A Rare Partner in Rare Disease

Commercialization services that help orphan drugs reach their potential

A Rare Partner in Rare Disease

Commercialization services that help orphan drugs reach their potential
Our unique blend of commercialization services is designed to help all types of orphan drugs in development.
RDT is a full-service partner for:
  • Early-stage orphan drugs in development in need of clinical trial support
  • Late-stage orphan drugs looking for regulatory support for FDA approval
  • Approved rare disease treatments looking for sales and marketing support

RDT is…

Flexible

Agile leadership adapts to the needs of each rare disease community

Experienced

Experts in targeted education using a specialized salesforce

Visionary

Rare disease clinical trial adaptations that are future-focused

Connected

Relationships with thought leaders in close-knit communities

Inspired

Exclusively focused on treatments with high unmet medical needs

Efficient

Lean, integrated processes streamline the FDA approval process

Rare Disease Marketing and Sales Support

Specialized expertise for orphan drugs

Rare Disease Marketing and Sales Support

Specialized expertise for orphan drugs

Combining decades of experience in rare disease with the latest targeting technology allows us to partner with influential thought leaders. One of the most challenging parts of commercializing rare disease treatments is getting them in the hands of hard-to-reach patients.

Combining decades of experience in rare disease with the latest targeting technology allows us to get orphan drugs in front of the physicians who can prescribe them. One of the most challenging parts of commercializing rare disease treatments is getting them in the hands of hard-to-reach patients. 

Our orphan drug commercialization process combines precision and expertise

Identifying patients and their behaviors

Finding specialists that are seeing rare patients

Articulating an unmet need in a rare disease to identify the right patients

Creating compelling materials that are credible and informative

Being top-of-mind with patients or physicians during each office visit

Building confidence so the physician and patient are comfortable with the treatment choice

Gaining favorable access to help ensure fulfillment

FDA Approval Accelerator

Supporting orphan drug FDA submission for the treatment of rare disease

FDA Approval Catalyst

Supporting orphan drug FDA submission for the treatment of rare disease

 

Navigating the regulatory process for an Investigational New Drug (IND) application, a Biologic License Application (BLA), or a New Drug Application (NDA) with the US Food and Drug Administration is complicated. We have secured FDA approval for our global partners rare disease treatments by satisfying the FDA requirements for orphan drug applications.

Navigating the regulatory process for a New Drug Application (NDA) with the US Food and Drug Administration for orphan drugs can be complex. We have helped multiple partners get FDA approval for rare disease treatments by satisfying the FDA requirements for orphan drug applications.

Critical roles at RDT to help get FDA approval for orphan drugs

Regulatory

Clinical Trials

Medical

Rare Disease Experts

Disease State Specialists
(staffed as needed)

Manufacturing Quality Assurance

Pharmacovigilance

Regulatory

Clinical Trials

Medical

Rare Disease Experts

Disease State Specialists
(staffed as needed)

FDA Liaison

Clinical Trial Consulting for Rare Disease

Study design support and optimization for orphan drugs

Clinical Trial Consulting for Rare Disease

Study design support and optimization for orphan drugs

Some rare disease treatments in early-stage development through late-stage development (entering the pivotal trial phase) may need a partner to help ensure the trial design is optimized. There are unique considerations with a rare disease clinical trial where we can help, including:

  • Enrollment size
  • Inclusion/exclusion criteria
  • Recruitment methods
  • Study site selection
  • Study drug logistics
  • Endpoint selection