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.

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.

Top of the green chain

Pharmaceutical companies have long grappled with getting their supply chains in order, especially when it comes to keeping them sustainable. But between lax reporting and environmental scandals, supply chains have traditionally been decidedly ungreen. Andrea Valentino talks to David McClintock and Camille Messer of sustainability ratings company EcoVadis about how a new joint initiative could finally help the industry clean up – and how the latest technology is pushing it along.

Only as strong as the weakest link

Pharmaceuticals are particularly difficult to transport, with a number of potential areas of weakness within the supply chain. Greater data sharing between partners can provide opportunities as well as challenges. Michael Shaw investigates how new technologies can strengthen pharmaceutical logistics and allow drugs manufacturers to comply with stringent new regulations.

Piece by piece

For over 20 years, contract manufacturing organisations (CMOs) have played an increasingly important role in the pharmaceutical industry. The need to lower the time to market, improve process efficiency and reduce costs are all key factors that have resulted in building on this trend, and will continue to do so for the foreseeable future. Emma Green discusses the key considerations when choosing and working with a CMO.