The Shackelford Pharma Mission
Shackelford Pharma Inc. is focused on developing, obtaining regulatory approval for, and commercializing drugs to address neurological conditions.
Building on the pioneering work of Dr. Alan Shackelford and his treatment of over 25,000 patients to date, the company is developing therapies targeting the endocannabinoid system of the human body. This system, only discovered in recent decades, may play a critical role in
many important bodily functions and their dysfunction. The endocannabinoid system has been implicated in key neurological conditions such as seizures, migraines, and cognitive impairment.
Because little research has been done in this area to date, Shackelford Pharma believes that it has an exciting opportunity to address high unmet medical needs by developing novel drugs targeting the newly discovered endocannabinoid system. Ultimately offering hope to millions of
patients suffering with high unmet medical needs.
A world-class experienced team of entrepreneurs, scientists and pharmaceutical commercial personnel are backing Dr. Shackelford’s real-world clinical experience.
From Dr. Shackelford’s database, we have identified 27 indications to date, 14 of which are considered rare/orphan diseases. These potential indications were filtered for the best
commercial opportunities which are now being used to focus our efforts on three
distinct parallel and highly encouraging tracks to bring Shackelford Pharma’s cannabinoid medicines to market:
Prescription: pharmaceutical products (drug identification number) that will be pursued for full regulatory approval (FDA) are our primary focus. High unmet needs such as rare diseases and “Orphan drugs” — which government’s have made a public health priority for rare disease that do not always get the industry research and development needed to produce these drugs for people in need. Our R&D and Dr. Shackelford's clinical experience indicates cannabinoids will be a highly valuable addition to the orphan drug spectrum.
Dependent upon business, regulation
and legal considerations, Shackelford Pharma will also consider developing
products for the following markets:
Pharmaceutical Grade Hemp CBD treatments : under the Shackelford Brand, would be clinically tested and produced under strict protocols to ensure efficacy and pharma grade quality in terms of dosages, purity and delivery systems.
Dispensary: Future potential for SPI dispensary products developed in accordance to the laws and regulations of countries in which we intend to launch. These products would be intended for medical cannabis dispensaries and formulated using cannabis-derived THC and CBD, and may contain lower order cannabinoids, terpenes and other plant-derived molecules.
SPI is dedicated to alleviating human suffering through the development of pharmaceutical grade cannabinoid therapies for a range of unmet medical needs.
By utilizing pre-FDA approved synthetic material (THC & CBD) development timelines have been significantly shortened.
Our goal is to become the global leader in the development and commercialization of cannabinoid-based medical and well-being products
By using FDA (and DEA) approved synthetic dronabinol, the team can take advantage of the FDA’s 505(b2) pathway. This pathway allows re-purposing of exiting approved drugs in new therapeutic areas and delivery system, also significantly shortening the timelines for study completion. These products will be introduced to select global markets in the short, medium, and long-term time frames.