Contents In this issue 8


6 News & numbers The headlines and figures impacting the sector.


Regulatory


8 Centralised submission The change from the Clinical Trials Directive to the Clinical Trials Regulation in Europe has been long and slow, but now that the new regime is in place there is one burning question – has it produced the improvements that regulators were expecting? Jim Banks puts that question to Alexander Roussanov, life sciences and privacy partner at law firm Arnold and Porter Kaye Scholer LLP, and Edyta Maciołek, regulatory affairs manager at JJP Biologics.


11 AI for medical writers – friend or foe? Trilogy Writing & Consulting


Data management


14 Oncology’s data puzzle Oncology trials generate huge volumes of data from many different sources, and they do so over long periods of time. The payoff of demonstrating an effective therapy for cancer can be huge for patients and pharmaceutical companies, but collecting, cleaning,


4 Clinical Trials Insight / www.worldpharmaceuticals.net 14


analysing and interpreting data from studies can be a challenge. Monica Karpinski speaks to Peter Hall, senior clinical lecturer in cancer informatics at the University of Edinburgh, and Charlotte Stuart, head of data management and information systems at the University of Southampton’s Clinical Trials Unit, to find out why certain data management challenges are unique to oncology trials, and how organisers and statisticians work to overcome them.


Clinical supply & logistics


18 Innovations and hurdles The discovery and development of CAR T-cell therapies will go down in the annals of medical history. But while remarkably effective against a range of cancers, these advanced therapies require a complex pipeline of production – one that first includes extracting components from the blood of patients. Andrea Valentino speaks to Federico Rodriguez Quezada, an industry veteran and consultant, and Dr Jeffrey Winters of the Mayo Clinic, to learn how the complexity presents challenges in the supply chain, and what can be done to get the finished product to patients quicker.


21 Biosample safety in clinical trial management Clinigen


22 Cold challenge: safeguard cell and gene therapies during clinical trials Thermo Fisher


27 Clinical trials and the commercial supply chain Abacus Medicine Pharma Services


28 Unexpected events You can’t forecast everything: the


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41