Andrea Mislak Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

• Collaborate with over 20 external clients and key stakeholders that partner with KBI for biomolecule manufacturing to maintain key milestones and program deliverables under strict timelines• Evaluate program objectives within a cross functional team, prioritize critical issues, and effectively communicate those issues alongside situational risk benefit scenarios to facilitate client’s informed decision-making concerning program’s scientific strategy and business objectives• Actively manage over 60 GMP and non-GMP stability programs that support Phase I through Phase IIb clinical development; Represent KBI as the SME for formulation development, in-use compatibility, and stability strategy, implementation, and interpretation of analytical data• Lead a team of 13 scientists, ranging from in-process manufacturing support associates to Ph.D. scientists, responsible for the coordination, organization, execution, technical decision-making, scientific guidance, and primary review of raw data in support of QC bioassay evaluations for all on-going stability programs, reference material characterizations, and in-use compatibility evaluations • Author protocols, SOPs, test methods, and controlled documents in accordance with ICH guidelines and cGMP regulatory and safety requirements; author complex technical reports and data summaries• Directly compose, design, and oversee laboratory investigations (LIRs) of out of specification (OOS) results and implement deviations and/or CAPAs as appropriate, interfacing and collaborating with the client, internal stakeholders and QA to achieve sound scientific justifications and timely closures• Design and execute all aspects of analytical method qualifications in accordance with ICH guidelines

Durham, North Carolina, Us

Durham, North Carolina, Us

Durham, North Carolina, Us

New Haven, Ct, Us

In the laboratory of Dr. Karen Anderson, I identified a recently discovered human mitochondrial polymerase, PrimPol, as a novel mechanism of host toxicity of antiviral nucleoside analogs used in the treatment of AIDS. I performed the first transient-state kinetic analysis of human PrimPol, one of only two human mitochondrial polymerases. My research also sought to understand the mechanisms of inhibition and the development of drug resistance of antivirals targeting HIV reverse transcriptase using structural and kinetic methodologies.

New Haven, Ct, Us

Organized and executed career development events for student scientists. My specific contributions include the following:• Co-Director of the Career Development Peer Group Program to facilitate self-assessment and career exploration of student scientists; organize monthly workshops to support participant development (http://campuspress.yale.edu/cdpgprogram/)• Initiated and led a Boston Biotech Job Trek for students interested in careers in the pharmaceutical and biotech industry; contact and develop relationships with industry scientists at Pfizer, Merck Research Labs, Biogen Idec, and H3 Biomedicine to serve as panelists and showcase the opportunities available in the industry sector • Participated in social media outreach about research scientists and was solicited as an interviewee in a podcast about graduate school

Rahway, New Jersey, Us

• Supported development of an oncology program in target validation as the DMPK subject matter expert; developed HPLC methodology to separate oncometabolite (R)-2-hydroxyglutarate from (S)-2-hydroxyglutarate and used the method to assess the efficacy of small molecule inhibitors in cell-based screening assays in support of lead optimization and SAR strategies• Group leader of the centralized preclinical Bioanalytical Group, coordinated operations and review, evaluation, and interpretation of dose limiting toxicity, maximum tolerable dose, PK/PD, and routine pharmacokinetic studies in preclinical species in support of inhibitor nominations for NDA filing and advancement to the clinic• Managed the outsourcing strategy and collaborated with an external certified research organization to process 70% of the routine PK analysis for the Boston site; performed the primary data review of HPLC-MS/MS chromatograms and evaluated studies for compliance to discovery phase bioanalytical guidelines

Rahway, New Jersey, Us

• Founding member of the centralized in vitro adsorption, distribution, metabolism, and elimination (ADME) working group, implemented and validated protocols and experimental best practices identified internally and across Merck sites• Associate Scientist contributor on 3 global DMPK committees: Tissue Working Group, Acceptance Criteria for Discovery, and Alliance Partner Data Exchange; communicated the benefits and limitations of the practical applications of committee deliverables• Optimized methods for quantifying exposure levels of inhaled drugs in a preclinical sheep model; evaluated lung homogenization techniques (i.e. mechanical homogenization versus sound waves), the use of surrogate matrices as a diluent for the lung tissue, optimization of extraction efficiency methods, analytical validation of study runs for adherence to acceptance criteria, and quantification of dose/exposure/pharmacodynamics correlations and modeling • Performed lab management, system suitability testing and calibration, instrument maintenance, documentation of DMPK scientific strategy meeting, interviewing, on-boarding, and training of new personnel

Rahway, New Jersey, Us

• Performed small molecule analysis via HPLC-MS/MS in biological matrices, calculated and interpreted pharmacokinetic parameters (area under curve, AUC), volume of distribution (Vdss), clearance (Cl), mean retention time (MRT), half-life (t1/2), Tmax, and Cmax in preclinical species to support PK/PD modeling of compound efficacy• Executed in vitro adsorption, distribution, metabolism, and elimination (ADME) assays including microsomal, hepatic, and plasma stability, plasma protein binding, blood to plasma ratio, CYP induction and inhibition, reaction phenotyping, and disposition studies to understand in vivo – in vitro correlation (IVIVC)• Prepared dosing formulations in support of IV, PO, IP, and cassette IV in vivo pharmacokinetic studies

Boston, Ma, Us

• Developed a residential community comprised of forty-three undergraduate students• Demonstrated success in conflict and risk management, event planning, and leadership• Amassed teamwork and collaborative skills working with fellow resident assistants

Boston, Ma, Us

In the laboratory of Dr. Kim McCall, I investigated the role of programmed cell death in patterning the Drosophila thread1 mutant arista. • Evaluated mRNA expression qualitatively by in situ hybridization and transcript levels quantitatively by RT-PCR• Techniques conducted include DNA/RNA isolation and purification, primer optimization, cDNA synthesis, in vitro transcription reactions, in situ hybridization, gel electrophoresis, PCR, and RT-PCR

Doctor Of Philosophy (Ph.D.), Pharmacology

Biochemistry And Molecular Biology