All articles by Blatha
New direction
The growth of direct-to-patient (DtP) clinical trial strategies is expected to continue for the foreseeable future. Adopting a DtP approach has the potential to improve recruitment, retention and efficiencies, as well as reduce costs. However, legal and regularity barriers can hinder implementation. Emma Green considers the challenges.
Medicine for the planet: sustainable packaging
The primary job of packaging is to ensure the safety of pharmaceutical products, but the wrong choice of material can be detrimental to a company’s sustainability goals – especially if it ends up in landfill or the oceans. Paul King explores the trade-offs involved in designing packaging and asks what a truly sustainable package looks like in 2018.
Keep on track and trace: benefit of traceability in the supply chain
With regulatory requirements evolving fast, much of the discussion around track and trace revolves around meeting compliance deadlines. However, there is a strong business case for track and trace too. Dr Jyrki Syvaeri of Boehringer Ingelheim, Robert Jan van der Horst of DSM Sinochem Pharmaceuticals and Tania Snioch of GS1 speak to Emily Gibbs about how traceability projects can intersect with a pharma company’s business goals and deliver value across the entire supply chain.
Getting ready for serialisation: ‘track and trace’ solutions
EU and US deadlines for serialisation, and track and trace are fast approaching, but many pharmaceutical companies remain dangerously unprepared. With time running out, Patrick Kingsland speaks to Santen’s Pasi Kemppainen and Sai Mungara of Dr Reddy’s Laboratories about choosing the right IT architecture and harmonising legacy applications with new serialisation solutions.
Calculating risk
Last year, the International Society for Pharmaceutical Engineering released the second edition of ‘Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products’, to help manage the risk of cross-contamination in shared facilities. What kind of strategies does the guide recommend and what challenges does cross-contamination still pose to the pharmaceutical industry? Patrick Kingsland asks guide co-author Stephanie Wilkins.
A winning combination: digital solutions for medical treatments
The market for combination products is rapidly expanding, in part due to advances in digital health technology. World Pharmaceutical Frontiers considers the directions these developments are taking, the inherent challenges when integrating digital solutions into medical treatments, and how pharma companies can get ahead of the curve and plan for a future in which combination therapies dominate the market.
Combinational pride: the complexity of mixing drugs, devices and biologics
As combination products become more prevalent, they pose a number of regulatory challenges. Essentially, it isn’t always clear whether a product should be regulated as a drug, biologic or medical device. This means pharma companies need to start thinking about these issues from very early on in the process. Steve Dew, associate director of combination products and medical devices at Biogen, speaks with Emily Gibbs about the key issues.
Safely delivering the goods: a successful supply chain
It is often the final stage of a drug’s journey that can be the most hazardous. Ensuring the cold chain is not broken means understanding a number of variables. Erik Agterhuis, senior manager of logistics and EU supply chain at Kite Pharma, outlines the considerations one must make in order to ensure successful delivery.
Packing heat: temperature control during storage and distribution
Uncontrolled temperature fluctuation during distribution and storage can be a significant source of revenue loss, and pharmaceutical companies are increasingly looking for new ways to prevent excursions and improve monitoring systems. James Krupa, director of clinical supplies at Shire, speaks to Patrick Kingsland about the efficacy of sharing strategies and other best practice for optimising storage options, monitoring temperatures in difficult conditions and preparing for unexpected circumstances.
Room for improvement: cold-chain pharmaceuticals
Huge investment and attention have been spent on improving and standardising the safe shipment of cold chain pharmaceuticals, but to what extent is there a danger of all this attention meaning we take logistics surrounding room-temperature products for granted? Russell Brierley, Lupin’s director of clinical supplies, outlines some of the challenges involved in the transport of pharmaceuticals at controlled room temperature and putting the right steps in place to ensure their safe delivery.