Jake Leonard is an integral player at Catalent as a Pharmaceutical Chemist II at Catalent’s San Diego facility that focuses on early phase pre-clinical development, bioavailability enhancement and Phase I/II clinical manufacturing.
Jake received his B.S. in Biochemistry from The University of San Diego, where he initially intended on becoming an orthodontist as he enjoys seeing people smile confidently. The thought of working in peoples’ mouths for decades seemed bleak in comparison to his passion for chemistry, which he discovered in the research labs at USD. Looking for a job during college led him to the pharmaceutical industry, where he was hired as an analytical and formulation chemist at Pfizer, La Jolla, in the Vaccine Immunotherapeutics division. Jake’s interest in the biotech industry flourished into his subsequent career.
After graduating early and seeking a full-time position, his career began at Regulus Therapeutics as a Research Associate in the Formulation Development group. Jake developed preclinical formulations and optimized clinical Drug Products for oligonucleotide therapies that treated various indications, from Hepatitis C to Alport’s Syndrome.
At Catalent, Jake focuses on developing formulations for molecules in pre-clinical stages to be administered intravenously, subcutaneously, intramuscularly, intradermally, dermally or via an ophthalmic delivery or oral-solution. Jake and his colleagues also specialize in accelerating the lifecycle of an investigative new drug through performing rapid and efficient formulation screening for newly discovered molecules with solubility or stability issues. This allows for significantly expedited Proof of Concept (POC) in vivo studies, which can directly translate to sooner first-in-human trials and therefore therapies that more readily reach patients.
Discover what drives his passion for parenteral drug development. Access his works that include 6 peer reviewed publications and scientific posters to help you develop your next strategy.
Get to know this Catalyst in parenteral drug development.
Key Expertise: Parenteral Drug Development
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A CONVERSATION WITH JAKE LEONARD
Can you elaborate on your team’s approach to the formulation screening process?
For each new molecule that comes through our group, we first assess its solubility potential by subjecting it to a robust list of excipients, all of which have been used in approved parenteral drug products. Next, the short-term stability of the molecule in each excipient is determined. The data from the solubility and stability in each excipient is taken into consideration when designing test formulations, which are combinations of excipients at tolerable levels for POC studies. During the test formulation development, important factors are considered such as order of addition, viscosity, osmolality, and pH, among others.
What are some of the solubility or stabilization factors you look for when searching for new molecules?
Regarding solubility, we strive for a concentrated, clear solution, which can be described as transparent and free of particulates. Regarding stability, the ideal solution will be both physically and chemically stable. Physical stability is assessed by the visual observation of aggregate presence via the naked eye, while chemical stability is assessed by the observation of degradation via analytical instrumentation such as UV-Vis spectroscopy. Formulations can exhibit physical or chemical instability, or both, but ideally neither.
What benefits does your team’s approach provide for Catalent?
What makes my team unique is our robustness; when a client wants to develop an oral formulation but needs proof of concept data for program funding, we can accommodate that temporary need and later transfer the project to the oral team, if possible. This method saves time, money, and resources for the client and in turn provide savings which directly benefit the patients suffering from the indication that the molecule strives to treat.
What are some additional projects that you are currently working on at Catalent?
I am leading the project for the implementation of an Electronic Laboratory Notebook software for the site. Our current documentation practices are paper-based. Through this effort to transition to electronic documentation, I support the growth of Catalent’s newly activated value – Innovation.
Also, my colleague Kelly Halderman will be at AAPS this year presenting some of our group’s work, which discusses the NDA-enabling methods for assessing the compatibility between active pharmaceutical ingredients and materials used during IV infusion administration. If you are there, be sure to stop by her poster for more information! The poster is titled IV Infusion In-Use Compatibility of the Regulatory Hormone Melatonin.
What has been your greatest achievement at Catalent?
My greatest achievement at Catalent was my completion of Lean Six Sigma Greenbelt training. The tools I learned have allowed me to improve injectable development processes in an efficient fashion, and lead projects as an effective leader.
ACCESS JAKE’S LATEST CONTENT
- Poster – Development of Oligonucleotide Based mIR 132 Antagonists for the Treatment of NASH
- Poster – Efficacy of RGLS4326 in Human Primary 3D-Cyst Cultures derived from Autosomal Dominant Polycystic Kidney Disease (ADPKD) Donors
- Poster – Discovery and Preclinical Characterization of RGLS4326 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Poster – PRECLINICAL DEVELOPMENT OF miR-10b ANTAGONIST FOR THE TREATMENT OF GLIOBLASTOMA
- Article – microRNA-17 family promotes polycystic kidney disease progression through modulation of mitochondrial metabolism
- Ebook – The Science of Cooking – Understanding the Biology and Chemistry Behind Food and Cooking