How is your model unique?
Our model is unique because our approach to product development is unique. Instead of focusing on one or two aspects of development like regulatory or clinical, we think about development from a holistic perspective. Our goal is to provide our clients with both high level strategic and operational expertise to accelerate development. That comes from spending time and effort up front to design the optimal strategic and operational plan and then assembling the best team to execute that plan.
How are you different than a CRO?
CROs have a very different business model. The industry has grown to such an extent that most are focused on executing on a final protocol provided to them by a client company. They fill out a “bid grid” and can successfully compete on the basis of cost and having a good track record of operational execution. Generally, they don’t understand or get involved with the larger development plan and almost never are asked to design an entire development program for their clients. That’s what we do. It’s a different business model. Unlike CROs, we maintain only highly experienced people who have the expertise to manage broad development programs. We use hand-picked vendors including CROs to perform tasks such as data management. We establish high standards up front and actively manage each vendor to ensure a quality work product.
Why do you insist on being part of the development planning process?
We won’t execute a development plan or a clinical protocol that we don’t believe has a strong likelihood of generating a valid and relevant answer, or that won’t build value in the asset. That would be a disservice to patients in the clinical studies, and a waste of our client’s money and everyone’s time and effort. We want to make a difference to patients and add value to our partner clients, not just execute a program because it is there.
Could RRD run an entire development program for a product from preclinical to Phase 2 proof-of-concept by itself?
Yes. That’s a key aspect of working with RRD. We have very experienced personnel, along with our extensive network of affiliates with world-class technical, therapeutic, and regulatory expertise, who can provide the strategic guidance necessary to identify and guide the optimal development program for each product we work on. Once the plan is developed, we have senior program leaders who have generally 20+ years of product development experience to lead project teams to operationalize and successfully execute the programs.
What are the advantages of working with RRD over using a combination of consultants?
Unlike consultants, we bring an integrated approach to the development program and are responsible and accountable for its overall success. Since we also provide operational support to the program, we make sure that the strategy developed is grounded in reality and can be operationalized to meet the goals that the company has for the product.
What are the relative cost efficiencies of your model?
The budget for the development team that we provide to companies is based on fractional FTEs. In most cases, this is much less than what it would cost our clients to build an internal team of several fulltime employees to obtain the same level of experience in all of the functional areas represented on RRD’s development teams. Using RRD, our partners get a development team that has worked together on many successful projects and will also get the broad mix of expertise and capabilities required to execute a development program. This mix includes high level product development strategy and operational planning, clinical and regulatory program management, regulatory strategy, regulatory agency liaison expertise and submissions capabilities, medical writing, clinical operations, clinical project accounting, quality systems, and vendor management.
How does your model work with a small company?
We often work with small companies who use RRD and our model instead of building internal infrastructure, at least until more data is generated to help determine the potential clinical and commercial value of their products. We typically get involved as the IND planning activities begin and work with the company to identify the regulatory and overall development strategy for the program. We then continue to work with the company to prepare the pre-IND meeting request, prepare the pre-IND briefing document, conduct the pre-IND meeting with FDA, and prepare the IND. We also take responsibility for planning and managing all aspects of the initial clinical studies in humans. Generally after proof of concept has been demonstrated in humans, we help transition operational responsibilities to the company.
How does your model work with a larger company?
We also work with larger companies to allow them to expand their bandwidth and take on new programs beyond what their current internal resources would allow. In these situations, we take responsibility for an entire regulatory and/or clinical program and integrate our activities into the overall R&D group within the company.
Can you work in a situation where there is no company, just a product?
RRD’s staff includes business, legal, and management professionals, and thus we can provide partners with the full range of functions required to operate a company. RRD manages these companies in compliance with federal, state, and local laws and regulations, and in a manner that complies with the contractual and financial reporting requirements of the partners. 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 partners and their investors.
Does RRD participate in any risk-sharing with its partner companies?
RRD will consider potential risk-sharing engagements under a Product Development Agreement (PDA) utilizing our PDT model. Since we do not have an investment fund, risk-sharing engagements may include equity participation as component of the overall development budget for services or various success fee arrangements.
What is RRD’s relationship to ClearPath Development Company?
ClearPath is an RRD sister company and development partner for programs that include the formation of new development companies (DevCos) where assets are in-licensed by ClearPath along with structured financing through outside investors. ClearPath leverages the execution capabilities of RRD for these programs. The ClearPath model is ideally suited for pharma companies desiring to de-risk development of internal assets with the ability to reacquire the asset at hPOC through a purchase option.