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|Imaging interoperability is an essential step to ensuring that patients receive the most beneficial care plans.
|Merete Jørgensen: Since 2004, Merete Jørgensen has been building up the area of clinical trials disclosure at Novo Nordisk, and is responsible for the registration of clinical trials at clinicaltrials.gov, and EudraCT and establishment and maintenance of the Novo Nordisk clinical trials website.|Reports must strike a fine balance between transparency and protecting sensitive information.|Behtash Bahador leads quality and compliance on CISCRP’s programme that communicates non-promotional, unbiased, and accessible trial results for patients and the public. He works with industry sponsors on implementation and aligning best practices in health communication with regulatory and industry guidelines.|Results must be communicated accurately.
|Barry Drees is a co-founder and senior partner at Trilogy Writing & Consulting, where he leads submission teams and provides training. He is a frequent speaker on medical writing, statistics and other topics for Management Forum, the Drug Information Association and the European Medical Writers Association.|Lisa Chamberlain James is a senior partner and CEO at Trilogy Writing & Consulting. Aside from management activities, she also leads client projects, with extensive experience in a variety of documents, and a special interest in drug safety and patient information.
|Italo Poggesi is scientific director of global clinical pharmacology/quantitative sciences at Janssen. Since completing a degree in chemistry and a PhD in bioengineering he has held different positions in the pharmaceutical industry in the areas of pharmacokinetics, metabolism and drug development.|K/PD modelling has become an integral part of the drug development process.|Preclinical predictive modelling is making drug development more efficient and objective.
|Dr Christopher Milne is director of research at Center for the Study of Drug Development at Tufts University (Tufts CSDD) and research associate professor at Tufts University School of Medicine, Innogen Center associate (University of Edinburgh). He has published over 100 book chapters, white papers and articles.|As budgets lessen, the collaboration of pharma and academic establishments may be the answer to developing new medicines and devices.
|Margaretta Nyilas is senior vice-president, clinical and business operations, at Otsuka Pharmaceutical Development & Commercialization. Her work on drug development has led to regulatory approvals on multiple indications for CNS compounds.|The biopharmaceutical industry is trying to harness potential digital connectivity.|Technology will need to evolve in step with increasing amounts of data and this, in turn, will require that those using it will need a thorough understanding of how to analyse the reams of new information in order to put it to best use.
|Dr Sanjay Sethi, MD, is a professor and chief of the division of pulmonary, critical care and sleep medicine in the department of medicine in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. He is also director of the university’s clinical research office.|In a climate of dwindling budgets and increasingly complex technology, a well organised trial stands the best chance of being a successful one.
|Packaging can influence patients’ attitudes to the treatments they receive in trials.|A primary goal of blinding should be to limit the likelihood of patents being able to differentiate between products based on appearance.
|Dr Nilay Shah is chair of the division of healthcare policy and research at Mayo Clinic, and an associate professor of health services research in the Mayo Clinic College of Medicine. His research focus is on chronic care delivery. He is also testing the role of decision support tools for patient-centred knowledge translation.|Combining EHRs with other metrics gives researchers a detailed picture of a patient’s health.|The proliferation of new databases and a decentralised recruitment system means that researchers must be careful to balance RWD’s power with patient confidentiality.
|Dr Humaid al-Shamsi: In 2014, Dr Humaid al-Shamsi joined the MD Anderson Cancer Center, University of Texas, as an assistant professor of medical oncology. He moved to the University of Sharjah in 2017 and is an associate professor of oncology. Shamsi routinely conducts research and has a special interest in colorectal cancer.|It is hoped that MD Anderson’s discovery of Non-V600 BRAF mutations will help to tailor treatments for cancer patients, particularly those that have negative effects, such as chemotherapy.