Draft Programme - all times are BST (UK time)
Monday 18 October
     
09.00 - 09.15   Chair's Opening and introduce new Fellow (Auditorium)
Sherri Dudal (Roche) and Jo Goodman (AstraZeneca)
 
09.15 - 10.00   Session 1: New Fellow Keynote address (Auditorium)
Chairs: Sherri Dudal (Roche) and Jo Goodman (AstraZeneca)

Scope: Announcing the appointment of our fourth DMDG fellow. DMDG fellows are members who have made outstanding contributions, long term commitment and high-level service to the DMDG. Fellows belong to a distinguished category of membership who have the privilege of membership without site-based representation.

The appointment will be followed by a keynote address.
 

10.00 - 10.300   Bring-Your-Own-Coffee, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)

  Session 2a: Early Careers - Poster Blitz (Auditorium)
Chair:
Sarah Armstrong, DMDG Apprentice Committee member (GW Pharma)

Scope: Firstly, we have the student poster blitz session. This is a chance for students who are presenting posters during the open meeting to promote their research via a brief 2 minute “elevator pitch”. For many it is an opportunity to stand to a large (but welcoming!) audience for the first time.

Session 2b: Early Careers Meeting - Best Presentation (Auditorium)
Chair:
Sarah Armstrong, DMDG Apprentice Committee member (GW Pharma)

Scope: Secondly, we have the winner of best presentation from the DMDG Early Careers meeting, held earlier this year. Chloe Whitehouse (MSD) will present her work on…

  • Blood-Brain Barrier “on-a-Chip” model for Testing Drug Permeability into the Brain
    Chloe Whitehouse (University of Nottingham)
12.00 - 13.000   Bring-Your-Own-Lunch, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)
 
13.00 - 14.45  
Session 3: Mechanistic safety – where DMPK meets safety Auditorium)
Chairs: Melanie Sakatis (GSK) and Nicola Wilsher (Astex Therapeutics)

Scope: DMPK and Safety are complementary sides of the same coin, both biological disciplines working to understand how the drugs that we develop interact with biological systems. DMPK data is often pivotal to understanding the potential for drugs to cause toxicity, and investigating the mechanisms behind such affects. Suggested topics for this session may include (but not be limited to): metabolism-mediated safety effects, transporter-mediated effects, QST modelling using PBPK models, novel safety biomarkers, and any other topic where DMPK data has informed on safety. Interested speakers should send a working title and short description of their proposed talk to the session chairs for consideration.

Speakers:

  • Using DILIsym, a quantitative systems toxicology model, to assess bile acid transporter-mediated hepatotoxicity.
    Kylie Beattie (GSK)
  • Translational Quantitative Systems Toxicology to Predict Drug Toxicity: Focus on Gastrointestinal Modelling. IMI TransQST consortium.
    Chris Goldring (Liverpool Uni) and Carmen Pin (AZ)
  • Ex vivo molecular imaging in drug development: Case studies in drug distribution, safety, endogenous molecule analysis and immune deconvolution.
    Heather Hulme (AZ)
15.30 - 16.30   Session 4: Reflections on 50 years of DMDG (Auditorium)
Chair:
Jamie Henshall (UCB)

Scope: On the 50th anniversary of the DMDG, this session encourages us all to reflect on the origins, the changes and the future of the DMDG. Panellists have all been deeply involved with the DMDG over a number of years and include DMDG fellows and former chairs. We look forward to a lively and fascinating discussion, with time for Q+A from the audience.

Panellists:

  • Ian Gardner (Certara)
  • Michael Hall (Pharmaron)
  • Andrew McEwan (Reviresco Solutions)
  • Suzanne Iverson Hemberg (Sahlgrenska University Hospital, Sweden)
  • Ian Wilson (Imperial College London)
Tuesday 19 October
     
09.00 - 10.00   Session 5: Covid-19 – What have we learned? (Auditorium)
Chair:
Graeme Clark (Concept Life Sciences)

Scope: DMPK and Safety are complementary sides of the same coin, both biological disciplines working to understand how the drugs that we develop interact with biological systems. DMPK data is often pivotal to understanding the potential for drugs to cause toxicity, and investigating the mechanisms behind such affects. Suggested topics for this session may include (but not be limited to): metabolism-mediated safety effects, transporter-mediated effects, QST modelling using PBPK models, novel safety biomarkers, and any other topic where DMPK data has informed on safety. Interested speakers should send a working title and short description of their proposed talk to the session chairs for consideration.

Speakers: TBA


10.00 - 10.30   Bring-Your-Own-Coffee, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)

10.30 - 12.00   Session 6: Non-invasive imaging (Auditorium)
Chair:
Markus Walles (Novartis Pharma AG)

Scope: Clinical imaging like PET Imaging offers a range of methods for the support of drug development that are able to address major questions related to target validation and molecule biodistribution, target interactions and pharmacodynamics. Early PET studies, performed with very low drug doses-so called PET-microdosing-could be included in the drug development process to assess blood brain penetration of drugs, tumor penetration and transporter mediated drug-drug interactions of small molecule drugs in vivo as well as to investigate the biodistribution studies of biotherapeutics and new modalities.

Targeted radionuclide therapy on the other hand is an attractive and quickly developing therapy by which the concepts of diagnostic imaging (using gamma emitter) and therapeutic treatment (using beta emitter) are combined (so called Theranostics). This session will highlight preclinical and clinical strategies and applications for both PET microdosing and radioligand therapies which helped to move therapies forward in drug development.

Speakers:

  • Use of PET microdosing in drug development.
    Oliver Langer (Medical University of Vienna)
  • Phenotypic precision medicine with PSMA-targeted radioligand imaging and therapy.
    Ana Catafau (AAA/Novartis)
  • Translational Medicine approaches for RLI/RLT studies.
    Emanuela Pilati (AAA/Novartis)
  • Multi-modal imaging in rodent models of Rheumatoid Arthritis.
    Simon Campbell (GSK)
12.00 - 13.00   Bring-Your-Own-Lunch, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)

(12.15 - 12.45: DMDG ABM) (Breakout Room 1)
 

13.00 - 14.30   Session 7: DMPK/PKPD in special populations (Auditorium)
Chairs: Kunal Taskar (GSK) and Oliver Hatley (Certara)

Scope: The extent of expected differences in pharmacokinetics in diseased or pregnancy/paediatric populations is influenced by the impact of physiological changes (e.g. body weight, organ function, ontogeny, etc. ) on drug disposition. Furthermore, inflammatory markers or build-up of toxins are known to influence the activity or abundance the enzymes, transporters, as well as plasma protein levels and binding, driving some of the possible reasons for differential clearance and/or distribution of the drugs in disease or special populations. However, the underlying mechanisms these processes are poorly characterised. This session will aim on describing the general considerations for such ADME properties while considering the DMPK in special populations and will involve discussing relevant case studies and regulatory perspective.

Speakers:

  • Title TBA
    Kim Brouwer (UNC Eshelman School OF Pharmacy)
  • Title TBA
    James Yates (AZ)
  • Title TBA
    Eva Berglund (Uppsala University, Sweden)
14.30 - 15.00   Bring-Your-Own-Tea, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)
 
15.00 - 16.30   Session 8: PARALLEL SESSIONS (Breakout Rooms 1 & 2)

Session 8a - Training and recruiting the next generation of scientists – writing a “job spec”, apprenticeships, etc… (Breakout Room 1)
Chair: Steve Madden (Charles River Ltd)

Scope: Many industry surveys over the last few years have shown a growing skills gap across the Life Sciences industry in the UK with DMPK being one of the areas highlighted. As we continue to see the emergence of investigative therapies spanning multiple existing and new modalities, there is a strong risk that this skills gap will continue to grow. In this session, we will hear from multiple stakeholders on opportunities to mitigate against this risk and hear some success stories from other, related, subject areas.

Speakers:

  • Title TBA
    James O’Neill (Charles River Laboratories)
  • Title TBA
    Laura Bennett
  • Title TBA
    Simon Taylor (Pharmaron)
  • Title TBA
    Dan Carr
  • Title TBA
    Kayode Ogungbenro (University of Manchester)
Session 8b - Analytics of new modalities (Breakout Room 2)
Chair: Ranbir Mannu (Covance Laboratories)

Scope: Over the past 5-10 years, our understanding of biological systems has increased significantly alongside analytical technology. This has driven the rise in new modalities that target protein – protein or protein – nucleic acid interactions rather than the classical small molecule approach. These new modalities include peptides, oligonucleotides, hybrid and molecular conjugates utilize classical small molecules bound to a biological structure. This session will focus on the new analytical approaches to new modalities, focusing on various new technological approaches, hybrid methods and alternative regulatory requirements.

Speakers: TBA

Wednesday 20 October
     
09.00 - 10.00   Session 9: Free Communications (Auditorium)
Chair: Mo Alavijeh (Pharmidex)

Scope: The main role that DMPK/ADME/PKPD plays in drug discovery is the prediction of drug metabolism and pharmacokinetics in humans. Successful prediction can be expected to reduce the rate of attrition during drug discovery and development. This has led to the recognition that DMPK/ADME/PKPD are essential component of the drug discovery process. Both this and the need to screen ever greater numbers of compounds have led to major changes in both technology and the process of drug discovery. The overarching scope of this meeting is to bring hot topics within the DMPK/ADME/PKPD fields, and to reflect on the last 50 years of the DMDG. Please note: Oral Presenters will have 20 minutes total for presentation which includes 15 minutes to present and 5 minutes for Q&A.

Speakers:

  • Pharmacometabo- and Pharmacotoxico-dynamics - Linking Exposure to Changes in Endogenous Metabolic Pathways.
    Ian Wilson (Imperial College London)
  • Evaluation of in vitro systems for aldehyde oxidase CL predictions.
    Robert S. Jones (Genentech, USA)
  • Impact of the human metabolism profile of adavosertib (a selective WEE-1 inhibitor) on the prediction of clinical TDI.
    Kevin Beaumont (DMPK Director, Oncology R&D, AstraZeneca)
10.00 - 10.30   Bring-Your-Own-Coffee, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)
 
10.30 - 12.00   Session 10: The role of Clin Pharm and M&S in vaccine development- keep general to all vaccines (Auditorium)
Chair: Venkatesh Reddy (AstraZeneca)

Scope: Clinical Pharmacology and Pharmacometrics has only recently been introduced to vaccine discovery and development as a result of COVID-19 pandemic. The goal of this session is to show the value of clinical pharmacology and model informed drug development in addressing critical vaccine development questions to support accelerated vaccine programs. This session will start with a background on vaccine discovery and development (contrasting with other therapeutic areas such as small and large molecules) including a brief overview of the risk/benefit considerations in vaccines, the measures of protective immune response, vaccine platforms (mRNA, AAV, DNA, etc.). This will be followed by examples across the spectrum of applications from discovery through development through scientists from regulatory agencies, industry and academic scientists.

Speakers:

  • Role of Clinical Pharmacology in Vaccine World.
    Rosalin Arends (AstraZeneca)
  • MHRA/EMA/FDA perspective on Model-informed drug development applications for the clinical development of vaccines.
    Essam Kerwash (MHRA)
  • Translational M&S to inform vaccine dose decision-making.
    Sophie Rhodes (Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London)
  • Pharmacometrics: A shot in the arm for vaccine discovery and development.
    Daren Austin OBE (GSK)
12.00 - 13.00   Bring-Your-Own-Lunch, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)
 
13.00 - 14.30   Session 11: Genes as medicines (gene therapy, mRNA vaccines…) (Auditorium)
Chair: Steve Hood (GSK)

Scope: Over the past decade, the DMDG has become familiar with the science and development of oligonucleotides as therapeutic agents, with many member companies listing ASOs and siRNAs in their pipelines. While these molecules are “large” by NCE standards, they are dwarfed by the mRNA and gene therapy modalities that are emerging in the fight against rare diseases and, more recently, respiratory viruses such as COVID 19. These macromolecules require their own delivery systems to ensure optimal performance and often require several co-factors for their Mechanism of Action.

This session will focus on the “developability” of these new classes of nucleic acid based therapeutics and outline the challenges faced with bringing these future drugs to the clinic and beyond. We will reflect on the learnings from the RNA virus field and look into the multicomponent gene therapy platforms.

Speakers:

  • Defining the broad potential of RNA vaccines.
    Derek O’Hagen (GSK Vaccines, Rockville, NJ, USA)
  • Emerging PK/PD concepts for Gene Therapies.
    Ben-Fillippo Krippendorff (Roche)
  • Title TBA
    Speaker TBA
14.30 - 15.00   Bring-Your-Own-Coffee, Posters, Trade Exhibition (Virtual Coffee Bar, Poster Room and Exhibition Hall)
 
15.00 - 16.00   Debate: "The DMDG believes that the 20th century was the era for DMPK innovation and current drug discovery is just an industrialisation of these ideas” (Auditorium)
Ringmaster: Simon Taylor (Pharmaron)

Scope: The DMDG debate is back for another year and this one promises to be fun, feisty and filled with science! We have assembled two experienced and passionate debating teams eager to convince you of their arguments as they reflect on DMPK science over the last 50 years of the DMDG.

Proposing: Steve Hood, Suzanne Iverson

Against: Ian Wilson, Rasmus Jansson Lofmark
 

16.00 - 16.15   Chair's Closing Remarks (Auditorium)
 

Sponsored by: