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September 2017 Issue of The Medicine Maker

Welcome to the September issue of The Medicine Maker! This issue marks the magazine’s third anniversary since our release. Our cover features unites six industry gurus to discuss the impending US and EU deadlines for serialization compliance in the pharma industry. Upfront covers the landmark approval of Kymriah, how gold nanoparticles can bypass chemotherapy toxicity, and why drugs fail in clinical trials, or even post-approval. In NextGen, experts cover the challenges of manufacturing cell therapies, and why ex vivo screening could boost new drug development. Plus, we sit down with Abhijit Mukherjee from Dr Reddys to talk about the business of generics.

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Articles featured in this issue

Manufacture Business Practice

Here’s to Shared Successes!

| Stephanie Sutton

This issue marks The Medicine Maker's third birthday!

Manufacture Drug Delivery

The Golden Touch

| James Strachan

What does “manufacturing” drugs in the body mean for chemotherapy?

Manufacture Standards & Regulation

Making Therapeutic History

| William Aryitey

The FDA approval of Kymriah marks the first CAR-T cell-based gene therapy available in the US

Discovery & Development Business Practice

Leaving on a Jet Plane

| Stephanie Sutton

One of the biggest pharma trade shows in Europe kicks off at the end of October

Manufacture Small Molecules

Bright Spark

| James Strachan

Could electrochemistry give drug discovery and manufacturing a boost?

Business & Regulation Business Practice

Business-in-Brief

| James Strachan

Keeping close ties, locking-up loopholes, and calculating costs… What's new for pharma in business?

Discovery & Development Clinical Trials

Cater to the Customer

| James Strachan

Drugs often fail , both before and after reaching the market - but why?

Business & Regulation Quality & Compliance

Don’t Touch That Data

| Mark Stevens

Data integrity is an important part of pharma, but not everyone knows how to handle it

Manufacture Analytical Science

Out with the Old, in with the New?

| Alex Perieteanu

New analytical techniques could be used alongside old ones to get the best of both worlds

Manufacture Standards & Regulation

What’s on the Box?

| William Aryitey

The US and and EU deadlines are approaching, but is the industry ready for serialization?

Manufacture Standards & Regulation

Serialization Blind Spots

| Pavel Lotkov

Serialization is far from simple, and many companies overlook key aspects

Manufacture Contract Development Services

Twenty-First Century Cell Therapy

| Denis Bedoret

When making advanced medicines, the cost of manufacture must be lower than reimbursement

Manufacture Advanced Medicine

Getting Personal with Oncology

| Joe Olechno

Ex vivo screening techniques could revolutionize cancer treatment.

Discovery & Development Biosimilars

Champion of Generics

| Abhijit Mukherjee

Sitting Down With… Abhijit Mukherjee, COO of Dr. Reddy's Laboratories, India

Discovery & Development Small Molecules

The Small-Molecule Problem Solver

| Paul Evans

Today's small molecules are increasingly complex, but generic producers must keep track of trends

Discovery & Development Bioprocessing - Upstream & Downstream

Collaborating to Get Biopharma in the Fast Lane

| Stephanie Sutton

Scaling up a bioprocess doesn’t need to be a headache - especially when there are firms out there that can lend a helping hand

Discovery & Development Ingredients

Know Thy Raw Materials

| Chandana Sharma

Nine years ago we set out to characterize and evaluate our raw materials - this is what we found out…

Discovery & Development Formulation

The Formulation Complex

Unravelling the challenges and trends in formulation best practice – and why softgels and lipids are leading the way

Manufacture Bioprocessing - Single Use Systems

The Power of Collaboration

A look a Millipore Sigma’s global network of collaboration facilities, ‘M-Lab’

Other issues of 2017