Drug Met Symposium & Vendor Show

Date:   October 17, 2013
Venue: The Palace at Somerset Park, 333 Davidson Avenue, Somerset, NJ.

Mark your Calendar!
Details to appear!

“Models, Pharmacogenomics, Pharmacokinetics”

Venue: Hotel Somerset Bridgewater (formerly Crowne Plaza, formerly Somerset Plaza), 110 Davidson Avenue, Somerset, NJ 08873. [ directions ]

Exhibitor Info

Please contact Karen Dingley at karen_dingley@merck.com for information concerning exhibits.

Program   [ program book ]

08:00 am — Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks
Dr. Allen Jones, Chair, NJDMDG

09:10 am
“Novel Hepatic Model Systems for Investigating Mechanisms of Drug-Induced
Liver Injury (DIU)”
Edward L. LeCluyse, Ph.D. , Associate Investigator Institute for Chemical Safety Sciences The Hamner Institutes for Health Sciences, Research Triangle Park, NC

10:00 am
“Pharmacogenomics in American Indian Populations”
Erica L. Woodahl, Ph.D. , Associate Professor Department of Biomedical and Pharmaceutical Sciences University of Montana, MT   [ slides ]

10:45 am — Vendor Exhibit & Coffee Break

11:30 am
“Pharmacokinetics of Proteins and Peptides”
Joseph P. Balthasar, Ph.D. , Professor of Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY

12:15 pm — Lunch & Vendor Exhibit

1:45 pm
“Glucuronidation, sulfation, and pharmacokinetics of conjugated metabolite”
Swati Nagar, Ph.D. , Associate Professor, Temple University School of Pharmacy, Philadelphia, PA   [ slides ]

2:30 pm — Vendor Exhibit & Coffee Break

3:00 pm
“A panel of translational xenoreceptor, cytochrome P450, transporter and transplanted liver humanized mouse models for improved prediction of drug responses in Man”
Nico Scheer, Ph.D., Head of the tADMET^TM portfolio, Taconic Farms, Inc., Cranbury, NJ [ slides ]

3:45 pm — Program Closure

Directions to the Hotel Somerset Bridgewater

Hotel Somerset Bridgewater was formerly Crowne Plaza, formerly Somerset Plaza
110 Davidson Avenue, Somerset, NJ 08873
Phone: 732-560-0500

• From the New Jersey Turnpike:
  Exit 10 to Interstate 287 North. Follow 10 miles to Exit 10 (527 New Brunswick-South Bound Brook). Easton Ave towards South Bound Brook to first light, make left (Davidson Ave.)
• From New York City:
  Lincoln Tunnel to N.J. Turnpike South. Follow N.J. Turnpike directions mentioned above.
• From Route 287:
  • If traveling north: Exit 10 (527 New Brunswick-South Bound Brook). Follow sign towards Bound Brook, to light make left (Davidson Ave.)
  • If traveling south: Exit 10 (527 New Brunswick). Left on Easton Ave., to light, make left (Davidson Ave).
• From the Newark Airport
  Take NJ Turnpike South to Exit 10- I-287 North to Exit 10 (Easton Ave) to first light, go left on Davidson Ave. Hotel immediately on left.

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks
Dr. Allen Jones, Chair, NJDMDG

09:10 am
“Investigating Chemotherapeutic Drug Disposition and Toxicity using Transporter Knockout and Humanized Mice”
Dr. Lauren Aleksunes, Assistant Professor
Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ

10:00 am
“Evolving Trends in Complex Culture Systems and Their Utility in Drug Development: Focus on hepatotoxicity”
Mr. Albert Reising, Lab Head- Models of Organ Toxicity
Novartis Pharmaceuticals, East Hanover, NJ

10:45 am
Vendor Exhibit & Coffee Break

11:30 am
“Identifying and Eliminating Biotransformation Liabilities Early in Drug Discovery”
Dr. Kaushik Mitra, Department of Pharmacodynamics, Pharmacokinetics and Drug Metabolism
Merck, Rahway, NJ

12:15 pm
Lunch & Vendor Exhibit

01:45 pm
“Induction of Mouse Carboxylesterase Expression and Function following Developmental Pesticide Exposure: Role of the Constitutive Androstane Receptor the role of environment and development in regulating metabolism”
Dr. Jason Richardson, Assistant Professor
Department of Environmental and Occupational Medicine, Robert Wood Johnson Medical School, and Resident Member Environmental and Occupational Health Sciences Institute, Piscataway, NJ

02:30 pm
Vendor Exhibit & Coffee Break

03:00 pm
“UGT phenotyping, clearance predictions and DDI assessment”
Dr. Theunis Goosen, Associate Research Fellow
Pfizer

03:45 pm
Program Closure

Directions to the Hotel Somerset Bridgewater

Hotel Somerset Bridgewater was formerly Crowne Plaza, formerly Somerset Plaza
110 Davidson Avenue, Somerset, NJ 08873
Phone: 732-560-0500

• From the New Jersey Turnpike:
  Exit 10 to Interstate 287 North. Follow 10 miles to Exit 10 (527 New Brunswick-South Bound Brook). Easton Ave towards South Bound Brook to first light, make left (Davidson Ave.)
• From New York City:
  Lincoln Tunnel to N.J. Turnpike South. Follow N.J. Turnpike directions mentioned above.
• From Route 287:
  • If traveling north: Exit 10 (527 New Brunswick-South Bound Brook). Follow sign towards Bound Brook, to light make left (Davidson Ave.)
  • If traveling south: Exit 10 (527 New Brunswick). Left on Easton Ave., to light, make left (Davidson Ave).
• From the Newark Airport
  Take NJ Turnpike South to Exit 10- I-287 North to Exit 10 (Easton Ave) to first light, go left on Davidson Ave. Hotel immediately on left.

“Current Topics in DMPK and the New DDI Draft Guidance”

Crowne Plaza Somerset-Bridgewater Hotel
110 Davidson Avenue
Somerset, New Jersey

April 26, 2012
8:00 am – 3:45 pm

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks
Dr. Lian Zhou, Chair, NJDMDG

09:10 am
Drug Metabolism in Chimeric Mice with Humanized Liver [slides (PDF)]
Professor Hiroshi Yamazaki, Showa Pharmaceutical University, Machida, Tokyo

10:00 am
ADME in NAFLD: Genes and Big Jeans Increase the Risk of Adverse Drug Reactions [slides (PDF)]
Professor Nathan Cherrington, Pharmacology & Toxicology, University of Arizona, Tucson, AZ.

10:45 am
Vendor Exhibit & Coffee Break

11:30 am
Clarity on Transporters: Navigating the New FDA Draft Guidance on Drug Interactions [slides (PDF)]
Dr. Sid Bhoopathy, Chief Operating Officer, Absorption Systems, Exton, PA.

12:15 pm
Lunch & Vendor Exhibit

01:45 pm
The 2012 FDA Draft Guidance on Drug-drug Interactions: Enzyme Induction and Beyond [slides (PDF)]
Dr. Michael Sinz, Research Fellow, Metabolism and Pharmacokinetics, Bristol-Myers Squibb

02:30 pm
Vendor Exhibit & Coffee Break

03:00 pm
Update on the Progress of the IQc/FDA/Academia Collaboration on DDI Prediction and Thoughts on the DDI Draft Guidance
Dr. Scott Obach, Senior Research Fellow, Pharmacokinetics, Dynamics, and Drug Metabolism Department, Pfizer

03:45 pm
Program Closure

“Emerging Areas in DMPK: From CYPs and Transporters to Drug Interactions”

Somerset Crowne Plaza Hotel
110 Davidson Avenue
Somerset, New Jersey

October 6, 2011
8:00 am – 3:45 pm

Program:

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks
Dr. Lian Zhou, Chair, NJDMDG

09:10 am
New Insights on the Interplay of Intestinal CYP3A and P-gp in Influencing Intestinal Absorption of Dual Substrates
Dr. Dhiren Thakker, Ferguson Distinguished Professor and Associate Dean, Pharmacotherapy and Experimental Therapeutics, School of Pharmacy, University of North Carolina, Chapel Hill, NC

10:00 am
Active Intestinal Drug Uptake: The Double-Edged Sword Transporters [slides (PDF)]
Dr. Imad Hanna, Senior Fellow, Drug Metabolism and Pharmacokinetics, Novartis, East Hanover, NJ

10:45 am
Vendor Exhibit & Coffee Break

11:30 am
Pro-drug strategies to leverage transporters [slides (PDF)]
Dr. James Polli, Professor of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD

12:15 pm
Lunch & Vendor Exhibit

01:45 pm
ADME of Biologics – What Have We Learned from Small Molecules?
Dr. Thomayant Prueksaritanont, Sr. Scientific Director, Preclinical Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck, West Point, PA Malvern, PA

02:30 pm
Vendor Exhibit & Coffee Break

03:00 pm
Assessing modeling and simulation tools and methods for predicting drug interactions caused by induction (FDA/Industry/Academia Induction Group Work Product) [slides (PDF)]
Dr. Scott Obach, Senior Research Fellow, Pfizer Groton, CT

03:45 pm
Program Closure

“Current Scientific Concepts and Practices in DMPK: Drug Transporters, DDI, Formulation Strategies, and Clinical Pharmacology”

Somerset Crowne Plaza Hotel
110 Davidson Avenue
Somerset, New Jersey

April 13, 2011
8:00 am – 3:45 pm

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks [slides (PDF)]
Dr. Imad Hanna, Chair, NJDMDG

09:10 am
Structure and Function of Human “Multidrug And Toxin Extruders” (MATEs) [slides (PDF)]
Dr. Stephen Wright, Professor of Physiology, Biochemistry and Molecular Biophysics, Department of Physiology, University of Arizona, Tucson, AZ.

10:00 am
Factors Influencing Drug Delivery to the Brain: Multiple Mechanisms at Multiple Barriers [slides (PDF)]
Dr. William F. Elmquist, Professor and Department Head Department of Pharmaceutics, University of Minnesota, Minneapolis MN.

10:45 am
Vendor Exhibit & Coffee Break

11:30 am
Irreversible Inhibition of CYP2C19 by Some but not all Proton Pump Inhibitors and its Relevance to the Anti-Platelet Effect of Clopidogrel (Plavix) [slides (PDF)]
Dr. Andrew Parkinson, Chief Scientific Officer, XenoTech LLC, Lenexa, KS.

12:15 pm
Lunch & Vendor Exhibit

01:45 pm
Formulation-Dependent PK/PD and Human Dose Projections Using In silico, In vitro and In vivo Data
Dr. Tycho Heimbach, Senior Investigator, Drug Metabolism and Pharmacokinetics, Novartis Institute for BioMedical Research, East Hanover, NJ

02:30 pm
Vendor Exhibit & Coffee Break

03:00 pm
Developing the Clinical Pharmacology Section of a U.S. Package Insert [slides (PDF)]
Dr. Philip Mayer, Assistant Vice President of Clinical Pharmacology, Pfizer Global Research and Development, Collegeville, PA.

03:45 pm
Program Closure

“Drug Metabolism/Transport Interplay: Regulatory, Therapeutic and Toxicological Implications”

Somerset Crowne Plaza Hotel
110 Davidson Avenue
Somerset, New Jersey

October 13, 2010
8:00 am – 3:45 pm

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks
Dr. Imad Hanna, Chair, NJDMDG [slides (PDF)]

09:10 am
Regulation of Renal Drug Transport under Physiological and Pathological Conditions [slides (PDF)]
Dr. Rosalinde Masereeuw, Associate Professor, Department of Pharmacology and Toxicology, Radboud University Nijmegen Medical Centre, The Netherlands

10:00 am
Pharmacokinetic Determinants of Statin-Induced Myopathy [slides (PDF)]
Dr. Rommel G. Tirona, Assistant Professor, Department of Physiology and Pharmacology, The University of Western Ontario, London, Ontario

10:45 am
Vendor Exhibit & Coffee Break

11:30 am
Membrane Transporters in Drug Development [slides (PDF)]
Dr. Raymond Evers, Director, Transporters and In Vitro Technologies, Drug Metabolism and Pharmacokinetics, Merck and Co. Rahway, NJ.

12:15 pm
Lunch & Vendor Exhibit

01:45 pm
Regulatory Interplay between Vitamin D and CYP3A4 in the Small Intestine
Dr. Kenneth E. Thummel, Professor and Chair, Department of Pharmaceutics, University of Washington, Seattle, WA.

02:30 pm
Vendor Exhibit & Coffee Break

03:00 pm
Inter-Individual Variability in Human Drug Glucuronidation: What We Know and What We Need to Know [slides (PDF)]
Dr. Michael H. Court, Associate Professor, Department of Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Boston, MA.

03:45 pm
Program Closure

“Transporters, Discovery Metabolism, and Heavy Drugs”

Somerset Crowne Plaza Hotel
110 Davidson Avenue
Somerset, New Jersey

April 22, 2010
8:00 am – 3:30 pm

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

09:00 am
Introductory Remarks
Dr. Philip Krieter, Chair, NJDMDG

09:10 am
Monocarboxylate Transporters in Drug Disposition: Role in the Toxicokinetics and Toxicodynamics of the Drug of Abuse GHB [slides (PDF)]
Dr. Marilyn E. Morris, Professor, Department of Pharmaceutical Sciences, University at Buffalo, State University of New York

10:00 am
Disposition and Elimination of Organic Anions and Cations: Transporters and Decision Trees [slides (PDF)]
Dr. Douglas H. Sweet, Associate Professor, Department of Pharmaceutics, Virginia Commonwealth University

10:45 am
Vendor Exhibit & Coffee Break

11:15 am
Transporter Polymorphisms [slides (PDF)]
Dr. Kathleen Hillgren, Research Advisor, Lilly Research

12:00 pm
Lunch & Vendor Exhibit

01:30 pm
What is Down the Road for Drug Metabolism Support of Drug Metabolism? [slides (PDF)]
Dr. Ronald E. White, Distinguished Research Fellow, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb

02:15 pm
Vendor Exhibit & Coffee Break

02:45 pm
Deuterated Drugs: Opportunities and Limitations [slides (PDF)]
Dr. Aarti Sawant, Senior Scientist, PDM-CNS Discovery, Pfizer, Inc.

03:45 pm
Program Closure

“Transporters, Current Industry Practices, and Biologics”

Somerset Crowne Plaza Hotel
110 Davidson Avenue
Somerset, New Jersey

October 14, 2009
8:00 am – 3:30 pm

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

08:50 am
Introductory Remarks
Dr. Philip Krieter, Chair, NJ-DMDG

09:00 am
The Challenges of Designing Cyclic Prodrugs of Opioid Peptides that Permeate the Intestinal Mucosa and the Blood-Brain Barrier [slides (PDF)]
Dr. Ron Borchardt, Solon E. Summerfield Distinguished Professor, Department of Pharmaceutical Chemistry, School of Pharmacy, University of Kansas

09:50 am
In Vitro and In Vivo Induction of Cytochrome P450: A Survey of the Current Practices and Recommendations: A Pharmaceutical Research and Manufacturers of American Perspective [slides (PDF)]
Dr. Gondi Kumar, Senior Director, Department of Drug Metabolism and Pharmacokinetics, Celgene Corporation

10:45 am
Vendor Exhibit & Coffee Break

11:15 am
Inactivation Studies for Predicting Drug-Drug Interactions. Pharmaceutical Industry Recommendations and Recent Observations [slides (PDF)]
Dr. R. Scott Obach, Senior Research Fellow, Biotransformation Group, Pharmacokinetics, Dynamics and Drug Metabolism Department, Pfizer, Inc.

12:00 Nn
Lunch & Vendor Exhibit

01:30 pm
Pharmacokinetic Based Drug-Drug Interactions of Biologicals. Science and Development Strategies [slides (PDF)]
Dr. Frank-Peter Theil, Associate Director, Genentech, Inc.

02:15 pm
Vendor Exhibit & Coffee Break

02:45 pm
PK/PD Study Strategies for Biopharmaceuticals: Is Bigger Better? [slides (PDF)]
Dr. Sharon A. Baughman, Biotechnology Consulting

03:30 pm
Program Closure

“Current Topics in Drug Metabolism and Pharmacokinetics: Biologics and Transporters – What’s New?”

Crowne Plaza Hotel
110 Davidson Avenue
Somerset, New Jersey

April 29, 2009
8:45 am – 3:30 pm

Program

08:00 am
Registration / Continental Breakfast / Vendor Exhibit

08:50 am
Introductory Remarks
Dr. Robert M. Iannucci, Chair, NJDMDG, Johnson & Johnson, Raritan, NJ

09:00 am
Imaging Techniques and Pharmacokinetic Modeling/Simulation: Useful Quantitative Tools for the Drug Transport Scientist [slides (PDF)]
Dr. Kim Brouwer, Professor and Chair of the Division of Pharmacotherapy and Experimental Therapeutics
School of Pharmacy, and Professor, Curriculum in Toxicology, University of North Carolina

09:50 am
Regulation of Organic Anion Transporters and the Clinical Implication [slides (PDF)]
Dr. Guofeng You, Professor in the Department of Pharmaceutics, the Ernest Mario School of Pharmacy, Rutgers University

10:45 am
Vendor Exhibit & Coffee Break

11:15 am
Mechanism-Based Pharmacokinetic-Pharmacodynamic Modeling of Biologics
Dr. Donald E. Mager, Professor, Pharmaceutical Sciences, University at Buffalo, State University of New York

12:00 Noon
Lunch & Vendor Exhibit

01:30 pm
Role of Transporters in Drug Exposure During Lactation [slides (PDF)]
Dr. Patrick McNamara, Professor and Chair of the Department of Pharmaceutical Sciences, School of Pharmacy, University of Kentucky

02:15 pm
Vendor Exhibit & Coffee Break

02:45 pm
Regulatory and Scientific Issues that Impact Development of Biotherapeutics [slides (PDF)]
Dr. Peter Thomas, Senior Program Manager, Early Development, Covance Laboratories, Inc, Madison, WI

03:30 pm
Program Closure