Consulting Services
Advice and hands-on expertise to life science companies to advance programs and build companies
o Program Strategy Development
o Program Management
o Project Leadership
o Preclinical and Nonclinical Study Planning and Management
o Alliance Management
o Data Evaluation
o Medical Writing and Editing
o Team Formation and Development
o Gap Analysis
o Portfolio Management
o Governance Strategies
o Intellectual Property Management
Examples
Project Leadership and Program Management
Project Leadership and Program Management
Project Leadership and Program Management
Integrated strategy and planning of programs from pre-IND stage through development. Includes functional strategies (pharmacology, toxicology, CMC, regulatory, new product planning, finance, intellectual property), scenario-building, timeline generation, milestone planning, risk identification and mitigation, go/no go decision-making, target product profile development.
Team Formation and Development
Project Leadership and Program Management
Project Leadership and Program Management
Defining appropriate team membership for stage of program, developing team norms (e.g., meeting times, roles and responsibilities), developing program documentation, assessing team effectiveness, defining team communications with governance/management.
Data Evaluation and Gap Analyses
Project Leadership and Program Management
Preclinical and Nonclinical Study Management
Review and analysis of existing data and evaluation of support for therapeutic hypothesis and program go/no go criteria; assessment of additional studies and activities required to support current and future development stages.
Preclinical and Nonclinical Study Management
Preclinical and Nonclinical Study Management
Preclinical and Nonclinical Study Management
Developing study designs, writing and editing protocols, identifying CROs, monitoring studies, reviewing data, writing and editing study reports.
Medical Writing and Editing
Preclinical and Nonclinical Study Management
Medical Writing and Editing
INDs, IBs, briefing documents for meetings with health authorities, CTAs, grants, articles.
Alliance Management
Preclinical and Nonclinical Study Management
Medical Writing and Editing
Management of contractual R&D relationships between companies and academic institutions. Developing processes, as needed, ensuring contractual deliverables are fulfilled, and building and maintaining relationships.