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January 2016 Issue of The Medicine Maker

Welcome to the January issue. Our upfront topics range from a cross-country cancer cost comparison, to details of the French cancer trial tragedy. Our feature speculates on the future of the Biopharmaceutical Industry – discussing the role of Immuno-oncology, gene editing and other emerging therapeutic techniques. In best practice, Lisa Allen discusses the approaching deadline for the European Union’s REACH regulation, in NextGen, Miguel Forte discusses the role of vendors and manufacturing organizations to cell therapies, and we Sit Down With Diane Paskiet of West Pharmaceutical Services.

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Articles featured in this issue

Discovery & Development Clinical Trials

A Brave New Year

| Stephanie Sutton

How do we move on from a sombre start to 2016?

Business & Regulation Business Practice

Cross-Country Cancer Cost Comparison

Oncology medication prices can vary significantly between countries – but by how much and why?

Discovery & Development Drug Delivery

Bio-Butterfingers

Lipoprotein-nanoplatelets leave researchers hungry to explore drug delivery potential

Business & Regulation Technology and Equipment

The (FD)A-Team

Are you worried about implementing new manufacturing technology in your plant? Never fear, the FDA’s Emerging Technology Team may be able to lend a helping hand

Discovery & Development Clinical Trials

Clinical Trial Tragedy

A clinical trial of an FAAH inhibitor in France goes terribly wrong, but whether the compound or manufacturing are to blame remains to be seen

Business & Regulation Business Practice

All Eyes on EMA Approvals

From anti-cancer viruses to H3 blocking narcolepsy drugs – we present a year in European drug approvals

Discovery & Development Drug Delivery

Three’s a Charm

Nanoparticles help to deliver a three-in-one attack on metastatic melanoma cells

Business & Regulation Business Practice

The CMO Serialization Threat

The serialization deadlines are coming. It may seem an age away, but preparing for serialization is not as straightforward as you may think. Do you really want to get left behind?

Business & Regulation Business Practice

The Adverse Event Data Advantage

A personal experience led us to examine how adverse drug events data can be used to benefit the industry.

Manufacture Technology and Equipment

Layer by Layer

Does the fabrication of nanoparticles and nanocapules sound complex? Don’t worry – layer by layer technology allows for simple fabrication of complicated stuff.

Manufacture Advanced Medicine

Biopharma's Brave New Biology

We live in exciting times for the biopharma industry.

Discovery & Development Drug Delivery

Dosing For Compliance

| Sven Stegemann

Are current dosage forms really as easy and convenient for patients as pharma manufacturers say they are?

Business & Regulation Standards & Regulation

Are You REACH Ready?

The final deadline for the European Union’s REACH regulation is approaching – and the home stretch will be the most challenging, especially for pharma companies that have failed to recognize their role.

Manufacture Advanced Medicine

A Call for Cell Support

Engineered cell therapies hold exciting potential for the pharmaceutical industry – but only if contract manufacturing organizations and vendors play their part in the revolution.

Discovery & Development Business Practice

Thinking Inside – and Outside – the Box

Sitting Down With... Diane Paskiet, Director of Scientific Affairs at West Pharmaceutical Services, USA.

Discovery & Development Drug Delivery

From Brick Dust to Blockbuster?

| Sponsored by BASF

Many drug candidates are as poorly soluble as “brick dust”, making oral delivery a significant challenge.

Discovery & Development Analytical Science

Ultra-Engineering UHPLC from Scratch

| Sponsored by ThermoFisher Scientific

Incremental improvements to ultra-high performance liquid chromatography (UHPLC) have failed to deliver the tangible advances that researchers really want. Sometimes, a full overhaul by re-engineering from the bottom-up is the only way to innovate and move the field forward.

Manufacture Drug Delivery

Aptar Pharma’s Ophthalmic Squeeze Dispenser – Innovation based on experience

| Sponsored by Aptar

Although the discussion about the use of preservatives is still somewhat controversial, clinical evidence suggests that patients benefit from unpreserved eye drops especially in chronic conditions.

Manufacture Bioprocessing - Single Use Systems

The Rise of Asia’s Biotech Tigers

| Sponsored by GE Healthcare

The western world could be considered king of the biotech jungle, but eager biopharma tigers from the east are hungry for a piece of the action – and they are gaining ground. Can single-use technologies help them to catch up even faster? Jinghui Xu believes so.

Discovery & Development Drug Delivery

Screening, Identifying, and Quantifying Potential Genotoxic Compounds with High Resolution LC/MS

Analysis of chlorhexidine drug substance using an Agilent 6545 Accurate Mass Q-TOF System and MassHunter Mass Profiler Software.

Discovery & Development Analytical Science

Talking Extractables & Leachables testing using Orbitrap based mass spectrometry

Hear from Kate Comstock as she talks about her long experience with extractables testing in pharmaceutical companies

Discovery & Development Analytical Science

Talking Extractables & Leachables – no more unknowns?

Hear from Kyle D’Silva as he discusses new developments in GC-MS technology for Extractables and Leachables testing

Other issues of 2016