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.”


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."


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

Rosa & Co. Announces Strategic Research Agreement with Chugai Pharmaceutical Co., Ltd.

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 Chugai

Chugai 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/english/

Quantitative Systems Pharmacology Pioneers

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....

Sanofi and Rosa to Present Research Results at the 2019 ASCPT Annual Meeting

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. Klabunde

2) 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. to Present Research Results at the 2018 American Conference on Pharmacometrics

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.

Grünenthal and Rosa to present at the 2018 SID/IID dermatology 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

Rosa & Co. is looking to hire a Senior Engineer, PhysioPD™

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...

Dr. Christina Friedrich to present a webinar for the Committee on Credible Practice of Modeling & Simulation in Healthcare

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

"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