Programme
Monday 15th October
     
17:00-
19:00
  Registration opens and drinks reception
 
     
Tuesday 16th October
     
08:00-
09:00
  Registration continues
 
     
09:00   Chairpersons' Opening Address
Rowan Stringer (Novartis) and Johanna Haglund (MetaSafe – an Admescope company)
09:15   Session 1: Strategic collaborations: Pan European Industrial – Academic Partnerships
Chair: Pawel Baranczewski, Uppsala University (pawel.baranczewski@farmaci.uu.se)

Speakers:

  • What have industrial/academic partnerships ever done for us?
    Steve Hood, GSK
  • Quantitative Systems Pharmacology is alive and well in the UK
    James Yates, AstraZeneca
  • Academic–Industrial Partnerships in Drug Discovery-Opportunity or Foe for Academic Research. Comments from Academic Point of View
    Pawel Baranczewski, UDOPP, Uppsala University
10:45   Coffee, Posters, Trade Exhibition
11:15   Session 2: Strategic approaches to tissue quantification
Chair: Johan Bylund, Medivir (johan.bylund@medivir.com)

Speakers:

  • To measure or not to measure? Tactics of tissue exposure assessment in drug research
    Markus Fridén, AstraZeneca
  • Determination of total tumor concentrations in xenograft models; experiences from Merck oncology projects
    Carl Petersson, Merck KGA
  • Bioanalytical aspects of tissue quantification, experiences from a Medivir oncology project
    Rodrigo Palma Villar, Medivir
12:45   Lunch, Posters, Trade Exhibition
13:30   Session 3: Strategies for PKPD Modelling in Drug Discovery and Development
Chairs: Maria Kjellsson, Uppsala University (Maria.Kjellsson@farmbio.uu.se)

Speakers:

  • Preclinical PK/PD modelling to support First-in-Man trial in oncology
    Sheila Annie Peters, Merck KGaA
  • Translational pharmacokinetic-pharmacodynamic modelling predicts human exposure-target engagement
    Rasmus J. Löfmark, AstraZeneca
  • - Using modelling & simulation throughout clinical drug development
    Hanna Silber Baumann, F. Hoffmann-La Roche
15:00   Coffee, Posters, Trade Exhibition
15:30   Session 4: Student Poster Blitz/ Rosenön award
Chairs: Hugh Walton, Astex (Hugh.Walton@astx.com) and Johanna Haglund, MetaSafe – an Admescope company (johanna.haglund@metasafe.se)
16:30   Candlelight Keynote Speaker
Chair: Rasmus Jansson Löfmark, AstraZeneca, (Rasmus.Jansson.Lofmark@astrazeneca.com)

Speaker:         Magnus Ingelman-Sundberg, Karolinska Institute
Title:                Drugs, genes and precision medicine, a tour from RFLP to NGS
17:30 -
19:30
  Poster Session
Drinks Reception, Trade Exhibition
Chair: Hugh Walton, Astex (Hugh.Walton@astx.com)
19:30   Dinner (Own Arrangements)
     
Wednesday 17th October
     
08:45   Session 5: New Technologies in DMPK
Chair: Mark Seymour, Covance (Mark.Seymour@covance.com)

Speakers:

  • New Horizons in DMPK: The Next Wave of Automation
    Scott Summerfield, GSK
  • The Application of Ion Mobility Mass Spectrometry in DMPK Workflows
    Richard Clayton, Covance
  • Evaluation of transporter activity in stem cell derived renal models for drug clearance studies
    Katarina Breitholtz, AstraZeneca
10:15   Coffee, Posters, Trade Exhibition
10:45   Session 6: New Modalities – Part 1
Chair: Lars Weidolf, AstraZeneca (Lars.Weidolf@astrazeneca.com)

Speakers:

  • Chemical Analysis and Physicochemical Characterization of Peptides - a Chemistry Perspective
    Tomas Leek, AstraZeneca
  • ADME Characteristics of Semaglutide
    Mette Lund Pedersen, NovoNordisk
  • 14C-Labeling and Analysis Technologies to Enable Biologicals Drug Development
    Wouter Vaes, TNO
  • Highlights from the 1st workshop of the Peptide ADME Discussion Group
    Jesper Kammersgaard Christensen, NovoNordisk
12:30-
13:30
  Lunch, Posters, Trade Exhibition
 
13:30   Session 8: New Modalities – Part 2
Chair: Joanne Goodman, MedImmune (goodmanj@MedImmune.com)

Speakers:

  • Bioanalytical Strategy for Locked Nucleic Acids (LNA) Therapeutics: Lessons Learned
    Enric Bertran, F. Hoffmann-La Roche
  • Bioanalysis and Biodistribution of Dendrimer Nanoparticles
    Eric Gangl, AstraZeneca
  • Discussion and Reflection Points from the EBF Focus Workshop on New Modalities: Science and Regulations Joining Hands
    Philip Timmerman (on behalf of the European Bioanalytical Forum (EBF))
15:00   Coffee, Posters, Trade Exhibition
15:30 -
17:00
  Session 8: Free Communicationss
Chair: Graeme Scarfe, AstraZeneca (Graeme.Scarfe@astrazeneca.com)

Speakers:

  • Target-mediated drug disposition for small molecules: an overlooked area?
    Robert van Waterschoot, F. Hoffmann-La Roche
  • Application of in vitro parameters to predict non-linear absorption
    Katie Haughan, AstraZeneca
  • The rise of Deuterated Drugs
    Ray Cooke, Pharmaron
  • Development of a novel method to rapidly characterise uptake transporter activity in human hepatocytes in vitro: Applications and learnings
    Oliver Light, UCB
17:30 -
19:00
  Session 9: Debate: Lipinski Rules are no longer relevant – Future drugs will need to be >5 kDa if they are to become “profitable” medicines
Ringmaster: Steve Hood, GSK (steve.r.hood@gsk.com)
  • Proposing - Kevin Brady (UCB) and Ben Krippendorff (F. Hoffmann-La Roche)
  • Against - Dennis Smith (DMDG Fellow) and Barry Jones (AstraZeneca)
     
19:30-
00:00
  Drinks Reception, Conference Dinner
 
     
Thursday 18th October
     
09:00   Session 10: First In Human dose – regulatory and pharmacokinetic-pharmacodynamic considerations
Chair: Rasmus J. Löfmark, AstraZeneca (Rasmus.Jansson.Lofmark@astrazeneca.com)

Confirmed speakers:

  • The new EMA First In Human guideline
    René Bouw, MPA
  • IQ MABEL: First In Human MABEL approach and Survey Results
    Sherri Dudal, UCB
  • Integrated PKPD approach for the first-in-human dose selection of novel co-stimulatory cancer immunotherapies
    Wouter Driessen, F. Hoffmann-La Roche
10:30   Coffee, Posters, Trade Exhibition
11:00   Session 11: The Application of DDI and PBPK in Regulatory Environment
Chair: Anna Nordmark, MPA (Anna.Nordmark@mpa.se)

Confirmed speakers:

  • The use of Physiologically Based Pharmacokinetic Models for Regulatory Claims within EMA
    Anna Nordmark, MPA
  • Physiologically based pharmacokinetic modelling current capabilities, case studies, and future opportunities: A Consortium Perspective
    Venkatesh Pilla Reddy, AstraZeneca
  • Comparison Between the US FDA, EMA and Japan PMDA In Vitro DDI Guidances: Are we Closer to Harmonization?
    Brian Ogilvie, Sekisui XenoTech
     
12:45   Closing Remarks
13:00-
14:00
  Lunch and Delegates Depart
 

 

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