Rosa & Co. announced today the publication of an article titled, "Virtual patients inspired by multiomics predict the efficacy of an anti-IFNα mAb in cutaneous lupus." Rosa & Co. co-published the article with Servier, Research and Development and GENYO Center for Genomics and Oncological research in iScience on January 6, 2025.  To read the article: iScience journal article link. 

After 22 years, Rosa & Co. has created mechanistic models in a number of therapeutic areas and modalities. We have published a number of models when allowed by sponsors. However, an extensive list is available at the Disease Area page. To learn more, please reach out to us via our Contact page.  Our models have helped the decision process throughout the drug discovery and development process, including disease modeling, mechanism exploration, target selection, lead optimization, pre-clinical experiment design, and throughout the clinical trial process (dose selection, combination therapies, biomarkers, product comparison, regimen optimization, etc).  Below is the list of therapeutic and disease areas that Rosa & Co. have experience in: 

Autoimmune Diseases: Interstitial Cystitis, Primary Sjogren's Syndrome, Psoriasis, Rheumatoid Arthritis, Systemic Lupus Erythematosus

Cardiovascular Diseases: Atherosclerosis, Dyslipidemia, Hypertension

Central Nervous System Diseases: Alzheimer's Disease, Emesis, Frontotemporal Dementia, Multiple Sclerosis, Opioid Overdose Reversal, Pain, Parkinson's Disease, Schizophrenia, Vasomotor Symptoms

Dermatology: Acne, Atopic Dermatitis, Dermis/Aging, Erythema, Psoriasis

Gastroenterology:  Celiac Disease, Drug-induced Colitis, Inflammatory Bowel Disease

Immuno Oncology:  Acute Lymphoblastic Leukemia, Ewing's Sarcoma, Melanoma, Metastatic Melanoma, Non-Hodgkin's Lymphoma, Non-Small Cell Lung Cancer, Pancreatic Cancer

Immunology:  Acute Kidney Injury, Acute Respiratory Distress Syndrome, Celiac Disease, Endometriosis, Fibrosis, Sepsis, Sjogren's Disease, Stroke, Systemic Lupus Erythematosus, Vasculitis

Metabolic Diseases:  Cushing's Disease, Glycogen Storage Disease, Hypoglycemia, Type 1 Diabetes, Type 2 Diabetes, Urea Cycle Disorder, 

Oncology:  Acute Myeloid Leukemia, Breast Cancer, Colorectal Cancer, Diffuse Large B Cell Lymphoma, Gastrointestinal Stromal Tumor, Lymphoma, Non-Small Cell Lung Cancer, Small Cell Lung Cancer

Rare Diseases:  Glycogen Storage Disease, Hematology, Urea Cycle Disorder, Renal Diseases, Autosomal-Dominant Polycystic Kidney Disease, Chronic Kidney Disease

Respiratory:  Asthma, COPD

The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE), in collaboration with CDER’s Office of Translational Sciences and the Critical Path Institute (C-Path), has created a free, web-based training modules on model-informed drug development (MIDD).

One module in particular is an excellent summary of the different types of mathematical methods used in MIDD.  Here is a link for that module: 

Here is a summary of the transcript: 

Stacey Tannenbaum of Astellas Pharma presents an in-depth overview of model types utilized in model-informed drug development (MIDD), particularly focusing beyond basic pharmacokinetics (PK) to include disease progression and the impact of drugs at macro and micro levels. The discussion covers various aspects of disease modeling, quantitative systems pharmacology (QSP), and the nuances of drug effects on disease progression.

Key points include:

1. Foundational PK Principles: Emphasis on understanding drug disposition and exposure as critical to optimizing downstream pharmacokinetic/pharmacodynamic (PK/PD) interactions.
2. Disease Progression Models: Exploration of disease behavior without intervention and the various external factors that can alter disease progression, such as lifestyle changes or non-pharmaceutical interventions like placebo effects.
3. Quantitative Systems Pharmacology: Delving into QSP to analyze disease at a micro level, integrating drug intervention models to predict therapeutic outcomes.
4. Exposure Response Relationships: Discussion on different exposure metrics like area under the curve (AUC), C-max, and the importance of understanding these relationships to optimize dosing.
5. Model Types and Selection: Insights into choosing appropriate models based on disease mechanisms, including Emax models and target-mediated drug disposition (TMDD) models.
6. Challenges in MIDD: Highlighting the complexity of translating pharmacometric models into clinical practice, including regulatory challenges and the necessity for model validation.

The presentation aims to provide drug development scientists with a comprehensive view of the role of advanced modeling in understanding drug effects, optimizing dosages, and predicting clinical outcomes, emphasizing the shift from empirical to more mechanistic models in drug development.

Rosa will present four posters at the Fifteenth American Conference on Pharmacometrics (ACoP15).   

• Monday, November 11th
  • "A translational QSP model to characterize the preclinical pharmacodynamics of combining a KRAS G12C inhibitor with a SHP2 inhibitor." Poster M-068 from 7-9 am and 12:30-2 pm in collaboration with Genentech.  
• Wednesday, November 13th
  • "Adaptation of a Published Kidney Disease QSP Model to Represent Autosomal-Dominant Polycystic Kidney Disease and Evaluate Treatment Options." Poster W-033 from 7-9 am and 12:15-1:45 pm in collaboration with Otsuka Pharmaceutical Co, Ltd. 
  • "Parallel Tempering for Generation of Virtual Patients and Virtual Populations."  Poster W-034 from 7-9 am and 12:15-1:45 pm.
  • "Mathematical Optimization of a Thrombopoiesis Quantitative Systems Pharmacology (QSP) Model to Improve Chemotherapy Dosing." Poster W-102 from 7-9 am and 12:15-1:45 pm.
    See more at: ACoP15 Webpage

Rosa is seeking PhD students, postdoctoral scholars, and early researchers in academia and industry to present as part of Rosa World Wide Webinar series.  These webinars will support outstanding early career investigators by providing an opportunity for them to show their research to a broad audience.  We are looking for presenters whose research advances the adoption of modeling and simulation in drug development.  If you are an early career investigator with an interesting research presentation, please send a presentation title, an abstract (250 words max) a brief bio (100 words max) to marketing@rosaandco.com.  Rosa has been hosting a regular webinar series since 2011 and each webinar draws several hundred attendees from a mix of drug development disciplines from both industry and academia.  Each webinar includes a slide presentation followed by a brief Q&A session, lasting about an hour total.  The application deadline to present as an early career investigator is July 31, 2024.

Rosa & Co is pleased to announce the publication of "Life Scientists Improve QSP Model Quality and Impact" in Frontiers in Pharmacology, section Translational Pharmacology. 

Modelers and life scientists are both important for generating insights and value from QSP modeling. Because life scientists have specific expertise in disease pathology and physiology, having a life scientist participate in all phases of QSP modeling improves model development and outcomes.

The article is available at: https://doi.org/10.3389/fphar.2024.1392747.

The International Society of Pharmacometrics has announced the Outstanding Research Manuscript Award for 2023 is “Quantitative systems pharmacology model of the amyloid pathway in Alzheimer's disease: Insights into the therapeutic mechanisms of clinical candidates.” Authors: Vidya Ramakrishnan, Christina Friedrich, Colleen Witt, Robert Sheehan, Meghan Pryor, Jasvinder K Atwal, Kristin Wildsmith, Katherine Kudrycki, Seung-Hye Lee, Norman Mazer, Carsten Hofmann, Reina N Fuji, Jin Y Jin, Saroja Ramanujan, Michael Dolton, Angelica Quartino. https://pubmed.ncbi.nlm.nih.gov/36281062/ would like to congratulate all of the authors for their excellent work!

Rosa will present a talk and a poster at the Fourteenth American Conference on Pharmacometrics (ACoP14). Dr. Friedrich will present “QSP Modelers – Take Your Data Seriously, Not Literally!” during the Roller Coaster 2 session on Wednesday, 11/8/23. Dr. Dasika's Poster "Pathway-Driven Parameter Sampling Improves Quality and Efficiency of QSP Virtual Patient Generation" will be presented during the poster sessions on Tuesday, 11/7/23. https://www.go-acop.org/

Rosa’s Brian Schneider will attend the Health Economics & Outcomes Research (HEOR) Summit December 12 - 14, 2023 in Philadelphia, PA. 

https://heor-summit.com/

Rosa's Brian Schneider and Matt Marano will run a Roundtable at the event on November 9, 2023 in Cambridge, Massachusetts, USA. More information is available at

https://proventainternational.com/

Come talk with Rosa at the MarcusEvans Evolution Summit on September 11-13, 2023 at the Park Hyatt Aviara Resort, Golf Club & Spa , Carlsbad, CA.

Rosa & Co is pleased to announce the publication of "Using machine learning surrogate modeling for faster QSP VP cohort generation" which was published in CPT:PSP. The article is available at https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12999

Rosa & Co is pleased to announce that it will be presenting two posters at the Population Approach Group Europe (PAGE) 2023 meeting. Poster II-31 'Incorporating complex drug PK with multiple binding targets into a QSP model to predict combined PD effects.' will be presented by Jared Cui on Wednesday, June 28 from 15:35-17:00.https://www.page-meeting.org/d...II-63 'Development of a primary Sjogren’s Syndrome (pSS) quantitative systems pharmacology (QSP) model linking mechanistic pathways to clinical scores.' will be presented by Vincent Hurez on Wednesday, June 28 from 15:35-17:00. https://www.page-meeting.org/d...,

Matt Marano, Chief Commercial Officer of Rosa & Co,. and Brian Schneider, Vice President of Business Development for Rosa & Co., will be attending the MarcusEvans Evolution Summit on May 24-26, 2023, at the Encore Boston Harbor in Boston, MA. https://may23.evolutionsummit.com

Meet with Rob Singer and Matt Marano from Rosa & Co. at the MarcusEvans PharmaMarketing Summit in Westlake Village, CA on May 11-12, 2023, to learn more about Rosa’s ForecastMD® Market Modeling Platform and DueDiligenceMD™ offering. For more information about the Summit, see https://www.may23.pharmamarketingsummit.com/

Meet with Matt Marano, Chief Commercial Officer for Rosa & Co and Mike Reed, PhD, Chief Scientist for Rosa’s PhysioPD® QSP Platform at Proventa’s 5th Annual Clinical Operations Strategy Meeting in San Diego on May 11, 2023.Mike will be giving a Keynote Presentation titled, “The Growth of Modeling and Simulation Strategies in Pharmaceutical Research, Development and Clinical Programs.”
For more information see, https://proventainternational....

Rosa's Christina Friedrich will be on the panel for FDA workshop 'Creating a Roadmap to Quantitative Systems Pharmacology Informed Rare-Disease Drug Development. May 11, 2023. For more information about the workshop, see https://cersi.umd.edu/event/17...

Meet with Matt Marano, Chief Commercial Officer of Rosa & Co., to learn more about Rosa’s PhysioPD® Research Platforms at the MarcusEvans Evolution Summit in Montreux, Switzerland, on April 20-21, 2023. For more information about the summit, 

see https://www.april23.evolution-summit.com/

Meet with Rob Singer of Rosa Market Modeling at the Biotechgate Digital Partnering Meeting from February 6-10, 2023. For more information about the event, see https://partnering.biotechgate...

Rosa is seeking PhD students, postdoctoral scholars, and early researchers in academia & industry to present as part of the Rosa World Wide Webinar series. These webinars will support outstanding early career investigators by providing an opportunity for them to show their research to a broad audience. We are looking for presenters whose research advances the adoption of modeling and simulation in drug development. If you are an early career investigator with an interesting research presentation, please send a title, abstract, and a short bio to webinar@rosaandco.com.Rosa has been hosting the monthly “Impact” webinar series since 2011 and each Webinar draws several hundred attendees from a mix of drug development disciplines. The speakers and audience come from both industry and academia. Each Webinar includes a slide presentation followed by a brief discussion, lasting about an hour total. After the webinar, a recording of the webinar and slides from the webinar are posted on the webinar archive site. For your reference, you can see archived sessions and the upcoming Webinar schedule here: http://www.rosaandco.com/webin... to apply to present as an early career investigator is April 1, 2023.

Rosa will be participating in the Biotechgate Digital Partnering Meeting. Meet with Rob Singer of Rosa Market Modeling at the Digital Partnering Meeting from November 28 to December 2, 2022. For more information on the event, pleas see the websites at https://partnering.biotechgate... and https://www.digitalpartnering.com/.

Rosa & Co. announced today the publication of an article titled, “From Cold to Hot: Changing Perceptions and Future Opportunities for Quantitative Systems Pharmacology (QSP) Modeling in Cancer Immunotherapy,” which was published in Clinical Pharmacology & Therapeutics. To read the article see:

https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/psp4.12999

Rosa & Co. announced today the publication of an article titled, “Quantitative Systems Pharmacology Model of the Amyloid Pathway in Alzheimer’s Disease: Insights into the Therapeutic Mechanisms of Clinical Candidates,” which was published online ahead of print on CPT Pharmacometrics Syst Pharmacol. on October 24, 2022. To read the article:

https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12876

Rosa & Co. is pleased to announce the presentation of two posters at the 2022 ACoP13 meeting. The posters ‘QSP Model of Aß Accumulation Predicts Different Treatment Effects at Different Stages of Alzheimer’s Disease.’ and ‘Higher Fentanyl Exposures Require Higher Doses of Naloxone for Successful Reversals in a Quantitative Systems Pharmacology Model.’ will be presented on October 31 at the the ACoP13 meeting in Aurora Colorado. For more information about the meeting, see https://www.go-acop.org/

.

Matt Marano, Chief Commercial Officer for Rosa & Co. will be attending the upcoming Cell and Gene Therapy Strategy Meeting: Europe 2022 on Tuesday, October 11, 2022. See the following link for more details. https://proventainternational.com/211-partner/

Meet with Matt Marano, Chief Commercial Officer for Rosa & Co. at the upcoming Proventa Clinical Operations Strategy Meeting in Zurich on Monday, October 10, 2022. 

Meet with Rob Singer from Rosa & Co. at Biopharm America, Oct 4-5, 2022. https://buff.ly/3V0T5rd. Rob will be speaking with biotech and pharmaceutical companies about Rosa’s ForecastMD™ Platform and to investors about Rosa’s new DueDiligenceMD service. This will be a virtual meeting.

Rosa & Co. is pleased to announce it is offering DueDiligenceMD in addition to the ForecastMD™ Research Platform. For organizations that are evaluating assets for in-licensing, partnering, or acquisition, DueDiligenceMD quantifies and explains the expected physician demand for the asset, based on primary market research and an Excel®-based Revenue Model. DueDiligenceMD projects are typically completed within two weeks.Rosa & Co. is also enhancing our PhysioPD® Research with the use of Artificial Intelligence/ Machine Learning (AI/ML) techniques. PhysioPD Research provides biological context, facilitates insight into dynamics and causality, and supports hypothesis generation. Adding AI/ML techniques to PhysioPD Research speeds the identification of networks from data, supports empirical model and Virtual Patient creation, and enriches the insights extracted from simulation results.
See the press release at https://www.einnews.com/pr_news/590758247/rosa-announces-new-duediligencemd-pharma-asset-research-service-and-ai-ml-capabilities-for-physiopd

Rosa & Co. LLC is pleased to announce that Dr. Bill Brastow, Chief Technology Officer for Rosa Market Modeling, will present a webinar "Injecting Reality into Commercial Due Diligence for In-Licensing, Partnering or Purchasing Pharmaceutical Assets in Development" on Wednesday, August 17, 2022, at 12:00 to 1:00 pm EDT. As part of the Rosa World-Wide Webinar Series, this webinar focuses on how pharmaceutical and biotech companies can inject reality into the commercial opportunity analysis by measuring expected physician demand for the drug to inform revenue projections and decisions about in-licensing, partnering, or purchasing these assets.To learn more or register for the webinar, see: https://rosaandco.com/webinars

Rosa and Servier will be presenting a talk and a poster on modeling systemic lupus erythematosus next week at Quantitative Systems Pharmacology Conference 2022 (QSPC2022), in Leiden, the Netherlands https://www.qspc.eu/qspc2022. Dr. Christina Friedrich from Rosa will be presenting “Predicted efficacy of a pan neutralizing anti interferon-alpha (IFN-α) monoclonal antibody in a virtual systemic lupus erythematosus (SLE) patient cohort using a mechanistic SLE PhysioPD QSP model” on Friday 4/22. Rosa & Co. is a proud sponsor for this important QSP conference.

Come see Rosa at the Oncology Strategy Meeting, San Francisco, May 11, 2022. Live and in person! https://buff.ly/3LIhPyJ

Rosa will be at Oncology Europe 2022 on June 14, 2022. Mike Reed, Chief Scientist, PhysioPD will be presenting. Come meet us live and in person! https://buff.ly/3KgHmir

Rosa & Co is pleased to announce the release of a new video discussing how our ForecastMD™ Market Model Platform can quantify how a new prescription drug or diagnostic test may take market share from current options. The video is part of Rosa’s 20th-anniversary celebration. Click to see the ForecastMD™ Platform Dynamics video.

Rosa & Co is pleased to announce the release of a new video discussing how our ForecastMD™ Market Model Platform helps commercial teams from biotechnology, pharmaceutical, and diagnostic companies simulate physician demand for their new product in a variety of competitive scenarios. The video is part of Rosa’s 20th-anniversary celebration. Click here to see the ForecastMD™ Platform Overview Video.

Rosa & Co is thrilled to announce the release of a video celebrating its 20th-anniversary. The company is celebrating this historic event with videos, events, and news throughout the year. Click here to see our 20th-Anniversary Video.

Rosa & Co is pleased to announce the release of a new video discussing how the ForecastMD™ Excel-based Market Model is a durable asset that our clients can use over multiple years to quantify physicians' demand for their prescription drug or diagnostic test as the market changes over time. The video is part of Rosa’s 20th anniversary celebration. The video is available at Durable Asset. .

Rosa & Co is pleased to announce the release of a new video discussing how a ForecastMD™ Market Model can quantify physician demand for a prescription drug or diagnostic test under multiple product profiles or competitive scenarios. The video is part of Rosa’s 20th-anniversary celebration. The video is available at Market Model Implications.

Rosa & Co is pleased to announce the release of a new white paper “Commercializing Life Science Products. Which Product Properties Are Important in Convincing Physicians and Patients to Use My Product? And How to Ask This Question”. The paper describes a scientific approach to HCP product selection.

Rosa is excited to announce the launch of the ForecastMD™ Platform. Rosa's Life Sciences clients use this proprietary, quantitative market modeling technique to inform product design decisions and commercial viability assessments. See the press release.

Rosa & Co is thrilled to announce its 20th anniversary. The company will be celebrating this historic event with videos, events, and news throughout the year. See the 20th anniversary press release.

Rosa & Co. announced today the publication of an article titled, “Brief Report: Higher Fentanyl Exposures Require Higher Doses of Naloxone for Successful Reversals in a Quantitative Systems Pharmacology Model,” which was published on Research Square on December 22, 2021.
To read the article: https://www.auctoresonline.org

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) announced today that additional data in a quantitative systems pharmacology model supports the dose of naloxone hydrochloride that is included in the company’s ZIMHI™ (naloxone HCL Injection, USP) 5 mg/0.5 mL product.To read the press release: adamispharmaceuticals

Rosa & Co. announced today the contributions of Drs. Christina Friedrich, Vincent Hurez, and Maria-Luisa Ruiz to the article titled, “Quantitative systems pharmacology model-based investigation of adverse gastrointestinal events associated with prolonged treatment with PI3- kinase inhibitors,” which was published in CPT Pharmacometrics Systems Pharmacology on December 1, 2021.
To read the article: https://ascpt.onlinelibrary.wi...

Rosa & Co. is proud to announce that a poster authored by Rosa scientists will be presented at the upcoming virtual American Conference on Pharmacometrics (ACoP) meeting.Christina Friedrich, Ph.D., Chief Engineer at Rosa & Co. and Renee Meyers, Modeling Associate at Rosa & Co., will be presenting a poster titled, “Surrogate Modeling with Machine Learning for Faster Virtual Patient Cohort Generation in QSP Models.” The presentation will take place on Tuesday, November 9th from 8:45 AM to 9:30 AM and 12:45 PM to 1:30 PM EST. The 2021 ACoP Meeting will take place virtually from November 8-12, 2021.https://www.go-acop.org/

Rosa & Co. is proud to announce that a poster authored by Rosa scientists will be presented at the upcoming 14th International Congress of Inborn Errors of Metabolism (ICIEM) meeting. Rebecca Baillie, Ph.D, Principal Scientist and Chief of Staff at Rosa & Co, will be presenting a poster titled, “Using Modeling for Dose Recommendations of A Novel Drug for Urea Cycle Disorders”. The presentation will be a digital poster included within the Congress virtual platform.
The 2021 ICIEM meeting will take place virtually and in person from November 21-23, 2021. https://www.iciem2021.com.au/

Rosa & Co. is proud to announce that two posters authored by Rosa scientists will be presented at the upcoming Population Approach Group in Europe (PAGE) virtual meeting.Vincent Hurez, DVM, Ph.D, a Senior Scientist at Rosa & Co., will be presenting a poster titled, “Development of a systemic lupus erythematosus (SLE) QSP model linking systemic biomarkers to cutaneous clinical score (CLASI) outcomes”. The presentation will take place at Poster Session II on Monday, September 6, 2021, from 12:00 PM to 1:00 PM CET.https://www.page-meeting.org/d...
Rebecca Baillie, Ph.D., Principal Scientist and Chief of Staff at Rosa & Co., will be presenting a poster titled, “Reuse of a published model to support compassionate use of novel drug formulation for a rare disorder”. The presentation will take place at Poster Session III on Tuesday, September 7, 2021, from 12:00 PM to 1:00 PM CET.https://www.page-meeting.org/d... 2021 PAGE meeting will take place virtually from September 2-7, 2021.https://www.page-meeting.org/d...

Rosa & Co. announced today the contributions of Dr. Christina Friedrich, Chief Engineer at Rosa, to the article titled, “FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective,” which was published in The AAPS Journal on April 30, 2021.To read the article: https://link.springer.com/arti...

Today, Rosa & Co. announced that Dr. Tongli Zhang, Assistant Professor at the University of Cincinnati, will present a webinar entitled, “Integrating Quantitative Systems Pharmacology and Machine Learning, Why Bother,” on Wednesday, July 14th. As part of the Rosa World-Wide Webinar Series, this webinar focuses on Dr. Zhang’s vision of how an integration between Quantitative Systems Pharmacology and Machine Learning could utilize the strength of each method, overcome their limitations, better understand biomedical systems and eventually lead to the design of optimized treatments. To see the recorded webinar:https://www.rosaandco.com/webi...

Rosa & Co. announced today the publication of an abstract titled, “Modeling shows the NK3R antagonist, ACER-801, reduces treatment-induced vasomotor symptoms,” in the 2021 ASCO Meeting Library.Rosa team members Rebecca Baillie, Katherine Kurycki, Christina Friedrich, and Mike Reed worked with Acer Therapeutics on this research regarding their pipeline product, ACER-801. “Using a QSP neurobiology model as a research tool enabled us to evaluate the efficacy of the NK3R antagonist, ACER-801, to treat HD therapy-induced VMS. Simulations show ACER-801 may be highly efficacious for the treatment of induced-VMS. The research provided estimates of DDI with ACER-801 and tamoxifen and what clinical experiments would be needed to confirm those estimates.” To read the abstract: https://meetinglibrary.asco.or...

Today, Rosa & Co. announced that Dr. Vincent Hurez, Senior Scientist at Rosa & Co., will present a webinar entitled “Predicting subjective or complex clinical outcomes in QSP models: challenges and approaches” on Wednesday, May 12th.As part of the Rosa World-Wide Webinar Series, this webinar focuses on how complex clinical outcomes can be included in quantitative systems pharmacology (QSP) models.To see the recorded webinar: https://www.rosaandco.com/webi...

Panel discussion and posters showcase how PhysioPD™ Research fundamentally improves decision making at critical steps in drug development
SAN CARLOS, CA, USA, November 7, 2020 /- Rosa & Co. announced today that it will lead a panel discussion and present six poster presentations at the Eleventh American Conference on Pharmacometrics (ACoP11), to be hosted virtually from 9 -13 November 2020.Rosa & Co.’s presence at ACoP11 aligns with the theme of the conference - “Scaling New Heights” - encompassing scientific expertise and innovation, education, tools and resources, and the expanding role of pharmacometrics in protecting and improving human health. “We are excited to chair a panel discussion and present at a premier event such as ACoP11, which will be held safely in a virtual format,” said Christina Friedrich, Rosa & Co.’s Chief Engineer. “Our results illustrate how PhysioPD Research supports drug development and provides significant insights even when data are sparse, when clinical symptom scores are complex or qualitative, and when a clinical trial is not possible, as is the case for opioid overdose reversal. https://www.einpresswire.com/a...

NEWTON, MA – July 8, 2020 – Acer Therapeutics Announces Administration of ACER-001 in a Fasted State Increased Systemic Exposure of Phenylbutyrate in Healthy Volunteer Food Effect Study
Model suggests ACER-001, Acer’s taste-masked, immediate-release formulation of sodium phenylbutyrate, may offer improved disease management in patients with Urea Cycle Disorders compared to current treatments.
Anticipate submitting ACER-001 NDA in H1 2021 assuming successful completion of additional nonclinical work and long-term stability data, and subject to additional capital.
Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced data from a food effect study in healthy volunteers showing that administration of ACER-001 in a fasted state increased systemic exposure of phenylbutyrate (PBA), phenylacetate (PAA) and phenylacetylglutamine (PAGN) levels compared to fed state, and therefore based on modeling data may improve disease management in patients with urea cycle disorders (UCDs) when compared to currently approved treatments requiring administration with food. Read More

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) announced today the publication of an article entitled “Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level” in the peer reviewed publication “PLOS ONE, ” This study was done in collaboration with Rosa and Co.
Naloxone is an opioid antagonist used to treat narcotic overdoses. Naloxone works by reversing the detrimental effects of the opioid, including slowed breathing, brain dysfunction, loss of consciousness and death.

https://journals.plos.org/plos...

Today, Rosa & Co. announced that Dr. Bill Brastow, Chief Technology Officer at Rosa Market Modeling, will present a webinar entitled “Driving Market Share for Healthcare Products by Integrating Market Modeling” on Wednesday, March 18.
Hosted in partnership with Marcus Evans, this webinar focuses on how commercial teams and executive decision makers can obtain scientifically rigorous and statistically reliable real-world evidence to define which characteristics and performance levels will drive uptake of their product in the face of numerous potential competitive scenarios.
“Rosa Market Modeling tells you how much your product characteristics will impact share early in product development,” said Dr. Brastow. “Product teams can thereby design clinical trial endpoints and the rest of the product’s profile to maximize return”.
“The integration of Rosa Market Modeling with Rosa’s PhysioPD Research allows us to address in a wholistic manner the most critical clinical and commercial risks faced by our clients” said Ron Beaver, Founder, Chairman and CEO of Rosa & Co. “Both are unique, world-class capabilities that allow project teams and executives to gain understanding of drug-disease mechanisms and health care markets that are difficult or impossible to get in any other way.”
Dr. Brastow’s webinar brings together market modeling pioneers as well long-time executive-level customers to explain the methodology and to discuss how market modeling has guided their strategies for the successful commercialization of healthcare products in existing, and in some cases in entirely new markets.
For more information and to register, go to: https://event.on24.com/wcc/r/2...

Rosa & Co. LLC, known worldwide for its PhysioPD™ Research Platforms, announced today that their research poster abstract, to be presented at the ASCPT Annual Meeting “Vision 2020” in Houston TX, was chosen by the organization as a recipient of a Top Poster Ribbon for the high-quality of the abstract. The poster, entitled “Using Quantitative Systems Pharmacology (QSP) Models to Connect Biomarkers to Clinical Disease Activity Scores – Examples in Atopic Dermatitis and Psoriasis”, focuses on showing how mechanistic QSP models can integrate existing mechanistic and clinical data to generate plausible predictions of qualitative or complex disease scores in response to novel interventions. At the meeting, the poster will have a blue poster ribbon to denote the Top Poster honor.Visitors are encouraged to come and see the poster and meet the work’s first author, Rosa Chief Engineer Christina Friedrich, PhD., during the DX Modeling Poster Walk (Thursday March 19, 5:55pm - 6:25pm) and/or during Poster Session III (Friday March 20, 12:30pm - 1:45pm). Contact us to arrange a meeting at another time during the event.

Today, Rosa & Co. announced a webinar entitled "Mainstreaming MIDD: A Holistic and Integrative Approach", to be presented on February 19th by Rajanikanth (Raj) Madabushi, Ph.D. - Team Lead, Guidance and Policy & CDER Point-of-Contact for the MIDD paired Meeting Pilot Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, USFDA.
“Over the last few decades, it has become clear that MIDD is indispensable for efficient and effective drug development as well as regulatory evaluation of small molecule drugs and biological products,” stated the Team Lead. “MIDD provides powerful tools to address a variety of drug development and regulatory questions. The regulatory applications of MIDD can be broadly classified into four categories: dose optimization, supportive evidence for efficacy, clinical trial design, and informing policy."
Read More

San Carlos, CA, January 15, 2020 – Rosa & Co. LLC announced today that Jeffrey R. Sachs, Ph.D., a Senior Principal Scientist at Merck and Co., will demonstrate the power of Pharmacometrics in vaccine discovery and development in a live webinar
Rosa & Co.’s first webinar of 2020 will discuss the impact and future role of pharmacometrics on vaccine development. Pharmacometrics is the term used to describe mathematical models of biology, pharmacology, disease, and physiology utilized to portray and quantify interactions between xenobiotics and patients (human and non-human), including beneficial as well as adverse effects.
“Studies by the World Health Organization and others have concluded that prophylactic vaccines are safe and effective and have made an immense contribution to human and animal health,” stated Jeffrey R. Sachs, Ph.D., a Senior Principal Scientist at Merck & Co.“. more

MathWorks’ SimBiology Application Engineer to show the power of SimBiology and MATLAB for QSP model calibration and evaluation in live webinar
SAN CARLOS, CA, USA, December 4, 2019 /EINPresswire.com/ -- Rosa & Co. LLC announced today that Dr. Sietse Braakman, MathWorks’ SimBiology Application Engineer, will present a webinar entitled “A general workflow for parameter estimation to help establish confidence in model predictions” on December 11th.Since its inception in 2011, Rosa & Co.’s Worldwide Webinar Series is an invaluable resource for educating the industry about the impact of modeling and simulation on all phases of drug development – where outcomes have included reduced risk, reduced costs, increased confidence, as well as time and money savings. Speakers are experts from academia, industry, and regulatory agencies. More

Dr. Britta Goebel, Head of Translational Disease Modeling at Sanofi in Germany, will present a webinar entitled “Quantitative Systems Pharmacology (QSP) Modeling Support in Development of Novel Diabetes Treatments” on World Diabetes Day, November 14.
Since its inception in 2011, Rosa & Co.’s Worldwide Webinar Series has been an important resource for disseminating the impact of modeling and simulation on all phases of drug development – resulting in reduced risk, reduced costs, increased confidence, and saving time and money. Speakers have included experts from academia, industry, Rosa client companies, and internal experts.
“Diabetes is a global problem,” said Ron Beaver, Founder, Chairman and CEO of Rosa & Co. “QSP modeling of novel diabetes treatments helps shed light on the underlying mechanisms involved in diabetes as well as contributes to finding solutions for this debilitating disease.” More...https://www.einpresswire.com/a...

Case studies show how PhysioPD™ Research saves time and money, and provides critical information when a clinical trial is not an option.
Rosa & Co’s Chief Engineer Christina Friedrich, PhD, will present two key case studies at the 2019 American Association of Pharmaceutical Scientists Annual Meeting, AAPS PharmSci 360, taking place November 3-6 in San Antonio, Texas.“We are excited to present the conclusions of two case studies at a premier event such as AAPS PharmaSci 360,” said Christina Friedrich, Rosa & Co’s Chief Engineer. “Our results reveal how PhysioPD Research reduces risk and increases confidence in drug development as well as delivers significant insights when a clinical trial is not a possibility, as is the case for analyzing outcomes of intervention after an opioid overdose.” More...https://www.einpresswire.com/a...

Rosa’s PhysioPD™ Research fundamentally improves decision making at critical steps in drug development.
These case studies show the value of PhysioPD Research, and our ability to reduce and front-load risk, which has had a transformative impact on the economics of drug development for our clients.”— Ron Beaver, Founder, Chairman and CEO of Rosa & Co.
SAN CARLOS, CA, USA, October 15, 2019 -- Results from seven studies presented at the Tenth American Conference on Pharmacometrics (ACoP10) demonstrate the value of Rosa & Co.’s brand of quantitative systems pharmacology (QSP) – PhysioPD Research – in increasing confidence and reducing risk in drug development. These studies demonstrate improved candidate selection, clarification of disease and drug mechanisms, and the use of PhysioPD Research to extrapolate clinical results from adults to children to reduce risk in pediatric drug development. More...https://www.einpresswire.com/a...

Rosa & Co. LLC is expanding and seeking an Associate Life Scientist, a Senior Life Scientist, as well as a Biological Systems Modeler to join our PhysioPD™ consulting practice. Rosa is a drug-disease modeling and simulation company created to provide innovative modeling solutions to its biopharmaceutical clients and meaningful equity ownership to its employees. Life Scientists and Modeling Engineers work together in our PhysioPD practice to develop physiologically-based, dynamic mathematical models and conduct simulations of disease, drug action, and (pre)clinical studies. Full and part-time employment and project-based contracting opportunities are available throughout the United States. Interested individuals should email their resume or CV and an introductory letter to hr@rosaandco.com. Rosa is an equal opportunity employer. Upon hiring, proof of eligibility to work in the United States will be required. For more information, download the attached .pdf file

Rosa & Co. LLC, a drug development advisory firm known worldwide for its PhysioPD™ Research Platforms, today announced the initiation of a long-term Strategic Research Agreement with Chugai Pharmaceutical Co., Ltd. to provide Rosa’s PhysioPD research services.
The collaboration between Chugai and Rosa will provide Chugai a competitive research and development advantage across multiple therapeutic areas and throughout Chugai’s R&D pipeline, delivering unique scientific insights and actionable program recommendations, reducing risk and addressing complex and consequential decisions inherent in drug development.“Chugai strives to develop hand in hand with society through creation of innovative drugs and services. I am convinced that Rosa’s novel platform will provide a powerful tool to transform our research into real innovation.” said Kimio Terao, Department Manager of the Clinical Pharmacology Department, Translational Research Division, in Chugai. Rosa’s agreement with Chugai further extends Rosa’s position as the global market leader in PhysioPD Research, a Quantitative Systems Pharmacology (QSP) approach that translates biology into an interactive simulation platform representing physiology, disease, and intervention effects. It also reinforces the value that PhysioPD Research Platforms deliver through greater scientific insight and more informed drug discovery and development decisions. “We are extremely pleased to extend our relationship with Chugai. Over the last several years we have been working with them on various projects and this agreement validates the value PhysioPD Research brings,” said Rosa Founder, Chairman, & CEO Ron Beaver, PhD. “Our Strategic Research Agreements are a particularly efficient means to achieve the benefits of PhysioPD Research on a portfolio-wide basis”.About Rosa Rosa & Co was established in 2002 and is known worldwide for its PhysioPD™ Research Platforms which elucidate the connection between disease mechanisms, therapeutic interventions, and clinical outcomes. PhysioPD Research delivers credible scientific insights and actionable program impact that would be difficult or impossible to achieve with any other research approach. Pharmaceutical, biotechnology, and consumer goods clients realize significant return on investment when using PhysioPD Research for identifying responder patient populations, selecting predictive biomarkers, prioritizing or repurposing compounds, and predicting clinical efficacy of new targets. With decades of experience, 100+ presentations and publications, and mature business processes Rosa works effectively in complex organizational and scientific settings, ultimately helping clients reduce the risk of unsuccessful clinical trials or product submissions across their entire portfolio.About ChugaiChugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs.Additional information is available on the internet at https://www.chugai-pharm.co.jp...

From all of us at Rosa & Co, we wish you a wonderful year ahead!

Long before the world knew what to call ‘Quantitative Systems Pharmacology’ (QSP) in the realm of preclinical and clinical drug development, Ron Beaver, Founder, Chairman, and CEO of Rosa & Co. already had his moment of revelation. He realized that deeper understanding of empirical data and effective learning about the connection of drug and disease mechanisms are critical for more informed decisions at all stages in research and development. Driven by his passion for enabling effective experimental and trial design, he founded Rosa in 2002 to deliver an increase in confidence and reduction in risk in pharmaceutical and consumer product research and development. Today, the company holds a unique spot as a global industry-leading pharmacology solution provider for its breadth and depth of understanding of this space.Read more in Pharma Tech Outlook, Dec 2018: https://www.pharmatechoutlook....

Rosa & Co. LLC, an organization known worldwide for its PhysioPD™ Research Platforms, announced today that it will present two research posters at the 2019 ASCPT Annual Meeting Pre-Conference, “Advancing QSP Toward Predictive Drug Development: From Targets to Treatments,” in Washington, DC, March 13–17, 2019, in collaboration with Sanofi. The posters will address the use of QSP models in metabolic diseases as well as rheumatology research: 1) Incorporation of Renal SGLT Function into a Quantitative Systems Pharmacology (QSP) Model. M. Reed, M. Weis, R. Baillie, H.-C. Schneider, T. Klabunde2) Evaluation of Novel Anti-TNFα and IL-6R Therapies in a Rheumatoid Arthritis (RA) Quantitative Systems Pharmacology Platform (QSP). V. Hurez, M. Weis, R. Baillie, M. Rehberg, K. Beuke, N. Biesemann, C. Asbrand, T. Klabunde, M. Herrmann, M. Reed Meet us at the poster sessions on March 13 between 8 a.m.–5 p.m., or contact us to arrange a meeting at another time during the event.

Rosa & Co. LLC, an organization known worldwide for its PhysioPD™ Research Platforms, announced today that it will present posters with Takeda Pharmaceutical Company Ltd, and Boehringer Ingelheim GmbH at the Ninth American Conference on Pharmacometrics (ACoP9) in San Diego, California, October 7–10, 2018. The poster presentations will describe research in a range of therapeutic areas, including immuno-oncology, neurology, and respiratory diseases: On Monday Oct 8, in the morning, the research poster with Boehringer Ingelheim will be presented: "Development of the Respiratory PhysioPD™ Platform, a Quantitative Systems Pharmacology (QSP) Model, to Investigate Biological Mechanisms Underlying Bronchoconstriction". On Tuesday, Oct 9, in the morning, Rosa will present: "Evaluation of the Efficacy of a CD122 Biased Agonist for Treatment of Melanoma as a Monotherapy and in Combination with PD-1 Inhibition Using a Mechanistic Physiological Model". On Wednesday Oct 10, in the afternoon, the poster with Takeda will be presented: "Quantitative Systems Pharmacology Model to Quantify Benefits of DAO Inhibition in Schizophrenia". “When working with clients, we focus on giving them the tools to test hypotheses to make informed decisions about the disease pathophysiology, mechanism of action of the candidate drugs, and factors responsible for variability in the patient response,” said Rosa Founder, Chairman, and CEO Ron Beaver, PhD. “Using QSP and our PhysioPD™ Research Platform, we surface insights which help biopharma organizations to focus on most promising aspects of the drug efficacy and patient response.”The posters will be available at www.rosaandco.com/publications after the start of the ACoP9 meeting.

Dr. Katherine Kudrycki, Principal Scientist at Rosa & Co, will present "Evaluation of a novel therapy and identification of uncertainties critical to efficacy and competitive differentiation in a Psoriasis PhysioPD™ Platform. " at the 2018 SID/IID Dermatology meeting in Orlando, FL May 16-19, 2018.Together with Grünenthal, Rosa & Co developed a Psoriasis QSP model to mechanistically represent the physiology of a single chronic psoriatic plaque (including keratinocytes, immune cells, cytokines and chemokines and their regulation), drug PK and clinical outcomes (e.g., PASI score). At the meeting Dr. Kudrycki will demonstrate how the model was qualified and used to get insights into the therapeutic potential and efficacy of novel small molecule enzyme-specific inhibitors.For more information, contact Dr. Katherine Kudrycki at kkudrycki@rosaandco.com

We are hiring! Rosa & Co. is looking for a Senior Engineer to work with scientists in our PhysioPD practice to develop mechanistic QSP models and conduct simulations of disease, drug action, and (pre)clinical studies. Download the .pdf for more information: https://www.rosaandco.com/uplo...

The Committee on Credible Practice of Modeling & Simulation in Healthcare invited Rosa’s Chief Engineer, Dr. Christina Friedrich, to present a webinar on how to ensure model quality for Quantitative Systems Pharmacology (QSP) models. 
The committee, an initiative started by the Interagency Modeling and Analysis Group and Multiscale Modeling Consortium, aims to establish a task-oriented collaborative platform to outline good practice of simulation-based medicine.
On March 6 Dr. Friedrich's webinar introduced the concept of a Model Qualification Method (MQM) and presented two case studies to illustrate the utility of the method. 
The webinar was archived and is freely accessible at  https://youtu.be/xk3_8DyoSPQ

Genentech and Rosa will jointly present "Using a Quantitative Systems Pharmacology approach to investigate causes of the adverse GI events associated with prolonged treatment with PI3-Kinase inhibitors" at the 2018 ASCPT Annual meeting in Orlando, FL March 21-24, 2018. 

Happy holidays from all of us at Rosa & Co. Wishing you an amazing 2018!

Engineers work with Scientists in our PhysioPD practice to develop physiologically-based, dynamic mathematical models and conduct simulations of disease, drug action, and (pre)clinical studies.

Rosa & Co., LLC announced today that they will be presenting a record 12 research posters and presentations at the eighth American Conference on Pharmacometrics (ACoP8), to be held in Fort Lauderdale, FL, on October 15–18, 2017.

Rosa & Co announced today that Mike Reed, Chief Scientist at Rosa, will be participating in the panel discussion “QSP in oncology – practical application, challenge and opportunity” at the 32nd Annual meeting of the Japanese Society for the Study of Xenobiotics.

Rosa & Co announced today that Mike Reed, Chief Scientist at Rosa, and Michael Weis, Senior Engineer at Rosa, will present “Diabetes models big and small – case examples from 15 years of scoping, developing, and qualifying fit-for-purpose models for QSP research to support drug development” at the Insulin-Glucose Systems Pharmacology FDA workshop in Washington, DC on August 17-18, 2017.

Rosa & Co today announced that Dr. Meghan Pryor will be participating and presenting at the NIH Quantitative Systems Pharmacology and Neurotherapeutics Drug Discovery Workshop in Bethesda, MD, on July 26 – 27. Dr. Pryor will present a poster entitled “A Quantitative Systems Pharmacology Platform of Brain and Serum Progranulin (PGRN) to Investigate Targets in Frontotemporal Dementia (FTD)”. The poster shows how the PGRN PhysioPD Research Platform has been proven to be useful to simulate the effects of modulating different targets and investigating drug effects on increasing PGRN for the treatment of FTD.

Rosa & Co. LLC is pleased to announce the renewal of a multi-year Research Agreement with Sanofi to provide Rosa’s PhysioPD™ services. The continuing collaboration provides Sanofi with competitive research and development advantage with access to Rosa’s expertise in Quantitative Systems Pharmacology. 

Rosa & Co., LLC is proud to welcome Matt Marano as the company's Senior Vice President of Business Development. Mr. Marano will be responsible for leading the continued expansion of the company's worldwide PhysioPD™ commercial strategy. Mr. Marano joins the team from SolveBio (New York, NY) where he served as Senior Vice President of Commercial Development. During his tenure at SolveBio, he directed all sales and business development efforts, specifically focusing on VP- and C-level executives within the Life Sciences industry. Prior to SolveBio, Mr. Marano was Vice President of Sales and Business Development at Gen9 (acquired by Ginkgo Bioworks), a leading next-generation gene synthesis provider, where he successfully led the organization's commercial expansion in the United States, Europe, the Middle East and Africa.

"I am thrilled to be joining the world-class team at Rosa & Co. I've focused much of my career on expanding the commercial presence of some of the Life Science industry's most impactful companies, and Rosa is truly the world leader in Quantitative Systems Pharmacology solutions for the Life Sciences industry," said Matt Marano about his appointment. "We are fortunate that an executive of Matt's stature has joined our team. Together we can further expand our ability to offer PhysioPD Research to clients world-wide," said Founder, Chairman, & CEO Ron Beaver, PhD.

https://www.prnewswire.com/new...

Rosa announces that Mike Reed, Chief Scientist at Rosa will present at the 21st International Congress of Parkinson’s Disease and Movement Disorders meeting on June 7th in Vancouver, BC, Canada. The poster entitled "Application of a Qualitative Model to Elucidate the Role of the Alpha-Synuclein System in Parkinson’s Disease" describes the development of a Synuclein PhysioMap®, a graphical model architecture to support hypothesis generation and testing. The Synuclein PhysioMap enabled identification of key biological uncertainties and hypotheses and the recommendation of focused laboratory experiments to gain a better understanding of synuclein function in Parkinson’s disease.

Rosa announces that it will present two posters at the Society For Investigative Dermatology (SID) Annual Meeting on March 15th in Portland, OR. The first poster entitled " Mechanistic physiological modeling as a tool for enhancing dermatology research" describes the use of PhysioPD™ Platforms in dermatology drug research and development for acne, atopic dermatitis (AD), psoriasis, skin aging, and erythema indications will be presented by Christina Friedrich, Chief Engineer at Rosa & Co. The second poster entitled “Mechanistic modeling facilitates identification of key pathways involved in dermal aging and potential new targets for anti-aging intervention” is a joint presentation between Proctor & Gamble and Rosa & Co and will be presented by Katherine Kudrycki, Principal Scientist at Rosa. The poster describes the development of a Skin PhysioPD™ Research Platform, a quantitative physiological model representing the physiology of aged dermis and the effects of anti-aging treatments and the use of this Platform to research treatments for photoaged skin.

Rosa announces that Christina Friedrich, Chief Engineer at Rosa, will present at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting on March 15th in Washington DC. The poster entitled "Model Qualification Approaches For Quantitative Systems Pharmacology and Mechanistic Physiological Models" compares and contrasts newly proposed Quantitative Systems Pharmacology (QSP) qualification approaches with the use of the Model Qualification Method (MQM) in qualifying QSP/PhysioPD™ models.

Rosa and Co. LLC, founded in January 2002, is celebrating its 15-year milestone as an employee-owned drug-development advisory firm. As part of it’s anniversary celebration, Rosa has launched a new website (www.rosaandco.com) to better reflect its industry-leading scientific capabilities and support the development of the broader PhysioPD-style modeling community.

Rosa presented a poster (II-19) at the Population Approach Group, Europe (PAGE) called "Comparison of NLME and Mechanistic Physiological Modeling Methods Using Examples in Drug Discovery and Development". The work concluded that the two methods are complementary, but PhysioPD™ methods can be used earlier in discovery and development and tend to represent more complex mechanisms. (poster)

Profil™ Institute for Clinical Research, Inc. and Rosa & Co. LLC jointly announced today a strategic alliance to offer Profil Institute customers use of Rosa’s modeling technology to simulate disease physiology, drug action, patient variability, and trial outcomes for early phase clinical trials in diabetes and obesity. (press release)

Kenneth Locke, PhD, Chief Scientific Officer of Lithera, Inc., described the development of Lithera’s LIPO-102 as a pharmaceutical lipoplasty treatement for Grave’s disease and a non-surgical alternative to liposuction.  In a collaboration with Rosa, preclinical data was extrapolated to determine First-In-Human dosing that met constraints imposed by Section 505(b)(2) [21 USC §355]. “Rosa’s work allowed us to select the right FIH dose, and trial observations were very close - within 10% of what they predicted. The... modeling also allowed us to titrate directly to a final dose, and saved us significant time and cost...”, stated Dr. Locke.

The Rosa-FOCUS-IP alliance will strengthen FOCUS-IP’s innovative exploratory development programs and candidate licensing evaluations with the systematic use of Rosa’s best-in-class in silico drug-disease modeling & simulation capabilities. (Press Release).

Rosa announced novel results and qualification of a new Bile PhysioPD™ model that incorporates ‘omics data to predict ursodiol clinical data and explain inter-individual variability. The model and results were presented at the 2011 American Conference on Pharmacometrics, San Diego, CA. (Press Release).

Drs. Toufigh Gordi and Rebecca Baillie will be giving a talk entitled "Pediatric PK Modeling using AMS Data and PhysioPD Modeling of Ursodial in a Neonate Clinical Trial." on Monday, May 9, 11am - 12pm, at the Department of Pharmacy, University of Washington. (Invitation pdf).

Rosa today announced that results from its Diabetes PhysioPD™ collaboration with Pfizer will be presented at the Biorbis World PK/PD Summit in Cambridge, MA April 26-29, 2011. The Diabetes PhysioPD™ model was used to predict long-term clinical outcomes and select doses using only summary pharmacokinetic data from a competitor’s short-term Phase I clinical trial (Press Release).

In collaboration with Lithera, MediciNova, Pfizer, and Vitalea, Rosa will present 6 posters at the 2011 American Conference on Pharmacometrics, San Diego, CA. The posters illustrate PK/PD and physiological modeling in applications from preclinical to clinical development and advances in modeling methodology (Press Release).

Rosa today announced the appointment of Sharan A. Pagano, Vice President, Scientific Alliances, responsible for worldwide sales and account development, and the opening of Rosa’s Boston, MA office (Press release).

In collaboration with Vitalea Science, Inc., Rosa will present a poster at the 2011 American Society for Clinical Pharmacology and Therapeutics in Dallas, TX entitled "Compartmental Analysis of Urosodiol PK in Neonates using AMS" at 8:00 am on March 4, 2011 (see Abstract). The poster describes the first PK analysis of ursodiol in a pediatric population. The PK model uses Accelerated Mass Spectrometry (AMS) data in a first of kind study in neonatal ICU patients.

Rosa has formed a collaboration with Selventa™ to improve and accelerate drug discovery and development through biomarker identification and portfolio optimization (see News Release).

Dr. James Bosley, VP of Modeling and Simulation for Rosa, will participate as a member of an expert panel for the Clinical Pharmacology and Translational Research (CPTR) Open Forum.

In collaboration, Pfizer made an oral presentation and Rosa a poster presentatiton at the Cambridge Healthtech Institute's 8th annual Discovery on Target in Boston, MA. This third annual session was entitled "Diabetes Drug Discovery; Targeting Diabetes with Novel Therapeutics". The oral presentation was delivered by Avijit Ghosh, Ph.D.; Senior Principal Scientist; Department of Pharmacokinetics, Dynamics and Metabolism; Pfizer Global Research and Development. The talk covered systems modeling endeavors at Pfizer, including a collaborative study with Rosa, and was entitled "Systems Approaches to Modeling Diabetes within Pfizer With Applications to SGLT2i" (see slides). The poster was entitled "Modeling Glucose Metabolism in Diabetes" (see poster).

In collaboration with MediciNova, Rosa presented an oral presentation and a poster at the Cambridge Healthtech Institute's 8th annual Discovery on Target in Boston, MA. This inaugural session was entitled "New Ways to Target COPD and Other Chronic Pulmonary Diseases; Probing Novel Drug Targets, Disease Models, Biomarkers and Treatment Options". The oral presentation was entitled "MN-221, a Novel Beta2-Adrenergic Agonist for Treatment of Acute Asthma and COPD (see slides). The poster was entitled "PK/PD Modeling of MN-221 for COPD and Acute Asthma" (see poster).

In collaboration with MediciNova, Rosa presented two posters at the American College of Chest Physicians annual CHEST meeting for 2010 in Vancouver, BC. The posters will be presented on November 2 and 3. The first (Nov 2), entitled "Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling and Simulation Support the Novelty of MN-221, a Highly-Selective Beta2-Adrenergic Agonist for Treatment of Acute Asthma", will be presented in the 12:45 to 2 pm section on Asthma Treatments (see Abstract). The second poster (Nov 3), entitled "Pharmacokinetics and Pharmacodynamics of MN 221, a Novel, Highly-Selective Beta2-Adrenergic Agonist for Treatment of Acute Chronic Obstructive Pulmonary Disease", will be presented in the 12:45 to 2 pm section on COPD II (see Abstract). In both studies, modeling was used to predict drug efficacy in clinical trials for acute asthma and COPD, respectively. Both posters are available in the CHEST online supplement in October 2010, and can be accessed here: CHEST Asthma poster; CHEST COPD poster.

Rosa & Co is pleased to announce that Christina Friedrich, Ph.D., has joined Rosa as Principal and Chief Engineer, PhysioPD. Dr. Friedrich brings over 10 years of cutting-edge experience in developing and applying mathematical models of biologic/physiologic systems to product development issues faced by biotechnology, pharmaceutical, and consumer product companies. Before joining Rosa, Dr. Friedrich was the Director of Core Product Development at Entelos, Inc., where she designed and led the development of models in new disease areas, extended existing models into new markets, pioneered numerous methodologies, and led large research collaborations with bio-pharmaceutical companies. Dr. Friedrich holds B.S. degrees in Mathematics and Engineering Systems & Computation from MIT and a Ph.D. in Management Science & Engineering from Stanford University.

Rosa & Co, a leader in both classical PK/PD modeling and trial simulation and the emerging field of physiologically-based pharmacodynamic, or PhysioPD™, modeling, is pleased to announce that Toufigh Gordi, Ph.D., has joined Rosa as President of Rosa’s PK/PD and Clinical Pharmacology Services. Dr. Gordi is an accomplished clinical pharmacologist and pharmacometrician with significant industry, academic, and consulting experience. Prior to joining Rosa, Dr. Gordi had a successful PK/PD modeling and clinical pharmacology consulting business. Before that, he was a Senior Pharmacometrician at Hoffman La Roche, and an Associate Director of pharmacokinetics at Depomed Inc. and at CV Therapeutics. Dr. Gordi holds a M.Sc. in Pharmacy and a Ph.D. in Pharmacokinetics and Pharmacodynamics from Uppsala University, Uppsala, Sweden. He completed his postdoctoral training in the laboratory of Dr. William Jusko, in the Department of Pharmaceutical Sciences, State University of New York, Buffalo.

Rosa has launched its updated website to better reflect the breadth of its offerings and the depth of its experience. In the coming weeks, we will be revising our case studies and adding new ones, providing examples of models, and adding a list of selected clients. Please check back often for more news. In the meantime, if you have specific questions, please contact us.

This poster describes the use of modeling to predict therapy outcomes for European Medicines Agency (EMEA)-approved dose regimens, based on data from the US and US-approved dose regimens. The modeling allowed approval in the EMEA without additional clinical trials.

 

This poster describes a substantial collaboration in which a quantitative PhysioPD model of the (patho)physiological mechanisms and pathways that underlie type 2 diabetes mellitus was developed to characterize the pharmacological and toxicological attributes of single or multiple compound/target pairs. The ultimate goal of the modeling was to identify the impact of altered pharmacokinetics and the pharmacokinetic-pharmacodynamic relationship on target populations and lead optimization. Reference: PAGE 17 (2008) Abstr 1375 [www.page-meeting.org/?abstract=1375]

Gilead Sciences and Rosa will present two posters, entitled "Population Pharmacokinetics of Cobicistat in Adult Healthy Subjects and HIV-infected Patients" and "Population Pharmacokinetics of Tenofovir in Adult Healthy Subjects and HIV-infected Patients" at the 14th International Workshop on Clinical Pharmacology of HIV Therapy (IWCPHIV 2013) in Amsterdam, The Netherlands, from April 22-24, 2013. (Abstracts: Cobicistat,Tonofovir)

A Rosa collaboration will be featured in a presentation at the 2013 ASCPT preconference, Quantitative Systems Pharmacology: An Integrating Framework for Translational Medicine in Indianapolis, IN on March 5, 2013. The talk, entitled "Mechanistic and quantitative physiological models for the evaluation and prioritization of dermatology disease targets" describes construction of a quantitative, biological disease model. This model will enable prediction of clinical effects due to modulating different drug targets, thus supporting drug development decisions. (Abstract)

Rosa will present a talk at the 4th World PK/PD Summit, Nov 27-29, 2012, in Frankfurt, Germany. The summit will discuss improved PK/PD modeling and analysis to optimize translation of preclinical data into the clinic. Rosa's talk, entitled "Models and their Impact on the Drug Development Process", will describe differences in modeling approaches and how mathematical modeling can be used to address different types of decisions throughout the preclinical and clinical stages of the drug development process. (press release)

The International Society of Pharmacometrics will host a 2-day workshop in Bridgewater, NJ on Thursday and Friday, November 8-9. The workshop, entitled “Building Mechanistic Physiological Models to Support Decisions in Drug Discovery & Development: A Proven Systems Pharmacology Approach” will guide participants in creating a customized model with a focus on supporting drug development decisions. Participants will incorporate essential components, translate data into model equations, and test what-if scenarios with simulations. (Announcement)

Rosa will present a talk at the 3rd Pharmacokinetics & Pharmacodynamics Conference, Oct 24-26, 2012, in Philadelphia, PA. The talk, entitled "Pharmacokinetics and PhysioPD™ Modeling of Ursodiol in Neonates", describes how PK and PhysioPD™ modeling was used to explore the mechanisms underlying PK variability in neonates treated with Ursodiol for cholestasis. (Abstract)

Rosa will present a poster at the 17th International Inflammation Research Association, Conference in Bolton Landing, NY on September 9 - 13, 2012. The poster, entitled "Physiological model to investigate and prioritize targets for psoriasis" describes construction of a biological disease map, which provides the foundation for consolidating historical data and knowledge to ensure that a quantitative model is appropriately constructed for evaluating targeted pharmacodynamic endpoints and therapeutic potential. (Abstract)

The 13th annual International Conference on Systems Biology (ICSB) will host a Workshop entitled "Using Mechanistic Systems Pharmacolgy Modeling for Insight and Decision Support" on Aug 19, 10:30 am – 2:30 pm. The workshop will guide participants in creating a customized model with a focus on supporting drug development decisions. Participants will incorporate essential components, translate data into model equations, and test what-if scenarios with simulations.

Rosa will present a poster at the 3rd Annual Pacific Coast Statisticians and Pharmacometricians Innovation Conference, June 25-27, 2012, at Cal Poly in San Luis Obispo, CA. The poster is entitled “Using PK and PhysioPD modeling to clarify drug metabolism”. The poster describes how PK and PhysioPD models were used to explore the mechanisms underlying PK variability in neonates treated with Ursodiol (Actigall®) for cholestasis. (Abstract)

Rosa will present a poster at the 2012 American Diabetes Association’s 72nd Scientific Sessions, June 8-12, 2012, in Philadelphia, PA. The poster, entitled “Non-Invasive Prediction of Beta Cell Mass in Type 2 Diabetes: Insights from a Mathematical model” will be presented on Sunday June 10, 2012. The poster describes the use of a Diabetes PhysioPD model to predict changes in beta cell mass induced by a combination therapy. (Abstract)

Rosa will present at the American Society of Pharmacometrics event at Amgen, Seattle on Thursday, April 19 from 3-5pm. The presentation, “In Silico Study of Combination Therapy in Virtual NSCLC Tumor Cells Supports Strategic Development and Treatment Decisions” describes the use of a dynamic mechanistic model of the cancer cell lifecycle to explore the effectsof different combinations of cytotoxic agents, targeted growth signal inhibitors, anti-angiogenic agents, and metabolic disruption.  (Abstract)

Rosa's Dr. Christina Friedrich will present a pre-conference workshop entitled “Development of Mechanistic Systems Pharmacology Modeling for Insight and Decision Support” on Tuesday, 27 March 2012, as part of the 3rd Annual World PK/PD Summit, March 27 – 29, 2012 in Boston. The workshop participants will work through a real case study to learn how mechanistic systems pharmacology modeling can improve scientific and program insights and enhance the quality of decision-making throughout the discovery/development pipeline.

Rosa will present a poster at the 2012 Keystone Symposia: Advances in Islet Biology March 25 - 30, 2012, Monterey, California entitled "Non-invasive prediction of beta cell mass in type 2 diabetes: insights from a mathematical model." The poster describes the development of an improved approach to develop and validate biomarkers of pancreatic beta cell mass. (Abstract)

Rosa offers a free download of its Model Qualification Method (“MQM”), published in the White Paper, “Facilitating Drug Discovery and Development with Mechanistic Physiological Models that are ‘Fit for Purpose’”, to facilitate the broader adoption and use of mechanistic, physiologic models in pharmaceutical research and development. Rosa is also offering MQM-focused educational activities in 2012 in the EU and US. On March 2, 2012, there will be a seminar sponsored by an industry group in the San Francisco Bay Area (www.bapkpd.org); workshops will be offered on March 27 – 29, 2012 at the 3rd Annual World PK/PD Summit, in Boston (pkpd-summit.com) and on April 1 – 4, 2012 at the 5th Annual EFMC Short Course on Medicinal Chemistry, in Leiden, The Netherlands. (Press Release)

Mike Reed, PhD, Vice President of Rosa will participate in a roundtable panel to discuss "The Use of Physiological, Mechanistic Models in Drug Development and Therapy". This is a local event sponsored by the ASoP, to be held on Thursday, February 2, 2012; Bridgewater, New Jersey.

Rosa's Dr. Toufigh Gordi, President, PK/PD and Clinical Pharmacology Services, will be speaking at the 2nd Annual Pediatric Pharmacology Conference "Leveraging PKPD Studies, Modeling and Simulation Techniques to Enhance Pediatric Drug Development" on January 26, 2012, Rittenhouse Hotel, Philadelphia, PA. The title of the talk is “Pediatric PK Modeling using AMS Data and PhysioPD™ Modeling of Ursodiol in a Neonate Clinical Trial”. (Abstract)

In collaboration with Pfizer, Inc., Rosa will present a poster at the 2012 Keystone Symposia: Pathogenesis of Diabetes: Emerging insights into Molecular Mechanisms, in Santa Fe, New Mexico. The poster, entitled “Novel insights into the importance of insulin degradation in glucose metabolism” will be presented on Monday, January 30, 2012. The poster describes the use of a Diabetes PhysioPD model to interpret clinical data and evaluate the role of insulin degradation in insulin and glucose homeostasis. (Abstract)

Rosa's Chief Engineer, Dr. Christina Friedrich, will be presenting a short course at The European Foundation of Medicinal Chemists (EFMC) conference Target identification through application of systems and chemical biology on April 1-4, 2012. The topics she will cover are "Optimizing Lead Compound Selection Using Mechanistic Physiological Modeling" and "Qualifying Mechanistic Physiological Models for Use in Pharmaceutical Discovery and Development".

Rosa will present a poster at the 2012 Keystone Symposia: Cancer and Metabolism in Banff, Alberta, entitled “Virtual Combination Therapy in Virtual NSCLC Tumor Cells Supports Strategic Development and Treatment Decisions” on February 12, 2012. The poster describes the development and use of non-small cell lung cancer virtual cells to explore clinical variability in the mechanisms underlying tumor cell proliferation. (Abstract)

Advanced Research Associates, Inc. (ARA) and Rosa today announced an alliance that will provide Rosa’s noncompartmental pharmacokinetic analysis (NCA) capability to ARA customers as part of ARA’s data management and biostatistics offering. (press release)

In collaboration with Pfizer, Inc., Rosa will present a poster at the 2012 American Society for Clinical Pharmacology and Therapeutics annual meeting  in National Harbor, Maryland entitled "Role of Myostatin Pathway in Muscle Growth: Key Learnings from Retrospective Analysis of MYO-029 Preclinical and Clinical Data Thru PK/PD Modeling" at 7:00 am on March 17, 2012 (see Abstract). The poster describes PK/PD and other analysis of ACE-031, an Fc fusion of ActRIIB decoy receptor of myostatin in animal species and humans, and describes the positive impact the analysis has had in guiding further development.

Rosa & Co would like to congratulate all of the coauthers of "Enteric Microbiome Metabolites Correlate with Response to Simvastatin Treatment" on a their insightful research and interesting publication. (See News: Gut Bacteria May Affect Whether a Statin Drug Lowers Cholesterol).

Rosa today announced the appointment of Mike Reed as Vice President, responsible for managing strategic client collaborations. (Press release).

Rosa will present a poster (T3390) at the American Association of Pharmaceutical Scientists (AAPS) annual meeting. The poster is entitled "Pediatric PK Modeling using AMS Data and PhysioPD™ Modeling of Ursodiol in a Neonate Clinical Trial". The work concluded that AMS can successfully be used to measure drug concentrations in neonates, and that, with the limited data set, PhysioPD modeling provided a biological rationale for the variability, which could not be derived from the PK model. Furthermore, PhysioPD modeling has the potential of individualizing ursodiol therapy in neonates. (Abstract)

Rosa will present a poster (243) at the American College of Clinical Pharmacy (ACCP) annual meeting. The poster is entitled "Development of MN-221, a Novel, Highly Selective Beta2-Adrenergic Agonist for Treatment of Acute Asthma." The work concluded that PK/PD modeling: 1) enabled a prediction of the effect of MN-221 in patients with acute asthma, 2) supported dosing decisions, 3) predicted the impact of non-responders on trial outcome, and 4) suggested improved timing of FEV1 measurements. (Abstract)

Sharan Pagano, Rosa’s VP of Scientific Alliances, will be participating in BioPharm America 4th international partnering conference in Boston, MA sharing Rosa’s methods for accelerating early drug development with other biotechnology and pharmaceutical executives.

PharmaVoice highlights the alliance between Promedica and Rosa Market Modeling, Rosa's sister company, as an example of the kind of offering for which life-sciences companies are currently clamoring.

Rosa will be leading a workshop on its Model Qualification Method at the 12th International Conference on Systems Biology (ICSB) in Heidelberg, Germany.  The workshop will take participants through the process of building and qualifying PhysioPD models for use in drug discovery and development. (press release)

Rosa & Co. LLC is currentlly seeking a leader with a strong scientific background to support client business development activities. Reporting to the Senior Vice President of Scientific Alliances, the ideal candidate will partner with Clients Services on existing accounts and provide research and support for new account opportunities. (Announcement, pdf)

Rosa & Co. LLC, is pleased to announce the initiation of a multi-year Research Agreement with Sanofi Global R&D to provide Rosa’s market-leading PhysioPD services to worldwide Sanofi affiliates. The collaboration provides Sanofi a competitive research and development advantage and greater access to the extensive depth and breadth of Rosa’s expertise. Rosa’s agreement with Sanofi further extends Rosa’s presence as the global market leader in the Quantitative Systems Pharmacology field. (Press release)

Dr. Ananth Kadambi delivered the Keynote Address at the QSP Congress on April 28, 2015 in Basel, Switzerland. He discussed the philosophical and practical roles of QSP in the scientific process, common R&D applications, and key aspects of QSP market adoption.  Additionally, on April 29, 2015, Dr. Mike Reed presented a significant case study that covered creating and performing research with PhysioPD™ Research Platforms. Rosa also participated in two panel discussions during the conference on current and future applications of QSP. (Press release)

Bristol-Myers Squibb and Rosa will present a poster describing a Virtual Systems Pharmacology (ViSP) web-based environment at the ASCPT 2015 Annual Meeting in New Orleans, LA. The poster, entitled “Virtual Systems Pharmacology (ViSP) flexible web-based environment for running large multi-scale models” will be presented by Tarek Leil, Ph.D. during the Quantitative Systems Pharmacology Pre-Conference Poster Session on Tuesday, March 3, 2015, 12:45 PM - 1:45 PM and during the Late-Breaking and Encore Poster Session I on Thursday, March 5th, 2015 from 4:30 – 6:30 PM at the Hyatt Regency, Elite Hall Foyer. (Abstract)(Press release)

Dr. Ananth Kadambi will be speaking at the 19th North American ISSX Meeting/29th JSSX Meeting at the Hilton, San Francisco, on Wednesday, October 22, 2014 at 9:00 - 11:30 a.m. His talk is entitled “Application of Quantitative System Pharmacology Modeling to Translational Research”.

Dr Christina Friedrich will be speaking at the American Conference on Pharmacometrics (ACoP) in Las Vegas NV, on Monday, October 13th at 3-5 pm. Her talk is entitled “Quantitative Systems Pharmacology (QSP) informs in vitro to in vivo translation for PCSK9 antibody”.

Rosa's Dr. Gordi will be speaking to the Bio2Device Group in Sunnyvale, CA, on Aug. 26, 8:30 A.M. In his talk, entitled "Drug Development in silico: Models and Their Utility", Dr. Gordi will discuss the various types of study models and their application to the drug development process. (Abstract)

MedImmune and Rosa presented a poster, entitled "Quantitative Systems Pharmacology Modeling to Evaluate Clinical Response of an anti-TNFa/anti-Ang2 Bispecific Antibody in Rheumatoid Arthritis" at the American Society of Clinical Phamacology and Therapeutics Conference in Atlanta, GA on March 20, 2014. The poster describes a quantitative systems pharmacology model (PhysioPD™ Model) that represents the pathophysiology of rheumatoid arthritis, designed to address the target-mediated drug disposition kinetics of a bispecific antibody directed against TNFa and angiotensin 2. (Abstract)

Amgen and Rosa presented a poster, entitled "Pharmacology Model to Characterize the Effect of Blinatumomab in Patients With Adult B-Precursor Acute Lymphoblastic Leukemia" at the American Society of Clinical Phamacology and Therapeutics Conference in Atlanta, GA on March 18 (Biologics pre-conference) and 21, 2014. The poster describes key questions addressed with a quantitative systems pharmacology model (PhysioPD™ Model) that represents the pathophysiology of B-Precursor Acute Lymphoblastic Leukemia and the effect of blinatumomab, a T-cell activator that leads to B-cell death.

Rosa is pleased to announce the appointment of Ananth Kadambi, PhD, as Senior Vice President, PhysioPD, to manage their rapidly-expanding business in Japan and Asia. Dr. Kadami comes to Rosa from Evidera, where he served as as the Director of Modeling and Simulation. Previous to that, Dr. Kadambi rose from Team Leader to Vice President at Entelos Holdings, Inc. (Press release)

Rosa is pleased to announce the acquisition of the consulting service business of Entelos Holdings, Inc., which conducts mechanistic, physiologic, in silico modeling projects for customers in pharmaceutical research and development. The acquisition, which closed January 7, 2014, further extends Rosa’s presence in quantitative systems pharmacology and modeling and simulation research services and adds to Rosa's already significant expertise in cardiovascular, immunology, and metabolism biology, and human nutrition. (Press release)

Rosa is pleased to announce it has established an alliance with the KressWorks Foundation to develop a Ewing’s Sarcoma PhysioPD Research Platform, a quantitative model of the physiologic and pharmacologic mechanisms involved in Ewing’s Sarcoma. (Press release)

Rosa is pleased to announce that Katherine Kudrycki, Ph.D. has joined Rosa as Principal Scientist. In addition, Rosa has expanded its engineering team. (Press release)

Rosa will be presenting a talk entitled “Application of a physiologically-based model incorporating drug-specific PK modules to support optimization of GLP-1 receptor agonist combination therapies for type 2 diabetes” at the AAPS meeting on November 10-14, 2013 in San Antonio, Texas. (Abstract, Press release)

As the Expertise Partner, Rosa will be presenting the plenary session presentation entitled “Accomplishments and Challenges in Systems Pharmacology” at the Integrating Pharmacometrics Summit in Munich, Germany, Oct 21-23 2013. Dr. Ron Beaver will discuss the volume of experience and the wide-use of the systems pharmacology approach; what decisions in drug development can be supported; how we think about “value” and how we judge “quality”; dealing with scepticism and setting projects up for success; and how we apply this approach systematically to our pipeline. (Press Release)

Rosa's Dr. Toufigh Gordi will present a talk at the Target Meeting's 3rd World Conference on Drug Discovery on October 15-17, 2013. The talk, entitled 'Models and Their Utility in The Drug Development Process' will describe the advantages and shortcomings of different types of models for addressing different questions that arise in clinical drug development. (Abstract)

Rosa will present a symposium talk at the 28th Japanese Society for the Study of Xenobiotics, October 9-11, 2013, in Tokyo, Japan. The theme of the meeting is Expansion of Drug Metabolism and Pharmacokinetics to Promote Drug Development Innovation. The talk is entitled "“Application of Mechanistic Physiological Modeling in the Drug Development Process – Overview and Case Studies”. (Abstract)

The American Association of Pharmaceutical Scientists Bay Area Discussion Group will meet on Sept 12, 2013. Rosa's Dr. Toufigh Gordi will present a talk entitled "Models and Their Utility in the Drug Development Process" (Flyer)

Gilead Sciences and Rosa will describe a collaborative study in a talk entitled “A Large Population Pharmacokinetic Evaluation of the Influence of Demographic and HIV Disease Factors on the Pharmacokinetics of Elvitegravir, Cobicistat, and Tenofovir” at the 7th International AIDS Society conference (AIS 2013) in Kuala Lumpur, Malaysia from June 30 to July 3, 2013. (Abstract)

Kineta, Inc. announced today a strategic alliance with Rosa to create pharmacokinetic/pharmacodynamics (PK/PD) models of Kineta’s lead drug compound, Shk-186, to estimate an optimal dose and dose frequency for humans in preparation for upcoming multi-dose clinical trials. Shk-186 is a novel, immune-sparing, targeted therapeutic focused on autoimmune diseases. (press release)

Rosa will present a poster at the 2013 AAPS National Biotechnology Conference in San Diego, CA, May 20-22. The poster, entitled "Physiological model to investigate and prioritize targets for psoriasis", will describe the development and use of a custom-designed Psoriasis PhysioMap® for early development target prioritization (Press release)

Rosa will present two posters at the 2013 American Conference on Pharmacometrics, Fort Lauderdale FL, May 12-15. The first poster, "Physiological model to investigate and prioritize targets for psoriasis", will describe the development and use of a custom-designed Psoriasis PhysioMap for early development target prioritization. The second poster, "Using Qualitative Modeling in Drug Development", will describe how qualitative mechanistic modeling, or "PhysioMaps", have been used in drug discovery and development. (Press release)

Rosa announces that Douglas Chung, Engineer at Rosa, will present at the MathWorks SimBiology User Forum on October 27th in Bellevue, WA. Rosa & Co. developed the RateCalculator, a MATLAB script that calculates a set of reaction rates connected to a species of interest from an existing SimBiology model and plots the resulting values in an organized and informative way. The talk entitled "Computing and Graphing Fluxes to Facilitate QSP/PhysioPD™ Model Development and Calibration" demonstrates the use of this script in the context of a PhysioPD Platform to highlight both the mechanics of using it, and its utility in developing QSP/PhysioPD models. (Abstract)

Rosa & Co. LLC today announced their participation and poster presentation at ACoP7 to be held in Bellevue, WA on October 23-26, 2016. Rosa’s Dr. Christina Friedrich, Chief Engineer, PhysioPD™ will present a poster on Monday, October 24th, 2016 at 7:30am to 9:30am. The poster entitled “A Quantitative Systems Pharmacology Platform of Brain and Serum Progranulin (PGRN) to Investigate Targets in Frontotemporal Dementia (FTD)” will demonstrate that the PGRN PhysioPD Research Platform has proven useful to simulate the effects of modulating different targets and model drug effects on increasing PGRN for the treatment of FTD.

Rosa & Co.’s Chief Engineer, PhysioPD™, Dr. Christina Friedrich was recently interviewed for MedicalResearch.com, which publishes exclusive interviews with medical researchers published in major and specialty medical journals. The interview, entitled “Rosa & Co. Develop PhysioMap To Advance Drug Development Programs”, discusses Elan and Rosa’s collaboration in the development of a Synuclein PhysioMap®, a graphical model architecture to support hypothesis generation and testing. This collaboration provided insight into the function of alpha-synuclein in Parkinson's disease.

Rosa announces that Dr. Meghan Pryor, Engineer at Rosa, presented at the MathWorks SimBiology User Forum on September 20th in Boston, MA. Rosa & Co. developed the RateCalculator, a MATLAB script that calculates a set of reaction rates connected to a species of interest from an existing SimBiology model and plots the resulting values in an organized and informative way. The talk entitled "Computing and Graphing Fluxes to Facilitate QSP/PhysioPD™ Model Development and Calibration" demonstrates the use of this script in the context of a PhysioPD Platform to highlight both the mechanics of using it, and its utility in developing QSP/PhysioPD models. (Abstract).

Rosa announces that Dr. Christina Friedrich, Chief Engineer, PhysioPD at Rosa, will present a poster at the 4th World Parkinson Congress on Friday September 23, 2016 at 11:30am to 1:30pm. The poster entitled "Development of a qualitative systems pharmacology model to support hypothesis generation and testing for Parkinson's disease" will demonstrate that the research team identified key biological uncertainties and hypotheses and recommended focused laboratory experiments to gain a better understanding of synuclein function in Parkinson's disease (Press release, poster).

Rosa’s Dr. Michael Weis co-authored an encore poster presentation at the 2016 World Conference on Pharmacometrics (WCoP) entitled: “The International Society of Pharmacometrics’ (ISoP) Special Interest Group (SIG) on Quantitative Systems Pharmacology (QSP): Developing a Community and Advancing a Field”. The poster describes the work of the ISoP QSP SIG to advance the development and utilization of safe and efficacious medicines through the application of QSP.

Rosa announces that Dr. Mike Reed, Chief Scientist, PhysioPD™ at Rosa, will present a poster at the 2016 World Conference on Pharmacometrics (WCoP) on August 24th, 2016 at 12:45 pm – 1:15 pm in Brisbane, Australia. The poster entitled “Application of a quantitative systems pharmacology (QSP) model to evaluate xCT inhibition as a target for central nervous system diseases” will demonstrate that development of a Central Nervous System PhysioPD Research Platform is an illustrative research case of the key role that PhysioPD modeling can play in providing quantitative integration of internal and external knowledge, elucidating mechanistic insight, and supporting decisions in early stage drug discovery. (Press Release, poster).

Rosa's Christina Friedrich, Chief Engineer, PhysioPD™ and MathWorks’ Fulden Buyukozturk, Technical Evangelist, will present a joint webinar on July 13th, 2016 at 10:00 am and 2:00pm EDT. QSP/PhysioPD approaches aim to predict the safety and therapeutic impact of a drug by quantifying the dynamics of its interactions with underlying pathophysiology in order to guide and support drug development. This webinar will use a rheumatoid arthritis (RA) PhysioPD™ Research Platform developed by Rosa & Co to illustrate the utility of key features of MATLAB and SimBiology in exploring pharmaceutical research questions. (press release)

Rosa’s Dr. Michael Weis co-authored a poster at the Population Approach Group, Europe (PAGE) conference entitled: “The International Society of Pharmacometrics’ (ISoP) Special Interest Group (SIG) on Quantitative Systems Pharmacology (QSP): Developing a Community and Advancing a Field”. The poster describes the work of the ISoP QSP SIG to advance the development and utilization of safe and efficacious medicines through the application of QSP.

Rosa's Sharan A. Pagano, Senior Vice President of Scientific Alliances will present at the 7th Annual Shanghai Symposium on Clinical & Pharmaceutical Solutions through Analysis (CPSA Shanghai 2016) on Friday, April 22, 2016. The conference focuses on the current industrial landscape and the global need to bring products to market faster. Ms. Pagano’s talk, entitled “Mechanistic Physiological PhysioPD™ Models in Drug Development: A Proven Quantitative Systems Pharmacology (QSP) approach” will focus on the process of creating and conducting research using PhysioPD Platforms to drive scientific innovation in the pharmaceutical industry. PhysioPD Platforms are QSP models designed with multidisciplinary client team input. The PhysioPD research approach is planned to impact client decisions and has been successful across many therapeutic indications.(press release, slides)

Rosa & Co. LLC participated 2016 Roche QSP Methodology Workshop held on February 4 & 5th, 2016 in Basel, Switzerland. Dr. Christina Friedrich, Chief Engineer at Rosa, recently published an article on QSP model qualification, and participated in the workshop that brought together key opinion leaders from industry and academia to make a substantive contribution toward even broader implementation of QSP. The workshop capitalized on the group’s accumulated experience and applications to review and discuss evolving methodologies in the field. (press release)

Rosa & Co.’s Chief Engineer, Dr. Christina Friedrich published an article, “Model Qualification Method for Mechanistic Physiological QSP Models to Support Model-Informed Drug Development” in the CPT: Pharmacometrics & Systems Pharmacology Journal. QSP is being used increasingly by innovative R&D organizations as a powerful research approach that combines available data with scientific knowledge and engineering approaches to facilitate better understanding of biological systems, to improve decision-making, and to reduce risk and increase efficiency in drug discovery and development. Dr. Friedrich’s tutorial draws on years of experience to generate a rigorous, systematic, and broadly applicable Model Qualification Method (MQM) to ensure that QSP models are well-qualified and fit for their intended purposes. The MQM addresses questions of model relevance, scope, uncertainty, biological variability, and use of data, so that model-informed research can proceed with confidence. (Article) (press release)

Rosa & Co. LLC presented a poster at the 2015 Roche Pharma Research and Early Development (pRED) Symposium, held on November 2-3rd, 2015 in New York City. Rosa’s poster, entitled “Model qualification approaches for quantitative systems pharmacology (QSP) and mechanistic physiological models”, was presented by Dr. Christina Friedrich, Chief Engineer at Rosa. The poster compared several recently proposed model qualification approaches, including Rosa’s Model Qualification Method (MQM), to identify common themes and analyze differences. The symposium, entitled “Increasing Drug Development Success: Understanding Drug-Disease Interactions through Quantitative Systems Pharmacology”, was designed to bring together key global leaders in QSP to explore ways to leverage the interface of theoretical and experimental pharmacology to improve drug development efficiency. (press release)

Rosa & Co. LLC, today announced that Dr. Christina Friedrich, Chief Engineer, will lead a workshop at the QSP Congress Meeting on October 20th, 2015 in Boston, MA. The conference focuses on the uses and benefits of QSP in pharmaceutical drug development. Dr. Friedrich’s workshop is entitled ”Using Mechanistic Physiological Models in Drug Development: A Proven Quantitative Systems Pharmacology (QSP) Approach”. She will discuss the use of a systematic approach to model qualification, Rosa’s Model Qualification Method (MQM), which ensures that a model is developed and judged fit for use. Case studies and model examples will illustrate the MQM process. (press release)

Rosa & Co. LLC today announced it has five posters and a tutorial scheduled to be presented during the sixth American Conference on Pharmacometrics (ACoP6) in Crystal City, VA, October 4-7, 2015.  The poster presentations will describe research and a range of results including the application of PhysioPD Platforms to clinical trial design and translational research. The posters will be presented with Sanofi, Bristol Myers Squibb, Stiefel, (a GSK company) and by Rosa & Co. The MathWorks, Inc. tutorial uses a Rheumatoid Arthritis PhysioPD Platform developed by Rosa to illustrate the use of SimBiology and MATLAB to streamline QSP workflows. (Press release)

Rosa & Co. LLC today announced a co-marketing agreement with MathWorks, developer of mathematical computing software and maker of MATLAB, SimBiology and Simulink. The agreement between MathWorks and Rosa will provide drug development professionals examples of how to address real world challenges using state-of-the-art software tools and proven QSP modeling approaches. (press release)

Rosa & Co. LLC today announced its pleasure to be a premier sponsor for the Discovery on Target Conference in Boston, MA on September 21-24th, 2015. The Quantitative Systems Pharmacology Tract at the conference is designed as a knowledge and opinion exchange forum, highlighting strategy and implementation of QSP from early discovery to early clinical development in the pharmaceutical industry. In addition to its sponsorship, Rosa will be presenting a talk and teaching a short course as part of the QSP program. (press release}