3D printing expert from the FDA.

Manufacture Bioprocessing - Single Use Systems

When Single Use Meets Continuous Bioprocessing

| Mario Philips

Single-use technology could help pave the way towards continuous bioprocessing.

Manufacture Bioprocessing - Single Use Systems

The Great Debate: Stainless Steel Versus Single Use

| Ken Clapp

Will single use systems win out over stainless steel? Or is a hybrid approach best?

Business & Regulation Formulation

All Aboard for Continuous Coating

| Jason Teckoe and Charlie Cunningham

Robust formulation and coating expertise are required to get the best results with continuous coating.

Discovery & Development Technology and Equipment

The Science of Insolubility

Experts come together to discuss the chemistry of solubility and the drug delivery solutions of the future for dealing with poorly soluble compounds.

Discovery & Development Biosimilars

Accelerating the development of generic pharmaceuticals

In this article, triple detection SEC and MDRS are considered within the context of characterizing complex drug formulations, with specific case studies and results illustrating their application.

Discovery & Development Business Practice

Using Taylor Dispersion Analysis to determine oligomeric state of insulin

In this article, we take an introductory look at how TDA works, the information it provides and its complementary application to other techniques within the drug development workflow. In addition, example case study data will showcase the performance of TDA relative to dynamic light scattering (DLS) for assessment of the impact of a range of parameters on the monomer-dimer-hexamer equilibrium of insulin.

Manufacture Biosimilars

The optimization and scale-up of high shear granulation

This article explains how an inline probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by hardness.

Other issues of 2016