Preliminary Program - American Association of Pharmaceutical ...

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58 2009 AAPS Annual Meeting and Exposition Manufacturing, Science and Engineering (MSE) Programming TUESDAY AFTERNOON ROUNDTABLES Funded by a Grant from 2:00 pm – 4:00 pm The Pros and Cons of Development Approaches to Poorly Soluble Compounds (In-House Development and Manufacture vs. Outsourcing) Roundtable An increasing number of poorly soluble new chemical entities exhibit poor water solubility. This makes them difficult to develop into traditional solid dosage forms. Liquid and solid dispersion formulations have been used as possible dosage form approaches to enhance bioavailability for these poorly soluble compounds. Even though a solid formulation may be more difficult to characterize, some pharmaceutical companies still prefer to pursue liquid dosage forms only as a last resort if it means outsourcing the work to a CRO/CMO. This roundtable will focus on the decision process used by different companies to select the dosage form or forms they will pursue, and reasoning why liquid or solid dispersion dosage forms may or may not be the preferred route. It will examine if misconceptions exist regarding the difficulty to manufacture these dosage forms as well as the concern by some pharma companies to outsource the work using a contract company, which is often required for non-solid formulations. The impact of the in-house vs. CRO/CMO decision on the quality of the product, development timeline, and cost will also be discussed. Moderators Yunxia (Vivian) Bi, Ph.D. AstraZeneca David Fulper, Ph.D. Patheon Inc. Getting Over the “NIH” (Not Invented Here) Syndrome: Why Outsourcing of Liquidsemisolid Dosage Forms for Poorly Soluble Compounds Makes Sense Jeff Browne, Ph.D. Catalent Pharma Solutions Early Development of Poorly Water-soluble NCEs: Potential Advantages of Keeping Development Activities in House Abu T.M. Serajuddin, Ph.D. St. John’s University Wednesday, November 11, 2009 WEDNESDAY MORNING SYMPOSIA Funded by a Grant from 8:30 am – 11:00 am What Can the Pharmaceutical Industry Learn About Process Development and Manufacturing from Other Businesses? Symposium What can the pharmaceutical industry learn about process development and manufacturing from other businesses? Many other businesses, have adopted systems for product development and monitoring and control of manufacturing which are far more sophisticated than those used in a typical solid oral manufacturing production facility. Are there lessons which the pharmaceutical industry can learn from the chemical industry, automobile or aero industries, or those making other industrial or consumer products in highly controlled manufacturing environments? This symposium will have four speakers. These will include a senior executive from Pharma who will outline the current status in this industry. Other speakers will include a representative from the chemical industry, and two additional speakers with a wide range of experience across a range of industries who have consulted for Pharma companies and advised U.S. Food and Drug Administration (FDA). These speakers will address what could be learned from other industries focusing on issues such as knowledge management, and the use of lean, 6 sigma and parametric release in the pharmaceutical industry in comparison to others. Moderator Paul Sheskey, Ph.D. The Dow Chemical Company Current Pharma Industry Perspectives Parimal Desai, Ph.D. Wyeth Pharmaceuticals Quality by Design – Comparison with Other Industries Prabit Basu, Ph.D. Purdue University Chemical Industry Perspectives Clark Cummings, Ph.D. The Dow Chemical Company Leveraging the Knowledge Life Cycle to Better Enable Drug Development Michael Bregger Tunnell Consulting Thursday, November 12, 2009 THURSDAY MINI-SYMPOSIA 9:00 am – 11:00 am Role of Models in Design Space Mini-symposium A key element of the Quality by Design (QbD) paradigm of drug development is a delineation of design space for material and process parameters. Mathematical models can serve as a powerful tool in this approach. They can be used at every stage of design space development including but not limited to risk analysis to determine parameters that define a design space, gain process understanding and to optimize a process, propose a design space, and scale up/down a design space. In addition, learning from models could be leveraged to gain an understanding of impact of movements within/ outside the proposed design space, with minimal experimentation. The objective of this symposium is to illustrate the contribution of models in all phases of drug development following the QbD approach. Moderators Sharmista Chatterjee, Ph.D. U.S. Food and Drug Administration Cynthia Oksanen, Ph.D. Pfizer, Inc. Risk Analysis Using Drug Product Design Space Models Craig Dunbar, Ph.D. Vertex Pharmaceuticals Use of Mechanistic Models to Develop Design Spaces for Drug Substance Production Peter Clark, Ph.D. DynoChem, Inc. Using Modeling to Establish Clinical Relevance in Design Space Kazuko Sagawa, Ph.D. Pfizer Global Research & Development
59 2009 AAPS Annual Meeting and Exposition Physical Pharmacy and Biopharmaceutics (PPB) Programming at a glance Sunday Monday Tuesday Wednesday Thursday 8:00 am – 4:00 pm Short Course #6 Rational Design and Development of Solid Dispersions with Amorphous Drug for Improving Oral Bioavailability An additional fee is required to attend this short course 8:00 am – 10:00 am Monday Morning Roundtables Funded by a Grant from Roundtable Optimization of Systemic Exposure in Preclinical and Clinical Development: “Success Stories” of Proven Methods for Challenging Drug Candidates — What You Did Not Already Know! 7:00 am – 8:15 am Sunrise Session Solve your Problems in a Smarter Way: Use Design of Experiments 8:30 am – 11:00 am Symposium Application of Nanoparticulate Technology in the Development of Oral Dosage Forms: Impact on Drug Product Performance AAPS Graduate Student Symposium in Physical Pharmacy and Biopharmaceutics (PPB) Sponsored by During this Symposium, a presentation from the Research Achievement Award winner will be given. AAPS David Grant Research Achievement Award in Physical Pharmacy Sponsored by 8:30 am – 11:00 am Wednesday Morning Symposia Funded by a Grant from Symposium Extrapolation Preclinical Data to Predict Human Pharmacokinetics: Understanding and Practice 8:30 am – 11:00 am Symposium Excipient Variability: Why Some Lots Pass and Others Fail 9:00 am – 11:00 am Roundtable Predicting Oral Drug Absorption: Fiction and Facts 2:00 pm – 4:00 pm Tuesday Afternoon Roundtables Funded by a Grant from Roundtable Characterization of Amorphous Pharmaceutical Solids and Solid Dispersions 2:00 pm – 4:00 pm Roundtables Salts, Co-crystals, Polymorphs/Solvates, Nanoparticles, or Amorphous: How to Pick the Winner Tumor Targeting Using Nanotechnologybased Drug Delivery Systems 2:00 pm – 4:30 pm wednesday afternoon symposia funded by a grant from Symposium Microdialysis Role in the Development and Optimization of Drug Topical Delivery 5:30 pm – 7:30 pm Physical Pharmacy and Biopharmaceutics (PPB) Section Joint Membership Meeting and Reception
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