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Nuventra Pharma Sciences

Research Triangle Park, NC, US

Nuventra, Inc. is a clinical pharmacology consulting firm specializing in pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics (popPK). The pharmaceutical industry’s ‘go-to’ resource for PK/PD, Nuventra gives pharmaceutical companies and CROs rare access to a hands-on team of leading clinical pharmacology and PK/PD professionals experienced in a multitude of therapeutic areas and using leading PK/PD analysis software. We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic principals and making them understandable and usable for common sense drug development. Nuventra’s flexible business structure enables our expert consultants to integrate within our clients’ R&D group and help them maximize the potential of clinical pharmacology studies and PK analyses to pave the way toward marketing approval.

Nuventra was founded in 2008 by Geoffrey Banks,... Show more »

Nuventra, Inc. is a clinical pharmacology consulting firm specializing in pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics (popPK). The pharmaceutical industry’s ‘go-to’ resource for PK/PD, Nuventra gives pharmaceutical companies and CROs rare access to a hands-on team of leading clinical pharmacology and PK/PD professionals experienced in a multitude of therapeutic areas and using leading PK/PD analysis software. We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic principals and making them understandable and usable for common sense drug development. Nuventra’s flexible business structure enables our expert consultants to integrate within our clients’ R&D group and help them maximize the potential of clinical pharmacology studies and PK analyses to pave the way toward marketing approval.

Nuventra was founded in 2008 by Geoffrey Banks, Ph.D., (CEO) under the name ClinPharm Consulting, LLC. Dr. Banks formed a strategic partnership with Bill Wargin, Ph.D., (CSO), who is a leading pharmacokinetic consultant, and together they created the foundation for the company’s growth. Drs. Banks and Wargin realized that they had an extraordinary opportunity to create a consulting organization focused on an area of unmet need in the industry – clinical pharmacology and PK/PD. In developing the business paradigm, they recognized the benefits of having a team of industry veterans available for clients to address complex issues in clinical pharmacology and PK/PD. In 2009, M. Alexander Shaw, Ph.D., joined the company as a full partner and became the COO. In 2013, the company was renamed to Nuventra to reflect the impact that the company was making in the industry and it’s growth to become a leading consulting firm focused on clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and pharmacometrics (popPK).

Key Publications

  • Partnerships Remain Crucial to Future Development – By David Y. Mitchell Oct 2, 2012 Pharmaceutical Technology Volume 36, Issue 10, pp. 14
  • Application of a single-objective, hybrid genetic algorithm approach to pharmacokinetic model building – J Pharmacokinet Pharmacodyn (2012) 39:393–414 – Mark Sale, MD – Vice President, Modeling & Simulation and Executive Consultant, Population PK.
  • Example of PK/PD analyses on an anticoagulation compound conducted by Bill Wargin, PhD (CSO) – Pegnivacogin results in near complete FIX inhibition in acute coronary syndrome patients: RADAR pharmacokinetic and pharmacodynamic substudy. Povsic TJ, Wargin WA, Alexander JH, Krasnow J, Krolick M, Cohen MG, Mehran R, Buller CE, Bode C, Zelenkofske SL, Rusconi CP, Becker RC; RADAR Investigators. Eur Heart J. 2011 Oct;32(19):2412-9.
  • White Paper – Advising organisations on optimising clinical pharmacology studies to produce robust pharmacokinetic and pharmacodynamic (PK, PD) data sets. No one sets out to conduct a clinical study that will not meet its objectives. However, all too often, studies fail to meet their objectives.
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Nuventra Pharma Sciences has not listed any services.

Medical Device Clinical Trials
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PK/PD Modeling
Pharmacokinetics/Pharmacodynamics Modeling
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Population PK/PD, Allometric Scaling, Model Based Drug Development, Exposure/Response Analyses, etc.

Population PK/PD, Allometric Scaling, Model Based Drug Development, Exposure/Response Analyses, etc.

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Clinical Pharmacology
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Nuventra provides horizontal strategic planning across a drug development program. Instead of focusing on a single study, Nuventra determines how that study complements prior data and influences future decisions in a program. Our pharmacokinetic consultants and clinical pharmacology consultants apply their experience from prior... Show more »

Nuventra provides horizontal strategic planning across a drug development program. Instead of focusing on a single study, Nuventra determines how that study complements prior data and influences future decisions in a program. Our pharmacokinetic consultants and clinical pharmacology consultants apply their experience from prior drug programs as well as current interactions with regulatory agencies to determine logical next steps in rational drug development.

Examples of strategic clinical pharmacology/regulatory planning:

  • Evaluation if a standalone impaired renal study or impaired hepatic study be avoided because the patient population being studied is enriched for varying degrees of renal or hepatic function such that population PK analyses in late phase studies would satisfy regulatory requirements.
  • Using modeling and simulation techniques to extrapolate the expected exposure of a drug in adults to pediatrics to enable proper dose selection that provides sufficient and safe blood drug concentrations in a pediatric study.
  • Conducting clinical drug-drug interaction evaluations all potential drugs that a patient may take concomitantly with an investigational drug is not feasible. Nuventra can help determining which drug-drug interaction studies are needed in a poly-pharmacy patient population, including those drugs that may interact with metabolizing enzymes (CYP P450) or transporters or for drugs that are commonly used in the target population. Many times drug-drug interaction pharmacokinetic evaluation can be done in Phase 2 and Phase 3 studies using population pharmacokinetics modeling.
  • Appropriate presentation of different clinical pharmacology/PK/PD analyses within a regulatory submissions such as NDA/BLA/ANDA (small molecules, biologics, and biosimilars)

Clinical Pharmacology Plan – the backbone of drug development

The Clinical Pharmacology Plan is the backbone of a drug development strategy for a given drug. This document establishes the group of clinical trials to be completed during the development process, and includes initial synopses for each trial. The plan includes built-in contingencies for unexpected developments in the drug program.

Other Strategic Activities

  • Complete NDA/BLA/ANDA due diligence
  • Full service NDA/BLA/ANDA support
  • Interpretation of preclinical or early human data as a guide for next steps in clinical pharmacology programs.
  • DDI waiver justifications.
  • Pediatric study and PREA guidance.
  • In vitro/in vivo transporter and DDI study guidance.
  • Proactive risk management planning to identify and minimize development challenges.
  • Review of clinical pharmacology data/decisions that impact late phase studies.
  • Strategic planning for regulatory interactions associated with and without clinical pharmacology data.
  • Interpretation of industry guidance documents for individual clinical pharmacology development programs.
  • International trial advice and due diligence in support of expanding studies internationally.
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ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
Price on request

Nuventra takes a common sense approach to provide excellence in pharmacokinetics and help companies developing pharmaceuticals successfully navigate the drug development process leading to marketing approval. We make clinical pharmacology and pharmacokinetics more accessible for the industry while simultaneously providing robust... Show more »

Nuventra takes a common sense approach to provide excellence in pharmacokinetics and help companies developing pharmaceuticals successfully navigate the drug development process leading to marketing approval. We make clinical pharmacology and pharmacokinetics more accessible for the industry while simultaneously providing robust interpretation of data. Our highly experienced Pharmacokineticists conduct analyses in a fully validated computing environment with the latest PK modeling software.

Noncompartmental (NCA) PK Service Options

Nuventra offers five different options for supporting your program’s clinical PK/PD needs. All of our service options include noncompartmental clinical PK analysis with turn-around-times as fast as 24 hours. Reporting options range from simple outputs in SAS Transport Files, Microsoft Word & Excel to robust submission-ready reports. We will work with you to determine the most appropriate and cost-effective option for your particular program

Included Services Fundamental Basic Report Basic CSR Standard Premium
24-hour turn around time (if needed) x
PK parameters as outputs to SAS transport file or Excel x x x x x
Formatting of PK parameter outputs x x x x
Analysis using actual sampling times x x x x
Abbreviated PK report x
Generation of tables, listings and figures (TLFs) x x x
Complete written PK interpretation for CSR integration x x x
Full PK report and/or CSR integration (submission ready) x x
Integrate new PK data into overall program planning (Clinical Pharmacology Plan) x
One-on-one strategy session with a pharmacokineticist x
Scientific manuscript preparation x
Shell for NDA sessions 2.7.1 & 2.7.2 x
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PK/PD/TK Data Analysis
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Nuventra has the capabilities to conduct both Good Laboratory Practices (GLP) and non-GLP Toxicokinetic (TK) analyses by consultants and staff fully versed in these investigations.

GLP TK analyses:

  • Fully GLP compliant facility for conducting TK analyses.
  • GLP-compliant validated computing environment for conducting TK... Show more »

Nuventra has the capabilities to conduct both Good Laboratory Practices (GLP) and non-GLP Toxicokinetic (TK) analyses by consultants and staff fully versed in these investigations.

GLP TK analyses:

  • Fully GLP compliant facility for conducting TK analyses.
  • GLP-compliant validated computing environment for conducting TK analyses
  • Full complement of Standard Operating Procedures (SOPs) and Working Practices (WPs) to enable GLP-TK analyses.
  • Rapid and thorough Quality Assurance Unit (QAU).
  • Onsite archiving of GLP study materials.
  • Robust report templates that allow for thorough presentation and interpretation of TK data.

In addition to GLP and non-GLP TK analyses, Nuventra can provide overall nonclinical strategy to support clinical pharmacology investigations and overall drug development programs, including:

  • Incorporation of preclinical results within model-based drug development
  • Nonclinical vendor identification & management
  • Nonclinical pharmacology
  • In vitro investigations
  • Protein binding
  • CYP & Transporter drug-drug interactions
  • Bioanalytical
  • Toxicology
  • Translational research
  • Authoring nonclinical sections of regulatory documents
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Phase I clinical trials
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Full-Service Phase I Clinical Trials run by the PK/PD Experts at Nuventra. Protocol to CSR.

Full-Service Phase I Clinical Trials run by the PK/PD Experts at Nuventra. Protocol to CSR.

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Regulatory Affairs Consulting
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Nuventra has extensive regulatory affairs experience related to clinical pharmacology and pharmacokinetics. We regularly attend meetings with the FDA for clients (e.g., Pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings). We are familiar with the regulatory guidance documents for clinical... Show more »

Nuventra has extensive regulatory affairs experience related to clinical pharmacology and pharmacokinetics. We regularly attend meetings with the FDA for clients (e.g., Pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings). We are familiar with the regulatory guidance documents for clinical pharmacology and PK and also understand the current environment at the FDA related to clinical pharmacology and PK topics across many different therapeutic areas.

Nuventra personnel have had numerous interactions with FDA (CDER and CBER) across multiple Divisions and are experienced in determining issues of critical importance to FDA and advising clients on appropriate strategies to meet the challenges. Division within CDER for which we have interacted with include the Divisions of Anesthesia, Analgesia, and Addiction Products (DAAAP), Metabolism and Endocrinology Products (DMEP), Pulmonary, Allergy, and Rheumatology Products (DPARP), Cardiovascular and Renal Drug Products, Gastroenterology, and Neuropharm. Offices for which we have interacted with include the Offices of Hematology Oncology Drug Products, Orphan Products, Nonprescription Products (OTC).

The combined regulatory experience of our consultants includes efforts on approximately 50 IND projects and 20 NDAs. Our collective exposure to FDA has included participation in over 75 meetings with the Agency across diverse projects and therapeutic areas and Divisions. Regulatory writing experience spans large numbers of Investigator brochures, clinical study reports, clinical protocols, meeting briefing packets, IND annual reports, IND safety reports, etc.

Regulatory submissions that we support include focusing on the clinical pharmacology and pharmacokinetic sections of the following:

  • Briefing packets for pre-IND, end of Phase 1 (EoP1), end of Phase 2 (EoP2), pre-NDA, and Type C meetings.
  • Full IND preparation and maintenance as well as targeted efforts on clinical pharmacology, human PK/PD, and nonclinical ADME and toxicokinetic sections.
  • Investigator Brochure authoring and updates.
  • IMPD and international regulatory documents.
  • NDA/BLA/CTD components (including CTD Module 2)
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Computational Modeling
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Model Based Drug Development (MBDD) is a process where drug development decisions are supported by a mathematical simulation (or model) that determines the likelihood of success for a certain drug. The overall goals of MBDD are 1) to inform drug development strategies, 2) to select the optimal dose(s) for the next phase of... Show more »

Model Based Drug Development (MBDD) is a process where drug development decisions are supported by a mathematical simulation (or model) that determines the likelihood of success for a certain drug. The overall goals of MBDD are 1) to inform drug development strategies, 2) to select the optimal dose(s) for the next phase of development, and 3) to improve decision-making within clinical development programs.

By using mathematical and statistical methods, we build models of drug concentrations (pharmacokinetic) and/or drug responses (pharmacodynamic) over a time course (PK/PD). Such models allow one to understand how various dosing choices (e.g., dose amount, dose frequency, & dosing duration) can affect drug concentrations while also elucidating the relationship between drug concentration and the desired or undesired pharmacodynamic responses. In addition, these models help to characterize the PK/PD variability of drugs and assist in understanding the clinically relevant factors contributing to variability (for example: age, body weight, renal function, hepatic function).

Model Based Drug Development Services Include:

  • Evaluations and comparison trial designs based on simulation to enhance the likelihood of a successful outcome.
  • Creation of tailored MBDD plans to guide MBDD strategy throughout the drug development process.
  • Industry leading pharmacokineticists that are able to provide superior advice for modeling PK and pharmacokinetic/pharmacodynamic relationships.
  • Rational selection of the most salient model(s) for a given investigational compound and disease area.
  • Innovative methods and ideas, including the development of a revolutionary new algorithm for efficient population pharmacokinetic/pharmacodynamic (PK/PD) analysis by Mark Sale, MD (Vice President, Modeling & Simulation and Executive Consultant, Population PK)
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Clinical Trial Design and Consulting
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Nuventra has experience with the full range of clinical pharmacology studies needed for drug development programs. We provide insight and guidance from a scientific, clinical pharmacology, and pharmacokinetic perspective to enable the most efficient study design while maximizing data obtained from trials in healthy volunteers and... Show more »

Nuventra has experience with the full range of clinical pharmacology studies needed for drug development programs. We provide insight and guidance from a scientific, clinical pharmacology, and pharmacokinetic perspective to enable the most efficient study design while maximizing data obtained from trials in healthy volunteers and patients in the target indication.

We do not enroll or dose subjects in clinical trials but our high level of experience with designing, executing and analyzing data from clinical pharmacology & PK/PD studies makes us the best option for clients needing advice in this area of drug development. With an average of over 15 years of experience, our senior consultants work directly with the client to provide expertise at all levels of clinical pharmacology and pharmacokinetic drug development.

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Medical Writing
Price on request

Nuventra’s clinical pharmacology consultants and pharmacokinetic consultants have many years of experience authoring documents for submission to the FDA and other regulatory agencies. We have robust document templates and medical writing SOP’s to allow for production of high quality, submission-ready documents.

Examples of... Show more »

Nuventra’s clinical pharmacology consultants and pharmacokinetic consultants have many years of experience authoring documents for submission to the FDA and other regulatory agencies. We have robust document templates and medical writing SOP’s to allow for production of high quality, submission-ready documents.

Examples of documents Nuventra prepares include:

  • Clinical trial protocols and protocol amendments
    • We have an extensive library of clinical pharmacology study designs, including special patient population studies (e.g., renal impaired, hepatic dysfunction, healthy elderly, thorough QT, radiolabeled mass balance, ADME studies, etc.).
  • Clinical study reports (CSRs) with integrated PK and PK/PD data
  • Robust PK and PD reports
    • These PK and PD stand-alone reports can be attached to Clinical Study Reports as an appendix. Our stand-alone report structure has been used in numerous regulatory submissions. The structure of the report allows for the client to have an all encompassing PK, PD document that highlights the most important information but also contains all data needed for reproducing the pharmacokinetic and pharmacodynamic analyses.
  • FDA and EMA marketing applications including New Drug Applications (NDA) and Biologics License Application (BLA)
  • IND application preparation & maintenance
  • Investigator brochure development and maintenance
  • IMPD and international regulatory documents
  • Conference abstracts and scientific posters
  • Medical manuscripts and medical journal articles
  • General scientific writing
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Literature review
Price on request

Assessing, analyzing, and summarizing data obtained from public databases such as PubMed, TOXNET, Embase, is a strength of Nuventra. Our consultants with advanced degrees are well versed in literature searches and evaluating peer-reviewed research articles from their efforts in graduate and post-graduate research.

Nuventra has... Show more »

Assessing, analyzing, and summarizing data obtained from public databases such as PubMed, TOXNET, Embase, is a strength of Nuventra. Our consultants with advanced degrees are well versed in literature searches and evaluating peer-reviewed research articles from their efforts in graduate and post-graduate research.

Nuventra has worked on a series of unique INDs and a 505b(2) NDA for clients that were based solely on summary of literature articles obtained from public databases. The INDs were particularly novel and required buy-in from the FDA to base the IND and IND-enabling clinical studies solely on literature summaries. In fact, upon review of one literature-based IND the FDA medical reviewer had the following comment “This IND was written quite well and is a pleasure to read. Most interesting and novel”.

Our approach for including literature summaries in regulatory filings is to cast a broad net initially by searching for original publications and review articles. We refine search parameters based on a critical review of the results and narrow the pool of articles to those that are most relevant for the particular program. We use the literature database software package Endnote® by Thompson/Reuters to efficiently manage the literature articles and generate bibliographies.

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Pharmaceutical Due Diligence
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Nuventra’s senior level clinical pharmacology consultants and senior level pharmacokinetic consultants can provide expert assistance with due diligence of pharmaceuticals (small molecules) and biologics that companies are looking to in-license/out-license. Utilizing Nuventra’s consultants extensive experience in drug development,... Show more »

Nuventra’s senior level clinical pharmacology consultants and senior level pharmacokinetic consultants can provide expert assistance with due diligence of pharmaceuticals (small molecules) and biologics that companies are looking to in-license/out-license. Utilizing Nuventra’s consultants extensive experience in drug development, we can evaluate all nonclinical data, including animal PK, DMPK, in vitro/in vivo data, etc. combined with all clinical pharmacokinetic and clinical pharmacology investigations to provide a comprehensive assessment of legacy data and challenges moving forward for each drug. Analysis of regulatory interactions related to nonclinical, clinical pharmacology, and pharmacokinetic issues would also be conducted in a typical due diligence exercise to assess the level of FDA interaction to date and agreements made with the FDA for future studies/investigations.

Overall, Nuventra provides insight into each compound’s history and future, which gives companies the confidence to proceed with the licensing opportunity or to avoid a given compound due to liabilities associated with the drug.

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Project Management & Consulting Services
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Scientific Communication
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Editorial Support
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Regulatory Affairs Services
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Clinical Research
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Clinical Trials, Consulting, and Management
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Clinical Laboratory Services
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Pharmacology & Toxicology
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Computational & Statistical Analysis
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