September 21, 2011
Somerset, NJ


   Stuart C. Porter, PhD, Sr Director, Global Pharmaceutical R&D, Ashland Specialty Ingredients   Stu_Porter_Ashland_Bio.doc       Stu_Porter_EPTM_Presentation_Sept_2011_.pdf

Dr. Jianxin Li: Oral Controlled Release Formulations: Design Considerations  Jian-Xin_Li_Bio.doc


Michael Lowinger (Merck): Scaling the Challenges of a Melt Extrusion Process  Lowinger_Bio_and_Abstract.doc


Dr. Abu Serajuddin (St. Johns): Formulation Development Strategies for Lipid-based Oral Drug Delivery of Poorly Water-soluble Drugs  Serajuddin_Bio_and_Abstract.doc


Dr. Kwok Chow (Patheon): Process development using QbD: A CMO perspective


Dr. Jim Jiao (Pfizer):  Parenteral Formulation 


Dr. Lawrence X. Yu (FDA):  Scientific Bases of Generic Drug Review and Approval   Yu_Bio.doc


The ultimate goal for formulation development is robust, high quality commercial production.
During the late phase development, drug product based on formulation and corresponding
manufacturing process should meet requirements from regulatory and clinical need. Furthermore, the
end drug product should take into consideration convenience and commercial production. These all
pose challenges to formulation scientists. Successful formulation reduces the risk of manufacture with
built in product quality. Understanding of the manufacturing process is paramount to a formulation
proposal. A high quality formulation dictates the manufacturing process. It is poor practice to choose
your process then formulate accordingly. To meet the increasing need for formulation scientists to
understand the benefits of each production manufacturing process and the excipients used to achieve
optimum performance, this conference is organized to cover major pharmaceutical manufacturing
techniques such as dry blend, roller compaction, wet granulation, hot melt extrusion, liquid formulation
and etc. Successful formulation development streamlines the transformation from formulation to
production, setting guidelines for early stage formulation development.
The ultimate goal for formulation development is robust, high quality commercial production.
During the late phase development, drug product based on formulation and corresponding
manufacturing process should meet requirements from regulatory and clinical need. Furthermore, the
end drug product should take into consideration convenience and commercial production. These all
pose challenges to formulation scientists. Successful formulation reduces the risk of manufacture with
built in product quality. Understanding of the manufacturing process is paramount to a formulation
proposal. A high quality formulation dictates the manufacturing process. It is poor practice to choose
your process then formulate accordingly. To meet the increasing need for formulation scientists to
understand the benefits of each production manufacturing process and the excipients used to achieve
optimum performance, this conference is organized to cover major pharmaceutical manufacturing
techniques such as dry blend, roller compaction, wet granulation, hot melt extrusion, liquid formulation
and etc. Successful formulation development streamlines the transformation from formulation to
production, setting guidelines for early stage formulation development.