Our Approach

Industry Challenge

The pharmaceutical industry is highly dependent on small innovator companies to fill late-stage pipeline needs. As a result, innovators are focused on achieving hPOC to monetize their development investment through a transaction with a biopharma partner or an IPO.

The goal for these companies and their investors is simple:

Accelerate development
Minimize spend
Avoid building excess infrastructure
With the end result being a high-quality hPOC data package required by regulatory agencies and potential biopharma partners.

An Asset-Centric Approach to Drug Development

Our approach to drug development solves industry challenges. It is an asset-centric alternative to traditional high risk, cash intensive, time-consuming approaches.

RRD's Product Development Team (PDT) partnering model enables development of pharmaceutical-grade data packages to maximize the likelihood of closing a successful deal with a biopharma partner.

Our comprehensive approach integrates all critical development disciplines including strategy, regulatory, clinical, and CMC.

We work closely with partners to effectively and efficiently optimize asset value and quantify product potential regardless of an organization’s stage of development:

  • For innovators, we accelerate achievement of an asset’s human proof-of-concept (hPOC) value inflection point, significantly increasing an asset’s desirability to potential partners for late-stage clinical development and commercialization.
  • For established drug developers, we help expand pipelines with high quality, de-risked assets with demonstrated hPOC without the need to invest in additional fixed-cost infrastructure or vertical expansion.

See how we work

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Engagement Structures

Our partnership engagements primarily consist of two distinct structures:

  • RRD Product Development model with the partner company retaining intellectual property; no in-licensing of asset(s)
  • ClearPath Development model for in-licensed assets

Both models utilize the PDT structure, combining a world-class team of experts with a proven product development team engine that is scalable and flexible to meet the needs of both innovators and established biopharmaceutical companies. Within the PDT framework, we design strategies to optimize product value to a defined stage of development and control the quality and operational execution of the strategy for predictable achievement of value.

Strategic oversight and governance is provided by senior leadership from both RRD and our partner. The core PDT, with experience across the entire development continuum, executes the value creation strategy and provides oversight and management of CROs and other vendors to ensure operational excellence.

RRD Product Development Model

RRD partners with innovator companies to optimize limited resources and expertise to maximize asset value and attract potential partners. We also partner with established companies to effectively expand development bandwidth without the need for additional infrastructure. Utilizing the PDT development engine, the RRD Product Development model offers a pathway for generating hPOC data in a more highly efficient, cost-effective manner.

  • Partner retains the asset’s intellectual property (IP)
  • RRD shares risk in the partnership through equity participation or a success fee
  • Governance of the development program is through a joint Development Advisory Committee (DAC)

ClearPath Development Model

The ClearPath Development model provides an accelerated pathway to hPOC under tailored financing structures with multiple exit options for innovators and investors. The model brings together fundamental development elements to drive success:

  • High-quality asset within a vehicle structured for acquisition
  • Development capital through external investors
  • Strategic and operational execution team – RRD PDT development engine
  • Multiple exit options at hPOC
  • Access to de-risked, Phase 3-ready assets for potential biopharma partners