Vision Biotechnology Consulting

regulatory approval projects

Company Type: Medical Device Company
Task:	Perform statistical analyses and author 510(k) submission for rapid assay for use as an aid in the diagnosis of androgen disorders.
Results:	510(k) cleared by FDA in January 2019
Company Type: Medical Device Company
Task:	Design reproducibility studies, perform all statistical modeling and analyses, and collaborate on regulatory correspondence for novel blood collection and stabilization device for immunophenotyping.
Results:	510(k) cleared by FDA in June 2017
Company Type: Pharmaceutical Company
Task:	Design analysis methods and perform statistical analysis for expiration dating of novel, first FDA approved, drug for tardive dyskinesia. VBC performed multiple analyses on aggressive timeline to support FDA review and approval.
Results:	New Drug Application approved by FDA in April 2017
Company Type: Diagnostic Company
Task:	Design clinical study for home use male fertility test system, train, manage, and monitor clinical study sites, perform statistical analyses, author Clinical Study Report, and respond to regulatory inquiries during review
Results:	510(k) cleared by FDA in May 2016
Company Type: Diagnostic Company
Task:	Perform statistical analyses, author all 510(k) sections for new High-Sensitivity C-Reactive Protein immunoassay, and respond to regulatory inquiries during review
Results:	510(k) cleared by FDA in January 2015
Company Type: Diagnostic Company
Task:	Perform statistical analyses, author 510(k) sections, guide company in regulatory considerations, etc. for new Factor II/V Leiden genotyping assay for thrombophilia and associated mass spectroscopy instrument, and respond to regulatory inquiries during review
Results:	510(k) cleared by FDA in June 2014
Company Type: Diagnostic Company
Task:	Perform statistical analyses, author all 510(k) sections for new Vitamin D immunoassay, and respond to regulatory inquiries during review
Results:	510(k) cleared by FDA in July 2013
Company Type: Diagnostic Company
Task:	Author all 510(k) sections for new multi-analyte control for the verification of accuracy and precision of assays for Free Thyroxine, hCG, Testosterone, total PSA, and TSH; and respond to regulatory inquiries during review
Results:	510(k) cleared by FDA in March 2013
Company Type: Japanese Diagnostic company
Task:	Author CE Mark Technical File to enable European commercialization of new marker of glycemia
Results:	Project completed on time Certification granted 2012
Company Type: Diagnostic Company
Task:	Perform univariate and multivariate Cox regressions, ROC analyses, Kaplan-Meier analyses, absolute risk analyses, statistical simulations, and analyze precision, LOB/LOD/LOQ, and linearity data for prostate cancer prognostic test; author all statistical reports and 510(k) sections and respond to regulatory inquiries during review
Results:	510(k) cleared by FDA on 9/21/11
Company Type: Diagnostic Company
Task:	Perform method comparison analysis between immunoassay and turbidimetric inhibition assay for cardiovascular risk factor for submission in 510(k)
Results:	510(k) cleared January 2011
Company Type: Diagnostic Company
Task:	Guide statistical analysis; co-author clinical trial report and sections of PMA application for PCA3 as a risk factor for prostate cancer
Results:	PMA APPROVED BY FDA 2/15/12
Company Type: Pharmaceutical Company
Task:	Author Integrated Summary of Efficacy for new drug for induction of remission in ulcerative colitis
Results:	Review numerous clinical study reports and results of integrated analysis of pooled studies. Generated ISE within project timelines
Company Type: Diagnostic Company
Task:	Guide study design and perform all statistical analyses for method comparison and analytical studies conforming to CLSI standards. Author sections of supplemental 510(k) submission and subsequent responses to regulatory inquiries
Results:	510(k) cleared 8/17/10
Company Type: Pharmaceutical Company
Task:	Perform stability studies statistical analysis based on standard and accelerated conditions extrapolation and author reports for NDA
Results:	NDA submitted 1/4/10
Company Type: Pharmaceutical Company
Task:	Perform stability studies statistical analysis based on standard and accelerated conditions extrapolation and author reports for NDA
Results:	NDA Approved 2011
Company Type: Diagnostic Company
Task:	Perform statistical analyses and author 510(k) for Beta-hCG assay for early pregnancy detection
Results:	Product cleared by FDA in 12/07
Company Type: Diagnostic Company
Task:	Provide initial regulatory guidance to new company
Results:	Reviewed Pre-IDE for new multiplex test for active coronary artery disease (CAD) and provided guidance prior to initial FDA meeting on potential 510(k) submission regarding appropriate intended use, statistical approaches, and other considerations
Company Type: Diagnostic Company
Task:	Perform statistical analysis of method comparison between new nucleic acid detection immunoassay (NADIA) for serum total PSA and existing methods
Results:	Analysis completed on time and generated statistical section of 510(k) submission
Company Type: Diagnostic Company
Task:	Perform univariate and multivariate Cox Regressions and other statistical analyses for new ischemic stroke risk factor; compose statistical section of 510(k) and correspond with reviewing FDA statistician
Results:	Project completed on time; 510(k) cleared by FDA in 6/05
Company Type: Diagnostic Company
Task:	Perform biostatistical analyses on data from analytical and clinical studies of new Her-2/neu genetic imaging assay
Results:	Analyses and reports completed under urgent timeframe and submitted in 510(k) to FDA; Product cleared by FDA in 5/05
Company Type: Contract Research Organization
Task:	Author protocol for Phase II study of organ rescue drug for metastatic breast cancer chemotherapy; author Investigator Brochure and co-author IND
Results:	Developed statistical analysis plan and authored high-quality protocol and Investigator Brochure on time; IND approved and fast-track status granted 3/05
Company Type: Diagnostic Company
Task:	Perform biostatistical analyses on data from analytical and clinical studies of new lithium assay
Results:	Analyses and reports completed under urgent timeframe; 510(k) clearance and CLIA Waiver received 3/05 and 4/05, respectively
Company Type: Pharmaceutical Company
Task:	Review literature on omeprazole pharmacokinetics and pharmacodynamics and compose sections of NDA for new proton pump inhibitor
Results:	Extensive review performed; authored NDA sections; Product approved by FDA 6/04
Company Type: Pharmaceutical Company
Task:	Assist in composition of NDA
Results:	Authored section on use of screening test for categorization of patients who are likely to respond to new therapy for Lupus; company received Approvable Letter from FDA 10/04
Company Type: Japanese Diagnostic company
Task:	Perform biostatistical analyses on longitudinal diabetes trial evaluating new marker of glycemia; Author 510(k)
Results:	Multiple statistical techniques utilized. 510(k) authored on time. Product cleared by FDA 9/03
Company Type: Diagnostic company
Task:	Author 510(k) for new cardiac risk factor
Results:	VBC team worked collaboratively with client to perform statistical analyses and author and revise sections of 510(k). Product cleared by FDA 7/03
Company Type: Pharmaceutical Company
Task:	Author Clinical Trial Reports and Safety and PK/PD sections of CTDs for new capsule and tablet formulations of Omeprazole
Results:	Documents completed on time; Capsule CTD approved in 2/06; Tablet CTD approved in 3/06
Company Type: Diagnostic Company
Task:	CE Mark
Results:	Performed risk analysis and authored sections of technical file and essential requirements documents

clinical trials and biostatistics

Company Type: Diagnostic Company
Task:	Biostatistical analysis
Results:	Utilizing uni- and multivariate logistic regression analyses and other analytical methods, investigated the association of PCA3 (prostate cancer gene 3) with contemporaneous prostate biopsy outcomes and as a predictor of future biopsy results in both the placebo and active study arms of the dutasteride REDUCE trial, a major Phase 3 study of dutasteride as a chemopreventive agent
Company Type: Diagnostic Company
Task:	Study design and biostatistical analysis
Results:	Developed sample size rationale and statistical analysis plan for multi-center clinical study on multi-analyte platform for neonatal screening for cystic fibrosis, congenital hypothyroidism, and congenital adrenal hyperplasia
Company Type: Diagnostic Company
Task:	Study design and biostatistical analysis
Results:	Guided study design including providing sample size analysis for study on PSA as a prognostic marker following radical prostatectomy using new ultra-sensitive assay. Performed biostatistical analyses using various methods including univariate and multivariate logistic and Cox regressions, Kaplan-Meier survival analyses, etc. to identify optimal prognostic indicator representation of variable and to provide hypothesis for 510(k) trial for submission
Company Type: Diagnostic Company
Task:	Study design and sample size
Results:	Performed sample size analysis for clinical study to support 510(k) submission for intermittent glucose monitor system for critical care and other hospitalized patients receiving intensive insulin therapy. Provided guidance on study design and Pre-IDE submission to FDA
Company Type: Diagnostic Company
Task:	Study design and statistical methods
Results:	Provided guidance on clinical study design and statistical analysis plan for in vitro diagnostic multivariate index assay (IVDMIA) for rheumatoid arthritis
Company Type: Diagnostic Company
Task:	Develop risk scores for coronary heart disease and ischemic stroke
Results:	Using Framingham scores as a guide and the Atherosclerosis Risk in Communities (ARIC) trial database, risk scores developed which incorporate traditional and emerging vascular risk factors
Company Type: Diagnostic Company
Task:	Study design, sample size, and statistical analysis plan
Results:	Reviewed Pre-IDE submission to FDA and provided guidance on study design, sample size estimation, and statistical analysis concepts for instrument migration studies for three tests for sexually transmitted diseases
Company Type: Diagnostic Company
Task:	Study design and statistical analysis plan
Results:	Provided guidance on study design and statistical analysis plan for study on human papilloma virus (HPV) test
Company Type: Diagnostic Company
Task:	Provide statistical counsel and sample size analysis for large outcomes trial
Results:	Provided statistical guidance on use of time to event analyses in clinical trials and developed sample size estimations using log-rank, Cox regression, and Poisson Regression techniques for outcomes-based longitudinal trial of new non-invasive bioimpedance cardiography instrument for management of patients at risk for heart failure
Company Type: Pharmaceutical Company
Task:	Author clinical protocol on immediate release omeprazole formulation
Results:	High-quality protocol comparing pharmacodynamic effects of omeprazole vs. Nexium in nocturnal acid breakthrough authored and study completed successfully
Company Type: Diagnostic company
Task:	Perform exploratory statistical analyses of Atherosclerosis Risk in Communities (ARIC) trial
Results:	Utilized Kaplan-Meier techniques to elucidate synergy of new biomarker in relation to established risk factors. Results supported use of new marker as an adjunct to established methods in identification of patients at risk.
Company Type: Pharmaceutical Company
Task:	Develop database, manage data, and perform statistical and pharmacokinetic analyses on Phase I Safety and Pharmacokinetics Trial
Results:	Study completed on time; Data incorporated into NDA and European submission
Company Type: Pharmaceutical Company
Task:	Perform population pharmacokinetics analysis and determine drug-drug interactions
Results:	Analysis incorporated into pre-submission for FDA Oncology Drugs Advisory Committee panel meeting
Company Type: Pharmaceutical Company
Task:	Perform pharmacokinetic analyses on new drug in renally and hepatically impaired patients
Results:	Analyses completed on time and submitted to FDA to support NDA
Company Type: Diagnostic company
Task:	Perform biostatistical analyses to determine potential of new tumor markers
Results:	Multivariate logistic regression techniques used to identify multiple new sensitive and specific prostate, colon, breast, ovarian, and lung tumor markers; promising markers continued into next phase of development
Company Type: Japanese Diagnostic Company
Task:	Develop protocols for reference range and longitudinal efficacy studies of novel diabetes marker and manage both studies.
Results:	Protocols developed and studies completed on time. No documentation issues noted during study monitoring. Studies used in regulatory submission and supported eventual 510(k) clearance of product.
Company Type: Pharmaceutical Company
Task:	Perform sample size/power analysis for Phase III melanoma trial
Results:	High-quality report generated detailing sample size requirements for variety of scenarios
Company Type: Pharmaceutical Company
Task:	Perform sample size/power analysis for Phase II/III Hepatitis C Trial
Results:	High-quality report generated detailing sample size requirements for variety of scenarios
Company Type: Diagnostic Company
Task:	Design and author clinical study protocols for new nucleic acid amplification assay for prostate cancer
Results:	High-quality protocols generated and studies in-process
Company Type: Pharmaceutical Company
Task:	Author 3 pediatric clinical trial protocols for evaluation of proton pump inhibitors
Results:	Protocols completed under urgent timeframe and in review by FDA
Company Type: Diagnostic Company
Task:	Perform biostatistical analysis from angiography study Results: Univariate and multivariate logistic regression and ROC techniques utilized to assess efficacy of new marker as cardiovascular risk factor. High quality report generated on time
Company Type: Pharmaceutical Company
Task:	Perform pharmacokinetics analysis from subjects in Phase III melanoma trial and compare to results from healthy subjects
Results:	Analysis completed and incorporated into NDA and European submission
Company Type: Device Company
Task:	Design, manage, and analyze trial for safety and efficacy of vaccine administered with jet injector device in comparison to needle syringe
Results:	Study completed on-time, manuscript generated and published in Pediatric Infectious Disease Journal
Company Type: Pharmaceutical Company
Task:	Perform toxicokinetic and pharmacokinetic analysis from animal study of new cancer drug
Results:	Model-dependent PK analyses performed; Results show no cumulative toxic effect of drug administration over sustained period
Company Type: Pharmaceutical Company
Task:	Perform PK analyses from animal study on new oral dosage form of cancer drug
Results:	Site of highest absorption and slowest elimination identified in GI tract Results used to guide further development
Company Type: Pharmaceutical Company
Task:	Perform pharmacodynamic analyses from data arising from multiple PK studies in healthy subjects and cancer patients.
Results:	High quality report generated on time

manufacturing

Company Type: Pharmaceutical Company
Task:	Design protocols and manage physico-chemical characterization studies of new drug substance
Results:	Studies completed on time; Composed portions of CMC section for NDA
Company Type: Pharmaceutical Company
Task:	Manage manufacturing of scale-up and process validation lots of injectable drug under GMP
Results:	5 Lots manufactured and released in 3 month timeframe; materials used for Phase II and III trials
Company Type: Diagnostic Company
Task:	Troubleshoot manufacturing process with 75% failure rate
Results:	Driving factors identified; process optimized via factorial design; failure rate 0% in the 4 years since project completed
Company Type: Pharmaceutical Company
Task:	Provide technical guidance on drug substance process issues resolution
Results:	Provided guidance, designed experiments, and authored protocols to optimize chemistry parameters to achieve product specifications for color, clarity, and purity.
Company Type: Pharmaceutical Company
Task:	Assist in validation of drug substance manufacturing process.
Results:	Reviewed protocol for factorial design to establish tolerances of process chemistry steps.
Company Type: Pharmaceutical Company
Task:	Author SOPs for analytical development laboratory
Results:	Developed compliant SOPs for analytical methods transfer and GxP
Company Type: Pharmaceutical Company
Task:	Perform regulatory audit
Results:	Audit on development of pharmacogenomic assay performed and reported; results used to prepare for NDA
Company Type: Pharmaceutical Company
Task:	Analyze data from stability studies of drug substance and injectable drug product
Results:	Analysis completed under aggressive timeline and results incorporated into CMC section of NDA
Company Type: Pharmaceutical Company
Task:	Analyze drug product release data from scale-up lots and determine specifications
Results:	Using statistical methodologies, tolerance intervals determined and used to refine existing drug product specs.

design and development

Company Type: Diagnostic Company
Task:	Lead project team in development of four new pan-cancer diagnostic immunoassays
Results:	Assays currently in evaluation in multi-center PLCO (prostate, lung, colon, ovarian) study
Company Type: Diagnostic Company
Task:	Lead project team of scientists in assay and process development of new diagnostic immunoassay for ovarian cancer
Results:	Project completed on time and in full compliance with product design goals; clinical trial in process for eventual PMA submission
Company Type: Pharmaceutical Company
Task:	Perform GLP audit of pre-clinical pharmacokinetics/ toxicokinetics studies
Results:	Audit completed in compliance with GLPs, reports generated and used to address existing gaps and correct errors in draft study reports
Company Type: Diagnostic Company
Task:	Assess correlation of GMP level reagents to research prototype kit for cardiovascular disease marker
Results:	Cluster regression and other statistical methods used to establish relationship to prototype and provide guidance for continuing development/clinical trials
Company Type: Pharmaceutical Company
Task:	Design and analyze factorial design study for formulation development of new topical drug for oral mucositis
Results:	Multiple regression techniques used to screen and optimize formulations for animal and Phase I studies
Company Type: Pharmaceutical/Homeopathic drug company
Task:	Assist in development of clinical strategy.
Results:	Provided 3rd party review of clinical program strategy and SBIR application for pharmacokinetic trial.
Company Type: Device company
Task:	Design, perform, and analyze study to assess structural retention of drugs injected with new device
Results:	Structures retained; Report generated by VBC used to solidify co-marketing alliances with major pharmaceutical companies
Company Type: Diagnostic Company
Task:	Assist in optimization of reference methods for novel analyte.
Results:	Provided guidance on reduction of variability of HPLC-based reference method
Company Type: In-vitro diagnostic manufacturer
Task:	Manage entire development effort on non-invasive test for metabolic bone disease
Results:	Effort completed on-time and product currently approved OUS
Company Type: Research reagent company
Task:	Evaluate technology vis a vis application to diagnostic industry.
Results:	Thorough research performed. Report detailing applications in clinical diagnostics and high-throughput drug screening generated.
Company Type: Device company
Task:	Determine appropriate container material for disposable drug product container/delivery device
Results:	Material compatibility demonstrated for wide range of drug products with more than 3 potential container materials.

medical education

Company Type: Diagnostic Company
Task:	Author urology review
Results:	Authored expert review on markers of prostate cancer including the new genetic marker, PCA3. Review published in Future Drug
Company Type: Medical Education Company
Task:	Author monograph on early aggressive treatment of type 2 diabetes
Results:	Monograph generated and published underscoring the need for early therapy with glitazones in combination with other standard anti-hyperglycemic therapies
Company Type: Medical Education Company
Task:	Author monograph on Type 2 Diabetes as a vascular disorder and the role of insulin-sensitizing agents
Results:	Monograph generated and approved by Takeda for continuing medical education through AAPS
Company Type: Pharmaceutical Company
Task:	Author standard dossier on new proton pump inhibitor including pharmacology, safety and efficacy parameters, and application in various clinical conditions
Results:	Dossier composed on time and used in launch of new drug
Company Type: Medical Education Company
Task:	Author monograph on post-prandial hyperglycemia in Type 2 Diabetes
Results:	Monograph generated and approved by Novo Nordisk for continuing medical education through UCSD
Company Type: Medical Education company
Task:	Develop frequently asked questions for diabetes education website
Results:	Extensive literature review performed; FAQ on effects of Glucagon on glucose homeostasis and interactions with Amylin/Pramlintide authored