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Workshop

Drug-Drug Interactions: Update on Risk Assessment, Clinical Evaluation, and Regulatory Requirements


Speakers: Simon Wong, Jing Wang, Jialin Mao, Kari Morrissey (Genentech); Jingjing Yu (UW); Xinning Yang (FDA); Ilaria Badagnani (Theravance Biopharma); Yurong Lai (Gilead)
Organizers: Simon Wong (Genentech), Snow Ge (Nektar)
Date: 10/16/2018
Time: 8:45-17:00
Registration fee (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (2)Catalent Pharma Solutions; WuXi AppTec
Vendor show vendors registered to date: (22)Absorption Systems; BioDuro; BioreclamationIVT; Concept Life Sciences; Corning; Cyprotex; Cytovier; Envigo; Hurel Corp; ICON PLC; Intertek; KCAS Bioanalytical & Biomarker Services; Lonza; MicroConstants; Q2 Solutions; Quintara; Quotient Sciences; Sekisui XenoTech, LLC; Seventh Wave; Simulations Plus, Inc.; SOLVO Biotechnology; WORLDWIDE CLINICAL TRIALS
Registration: http://www.PBSS.org
Registration deadline:10/14/2018  (it will close sooner if the seating cap is reached)

About the Topic

The potential for clinical drug-drug interactions (DDIs) continues to be of key liability for the development of new medicines.  This comprehensive workshop will review techniques and strategy to assess the potential for DDI's from early discovery to clinical development. In addition, clinical case studies will be explored highlighting interactions with regulatory authorities and accompanying strategies to understand and mitigate risk and expedite compound advancement.

 
Specific topics to be covered: 
  • Assessment of enzyme-based DDI's (induction/inhibition) and reaction phenotyping
  • Large molecule therapeutic protein interactions with small molecules
  • Recent strategies to utilize physiologically-based modeling for risk assessment
  • Update on transporter-mediated DDI's and clinical assessment
  • Design and interpretation of clinical DDI studies
  • Clinically relevant biomarkers for the assessment of transporter-mediated DDI's
  • Update and commentary on recent (2017) FDA draft guidance for DDI's

 

Workshop Agenda

8:45-8:50   PBSS Welcome - Simon Wong (Genentech)

8:50-9:25   1. Introduction and DDI Basics on Inhibition, Induction and Reaction Phenotyping - Simon Wong (Genentech)

9:25–10:00   2. Assessment of Therapeutic Protein Drug-Drug Interactions with Small Molecules - Jing Wang (Genentech)

10:00-10:10   Major Sponsor Presentation - TBD

10:10-10:35   Break & Vendor Show  

10:35-11:20   3. Physiologically-Based Modelling and DDI Risk Assessment - Jialin Mao (Genentech)

11:20–12:00   4. Design and Interpretation of Clinical DDI Studies - Kari Morrissey  (Genentech)

12:00-1:00   Lunch   

1:00–1:45   5. What Can Be Learned from Recent NDAs? Key Findings on Drug Interactions for Drugs Approved by the FDA - Jingjing Yu (University of Washington)

1:45–2:30   6. Update of DDI Draft Guidance - Xinning Yang (FDA)

2:30-2:40   Major Sponsor Presentation - TBD

2:40-3:00   Break & Vendor Show  

3:00-3:45   7. Transporter-mediated DDIs – What’s new in 2017 FDA draft guidance and industry application and risk assessment - Ilaria Badagnani (Theravance Biopharma)

4:00-4:45   8. Clinical Biomarkers for Transporter Mediated DDI - Yurong Lai (Gilead)

4:45-5:15   Panel Discussion - All


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2018-11-16, Hybrid LC-MS for Protein therapeutics and biomarkers: Recent developments in characterization and quantification
2018-12-04, Challenges in Peptide Drug Discovery & Development: Biology, Chemistry, PK, Delivery, Regulatory and Beyond
2019-02-07, Covalent Inhibitor Drug Discovery & Development: Biology, Chemistry, PK, Safety and Case Studies (Jointly with Bay Area PKPD Network)
2019-03-07, Promising therapeutic approaches and transnational medicine from SPARK: an academic-industry collaboration to advance novel therapeutics (A Joint Symposium by PBSS and Stanford SPARK Program)
2019-03-11, Clinical Trials Essentials: An Intensive One-Week Course (register for the full week or half day sessions)
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