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October 2018 Issue of The Medicine Maker

Welcome to the October issue. Upfront investigates next-generation pain medications developed with
computer simulations, antibiotics derived from bear saliva, and the costs of falsified medicine. Daniel Maier argues that the development of an industrial process should begin when the product is still at the preclinical stage in “In My View”, while our cover feature examines the urgent need for pharma to generate data on safety for pregnant and lactating women and their fetuses and babies. In Best Practice, Mike Merges and Mike Sadick from Catalent discuss how to get analytical bioassay cell banks up and running, and in Business, we explore a proactive approach to discovering and investing in future leaders. We also Sit Down With…Kal Patel, MD, Senior Vice President of Digital Health for Flex.

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Articles featured in this issue

Manufacture Clinical Trials

A (Pregnant) Pause For Thought

| Roisin McGuigan

It’s time for maternal health to move on from the dark ages, and pharma has a duty to help.

Discovery & Development Analytical Science

Source of Light – and Inspiration

| Rich Whitworth

A new center for electron bio-imaging was officially opened by one of the three Nobel Prize winners.

Discovery & Development Drug Delivery

Eliminating Side Effects In Silico

| Roisin McGuigan

Next-generation pain medications could improve on current opioid offerings.

Manufacture Technology and Equipment

The Deadline for Innovation

| Stephanie Sutton

Nominations for The Medicine Maker’s annual Innovation Awards will close on Tuesday November 6.

Manufacture Technology and Equipment

Bearfaced Research

| Roisin McGuigan

A new method for discovering antibiotics makes use of an unusual source of complex microbial communities: bear saliva.

Business & Regulation Standards & Regulation

The True Cost of Falsified Medicine

| Roisin McGuigan

A recent review and meta-analysis highlights the huge impact of fake and substandard drugs.

Discovery & Development Drug Delivery

Injectable Innovation

| Roisin McGuigan

A company looks to give the humble injection an inventive makeover.

Manufacture Facilities

Trials of a Medicine Maker

| Stephanie Sutton

Eva decides to sort out her bioburden issues after a disturbing dream...

Discovery & Development Small Molecules

Planning for Production Scale

| Daniel Maier

The development of an industrial process should begin right at the start – the preclinical stage.

Manufacture Business Practice

Why Aren’t We Connecting?

| Kal Patel

Digital technology is all around us, but pharma isn’t quite getting it right… yet.

Manufacture Clinical Trials

Time for Pharma to Deliver?

| Roisin McGuigan

Is pharma putting women and children last?

Manufacture Clinical Trials

Pregnant Patients Deserve Better

| Anne Drapkin Lyerly

The lack of evidence available from pharma companies to guide care of pregnant women is ethically unacceptable.

Business & Regulation Clinical Trials

A Pharma Success Story

| Eric Gervais

One pharma company is working to pioneer safer drugs for use during pregnancy…

Business & Regulation Clinical Trials

Including Pregnant Women from the Start

| Catherine Spong

Including pregnant women in research isn’t as difficult as some might think…

Manufacture Clinical Trials

A Tall Task

| Roisin McGuigan

The PRGLAC Task Force hopes to change the landscape for research on pregnant and lactating women.

Business & Regulation Analytical Science

Banking for Bioassays

| Mike Merges and Mike Sadick

Analytical bioassay cell banks certainly have benefits. But it can be difficult to know what best practices to follow.

Business & Regulation Business Practice

Taking Charge – Come Rain or Shine

| Louis Fioccola

Are people born to lead or can they be cultivated?

Manufacture Business Practice

Digital Driver

| Kal Patel

Sitting Down With… Kal Patel, MD, Senior Vice President of Digital Health for Flex.

Manufacture Contract Development Services

Partners in Success

| Nick Shackley

A good CDMO is a true partner with advice on getting the most from your molecule.

Manufacture Bioprocessing - Upstream & Downstream

For Bioprocess Success: Simulate!

| Emily Thompson

A good CDMO is a true partner with advice on getting the most from your molecule.

Manufacture Analytical Science

Dissecting How Drugs Work

| Sven Poetzsch and Frank Fischer

Frank Fischer and Sven Poetzsch have a shared goal at Merck: to understand how medicines interact with human biology.

Manufacture Contract Development Services

Embracing Technologies & Enhancing Outcomes

| Sponsored by Johnson Matthey

What are the hottest trends and techniques in drug development?

Other issues of 2018