Besides my curiosity for basic science, I seek to transfer scientific discoveries and innovative technologies from academia to industry, where they can have an impact on real lives. Leveraging my graduate and postdoctoral training, I am interested in utilizing in-depth scientific analysis and insights to predict the feasibility and impact of novel therapeutics and biomedical technologies that are currently under development. Specifically, my main focus lies on precision medicine, large-scale data analysis, comparative medicine, as well as traditional pharmaceuticals.
As a part of this effort, I am acting as a scientific member of Beacon VP Capital, a hedge fund investing in publicly traded small- and mid-cap biotech firms that have drugs and medical devices in or near the final stage of the FDA approval process. The investment strategy relies on predicting the outcome of the approval processes based on scientific analysis conducted by a team of scientists. As of 2016, our predictions had a 80% accuracy rate with an average annualized return of 66% per stock, at a total evaluation of >40 FDA applications.
Over the past years, I have lead the evaluation of the following products under FDA review:
1. Molecular diagnostics – EXASHJ Noh. Exact sciences’ stool-DNA-based colorectal cancer screening test likely to get favorable review on its PMA. Seeking alpha 3/24/2014
Exact Sciences (NASDAQ:EXAS) is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. On March 27, 2014, the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration will review the premarket approval application (PMA) for the company’s Cologuard stool-DNA-based, non-invasive colorectal cancer screening test. After carefully reviewing the published scientific evidence, we believe that Cologuard will receive favorable review on its PMA.
2. Drug delivery device – AVNR
HJ Noh, J Guyette. Avanir’s drug-device combo experiencing minor FDA headaches. Seeking alpha 12/22/2014
It was recently announced on December 2, 2014 that Avanir would be acquired for approximately $3.5B by Otsuka Pharmaceutical Co., Ltd. (OTCPK:OTSKY), who shares a focus on central nervous system disorders. Prior to the acquisition announcement, with a looming November 26th PDUFA date for their drug-device combination AVP-825 (for treating acute migraines), the company announced preliminary feedback from the FDA concluding that approval of AVP-825 may be unlikely due to insufficient human factor validation data. Industry analysis varied on a spectrum, from optimism over an efficacious drug with an amendable device application, to pessimism that suggested the full FDA review could reveal additional concerns about the drug’s Phase III trial. The FDA’s Complete Response Letter (CRL), issued on November 26th, sided with the more optimistic outlook. After reviewing the published scientific evidence, we believe that AVP-825 has a sufficient safety and efficacy profile and that the FDA’s inquiry over human factor testing is a relatively minor hurdle that will be overcome once the human-device interface is optimized.
3. Small molecule drug – LGND
SR Wang, HJ Noh. Safety concerns may prevent FDA approval of ligand’s drug Aprela. Seeking alpha 9/3/2013
By October 3, 2013, the U.S. Food and Drug Administration (FDA) will decide whether to approve Ligand Pharmaceutical’s (LGND) drug Aprela for the treatment of menopausal symptoms and the prevention of postmenopausal osteoporosis in non-hysterectomized women. This drug is being developed by Ligand in partnership with Pfizer (PFE). After reviewing Aprela’s clinical trial results and relevant scientific literature, we believe Aprela will fail to receive FDA approval and, consequently, Ligand’s stock will underperform in the near term.