What We Do
RxMD’s services encompass strategy and execution in translational medicine, drug development and safety for small molecules, biologics and cell therapy. We have worked on assets approved for flu, HCV, HIV, HBV, erectile dysfunction and cell therapy. We have worked on programs where the asset could not be taken to approval. These include assets for asthma, skin and soft tissue infections, community acquired pneumonia, Huntington’s chorea, Parkinson’s. Our abiding principle is to give the drug the best chance to show it works. In this sense, every program we have worked on has been a success.
Translational Medicine
RxMD’s translational services bridge the gap between the discovery lab and the clinic. Strategic consulting covers the areas of due diligence, asset prioritization, safety margins, translational gap analysis, clinical development plans, differentiated target product profile, IND, regulatory interactions, Proof of Concept, etc. Our strategic consulting services are backed up with execution of the aforementioned.
Clinical Development
RxMD’s clinical development services, characterized by simplicity and efficiency, are based on robust science. We provide strategic input into the areas of Proof of Concept, selection of differentiated end-points, selection of exposure and response parameters for an exposure response analysis, partial and full extrapolation for pediatric development, handling of missing data, critical review of the statistical analysis plan, Integrated Summary of Efficacy, etc. We follow this up with best practices in execution – careful design of case report forms, deploying the right edit checks, diligent data review, review of dummy randomization TLFs and timely closure of a clean database. We repeat the execution in the sequential stages, from IND to commercialization
Drug Safety
RxMD’s primary focus is on Safety Science (not Safety Operations) in both the pre-marketing and pharmacovigilance settings. Strategic consulting in pre-marketing risk assessment covers the areas of the determination of identified and potential risks, safety margins, risk benefit assessments, guidance to the investigator, managing an overdose, developing the company core safety information, Integrated Summary of Safety and the label. We apply these strategic thoughts during the execution of the study in the areas of blinded safety review, comparison of event rates with background rates, etc. In the post-marketing phase, strategic services include formulating blueprints for causality assessments and pregnancy exposures. Additionally, we have authored several aggregate reports and Risk Management Plans.Client Speak
Usman "Oz" Azam, MD
Joseph H. Hoffman, MD
It is a pleasure to commend RxMD to any pharmaceutical company, large or small, that is in need of additional medical support in pursuit of its clinical research objectives.
Our Clientele
We have worked for U.S. and EU-based big pharma & biotech, for small molecules, biologics & cell therapy, across indications.
