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BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220426T093000
DTEND;TZID=Europe/Stockholm:20220426T120000
DTSTAMP:20260403T230741
CREATED:20220411T114853Z
LAST-MODIFIED:20220411T115121Z
UID:10000581-1650965400-1650974400@www.scilifelab.se
SUMMARY:New developments in upstream bioprocessing technologies seminar
DESCRIPTION:Presentation och demonstration av nya single use bioreactors (SUB) för mammalieceller.  \n\n\n\nregister to attend\n\n\n\nProgram:  \n\n\n\n9:30-10:15 Matthijs Neimeijer\, Cultivating red blood cells in singe-use bioreactors \n\n\n\n10:15-10:45 Fika och demonstration \n\n\n\n10:45-11:30 Michel Kensler\, Comparisons in scale up and down scale \n\n\n\n11:30-12:00 Questions
URL:https://www.scilifelab.se/event/new-developments-in-upstream-bioprocessing-technologies-seminar/
LOCATION:Air&Fire\, SciLifeLab Stockholm\, Tomtebodavägen 23A\, Solna\, Sweden
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220404T140000
DTEND;TZID=Europe/Stockholm:20220404T150000
DTSTAMP:20260403T230741
CREATED:20220325T125600Z
LAST-MODIFIED:20220325T143719Z
UID:10000569-1649080800-1649084400@www.scilifelab.se
SUMMARY:Information Meeting: Call for therapeutic oligonucleotide projects
DESCRIPTION:This digital information meeting will be held April 4\, 2022 at 14.00–15.00. At this meeting\, there will be a presentation of the call and you as an applicant will have the opportunity to ask questions about the call and the application process. \n\n\n\nregister here to receive zoom link\n\n\n\nApply in the call here\n\n\n\nThe mission of the Drug Discovery and Development Platform at SciLifeLab is to support researchers in developing new drugs\, transforming academic ideas into new treatments. To this end\, the DDD platform provides state-of-the-art drug discovery technologies to scientists across the country. Therapeutic oligonucleotides are a recent addition to the DDD platform’s capacity\, complementing the previous focus on small molecule and protein drugs. Oligonucleotide drugs have different modes of action\, and a potentially faster development compared to other drug types. Therapeutic oligonucleotide development is supported by the OligoNova Hub\, based in Gothenburg and part of SciLifeLab’s DDD platform. \n\n\n\nIn this call\, we are looking for project ideas for new therapeutic oligonucleotides that can be developed at DDD and OligoNova Hub. Approved project ideas will be developed in close collaboration between the academic laboratory and drug development experts at DDD and OligoNova Hub. The costs of the projects will mainly be covered by OligoNova\, but academic partners will be expected to contribute by paying for reagent costs. \n\n\n\nThe call is open for scientists with a doctoral degree at a Swedish university or higher institution. English should be used when filling out this application. You are responsible for ensuring that the application is complete. Incomplete applications will not be processed. Attach only material that we explicitly request. SciLifeLab DDD/OligoNova will not accept additional information after the closing date for applications\, except for information we ourselves explicitly request. Applications are reviewed by a review committee with international representation. \n\n\n\nCall Announcement FlyerDownload\n\n\n\nThe call is open March 28\, 2022 to May 13\, 2022.
URL:https://www.scilifelab.se/event/information-meeting-call-for-therapeutic-oligonucleotide-projects/
LOCATION:Online event via Zoom
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20220127T084500
DTEND;TZID=Europe/Stockholm:20220127T170000
DTSTAMP:20260403T230741
CREATED:20211130T143050Z
LAST-MODIFIED:20211130T160953Z
UID:10000492-1643273100-1643302800@www.scilifelab.se
SUMMARY:11th Symposium on Pharmaceutical Profiling in Drug Discovery and Development
DESCRIPTION:Uppsala University’s Department of Pharmacy hosts the 11th Pharmaceutical Profiling meeting on Thursday\, January 27\, 2022\, at The Humanities Theatre\, English Park Campus\, Uppsala. \n\n\n\nJanuary 27\, 2022The Humanities Theatre\, English Park Campus\, UppsalaConfirmed speakers \n\n\n\nKathryn A. Whitehead (Carnegie Mellon University\, US)Ola Engkvist (AstraZeneca\, Sweden)Carolina Wählby (Uppsala University\, Sweden)Samir EL Andaloussi (Karolinska Institutet\, Sweden)Ola Spjuth (Uppsala University\, Sweden)Pär Matsson (University of Gothenburg\, Sweden)Annabelle Biscans (AstraZeneca\, Sweden)\n\n\n\nWe highly encourage all participants to bring a scientific poster.
URL:https://www.scilifelab.se/event/11th-symposium-on-pharmaceutical-profiling-in-drug-discovery-and-development/
LOCATION:Humanities Theater\, Engelska parken\, Uppsala\, 75238\, Sweden
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211208T140000
DTEND;TZID=Europe/Stockholm:20211208T150000
DTSTAMP:20260403T230741
CREATED:20211124T131507Z
LAST-MODIFIED:20211206T105940Z
UID:10000491-1638972000-1638975600@www.scilifelab.se
SUMMARY:SciLifeLab Drug Discovery Seminar & DDD Exit event: Thomas Helleday
DESCRIPTION:Pharmacological targeting of MTHFD2 suppresses acute myeloid leukemia by inducing thymidine depletion and replication stress\n\n\n\n\n\n\n\nProfessor Thomas Helleday\, Karolinska Institutet \n\n\n\nSciLifeLab Drug Discovery Seminars\, hosted by the DDD platform\, is a series of educational lectures about recent developments\, technologies\, and trends in drug discovery and development that aims to enlighten\, and spark a discussion\, within the Swedish drug discovery community. \n\n\n\nAbstract \n\n\n\nThe folate metabolism enzyme MTHFD2 is consistently overexpressed in cancer but its roles are not fully characterized and current candidate inhibitors have limited potency for clinical development. Here we demonstrate a role for MTHFD2 in DNA replication and genomic stability in cancer cells\, and present optimised potent and selective nanomolar MTHFD2 inhibitors (MTHFD2i); protein co-crystal structures demonstrated binding to the active site of MTHFD2 and target engagement and that works in vitro and in vivo. \n\n\n\nThe results demonstrate a functional link between MTHFD2-dependent cancer metabolism and replication stress that can be exploited therapeutically with this new class of inhibitors. The work\, done in collaboration with the SciLifeLab DDD platform\, is accepted in the journal Nature Cancer and is the base for the creation of a new company: One-carbon therapeutics AB.  \n\n\n\nregistration
URL:https://www.scilifelab.se/event/scilifelab-drug-discovery-seminar-ddd-exit-event/
LOCATION:Air&Fire\, SciLifeLab Stockholm\, Tomtebodavägen 23A\, Solna\, Sweden
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211112T140000
DTEND;TZID=Europe/Stockholm:20211112T150000
DTSTAMP:20260403T230741
CREATED:20211014T151650Z
LAST-MODIFIED:20211020T131013Z
UID:10000467-1636725600-1636729200@www.scilifelab.se
SUMMARY:[Drug Discovery Seminar] PROTAC Degraders: From Fundamental Chemical Biology to Translation and Entrepreneurship
DESCRIPTION:SciLifeLab Drug Discovery Seminars\, hosted by the DDD platform\, is a series of educational lectures about recent developments\, technologies\, and trends in drug discovery and development that aims to enlighten\, and spark a discussion\, within the Swedish drug discovery community. \n\n\n\nAlessio Ciulli\n\n\n\nProfessor of Chemical Structural Biology \n\n\n\nCentre for Targeted Protein Degradation\, School of Life Sciences\, Division of Biological Chemistry and Drug Discovery\, University of Dundee \n\n\n\n \n\n\n\nAbstract\n\n\n\nProteolysis-targeting chimeras (PROTACs) are a new class of chemical tools and drugs that target disease-causing proteins for degradation. They are designed to harness the cell’s natural disposal system (the ubiquitin-proteasome) to specifically remove proteins. A PROTAC is a two-headed (i.e. bifunctional) molecule where one end binds an enzyme (an E3 ubiquitin ligase) and the other binds the target protein\, bringing the two proteins into close proximity as a ternary complex. The ligase is then able to label the target protein for ubiquitination and so degradation by the cell’s disposal system. Whereas conventional drugs only inhibit disease proteins by binding and locking up their most important functional parts for the duration of the drug’s action\, PROTACs can bind at any positions and rapidly cause the disease protein’s permanent and long-lasting destruction. Due to this revolutionary mode of action\, PROTACs can attack targets previously thought ‘undruggable’.  \n\n\n\nIn my lecture\, I will outline some key discoveries from my laboratory that have advanced the chemical structural biology of PROTACs\, and are providing fundamental insights into our understanding of their molecular recognition\, mechanism of action and drug design. I will also offer insights from our efforts to translate this fundamental science into molecular therapeutics to benefit patients\, via both partnerships with big pharma and formation of company spin-outs. Finally I will highlight the vision and mission of our recently announced new Centre for Targeted Protein Degradation at Dundee. \n\n\n\nShort Bio\n\n\n\n\n\n\n\nAlessio Ciulli holds the Personal Chair of Chemical Structural Biology at the School of Life Sciences\, University of Dundee. He is also the Director of the newly announced Dundee’s Centre for Targeted Protein Degradation (CeTPD). Dr Ciulli’s laboratory has made important contributions to selective chemical intervention on protein-protein interactions targets and to the development of proteolysis-targeting chimeric molecules (PROTACs) as a viable strategy for targeted protein degradation. Amongst his most significant discoveries are the fragment-based design of ligands for the E3 ligase von Hippel-Lindau (VHL)\, and their use to design one of the first VHL-based PROTACs: the BET degrader MZ1. Dr Ciulli’s Lab later illuminated fundamental insights into PROTACs’ mechanism of action\, solving the first crystal structure of a PROTAC ternary complex. Dr. Ciulli is the scientific founder of Amphista therapeutics\, a company that develops new protein degradation platforms. Before joining Dundee\, Dr Ciulli was a group leader at the University of Cambridge\, where he previously earned his PhD degree. Amongst his honours are the EFMC Prize for Young Medicinal Chemist in Academia\, the RSC Capps Green Zomaya Award in medicinal computational chemistry\, and election as Fellow of the Royal Society of Chemistry. \n\n\n\n \n\n\n\nRegistration
URL:https://www.scilifelab.se/event/drug-discovery-seminar-protac-degraders-from-fundamental-chemical-biology-to-translation-and-entrepreneurship/
LOCATION:Navet\, SciLifeLab Uppsala\, SciLifeLab Uppsala\, BMC C11\, Husargatan 3\, Uppsala\, 75237\, Sweden
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211110T140000
DTEND;TZID=Europe/Stockholm:20211110T150000
DTSTAMP:20260403T230741
CREATED:20211014T151000Z
LAST-MODIFIED:20211020T130718Z
UID:10000466-1636552800-1636556400@www.scilifelab.se
SUMMARY:[Drug Discovery Seminar] How protein degradation led to faculty entrepreneurship at Yale: A personal Perspective
DESCRIPTION:SciLifeLab Drug Discovery Seminars\, hosted by the DDD platform\, is a series of educational lectures about recent developments\, technologies\, and trends in drug discovery and development that aims to enlighten\, and spark a discussion\, within the Swedish drug discovery community. \n\n\n\nCraig Crews\n\n\n\n\n\n\n\n \n\n\n\nJohn C. Malone Professor of Molecular\, Cellular\, and Developmental Biology and Professor of Chemistry\, of Pharmacology\, and of Management; Executive Dirictor\, Yale Center for Molecular Discovery\, Yale University \n\n\n\nAbstract \n\n\n\nProf. Crews is the 2021 recipient of the Scheele prize from the Swedish Pharmaceutical Society for his seminal work on protein degradation. In this talk Prof. Crews will discuss his efforts to translate research from his lab into new biopharma ventures.  To date\, these entrepreneurial  efforts have resulted in a FDA approved drug (Kyprolis) and a new therapeutic modality (PROTACs).  While each of his four companies has been launched based on different science\, they have all followed a similar business model and Prof. Crews will discuss efforts at Yale to ’systematize’ faculty entrepreneurism via a core ‘biotech accelerator’ facility. \n\n\n\nregistration\n\n\n\nBiography \n\n\n\nCrews is the John C. Malone Professor of Molecular\, Cellular and Developmental Biology and holds joint appointments in the departments of Chemistry and Pharmacology at Yale University. He graduated from the U.Virginia with a B.A. in Chemistry and received his Ph.D. from Harvard University in Biochemistry. Dr. Crews has a foothold in both the academic and biotech arenas; on the faculty at Yale since 1995\, his laboratory has pioneered the use of small molecules to control intracellular protein levels.  \n\n\n\nIn 2003\, he co-founded Proteolix\, Inc.\, whose proteasome inhibitor\, Kyprolis™ received FDA approval for the treatment of multiple myeloma. Since Proteolix’s purchase by Onyx Pharmaceuticals in 2009\, Dr. Crews has focused on a new drug development technology\, which served as the founding intellectual property for his latest New Haven-based biotech venture\, Arvinas\, Inc.  \n\n\n\nCurrently\, Dr. Crews serves on several editorial boards and was Editor of Cell Chemical Biology (2008-2018). In addition\, he has received numerous awards and honors\, including the 2013 CURE Entrepreneur of the Year Award\, 2014 Ehrlich Award for Medicinal Chemistry\, 2015 Yale Cancer Center Translational Research Prize\, a NIH R35 Outstanding Investigator Award (2015)\, the AACR Award for Chemistry in Cancer Research (2017)\, Khorana Prize from the Royal Society of Chemistry (2018)\, Pierre Fabre Award for Therapeutic Innovation (2018)\, the Pharmacia-ASPET Award for Experimental Therapeutics (2019)\, the Heinrich Wieland Prize (2020) and the Scheele Prize (2021). In 2019\, he was named an American Cancer Society Professor.
URL:https://www.scilifelab.se/event/drug-discovery-seminar-faculty-entrepreneurship-at-yale-a-personal-perspective/
LOCATION:Air&Fire\, SciLifeLab Stockholm\, Tomtebodavägen 23A\, Solna\, Sweden
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20211028T130000
DTEND;TZID=Europe/Stockholm:20211028T140000
DTSTAMP:20260403T230741
CREATED:20210930T150158Z
LAST-MODIFIED:20211014T151926Z
UID:10000459-1635426000-1635429600@www.scilifelab.se
SUMMARY:[Drug Discovery Seminars] Targeting the oncogenic TGFβ signaling pathway in cancer to inhibit invasion and metastasis
DESCRIPTION:Maréne Landström \n\n\n\nOctober 28\, 13:00-14:00 \n\n\n\n \n\n\n\nregistration\n\n\n\nWelcome to join this Drug Discovery Seminar hosted by the Drug Discovery and Development Platform. \n\n\n\nPresenter: \n\n\n\nProfessor Maréne Landström\, M.D.\, PhD \n\n\n\nDept. Medical Biosciences\, Umeå University \n\n\n\nMaréne Landström is a professor in Pathology at Department of Medical Biosciences\, Umeå University\, Sweden. She has made her postdoctoral training at the Ludwig Institute of Cancer Research\, Uppsala Branch and have also been a group leader at Department of Immunology\, Genetics and Pathology\, Uppsala University before taking on her current position. \n\n\n\nAbstract: \n\n\n\nTransforming growth factor beta (TGFb) is frequently overexpressed in several forms of cancer including prostate cancer and this has been shown to correlate with poor prognosis. TGFb is transducing its canonical and non-canonical signals via its transmembrane TGFb Type II and Type I receptors (TbRII/TbRI) which are serine-threonine kinases. We have found that the TbRI undergoes proteolytic cleavage in cancer cells in a manner dependent on the ubiquitin-ligase tumor necrosis factor (TNF) receptor-associated factor 6 (TRAF6). The intracellular domain of TbRI (TbRI-ICD) is released from the cell membrane\, soluble and is transported to the nucleus in some specific forms of cancer to promote expression of genes causing invasion and metastatic growth. In collaboration with SciLifeLab DDD we have generated potential therapeutic antibodies to target this pathway which we are investigating the function of\, in our established preclinical models for prostate cancer.
URL:https://www.scilifelab.se/event/drug-discovery-seminars-targeting-the-oncogenic-tgf%ce%b2-signaling-pathway-in-cancer-to-inhibit-invasion-and-metastasis/
LOCATION:Online event via Zoom
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20210608T140000
DTEND;TZID=Europe/Stockholm:20210609T120000
DTSTAMP:20260403T230741
CREATED:20210503T135818Z
LAST-MODIFIED:20210607T152505Z
UID:10000373-1623160800-1623240000@www.scilifelab.se
SUMMARY:CryoEM in Drug Discovery
DESCRIPTION:CryoEM has quickly become an essential tool in academic research\, with more than 1200 cryoEM structures deposited in the PDB in 2019. CryoEM is now also showing a significant impact on drug discovery in industry and academia. \n\n\n\nThis symposium\, co-arranged by the Drug Discovery and Development platform and the CryoEM unit at SciLifeLab\, highlights some of the recent advances in the field and familiarises the audience with the requirements\, opportunities\, and limitations of the technique. Speakers include leading scientists from both major pharma companies and academia. \n\n\n\nBy attending this symposium\, you learn what cryoEM can bring to your research\, what resources are available to Swedish researchers\, and how to get started. We welcome both Swedish and international participants.  \n\n\n\n \n\n\n\n \n\n\n\n\nregister here to receive zoom link\n\n\n\n\n\n\n\nSession 1\n\n\n\nAll time slots below are in UTC+2 / CEST Time zone [Stockholm\, Sweden]. \n\n\n\nJune 8th – Afternoon\n\n\n\n14:00Welcome wordsAnnika Jenmalm-Jensen\, Infrastructure Director\, SciLifeLab14:05Introduction to the cryo-EM Unit at SciLifelabMarta Carroni\, SciLifeLab/Stockholm University\, Sweden14:15From Concept to Reality: CryoEM as an Integral Part of Drug Discovery and Development Corey Strickland; Merck\, Kenilworth\, United States14:55CryoEM at AstraZenecaChris Phillips; Astra Zeneca\, UK15:25Short break15:30An integrated cryo-EM and AI based approach for new vaccine identificationIlaria Ferlenghi\, GSK\, UK16:00Cryo-EM structure of Helicobacter pylori urease with an inhibitor in the active site at 1.68 Å resolution Hartmut Luecke\, University of Oslo\, Norway16:30CryoEM in industry\, with an artisanal touchAlexis Rohou\, Genentech\, United States17:00Wrap upMarta Carroni\, SciLifeLab/Stockholm University\, Sweden\n\n\n\nSession 2\n\n\n\nAll time slots below are in UTC+2 / CEST Time zone [Stockholm\, Sweden]. \n\n\n\nJune 9th – Morning\n\n\n\n09:00Session 2 WelcomeMarta Carroni\, SciLifeLab/Stockholm University\, Sweden09:00Cryo-EM and crystal structure of the emerging cancer target PAICS incomplex with a low-nanomolar inhibitorJana Skerlova\, Stockholm University\, Sweden09:15Using Cryo-EM for GPCR Drug Discovery and Development Patrick M. Sexton\, Monash University\, Parkville\, Australia09:55Short break10:00Cryo-EM at NovartisMaryam Khoshouei\, Novartis\, Switzerland10:30CryoEM of SARM1 reveals a trigger of axon degenerationKatie Cunnea\, Evotec\, UK11:00Concluding RemarksMarta Carroni\, SciLifeLab/Stockholm University\, SwedenPer Arvidsson\, SciLifeLab/Karolinska Institutet\, SwedenAnders Olsson\, SciLifeLab/KTH Royal Institute of Technology\, Sweden\n\n\n\n\n\n\n\nScientific committee\n\n\n\nMarta Carroni\, Head of Cryo-EM unit\, SciLifeLabPer Arvidsson\, Director Drug Discovery and Development platform\, SciLifeLabAnders Olsson\, Head of Protein Expression and Characterization unit\, SciLifeLab
URL:https://www.scilifelab.se/event/cryoem-in-drug-discovery/
CATEGORIES:Event
LOCATION:https://www.scilifelab.se/event/cryoem-in-drug-discovery/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20210604T130000
DTEND;TZID=Europe/Stockholm:20210604T134500
DTSTAMP:20260403T230741
CREATED:20210518T091847Z
LAST-MODIFIED:20210520T115320Z
UID:10000387-1622811600-1622814300@www.scilifelab.se
SUMMARY:Drug Discovery Seminars: An adaptable Drug Affinity Conjugate (ADAC) targeting CD40
DESCRIPTION:Proof of Concept and Pharmaceutical profiling\n\n\n\nSara Mangsbo\, Uppsala University\n\n\n\nAbstract: \n\n\n\nMuch attention has focused on developing CD40 directed agonistic monoclonal antibody therapy. Monoclonal antibodies targeting CD40 have been profiled for their epitope specificity and isotype in relation to their agonistic potential. Still\, clinical impact relies on a well-balanced clinical efficacy versus target-mediated toxicity. As CD40-mediated immune activation must rely on a combination of stimulation of antigen-presenting cells alongside antigen-presentation\, for efficient T cell priming\, alternative approaches to improve the therapeutic outcome of CD40-targeting strategies should focus on providing optimal antigen presentation together with CD40 stimulation. We have developed a bispecific antibody targeting CD40 as a means to carry in cargo (herein synthetic peptides) into antigen-presenting cells through a non-covalent\, high-affinity interaction between the antibody and the cargo peptide\, further referred to as the Antibody Drug Affinity Conjugate (ADAC) technology. The ADAC can improve both CD4+ and CD8+ T cell expansion in vitro and significantly improve CD8+ T cell proliferation in vivo. In addition\, the strategy leads to a stabilization of the half-life of the synthetic peptide. Future applications of ADAC involve pandemic preparedness to viral genetic drift as well as neoepitope vaccination strategies where the bispecific antibody is an off-the-shelve product\, and the peptide antigen is synthesized based on next-generation sequencing data mining.  \n\n\n\nA short speaker biography: \n\n\n\nSara Mangsbo (PhD) is Associate senior lecturer in antibody drugs and Associate professor in Experimental clinical immunology at Uppsala University. Dr Mangsbo earned her PhD in 2010 in cancer immunotherapy at Uppsala University and has since then focused her research on antibody-based drug delivery and synthetic long peptides and was recently awarded the SITC team award within the SLP stream. She is a serial entrepreneur and has founded Immuneed AB\, a service provider of immunotoxicity measurements in human whole blood. She is the Chief Development Officer of Ultimovacs and the co-founder of Vivologica AB and STRIKE pharma AB.  She drives a translational research project with the ambition and track-record of taking research projects into clinical trial testing.   \n\n\n\nRegistration
URL:https://www.scilifelab.se/event/an-adaptable-drug-affinity-conjugate-adac-targeting-cd40-proof-of-concept-and-pharmaceutical-profiling/
CATEGORIES:Event
ATTACH;FMTTYPE=image/jpeg:https://www.scilifelab.se/wp-content/uploads/2020/02/pills_600x200px.jpg
LOCATION:https://www.scilifelab.se/event/an-adaptable-drug-affinity-conjugate-adac-targeting-cd40-proof-of-concept-and-pharmaceutical-profiling/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Stockholm:20210526T150000
DTEND;TZID=Europe/Stockholm:20210526T160000
DTSTAMP:20260403T230741
CREATED:20210428T095007Z
LAST-MODIFIED:20210602T140817Z
UID:10000370-1622041200-1622044800@www.scilifelab.se
SUMMARY:Role of physiologically-based pharmacokinetics in regulatory submissions
DESCRIPTION:Fabienne Gaugaz Slides from the webinarDownload\n\n\n\nLuzon et al\, 2017Download\n\n\n\nAbstractPhysiologically based pharmacokinetic (PBPK) is an approach that help predict the absorption\, distribution\, metabolism and excretion (ADME) properties of candidate drugs in animal/human and evaluate the effects of intrinsic (e.g. organ dysfunction\, age\, genetics) and extrinsic (e.g. diet\, smoking habit\, drug-drug interactions) factors\, alone or in combinations\, on drug exposure\, during drug discovery and development process. Currently\, different software (i.e. SimCYP\, PK-Sim\, GastroPlus etc) are available to perform the PBPK simulations\, and the simulations are often part of regulatory submissions of small molecules and biologic new drug candidates (CD). \n\n\n\nIf successful\, the simulations may complement or replace the experimental study and/or help to explain different findings\, scenarios related to estimation of exposure and effect of new CDs. Therefore\, the regulatory authorities i.e. EMA and FDA provided guidelines\, which described how to report PBPK models and simulations in a regulatory context.Dr Gaugaz in her presentation will discuss role of PBPK simulations from small molecules and biologic CDs in submissions\, from regulatory point of view. \n\n\n\nPresenterDr Fabienne GaugazPharmacokinetics Assessor\,Medical Products Agency (Läkemedelsverket)Dag Hammarskjölds Väg 42\,752 37 Uppsala \n\n\n\nBiographyDr Fabienne Gaugaz is pharmacokinetics assessor at the Swedish Medical Product Agency (Läkemedelsverket)\, which entails the evaluation of the pharmacologically-based pharmacokinetics (PBPK) simulations related to small molecules and biologic drug candidates. Dr Gaugaz previously worked at Bayer (Wuppertal\, Germany) as lab head of research pharmacokinetics. Fabienne made her postdoc project at Karolinska Institutet (KI) and Uppsala University (UU). Dr Gaugaz obtained her Ph.D. in 2013 in pharmaceutical biology at the Institute of Pharmaceutical Sciences\, Swiss Federal Institute of Technology (ETH) in Zürich\, Switzerland and her M.Sc. in Pharmacy\, ETH\, Zürich\, Switzerland.
URL:https://www.scilifelab.se/event/role-of-physiologically-based-pharmacokinetics-in-regulatory-submissions/
CATEGORIES:Event
LOCATION:
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