Preliminary Program - American Association of Pharmaceutical ...

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2009 AAPS Annual Meeting and Exposition
AAPS Drug Design and Discovery (DDD) Programming
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Sunday, November 8, 2009
8:30 am – 4:00 pm
Learning the Drug Discovery and
Delivery Interface Process
Short Course #2
An additional fee is required to attend this short course
The main goal of this Short Course is to provide
scientists with an overview of the multidisciplinary
concepts that underpin the drug discovery and
delivery interface (D3I) for small molecules. This will
be accomplished using traditional teaching modules
followed by application of these concepts via group
participation in a game format. This short course will
be divided into two parts. In the morning, facilitators
will provide an introduction to the basic concepts
of hit identification, lead optimization, and clinical
development. This will be accomplished using
prepared course materials. This introduction will
be followed by a detailed overview of the structureactivity
relationships (SAR) that are necessary for a
new molecular entity to have pharmacologic activity
in a human disease state, and the structure-property
relationships (SPR) that are necessary to enable
delivery of the drug to patients. This session will be
concluded by a review of the expected attributes
of a successful clinical candidate. The afternoon
session will reinforce these concepts through group
participation in a D3I game. Participants will be
assigned to groups consisting of representatives
of the various disciplines responsible for drug
discovery and drug delivery (e.g., medicinal chemist,
biologist, ADME scientist, toxicologist, process
chemist, formulator, etc.). Each team will be given
identical product profiles, a timeline, and a budget;
there will be 2 to 3 rounds in the game. In each
round, the teams will be expected to work together
to create a plan within timeline and budget for
their molecule. Challenges in the game will come
from unexpected obstacles which often appear
when least expected in drug discovery. To this
end, the teams will receive a Gotcha Card and then
asked to adjust their plan in response to this new
information. At the end of the round, the teams will
present their proposal and explain how they arrived
at their solution. They will be given a score based on
their solutions and whether they were able to deliver
the plan within the allotted timeline, and budget.
The teams will also be asked to compare notes for
each Product Profile since it is likely that each team
will arrive at a different solution depending on the
experience level of the participants on the team. It
is also expected that the course facilitators will use
this game format to help the participants learn more
about the significant challenges and stark realities
of contemporary drug discovery.
Moderators
Jeffrey Silverman, Ph.D.
Consultant
Debra Luffer-Atlas, Ph.D.
Eli Lilly and Company
Monday, November 9, 2009
MONDAY AFTERNOON ROUNDTABLES
2:00 pm – 4:00 pm
Navigating the New Rules Regarding
Patent Law: Decodifying ‘Obviousness’,
‘Limited Claims’, and How it Affects New
Composition of Matter Patents
Roundtable
There have been continuous changes implemented
by the US PTO to streamline the patent filing and
approval process, and reduce patent prosecution
times. With it have come several changes to the
content of patents and continuation filings, which
significantly impact/limit patenting chemical,
pharmaceutical and biotech inventions. For
example, U.S. and international law denies
patentability to subject matter which is “obvious”
or which lacks an “inventive step”. However,
such rulings differ from country to country. This
roundtable will invite discussion from patent law
experts regarding these recent developments,
such as what counts as “obvious” in the context of
chemical, pharmaceutical, and biotechnological
inventions, limits on claims and continuation
applications.
Moderators
Michael Bornstein, Ph.D.
Bornstein Consulting, LLC
Jeffrey A. Lindeman, Ph.D.
O’Brien Jones PLLC
New Regulations in Patent Law for the Pharma
Industry
Scott Bornstein, J.D.
Greenberg Traurig, LLP
Presentation Title to Be Determined
Barry Schindler, J.D.
Greenberg Traurig, LLP
A Look at Post-KSR Cases: Is the Perceived
Change Really that Great?
Irem (Remy) Yucel, Ph.D.
U.S. Patent and Trademark Office
JOINT MEMBERSHIP MEETING AND
RECEPTION
5:30 pm – 7:00 pm
Drug Design and Discovery (DDD)
Section Joint Membership Meeting
and Reception
Tuesday, November 10, 2009
TUESDAY SUNRISE SESSIONS
7:00 am – 8:15 am
The Blood Brain Barrier
Sunrise Session
Pharmacokinetic assessment in early drug discovery
is now a commonly accepted approach to increase
the chances of identifying candidates with suitable
properties for further development. For CNS
therapeutics, there is the additional requirement
of blood brain barrier (BBB) penetration and brain
localization. Several tools, both old and new, are
being applied to guide drug design and medicinal
chemistry to increase brain penetration. This
sunrise session will contain presentations about
in silico prediction tools for BBB, discuss in vitro
models of the BBB, and present a case study of BBB
enhancements in drug discovery.
Moderator
Nurulain Zaveri, Ph.D.
Molecular Medicine Research Institute
Key Principles for Optimization of CNStargeted
Therapeutics
Stephen Hitchcock, Ph.D.
Amgen Inc.
Opioids, Pgp, and the Blood-Brain Barrier
Andrew Coop, Ph.D.
University of Maryland School of Pharmacy
Graduate Student Symposium
8:30 am – 11:00 am
AAPS Graduate Student Symposium
in Drug Design and Discovery (DDD)
Sponsored by