Brian Laffin Email & Phone Number

Fort Lauderdale, FL, US

Clinical development and translational medicine consulting for AI, biotech, and pharma companies.Specializing in:-Clinical biomarker planning and implementation-Integration of machine learning approaches and digital biomarkers-Research project scoping, design, and data analysis-Competitive landscape analysis and portfolio optimization-Patient selection and.

North Melbourne, Victoria, AU

• Achievements:
• Contributed multiple innovative trial designs with unique biomarker-driven stratification approaches
• Developed GBM translational strategy from ground upResponsibilities:
• Clinical and Translational Lead for Telix radiopharmaceutical theranostic assets in GBM
• Leadership of pivotal trial design, regulatory document authoring, and safety-related documents / plans for GBM studies
• Representation of Telix at relevant scientific congresses

Lawrence Township, NJ, US

• Achievements:
• Identified novel indications for label expansion of approved therapies and initiated external collaborations for PoC
• Successfully initiated phase 0 studies to gain translational knowledge of competitive MOAs for positioning of internal assets and guiding patient stratification / selection approaches
• Lead internal efforts to identify and implement novel imaging technologies and related endpoints for difficult to treat immune disordersResponsibilities:
• Design and implementation of clinical biomarker plans for FIH through Phase 2 / PoC studies, authoring of clinical protocols, and planning of parallel translational experiments
• Leadership of above-asset research coordination efforts and academic collaborations

Lawrence Township, NJ, US

• Achievements:
• Created and co-chaired internal working group for company-wide coordination of dermatology research efforts, with more than 75 members spanning all phases and functions of development
• Designed and implemented core clinical biomarker plan components used across all atopic dermatitis studies to maximize disease state knowledge, facilitate portfolio optimization, and prepare for combination therapies
• Successfully championed adoption of new biomarker sampling techniques and wearable techResponsibilities:
• Design and implementation of clinical biomarker plans for FIH through Phase 2 / PoC studies, authoring of clinical protocols, and planning of parallel translational experiments
• Strategic contributor to novel clinical trial design activities and overhaul of ICFs, to better enable portfolio-level research and inform combination therapy strategy

Lawrence Township, NJ, US

• Achievements:
• Met and exceeded assigned metrics for all assessment periods and for 100% of special projects outside of normal MSL responsibilities
• Trained successors to my roles as training lead and MSL for the New England territory, in preparation for transition to BMS immunology early development role
• Invited participant in roundtable discussions at BMS career development workshopsResponsibilities:
• Provided pathology/biomarker education and clinical trial support to academic and community hospitals of all sizes, reference labs, and CROs
• Responded to physician inquiries, discussed on and off-label clinical data, and facilitated academic research collaborations

Lawrence Township, NJ, US

• Achievements:
• Met and exceeded assigned metrics for all assessment periods and for 100% of special projects outside of normal MSL responsibilities
• Contributed to development of new training curriculum for diagnostics MSL team and served as training lead, with 100% of assigned trainees completing field readiness tests on first attempt and on schedule
• Helped establish multiple institution-level collaborations between BMS and academic hospitalsResponsibilities:
• Provided pathology/biomarker education and clinical trial support to academic and community hospitals of all sizes, reference labs, and CROs
• Responded to physician inquiries, discussed on and off-label clinical data, and facilitated academic research collaborations

Munich, DE

• Achievements:
• Biology lead for internal AZ immune cell tumor mapping project using digital image analysis / machine learning, leading to publication
• Made critical contributions to business development activities leading to 3 large multi-project agreements with pharmaceutical customers
• Developed oncology / pathology educational materials for internal programmers and statisticiansResponsibilities:
• Project scoping and writing of SOWs, proposals, alliance roadmaps, data transfer specifications, and SOPs.
• Data analysis, project report writing, and preparation / presentation of results to internal and external teams.

Munich, DE

• Achievements:
• Developed novel internal image analysis tools for IHC assay development, hybridoma screening, vendor qualification, and preclinical xenograft tumor studies
• Contributed to internal product development and technology refinement by serving as internal SME on histology and tumor biology
• Completed all assigned project deliverables on time and within scopeResponsibilities:
• Hands-on generation of digital pathology and image analysis algorithm solutions for client and internal projects
• Guide product and method development through detailed iterative testing under version control

Broomfield, Colorado, US

• Achievements:
• Developed more than 200 fit-for-purpose IHC and ISH assays, including 20+ clinical trial assays, on time and within budget
• Wrote rule-based image analysis algorithm that determined the H-score cut point for an IHC assay used in a pivotal oncology trial
• Presented groundbreaking image analysis work on macrophage typing and spatial tumor analysis at SITCResponsibilities:
• Interpretation of IHC assay development data and determination of further optimization steps
• Technical support and mentoring of image analysis and assay development scientists leading to independent competence and project execution

Denver, CO, US

I investigated signaling pathways downstream of the human aldose reductase enzymes in an effort to forge a mechanistic link between diabetes-related alterations in sugar metabolism, cataract, tissue hypoxia, inflammation, and potentially diabetic's increased cancer risk.

Houston, TX, US

I was involved in a large team effort to understand the role of various populations of so-called "cancer stem cells" or tumor initiating cells in the development of anti-androgen resistance and relapse after hormone ablation therapy, and using bioinformatics approaches to identify genes critical to these processes.

College Station, TX, US

I conducted neuroendocrine toxicology studies related to the ability (or inability) of various pyrethroid pesticides to disrupt neurodevelopment and sexual development in mammals.

College Station, TX, US

Characterized role of Singleminded-2s (SIM2s) in breast carcinogenesis. Assisted with characterization of the role of SIM2s and PER proteins in mammary gland development and differentiation.

College Station, TX, US

Performed large-scale protein purifications and kinetic analyses of mutant enzymes.