“Successful Clinical Trials in the Era of Genetics-based Medicine” As the genomic revolution continues to unfold, clinical trials are increasingly involving genetic testing, especially for rare disease therapies that include a genetic component. Due to the often-limited size of these trials’ patient populations, sponsors and contract research organizations (CROs) often struggle to effectively recruit, engage …
Our client, a leading biotech innovator committed to developing revolutionary personalized therapies for dementia and Alzheimer’s disease patients, relies heavily on positive outcomes from its clinical trials. Yet, identifying appropriate patients with the right gene mutation for these trials can be a challenge. When trial sites failed to identify enough patients for a phase 3 …
Rapid advances in genomic science and the implementation of personalized medicine require new approaches to health plan policy and evidence review processes. InformedDNA genetics experts have developed a forward-thinking approach with its Coverage Decision Framework™, enabling health plans to develop timely policies that ensure members have access to the most current, effective and safe approaches …
Patient enrollment can be difficult for clinical trials targeting rare genetic diseases. These trials typically target very small patient populations, leading to challenges in enrolling patients. Also, enrollment is often restricted by logistical and social barriers such as language, participants’ ability to take time off from work, and participants’ ability to travel to research sites. …
Whitepaper: Patient Diversity in Rare Disease Clinical Trials Read More »
Patient populations affected with orphan diseases are rare and patient identification can be challenging and time-consuming. Our pharmaceutical client, while anticipating likely FDA approval for its new gene therapy, faced significant challenges identifying affected patients and encouraging the adoption of genetic testing into community physician practices. Learn how the InformedACCESSTM solution we deployed with our client resulted …
Case Study: Post-Market Success for a New Gene Therapy Read More »
In 2012, a leading not-for-profit, community-based health system turned to InformedDNA to provide genetic counseling services as part of its genetics program for their patients. They continue to use these services today. The primary challenges that we address for our client include: Meeting current Commission on Cancer (CoC) and NAPBC standards regarding genetic counseling and …
Case Study: Expanding Access to Genetic Counseling Expertise Read More »
Many health systems are struggling to keep up with the increasing demands for genetic counseling. Providers know that delays can impact outcomes, particularly in cancer patients. Many turn to InformedDNA for help. One such health system anticipated this challenge back in 2015 and has been our client ever since. The primary initial challenge for our …
Having a genetics services partner throughout the clinical trial and pre- and post-market stages of rare disease drug development is an asset to pharmaceutical companies as well as to patients. As our client worked its way through the complex process of gaining FDA approval for the first-ever treatment for adults with the rare disease Acute …
Case Study: Accelerating a Clinical Trial for Patients with a Rare Disease Read More »
Until recently, many patients with rare disorders faced few to no treatment options. Gene-based therapies are beginning to change this reality. However, lack of physician awareness, limited access to genetic testing, and delays in diagnosis prevent many eligible patients from receiving these life-changing therapies. Through a partnership with a leading biotech company, InformedDNA provided patient …
Case Study: Genetics Experts Support a Rare Disease Drug Pipeline Read More »
Conducting rare disease clinical trials is complex. Incorporating genetic testing and the resulting data can introduce nuances and complications that increase the complexity even more. Understanding the unique obstacles and how to strategically navigate them is a key to clinical trial success. In this whitepaper, InformedDNA shares strategies for overcoming primary challenges, including: InformedDNA is …
Whitepaper: Incorporating Genetics into Clinical Trials Read More »
