Providing strategic and operational consulting in translational science and drug development for emerging biotechnology companies and investors

I led clinical drug development efforts at Alkahest, a clinical-stage biotechnology company whose mission is to enrich the health and vitality of humankind through transformative therapies that counterbalance the aging process.

Clinical Lead & Medical Monitor for pivotal 8000-subject phase 3 vaccine trial; wrote BLA and participated in advisory committee preparation; Project Team Lead/Clinical Lead for phase 2 asthma development program working with external development partner; Head of Drug Safety and Pharmacovigilance Department.

Served as the Project Team Leader (PTL) for a high-profile phase 2 ophthalmology drug development program; accountable for all aspects of strategy and budget; successfully led cross-functional team as we made data-driven decisions in a highly complex matrix environment; created substantial portfolio value.

In the latter half of my tenure with Amgen I was responsible for the safety and pharmacovigilance of Prolia, a novel antibody-based therapeutic agent for osteoporosis. Prior to my role on the Prolia team I worked in the early development safety group with responsibilities for several Phase 1 and pre-clinical molecules in various therapeutic areas including oncology and inflammation. I was also the co-chair of the Amgen Hepatotoxicity Safety Advisory Committee (HSAC) that reviewed cases of suspected hepatotoxicity and created template protocol language that was consistent with regulatory guidance in this important area of Drug Safety.

As a medical toxicology fellow at Banner Good Samaritan Hospital, I cared for patients suffering from adverse drug events, therapeutic misadventures, bites, stings, plant exposures and overdoses on an inpatient service in an ICU. I also advised physicians from various medical specialties on issues in pharmacotherapy and patient management. In addition to its heavy emphasis on the care of critically ill toxicology patients, the Banner Good Sam Fellowship provided training in clinical pharmacology, drug-drug interactions and the critical review of clinical trial data. As a fellow I lectured to other healthcare providers on a weekly basis on various topics in clinical toxicology and pharmacology, presented at national and international meetings and was a sub-investigator in FDA-sponsored Phase III scorpion antivenin trial.

In this role I worked as a management consultant for select clients in the Healthcare industry.

Completed emergency medicine residency training program at a busy level one trauma center with more than 60,000 patient visits per year; resident research project on decision analysis in the cost-effective use of abdominal Computer Aided Tomography scanning in trauma patients

My research interests included protein engineering, structure-based drug design & HIV protease. Research projects included: expression and characterization of a novel Drosophila protease using the baculovirus expression system. My other duties included: preparation of media and reagents for experiments, DNA sequencing, protein purification, and the cloning of mammalian and bacterial cell lines.