Programme
Monday 18th January
     
17:00 - 19:00   Registration opens and drinks reception
 
     
Tuesday 19th January
     
08:00 - 09:00   Registration continues
 
     
09:00 - 09:15   Chairpersons' Opening Address
Johanna Haglund, SPS Chair and Mark Seymour, DMDG Chair
 
09:15 - 10:45   Session 1: Oral delivery beyond rule of 5
Chair: Stephen Buckley, NovoNordisk (spby@novonordisk.com) and Rasmus J Löfmark (Rasmus.Jansson.Lofmark@astrazeneca.com)
Scope:
Historically, Lipinski's rule-of-five (Ro5) has served as guide for the design of drug compounds amenable to delivery via the oral route. Importantly, its implementation in the traditional druggable target space has resulted in a reduction of attrition originating from poor PK. However, the on-going transition in drug discovery towards alternative means for binding and modulating (often challenging) biological targets has necessitated a rethinking of the approach towards the design, formulation and oral delivery of new modalities. These so-called beyond the Ro5 (bRo5) small molecules (e.g., PROTACs), peptide/peptidomimetics and nucleic acid-based modalities provide new challenges (and opportunities) with respect to their amenability towards oral dosing. This session will highlight the strategies – both chemistry and formulation – being harnessed to overcome the inherent complexity associated with the oral administration of bRo5 and new modalities.
 

10:45 - 11:15   Coffee, Posters, Trade Exhibition
 
11:15 - 12:45   Session 2: DMPK of oligonucleotide-based therapies
Chair: Shalini Andersson, AstraZeneca (shalini.andersson@astrazeneca.com)
Scope:
Oligonucleotide-based therapies, with their characteristic mode-of-action, shows a great potential to treat diseases that have previously been challenging to treat and are also expanding from rare diseases to broader patient populations. Currently there are 10 approved oligonucleotide drugs and several more in clinical trials. Natural oligonucleotides have poor DMPK properties with poor cell penetration and are readily degraded by nucleases. Chemical modifications, of both the nucleotide backbone and the sugar moiety, have improved the “drug-like” properties of oligonucleotide drugs. Additionally, the use of enhanced delivery to specific cell types and conjugation of oligonucleotides to multivalent N-acetylgalactosamine (GalNAc) has also enabled low clinical dose and infrequently subcutaneous dosing. Furthermore, there are promising pre-clinical data suggesting that the use of targeted drug delivery has the potential to target specific cell types beyond hepatocytes in the human body at low therapeutic doses.
However, there are challenges in terms of driving oligonucleotide-based therapy projects forward in the drug discovery, development and clinical phases. These challenges are experimentally based (e.g. drug quantification, metabolite characterization), experimental design based (e.g. drug-drug interaction assessment, duration of in vitro/in vivo studies) as well as regulatory considerations. This session will focus on the DMPK pitfalls, tactical considerations, challenges and recent advancements in this highly expanding field.
 

12:45 - 13:30   Lunch, Posters, Trade Exhibition
 
13:30 - 15:00   Session 3: PKPD of New Therapeutic modalities: learnings from clinical successes and remaining challenges
Chairs: Karelle Menochet, UCB (Karelle.Menochet@ucb.com)
Scope:
More pharmaceutical companies are moving beyond traditional small molecules and monoclonal antibodies to become modality agnostic. Understanding of the mechanism of action and the dynamics of novel targets is therefore critical to choose the appropriate modality to prosecute targets that were thought undruggable with traditional approaches. The aim of this session is to review the PKPD understanding of new modalities that have recently gained market approval (gene and cell therapy) and to highlight the impact that early PKPD understanding can have on drug design (PROTACs, peptides).


15:00 - 15:30   Tea, Posters, Trade Exhibition
 
15:30 - 16:30   Session 4: Student Poster Blitz/ Rosenön award
Chairs: Lilly Collins, DMDG Apprentice Committee member (l.collins@sygnaturediscovery.com), Johanna Haglund, SPS Chair (johanna.haglund@admescope.com) and Suzanne Iverson Hemberg, SPA Committee (suzanne.iverson.hemberg@vgregion.se)
Scope:
Student poster blitz: This is a chance for students who are presenting posters during the open meeting to promote their research through an "elevator-pitch" 2-minute oral presentation in a quick-fire format.

The second part of this session will be the Rosenön award organised by the Swedish Pharmaceutical Society, Pharmacokinetic and drug metabolism section. To stimulate research within the areas drug metabolism, pharmacokinetics and/or pharmacodynamics AstraZeneca, Admescope Sweden and Pharmetheus sponsor the Rosenön Award with 30 000 SEK, to be awarded to the best doctoral thesis of the year, defended at a Swedish university. See details here:
https://www.apotekarsocieteten.se/stipendier-och-priser/vara-priser/the-rosenon-award/

 

16:30 - 17:30   Candlelight Keynote Speaker:
Tommy B. Andersson, PhD, Prof. Emeritus

Chair: Rasmus Jansson Löfmark, SPS committee (Rasmus.Jansson.Lofmark@astrazeneca.com)
 

17:30 - 19:30   Poster Session
Drinks Reception, Trade Exhibition
 
19:30   Dinner (Own Arrangements)
     
Wednesday 20th January
     
08:45 - 10:15   Session 5: Novel approaches for studying hepatobiliary elimination and transporter inhibition
Chairs: Laurent Salphati, Genentech (salphati.laurent@gene.com) and Carina Cantrill, Roche (carina.cantrill@roche.com)
Scope:
The characterization of the mechanisms driving the hepatic elimination of drugs and the assessment of transporter inhibition are essential activities during drug development. These investigations are critical for the prediction of human pharmacokinetic parameters and the evaluation of the potential for drug-drug interactions (DDI). However, the processes involved in hepatobiliary elimination are often studied in independent experiments or systems, leading to challenges in data integration. Similarly, models for transporter inhibition studies and DDI predictions are still being tested and optimized. This session will highlight novel in vitro models/approaches that attempt to assess simultaneously the combined effects of hepatic transporters and enzymes, and their use in predicting drug disposition. Recent developments in the study of transporter inhibition will also be presented.
 

10:15 - 10:45   Coffee, Posters, Trade Exhibition
10:45 - 12:30   Session 6: Organ-on-a-chip: hype or revolution?
Chair: Reiner Class, UCB (reiner.class@ucb.com) and  Graeme Scarfe, AstraZeneca (graeme.scarfe@astrazeneca.com)
Scope:
The use of traditional cell culture and animal models in preclinical drug screening did not significantly reduce high drug attrition rates in clinical trials. There is general agreement in the scientific community that this is largely due to their inability to accurately predict the human response. Microphysiological systems (MPS) are currently considered the most promising alternative and a milestone in preclinical drug testing. MPS interconnect human organoids with a flow thus mimicking the human body in a physiologically relevant manner. MPS have the potential to recapitulate the in vivo drug processes of ADMET, simulate PK/PD and drug-drug interactions, and ultimately guide drug candidate screening and dose selection for clinical trials. The session will highlight the various technological approaches in the MPS field, showcase selected platforms, present data and their clinical correlation. Representatives from leading organizations will share their experience and data, discuss regulatory acceptance, and provide an outlook.
 

12:30 - 13:30   Lunch, Posters, Trade Exhibition
 
13:30 - 15:00   Session 7: PBPK and PD models of biologics & new modalities – An integrated approach
Chair: Kunal Taskar, GSK (kunal.s.taskar@gsk.com)
Scope:
There have been several recent advances and improvements in understanding the ADME of biologics and within this area PBPK models has played, and will play, an important role. This session aims to cover basics to advanced information on PBPK modeling of biologics and it’s various applications including PD of biologics. The PBPK-PD applications aims to not only include target identification to FTIH, but also the use of PBPK to address the immune reaction mediated DDIs and in addition regulatory aspects. The cytokine mediated drug metabolizing enzymes-transporter changes and their modelling strategies for clinical perspective as well as retrospective predictions is gaining popularity in recent times. This session will primarily focus on biologics but applications of PBPK modelling to other new modalities is also encouraged.
 

15:00 - 15:30   Coffee, Posters, Trade Exhibition
 
15:30 - 17:00   Session 8: Free Communicationss
Chair: Jamie Henshall, DMDG Committee (Jamie.Henshall@ucb.com)
Scope:
This is an open session for any hot topics or informative case study that you would like to share with the community but may not fit into the themes of any of the other sessions. Any topic submitted that is not chosen for an oral presentation, can present in the poster session. Please contact Jamie Henshall (Jamie.Henshall@ucb.com ) for further details or to submit an abstract.
During this session there will also be summary talk from the Peptide Workshop and the Biotransformation Workshop that is arranged in conjunction with the DMDG-SPS meeting
 

17:30 - 19:00   Session 9: Debate: Title TBD
Ringmaster: Steve Hood, GSK (steve.r.hood@gsk.com)

Scope:
The legendary DMDG debate returns for another round. There will be someone proposing for and someone proposing against, and we have the audience. Let the battle(s) begin…
     
19:30 - 00:00   Drinks Reception, Conference Dinner
 
     
Thursday 21st January
     
09:00 - 10:30   Session 10: Applications of AI/Machine Learning in DMPK/PKPD considerations
Chair: Becky Scott, GSK (rebecca.j.scott@gsk.com)
Scope:
Artificial Intelligence (AI) /Machine Learning in Pharma has attracted a growing interest in recent years and the adoption of AI/ML techniques is starting to establish both in drug discovery and clinical trials. But where are the applications in DMPK/PKPD? AI deals with computer systems able to perform human-like tasks or solve complex problems whereas Machine Learning (ML) is a subfield of AI whose aim is to learn from data in order to find hidden patterns that could be exploited for classification or clustering purpose. The aim of this session is to focus on applications, rather than theory, of AI/Machine Learning within the DMPK/PKPD field.
 

10:30 - 11:00   Coffee, Posters, Trade Exhibition
 
11:00 - 12:45   Session 11: Clinical Pharmacokinetics
Chair: Anna Nordmark, ScanDev (Anna.Nordmark@scanddev.se) and Joanna Parkinson, AstraZeneca (Joanna.Parkinson@astrazeneca.com)
Scope:
Clinical pharmacokinetics is a central aspect in clinical development. The type of clinical studies designed to describe PK varies in type (e.g. human ADME, DDI studies, food interaction, PKPD, healthy versus diseased, pediatrics) and in size. Accurate characterization of PK in clinics is often challenging, depending on the route of administration or the patient population. The aim of this session is to focus on innovative approaches, emerging topics and new regulatory considerations within this field. We invite speakers from the pharma industry to provide experiences, case examples and approaches used.
 

12:45 - 13:00   Closing Remarks
 
13:00 - 14:00   Lunch and delegates depart
 

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