Meet Our Consultants

Aleks Davis BS, MBA

Partner and Chief Executive Officer
B2S Life Sciences

Ronald R. Bowsher PH.D.

Partner and Chief Scientific Officer
B2S Life Sciences

William Nowatzke PH.D., DABCC

Vice President - Laboratory Operation, Biomarkers, and CLIA
B2S Life Sciences

Melissa Johnson

Director of Client Engagement and Marketing
B2S Life Sciences

Amber Bechert

Director of Quality and IT
B2S Life Sciences

An expert consultation experience with B2S is client-focused, conscientious, and driven by mutual success. As thought leaders in topics such as biotherapeutic drug development, clinical trials statistics, regulated bioanalysis, ADME, immunogenicity assessments, immune safety assessments, novel biomarker assays, CMC, and quality and regulatory compliance, our consultants offer a unique perspective that has been sculpted by years of industry application. Contact us today for support in the following areas:

  • Peptide therapeutics and biosimilars
  • Support for immunogenicity testing
  • Clinical drug development, PK and modeling
  • Clinical trials statistics and outcomes research
  • CMC support
  • Technical and medical writing
  • Study design, plans, analyses, and reports
  • Bioanalytical method development and validation
  • Development, registration and commercialization
  • PK/PD sampling requirements
  • Planning number of animals or subjects
  • Integrated PK/TK and/or PD analyses
  • Simulations and predictions
  • Design of critical-path studies
  • Defining scope of PK/TK or PD assessments
  • Establish key study objectives
  • Classic and non-compartmental PK/TK models
  • Population PK/PD modeling
  • Exposure-response modeling
  • Expert interpretation of study results
  • Facilitation of strategic decisions
  • Writing reports and creating presentations
  • GLP compliance and QA/QC
  • Regulatory interactions and engagement
  • Study design and protocol recommendations
  • Standalone PK/TK or PD report
  • Integrated components of study final report
  • B2S standard or customer specified report
  • Content and format – QA and QC
  • Project evaluation and drug strategies
  • Development and registration
  • Regulatory submissions – IND, NDA, BLA
  • CTD – study report or summary

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