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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.

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