Luke Utley Email and Phone Number

Providing guidance and insight to companies looking to transition molecules from lead optimization through phase 1 clinical trials.

At Alnylam I am the DMPK representative on development stage projects intended to treat multiple rare diseases. I have contributed to IND/CTA filings as well as clinical protocol design and CSR publications. My responsibilities include:Planing and execution of IND and post IND studies to support first in human dose selection and escalation.Implementation of biomarker assays via CRO partners to measure target engagement and support the use of surrogate endpoints in clinical studies.Development of clinical protocol designs for PK and PD sampling and analysis.Execution of pharmacokinetic analysis, dose prediction and effect modeling on pre-clinical and clinical data to support dose level and dose schedule selection.

At Agios I oversee and coordinate in-vitro and biotransformation aspects of drug development projects. I am responsible for evaluating and managing risk due to potential drug-drug interactions faced by our programs. I manage our workflow via multiple outsourcing partners to design experiments, interpret data in order to resolve issues of clearance, drug elimination and drug-drug interactions. I have prepared the relevant sections of various regulatory documents including briefing books, IND tabular and written summary sections, clinical laboratory manuals, investigator brochures and responses to agency questions.

Responsible for establishing and growing the metabolite identification function at AstraZeneca Waltham site. Trained and mentored one PhD and four BS level scientists in metabolite identification. Guided those individuals in selecting training and educational venues to further their career goals. Established methods for elucidating metabolite structures produced in in-vitro and in-vivo samples. Established a reactive metabolite trapping screen that supports multiple compounds per month. Evaluate cross species metabolic profiles of investigational compounds incubated in hepatocytes. Provide mechanistic feedback to guide chemistry in reducing metabolic turnover of compounds. Provide insight into potential mechanisms of activity or toxicity due to metabolic mechanisms. Design bespoke experiments to elucidate metabolic pathways. Worked in collaboration with Analytical Chemistry to establish NMR metabolite profiler system. Performed lab work to develop scale up methods, identified training venues to improve group's knowledge of the NMR system and designed test system to further training and validation. Responsible for representing DMPK functionality in project core teams. Use Spotfire to establish QSAR relationships and interpret DMPK data to aid in structural design. Determine mechanisms of clearance from in-vitro/in-vivo correlations. Represent Waltham DMPK group in local and global initiatives such as the GHP IACUC, the biotransformation scientific leadership group, predictive metabolism network, and the DMPK capital investment network. Coordinated 2010 capital equipment request process. Currently responsible for spearheading and organizing the DMPK Design Team Lead training curriculum. Served as interim team leader for the in-vitro group during leader's maternity leave. Performed mid-year goal reviews and kept team leader up to date on department events.

Responsible for the preparation and analysis of samples primarily by LC-MS-MS. Supervised one direct report and managed two others in a matrix organization. Served as a lab mentor for others in bioanalytical laboratory. Developed, troubleshot and validated analytical methods for use in pre-clinical and clinical studies intended for FDA submission. Validated multiple methods for IND submissions. Wrote validation and analysis summary documents for regulatory submissions. Collaborated with biotransformation group on methods for quantification of metabolites. Developed and published a novel method for quantification of metabolites using nanospray LC-MS.

Implemented and developed CRL's Metabolite Screening and Identification Service. As part of a multi-discipline team provided assistance to clients in the interpretation of metabolite structure elucidation data. Directly oversaw the analytical support for in-vitro metabolism projects. Responsible for the preparation and analysis of biological samples primarily by LC-MS-MS. Prepare and deliver project data and reports to clients for the purpose of regulatory submissions. Responsible for supervising several individuals (3-4 depending on project needs) and for maintaining project timelines. Well versed in the use of Watson data management system.

Developed in-vitro metabolite screening methods via LC-MS. Performed sample analysis by LC-MS, GC-MS and DIP-MS to support chemical synthesis group. Performed structure elucidation of metabolites and natural products in conjunction with NMR function as part of an interdisciplinary team. Responsible for method development and validation in support of an Investigational New Drug application. Supervised and documented the progress of method validations, as well as routine sample analysis performed under GLP guidelines. Wrote method validation sections for IND documentation. Developed methods for transfer to large scale testing facilities and for use in PK studies at RTI. Prepared data summaries and reports for clients intended for use in regulatory submissions. Prepared budget estimations for use in contract bids. Oversaw daily operation of the BOC Mass Spectrometry facility. Management duties involved direct supervision of two individuals.

Responsible for confirming the presence of suspected illicit drugs and their metabolites in serum and urine samples by GC/MS, after extraction by SPE or liquid/liquid methods. Performed structural elucidation by GC/MS. Evaluated instrument platforms for implementation in forensic use. Supervised one individual in the screening of serum samples for phenylbutazone and metabolites by HPLC, and reviewed data generated. Assisted in review of data prior to release. Prepared data reports for use in judicial hearings. Work was done in compliance with ISO 17025 standards.

Responsible for developing, validating and implementing LC/MS methods for use in GLP contract research. Developed methods for the identification and quantification of: steroids, synthetic peptides, natural peptides, drugs, natural products, pesticides and explosives from various matrices. Performed bench extractions using liquid/liquid and SPE methods. Performed routine analyses by GC/MS and ELISA. Performed structural elucidation by LC-MS/MS and GC/MS Involved in preparing data files for use by clients, as well as general laboratory work. Trained several individuals in the use of LC/MS. Joined the lab as a graduate student assistant in Fall, 1997; officially appointed September, 1998.

Responsible for presenting laboratory course lecture, grading of assignments and exams, and conducting small group discussion sessions. Work was partially concurrent with employment at the ATCL (see above

Laboratory of Wayne McCormack. Responsible for analysis of avian immunoglobulin genes by Northern Blot analysis and RT-PCR.

Laboratory of Dr. Alfred Lewin. Assisted with research into auto-catalytic RNA structures.