Biopharma Development Consulting

At RRD biopharma development we approach biopharmaceutical product development holistically and believe that successful product development depends on:

  • Determining the right strategy
  • Designing the most efficient plan for successfully executing that strategy
  • Rigorous program management

Only then can you be assured that you are on the right path.

Our partnerships often begin with expert consulting services delivered by our team of product development professionals with experience in the biopharma industry, FDA, and CROs.

Expert consulting services include:

  • Strategy
  • Medical
  • Integrated Operational Development Planning
  • Clinical Pharmacology and Pharmacometrics
  • CMC Development
  • Quality Assurance and QMS
  • Clinical Operations
  • Data Management
  • Biostatistics
  • Toxicology

Our consultants seamlessly integrate into our product development teams, staying involved throughout the duration of the program.

Unlike CROs or other consulting groups, RRD biopharma development was created specifically to provide end-to-end development services to partner companies. Our team of development professionals have deep expertise in all:

Stages of development

Major product classes

Major therapeutic areas

“The best way to find out whether you’re on the right path? Stop looking at the path.”

Marcus Buckingham, author and researcher

The Right Strategy:
  • Begins with a clear understanding of the product attributes
  • Considers the product characteristics in relation to the spectrum of potential indications, patient populations, and medical needs with input from internal and external experts
  • Includes a Target Product Profile (TPP) utilizing a multidisciplinary team (Regulatory, Scientific, Clinical, Medical, Commercial, CMC, etc.) to realistically assess whether the new product can meet the target needs in comparison to existing products or products in development
  • Includes strategic input from all key functional areas regarding how to achieve the strategic goals
  • Defines major development milestones, and success criteria including definition of human Proof-of-Concept (hPOC)
  • Defines geographic scope of development program (US, EU, Global)
  • Must be based on sound scientific, medical, regulatory, development, and commercial principles
The Final Operational Plan to Drive Execution Should:
  • Clearly identify the goals and objectives of the plan
  • Be based on synthesis of functional area development strategies
  • Integrate tasks of all development functions and external vendors
  • Identify key development milestones including definition of hPOC
  • Include data-driven timelines and budgets
  • Include risk analysis and plan to manage or mitigate
  • Include Quality Plan to assure high quality data and documentation to meet compliance requirements of regulatory agencies and pharma partners
Both the Strategy and the Operational Plan Must Then be Reassessed on an Ongoing Basis, Taking Into Account:
  • Existing and newly identified risks
  • Changes in the therapeutic and regulatory environment
  • Newly emerging data from the program and scientific discoveries