Provides consulting services to the pharmaceutical and biotechnology industries in the areas of drug development, including creation of study protocols and clinical development plans; data review; NDA and sNDA submissions; FDA meeting preparation and negotiation; FDA Advisory Committee meeting planning; pharmacovigilance; and medical writing.
To transform scientific findings into clinical treatments, to promote global pharmaceuticals and healthcare management, cooperation, communication, and development. My clinical background as a physician and extensive clinical and medical experiences in different countries/settings offer me a unique ability to communicate with physicians and scientists around the world. Would like to apply my knowledge and skills to pursue positions in clinical and drug development, medical/clinical and regulatory affairs, business development and management in pharmaceutical, biotech, medical device, CRO, and consulting settings.
Over 20 years experience in clinical development (Phase I-IV) in multiple CNS indications (Alzheimer’s disease, neuropathic pain, epilepsy, Parkinson’s disease, restless legs disorder, stroke, multiple sclerosis, cognition, schizophrenia, bipolar disorder); extensive knowledge and leadership experience of Early Clinical Development from FIH to Proof of Concept; experienced matrix leader of multidisciplinary Phase III development programs in neurology and psychiatry indications, on the interface with regulatory, drug safety, clinical, operational, and health outcomes functions.
Senior clinical vaccinologist/immunotherapist with extensive experience in translational-stage development of biologics within public health and commercial environments; broad background in molecular biology, cellular immunology, infectious diseases, oncology, regulatory affairs, adjuvants, medical affairs, and clinical trial design; skilled in the design and implementation of major development programs that have moved products into the clinic and through licensure; unique ability to determine root causes and resolve problems in the development, planning, and implementation phases of large-scale, highly complex projects.
A seasoned Pharmaceutical Executive with over 15 years of industry experience having worked across all stages of clinical drug development and medical affairs on products that have successfully reached the market including: Kadcyla®, Elelyso®, Intermezzo®, the trastuzumab biosimilars Ogiviri®, as well as secondary indications for Pradaxa® and Sutent®. Deep experience with large and small molecules, biosimilars, combined drug devices, and vaccines in therapeutic areas including oncology, immuno-oncology, rheumatology, pain, orphan diseases, CNS, cardiovascular, and women's health. Led, built, and championed organizations at Pfizer, Purdue, and Juniper and is passionate about bringing the highest performing goal-oriented teams together. Continues to hone and remain relevant in medicine as preceptor in Internal Medicine at Yale. Collectively, these experiences add value and perspective in understanding global marketplace dynamics and its intimate relationship with developing new therapeutics for patients in areas of unmet medical need.
A senior pharmaceutical executive with extensive experience in pharmaceutical consulting, medical affairs and running medical research programs globally, including both early and late stages of drug development, product line-extensions and new product evaluation.
Infectious Disease trained, with research focus on virology and host cellular immune response to viruses (HIV); Phase II/III and IV studies (HIV, HBV, HCV); translational research (HBV cure, HCV, sepsis); regulatory experience (HBV, HIV) - includes NDA, IND, Type II submissions; GPVE experience (HBV therapeutic was target molecule); other experience (establishment, monitoring/communication with Data Monitoring Committees (DMCs) and Event Adjudication Committees (EACs); investigator networking (extensive experience and multiple relationships developed throughout Asia-Pac, EU, North and South America); matrix experience (extensive experience working within the pharma matrix, leading up and down); writing experience (extensive as relates to publications, regulatory documents and other internal pharma documents); teaching experience.