ORGANIZATION: The National Institute for Health and Clinical Excellence (NICE) is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health in England and Wales. PROBLEM OR ISSUE ADDRESSED: A NICE technology appraisal is a review of clinical effectiveness and cost-effectiveness evidence leading to recommendations on the appropriate use of new and existing medicines and treatments for the National Health Service (NHS) in England and Wales. Technology appraisals require certain types of evidence about a product which is often different from regulatory requirements. Gaps in the evidence submitted for technology appraisal increase the likelihood that the product is not recommended for use on the NHS or that the technology appraisal is delayed while attempts are made to fill the evidence gap. GOALS: To improve the quality, relevance and completeness of evidence on products submitted to NICE for technology appraisal by offering companies the opportunity to obtain product-specific advice on their development plans at an early stage of development. With this in mind we set up a consultancy service to provide advice to technology developers interested in ensuring their clinical development studies generate the evidence which is relevant to technology appraisal. OUTCOMES ITEMS USED IN THE DECISION:  Following a face-to-face discussion attended by company representatives, NICE staff and clinical and economic experts, a written report is issued to the company. This report responds to the questions the company posed, and  provides advice on issues such as clinical trial designs, trial populations, endpoints to include, sub-groups to explore, construction of economic models etc. IMPLEMENTATION STRATEGY: The feasibility of a Scientific Advice Programme was explored in a pilot project in 2007 in which scientific advice was provided on HTA evidence plans of a product in development prior to the commencement of Phase III development. Following a ‘proof of concept’ project in 2008, the programme was launched in 2009. RESULTS:  Within the first 6 months of setting up we have had 15 projects booked in.  Initial feedback from the face-to face meetings has been positive. A detailed review of the experiences of the first few months of the programme will be presented. LESSONS LEARNED: General issues will be highlighted such as what information to include in briefing books (information on the product in development), what questions to ask NICE, who to bring to the face-to-face meeting, when the best time is to ask for advice etc.