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March 2019 Issue of The Medicine Maker

Welcome to the March issue! How much is a medicine worth? What about a human life? These questions are the focus of this month’s cover feature on cell and gene therapies. Meanwhile in Upfront, researchers develop a new AI platform that aims to harness scientific data for improved drug development, and we ask whether financial relationships between oncologists and pharma affect clinical practice in inappropriate ways. In Business, Peter Beavis argues that too many companies are missing out on crucial R&D tax credits; and Angela Osborne reveals how she created her own space in the cell and gene therapy industry, in Profession. We also Sit Down With Dave Tudor, who is working on “grand challenges” at the Medicines Manufacturing Innovation Centre, Scotland, UK.

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Articles featured in this issue

Business & Regulation Standards & Regulation

So Long and Thanks for all the Drugs

| Stephanie Sutton

Scott Gottlieb prepares to leave the FDA after accomplishing much.

Discovery & Development Analytical Science

The Color of Chirality

| Maryam Mahdi

Forty years ago, it was theorized that chirality had a color composition that could be measured… and finally the theory has been proven.

Business & Regulation Profession

Full Disclosure

| Maryam Mahdi

Oncologists frequently receive “gifts” from pharma companies, but how much is too much?

Discovery & Development Technology and Equipment

Soak it Up!

| Maryam Mahdi

Researchers at the University of California, Berkeley have developed a drug sponge to mop up excess chemotherapy.

Discovery & Development Drug Discovery

RePURPOSED

| Maryam Mahdi

Recycled and reused: scientists develop a library to help teach old drugs new tricks.

Discovery & Development Drug Discovery

Connecting the Data

| James Strachan

A new AI platform aims to harness scientific data for improved drug development.

Discovery & Development Advanced Medicine

Perusing the Pipeline

| James Strachan

With cell and gene therapies being all the rage, we take a peek at some of the advanced therapies coming down the pipe.

Business & Regulation Quality & Compliance

Animal-Free; Risk-Free

| Aaron Schieving

If you or your supplier are working with animal-derived components, you run the risk of exposing patients to dangerous contaminations.

Manufacture Biosimilars

It’s Complicated

| Bérangère Tissot

The potential market for complex generics is substantial, but navigating the FDA’s guidance for proving “sameness” is a real minefield...

Manufacture Advanced Medicine

NextGen Now: Delivering Tomorrow's Facilities Today

| Ryan McDonough

If cell and gene therapy products are to successfully reach patients, then the industry will need more facilities capable of manufacturing them.

Business & Regulation Advanced Medicine

Advanced Therapies: The Price is Right?

| Dan Ollendorf

Are healthcare systems and manufacturers ready to embrace evidence-based pricing to lessen the impact of upfront costs of advanced therapies?

Business & Regulation Advanced Medicine

Let's Meet in the Middle

| Bill Milligan

As long as payers recognize the value of a curative treatment and manufacturers are flexible with payment plans, patients will have access to ATMPs.

Business & Regulation Advanced Medicine

C&G Therapy? That’ll Do NICEly

| James Strachan

Nick Crabb explains the UK’s health technology assessment agency's (NICE's) approach to cell and gene therapies.

Manufacture Packaging

A Step Change in Pharmaceutical Glass Packaging Innovation

| Sponsored by Corning

Valor® Glass is a revolutionary, new aluminosilicate glass composition, developed specifically for pharmaceutical use to eliminate delamination.

Business & Regulation Advanced Medicine

Building a Business: Lessons Learned with Angela Osborne

| Maryam Mahdi

Angela Osborne has created her own space in the industry and is helping the cell and gene therapy industry bloom.

Manufacture Bioprocessing - Upstream & Downstream

The Upstream/Downstream Process Balancing Act

| Serena Fries Smith, Hunter Malanson

Early collaboration and open communication between upstream and downstream are crucial to ensure a consistent end-to-end bioprocess.

Business & Regulation Standards & Regulation

Tax Credits: Your Work is Worth it

| Peter Beavis

Research and development tax reliefs are available for businesses in many countries, but some companies are not taking advantage.

Manufacture Business Practice

Scottish Pride and Innovation

| Stephanie Sutton

Sitting Down With… Dave Tudor, Managing Director of the Medicines Manufacturing Innovation Centre (MMIC), Scotland, UK.

Other issues of 2019