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October 2015 Issue of The Medicine Maker

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Articles featured in this issue

Business & Regulation Business Practice

Hiding in Plain Sight

| Charlotte Barker

Mislabeled, substandard or falsified medicines are the perfect opportunity for criminals looking for low risks and high rewards.

Business & Regulation Standards & Regulation

Too Fast and Furious?

| Stephanie Sutton

Expedited regulatory approvals bring medicines to market faster – but are they the right drugs?

Manufacture Small Molecules

Digging for Drugs

Genome mining hunts for bacteria micro-chemists that could help develop innovative drugs.

Discovery & Development Drug Delivery

The Medicine Monitor

A digital pill submitted for regulatory approval tells caregivers if you’ve taken your medicine

Discovery & Development Formulation

Benign by Design

Researchers redesign existing drugs to be more biodegradable and environmentally friendly.

Manufacture Technology and Equipment

Big Pharma Gets Played

| Stephanie Sutton

As the industry makes its video game debut, the big question is: will you prioritize patients over profit? Here’s our big review.

Business & Regulation Standards & Regulation

All Change at the Top

| Stephanie Sutton

The EMA fights to reinstate its former executive director – and the FDA’s new leader is still unconfirmed

Discovery & Development Clinical Trials

Cancer Complexity

| James Ritchie

Clinical development is outmoded; we are witnessing serious attrition in cancer R&D. Perhaps it’s time to live and die by the mantra: “no biomarker, no trial”.

Manufacture Quality & Compliance

Painting a Better Picture of Quality

| Christian Mänder, Thomas Friedli

When seeking to measure quality across an organization, what is the right approach?

Manufacture Facilities

Embracing Rapid Microbiology

| Tim Sandle

Microbiological approaches are faster and more advanced than ever before – so why on earth isn’t the pharma industry using them?

Manufacture Standards & Regulation

When Fakes Attack!

| Mark Davison

Regulators are driving serialization and tamper-evident packaging initiatives, but is the pharma industry fully primed to defend against counterfeits?

Business & Regulation Business Practice

The Problem of Counting Counterfeits

| Stephanie Sutton

Recently, Tim Mackey and colleagues examined the extent to which counterfeit drugs had penetrated global legitimate supply chains.

Business & Regulation Business Practice

Fighting Spirit

| Stephanie Sutton

Grant Lindman is director of Eli Lilly’s global anticounterfeiting operations and is passionate about fighting fake medicines.

Manufacture Technology and Equipment

Fighting Fakes

Track and trace is often used on pharmaceutical packaging but what if an invisible code could be applied directly to a tablet?

Manufacture Bioprocessing - Single Use Systems

Disposing of the Past and Embracing Single-Use Technology

| Stephanie Sutton

Single-use technology is ready to lend a helping hand to biomanufacturing, but is the industry ready to turn away from stainless steel?

Manufacture Advanced Medicine

The Hype, Hope and Reality of Personalization

| Behzad Mahdavi, Uwe Gottschalks, Nuala Trainor, Tim Smith

Personalized cell-based therapies have been hyped as the future of medicine, but are current manufacturing technologies up to the task?

Business & Regulation Business Practice

Harnessing Emerging Markets

| Ambuj Jain

How can the pharma industry capitalize on the growth potential of emerging markets?

Business & Regulation Small Molecules

An Instinct for Innovation

| Stephanie Sutton

Sitting Down With... John Talley, Chief Scientific Officer at Euclises Pharmaceuticals, St. Louis, USA.

Manufacture Bioprocessing - Single Use Systems

Bringing Vaccines into the 21st Century

| Sponsored by GE Healthcare

Lawrence (Larry) Lesko is a bioanalytical veteran with many years of academic and FDA experience under his belt.

Discovery & Development Formulation

The Medicine Maker × Catalent Applied Drug Delivery Institute

| Sponsored by Catalent

There are many hurdles in drug development, but your chances of success increase significantly if you pay more attention to API optimization from the outset.

Manufacture Technology and Equipment

Realizing 3D Potential by Printing a Clearer Picture

Ronan Daly describes his research in combining inkjet printing and medicines.

Discovery & Development Drug Delivery

Printing Medicines for Express Delivery Through the Cheek

Javier Morales tells us why he is investigating inkjet printing for the development of buccal films for the delivery of biologic drugs.

Manufacture Business Practice

Utilization of kinITC in AFFINImeter

| Sponsored by Malvern Panalytical

This application note describes how and when can kinetic information be retrieved from ITC power curves.

Manufacture Business Practice

Characterization of IgG monomers & their aggregates

| Sponsored by Malvern Panalytical

Two antibody samples were characterized using column calibration and multi-detection SEC, and the results compared...

Discovery & Development Drug Delivery

Using Raman Spectroscopy to Understand the Conformational Stability of Protein Therapeutics

| Sponsored by Malvern Panalytical

Use of a novel combination of dynamic light scattering and Raman spectroscopy to elucidate the conformational stability and structure of proteins in biopharmaceutical formulations

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 1

| Sponsored by Malvern Panalytical

In Part One, we provide an overview of the key principles of DLS: theory, correlation statistics, deconvolution algorithms, and the intensity to mass transform.

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 2

| Sponsored by Malvern Panalytical

In Part Two, we cover the influence of concentration effects and particle interactions on DLS results and provide a roadmap for identifying and distinguishing each type of concentration effect.

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 3

| Sponsored by Malvern Panalytical

In Part Three, we cover the basic types of DLS deconvolution algorithms used to extract the intensity weighted particle size distribution from the measured correlogram.

Discovery & Development Drug Delivery

Overview of Key Principles of Dynamic Light Scattering to protein therapeutic formulations – Part 4

| Sponsored by Malvern Panalytical

In Part Four, we address frequently asked questions related to the application of DLS to the characterization of protein therapeutic formulations.

Other issues of 2015