Winnie Pak, Phd Email and Phone Number
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- 20+ years of experience in the pharmaceutical/biotechnology industry including clinical trial recruitment support, relationship building with thought leaders/health care providers, strategic program management, liaising with early-development partners, laboratory research development, data management, and regulatory affairs- Rescued/supported clinical trial recruitment in multiple indications, saving upwards of close to a year on development timelines- Led global medical affairs strategy and execution for an Alzheimer's indication- Built out MSL territory in support of recruitment and in preparation for launch of rare disease indications- Managed consultants and vendors in results-driven environments in overseas partnerships, nonclinical studies, IND-, NDA- and MAA-enabling studies, NDA-review process, Advisory Committee preparations, and post-marketing commitments- Strong scientific background: PhD in Neurosciences from the UC San Diego/The Salk InstituteSelect Skills: Medical Affairs-KOL/HCP Relationships | Advisory Boards | Research and Analysis | Critical Problem Solving | Nonclinical Development | IND | NDA | FDA Advisory Committee | Basic Science
Elevated Clinical
View- Website:
- elevatedclinical.com
- Employees:
- 1
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Founder, Head Of StrategyElevated ClinicalUnited States
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Head Of StrategyElevated Clinical Jul 2024 - PresentSupport 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.
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Board MemberDiverse Research Now Jul 2024 - PresentSan Diego, California, UsA minority participant advocacy group offering unique programs and services to help diversify clinical trials. -
Board MemberGeorge G. Glenner Alzheimer'S Family Centers, Inc.® Jun 2022 - PresentChula Vista, Ca, UsGeorge 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. -
Senior Director, Clinical & Medical AffairsAlzheon, Inc. | Preserving Future Memories Mar 2022 - Jul 2024Framingham, Ma, UsResponsible 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 -
Medical Science Liaison, Rare DiseasesTravere Therapeutics Oct 2020 - Mar 2022San Diego, California, UsDeveloped 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 -
Director, Program And Alliance ManagementTravere Therapeutics Sep 2017 - Oct 2020San Diego, California, UsManaged 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
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Associate Director, Program ManagementAcadia Pharmaceuticals Jan 2016 - Sep 2017San Diego, California, UsManaged 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. -
Senior Program ManagerAcadia Pharmaceuticals Sep 2010 - Dec 2015San Diego, California, UsProgram 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.
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ConsultantMentara, Inc. Mar 2004 - Sep 2010Provided 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.
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Postdoctoral FellowSalk Institute For Biological Studies Sep 2004 - Sep 2005La Jolla, Ca, UsMolecular 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. -
Postgraduate ResearcherUniversity Of California, San Francisco 1998 - 1999San Francisco, California, UsDepartments 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. -
Research InternNational Institutes Of Health Jun 1998 - Sep 1998Bethesda, Md, UsNational Institute of Neurological Disorders and Stroke, Advisor: Daniel AlkonProject: Design a nested PCR method for Drosophila calexitin -
Undergraduate ResearcherUniversity Of California, Davis 1997 - 1998Davis, California, UsDepartment 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 -
Research And Development InternGenentech 1996 - 1997South San Francisco, California, Us1996 - Laboratory Quality Control: capillary electrophoresis1997 - Research and Development: glycation of nerve growth factor1996-1997 - Genentech-UC Davis Campus Liaison -
Researcher InternNasa Ames Research Center Mar 1994 - Sep 1995Moffett Field, California, UsIn conjunction with SETI Institute and San Jose State University, Advisor: Friedemann FreundProject: Electrical currents in rocks as a possible predictor of earthquakes
Winnie Pak, Phd Skills
Winnie Pak, Phd Education Details
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Uc San DiegoNeurosciences -
University Of California, DavisBiochemistry
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University Of California, DavisPsychology
Frequently Asked Questions about Winnie Pak, Phd
What company does Winnie Pak, Phd work for?
Winnie Pak, Phd works for Elevated Clinical
What is Winnie Pak, Phd's role at the current company?
Winnie Pak, Phd's current role is Founder, Head of Strategy.
What is Winnie Pak, Phd's email address?
Winnie Pak, Phd's email address is ww****@****hoo.com
What schools did Winnie Pak, Phd attend?
Winnie Pak, Phd attended Uc San Diego, University Of California, Davis, University Of California, Davis.
What are some of Winnie Pak, Phd's interests?
Winnie Pak, Phd has interest in Kids, Collecting Antiques, Gardening, Electronics, Home Improvement, Crafts, Music, Automobiles, The Arts, Movies.
What skills is Winnie Pak, Phd known for?
Winnie Pak, Phd has skills like Clinical Development, Biotechnology, Neuroscience, Drug Discovery, Life Sciences, Pharmacology, Clinical Trials, Gcp, Pharmaceutical Industry, Lifesciences, Cro, Drug Development.
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