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November 2018 Issue of The Medicine Maker

“Welcome to the November issue. Upfront investigates the transparency of European clinical trials, gene-editing to protect mice from cocaine overdose and addiction, and how the FDA thinks manufacturing can be modernized. Frank Cordes explains how integrating automation and informatics will be made possible by Industry 4.0 in “In My View,” while our cover feature explores the pharma industry’s role in biodefense. In Best Practice, Mario Philips, Vice President and General Manager at Pall Biotech, discusses the evolution of single-use technology; and in Business, academics from the Campbell School of Business in the US explain the empirical evidence linking technology and financial decisions for start-ups in the pharma industry. We also Sit Down With Vivek Sharma, CEO of Piramal Pharma Solutions.

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Articles featured in this issue

Business & Regulation Business Practice

The Face of Science (and the Fifty Pound Note)

| Stephanie Sutton

Recognizing and celebrating the efforts of both male and female scientists.

Business & Regulation Small Molecules

Let’s Modernize Manufacturing

| Stephanie Sutton

The FDA’s Janet Woodcock explains how manufacturing will change in the coming years.

Manufacture Small Molecules

Press It! Plug It! Play It!

A new automated chemical synthesis machine aims to remove some of the repetitive processes from a scientist’s day.

Discovery & Development Clinical Trials

How Transparent Are Trials?

| Stephanie Sutton

Only 50 percent of clinical trial results in Europe are reported, but big pharma shares far less than half the blame.

Discovery & Development

Coke Zero’d

| James Strachan

Genetically engineered skin cells expressing highly potent cocaine hydrolase reduce cocaine-seeking behavior in mice.

Manufacture Drug Delivery

Seeds of Change

A nanofluidic device, smaller than a grain of rice, aims to deliver localized immunotherapy without side effects.

Manufacture Business Practice

Solutions In Silico

| James Strachan

Collaboration seeks to use artificial intelligence to predict how patients will respond to immunotherapy.

Business & Regulation Business Practice

Business-in-Brief

| Stephanie Sutton

A new gene therapy, a procurement process gone wrong, and backing away from a biosimilar…

Business & Regulation Business Practice

Trials of a Medicine Maker

Eva discovers that Gene's project management skills leave a lot to be desired...

Manufacture Business Practice

I’m a (Blockchain) Believer

| Richard Shute

Can blockchain transform how we use, share, interact with and benefit from it.

Manufacture Small Molecules

The Revolution Rises

| Frank Cordes

Industry 4.0 is making progress and should encourage the adoption of new technologies.

Manufacture Vaccines

Outbreak

| Stephanie Sutton

Meet the companies and researchers protecting us from bioterrorists who plan to harness the destructive power of infectious diseases.

Manufacture Vaccines

Rising to the Challenge

| Gary Nabors

How can we prepare ourselves for the threats of emerging infectious disease?

Manufacture Vaccines

The Intersection of Infection and Biodefense

| Marcus Horwitz

A single vector vaccine has been developed that could offer protection against tularemia, anthrax, plague and melioidosis.

Manufacture Vaccines

A Winning Bid

| Jim Jackson

Emergent Biosolutions, has become a multinational biopharma company, despite working in some difficult therapeutic areas including biodefense.

Manufacture Small Molecules

Back to Basics

| David Walker

David Walker discusses the threat of bioterrorism and the importance of basic research.

Manufacture Bioprocessing - Single Use Systems

The Next Chapter in Single Use

| Mario Philips

Disposable technology has found its place in the biopharma industry, but where does the story go from here?

Business & Regulation Business Practice

The Winning Strategy for Start-Ups

| Hyunsung Kang and Xin Geng

The business of making biopharmaceuticals is expensive – so the more data you have to back up decisions, the better.

Discovery & Development Business Practice

Changing Mindsets

| Vivek Sharma

Sitting Down With... Vivek Sharma, CEO of Piramal Pharma Solutions.

Manufacture Biosimilars

The Good and the Bad of Biosimilars

| Sponsored by GE Healthcare

The biosimilars market is suddenly booming, but such steep competition means that only the wise will survive.

Manufacture Analytical Science

All Eyes on E&Ls

| Stephanie Sutton

Extractables and leachables require rigorous analysis to protect patient safety.

Manufacture Bioprocessing - Upstream & Downstream

Keys to Consistent Bioprocessing

| Serena Fries Smith

How to develop a robust and consistent bioprocess.

Manufacture Analytical Science

The New Antibody Formats on the Block

| Patrick Endres

Innovation is being boosted in manufacturing and purification techniques.

Manufacture Bioprocessing - Upstream & Downstream

Easing Ion-Exchange Chromatography

| Romain Dabre

Why salt-tolerant resins make for “happier” biomolecules with better binding.

Other issues of 2018