Randolph Abutin Email & Phone Number

Waltham, Massachusetts, United States

Design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes’ diverse small molecule and biologics drug candidates. Serve as the nonclinical toxicology representative on Alkermes’ Discovery and Development project teams and will be the single point of accountability for all strategic, study-related, and regulatory aspects of the teams they manage.

Cambridge, Massachusetts, United States

Support preclinical safety (toxicology), pharmacokinetic, and bio distribution studies for advancing Red Cell Therapeutics. Manage CROs including assisting in CRO selection, requesting study quotes, leading internal quote approval, monitoring CRO performance against protocols and GLP compliance, tracking invoices and study phases. Review non-GLP and GLP study protocols, amendments, and reports. Collaborate with scientists internally throughout non-GLP and GLP study conduct. Coordinate study-related activities between all internal functions and CROs to meet program needs and timelines. Quality check protocols, amendments, reports, and regulatory submission documents.

Lexington, Ma

Initiate, direct, and execute projects/studies of diverse scope in a GLP environment. Develop non-clinical toxicology strategies to advance drug candidates from preclinical to clinical development for Sponsor. Plan, execute, monitor, and interpret toxicology studies for advancing Sponsor’s drug candidates. Develop strategies for the application of broad scientific principles and concepts for the preclinical assessment of various treatment modalities, including pharmaceuticals and/or medical devices.

Served as study director in the direction and execution of non-clinical studies in compliance with FDA, OECD, and MHLW Good Laboratory Practices (GLP) in the conduct of nonclinical research. Designed, managed, interpreted, and presented data on assigned studies in rodent, canine, porcine, rabbit, and non-human primate models.Experience Includes: General Toxicology, Surgery, Pharmacokinetics, Inflammatory Models, and Oncology Efficacy ModelsExperienced in working with small molecules, monoclonal antibodies, gene therapy products, oligonucleotides, and bacterial proteins for numerous pharmaceutical and biotechnology companies.Utilized Povantis for data presentation/analysis and WinNonlin for pharmacokinetic data analysis.Provided technical and scientific guidance to the research staff.Participated-in and coordinated all phases of the study planning process with the appropriate departments.Provided input on study proposals, scheduling, and cost estimates.Continued review of new regulatory guidelines and scientific literature.Trained new toxicology study directors and advised colleagues as needed.2006-Summer 2010 IACUC Member, Chairperson (2009-2010)

Supervised, trained employees, and performed genetic toxicology studies to ensure study compliance with study protocols, internal standard operating procedures, and FDA, OECD and MHLW GLP regulations.Executed all in vitro and some in vivo aspects of the commercial Muta *Mouse assay including animal dissection, DNA extraction/purification, phage rescue, bacterial culture, positive selection plating, and plaque scoring. Performed all aspects of the DNA postlabeling adduct assay-including DNA extraction, purification, 32P-ATP labeling, and quantitation of DNA adducts formed from in vitro and in vivo sources.Performed certain aspects of cytogenetics and unscheduled DNA synthesis genetic toxicology assays. Performed all laboratory aspects of the in vitro micronucleus microwell and scoring of in vivo mouse micronucleus assays. Performed some laboratory aspects Communicated frequently with the Study Director regarding the conduct of studies.Assisted the Study Director in preparing sponsor reports.Responded to Quality Assurance Unit audits and queries.

Analyzed environmental sample for heavy metal and volatile organic compound content in accordance with departmental protocols and U.S. Environmental Protection Agency protocols and regulations. Instrumentation utilized: GC/FID, GC/ECD, graphite furnace AA, and flame AA.Performed analysis of standard test material provided by state and federal agencies for laboratory certification.Extracted and quantified pesticide residue from various environmental matricies through GC/ECD following EPA GLPs and standard operating procedures.Developed a specialized lab-specific mass spectral library for GC/MS.

Extracted and quantified pesticide residue from various environmental matricies through GC/ECD following EPA GLPs and standard operating procedures.Developed a specialized lab-specific mass spectral library for GC/MS

Ph.D, Pharmacology And Toxicology

B.S, Biochemistry