Proven Expertise in Securing Post-Market Access
Leverage experienced, board-certified genomic specialists to ensure post-market access
The rise in precision medicine is creating new opportunities to integrate genomics expertise into clinical trials and post-market programs. At InformedDNA, we address all aspects of the drug development/delivery continuum of care. Our genomics experts help our biotech and pharmaceutical client and CRO partners broaden pharmaceutical market access to derive the greatest post-market value from their research.
Genomics-Informed Strategies Increase Medical Market Access
Genetic testing lends itself to inefficient processes and high-cost programs, both of which are barriers to precision medicine drug success. Our team of genomic experts work with leading biotech and pharmaceutical companies to develop and implement genomics-informed strategies that reduce overall research costs, speed time to enrollment for clinical trials, expand pharma market access, and ultimately, increase profits.
Tap into vast genomic datasets and genotype/phenotype data for insights, publication, and pipeline development.
Design informed consent protocols that enable research beyond the initial genetic test or clinical trial.
FDA Advisory Support
Collect patient-reported outcomes and real-world evidence data for FDA submission.
Clinical Trial Development
Generate data in all trial stages that secures optimal patient access to treatment from payors.
Test pivotal trial protocols with payors through payor research and advisory boards comprising former payors.
Secure drug reimbursement through negotiations with payors to mitigate financial barriers to access.
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Applied Genomics Resources and Expertise
“The emerging trend toward faster regulatory approvals emphasizes the need for market access integration throughout clinical development.”
“Improving collaboration among pharmaceutical companies, regulators, and payors earlier in the drug development and clinical trial process is the best way to help ensure patients can access innovative therapies affordably.”
Incorporate Payor Needs Into Trial Design to Gain Medical Market Access Faster
In the era of precision medicine, health plans face increasingly complex questions of which drugs/biologics and/or genetic tests to cover for their members. With in-depth knowledge of the FDA, genetic diseases, and genetic testing technologies, InformedDNA helps biotech and pharmaceutical companies gain market access by meeting payor needs for clinical trial data that demonstrates:
- Evidence-based, compelling efficacy and safety
- A specific target market with an unmet need
- Pricing that reflects product value
Take Advantage of FDA Accelerated Approval Pathways for Precision Medicine
The FDA has established new pathways to approval based on lesser data and evidence than historical standards. The Fast Track designation allows for approval based on a single Phase II trial with human, animal, or laboratory data showing promise of efficacy.
With this designation, breakthrough drug designation was developed to anticipate technological advances, including the benefits of precision medicine. The genomics experts at InformedDNA help biotech and pharmaceutical partners design clinical trial protocols that align with Fast Track standards to get hopeful drugs to patients faster.
Secure Pharmaceutical Market Access by Addressing all Four Stages of Clinical Development
Payors rely on clinical evidence when determining whether to include a treatment option in their insurance plans. They want to know how a drug will perform in the market. Incorporating the payor perspective into clinical trial design at every stage—well before the clinical trial begins—helps generate compelling evidence that will be accepted by payors and enable patients to access new treatments.
The genomics experts at InformedDNA collaborate with biotech and pharmaceutical clients to design clinical trial protocols that ensure post-market success. We assist clients at every stage of the clinical development process:
- Pre-clinical (early) stage – Garner payor feedback to understand how to position a new therapy in market
- Late stage – Test pivotal trial protocols with payors through primary payor research and advisory boards comprising former payors
- Launch and post-launch stages – Support reimbursements with payors as regulatory approvals are gained for pharmaceutical market access in developed and emerging markets
- Lifecycle management stage – Ensure payors realize expected value and assess whether a treatment’s efficacy can be expanded into new uses
Your Trusted Partner in Applying Genomic Science
InformedDNA is the nation’s first telehealth genomics services company. Our real-world clinical guidance, cost management and patient navigation solutions are built upon the most current genomics insights and are designed to optimize clinical decisions across the care delivery spectrum.
We have helped manage the health benefits of more than 100 million covered lives and have navigated hundreds of thousands of people to the right treatments or clinical trials.