Winnie Pak, Phd Email & Phone Number

United States

Support neurodegenerative disease therapies accelerate subject recruitment and save their timelines.Promote disease state education to the broader neurology and primary care providers community in order to raise awareness of current therapeutic options and diagnostic practices to achieve earlier detection.Effective outreach to under represented communities in clinical trial recruitment in an effort to move the needle for early detection in communities that have historically been diagnosed late in disease progression.

San Diego, California, Us

A minority participant advocacy group offering unique programs and services to help diversify clinical trials.

Chula Vista, Ca, Us

George G. Glenner Alzheimer's Family Centers is a 501(c)(3) with a mission is to provide affordable and accessible adult day care and support services to families affected by Alzheimer’s and other forms of memory impairment. We do this by providing innovative adult day programs, family support, case management, crisis intervention, family and community education, advocacy, information and referrals.

Framingham, Ma, Us

Responsible for global medical affairs strategy for Alzheimer's disease indication; worked cross functionally to support/rescue recruitment in a difficult-to-enroll Phase 3 program (APOE4/4 participants); developed territory covering North America and Europe from scratch, with over 100 KOL/HCPs under management; responsible for disease-state education and awareness campaigns across global territory; covered regional to international AD conferences with poster and podium presentations, including medical affairs exhibitor presence; procured consultants and collaborated with CMO/CSO to forward publication strategy; supported Commercial activities in market access, advocacy, and brand marketing

San Diego, California, Us

Developed territory and managed KOLs/HCPs covering Texas, Louisiana, Georgia, Florida; disease-state education and trial recruitment for rare kidney (IgA nephropathy and FSGS) and ultra rare brain/liver (CTX) indications; increased breath and depth of territory to over 80 experts under management; collaborated with Government Affairs and external stakeholders on RUSP application to add CTX onto Newborn Screening Program nationwide; member of DEI committee working on implementing meaningful initiatives company-wide

San Diego, California, Us

Managed rare and ultra-rare disease programs with Phase 1 to 4 studies, from clinical development to NDA/MAA submission preparations to commercial efforts to close-down activities; integrated cross-functional teams to accomplish diverse tasks ranging from supporting subject recruitment to overcoming CMC challenges to generating data scenarios to empowering patient communities through education campaigns

San Diego, California, Us

Managed Nuplazid program from Phase 3 through NDA review/approval and postmarketing commitments to the pursuit of additional indications and preparation for MAA submission; wide range of integral roles including generation of eCTD Module 2 summary documents, addressing NDA inquiries, generation of content in preparation for Advisory Committee, overseeing label-extension studies and participating in strategic planning and startup of new indications.

San Diego, California, Us

Program managed a pre-IND and Phase 1 program and a pre-NDA indication, with a wide range of personal responsibilities including nonclinical and clinical study data analyses for presentations and reports, content generation for IND, NDA, IBs, IMPDs, SOPs, FDA Meeting briefing packages, presentations and budgets.

Provided drug development services for a variety of clients from biotechnology start-ups to global pharmaceutical companies, including medical writing and documentation support of IND, NDA and IMPD filings, IBs, review of analytical methods, preclinical and clinical protocols, preclinical and clinical study reports, validation documentations, SOPs, monitoring clinical data and management of data supporting both preclinical and clinical development.

La Jolla, Ca, Us

Molecular Neurobiology Laboratories, Advisor: Dennis O'LearyFocus: Sub-cortical targeting of retinal ganglion cellsPublication: Quina LA, Pak W, Lanier J, Banwait P, Gratwick K, Liu Y, Velasquez T, O'Leary DD, Goulding M, Turner EE (2005) Brn3a-expressing retinal ganglion cells project specifically to thalamocortical and collicular visual pathways. Journal of Neuroscience 2005 Dec 14;25(50):11595-604.

San Francisco, California, Us

Departments of Pharmaceutical Sciences and Pharmaceutical Chemistry, Advisor: Deanna KroetzProjects: - Effects of cytochrome P450 metabolites of arachidonic acid in the pathogenesis of hypertension- Placental transport of nicotine in humansPublication: Xu F, Straub WO, Pak W, Su P, Maier KG, Yu M, Roman RJ, Ortiz De Montellano PR, Kroetz DL (2002) Antihypertensive effect of mechanism-based inhibition of renal arachidonic acid omega-hydroxylase activity. American Journal of Physiology: Regulatory, Integrative and Comparative Physiology 2002 Sep;283(3):R710-20.

Bethesda, Md, Us

National Institute of Neurological Disorders and Stroke, Advisor: Daniel AlkonProject: Design a nested PCR method for Drosophila calexitin

Davis, California, Us

Department of Cardiovascular Medicine, 1998: exercise-pressor reflexDepartment of Neurobiology, Physiology and Behavior, 1997 1998: avian intrapulmonary chemoreceptorsDepartment of Cell Biology and Human Anatomy, 1997: fibroblast growth factor

South San Francisco, California, Us

1996 - Laboratory Quality Control: capillary electrophoresis1997 - Research and Development: glycation of nerve growth factor1996-1997 - Genentech-UC Davis Campus Liaison

Moffett Field, California, Us

In conjunction with SETI Institute and San Jose State University, Advisor: Friedemann FreundProject: Electrical currents in rocks as a possible predictor of earthquakes

Phd, Neurosciences

Bs, Biochemistry

Bs, Psychology