Kristen Nickens, Phd Email & Phone Number

Washington, Dc, Us

Cder/Opq/Office Of Biotechnology Products

• Coordinates a team of at least three full-time primary product quality assessors and provides guidance, leadership, and training focused on both individual and collaborative team success• Involved in a variety CDER-mission focused teams and activities, such as working groups, trainings, and presentations

Cder/Opq/Office Of Biotechnology Products

• Performed secondary-level oversight of product quality assessments and facilitated the review work of 3-4 primary assessors• Strategically collaborated with Senior Management to plan and execute work-flow management tools and approaches, as well as participated in work-force hiring and engagement• Performed risk-based product quality assessments for a range of biotechnology products

Cder/Opq/Office Of Biotechnology Products

• Performed risk-based assessments of CMC information submitted in pre-INDs, INDs, BLAs, post-approval • Communicated product quality recommendations with pharmaceutical company representatives, scientists, internal and external customers, supervisors, senior-level management, and inter-disciplinary teams • Conducted international and domestic pre-approval and biosimilar-associated comparative analytical assessment inspections

Cber/Office Of Tissues And Advanced Therapies

• Successfully and simultaneously conducted CBER mission-driven biological research and biological product quality review of regulatory submissions • Product quality review and examination of CBER-regulated products submitted as original INDs • Reviewed protocol amendments (i.e. media formulation changes), examined Humanitarian Device Exemption submissions, examined Master Files (monoclonal antibodies, devices, and drugs), examined product labels, and participated in the review of pre-IDE and pre-IND applications submitted to the FDA• Evaluated methods used in obtaining scientific results, and assisted in determining the safety, effectiveness, validity, and completeness of cell therapy, associated medical devices, and tissue-engineered products regulated

• Lead on novel assay development for the clinical detection of prostate cancer in bio-specimens and benefit of the overall public health• Experience in Institutional Review Board material preparation and submission• Experience in biological specimen collection, storage and quality assurance• Conduct systematic literature reviews on basic research and translational public health studies• Develop, evaluate, and compose laboratory standard operating procedures• Exposure to SAS: public health data analysis and reporting• Establish multidisciplinary collaborations with senior scientific staff, industry executives, and technology transfer experts to successfully reach project goals• Filed United States Patent Application for the developed assay• Developed product cost analysis and budget plan for invention commercialization • Presented data at a nationally recognized conference (Society for Basic Urological Research, Inc.)• Experienced grant writer and manuscript peer-reviewer

Rockville, Md

• Worked with a multidisciplinary team to coordinate career fair• Recruited company sponsorship• Participant recruitment

• Co-fellow/translational medicine consultant for the personalized medicine virtual intern group• Interviewed, evaluated and selected interns• Led discussions on science advocacy with a focus on evidence-based scientific research that effects public health issues and science policies• Developed health disparities curriculum • Conducted weekly virtual communication-based discussions with interns and other policy fellows

• Gained expertise in project development, execution and evaluation• Established and met project metrics: analyzed, evaluated and presented progress to senior committee members• Experienced grant writer and manuscript peer-reviewer• Received National Institutes of Health Research Supplement to Promote Diversity in Health Related Research. Supplement to NIH R01CA107972 to Susan Ceryak• Conducted, analyzed, and published original basic science research results in peer-reviewed journal (Nickens et al., 2012)• Conducted and published results of a systematic literature review on a public health carcinogen (Nickens et al., 2010)• Orally presented and defended original research thesis• Presented data at nationally recognized conferences (American Association for Cancer Research, The United Mitochondrial Disease Foundation)• Worked in a diverse and multidisciplinary laboratory environment• Established local and national collaborations to reach research goals

• Post-baccalaureate research training focused on understanding the regulation of TGF-beta signaling in carcinogenesis• Gained exposure to the federal government and programs developed for the protection and promotion of public health• Trained in cutting edge molecular biology and immunological experimental techniques

• Post-baccalaureate research training on the role of TGF-beta isoform compensatory mechanisms in autoimmunity and inflammation in in vivo murine models• Gained exposure to the federal government and programs developed for the protection and promotion of public health• Trained in cutting edge molecular biology techniques

• Science outreach• Provided advisement, mentorship, and educational instruction and development to student participants• Program coordination and communications liaison• Conducted program evaluations and provided written and oral assessments of progress to program managers

Conducted research on the physical mechanisms of T-cell activation.

Conducted research on early-onset periodontitis and its effects on a vitamin D receptor polymorphism.

Investing Now is an enrichment program focused on academic success through advising, tutoring, and mentoring underrepresented students in math and science throughout their high-school years. I began as a participant and progressed to a tutor and volunteer for the program.

Phd, Molecular Medicine/Oncology

Received the National Institutes of Health Research Supplement to Promote Diversity in Health-Related Research to support graduate thesis.

Bs, Biology

Activities and Societies: Beta Kappa ChiAwarded a Team Approach to Research Excellence (TARE) fellowship to study the effects of inorganic.

Certificate, Chief Science Officer: Pathways To Leadership, Careers In Life Science

36-hour certificate program in Leadership, Negotiation, Project Management, First-line Supervision and Finance focusing on relevance.

Certificate, Understanding Patents And The Patent Applications Process For Engineers And Scientists

Review the context of Patents within the various IP Regimes; An overview of the patent application process (from filing strategy.

High School Diploma