Syntropy medica works with companies on the challenges they face in today’s drug development environment:
With fewer products in the pipeline, senior management demands an optimal return on investment from EVERY product in development.
Many products are now very complex – both in their structure and their pharmacology. For specialty products, the move from small molecules to (for example) monoclonal antibodies means understanding complicated disease biology and processes.
Regulatory authorities are demanding more and more data as part of a new drug submission. In addition to expanded requirements for clinical endpoints and safety, many products must now have an appropriate companion biomarker identified and validated. The total regulatory burden has increased by almost 50% over the last 10 years.
Once, evidence of efficacy and safety was enough to allow a drug to be marketed and reimbursed. In today's resource-constrained environment, demonstrating clinical value is a critical threshold for products. Agencies responsible for health technology assessments demand clear and compelling reasons to recommend reimbursement by payors.
Communication begins as soon as somebody has something to say about the product. Although many companies organize the terminology for their products post-submission, this is too late. Company staff frequently present information on the product pre-submission and need to do this clearly, consistently and robustly. In today's litigious environment, reducing risk by ensuring appropriate external communication has become even more important.
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