2012 AAPS Graduate Student Award in Quality By Design and Product Performance The Quality By Design and Product Performance Focus Group of AAPS will annually present an award to promote the group’s goals to: • • provide a scientific forum which creates and fosters multidisciplinary collaborations leading to enhanced product performance consistent with predefined objectives for greater patient benefit. leverage, advance and accelerate science and risk-based approaches and technologies and develop strategies which link the critical quality attributes, product, process and the patient throughout the product life cycle. After consultation with the group’s membership at FIP PSWC 2010 / AAPS Annual Meeting 2010 it was decided this would be best achieved by promoting these types of activities in graduate students as they would then take this type of thinking into future careers and it may also stimulate fundamental academic research in this area. Selection will be made on the basis of the student judged by the committee to have provided the most outstanding contributions in the above field through their graduate research. There are no citizenship requirements for this award. All interested candidates are encouraged to apply. Students must be in their final year of graduate studies leading to the Ph.D. degree (or will be awarded their Ph.D. in 2012). The student selected will receive a commemorative plaque and a cash award of $500.00. Each award will be assessed against the following criteria: 1. 2. 3. 4. 5. 6. Integrates science from several disciplines Demonstrates that understanding or defining product performance in the target patient population with respect to target in vivo product performance for the intended efficacy and safety profile including suitability for dosing compliance is a central theme of the work Introduces new techniques or new ways of using science or new ideas to understand product performance in the patient Defines product release criteria and /or manufacturing conditions based on target in vivo product performance Demonstrates a tangible benefit to patient and society Has been communicated to the wider community The winner will be invited to contribute a short article to the The Quality By Design and Product Performance Focus Group Newsletter. For more info on this Focus Group go to http://www.aaps.org/inside/focus_groups/QBDPP/index.asp. Nomination Requirements 1. 2. 3. The completed nomination form. Include a supporting letter signed by your graduate advisor, and the additional information, not to exceed four pages in length. The additional information should encompass the thesis work (may encompass published work or other work in progress), so as to present an integrated view of the overall research program. The nomination form and all supporting materials, must be sent as a single pdf file to awards@aaps.org by May 14, 2012. A single Microsoft Word document will be acceptable if pdf capability is not available. Failure to submit in the proper format will be subject to return without consideration. The award name “2012 AAPS Graduate Student Award in Quality By Design and Product Performance” must be shown in the subject line of your email. FAXED OR MAILED NOMINATIONS WILL NOT BE ACCEPTED. Selection Procedures The nomination materials are forwarded to a selection committee comprised of representatives of the AAPS Quality by Design and Product performance Focus Group. 2012 AAPS Graduate Student Award in Quality By Design and Product Performance Name of Ph.D. Candidate University Title of Nomination Title of Thesis Please have your thesis advisor complete and sign the following recommendation. I am nominating On the basis of Thesis Advisor Name (please print) Signature and Date Please indicate Nominee’s name and permanent address for further notification. Name Organization/Institution Address City State Zip Daytime telephone Email Fax Abstract Country **Not to exceed four pages** 2012 AAPS Graduate Student Award in Quality By Design and Product Performance Name of Ph.D. Candidate University Title of Nomination Provide a brief summary of you PhD research: Describe how your PhD research integrated science from several disciplines: Describe how your work contributes to understanding or defining product performance in the target patient population with respect to target in vivo product performance for the intended efficacy and safety profile including suitability for dosing compliance is a central theme of the work: How has your research resulted in new techniques or new ways of using science or new ideas that result in better understanding of product performance in patients? How can the understanding from your PhD be used to set product release criteria and/or manufacturing conditions based on target product performance in the patient? Have any tangible benefits to the patient or society arisen (or could potentially arise) out of your PhD? Have the results of your PhD been communicated to the wider community? If not, what are the plans to do so?