Preliminary Program - American Association of Pharmaceutical ...

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