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July 2019 Issue of The Medicine Maker

Welcome to the July issue where, in our cover feature, we explore the sky-high potential of ADCs – will they live up to the hype? Upfront dives into the microbiome (the gut and the skin), plus regulatory developments in the Chinese advanced therapy sector. The challenges of drug repurposing are tackled in In My View, alongside the ever-evolving pharma job market. In Business, we lay out the steps to successfully commercializing orphan drugs, and find out how Merck has been preparing for a no-deal Brexit. In Profession, Claudia Zylberberg reveals her lessons learned. And finally, we Sit Down With serial entrepreneur and Medicine Maker Power Lister, Nigel Therobald.

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Articles featured in this issue

Business & Regulation Trends & Forecasts

Are You Suffering from Brexit Fatigue?

| James Strachan

The uncertainty surrounding the UK’s future with Europe is having a measurable effect on pharma. But it looks like the end is nowhere in sight.

Discovery & Development Drug Discovery

Solutions In… the Skin-Biome

| Maryam Mahdi

At the helm of SkinBioTherapeutics, Catherine O’Neill and her team are exploring the ways in which probiotic bacteria can be used topically.

Manufacture Technology and Equipment

A Smarter – and Synthetic – Workflow for Bioengineering

| Maryam Mahdi

Can artificial approaches trump the conventions of traditional organic synthesis for the production of raw pharmaceutical products within cells?

Discovery & Development Technology and Equipment

Playing for Change

| Maryam Mahdi

The game “Tumor Quest” seeks to improve people’s understanding of cancer.

Business & Regulation Business Practice

Business in Brief

| Maryam Mahdi

Scouting for new leadership, prices hikes and successful acquisitions. What’s new for pharma in business?

Business & Regulation Supply Chain

The Road to Interoperability

| Maryam Mahdi

The FDA has accepted TraceLink's blockchain and digital recall projects into its DSCSA Pilot Program.

Discovery & Development Drug Delivery

Attack of the Drug Eaters

| Maryam Mahdi

How do we battle gut bacteria that reduce medicine efficacy?

Business & Regulation Standards & Regulation

Cutting Out the Middleman

| Maryam Mahdi

What are the consequences of allowing patients to purchase cell and gene therapies directly from hospitals?

Business & Regulation Business Practice

Expect the Unexpected

| Yong Guo

Scientific careers are inherently unpredictable, but there are a number of steps we can take to be prepared.

Manufacture Standards & Regulation

Quality, Not Quantity

| Iain Moore

Qualitative risk assessments are a great way to approach quality management and train your operators at the same time.

Discovery & Development Drug Discovery

A New Purpose

| Gerallt Williams

Drug repurposing is in vogue, but it’s not always as easy as you think.

Manufacture Advanced Medicine

Logistics Will Prevail

| Sam Herbert

Sam Herbert walks us through the past 50 years of pharma logistics.

Discovery & Development Formulation

The Perfect Cover Up

| Sponsored by BASF

With many APIs exhibiting a strong, bitter taste, taste-masking is essential, particularly for pediatric patients.

Discovery & Development Advanced Medicine

New Frontiers in ADC Development

| Maryam Mahdi

Will antibody drug conjugates live up to the ever-growing expectations surrounding them?

Business & Regulation Business Practice

How to Commercialize an Orphan Drug

| George A. Chressanthis, Animesh Arun

Orphan drugs for rare diseases represent a significant unmet medical need for pharma, but commercialication can be tricky...

Business & Regulation Business Practice

Perpetual Preparedness

| James Strachan

With a no-deal Brexit still a real possibility, Merck continues to prepare for the worst case scenario.

Manufacture Bioprocessing - Upstream & Downstream

MilliporeSigma: A Biosafety Revolution

| Afshin Sohrabi, Audrey Chang, Martin Wisher

Biopharma manufacturers have been using the same assays for viral safety testing for decades.

Business & Regulation Profession

Foresight is 20/20: Lessons Learned with Claudia Zylberberg

| James Strachan

Claudia Zylberberg reveals her career lessons learned and offers her perspective on the now booming advanced therapies industry.

Business & Regulation Business Practice

Fourth Time’s a Charm

| James Strachan

We sit down with Nigel Theobald, Chief Executive, N4 Pharma. He tells us the story of his career and offers some advice for budding entrepreneurs.

Other issues of 2019