Programme (All timings are Amsterdam time (CET) - exact timings and parts of agenda may be subject to change)

Scope of the meeting
The overarching scope of this meeting is to bring hot topics within the DMPK/ADME/PKPD fields. The agenda is varied with a future focus.

Monday 3 October
     
10.00 - 12.00   Registration opens
 
12.00 - 13.00   Welcome lunch
 
13.00 - 13.15   Chairpersons' Opening Address
 
13.15 - 14.45   Session 1: PKPD challenges of New Drug Modalities

Scope:
New therapeutic drug modalities, such as oligonucleotides, cell therapy, gene therapy, gene editing, and PROTACs are breaking therapeutic barriers and are starting to show substantial clinical impact and benefit to patients. Key to the success of these new modalities are desirable DMPK/PKPD properties. While DMPK and PKPD properties of these drug modalities follow established principles of Pharmacokinetics and Pharmadocynamics, new modalities often require rethinking what are important processes and scientifically justified regulatory packages.
The purpose of this session is to address current advancements in DMPK and PKPD insights within these therapeutic classes. It will focus on the very new modalities, pitfalls, tactical considerations, challenges and recent advancements in this highly expanding field.

Please contact Rasmus Jansson Löfmark (Rasmus.Jansson.Lofmark@astrazeneca.com) and Ben-Fillippo Krippendorff (ben-fillippo.krippendorff@roche.com) for further info or would like to submit an abstract within this field of cell therapy, oligonucleotide-targeting, gene therapy, gene editing, or PROTACs/protein degraders.

Topics in scope:

  • Oligonucleotides and Targeting beyond the liver
  • Pharmacokinetics or PD of new modalities such as gene therapy and gene editing
  • Cell therapy and PK/PD
  • Proteins degraders (e.g. PROTACs)

14.45 - 16.15   Session 2: Advantages and challenges of new or repurposed in vitro ADME(T) assays for new modalities

Scope:
In vitro models aim to reduce/refine/replace the use of in vivo studies (3R) and save time and money in the drug development plan. Many new drug modalities are under development and it is a challenge to establish in vitro models that are adapted to their own specific DMPK and physico-chemical properties with maximal reproducibility and predictivity of the DMPK/safety and drug interaction risk. This session will focus on the strategies and in vitro approaches specifically developed or repurposed for innovative therapeutic modalities, such as oligonucleotides, antibodies, and PROTACs, for predicting their fate and risk of drug-drug interaction. Their values, advantages, limitations, place in the drug development plan and their potential integration into IVIVE-linked physiological-based pharmacokinetic modelling will be discussed.

Please contact Parmentier (yannick.parmentier@servier.com), Christine BAIN (christine.bain@active-biomarkers.com), Sibylle Neuhoff (sibylle.neuhoff@certara.com), Pawel Baranczewski (pawel.baranczewski@farmaci.uu.se) for further details or to submit an abstract.

Topics in scope:

  • immunogenicity prediction of antibodies
  • In vitro assays for assessing anti repression effect of anti-cytokine
  • In vitro DMPK assays for oligonucleotides, Protac, antibodies

16.15 - 16.45   Coffee, Posters, Trade Exhibition
 
17.00 - 18.30   Session 3: DEBATE

Scope:
A recurring theme and unique feature of the DMDG organisations. 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…

  • Topic to be announced

18.30 - 19.15   Drinks Reception
 
     
EVENING   Dinner (own arrangements)
 
     
Tuesday 4 October
     
08.30 - 10.00   Session 4: PKPD modelling of immuno-oncology drugs

Scope:
The pharmaceutical industry is clearly moving toward more mechanistic and quantitative PK and PKPD modeling to gain a deeper understanding of translational pharmacology. This session will aim to cover quantitative PKPD modeling of immuno-oncology drugs, spanning different modalities, to demonstrate how PKPD modeling has been used to further elucidate the mechanism of action, predict the clinical response and improve compound survival in the clinic.

Please contact Caroline Rynn (caroline.rynn@roche.com), Etienne Chatelut (chatelut.etienne@iuct-oncopole.fr), Laurence Del Frari (laurence.del.frari@pierre-fabre.com) and Sarah Lobet (sarah.lobet@univ-tours.fr) for further details or to submit an abstract.

Topics in scope

  • PB/PK/QSP models for immuno-oncology therapies
  • PKPD modeling to inform preclinical and clinical study design
  • Modeling to tailor drug administration & regimen
  • Dose setting: pharmacological active dose, anticipated therapeutic dose etc
10.00 - 10.30   Coffee, Posters, Trade Exhibition
 
10.30 - 12.00   Session 5: Leveraging Machine Learning (ML) for DMPK modelling

Scope:
Early determination (pre-clinical) of Drug Metabolism and Pharmacokinetics (DMPK) properties of compounds can improve decision making in drug discovery and selection of more efficacious compounds with appropriate DMPK properties. Both, in-vitro and in-vivo studies are exploited for pre-clinical screening, however, mentioned pipelines are long, complex, and depend on numerous undetermined factors. Our session “Leveraging Machine Learning for DMPK modeling” focuses on providing the impact of Machine Learning in drug discovery and development and DMPK analysis, yielding accurate predictions and insights. Machine Learning models enhance the accurate prediction of favorable physicochemical characteristics (e.g., solubility and permeability), pharmacokinetics (PK), safety, to prescreen covariates in PK‐pharmacodynamic data, and possibly efficacy of drug candidates. During our session, we will discover different applicability domains and limitations of Machine Learning in DMPK modeling.

Please contact, Dr. Ashwani Sharma (ashwani.sharma@insight-biosolutions.com), Dr. Nazanin Golbamaki (nazanin.golbamaki@rd.loreal.com) and Dr. Cornelis Hop (hop.cornelis@gene.com) for further details or to submit an abstract.
 

12.00 - 13.00   Lunch, Posters, Trade Exhibition

13.00 - 14.30   Session 6: Student Session

Scope:
Call for abstracts - students, short oral presentations, posters.

We welcome student abstracts in the field of pharmacology (ADME, PK, PD, DDI). All submitted abstracts will be reviewed by the selection committee and chosen to be part of a short-oral presentation (15 minutes) or poster presentation. A “Best Student oral presentation” and “Best Student poster presentation” awards will be announced during the DMDG/GMP/SPS congress 2022. Winners will be designed according to participants' vote (at 60%) and to selection committee vote (at 40%).

The program is open to all students at the Undergraduate, Masters, and Doctoral levels. Non student advisors or collaborators should be acknowledged appropriately, as coauthors or otherwise. However, students are requested to honour the spirit of the program by submitting only work for which they are primary investigators. Presenters must be present during the congress.

Please contact Carla Troisi (carla.troisi2@unibo.it), Sarah Lobet (sarah.lobet@univ-tours.fr), Anis Nouichi (anisnouichi19@gmail.com) and Anna Zerdoug (anna.zerdoug@univ-rennes1.fr) for further details or to submit an abstract.

Selection Committee: Dr. Ashwani Sharma (ashwani.sharma@insight-biosolutions.com)
 

14.30 - 16.00   Session 7: Free Communications

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. We would particularly like to encourage Early Career Scientists to use this session to share your data and gain some experience at presenting in front of a friendly audience. Any topic submitted that is not chosen for an oral presentation, can be presented in the poster session.

Please contact Graeme Scarfe (Graeme.Scarfe@soseiheptares.com) and Sarah Armstrong (sarah.armstrong@jazzpharma.com) for further details or to submit an abstract.

16.00 - 16.30   Coffee, Posters, Trade Exhibition
 
16.30 - 18.00   Session 8: Importance of diseases and disease progression for translational PBPK-models

Scope:
Physiologically based Pharmacokinetic (PBPK) models are mathematical translational tools aiming to reduce costs and to support strategy of drugs in discovery and development. PBPK is also used to inform, predict, and anticipate drug behaviours in sub-populations for whom clinical data may be inaccessible or challenging to obtain. As those models are based on physiological parameters, they represent the ideal tool to study the disease's consequences and disease progression on the pharmacokinetics of active pharmaceutical ingredients. This session will focus on the strategies to implement the impact of diseases on preclinical and human physiologies in a PBPK model in order to predict drugs’ pharmacokinetic and impact of sources of PK variability at all stages of a drug product development.

Please contact Maxime Le Merdy (maxime.lemerdy@simulations-plus.com), Olivier Nicolas (olivier.nicolas@sanofi.com), Jeremy Perrier (jeremy.perrier@phinc.fr), Sibylle Neuhoff (sibylle.neuhoff@certara.com), Kunal Taskar (kunal.s.taskar@gsk.com), for further details or to submit an abstract.

Topics in scope:

  • In vitro to in vivo extrapolation suitable to be linked to PBPK models
  • Preclinical to clinical extrapolation
  • Clinical to clinical extrapolation
18.00 - 18.45   Session 9: Candle light Lecture

Scope:
The Candlelight Keynote lecture is a recurring feature from the Swedish Pharmaceutical Society and started as a serendipity. A number of symposiums back (called Rosenön meeting) there was a big snowstorm and the power was shut down. To continue with the show, the conference moved to the cafeteria where candles were lit and the lecture was continued. Ever since, there has been a so-called Candle light lecture where an important contributor in the field of PK and Drug metabolism has been invited to make a presentation supported by candle lights, chalks and a board. We are now coming back from a Pandemic and never were so dependent on electronic and digital tools. However now, switch off the spotlights, and enjoy an "unplugged" lecture for this year's meeting.

Please contact : Suzanne Iverson (suzanne.iverson.hemberg@vgregion.se)
 

     
19.30 boarding
20.00 seated
  Conference dinner - river boat cruise (optional)
 
     
Thursday 5 October
     
08.30 - 10.00   Session 10: Deep dive into the ICH M12 guideline on "Drug Interaction Studies"

Scope:
This session will focus on the new ICH M12 guideline on "Drug Interaction Studies". After describing the latest additions, experts from regulatory bodies and from industry will discuss the impact of the harmonization. Specific aspects may include DDI in patients, special populations and administration routes that are not that common. This session may provide an opportunity, through a panel discussion, to discuss DMPK and Clinical Pharmacology aspects for drug interaction assessments to enable addressing specific questions.

Please contact: Anna Nordmark (anna@nordmarkclinpharm.se) Kunal Taskar (kunal.s.taskar@gsk.com) or Vassilios Aslanis (val@galecto.com  for further details or to submit an abstract.

Topics:

  • New changes implemented in the M12 ICH guideline, interpretation, impact on our ways of working
  • DDI in patients and special populations
  • The different modalities / administration route aspect
  • Panel discussion
10.00 - 11.30   Session 11: Drug-Drug Interactions: Next steps towards the harmonization

Scope:
The purpose of this session is to address the recent research within the drug-drug interaction (DDI) field, also considering the ICH guideline M12, which is under finalization, with focus on the harmonization of substrates, inhibitors and inducers to be used when performing DDI studies of the main drug metabolizing enzymes and transporters. In addition, the clinical implications and significance of the results obtained in vitro will be addressed. The session will pay attention to the strategies to assess DDI risks, not only with phase I metabolites but also phase II metabolites, which can be more prone to cause interactions than the parent drug. Emphasis will also be on emerging trends such as transporter DDI, ADME biomarkers and the use of different cocktail combinations for the simultaneous evaluation of multiple DDI pathways. The optimisation of the different DDI methods and approaches and the understanding of transporter-mediated disposition is of great significance for later clinical development.

Please contact: Olivier Nicolas (olivier.nicolas@sanofi.com) and Mia Lundblad (mia.lundblad@respiratorius.com) for further details or to submit an abstract.

Topics to include:

  • DDI risk assessment with metabolite
  • Optimisation of Clinical DDI studies: ADME Biomarkers as a surrogate / drug substrate cocktail approach
  • Transporter DDI risk assessment
11.30 - 12.15   Refreshments, Coffee, Posters, Trade Exhibition
 
12.15 - 13.30   Session 12: Biotransformation strategies applied to rapid drug development, ASOs, SiRNAs or modified therapeutic proteins

Scope:
For the Biotransformation session at this year’s open meeting we would like to focus on two main themes.

  1. For ASOs, SiRNAs and modified therapeutic proteins, biotransformation data up to now has not typically been included in regulatory filings due to minimal safety concerns associated with these classes of drugs. However there is increasing evidence that biotransformation studies conducted during the drug discovery and development pipeline may both streamline the lead candidate selection and optimization process and also provide insight into translation from animal models to human. We are looking for speakers who work in this area that would be willing to share case studies around the biotransformation strategies employed in the development of these 'new modalities'.
  2. Recently, and particularly during the recent pandemic, there have been several examples of accelerated drug development to support early registrations. We would be interested in discussing biotransformation strategies that need to be considered to support these fast development programs, ideally with examples. What needs to be done and when? Is MIST assessment required? Is a hADME needed to support the initial registration or can sufficient data be generated by other means?

If you are interested in contributing to this session, please send an abstract to either alexander_david.james@novartis.com or markus.walles@novartis.com.
 

13.30 - 14.00   Closing Remarks

14.00   Delegates depart