DDI-2017

20th Anniversary of the International Conference on Drug-Drug Interactions:

Pioneer Symposium: Key Scientific Concepts and technical Approaches; Regulatory Perspectives and Clinical Practice; Extended Clearance Concept on Drug Interactions; Drug Metabolites as Contributors to Drug Interactions; Drug-transporter Interactions; Enzyme Induction and Nuclear Receptors; Novel Approaches in Drug Interactions; Biologics-Drug Interactions

June 19 – 21, 2017

Husky Union Building, University of Washington; Seattle, WA, USA

4001 NE Stevens Way, Seattle, WA 98195

(206) 543-8131

 

REGISTRATION DISCOUNT UNTIL MAY 19, 2017

 

Featuring the Following Experts:  Ken Thummel; Leslie Benet; Kim Brouwer; Brian Houston; Yuichi Sugiyama; Larry Wienkers; Albert Li; Isabelle Ragueneau-Majlessi; Phil Hansten; John Horn; Lei Zhang; Jashvant Unadkat; Ayman El-Kattan; Mathena Varma; Ken Grime; Niresh Hariparsad; Jan Wahlstrom; Nina Isoherranen; Bo Feng; Kenneth Brouwer; Robert Foti; Yurong Lai; Jane Kenny; Julia Cui; Li Di; Theunis Goosen; Jailin Mao; Yuan Chen; Elimika Fletcher; Pratap Singh; Stephen Wang.

 

DDI-2017 is a yearly event providing a comprehensive update on the status of the science of drug-drug interactions and its relevance to drug development. The conference will include a review on the current status of DDI potential of biologics, industrial perspectives and other relevant topics.

 

Organizing Chairs:

Albert P. Li, APSciences/In Vitro ADMET Laboratories, Inc.

Isabelle Ragueneau-Majlessi, University of Washington

Jashvant Unadkat, University of Washington

Kenneth Brouwer, Qualyst Transporter Solutions, LLC

Jane Kenny, Genentech

Theunis Goosen, Pfizer, Inc.

Jan Wahlstrom, Amgen Inc.

Stephen Wang, Pfizer, Inc.


MONDAY, JUNE 19, 2017

DDI-2017 – DAY 1

 7:00 AM – 8:00 AM – REGISTRATION

 Welcome Remarks: Albert P. Li, APSciences/IVAL

 Opening Remarks (Ken Thummel, University of Washington; Seattle, WA)

 

Session 1: Pioneer Symposium: Key Scientific Concepts and Technical Approaches (Chair: Albert P. Li)

 

Biopharmaceutics Drug Disposition Classification System (BDDCS) and Drug-Drug Interactions (Leslie Z. Benet, University of California San Francisco; San Francisco, CA)

 

Hepatic Efflux Transporters: Relevance to Drug-Drug Interactions and Drug Toxicity (Kim Brouwer, The University of North Carolina at Chapel Hill; Chapel Hill, NC)

 

Assessment of Transporter-mediated Drug-drug Interactions: Implications of Unresolved Issues. (J Brian Houston, University of Manchester; Manchester, UK)

 

Can the Prediction of Complex Transporter (uptake, efflux)/Enzyme-mediated Drug-drug Interactions be Possible Using a Proposed Physiologically-based Pharmacokinetic (PBPK) Model with In Vitro Ki Values ? (Yuichi Sugiyama, Sugiyama Laboratory, RIKEN Innovation Center, RIKEN, Research Cluster for Innovation, RIKEN; Yokohama, Japan)

 

Mechanism-based P450 inhibition:  Scientific Concepts and Relevance to Drug Development (Larry Wienkers, Amgen Inc.; Thousand Oaks, CA)

 

Physiologically relevant in vitro experimental systems for DDI evaluation:  novel approaches with human hepatocytes and enterocytes (Albert P. Li, In Vitro ADMET Laboratories, Inc.; Columbia, MD)

 

Session 2:  Regulatory perspectives and clinical practice (Chair: Isabelle Ragueneau-Majlessi)

 

20 years of progress in drug-drug interaction evaluation: overview of the Literature and NDA reviews (Isabelle Ragueneau-Majlessi, University of Washington; Seattle, WA)

 

Recommendations for Patient-Specific Drug Interaction Decision Support (Phil Hansten, University of Washington, Seattle, WA)

 

Application of Evidence Based, Patient Specific Drug Interaction Screening (John Horn; University of Washington; Seattle, WA)

 

Comparing Various In Vitro Prediction Criteria to Assess the Potential of a New Molecular Entity to Inhibit Organic Anion Transporting Polypeptide 1B1. (Lei Zhang, (invited) Silver Spring, MD)

 

Cryopreserved Human Enterocytes for the Evaluation of Drug-drug and Food-drug Interactions (Albert P. Li; In Vitro ADMET Laboratories, Inc.; Columbia, MD)

 

END OF DAY 1

 

TUESDAY, JUNE 20, 2017

DDI-2017 – Day 2

 

7:00 AM – 8:00 AM – REGISTRATION

 

Session 3: Extended Clearance Concept in Drug Interactions (Chair: Jashvant Unadkat)

 

Transport vs. metabolism:  What determines the PK and PD of drugs? Insights from the Extended Clearance Model?  (Jashvant Unadkat, University of Washington; Seattle, WA)

 

The Application of the Extended Clearance Classification System in Projecting ADME Behavior and Drug-Drug Interactions in Early Discovery and Development: Industrial Perspective (Ayman El-Kattan, Pfizer, Inc.; Cambridge, MA)

 

Predicting Transporter-mediated PK and DDIs: Building a framework and gaining confidence (Manthena Varma, Pfizer, Inc.; Cambridge, MA)

 

Session 4

Session 4: Drug metabolites as contributors to drug interactions (Chair:  Jan Wahlstrom)

 

Drug metabolites as contributors to clinical drug-drug interactions:  AstraZeneca perspectives (Ken Grime, AstraZeneca R&D; Gothenburg, Sweden)

 

Aldehyde Oxidase Metabolite as a Perpetrator of Drug-Drug Interactions Niresh Hariparsad; Vertex Pharmaceuticals. Boston, MA)

 

Drug metabolites as P450 inhibitors:  Translation to the clinic Jan Wahlstrom, Amgen, Inc.; Thousand Oaks, CA)

 

CONTINUED

Session 4: Drug metabolites as contributors to drug interactions (Chair:  Jan Wahlstrom)

 

Regulation of P450 expression by drug metabolites (Nina Isoherranen, University of Washington, Seattle, WA)

 

Session 5:  Drug-transporter Interactions (Chair: Kenneth Brouwer)

 

Evaluation and Quantitative Prediction of Renal Transporter-Mediated Drug-Drug Interactions (Bo Feng, Pfizer Inc.; Cambridge, MA)

 

Inhibition of Human Hepatic Bile Acid Transporters as Contributing Factors to Drug-Induced Liver Injury (Kenneth Brouwer, Qualyst Transporter Solutions, Durham, NC)

 

Drug Metabolism and Transport at the Therapeutic Site of Action (Robert S. Foti, Amgen Inc.; Cambridge, MA)

 

Application of endogenous probes for early assessing drug-drug interactions in human  (Invited)(Yurong Lai, Bristol-Myers Squibb Company; Princeton, NJ)

 

END OF DAY 2

 

WEDNESDAY, JUNE 21, 2017

DDI-2017 – Day 3

 

7:00 AM – 8:00 AM – REGISTRATION

 

Session 6: Enzyme Induction and nuclear receptors (Chair: Jane Kenny)

 

Using Rifampicin data and models to guide assessment of clinically significant CYP3A4 induction risk (Jane Kenny, Genentech; S. San Francisco, CA)

 

Acute and persistent gene expression effects upon neonatal exposure to PXR and CAR ligands (Julia Yue Cui, University of Washington; Seattle, WA)

 

Session 7:  Novel approaches in drug interactions (Chair: Theunis Goosen)

 

Novel Cytochrome P450 Reaction Phenotyping for Low-Clearance Compounds Using the Hepatocyte Relay Method (Li Di Pfizer, Inc.; Cambridge, MA)

 

Characterization of UGT Inhibition as a Necessary and Important Strategy in Drug Development (Theunis C. Goosen, Pfizer Inc.; Groton, CT) 

 

Physiologically Based Pharmacokinetic Model of Organic Anion Transporting Polypeptide Victim Drug using Human Hepatocytes Cultured in Human Plasma Data (Jialin Mao, Genentech; S. San Francisco, CA)

 

Physiologically Based Pharmacokinetic Model for Itraconazole Pharmacokinetics and Drug–Drug Interaction Prediction (Yuan Chen; Genentech; S. San Francisco, CA)

 

Session 8:  Biologics-Drug Interactions

(Chair: Stephen Wang)

 

DDI Potential Assessment and Challenges for Therapeutic Proteins and ADCs (Elimika Pfuma Fletcher, U.S. Food and Drug Administration; White Oak MD)

 

Human Pharmacokinetics and Pharmacodynamics Predictions for mAbs Exhibiting Target-mediated Drug Disposition: Case Study Examples (Pratap Singh, Alexion Pharmaceuticals; New Haven, CT)

 

DDI of Biologics, Pfizer Experience (Stephen Wang, Pfizer, Inc.; Cambridge, MA)

 

Concluding Remarks (Albert P. Li)

 

END OF DAY 3

 

END OF CONFERENCE

 

About Institute for Scientific Communications, Inc.

 

The Institute for Scientific Communication is a not-for-profit organization with the mission to distribute scientific knowledge via effective communications.  ISC sponsors conferences and workshops to allow exchange of scientific observations and ideas, with the ultimate goal being timely application of the latest scientific discoveries to better human lives. Please visit our web site at www.ifscomm.org.

 

 

POSTER PRESENTATIONS:

 

Poster Presentations are always encouraged.  Please submit your poster abstract for approval by the organizing board by May 19th.  Poster size should be no larger than 3 feet high by 6 feet long.  Abstracts of posters will be included in the conference materials and will be available on the ISC website. The conference materials will be posted on the basis of availability from the author or presenter.  There is no formal poster presentation scheduled.  All posters will remain displayed throughout the conference.  Please be prepared to display your poster during registration on Sunday, June 18th   or before the first session begins on Monday, June 19th.  Poster presenters will have ample time for discussion during breaks and Panel discussions. Submit posters abstracts for approval to Nola Mahaney, ISC; 9221 Rumsey Road, Suite # 8; Columbia, MD 21045 or email files attachment to [email protected]. Approved poster applicants are responsible for completing a conference attendance registration form and payment of fee – visit www.ifscomm.org   – and for the shipping of the poster itself.  Please contact Nola Mahaney for any questions or comments.  Please refer to “Travel Information” for hotel address and shipping information.