From Wikipedia, on this day in 1328: English friar William of Ockham, who popularised the methodological principle known as Occam's razor, secretly left Avignon under threat from Pope John XXII.
Occams has co-authored another publication: Selection of the Recommended Phase 2 Dose for Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1 with Justin Wilkins as Occams author. It is open access so you can directly download your copy!
Occams is extremely proud to be part of the nlmixr team that has just published a landmark comparison paper between the nlmixr/FOCEI and NONMEM/FOCEI algorithms, and between the nlmixr/SAEM and Monolix/SAEM algorithms. nlmixr is a free and open-source R-package that implements non-linear mixed effect modelling, and this publication now demonstrates that in both sparse and rich data situations, nlmixr can provide parameter estimates that match those obtained from the industry standards. The paper has been published in CPT:PSP and is now available in early view: Performance of the SAEM and FOCEI Algorithms in the Open-Source, Nonlinear Mixed Effect Modeling Tool nlmixr with Rik Schoemaker as first author, and Justin Wilkins as one of the co-authors.
Occams has co-authored another publication: Population pharmacokinetics and covariate analysis of Sym004, an antibody mixture against the epidermal growth factor receptor, in subjects with metastatic colorectal cancer and other solid tumors with Janet Wade and Rik Schoemaker as Occams authors. Contact us if you would like a copy!
Occams has co-authored the just-released ground breaking nlmixr tutorial in CPT:PSP, and as it is open access, we can provide a direct download: Nonlinear Mixed-Effects Model Development and Simulation Using nlmixr and Related R Open-Source Packages with Justin Wilkins and Rik Schoemaker as Occams authors.
We have finally been able to publish the paper associated with the PAGE presentation by Lutz Harnisch in 2016(!) and as authors we can provide a free download: Modeling and simulation of the modified Rankin Scale and National Institutes of Health Stroke Scale neurological endpoints in intracerebral hemorrhage with Rik Schoemaker as first author, in Journal of Pharmacokinetics and Pharmacodynamics.
Occams has co-authored another publication: Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types with Justin Wilkins as first author, in Advances in Therapy.
Occams has co-authored another publication, and as it is open access, we can provide a direct download: Systemic pharmacokinetic/pharmacodynamic analysis of intravitreal aflibercept injection in patients with retinal diseases with Julia Winkler as Occams author, in BMJ Open Opthalmology.
Occams has authored another publication, and as it is open access, we can provide a direct download: Time-varying clearance and impact of disease state on the pharmacokinetics of avelumab in Merkel cell carcinoma and urothelial carcinoma with Justin Wilkins and Janet Wade as Occams authors, in CPT:PSP.
The nlmixr team is delighted to announce that it will be running another nlmixr workshop at PAGE in Stockholm on Tuesday 11 June 2019. Recent updates incorporating a solid FOCE-I algorithm greatly enhance the applicability of the R-based free and open-source package for non-linear mixed effect modelling! Places are limited and can be reserved here.
We are pretty proud to see our work being used in an EMA recommendation on How should results/predictions of pharmacokinetic analyses be presented to facilitate decision making about the adequacy of the proposed dosing regimen in paediatric patients? referencing Brivaracetam population pharmacokinetics in children with epilepsy aged 1 month to 16 years by Rik Schoemaker, Janet Wade and Armel Stockis, in the European Journal of Clinical Pharmacokinetics.
Julia Winkler, Rik Schoemaker, and Armel Stockis have authored another new publication! Population Pharmacokinetics of Adjunctive Lacosamide in Pediatric Patients With Epilepsy, in The Journal of Clinical Pharmacology.
Julia Winkler, Rik Schoemaker, and Armel Stockis have authored a new publication: Modeling and simulation for the evaluation of dose adaptation rules of intravenous lacosamide in children, in Epilepsy Research.
We look forward to seeing and talking to all our friends and colleagues!
Occams has just co-authored a new publication, with Justin Wilkins as final author: Data standards for model-informed drug development: an ISoP initiative, in Journal of Pharmacokinetics and Pharmacodynamics.
- I-59: Population pharmacokinetic analysis of M7824 (MSB0011359C) in different cancer types, by Justin and colleagues
- II-32: Drug-disease model describing the effect of intraarticular injected sprifermin on cartilage thickness measured by magnetic resonance imaging in osteoarthritis patients, by Julia, Rik and colleagues
On 20 April 2018 at 9:15 Marina Senek defended her PhD thesis New approaches for levodopa treatment in Parkinson’s Disease with aplomb at the Department of Neuroscience, Uppsala University. Janet Wade was on the board of examiners.
Occams has just authored a new publication, and as it is open access, we can provide a direct download: Evaluation of brivaracetam efficacy as monotherapy in adult patients with focal seizures by Rik Schoemaker, Janet Wade Joseph D'Souza, and Armel Stockis, in Epilepsy Research.
The entire Occams team will be present at ACoP8 in Ft. Lauderdale, and we will be presenting three posters:
Rik will be presenting a poster on Tuesday on nlmixr: an open-source package for pharmacometric modeling in R (T-012). This poster will be part of the Poster Spotlight session to highlight the integration between statistics and pharmacometrics.
Justin will be presenting two posters on Wednesday on Clearance over time and effect of response in the pharmacokinetics of avelumab (W-079) and Population pharmacokinetic analysis of avelumab in different cancer types (W-080).
Justin has served as a member of the ISoP Board of Directors since 2016. During this time, he has served as Secretary and a member of the Executive Committee, the chair for the Standards and Best Practices Committee, chair-elect for the Nomination Committee, and as leader or key contributor for several ISoP initiatives. Justin will succeed Jin Yan Jin as President-Elect at the end of ACoP8 (October 2017), and will start his Presidential term at the end of ACoP9 (October 2018).
The oral presentation at PAGE 2016 on scaling brivaracetam effects from adults to children has now been published in Clinical Pharmacokinetics! It is open access, and so we can provide a direct download: Extrapolation of a Brivaracetam Exposure–Response Model from Adults to Children with Focal Seizures by Rik Schoemaker, Janet Wade and Armel Stockis.
As part of a series of articles to commemorate the retirement of pharmacometrics legend Meindert Danhof, Justin Wilkins
collaborated with Mats Karlsson of Uppsala University, Daniela Conrado and Klaus Romero of the Critical Path Institute and Céline Sarr of
Pharmetheus on an article discussing open innovation and sharing. We're delighted that it's now available online here!
We are all attending PAGE in Budapest from 6 to 9 June 2017! Come and see our posters:
- II-03: nlmixr: an open-source package for pharmacometric modelling in R, by Rik, Justin and colleagues
- II-49: Population PK analysis of Sym004 and the influence of variations in base model structure on covariate model building, by Janet, Rik and colleagues
The presenters will both be by their posters between 15:10 and 16:40 on Wednesday 7 June - come visit us!
In collaboration with DDMoRe, Justin Wilkins and colleagues have published a white paper describing the new Thoughtflow standard for facilitating provenance-based capture, storage, and reporting of knowledge, including assumptions and decisions, as well as supporting reproducibility in pharmacometrics.
Visit the Thoughtflow community group here!
This award recognizes outstanding and sustained leadership, mentorship, and outreach contributions to the field of pharmacometrics and to the development of the strategic vision for the future direction of the field. The award will be presented at the opening of the ACOP8 meeting in Fort Lauderdale, Florida, on Sunday, 15 October, 2017, which we will all be attending. Rik is in good company - previous winners of this distinguished award include such luminaries in our field as Sandy Allerheiligen, Larry Lesko, Richard Lalonde, Hartmut Derendorf, William Jusko and David D’Argenio.
Rik is the heart and soul of PAGE, having overseen the organization of Europe’s pharmacometrics conference since 1996. Instrumental in shaping its sharp focus on science and its long tradition of supporting student research, Rik has been key in the development of an untold number of our past, present and future peers. It is safe to say that PAGE, and indeed the field of pharmacometrics in general, would not be what it is without him. If this were not enough, Rik is author and co-author of over 170 publications, including a number of original research articles, and is a key part of the team behind nlmixr, a new tool being developed for nonlinear mixed-effects modelling. If there is a more deserving candidate for the ISoP Leadership Award in 2017, we are hard pressed to think of one. Congratulations, Rik!
Occams has just authored a new publication, and as it is open access, we can provide a direct download: Brivaracetam population pharmacokinetics in children with epilepsy aged 1 month to 16 years by Rik Schoemaker, Janet Wade and Armel Stockis, in the European Journal of Clinical Pharmacokinetics.
We are proud to announce that Julia Winkler has joined the Occams family, effective 1 January 2017. Julia brings a wealth of industry and consulting experience in pharmacometrics across a broad range of indications, strengthening our dream team even further. Welcome aboard, Julia!
We have secured a new domain and Occams now sits maturely at Occams.com. Our email addresses will be updated shortly, but you will still be able to contact us using the occams.eu extension!
On 9 December 2016 at 9:15, Anne-Gaëlle Dosne defended her thesis with the title Improved methods for pharmacometric model-based decision making in clinical drug development brilliantly at Uppsala University, and Rik Schoemaker was her external examiner.
Occams is very proud to be playing a supporting role in the release of nlmixr, an open source package for population PK and PKPD modelling developed by Wenping Wang and Yuan Xiong. nlmixr builds on Wenping's RxODE package for simulation of nonlinear mixed effect models using ordinary differential equations, by implementing parameter estimation algorithms like nlme, gnlmm and SAEM. nlmixr greatly expands the utility of existing packages (like nlme) by providing an efficient and versatile way to specify pharmacometric models and dosing scenarios, with rapid execution due to compilation to C++.
The source is now available at https://github.com/nlmixrdevelopment/nlmixr along with a vignette, and the models and datasets used in the nlmixr/nlme poster to be presented at ACoP (W-66): nlmixr: an open-source package for pharmacometric modelling in R on Wednesday, 26 October, 2016, 7:30-9:30 am. At this point, nlmixr is still very much in a testing stage and is under lively development. Get in touch, see us at ACoP to discuss ways you could contribute (Wenping Wang, Yuan Xiong, Justin Wilkins and Rik Schoemaker will all be there), or try it out for yourself, and experience the joy of a population modelling package within R! A live demo will be possible, so come see Rik if you are interested!
Occams will be represented at WCoP 2016 in Brisbane by Rik Schoemaker. Meet him there or come see his poster on nlmixr: an open-source package for pharmacometric modelling in R on Monday, 22 August, 2016, 12.15-1:15 pm. nlmixr is a highly exciting open-source development that allows non-linear mixed effect modelling using R and the nlme package, but implementing full dosing flexibility along with ordinary differential equations, and computational speed by compiling to C. A live demo will be possible, so come see Rik if you are interested!
At Occams we believe in providing academic output next to our consultancy work, and we are therefore happy to announce that we have co-authored two publications over the last months:
- Peter L. Bonate, Malidi Ahamadi, Nageshwar Budha, Amparo de la Peña, Justin C. Earp, Ying Hong, Mats O. Karlsson, Patanjali Ravva, Ana Ruiz-Garcia, Herbert Struemper, and Janet R. Wade. Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group. J Pharmacokinet Pharmacodyn (2016) 43: 123.
- Rik Schoemaker, Janet R. Wade, and Armel Stockis. Brivaracetam Population Pharmacokinetics and Exposure-Response Modeling in Adult Subjects With Partial-Onset Seizures. Journal of Clinical Pharmacology (2016). doi: 10.1002/jcph.761.
We are extremely proud and honoured that Occams is has been granted two oral presentations at PAGE 2016! One will be presented by Lutz Harnisch (Pfizer) in a collaborative project with Pharmetheus, Occams and Pfizer with the title Modelling and simulation of neurological endpoints (modified Rankin Scale [mRS] and National Institute of Health Stroke Scale [NIHSS]) to aid clinical trial design in intracerebral hemorrhage (ICH), and one will be presented by Rik Schoemaker (Occams) with the title Extrapolation of a Brivaracetam Exposure-Response Model from Adults to Children on work performed while at Exprimo in collaboration with UCB.
Occams is committed to supporting global training, research and development in the field of pharmacometrics. Our consultants are variously associated with PAGE and the International Society of Pharmacometrics (ISoP), and in 2016 we are proud to be sponsors of PAGE (www.page-meeting.org), WCoP (wcop2016.org) and PMX Benelux !
Occams will be represented at ACoP 2015 by Rik Schoemaker. Meet him there or come see his poster (T-50) on Modeling the Effect of Levetiracetam on Daily and Aggregated Seizure Counts in Adults and Children on Tuesday, October 6, 2015, 7.30-9.00 am.