Having a partner with genetics expertise throughout the clinical trial and pre-and post-market stages of drug development, especially for rare diseases, is an asset to biotech companies as well as patients. From guiding patients through a remote screening process to providing pre-and post-test genetic counseling about the disease and treatment options, we work hand-in-hand with our clients.
For example, Passage Bio, a genetic medicines company, is developing transformative therapies for rare, monogenic central nervous system disorders, including PBFT02, an adeno-associated virus (AAV)-delivery gene therapy, for the treatment of patients with FTD with progranulin (GRN) mutations. They chose to partner with InformedDNA to support their efforts.
Similarly, Alector is a biotechnology company currently working to advance their Phase III clinical trial evaluating the efficacy of AL001 in slowing the progression of FTD in GRN mutation carriers. They are sponsoring the Progranulin Gene Frontotemporal Dementia (PG FTD) Study — a U.S. observational study conducted by our team of genetic experts that will investigate the genetic background of individuals with FTD and its relation to the progranulin gene (GRN). They too chose to partner with InformedDNA to support their research program.
The benefits of genetics expertise
Partnering together with genetics experts is important because genetic mutations have implications for both the individual being tested as well as their family members. For the individual, a particular gene mutation can confirm a diagnosis of familial FTD, establish the specific genetic cause, and provide an opportunity to participate in current or future clinical trials of potential therapies.
There are many ways in which InformedDNA helps clinical trial sponsors and contract research organizations (CROs) at biotech companies successfully leverage genetics for gene-based clinical trials:
- Outreach and education to patient communities, enlarging the pool of potential candidates.
- Empathetic genetic counseling that improves patient and provider access to genetics expertise and their experiential satisfaction through a proven telemedicine model.
- Highly trained and trusted advisors to time-challenged physicians who welcome genetics expertise.
- Acceleration of the process from clinical trial to FDA approval by increasing patient identification, reducing time to complete clinical trial enrollment, improving patient engagement and retention.
- Working with health plans to ensure the most appropriate gene therapy eligibility criteria.
To learn more about our expert genetics services for clinical trial sponsors and CROs, send an email to email@example.com, give us a call at 844-846-3763, or fill out the form below to be contacted.