All articles by Ky Nikitha
Ky Nikitha
The cold war
Cold-chain shipping involves navigating a number of challenges to prevent product wastage. Eva-Lotta Persson, MSc/CSCP clinical supply chain lead, AstraZeneca R&D Mölndal, speaks to Kerry Taylor-Smith about how to overcome these issues to ensure an efficient, effective cold chain.
The heat is… off
Temperature-controlled products present a logistical challenge. Their safe transportation and storage are essential to their efficacy. Ensuring effective infrastructure and maximising the use of digital tools are two key strategies to help optimise the supply chain. Didier Basseras, vice-president of clinical supplies for clinical supply chain at Sanofi-Aventis R&D, speaks to Bradford Keen about best practices to keep drugs safe.
The mind leading the blind
Interactive response technology (IRT) systems are crucial to the efficient management of clinical trials. The medium has evolved from a telephone-based interface to one based almost entirely on computers, and issues concerning training, interoperability and safety remain. Greg Noone talks to consultant and former Pfizer executive director Michael Moorman about the contribution made by these programs, and the pitfalls when a trial relies on a poorly designed variant.
All things considered
Every clinical trial needs not just the investigational product but a host of ancillary supplies, ranging from laboratory equipment to the paper required for audit trails. Kim Thomas asks Kevin Crawford, head of clinical operations at Tenax Therapeutics, for some tips on procuring, stocking and distributing ancillary supplies to clinical sites.
Stamp of approval
For years, clinical trials have been stymied by confusing regulations and high levels of patient drop-out, all of which wastes money and prevents drugs from getting to the people who need them. By using clinical quality management systems (CQMSs) and good clinical practice (GCP), which help clinicians carefully plan and conduct trials, the process is made far simpler. Andrea Valentino talks to Melissa Suprin, head of quality risk management at Pfizer, about how CQMSs can help clinical researchers – and how the scattered regulatory finally seems to be getting organised.
Central to success
There is increasing emphasis on the importance of patient-centricity within clinical trials, including encouragement from the FDA to incorporate the patient voice through the drug development process. Diana Villalobos, vice-president, clinical, at Dermavant Sciences, speaks to Emma Green about how to implement this approach to maximise recruitment and retention.
A helping hand
Since 1997, pharma has been looking at additive manufacturing (3D printing), trying to understand what role it will play. Its value is clear, but to pinpoint where it should be used best still remains a challenge. Andrew Tunnicliffe speaks with Professor Clive Roberts, head of the School of Pharmacy at the University of Nottingham, and explores the possibilities.
The first move
There is increasing talk of ‘patient-centricity’ within the industry. Incorporating this concept into drug delivery can be challenging but provides huge opportunity to improve adherence. Louise Thomas speaks to John Burke, senior consultant at Team, about the best practices when implementing this approach.
Ride the wave
The ability to share data throughout the entire supply chain is essential to optimise logistical services for pharmaceutical products. To achieve this goal, the implementation of digital technologies plays a key role. Emma Green speaks to Niels Hackius, research associate at the Hamburg University of Technology, about the range of tools available, particularly the value of blockchain.
Agent nanoparticles
Using gold nanoparticles and an intriguing protein pair called SpyTag and SpyCatcher, researchers at the University of Lincoln have pioneered a new approach for delivering nanomedicine more cheaply and effectively. Isabel Ellis talks to senior lecturer and lead author Enrico Ferrari about sneaking medicine through the bloodstream.