Our successes include, but are not limited to the following:
 

Client #1 – Late Phase Program in Melanoma

Initial Client Need:

Versante was commissioned to validate the results of the analysis conducted by the company’s pharmaceutical partner. The clinical study data was transferred to Versante for review and re-analysis.

Services Provided:

  • Versante served as the company’s Biometrics Department.
  • Re-analyzed the prior melanoma data obtained from the Pharmaceutical Partner who initially conducted the analysis.
  • Designed the Phase 3 pivotal study (the largest ever in melanoma).

Critical Contributions / Ultimate Outcome:

  • The re-analysis of the data by Versante resulted in additional important findings. These findings led to increasing the proposed dose to a higher and more efficacious one with a similar safety profile.
  • The higher dose significantly improved the chance of the study being successful.
  • Developed the statistical section of the protocol and the statistical analysis plan. Led the statistical negotiations with the FDA during the development of the protocol which eventually led to it being approved under a Special Protocol Assessment (SPA) agreement.

Client #2 – Early and Mid Phase Program in Hepatitis C

Initial Client Need

Given the biotech company’s dissatisfaction with the Global CRO that conducted the prior studies, Versante was asked to provide all biometric services for the organization.

Services Provided

  • Versante served as the company’s Biometrics Department Designedand designed all the 3 Hepatitis C studies over a three year period.

Critical Contributions / Ultimate Outcome

  • Redesigned the proposed Phase 2 Hepatitis C study. This design was more efficient and significantly reduced the safety risk for patients who were to receive the combination product.
  • The above change led to FDA acceptance of the proposed study which otherwise would have been rejected.

Client #3 – Late Phase Program for Multiple Sclerosis

Initial Client Need

Versante was contracted to validate key analyses performed on Phase 2 Multiple Sclerosis (MS) data by one of the largest CROs in the world.

Services Provided

  • Additional analyses of data, and checking to validate the analyses performed by the global CRO.
  • Numerous exploratory subgroup analyses to evaluate the predictive capabilities (of efficacy) of several biomarkers, and identification of subpopulations that responded to treatment.
  • Responses to address the questions and issues raised by potential partners.

Critical Contributions / Ultimate Outcome

  • Found significant mistakes in several of the analyses of the key endpoints, including the primary analysis.
  • Corrected the statistical methodology that was used. The resulting analyses prevented potential partners/investors from raising issues about the credibility of the analyses.
  • Identification of a responsive subpopulation. This led to the planning of a second phase 2 study, and discussion points for partnering activities.

Client #4 – Early, Mid and Late Stage Programs for Multiple Sclerosis

Initial Client Need

Versante was contacted because of its prior experience with Multiple Sclerosis studies. The role was to provide further insights into study designs and clinical plans (Phases 1-3), and to assist with the analyses of safety and PK data.

Services Provided

  • Significant input and help in developing the clinical strategy for the MS Program.
  • Improved design of the second stage of the phase 1 study.
  • All the PK, PD and safety analyses.

 Critical Contribution / Ultimate Outcome

  • Design improvement which led to a clear result: that the test treatment could be differentiated from the active control via the use of biomarkers.
  • Findings which resulted in potential partners/investors coming to the table. The latter would not have been possible without the design improvement.

Client #5 – Rhinitis, Oncology and Hepatitis B

Initial Client Need

Based on a referral, the Chief Medical Officer of the client company requested that Versante serve as the company’s Biometrics Department for clinical studies, and provide all needed biometrics services.

Services Provided

  • Advice the preclinical groups and participate in meetings with the FDA.
  • The design of all new studies.
  • Re-analysis of the Rhinitis data from the completed studies. The latter identified potential responder subgroups for partnering possibilities.
  • Participation in Data Safety Monitoring Boards (DSMB) and Data Monitoring Committees (DMC).
  • Substantial input to protocol and strategy for regulatory filings.
  • Participation in meetings with the FDA and EMEA to present and discuss statistical issues.
  • Compilation of the data from studies conducted by several other CROs. The latter helped to identify and then address issues related to the lack of consistency and documentation across different studies, inaccuracies and missing safety data. Provided a package to the company for an electronic data filing for a clinical hold submission in a time frame that the other CROs could not meet.
  • The lifting of the Clinical hold, with some restrictions. This then allowed the program to move forward.
  • Design of, and statistical methods for, all pivotal studies, and also for the lot-to-lot consistency and bridging studies.

Client #6 – Prostate Cancer

Initial Client Need:

Versante was contacted and hired because the Client did not have a biometrics department, and lacked statistical leadership. Its role was to provide the required services.

Services Provided:

  • Statistical leadership for all of the company’s drug programs.
  • Statistical analysis and SAS Programming support for the clinical study reports.

Critical Contributions / Ultimate Outcome:

  • Convinced management to introduce survival as a key endpoint of the study.
  • Provided statistical leadership in the development of the pivotal Phase III study protocol and interactions with the FDA.
  • Phase III protocol approved under a Special Protocol Assessment (SPA) by the FDA.
  • The result of the completed Phase III study showed a significant survival benefit.
  • FDA advisory board voted for approval resulting in an approvable letter.
  • Provided statistical analysis and interpretation of the results of the analysis, and SAS programming support. This support was critical for the production of all the clinical study reports needed for the BLA submission.
 
 
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