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Quotient-Gillian-2_Layout 1 28/10/2014 11:48 Page 1 Healthy volunteer studies for oncology drug development Clovis Oncology has chosen Quotient Clinical’s RapidFACT™ approach for rociletinib, a promising oral candidate drug for the treatment of EGFR-resistant non-small cell lung cancer. Performed on healthy volunteers, this flexible, data-driven Phase I development study enabled rapid development of an optimized salt formulation. Gillian C. Ivers-Read, Executive Vice President, Technical Operations and Chief Regulatory Officer and one of the co-founders of Clovis Oncology, described how working with Quotient Clinical led to the quick and efficient completion of the study. “Quotient is… an honest and straightforward company with a very progressive attitude.” Gillian C. Ivers-Read Clovis Oncology is a US-based biopharmaceutical company that focuses on acquiring, developing and commercializing cancer treatments for global markets. The company’s current development programs are targeted at specific subsets of cancer, and combine personalized medicine with companion diagnostics, aiming to create therapeutics that are directed at the patients most likely to benefit from them. Gillian explained: “Our overlying philosophy is to develop drugs that will be important for patients. In order to achieve this, the company ethos is to evaluate information, both positive and negative, and make decisions in a fast and proactive way, to keep projects moving ahead.” A significant unmet clinical need Non-small cell lung cancer Clovis owns global development and commercialization rights to rociletinib, one of three product candidates in clinical development, which is currently in Phase II development for the treatment of non-small cell lung cancer. At present, when patients are diagnosed with lung cancer, they are tested to see whether they have certain epidermal growth factor receptor (EGFR) mutations on the cell surface and, if positive, are treated with tyrosine kinase inhibitors such as Tarceva® or Iressa®. Initially, patients respond very well to these drugs but, after about a year, they tend to develop resistance and relapse. More than 50 percent of this drug resistance is driven by the T790M ‘gatekeeper’ mutation, and rociletinib is the first drug to be identified that specifically targets this mutation. In epidemiological terms, about 15 percent of all lung cancers in Europe and the US are EGFR positive, and about 60 percent of these develop the T790M resistance mutation. However, these figures are doubled in Asian populations, and the biggest demographic to be affected is comparatively young, nonsmoking Asian women. As such, rociletinib is a key potential therapy for a significant unmet clinical need, and an important candidate to push forward through an accelerated clinical development program. Choosing a study partner Drug development is complicated and challenging, and a culture of thorough, open communication between both internal teams and external partners is essential. Quotient-Gillian-2_Layout 1 28/10/2014 11:48 Page 2 About RapidFACTTM RapidFACT – Rapid Formulation development And Clinical Testing RapidFACT dramatically speeds up the optimization of drug products for downstream development for all routes of delivery. Quotient Clinical’s team of experts assess candidate molecules and share ideas on the design of development programs. RapidFACT programs have been successfully used for: • evaluating solubilization technologies; • optimizing modified release systems; • changing route of delivery; • and developing combination products. Gillian added: “Contract partners must be able to form a good interactive project team, and must deliver timely, quality work. From the outset, we were impressed with Quotient Clinical; as a company, it appears to have a similar business culture to our own, particularly in terms of flexibility and fast working, and we began to discuss options for studying rociletinib in healthy volunteers.” It is frequently inappropriate to perform oncology drug studies on healthy volunteers, purely because of their significant safety profiles; however, rociletinib is a targeted therapy and therefore does not have the adverse event profile of some chemotherapeutic agents. Gillian continued: “In discussion with Quotient’s medical team, we established that performing the studies in healthy volunteers was a safe option and would make it considerably faster to transition patients to what could be a therapeutic dose. Usually in oncology, studies like this must work up doses gradually, but what tends to happen is that the first few doses are really sub-therapeutic. This would therefore be a great advantage to get to the right level to see some efficacy as soon as possible.” The healthy volunteer study, designed in association with Quotient and based on its proprietary RapidFACT program, looked at different formulations to take forward to a clinical study and, in particular, at moving from a free base to a salt formulation. The aim was to quickly transition patients to this new formulation, establishing doses of the salt which would give similar plasma levels to the doses already showing efficacy in the free base form. “Typically in these kinds of trials, the drug is made at a manufacturing unit, and then released, packaged and shipped to wherever the study is being held. What makes Quotient unique is the way in which the pharmaceutical products are made on site and transferred, without leaving the building, to the clinical unit and a good, large and reliable pool of healthy volunteers. That is where so much time is saved. We have never found a group in the US that does this, and this workflow instantly cuts two to three months out of the study timeline.” “We had a tight timetable but the company’s capacity to dose the healthy volunteers, get the pharmacokinetic data back and be ready to call us with results, all in a matter of days, made a huge difference. We could then work with the information they had provided and decide quickly on the next step, the next dose. This way of working is very flexible, and enabled us to make the necessary decisions in a timely way, moving the drug forward as efficiently and safely as possible.” A positive experience Gillian concluded: “From the outset, it was apparent that Quotient had the same kind of philosophy as Clovis; an honest and straightforward company with a very progressive attitude. Once the team had understood the scope of the project and given us a timeline, they absolutely stuck to that. Everything went efficiently, there were no surprises. And, when we needed to add additional scope, additional arms onto the project, they were very flexible. This made it easy for us, and they responded to the urgency that we felt in getting things started. Having the vision to develop the ‘single site’ way of working is truly innovative, and offers a company like Clovis a really efficient option. The entire study was a very positive experience.” Quotient Clinical +44 (0) 115 974 9000 or +1-800-769-3518 (USA) [email protected] www.quotientclinical.com John McDermott, Director, Drug Product Optimization [email protected] www.quotientclinical.com