CORE CONSULTING SERVICES: MITIGATING RISK, ACCELERATING PROGRESS
Navigating oncology drug and device development is fraught with scientific, regulatory, and commercial complexities. Without expert guidance, programs can face costly delays, clinical holds, or suboptimal asset valuation. Our specialized services are designed to proactively address these critical development gaps, ensuring your program progresses efficiently and strategically.
Medical Monitoring, Advanced Drug Safety, & Trial Execution
Our Service: We provide protocol-specific safety oversight informed by extensive real-world trial experience and leadership roles on Immunotherapy and Hepatic Injury Safety Councils. Our approach includes rigorous signal detection and benefit-risk framing.
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Value to You: We help you avoid inadequate safety preparation that can trigger clinical holds or misinterpretations of critical safety signals. Our expertise ensures robust safety profiles and proactive risk mitigation, safeguarding patient well-being and trial integrity.
Regulatory Strategy & Agency Engagement
Our Service: We manage end-to-end regulatory strategy for INDs, NDAs, global submissions, 510(k), Pre-Subs, De Novo Submissions, and Pre-Market Approval (PMA). Our team has led successful FDA negotiations that avoided clinical holds and facilitated complex adaptive trial designs. Services include briefing document development, pre-submission strategy, and mock panel sessions. Our regulatory insight is strengthened by a Master's in Regulatory Science and RAC certification.
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Value to You: We prevent inadequate regulatory preparation that delays approvals or triggers clinical holds. Our proactive engagement ensures your submissions are robust, strategically aligned, and positioned for optimal agency review, accelerating your path to market.
Asset Positioning for Licensing & M&A
Our Service: We create data packages tailored to licensing, M&A, or strategic exit scenarios. We anticipate and resolve common diligence objections, ensuring technical narratives are aligned with commercial value. Support includes scientific whitepapers, slide decks, and executive briefings for internal and external stakeholders. Our strategic insights are informed by advanced training from Harvard Business School and MIT in entrepreneurship exit to large-firm acquisition and integration.
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Value to You: We help you avoid weak due diligence of submitted materials that distorts asset valuation and leads to ineffective partnerships. Our strategic positioning maximizes your asset's value and facilitates successful negotiations, ensuring optimal commercial outcomes.
Client Partnerships
We partner with innovative biotech teams and strategic investors who are committed to advancing breakthrough oncology therapies. Our ideal clients include:
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Oncology biotech teams advancing targeted therapies, including small molecule, signal transduction effectors, such as RAS, PI3K, CDK; biologics, such as ADC platforms, bifunctional antibodies, and T-cell engagers; cancer vaccines; and other emerging modalities.
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Programs with early to mid-stage clinical data seeking regulatory clarity or business development acceleration.
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Investors or C-suite teams requiring independent, senior-level oncology insights for portfolio decisions.
