Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.

June 2016 Issue of The Medicine Maker

Welcome to the June issue. Upfront features drug delivery to the placenta, an update on the French clinical trial tragedy, the futility of drug demand forecasting and more. Our cover feature takes a look at Ireland’s National Institute for Bioprocess Research and Training – NIBRT. Best Practice looks at elemental impurities derived from packaging, and the challenges of demonstrating biosimilarity, and NextGen focuses on the future of pharma manufacturing apps. We also Sit Down With Ibraheem “Ibs” Mahmood, President and Chief Executive Officer, DrugDev.

Register to download

Register here to download any issue of The Medicine Maker for FREE.

Login

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine
Register

Or Login via Social Media

By clicking on any of the above social media links, you are agreeing to our Privacy Notice.

Articles featured in this issue

Discovery & Development Clinical Trials

The Ups and Downs of Medicine’s Vanguard

| Stephanie Sutton

Cell therapy successes are widely hailed as breakthroughs, but will adverse effects and patient deaths hold the field back?

Discovery & Development Drug Delivery

Placental Payloads

| James Strachan

Tumor cells and phages inspire a new drug delivery method targeting the placenta

Business & Regulation Business Practice

Is Forecasting Futile?

| James Strachan

A survey-based report highlights wildly inaccurate drug demand projections

Business & Regulation Clinical Trials

Clinical Trials in Safety Spotlight

| James Strachan

The EMA says it will review its standards for first-in-human trials

Business & Regulation Clinical Trials

Failure to Launch

| James Strachan

How difficult is it to develop a new drug? Statistics have the answer

Business & Regulation Business Practice

A Vouch for Caution

| James Strachan

Will expanding the Priority Review Voucher scheme defeat its original purpose?

Business & Regulation Standards & Regulation

Shaking Up European Drug Prices

| Stephanie Sutton

Will future drugs in Europe be priced based on therapeutic outcomes?

Business & Regulation Business Practice

The Great British Exit

| James Strachan

The UK votes to leave the European Union: what happens next, and what are the implications for pharma?

Business & Regulation Business Practice

Big Pharma Ups its Game

| Stephanie Sutton, James Strachan

A video game built about the pharma industry adds marketing and malpractice capabilities

Manufacture Business Practice

All Hail the ADC Heroes

| Christa Myers

Amazing innovation is happening all around us in the pharma industry. We should take the time to look outside of our own unique areas to congratulate the efforts of others.

Manufacture Small Molecules

Codes, Drugs, and Rock ‘n’ Roll

| Mark Davison

Europe has set the stage for safer supply chains with its Falsified Medicines Directive. Next, the spotlight could fall on using serialization to boost patient centricity.

Manufacture Quality & Compliance

Thinking Outside the Tox

| Sandy Mackay

Decisions around toxicology testing must be made using scientific methods, not emotions or politics.

Business & Regulation Business Practice

Sustaining the Biopharma Boom: Train and Retain

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

Manufacture Technology and Equipment

Finger on the Biopharma Pulse

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

Discovery & Development Technology and Equipment

Believe in Bioinformatics

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

Manufacture Analytical Science

Know Your Process, Know Your Product

When an industry grows rapidly, innovative approaches are required to ensure sustainable growth. Here, we speak to leaders at Ireland’s National Institute for Bioprocess Research and Training – NIBRT – to find out how a focus on talent, training and technology is changing the face of the field.

Business & Regulation Business Practice

A Tale of Irish Biopharma

Ireland can boast of many success stories when it comes to biopharma investment. Here, Barry Heavey from IDA takes us on a tour of recent investments and explains why talent and training are key.

Business & Regulation Packaging

Insights into Elemental Impurities

| Dennis Jenke

Packaging components can leach into drug products and become foreign impurities. Guidelines exist for the testing of drug products for elemental impurities, but how are these applied to elemental impurities derived from drug product packaging?

Discovery & Development Biosimilars

Finding Fingerprints of Biosimilars

| Fiona Greer

After finally breaking into the US market, biosimilars have created a real buzz in the industry, but the best practice for demonstrating similarity can be daunting to say the least.

Manufacture Small Molecules

Pharma Manufacturing? There’s an App for That

| George Mashini

Mobile technology and apps have become a staple of the pharma industry in terms of disseminating information to patients. Much less is known about their impact on manufacturing, but thanks to developments in cloud computing, the sky’s the limit.

Discovery & Development Technology and Equipment

Trial Trailblazer

| Ibraheem “Ibs” Mahmood

Sitting Down With... Ibraheem “Ibs” Mahmood, President and Chief Executive Officer, DrugDev, founded in the UK and headquartered in King of Prussia, PA, USA.

Manufacture Bioprocessing - Upstream & Downstream

Breaking the Bioprocessing Mold

| Stephanie Sutton

Manufacturers have gotten to grips with the complexities of batch-based bioprocesses, but breaking into the realm of continuous bioprocessing can lead to even greater efficiency.

Discovery & Development Drug Delivery

Bioavailability by Design

| Stephanie Sutton

Few oral biologics have made it to market, and though the challenges are well known, the benefits are huge and the task is not impossible. New technologies can help.

Discovery & Development Formulation

Formulating for the Perfect Tablet Finish

| Ali Rajabi-Siabhoomi

When it comes to film coating, there’s more than meets the eye. Is the drug or tablet core sensitive to acidity or moisture? What release profile is needed? And finally, how will the patient react to the finished product?

Discovery & Development Business Practice

Assessing Drug Encapsulation Efficiency using Nanoparticle Tracking Analysis

In this application note we describe the use of Nanoparticle Tracking Analysis (NTA) for size and concentration measurements of drug delivery nanoparticles. In addition, by using a fluorescently tagged drug molecule, it was possible to determine how many drug delivery nanoparticles had successfully been loaded with drug molecules.

Discovery & Development Business Practice

Measurement and characterization of protein-LMW compound interactions

Measurement and characterization of binding interactions between proteins and low-molecular weight (LMW) ligands are a focus of academic research and drug discovery. Isothermal titration calorimetry directly measures heat released or absorbed in a binding event, providing means for studying protein-small molecule interactions in solution without the need for labeling or immobilization. Importantly, ITC is often utilized to characterize differences in entropic and enthalpic contributions to binding of novel ligands.

Discovery & Development Business Practice

Using Automated Light Scattering Measurements to Support Predictive Protein Formulation Screening

High concentration, low-viscosity, stable therapeutic protein formulations are needed to enable low-volume parental administration. This article explores how a fully automated light scattering system supports the rapid screening of small volume samples in well plates for the rapid identification of suitable biologics during early phase development.

Manufacture Business Practice

Using GPC/SEC for excipient characterization

OMNISEC measures the Critical Quality Attributes of polymeric pharmaceutical excipients with unrivalled sensitivity supporting their efficient use to formulate safe and effective pharmaceutical products.

Discovery & Development Business Practice

Detecting agglomerates within pharmaceutical formulations

Particle agglomeration can compromise the clinical efficacy of pharmaceutical products and must therefore be closely controlled. This article provides practical guidance on using automated imaging for efficient agglomerate detection.

Discovery & Development Business Practice

Investigating the deagglomeration profiles of dry powder inhaler formulations

Which equipment can measure how the particle size delivered by a dry powder inhaler (DPI) changes as a function of applied air flow rate, providing a deagglomeration profile which can be used to compare the performance of different formulations in a device and improve drug delivery.

Other issues of 2016