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June 2018 Issue of The Medicine Maker

“Welcome to the June issue. Upfront investigates an FDA crackdown on unproven stem cell clinics and concerns that post-Brexit border delays could turn the UK into a “second tier state for pharmaceutical imports.” Phil Morton makes the argument for Albumin in “In My View,” while our cover feature looks at the three frontrunners of The Medicine Maker 2017 Innovation Awards. In Best Practice, we explore plastic recycling in biopharma manufacturing and the upcoming serialization deadlines; and in Profession, Valarie Higgins from Almac discusses how clinical trials have evolved over the years. We also Sit Down With Ajaz Hussain, President, National Institute for Pharmaceutical Technology and Education, Minnesota, USA.

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Articles featured in this issue

Manufacture Business Practice

Facing the Good Problems

| James Strachan

The cell therapy industry faces a number of complex problems. Fortunately, they’re good problems to have.

Business & Regulation Advanced Medicine

FDA Quackdown

| James Strachan

Regulators step in to stop stem cell clinics from marketing unproven therapies.

Business & Regulation Business Practice

Hold Me Closer, UK Pharma: 2.0

| James Strachan

Concerns abound that post-Brexit border delays could turn the UK into a “second tier state for pharmaceutical imports.”

Manufacture Technology and Equipment

AI Picks Parkinson’s

| James Strachan

Could artificial intelligence help repurpose old drugs for suffers of the degenerative disorder?

Business & Regulation Business Practice

Style Over Substance

| James Strachan

Pharma TV ads are getting longer, less humorous and more nostalgic — while containing fewer facts.

Business & Regulation Business Practice

American Patients First?

| James Strachan

Will President Trump’s prices plan deliver for Americans patients?

Manufacture Small Molecules

Poles Apart

| James Strachan

A generic and inexpensive way to seperate chiral molecules: magnets

Manufacture Business Practice

Trials of a Medicine Maker

The challenge of convincing senior staff to invest in continuous bioprocessing.

Manufacture Technology and Equipment

The Medicine Maker 2018 Innovation Awards

| Stephanie Sutton

Nominations for the 2018 Innovation Awards are open!

Discovery & Development Drug Delivery

ADCs Assemble

| Charlie Johnson

Antibody drug conjugates have not yet lived up to their potential, but there is hope – if we turn to the right solutions and techniques.

Discovery & Development Drug Delivery

The Argument for Albumin

| Phil Morton

Products are becoming increasingly complex and we need to get better at recognizing the strategies with the best advantages.

Manufacture Drug Delivery

Driving Quality in Injectables

| Arnaud Forunier

As we meet increasing demand and satisfy trends towards self-administration in the injectables market, patient safety must remain the primary driver for innovation.

Manufacture Clinical Trials

The Winning Formula

| Adrian Wildfire

We must find ways to better help vaccine manufacturers to fight the flu – and this is why we developed a new challenge agent for H3N2.

Manufacture Technology and Equipment

Looking to a New Reality

| Nicholas Vertommen

The path to market for a biosimilar involves an abbreviated approval process, focused on proving “biosimilarity”.

Discovery & Development Bioprocessing - Upstream & Downstream

Boosting mAb Manufacture

| David Westman

mAbs are an important growth area for the biopharma industry – so we need more effective purification technologies.

Manufacture Business Practice

From Single-Use to Re-Use

| Jacqueline Ignacio

Even plastic used for biopharma manufacturing can be recycled, if we put our minds to it.

Manufacture Packaging

Track & Chase

| William Minaeff

Serialization deadlines will shortly be upon us – but, rather than entering into a blind panic, consider the long term.

Discovery & Development Clinical Trials

Coping With the Complex Clinical Trial Landscape…

| James Strachan

Valarie Higgins discusses how clinical trials have evolved over the years and the key lessons she has learned while building her career in the industry.

Business & Regulation Business Practice

Ahead of the Curve

Sitting Down With... Ajaz Hussain, President, National Institute for Pharmaceutical Technology and Education, Minnesota, USA.

Manufacture Bioprocessing - Upstream & Downstream

Intensify, Connect, and Continue

Thanks to the emergence of intensified and connected processes, the path to continuous biopharma manufacturing is open.

Other issues of 2018