Introduction

 

Jan 17, 2012
  • Rosa's Dr. Gordi to speak at the 2nd Annual Pediatric Pharmacology Conference 2012
  • 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)

Jan 17, 2012
  • Rosa's Dr. Mike Reed to Participate in Roundtable Panel of American Society of Phamacometrics
  • 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.

Jan 17, 2012
  • Pfizer and Rosa to present at Keystone Symposia: Pathogenesis of Diabetes
  • 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)

Dec 16, 2011
  • Rosa's Dr. Friedrich to present a course at The European Foundation of Medicinal Chemists
  • 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".

Dec 13, 2011
  • Dr. Maurer presents “Translational M&S in Support of Rational Drug Discovery...” webinar
  • Rosa today announced that Dr. Tristan Maurer, PhD, from Pfizer Pharmaceuticals will present a webinar entitled “Translational Modeling & Simulation in Support of Rational Drug Discovery: Principle Challenges and Examples” on December 13, 2011. This is the latest webinar in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development”. (Webinar)

Dec 1, 2011
  • Rosa to present at Keystone Symposia: Cancer and Metabolism
  • 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)

Nov 14, 2011
  • ARA and Rosa Partnership Integrates Data Management, Pharmacokinetics, and Biostatistics
  • 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)

Nov 14, 2011
  • Dr. Jusko presents “Moving PK/PD From Basic Towards Systems Pharmacology” webinar
  • Rosa today announced that Dr. William J. Jusko, PhD, from SUNY Buffalo will present in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” on November 14, 2011. (Webinar).

Nov 11, 2011
  • Pfizer and Rosa to present at ASCPT 2012 meeting
  • 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.

Nov 2, 2011

Oct 27, 2011
  • Dr. Mike Reed Joins Rosa & Co. Executive Management Team
  • Rosa today announced the appointment of Mike Reed as Vice President, responsible for managing strategic client collaborations. (Press release).

Oct 25, 2011
  • Rosa presents at AAPS 2011 in Washington, DC
  • 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)

Oct 19, 2011
  • Rosa presents at ACCP 2011 in Pittsburgh, PA
  • 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)

Oct 17, 2011
  • Dr. Friedrich presents “Developing Models Fit for Purpose... Model Qualification Method” webinar
  • Rosa today announced that Dr. Christina Friedrich from Rosa & Co will present in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” on October 17, 2011. (Webinar).

Sep 19, 2011
  • Dr. Holford presents “Clinical Pharmacology = Disease Progression + Drug Action” in webinar
  • Rosa today announced that Dr. Nick Holford from the University of Auckland, New Zealand will present in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” on September 19, 2011 3:30 - 4:30 pm EDT. (Webinar)

Sep 7, 2011
  • Rosa attending BioPharm America 2011 on September 7-9th, 2011
  • 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.

Aug 1, 2011
  • Rosa's Market Modeling highlighted in PharmaVoice for its strategic alliance with Promedica
  • 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.

Jul 26, 2011
  • Rosa’s Christina Friedrich to lead Model Qualification Workshop at ICSB 2011 on August 28, 2011
  • 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)
  • At the same meeting, Dr. Friedrich will present a poster that illustrates how a PhysioPD model was used in drug development in collaboration with Vitalea Sciences. (poster)

Jul 26, 2011
  • Dr. Sauro presents “Standards and Software in Biomedical Systems Modeling” in webinar series
  • Rosa today announced that Dr. Herbert Sauro from the University of Washington, Seattle will present in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” on July 26, 2011. (Webinar)

Jun 20, 2011
  • Dr. Rebecca Baillie to present “How to build a PhysioPD model” in Impact webinar series
  • Rosa today announced that Dr. Rebecca Baillie from Rosa & Co will present in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” on June 20, 2011. (Webinar)

Jun 8, 2011
  • Rosa presents at PAGE 2011 in Athens, Greece
  • 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)

Jun 8, 2011
  • Profil Institute and Rosa Form Strategic Partnership to Enhance Diabetes/Obesity Clinical Trials
  • 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)

Jun 3, 2011
  • Kenneth Locke, CSO of Lithera, Inc., Highlights Rosa Collaboration at Biotech Discussion Group
  • 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.
  • (more at: Lithera, Inc. and 2011 San Diego Biotech Discussion Group).

May 24, 2011
  • Dr. Savic presents “Overview of modeling tools in drug development” in Impact webinar series
  • Rosa today announced that Dr. Rada Savic from Uppsala University will present in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” on May 24, 2011. (Webinar)

May 5, 2011
  • Rosa and FOCUS-IP Form Strategic Alliance for Enhancing Proof-of-Concept Drug Development
  • 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).

Apr 25, 2011
  • Rosa Qualifies a Novel Method for Predicting Pediatric Clinical Data in Bile Acid Metabolism
  • 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).

Apr 21, 2011
  • Rosa’s Drs. Gordi and Baillie to speak at the Seattle Pharmacometrics Group
  • 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).

Apr 18, 2011
  • Rosa Diabetes PhysioPD™ Collaboration with Pfizer to be Presented at World PK/PD Summit
  • 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).

Apr 4, 2011
  • Rosa kicks-off new webinar series “Impact of Modeling & Simulation in Drug Development”
  • Rosa today announced that Dr. Jogarao V. Gobburu, Head of the US FDA Division of Pharmacometrics, will present the inaugural webinar in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” ” on April 18, 2011 at 1:00 pm EDT (GMT -5:00) (Press Release)(Webinar).

Apr 3, 2011
  • Rosa to present six posters at the ACoPs meeting in 2011
  • 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).

Mar 7, 2011
  • Rosa appoints Sharan A. Pagano as Vice President, Scientific Alliances, and opens Boston office
  • 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).

Mar 2, 2011
  • Rosa and Vitalea to present at ASPCT 2011 meeting
  • 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.

Feb 1, 2011
  • Selventa and Rosa Announce Strategic Partnership for Early Stage Drug Discovery and Development
  • Rosa has formed a collaboration with Selventa™ to improve and accelerate drug discovery and development through biomarker identification and portfolio optimization (see News Release).

Nov 16, 2010
  • Rosa’s Bosley to Participate in Expert Panel at AAPS
  • 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.

Nov 3, 2010
  • Rosa and Pfizer present at Discovery on Target 2010 Diabetes meeting
  • 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).

Nov 3, 2010
  • Rosa and MediciNova present at Discovery on Target 2010 COPD meeting
  • 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).

Nov 2, 2010
  • Rosa and MediciNova present at CHEST 2010 meeting
  • 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.

Oct 11, 2010
  • Dr. Friedrich Joins Rosa & Co. as Principal and Chief Engineer, PhysioPD™
  • 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.

  • "Adding Dr. Friedrich to our staff significantly strengthens our already top-class systems engineering capabilities. I am honored that someone of her experience and stature has agreed to join our team and help build our PhysioPD intellectual property and client service business worldwide," said Dr. Ron Beaver, PhD, Rosa’s Cofounder, Chairman, and CEO.

Oct 1, 2010
  • Dr. Toufigh Gordi Joins Rosa & Co LLC as President of PK/PD and Clinical Pharmacology Services
  • 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.

  • "Adding Dr. Gordi to our staff significantly strengthens our already top-class consulting capabilities. I am honored that someone of his stature has agreed to join our team and help build our PK/PD and Clinical Pharmacology services business worldwide," said Dr. Ron Beaver, PhD, Rosa’s Cofounder, Chairman, and CEO.

Oct 5, 2009
  • Rosa launches updated website
  • 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.

Oct 4, 2009
  • Rosa presents poster “PK Modeling, Simulation, and Scaling of Adult and Pediatric Data to Support International Regulatory Submissions” at 2009 American College of Pharmacometrics (ACoPs) meeting
  • 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.

Jul 15, 2009 
  • Rosa’s PK/PD Modeling dramatically alters dose selection for proof-of-concept trial
  • Rosa’s modeling of complex respiratory data for an emerging publicly-held pharmaceutical company showed that an unexpectedly large number of non-responders in a trial arm was responsible for a counter-intuitive dose-response curve. In addition, the modeling showed that the cardiovascular risk was not as high as had been thought initially. The modeling process allowed the company to convince investors and investigators to continue with a significantly higher dose, averting not only the waste of a trial but possibly the failure of the company.

May 1, 2009 
  • Cofounder Ron Beaver, PhD assumes roles of Chairman, President, and CEO
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Jun 19, 2008
  • Rosa and Merck & Co., Inc. jointly present the PhysioPD™ poster “Alteration of glucose and insulin regulatory networks in Type 2 diabetes mellitus” at Population Approach Group in Europe (2008)
  • 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]