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September 2014 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

The Magazine for Medicine Makers

| Charlotte Barker

If you work in the development or manufacture of drugs and biologics – this is your magazine.

Manufacture Vaccines

World War Ebola

| Stephanie Sutton

New vaccines, experimental treatments for patients, and cash donations make their mark on the Ebola outbreak.

Business & Regulation Standards & Regulation

FDA’s Most Wanted

| Stephanie Sutton

Top food and pharma fugitives are named and shamed.

Discovery & Development Ingredients

CPhI in Numbers

| Charlotte Barker

In October, CPhI Worldwide 2014, along with ICSE, P-MEC and InnoPack, comes to the City of Light - Paris. Here, we bring you some key facts and figures about the event.

Business & Regulation Standards & Regulation

Controversial Shuffle for EC Pharma Policy

| Charlotte Barker

European Commission (EC) plans to transfer governance of the medicines dossier from health to enterprise has upset public health NGOs.

Discovery & Development Clinical Trials

Translation Twists and Turns

| Charlotte Barker

Could tackling bottlenecks in early-stage R&D provide a faster route to the clinic?

Business & Regulation Biosimilars

Copycat Drug Drama

| Charlotte Barker

Lilly and Sanofi go head-to-head on a diabetes drug. Meanwhile, Hospira sues the FDA over a new generic approval.

Manufacture Clinical Trials

Ebola: Ground Zero

| Charlotte Barker

We speak to Derek Gatherer from the Division of Biomedical and Life Sciences at Lancaster University, UK, to get an overview of the Ebola outbreak.

Business & Regulation Standards & Regulation

Clinical Compromise for Europe

| Markus Hartmann

After years of intense criticism, the European Parliament has adopted a new regulation for clinical trials that will replace the current EU Clinical Trials Directive by mid-2016.

Manufacture Facilities

Aseptic ‘Warehouse’ Danger

| James Agalloco

Is there a ‘safe’ hold time for sterilized items? And, if so, how can those hold times be reliably validated?

Manufacture Small Molecules

Medicines and the Microbiome

| Tim Sandle

We now know more than ever before about the complex ecosystem of bacteria, fungi, and viruses within our bodies

Business & Regulation Business Practice

Facing up to Neglected Diseases

| Faiz Kermani

The World Health Organization has compiled a list of 17 tropical diseases that deserve higher priority.

Manufacture Business Practice

The Future of Medicine Manufacture

| Gert Moelgaard

Economic pressures, new technology and the rise of biologics are all having a huge impact on the pharmaceutical industry. What will the next 10 years hold for drug and biologics manufacture?

Manufacture Bioprocessing - Upstream & Downstream

The Biomanufacturing Facility of the Future

| Guillaume Plane

Guillaume Plane takes us on a tour of the facility of the near future.

Manufacture Business Practice

Embracing the Digital Enterprise

Today’s pharmaceutical manufacturing operations capture huge amounts of data. Unfortunately, in many cases the data pass by without actual context.

Manufacture Quality & Compliance

The Evolution of Operational Excellence

In today’s competitive market, OPEX is – or at least should be – a priority for all pharmaceutical manufacturers.

Business & Regulation Small Molecules

Antibiotic Apocalypse: Part I

| Stephanie Sutton

Antibiotics were once hailed as wonder drugs in the war against infection, but now it looks like bacteria might have the upper hand. How can we turn the tide?

Manufacture Advanced Medicine

Pushing Stem Cells from Promise to Product

Manufacturing stem cells for use in research is one thing; doing it on a commercial scale – with all the associated costs and scale-up issues – is an entirely different ballgame.

Business & Regulation Business Practice

Tackling Serious Organizational Failure

An FDA Warning Letter can be a real wake up call. How can you address the root of the problem to protect against future violations?

Business & Regulation Business Practice

Boosting Access to Medicine

Sitting Down With… Wim Leereveld, founder and CEO of the Access to Medicine Foundation

Other issues of 2014