AAPS Webinar Proposal Submission Form Instructions: Please note that forms will be immediately rejected unless all requested information is complete. 1. Please complete this form in its entirety by placing your cursor in the gray boxes and typing the information. 2. There is an example of an appropriately completed form on pages 4-6 for your reference. 3. Save the completed form on your desktop and then submit by emailing as an attachment to the addresses shown at the bottom of the form. This form will be submitted to the AAPS Electronic Program Development Committee (EPDC) for review and their feedback will be sent back to you promptly. Your Section or Focus Group: Do you have the support of your Section or Focus Group leadership as each group has a finite number of allotted webinars per year? ____Yes ____No Proposed Webinar Title: Primary Webinar Organizer (that is probably you): Name: Company: Phone: Email: Webinar Presenter #1: Name: Company: Phone: Email: Webinar Presenter #2 (optional): Name: Company: Phone: Email: Webinar Moderator: Name: Company: Phone: Email: Program Objectives: (in bullet point format, outlining the topics to be discussed) Abstract: (175 word minimum) Who will benefit most from this webinar? Please check the gray boxes for all relevant sections, words, and terms applicable to the proposed webinar. The items you check will be used to index your event listing on the AAPS website. Analysis and Pharmaceutical Quality Section Clinical Pharmacology and Translational Research Section Formulation Design and Development Section Physical Pharmacy and Biopharmaceutics Section Regulatory Sciences Section ADME Analytical Method Development Animal Welfare Bioequivalence Biopharmaceutics Biopharmaceutics Classification System Biotechnology Chromatography Biotechnology Section Drug Design and Discovery Section Manufacturing Science and Engineering Section Pharmacokinetics, Pharmacodynamics and Drug Metabolism Section Forced Degradation Formulation Formulation Design and Development Freezing and Drying Technologies Guidance on Drug Interactions Hot Melt Extrusion HPLC Human Cytochromes P450 Clinical Trials Combination Products Compliance Trends Continuous Process Delivery Discovery Drug Delivery Drug Disposition Drug Manufacturing Drug Transport Fluid Drying Excipients Fluid Drying ICH Q8- Q9- Q10 Immunogenicity In Vitro Release and Dissolution Testing IND Inhalation and Nasal Technology Manufacturing Mass Spectrometry Modified Release Nanotechnology NDA Non-Clinical Dose Formulation Analysis PAT Pharmaceutical Manufacturing Please enter below any other terms NOT listed above that can be used as search terms. Please do NOT include terms or words used in any titles or description of your event. Enter Keywords: Please review this proposal with your presenter(s). It will be the basis for the webinar brochure. Send your presenter and moderator the Webinar Guidelines Send your presenter the Speaker Release Form Email completed form to: Stacey May, Director of Public Relations, Outreach, and eLearning, and send a copy to: Meredith Weston, eLearning Program Manager WestonM@aaps.org EPDC-approved webinars are scheduled on a first-come, first-served basis. EXAMPLE OF AN APPROPRIATE WEBINAR SUBMISSION Your Section or Focus Group: Discovery Modeling and Simulation Focus Group and DDDI Do you have the support of your Section or Focus Group leadership as each group has a finite number of allotted webinars per year? _X_Yes ____No Proposed Webinar Title: In Silico Tools in Preformulation and Formulation Development Name: Company: Phone: Email: Primary Webinar Organizer (that is probably you): Jane Smith Concordia University Wisconsin 555-555-5555 jane@cuw.edu Name: Company: Phone: Email: Webinar Presenter #1: John White Merck & Co., Inc. 555-555-5555 jwhite@merck.com Name: Company: Phone: Email: Name: Company: Phone: Email: Webinar Presenter #2 (optional): n/a Webinar Moderator: Chris Brown Genentech, Inc. 555-555-5555 brownck@gene.com Program Objectives: (in bullet point format, outlining the topics to be dicussed) Predicting and Optimizing Physical Properties - Prediction of PhysChem properties - Optimization of properties at the design stage. SPR approaches - Correlation between physical attributes and ADME properties Absorption and Formulation Modeling - Simple absorption models and application for preclinical studies - Leveraging commercial software packages BCS and BDDCS Predictions - Predictions of solubility, permeability, and metabolism to forecast regulatory risks Abstract: (175 word minimum) The formulation of a drug can impact its route and frequency of administration, its ADME and safety profiles as well as its shelf-life. The preformulation development and characterization of the physicochemical properties of a drug candidate provide the basis for the selection of suitable preclinical or clinical formulations. Properties such as molecular weight, pKa, log D7, solubility and particle size can affect drug absorption and bioperformance. However, most of these properties are commonly experimentally measured to determine a formulation strategy, which requires a significant amount of time and resource investment. Accurate prediction of these properties would preclude the need for experimental assessment. Thorough understanding of the physicochemical properties can then accelerate formulation development, optimize bioperformance, and reduce timelines and risks associated with drug candidates development. In silico approaches have the promise for guiding and enabling rapid formulation selection at an early stage. This webinar will summarize efforts made around the prediction of physicochemical properties of molecules and modeling of the absorption and bioperformance of drug candidates, and will describe how this information can be used to reduce the risks present in drug development. Who will benefit most from this webinar? Industry scientists seeking to gain an understanding of the utility of current in silico modeling approaches and applications towards the characterization and formulation development of new drug candidates. Academic scientists with interests in translation of drug discovery and into preclinical development. Please check the gray boxes for all relevant sections, words, and terms applicable to the proposed webinar. The items you check will be used to index your event listing on the AAPS website. X X X X X Analysis and Pharmaceutical Quality Section Clinical Pharmacology and Translational Research Section Formulation Design and Development Section Physical Pharmacy and Biopharmaceutics Section Regulatory Sciences Section ADME Analytical Method Development Animal Welfare Bioequivalence Biopharmaceutics Biopharmaceutics Classification System Biotechnology Chromatography Clinical Trials Combination Products Compliance Trends Continuous Process Biotechnology Section X Drug Design and Discovery Section Manufacturing Science and Engineering Section Pharmacokinetics, Pharmacodynamics and Drug Metabolism Section X X Forced Degradation Formulation Formulation Design and Development Freezing and Drying Technologies Guidance on Drug Interactions Hot Melt Extrusion HPLC Human Cytochromes P450 ICH Q8- Q9- Q10 In Vitro Release and Dissolution Testing IND Inhalation and Nasal Technology X Delivery Discovery Drug Delivery Drug Disposition Drug Manufacturing Drug Transport Fluid Drying Excipients Fluid Drying Manufacturing Mass Spectrometry Modified Release Nanotechnology NDA Non-Clinical Dose Formulation Analysis PAT Pharmaceutical Manufacturing Please enter below any other terms NOT listed above that can be used as search terms. Please do NOT include terms or words used in any titles or description of your event. Enter Keywords: Preclinical modeling, simulation, computational tools, BCS, BDDCS Please review this proposal with your presenter(s). It will be the basis for the webinar brochure. Send your presenter and moderator the Webinar Guidelines Send your presenter the Speaker Release Form Email completed form to: Stacey May, Director of Public Relations, Outreach, and eLearning, and send a copy to: Meredith Weston, eLearning Program Manager WestonM@aaps.org EPDC-approved webinars are scheduled on a first-come, first-served basis.