Denise Ramsey, BA, MBA
Co-Founder | Principal Development Consultant
With over 20 years of experience in the biotechnology industry, Denise brings a strong track record of strategic leadership and operational excellence. She is a high-performing team leader who keeps the big picture in focus while managing the critical details required to meet company objectives.
Denise excels at leading global cross-functional teams across all phases of the product lifecycle — from preclinical development through post-launch. Her expertise includes alliance management, complex strategic program execution, and initiatives beyond clinical development.
She offers a comprehensive skill set spanning product lifecycle strategy, risk and financial oversight, and vendor management. Denise’s ability to effectively engage with executive leadership and report to Boards makes her an invaluable partner in driving organizational efficiency and achieving strategic goals.
Bryan Suggitt, BS, MS
Co-Founder | Principal Validation & Quality Engineer
Bryan is a seasoned chemical engineer with over two decades of experience leading complex validation and qualification programs in the life sciences industry. He is a highly effective leader and a trusted partner to Engineering, Manufacturing, Quality, and IT teams.
Bryan’s strengths lie in building high-performing teams, applying a lean, risk-based approach to qualification, and ensuring GMP compliance across the entire system lifecycle. His ability to harmonize quality expectations with practical execution makes him a standout contributor in both startup and established environments.
Combining strategic insight with deep technical expertise, Bryan brings a hands-on, quality-focused mindset that consistently drives operational excellence and regulatory confidence.
Founder’s Strategic Impact on Drug Development Success
Program Lead for initiating clinical studies in gastrointestinal cancers, including metastatic colorectal cancer (mCRC) — an indication now approved alongside several others in oncology.
Served as Program Lead through Phase II/III development, culminating in commercial launch. Managed stakeholder concerns and scientific controversy surrounding off-label Avastin use prior to Lucentis approval.
Initial Program Lead at BioMarin, responsible for initiating Phase I studies. The program later transitioned to MedImmune/Pfizer and is now approved for HER2-negative breast cancers.er.
Led engineering efforts to develop facility infrastructure supporting commercial delivery of this cystic fibrosis therapy.
CMC Program Lead for Phase II development and injectable device concept, now approved for multiple allergic and inflammatory conditions. Also led engineering response to market research and commercial input on alternative device configurations.
Served as CMC and Engineering Lead focused on refining dosing strategies and combination therapies (e.g., hypertonic saline) to enhance efficacy for cystic fibrosis patients.
Validation Lead responsible for authoring regulatory submissions detailing validation strategy and execution for this landmark breast cancer therapy.
Commercial Program Lead overseeing sales training, regulatory-compliant marketing materials, and payer access planning. Ensured alignment between commercial strategy and regulatory requirements to protect patient access.
Initial Program Lead for the only approved therapy to increase linear growth in children with achondroplasia. Managed complex stakeholder dynamics, including advocacy groups both supporting and opposing the therapy.
Led the commercial launch team, coordinating publication planning, reimbursement strategy, supply chain readiness, and payer positioning. Achieved full commercial readiness within two months post-FDA approval, with sales surpassing targets within six months.