Defining the Right Critical Path is Crucial

IP Owners, PE/VC, Biotech/Biopharma

Focus on science & technology
Avoid dilution and ensure equity preservation
Expand capital raising efforts

Optimize development pathways
Provide gating & optionality
Achieve operational excellence
Continuously assess marketability & commercial opportunity

InnoDev Partners

InnoDev Delivers Efficient Drug Development Through Strategic Planning and Collaboration

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Strategic Program Design

Thorough due diligence
Comprehensive development plans based on precedent strategies, regulatory guidelines, gap analysis, unmet medical need and market opportunity
Target Product Proﬁles (TPP) created at outset, deﬁning key differentiators, competitive advantages and setting benchmarks for success
Program Chronicle with robust development detail serves as sole Tech Transfer document

Phase Specific Program Creation

Optimal development path, identifying key studies early in program to deﬁne position in market and facilitate early go/no go decisions
Ongoing regulatory assessment
Ensure alignment between scientiﬁc goals and business objectives

Proactive Financial Planning

Realistic and size optimal budgets that support program development and offer return on investment at critical junctures
Clearly identified value inflection points throughout development
Ongoing support to capital expansion efforts, including IPO planning

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Strategic Exit Considerations

Evaluate potential exit strategies for individual programs or entire companies
Align exit plans with overall business strategy and investor expectations

Flexible Partnerships with Shared Risk Aligned to Drug Development Objectives Allows Company/Investors to Retain Equity & Build Value

Diagram depicting business structure of InnoDev Partners, LLC with three segments: Investors, IP Owners New Co, and Retained Equity, linked by operational fee and milestone-driven compensation.

Structure creates a dynamic, collaborative environment, optimizing drug development outcomes while balancing interests of all stakeholders:

Adaptive risk sharing model fostering collaboration & accountability
Flexible funding mechanisms attract strategic investors & operational partners
Exit strategy flexibility accommodates different investor/ownership objectives

Our Experience

Treatment Area	Entry	Exit	Outcome	Highlights
Type 2 Diabetes	Lead Op	End of Phase 2	Outlicensed to large pharma	Parallel processed 3 leads to determine compound with best profile Novel P1 study to identify dose for PoC IND to NDA submission 29 months Multiple products on global market
Genitourinary	Phase 1	End of Phase 2	Outlicensed to large pharma	New indication requiring regulatory input Repositioned deprioritized pharma asset Product in Europe and Asia
Cardiovascular	Pre-IND	End of Phase 2	Discontinued Phase 2 data failed to meet commercial criteria	Designed preclinical program to understand differentiation from competitors Unique clinical study design to test and generate data to differentiate compound in crowded space
Gastrointestinal	Phase 1	End of Phase 3 and NDA filed successfully	Acquired by specialty pharma	Creative P3 design enabled parallel submissions in US as well as EU FDA guidelines revised to reflect clinical endpoints used/agreed for this program Product approved in the US and EU after big pharma purchased for $1.47B Challenging negotiations re DEA scheduling
Antibiotic	Phase I	Phase 3	Part of pipeline acquired by specialty pharma	Developed IV and oral formulations Responsible for working with experts to conduct modeling to determine PK/PD relationship, MIC and dose Designed P2 study with new endpoint FDA demanded for complicated skin infections Conducted global clinical studies for seasonal indications
Oncology	Lead Op	Pre-IND	Outlicensed to mid-size China biotechnology company	Challenging CMC issues Challenging PK and tox issues but successfully defended clinical plan
Oncology	Lead Op	End of Phase 3	Phase 3 data failed to meet regulatory endpoint	Designed preclinical studies to identify best development candidate Conducted novel P1 NHV study to assess PK/PD and multiple P1/P2 clinical trials in USA and one large global P3 trial and brought CMC through validation runs