Hanson Drug Co.
circa 1950s
Randall Kaye, MD brings the deep-rooted pharmaceutical instincts of a family legacy and the hard-won expertise of a seasoned Chief Medical Officer to early-stage biotech founders navigating their most critical inflection points.
In the early 1950s, on a quiet street in Southeastern Massachusetts — directly across from the Ocean Spray headquarters — a pharmacist named Hanson opened a small neighborhood drugstore.
The business almost didn't happen. It took a $500 loan from the owner of Ocean Spray himself — a neighborly act of belief — to install the soda fountain that would make the pharmacy a true community anchor. That faith was repaid many times over, not just in commerce, but in the generations of care that followed.
Pharmacy ran in the family. Randall Kaye's mother worked those counters. The rhythms of compounding, dispensing, and caring for patients were household vocabulary long before medical school. That foundation — the idea that science exists in service of people — has never left.
Today, Hanson Drug Co. LLC carries that name forward not as nostalgia, but as a commitment: the same attentiveness to patients, the same rigor, and the same integrity that built a community pharmacy, now applied at the frontier of drug development.
"The best drug development advisors are the ones who never forget that a patient is waiting at the other end of every data package."
Hanson Drug Co. LLC provides CMO-level advisory to early-stage biotech companies that need seasoned medical leadership without the full-time overhead.
Full-spectrum clinical program design and execution — from IND-enabling studies through late-stage registration trials. Expertise in CNS and neurological indications, with a track record of programs reaching NDA/BLA submission.
Strategic guidance on FDA interactions, submission planning, and navigating the regulatory pathway from first-in-human through approval. Deep experience in breakthrough therapy designations, special protocol assessments, and pre-NDA/BLA meeting preparation.
Building the medical and clinical functions that early-stage companies need as they grow. From first clinical hire strategy to board-level medical advisory, helping founders make the right decisions at the right time.
Four decades at the intersection of medicine and drug development, from academic training to leading clinical strategy at public and late-stage biotech companies.
Led clinical development and medical strategy for this CNS-focused biotech developing next-generation 5-HT2C agonists for neurological disorders including Dravet syndrome and other developmental epileptic encephalopathies. Oversaw program design through registration-enabling trials.
Served as CMO at this commercial-stage CNS company with a pipeline spanning major depressive disorder, treatment-resistant depression, and migraine. Contributed to clinical development programs as Axsome advanced toward and achieved multiple NDA approvals.
Senior clinical role at Avanir, the CNS specialty company best known for NUEDEXTA (dextromethorphan/quinidine), the first FDA-approved treatment for pseudobulbar affect. Contributed to clinical programs and regulatory strategy during a period of significant pipeline expansion.
A career built across academic medicine, large pharma, and emerging biotech — with deep roots in neurology and CNS therapeutics. Randall Kaye trained as a physician before transitioning into clinical drug development, bringing genuine patient-care perspective to every program he has led.
Early-stage biotech founders face decisions that shape the entire trajectory of their programs. Randall Kaye brings the perspective of a physician, the discipline of a career drug developer, and the instincts of a family that has been in pharmacy for three generations.
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