Day 1: November 28, 2023
13:00 - 16:45 CET
Presentations & Panel Breakouts
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15:45 - 16:45 CET | BO 1: Computational methods and model based approaches in drug development
Saving Resources with Simulation: Population PK Models in Bioequivalence Trials
Rebeka JerebHolistic approach to wet ball milling process modeling
Nemena AničičData science in pharmaceutical development
Dejan VeluščekR-Shiny App for Clinical Data Exploration
Jaclyn AmbergModerator: Uroš Markoja
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15:45 - 16:45 CET | BO 2: Proud off - Scientific challenges A
Goodbye team, hello new team - Collaboration with JUST Evotec
Andreas HoffmannIdentification of fragments as root cause for similarity offset in SOK583 - VEGF-A 121 interaction
Franz KremplMechanism of action evaluation tool (MET)
Beata BozokiSignal-to-Noise for a more accurate determination of immunogenicity response
Davide GuerrieriModerator: Martina Mueller Raschke
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15:45 - 16:45 CET | BO 3: Proud off - Scientific challenges B
Group sequential design in biosimilar studies
Jessie WangThe Integrated Summary of Immunogenicity as Key Component during Interchangeability Evaluation
Johann PötzlUtility of Real-World Evidence (RWE) in Biosimilar development
Sinha Samriddhi BuxyQuantitative Signal Detection in Patient Safety using Advanced Statistical Algorithms
Amit KubavatModerator: Andrea Stosik
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15:45 - 16:45 CET | BO 4: The ongoing impact of AI on Pharma
The ongoing impact of AI on Pharma
Richard PughModerator: Biljana Janković
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15:45 - 16:45 CET | BO 5: Regulatory and QbD
GloRIA - Our Vision
Andrea FischerGP2411 experience with applying ICH Q12
Thomas StanglerMATURE BRANDS - NVS off patent innovative medicinal products transfer to SDZ
Sandeep Kumar Navva505b2 Cyclophosphamide – Building the Bridge for first cycle Approval in 13 M in US
Mateja Egart, Vid PužModerator: Bindu Hima
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15:45 - 16:45 CET | BO 6: Proud off - Scientific challenges C
From Silos to Synergy: Connecting the Dots of Diverse Expertise
Sumanth PrabhuBCS-based biowaiver approach as an alternative to in-vivo bioequivalence for Solriamfetol FCT- a case study
Aakash DapleLisdexamfetamine Dimesylate HGC mass gap in accelerated stability storage conditions – a bittersweet symphony
Harald HofbauerTake my breath away - Optimization of process parameters to enable filling of thixotropic gels
Nejc KlemencModerator: Ambrin Fatima
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15:45 - 16:45 CET | BO 7: Proud off - Scientific challenges D
Leave the world a bit better place - Mutagenic Impurities
Filip de BockRisk and Mitigation Approaches Adopted to Crack the Critical Pivotal BE Studies of Phytonadione Tablets 5 mg
Jigneshkumar SavaliyaSuccessful development and FAT of a novel generic dry powder inhaler automated assembly line of the Brahms device
Jan Fiedler, Daniel McCree & Pierre SolcherQ1/Q2 deformulation of opthalmics - measuring few components can be like a puzzle of 1000 pieces
Simona PeterlinModerator: Jerca Pahor
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15:45 - 16:45 CET | BO 8: Panel Discussion: Power of Scientists
Panel Discussion: Power of Scientists
Claire D'Abreu-Hayling, Alex George, Matej Horvat, Mateja Prunk, Julia Antonia Brinkmeier, Sridevi ChallaModerator: Luka Peternel
Day 2: November 29, 2023
13:00 - 16:45 CET
Poster & Panel Breakouts
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15:45 - 16:45 CET | Poster Breakout Room 1
High5OLA: Triple First, Fast & Focused Olaparib BE study in patients
Kaja Gantar‘Just a white powder’ – complexity of formulation and device characteristics in respiratory product development
Heinrich Martin ÜblerNitrofurantoin Success Journey-Strategizing project execution with collaborative approach
Deepthi CherukuriProcess Optimization of Oligonucleotide-loaded Lipid Nanoparticles: Design of Experiments and Biological Characterization
Miha HomarBioequivalence study on Beclometasone/Formoterol HFA pMDI
Jeevan YewalModerator: Stefan Grgić
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15:45 - 16:45 CET | Poster Breakout Room 2
Out of the box strength waiver approach Azilsartan decreasing the risk and cost of BE study
Eva Furlan KoprivecMicroflux applicability for on-track development of complex drug products
Tilen HuzjakEU / UK bridging study to address MHRA guidance for Sandoz Be/Fo pMDIs 100/6mcg and 200/6 mcg pMDI products
Miriam KleinIf you want to go fast, go alone. If you want to go far, go together; Successful NCE-1 filing of Upadacitinib ERT – A story of cross country collaboration
Joydeep MazumderZanubrutinib Project Triumph: A Journey to Success: Strategizing product development with collaborative approach
Kodukula GouthamiModerator: Vesna Petrovska Jovanovska
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15:45 - 16:45 CET | Poster Breakout Room 3
Strength of Team work
Bojan TasičFrom Zero to Hero: Rapid Nasal Spray Performance Optimization for IVBE Testing
Jernej GrmašChallenges with developing an in-vitro dissolution method for orally inhaled drug products in the Kepler platform
Marie Gerda HellfritzschHuge cost saving if health authorities accept proposed clinical study waiver for the change in composition of Buprenorphine 4-day TTSM
Lea ElsnerReproxalap - a textbook example for an enantiotropic solid-state system
Verena AdamerModerator: Arthur Pichler
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15:45 - 16:45 CET | Poster Breakout Room 4
Model Based Similarity Assessment for Optimizing the Design of Clinical PK Similarity Studies
Roland BaumgartnerEfficient simulation-based approach for blinded sample size re-estimation of PK similarity studies
Rachid El GaltaMass spectrometry based characterization of antibody-drug conjugates
Lomary MoonFc methionine oxidation results in capture artefact of BLI and SPR analytics of IL-4Ra/Dupilumab interaction
Franz KremplIn silico molecular docking & dynamics to streamline biosimilar development
Monika Pintar HitzlModerator: Armin Fuchs
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15:45 - 16:45 CET | Poster Breakout Room 5
The Achilles’ heel of circulating CD20 is the key to a highly target-tolerant assay for the quantification of ocrelizumab
Philip VlaicuVolumetric Absorptive Microsampling (VAMS) a promising alternative to traditional sampling techniques
Ana Villalba IzquierdoLead assay concept and bioassay comparability study of DLC317
Beata BozokiAssessment of the ocular and systemic PK of SOK583 and Eylea after intravitreous administration to rabbits
Francis DodellerAdvanced in vitro models – finding the gaps to effectively support biosimilar development
Patricio Godoy TapiaModerator: Tanja Špec Anzelc
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15:45 - 16:45 CET | Poster Breakout Room 6
How to transform a regulated laboratory from paper-based to paperless documentation
Christian FetzerNeuro Fuzzy modeling to predict pharmacokinetic (PK) performance of respiratory products
Dejan KrajcarDesign options for SDZ clinical trials
Arne RingEnhancing Tech Transfer to Manufacturing: DP Development Activities for EGI014
Manca LogarHarvesting the Power of Data: Development of customized Database
Sebastian HolodaModerator: Irenej Jerič
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15:45 - 16:45 CET | BO 7: Panel Discussion: Science meets Culture
Panel Discussion: Science meets Culture
Christoph Huestebeck, Florian Bieber, Jan Humljan, Simon Hedgecock, Jutta AmersdorfferModerator: Christina Rhima
