Development Approach

Project Team Integration

Once the development path has been chosen, RRD provides experienced project management, regulatory affairs, and clinical operations teams to manage and execute key development functions. Our multi-disciplinary teams integrate seamlessly within our clients’ existing company structures and are with our clients from the engagement’s onset through proof-of-concept. The result is a fully integrated and highly adaptable development package with strategy-minded oversight from concept to completion. In addition to scientific and program management staff, the RRD team includes a team of professionals who can provide clients with the entire range of functions required to operate a company. RRD manages these companies in compliance with all federal, state, and local laws and regulations, and in a manner that fully complies with the contractual and financial reporting requirements of the clients. Outside audit, tax, legal and other service providers are engaged, as required, and all such corporate management services are rendered at a minimum of cost to our clients and their investors. Once an integrated development plan has been formed, RRD helps clients implement a regulatory driven strategic plan. Because this plan has been jointly formulated, we do not provide a strategy that cannot be executed and we do not execute a plan that does not make strategic sense. We know how to execute drug development, and can integrate all of the key areas (regulatory, clinical, nonclinical, CMC, quality) to achieve a successful development program, providing a holistic approach so that nothing is overlooked. RRD’s team can assist with or oversee clinical execution capabilities which a company would obtain from using internal FTEs and/or an outside CRO.

Tactical Development

The combination of RRD’s product evaluation, strategic and operational planning, and broad development capabilities provides companies and investors with increased efficiency and the flexibility needed to be successful in the current economic and market environment.

Critical parts of this process include:
 

• Rigorously evaluating in-licensing opportunities to clearly understand the strengths and risks associated with the product
   
• Evaluating and prioritizing the development of existing assets to focus existing resources to maximize the value of the best assets
   
• Building value in product candidates without fixed-cost corporate vertical growth

RRD’s cost effective and efficient development model also enables investors to partner with us to establish a product development entity focused on bringing products through to proof-of-concept, or the next significant value inflection point, without having to spend money building costly infrastructure.