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October 2016 Issue of The Medicine Maker

“Welcome to the October issue. Upfront investigates how to make biopharma medicines on demand, GDUFA II, and the EMA’s fight for transparency. In our cover feature, find out what poker can teach us about the biosimilars business. NextGen looks at how to make cell therapies more widely available, and in Business, Alain J. Gilbert argues that orphan medicines are better off alone. We also sit down with Carol Lynch, Global Head Biopharmaceuticals at Sandoz.

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Articles featured in this issue

Manufacture Business Practice

When Free is Not Good Enough

| Stephanie Sutton

Why has Médecins Sans Frontières rejected an offer of free vaccines from Pfizer?

Manufacture Advanced Medicine

Freeze-Dried Pharma

| James Strachan

Lyophilized gene networks synthesize biomedicines ondemand – with just a sprinkle of water.

Business & Regulation Biosimilars

Negotiating GDUFA II

| James Strachan

Are reduced GDUFA fees on the horizon for contract manufacturers?

Business & Regulation Packaging

Serialization Standardization

| Stephanie Sutton

A consortium of vendors and pharma companies search for a single, serialization standard.

Business & Regulation Standards & Regulation

The Fight for Transparency

| James Strachan

The EMA says “yes” to transparency, but some pharma companies have other ideas.

Manufacture Business Practice

And the Facility of the Year is…

| Stephanie Sutton

Genentech’s Cell Culture Biologics Drug Substance Plant 2 in Vacaville, California.

Manufacture Vaccines

Plague Prevention

| Stephanie Sutton

Bioterrorism concerns prompt the UK government to fund development of a vaccine for plague.

Manufacture Vaccines

Fighting Flu

| Derek Gatherer

Can bioinformatics point the way towards a universal flu vaccine?

Discovery & Development Dosage Forms

Swallowability by Design

| Thomas Hein

Tablets are the most common dosage form, but have you considered all of your options?

Manufacture Small Molecules

Save Our Insoluble Compounds!

| Kohsaku Kawakami

Can supersaturation save us from solubility problems?

Manufacture Vaccines

A Universal Shot

| Derek Gatherer

A universal flu vaccine is not impossible for the industry – we just need bioinformatics.

Business & Regulation Biosimilars

Bluff or Serious Biosimilar Bet?

| Eva McLellan and Martyn Smith

The players and chips are ready, what can poker teach us about the biosimilars business?

Manufacture Advanced Medicine

Brave New Factories

| Brian Hampson

Manufacturing specialists must develop cell therapy factories that can meet high demands.

Business & Regulation Business Practice

Ensuring Orphans Thrive

| Alain J. Gilbert

Big pharma CEOs should be wary of because orphans are usually better off alone.

Business & Regulation Biosimilars

Biosimilar Champion

| Carol Lynch

Sitting Down With... Carol Lynch, Global Head Biopharmaceuticals, Sandoz.

Discovery & Development Bioprocessing - Upstream & Downstream

Better Bioanalytics = Better Bioprocesses

| Fredrik Sundberg

Are you up-to-date with new analytical platforms that can give you the edge?

Discovery & Development Formulation

The Formulation Complex

| Thomas R. Tice, Firouz Asgarzadeh, Norbert Maurer, and Anthony J. Hickey

Experts discuss the trends and challenges in the development of complex dosage forms.

Other issues of 2016