Large pharma, small pharma- same regulations, suprisingly different approaches and needs. As a consultant, I specialize in helping small pharma easily, efficiently, and affordably incorporate advanced safety analytics that serve a far greater purpose than simply regulatory compliance: investor due dilligence.
Recently, a small pharma successfully sold a pre-market asset to a large pharma in no small part due to it’s advanced command of the asset’s safety profile. The investors asked far more rigourous questions than FDA, but we were ready due to the advanced safety analytics I and my team had put in place for them.
Yes, it’s important to follow regulatory Guidance, such as the recently (Dec 2025) finalized IND Safety Final Rule related safety guidance. However for small pharma, getting to the next financial goalpost is even more important, because without finance, there can be no efficacy or safety data at all!
Additional proof points:
- Saved Revenue Stream: I’ve helped a company explore the association between concomitant estrogen use and Alanine Aminotransferase (ALT) elevations. We presented statistical analyses and logical arguments to regulatory authorities that resulted in the contraindication of only Ethinyl Estradiol (EE) estrogens (in many oral contraceptives) rather than all estrogens (including hormone replacement therapies) in a mostly elderly population. All patients were able to continue to benefit from the use of this beneficial drug- a revenue stream that, without advanced safety analytics, would have been halted.
- Shorten Regulatory Reponse Times: I’ve helped companies to define and characterize safety topics of interest in order to quickly and authoritatively answer regulatory queries. For one company, we integrated together 24 studies from the ISS and 12 additional studies, while realizing more than 60% efficiency gains by the third query.
- Investor Due Dilligence: A pre-market small pharma in Phase III had potential investors who were very concerned and asking far more penetrating safety questions than the health authorities. By aggregating data across indications and applying innovative methods of safety data analysis, we were able to cogently answer all of their questions. This resulted in a successful acquisition of the program.
Looking forward to helping your company command its safety story!