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September 2015 Issue of The Medicine Maker

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Articles featured in this issue

Discovery & Development Clinical Trials

Clinical Trial Clarity

| Charlotte Barker

Drug makers and regulators are taking steps towards transparency, but is it enough?

Discovery & Development

Wasps Versus Cancer

Do Brazilian wasps hold the promise of a new anticancer therapy? The answer is in the sting

Manufacture Analytical Science

Quantum Leap in Real-time Monitoring?

| Stephanie Sutton

Continuous monitoring of pharma products with an innovative matchbox-sized laser

Business & Regulation Business Practice

Fighting for Freedom of Speech

| Stephanie Sutton

Drug companies claim that off-label drug promotion is protected by freedom of speech

Manufacture Advanced Medicine

Antibody Attack

| Stephanie Sutton

DNA vaccine helps turn patients’ own cells into antibody-producing factories

Business & Regulation Business Practice

CPhI in Numbers

| Stephanie Sutton

CPhI Worldwide 2015 in Madrid is just around the corner. Are you ready for showtime?

Discovery & Development Technology and Equipment

All Eyes on Antibiotics?

| Harparkash Kaur

When you think about counterfeit and falsified medicines in developing countries, antimalarials are likely to spring to mind first – but we shouldn’t forget that antibiotics are also important targets for fraudsters. In either case, more quality control testing is needed.

Manufacture Technology and Equipment

The Redeployment Dilemma

Pharma companies often redeploy or sell equipment, but without sufficient expertise it’s easy to fall foul of dangerous cargo regulations and other liability risks.

Manufacture Small Molecules

Fixing the Negative Perception of QbD

| Christoph Herwig

‘Quality by design’ has been around for years, but still the benefits are hardly leveraged in medicine manufacture. I firmly believe that knowledge management can help.

Manufacture Technology and Equipment

A New Dimension to Medicine Manufacture

| Stephanie Sutton

Fabricating medicine using a printer may sound like the stuff of science fiction, but the technology exists – and the pharma industry has finally taken the plunge.

Manufacture Technology and Equipment

Big Pharma’s 3D Focus

| Clive Roberts

Some people say that pharma companies can be wary of new technology, but in my experience big pharma is always keen to explore promising new technologies and ideas

Manufacture Technology and Equipment

From Pharma-Grade Filaments to Capsular Delivery Systems

Our research team has been investigating innovative manufacturing technologies to develop custom drug delivery systems, and one area of interest for us is 3D printing.

Manufacture Technology and Equipment

Appreciating the Potential of 3D Printing

| Stephanie Sutton

Aprecia was actually founded in 2003 specifically to focus on – and unlock – the potential of 3D printing for pharmaceutical applications.

Manufacture Technology and Equipment

Chemical Creations

| Lee Cronin

Lee Cronin, Regius Chair of Chemistry in the Department of Chemistry at the University of Glasgow (UK), is involved in ambitious experiments exploring the assembly and engineering of chemical systems, with the ultimate goal of understanding the origins of life.

Manufacture Technology and Equipment

Bioprinting Better Drug Development

| Alan Faulkner-Jones

Only a fraction of drug candidates that begin pre-clinical testing are ever approved for human use. The low success rate can be partly attributed to the differences in response between humans and the animal models currently used for testing.

Manufacture Technology and Equipment

Thinking Outside the Pyramid

| Stephanie Sutton

Simon Gaisford, Reader in Pharmaceutics and Head of the Department of Pharmaceutics at University College London (UCL) has a keen interest in the concept of 3D printing solid dosage forms.

Manufacture Technology and Equipment

3D Printing 101

| Stephanie Sutton

3D printing – also known as additive manufacturing – is the process of making a 3D object from a digital file. The object is designed on a computer and then printed by laying down or printing successive layers of a material.

Manufacture Technology and Equipment

Inkjet Innovation

| Stephanie Sutton

Although our September cover feature focused on 3D printing, it is not the only printing technique that is being investigated in pharma applications; inkjet printing could also have a place in the manufacture of tomorrow’s medicines.

Manufacture

The Trojan ADC Challenge

| Aad van de Leur

Often touted as ‘magic bullets’ against cancer, antibody-drug conjugates (ADCs) aim to combine the effectiveness of chemotherapy with the specificity of antibodies. But the same complexity that imbues them with desirable qualities adds many hurdles to development and manufacturing processes. Fortunately, solutions – and expertise – are on the rise.

Business & Regulation Business Practice

Accepting R&D Failure

| Stephanie Sutton

To file, or not to file – that is the question when it comes to IND applications. Companies don’t always make the right choice, but learning when to abandon ship can open the door to potential future gains.

Discovery & Development Clinical Trials

The Cautious Comeback of Oral Peptides

| David J. Brayden

After the initial hype and subsequent clinical failure of oral peptide formulations in the 1990s, pharma took a step back. Today, select oral peptides are yielding positive data in advanced clinical trials.

Business & Regulation Business Practice

How to Ace Interviews

Is it time to update your resume and fine-tune your interview skills? Biopharma is seeing an unprecedented jobs boom and your dream role could be just around the corner.

Business & Regulation Business Practice

The Joy of Discovery

| Stephanie Sutton

Sitting Down With... David Baltimore, Nobel Laureate, President Emeritus and Robert Andrews Millikan Professor of Biology, California Institute of Technology, USA.

Manufacture Quality & Compliance

Getting Under the Skin of Extractables and Leachables

| Stephanie Sutton

There are key benefits to having an industry standard for E&L studies – but a standard is only the beginning. The bigger question is what comes next and how do we dig even deeper into single- use systems?

Other issues of 2015