Preliminary Program - American Association of Pharmaceutical ...
Preliminary Program - American Association of Pharmaceutical ...
Preliminary Program - American Association of Pharmaceutical ...
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65<br />
2009 AAPS Annual Meeting and Exposition<br />
AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) <strong>Program</strong>ming<br />
New INTERACTIVE FEATURE for all Roundtable Sessions!<br />
Click on roundtable moderator names to submit questions that you would like to be addressed at the roundtable session in Los Angeles.<br />
Sunday, November 8, 2009<br />
Sunday, November 8, 2009<br />
8:30 am - 4:00 pm<br />
RNA-targeting Therapeutics: Issues and<br />
Advances<br />
Short Course #1<br />
An additional fee is required to attend this short course.<br />
The use <strong>of</strong> oligonucleotides as therapeutic<br />
agents has elicited a great deal <strong>of</strong> interest. Basic<br />
understanding <strong>of</strong> the pharmacokinetics and<br />
delivery <strong>of</strong> antisense oligonucleotides and siRNA<br />
as tools for silencing genes or regulatory RNAs<br />
is foundational to their appropriate design and<br />
application. The short course will consist <strong>of</strong> the<br />
following lecture topics: basic knowledge <strong>of</strong> siRNA<br />
and antisense and in vivo uptake mechanisms/<br />
pathways <strong>of</strong> oligonucleotide uptake into cells,<br />
overview <strong>of</strong> RNA-targeting therapeutics-basic<br />
primer, siRNA promise and challenges <strong>of</strong> RISC based<br />
targeting <strong>of</strong> mRNA, specific in vivo targeting <strong>of</strong> siRNA<br />
advances and challenges, antisense advances and<br />
challenges <strong>of</strong> single-strand, pharmacokinetics and<br />
ADME characterization <strong>of</strong> siRNA in animal models,<br />
pharmacokinetics and ADME characterizations <strong>of</strong><br />
siRNA in humans, MicroRNA, a new target for RNAtargeting<br />
therapeutics, and regulatory pathways for<br />
oligonucleotide therapeutics.<br />
Moderators<br />
Pei Fan (Jane) Bai, Ph.D.<br />
U.S. Food and Drug Administration<br />
Richard Geary, Ph.D.<br />
ISIS <strong>Pharmaceutical</strong>s, Inc.<br />
Antisenseantisense: Advances and Challenges<br />
<strong>of</strong> Single-strand Antisense<br />
Richard Geary, Ph.D.<br />
ISIS <strong>Pharmaceutical</strong>s, Inc.<br />
Uptake Mechanisms <strong>of</strong> Oligoneucleotides<br />
Frank Bennett, Ph.D.<br />
ISIS <strong>Pharmaceutical</strong>s, Inc.<br />
Therapeutic Development <strong>of</strong> MicroRNA:<br />
Promises and Challenges<br />
Peter Linsley, Ph.D.<br />
Merck and Co., Inc.<br />
Progress in the Delivery <strong>of</strong> siRNA<br />
Mark Tracy, Ph.D.<br />
Alnylam <strong>Pharmaceutical</strong>s<br />
Oligonucleotide Therapeutics: Regulatory<br />
Pathway<br />
Pei Fan (Jane) Bai, Ph.D., invited<br />
U.S. Food and Drug Administration<br />
Clinical Pharmacokinetic and Safety Studies<br />
<strong>of</strong> RNAi in Humans<br />
John DeVincenzo, Ph.D.<br />
University <strong>of</strong> Tennessee Health Science Center<br />
8:30 am – 4:00 pm<br />
Transporter-mediated Drug-drug<br />
Interactions: Possible Criteria that<br />
Warrant In Vivo Transporter-mediated<br />
DDI Studies via In Vitro Assessments<br />
Short Course #5<br />
An additional fee is required to attend this short course<br />
It is widely recognized that membrane transporters<br />
play an important role in modulating drug<br />
absorption, distribution, and elimination.<br />
Superfluity <strong>of</strong> publications in the recent years<br />
advances the understanding <strong>of</strong> these processes,<br />
and enables the interpretation <strong>of</strong> underlying<br />
mechanisms responsible for the modification<br />
<strong>of</strong> pharmacokinetic and pharmacodynamics.<br />
Furthermore, an increased interest has been shown<br />
by both regulatory agencies and pharmaceutical<br />
industry to understand the potential clinical<br />
implications <strong>of</strong> transporter-mediated drug-drug<br />
interactions for new drugs. For pharmaceutical<br />
scientists, the challenge ahead will be the<br />
successful translation <strong>of</strong> this basic awareness <strong>of</strong><br />
drug transporters to applications in drug discovery<br />
and development. This short course will introduce<br />
the basic concepts <strong>of</strong> drug transport, the role <strong>of</strong><br />
transporters in drug-drug interactions (DDI), the role<br />
<strong>of</strong> transporters in toxicity, models for characterizing<br />
drug transporters, and give examples <strong>of</strong> translation<br />
<strong>of</strong> preclinical knowledge into the clinical setting.<br />
Moderators<br />
Yurong Lai, Ph.D.<br />
Pfizer, Inc.<br />
Joseph Polli, Ph.D.<br />
GlaxoSmithKline plc<br />
Overview <strong>of</strong> Efflux Transporters Mediated<br />
Drug-drug Interaction<br />
Douglas H. Sweet, Ph.D.<br />
Virginia Commonwealth University<br />
Overview <strong>of</strong> Uptake Transporters Mediated<br />
Drug-drug Interaction<br />
Richard Kim, Ph.D.<br />
University <strong>of</strong> Western Ontario<br />
In Vitro Drug Transport Drug Interaction<br />
Studies-Design, Data Analysis, and<br />
Recommendation for Clinical Studies<br />
Shiew Mei Huang, Ph.D., invited<br />
U.S. Food and Drug Administration<br />
Possible Criteria that Warrant In Vivo Renal<br />
Transporters Mediated DDI Studies and<br />
In Vitro Assessments<br />
Kathy Giacomini, Ph.D.<br />
University <strong>of</strong> California, San Fransisco<br />
Possible Criteria that Warrant In Vivo Hepatic<br />
Transporters Mediated DDI Studies and In<br />
Vitro Assessments<br />
Yurong Lai, Ph.D.<br />
Pfizer, Inc.<br />
Possible Criteria that Warrant In Vivo<br />
Gastrointestinal Efflux Transporters-mediated<br />
DDI Studies and In Vitro Assessments<br />
Joseph Polli, Ph.D.<br />
GlaxoSmithKline plc<br />
Monday, November 9, 2009<br />
MONDAY MORNING ROUNDTABLES<br />
Funded by a Grant from<br />
8:00 am – 10:00 am<br />
Biotherapeutics and Modulation <strong>of</strong> Drug<br />
Transporters<br />
Roundtable<br />
Therapeutic proteins (cytokines, interleukins,<br />
and monoclonal antibodies) are becoming widely<br />
popular for many therapeutic area and diseases.<br />
However, the interaction <strong>of</strong> drug transporters/<br />
enzymes and biotherapeutics remains largely<br />
unknown. It has been shown that interferons can<br />
have an impact on drug transporters that may alter<br />
the pharmacokinetics and pharmacodynamics <strong>of</strong> a<br />
conventional drug. For example, interferon-alpha<br />
induces a significant dose-dependent inhibitory<br />
effect on P-gp intestinal activity and results in<br />
increased bioavailability <strong>of</strong> digoxin. The findings<br />
could have important clinical relevance because<br />
interferon-alpha is widely used in cancer, antiviral<br />
therapy, and could be associated with efflux<br />
transporter substrates, such as anticancer drugs.<br />
The goal <strong>of</strong> this session is to increase awareness<br />
among the audience about this rapidly emerging<br />
area, and to share case studies that highlight the<br />
interplay between these systems.