Navigating the Complexities of Cancer Drug & Device Development with Unrivaled Expertise
In the high-stakes world of oncology, precision and foresight are paramount. We empower biotech innovators to accelerate their assets from discovery to market, mitigating critical risks and maximizing valuation through scientifically rigorous strategy and execution
PROVEN IMPACT
Our track record speaks to our ability to transform challenging oncology programs into successful assets. These representative case studies highlight our strategic intervention and the tangible value delivered.
Strategic Case Studies
Challenge
Early termination due to broad population failure.
Our Intervention
Retrospective subgroup analysis revealed significant anti-tumor activity in biomarker-defined patients
Measurable Outcome/Impact
Successful out-licensing and progression to registration studies; presented at JPM Healthcare Conference
Our track record speaks to our ability to transform challenging oncology programs into successful assets. These representative case studies highlight our strategic intervention and the tangible value delivered.
OUR DISTINCTIVE APPROACH:
Executive Leadership
Our Distinctive Capability:
Former Executive Medical Director at Pfizer with 20+ years guiding programs from pre-IND through post-marketing.
Direct Benefit To Your Program
Gain strategic oversight from a seasoned industry veteran, anticipating challenges and accelerating decision-making.
Pathway-Specific Expertise
Our Distinctive Capability:
Deep, hands-on experience in small molecules, biologics, and novel modalities, with specific focus on RAS pathway and signal transduction (e.g., PI3K, Notch, CDK, PARP inhibitors), bifunctional antibodies, T-cell engagers, cancer vaccines, ADCs
Direct Benefit To Your Program
Ensure optimal target validation, biomarker strategy, and clinical design, leading to more precise patient selection and de-risked development pathways.
Regulatory Navigation
Our Distinctive Capability:
Direct experience leading INDs, NDAs, 510(k), De Novo, PMA, and strategic FDA/EMA interactions across multiple solid and hematologic tumors. Expertise in pediatric exclusivity strategies.
Direct Benefit To Your Program
Proactively identify and mitigate regulatory risks, streamline agency interactions, and achieve critical milestones efficiently, avoiding costly clinical holds and delays.
Translational Strategy
Our Distinctive Capability:
First-hand, real-world understanding of resistance mechanisms, biomarker strategies, and clinical pharmacology optimization.
Direct Benefit To Your Program
Bridge the gap between preclinical insights and clinical success, optimizing trial design for robust data generation and clear go/no-go decisions.
Our leadership team brings a unique blend of deep industry experience, rigorous academic foundation, and a proven track record of success in oncology drug development.
This expertise is not merely theoretical; it is forged from decades of hands-on program leadership and strategic decision-making.
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Executive Leadership: Executive roles in oncology drug development at Pfizer and AstraZeneca, including Global Clinical and Program Lead for RAS inhibitors and 14 other small molecules; bifunctional antibodies; and Antibody-Drug Conjugates with a variety of payloads.
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Safety Council Leadership: Co-chair of Immunotherapy Safety Council and member of Hepatic Injury Council, providing critical insights into drug safety and risk management.
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Academic Foundation: Advanced degrees from Harvard Medical School, UC Berkeley (Honors Graduate, Valedictorian), University of Connecticut (MPH), SDSU (MS Regulatory Affairs), and Johns Hopkins (MBEE, Business Enterprise).
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Continuing Education: Advanced certificates in Leadership and Digital Technology from MIT Sloan, Harvard Business School, and Stanford, demonstrating a commitment to cutting-edge strategies.
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Academic Appointment: Affiliate Teaching Professor at UC San Diego Graduate Program in Drug Development, reflecting a dedication to shaping the next generation of biopharma leaders.
OUR LEADERSHIP AND EXPERTISE