Rosa & Co. announces the contributions of Rosa scientists to the publication of an article on modeling PI3K-inhibitor-induced colitis

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.wiley.com/doi/10.1002/psp4.12749

Adamis Pharmaceuticals Updates Comparative Pharmacology Model Data Supporting the Higher 5 mg Intramuscular Dose of Naloxone in ZIMHI™

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: https://ir.adamispharmaceuticals.com/news-releases/news-release-details/adamis-pharmaceuticals-updates-comparative-pharmacology-model

Rosa & Co. announces the presentation of a poster at the 2021 ACoP meeting

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. announces the presentation of a poster at the 2021 ICIEM meeting

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. announces the presentation of two posters at the 2021 PAGE meeting

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/default.asp?abstract=9867

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/default.asp?abstract=9589#

The 2021 PAGE meeting will take place virtually from September 2-7, 2021.
https://www.page-meeting.org/default.asp?id=46&keuze=meeting

Webinar discusses integrating QSP and Machine Learning

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/webinars/2021/integrating-quantitative-systems-pharmacology-and-machine-learning-why-bother

Rosa & Co. announces the publication of an abstract in 2021 ASCO Meeting Library

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.org/record/200079/abstract

Webinar shows how Rosa PhysioPD models can integrate subjective or complex clinical outcomes

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...

Rosa & Co. announces contributions of Dr. Christina Friedrich to the publication of an article on FDA-Industry Scientific Exchange

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/article/10.1208/s12248-021-00585-x

Rosa & Co’s 11th Consecutive Appearance at ACoP Showcases the Power of QSP Modeling with PhysioPD™ Research

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.”

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Model Suggests ACER-001 May Offer Improved Disease Management in Patients with Urea Cycle Disorders

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. More...


Adamis Pharmaceuticals Announces Publication of Research with Rosa

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. More...

Webinar showcases how Rosa Market Modeling is used to optimize competitive positioning

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/2200637/7C094DDC9B8B2F7A4226C22C0DED82B8

Webinar to showcase how an integrative and holistic approach benefits model-informed drug development outcomes

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."

More...

Rosa & Co.’s first webinar of 2020 to showcase the importance of mathematical models for vaccine R&D

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...

Rosa & Co.’s partner MathWorks showcases features and workflows that facilitate parameter estimation in QSP models

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...

Rosa honors World Diabetes Day with webinar on how QSP supports the progress of new diabetes treatments

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...

Dr. Christina Friedrich to present the power of QSP modeling at the AAPS Annual Meeting

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...

Rosa & Co. Presents Results of 7 QSP Studies in 10th Consecutive Appearance at ACoP10

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...

Rosa & Co. LLC is expanding and seeking scientists and modelers

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

"I am grateful to our many clients who have challenged us over the past 15 years to conduct PhysioPD Research on the frontier of science."
—Ron Beaver, PhD, Founder, CEO
Learn more about PhysioPD