Adele Blackler, PhD is the principal consultant for Adalheidis Consulting, LLC and available for long-term or short-term projects in the US.
Dr. Blackler has excelled in a variety of industries, with a focus on diagnostics, Laboratory Developed Tests and applications for mass spectrometry. With a strong background in business analytics, clinical affairs, and product development, Dr. Blackler excels at navigating and succeeding in a variety of regulated environments, including GLP, CAP, CLIA, and ISO.
Key Accomplishments:
- 6 years of product development experience. Initial product scoping, requirements, market estimation, market surveys, development and validation for CLIA and GLP environment, improvements to on-market products, user training documentation, post-installation user support.
- Developed and implemented an IRB-approved, prospective clinical study. Wrote the clinical protocol, developed and built sample collection kits and processes for in-house sample analysis. Cross-functional management and coordination of internal and external laboratories. Successful Site Initiation Visit (SIV) and study launch within 6 weeks of start.
- Designed, purchased and oversaw testing and feasibility for custom liquid handling systems and custom built software systems
- Led a critically important effort to increase the company's presence in peer-reviewed journals and provided well-respected and impactful internal peer feedback to other scientists.
- Development, validation and implementation of several new methods for sample processing that resulted in more accurate results reporting, saved costs on sample processing and halved sample processing time
- Lead the development and planning for quarterly and yearly goals and roadmap for R&D department
- Developed an assay tracking mechanism that streamlined the development process, clarified handoffs, and focused group work on delivering new assays for a diagnostic test
- Signed multiple 6-figure fee-for-service and business development contracts and increased realized revenue by 8-fold
Dr. Blackler's areas of expertise include the following:
Clinical development, study design and protocol development.
▪ Retrospective or prospective study design, Statement of Work (SOW) and clinical trial protocol development
▪ Standard Operating Procedure (SOP) and Case Report Form (CRF) development
Scientific and technical writing
▪ Peer reviewed manuscripts, grants and submitted articles
▪ White papers and sales collateral
▪ Training and lecture material and presentations
Project Management
▪ Gap analysis, user needs assessment and new process development and implementation
▪ Timeline and critical path development
▪ Development and implementation of staff cross-training for necessary redundancy and knowledge transfer
Mass spectrometry and proteomics
▪ Extensive experience with LC/MS/MS, QqQ, GC/MS, MALDI-TOF
▪ Instrument scoping, setup, and optimization
▪ Proteomic study design and data interpretation
Laboratory Information Management System (LIMS)
▪ Design, testing, SQL, and implementation
▪ Process documentation