Senior Manager Clinical Scientist

Lindsey H. Millard, PhD,PSM

360-***-**** **********@*****.***

Bellingham, WA

EXECUTIVE SUMMARY

Highly motivated translational scientist with a PhD in pharmacology, a MS in professional science masters and a certification in project management for Biotechnology. Currently, I am working within the pharmaceutical industry within translational sciences. Gained an excellent foundation in clinical knowledge after 6 years in medical affairs. Went on to learn the impact of non-clinical, discovery and cross-functional collaborations. Worked in a variety of specialty disease states including, ophthalmology, Car-T, Pain, Oncology and anti-microbials. Over the last 8 years, I have focused my career working cross-functionally to deliver and translate scientific data to clinical development.

CORE COMPETENCIES

Early Phase studies

Regulatory Document writing & review

Safety Pharmacology Studies

Vendor Management

Sample Analysis Plans

Biomarker validation & analysis

Data Analysis

Clinical Study Document Review

PROFESSIONAL EXPERIENCE

Ensysce Biosciences La Jolla, CA Mar 2022-Current

Director of Translational Sciences

Manage translational sciences studies across 3 IND programs and on Pre-IND program:

Collaborate with team members to execute pre-IND projects

Assist in study design for PK/PD & MTD studies in both clinical and non-clinical studies

Work with external vendors to execute studies

Analyze interim PK & PD data using PK Solver

Communicate results to upper management

Support the review of study data to inform the next steps for dose selection

Review and contribution to regulatory documents, agency communications and scientific publications

Lead cross-functional program team meetings & server as the primary contact for all activities related to the studies

Maintain timelines for portfolio management

Communicate program scope, deliverables, timelines and any changes that may affect these

Bristol Myers Squibb Seattle, WA Jan 2021-Mar 2022

AD, Translational Medicine Planning & Execution Lead-Early development

Managed portfolio assets across 11 early and late phase global clinical studies for clinical biomarker, safety and exploratory translational data

Serve as the point of contact for the translational team across 11 studies

Work cross-functionally to align expectations, deliverables and data delivery timelines to target 4 sBLA filings

Served as an integrated translational medicine liaison & core team member to drive strategic and process initiatives

Created structure and processes to aid teams to visual program deliverables

Communicate company goals and objectives and track translational deliverables

Coordinate with publications team and translational scientists to align translational data across studies to create a publication plan

Provide regular updates to key stakeholders and senior management using Smartsheet trackers and dashboards

Identify issues and risk mitigation strategies for portfolio assets

Lead clinical data meetings, provide regular agendas and meeting minutes

Pharmolecular Seattle, WA 2017-2021

Translational Scientist

Filed 2 INDs with FDA acceptance

Identify and design assays to support biomarker analysis on clinical studies.

Work with external vendors and KOLs to identify mechanism of action studies

Directly manage non-clinical in vivo pharmacokinetic (PK) studies from vendor contracts to final study reports

Directly design and manage IND enabling Toxicology (TK) and safety pharmacology studies

Oversee the method development and validation of analytical methods

Assist in the execution, running and closeout of a phase 1 clinical PK SAD study

Implement PK assessments in collaboration with the clinical team and external vendors in early phase clinical studies.

Review of clinical documents such as protocols, ICFs and data management plans

Direct development of site initiation slides and protocol development

Directly managing ongoing activities in a phase 1 clinical study

Track study progress across non-clinical studies

Manage contracts with external vendors

Track data deliverables

Coordinate meetings, provide agendas and meeting minutes

CTI Biopharma Seattle, WA 2014-2017

Senior Clinical Pharmacologist & Translational Scientist

Assist in the development, execution and management of nonclinical pharmacology and toxicology studies

Identify vendors to complete non-clinical studies

Manage non-clinical metabolism and transporter studies

Assist in the preparation of non-clinical toxicology and pharmacology EMA and FDA submissions

Review, analyze and present non-clinical data

Assist in the protocol design, study implementation and study report generation of 8 phase 1 clinical pharmacology studies

Work cross functionally to manage pharmacology components of 2 phase 3 clinical studies

Assist in the design and implementation of an ongoing pediatric PK study

Review and analyze clinical pharmacology and clinical pharmacokinetic/pharmacodynamic data

Review abstracts and papers for publication and present relevant clinical and non-clinical findings at key scientific meetings

Manage a phase III study collaboration with key investors by organizing meetings, providing agendas and tracking decisions

Provide functional area budget proposals and assist in budget planning and execution

Acucela Seattle, WA 2011-2014

Clinical Scientist

Non-clinical:

Implement a whole-eye organ perfusion system in the non-clinical lab

Supervise 3 biologists to develop, run, and maintain an organ ocular perfusion assay to screen for drug candidates

Prepare and present pre-clinical data at internal and external meetings

Clinical:

Provide a monthly company-wide newsletter identifying potential drug targets, new MOAs and indications, recent publications

of interest, regulatory intelligence and as well as a competitive landscape overview

Assist in the review of ongoing study data including adverse events, primary efficacy variables and safety endpoints

Assist in the development of NDA submission documents and clinical study reports

Support clinical leads to prepare key pharmacology protocols and study reports

Maintain cross-functional collaborations with internal teams providing scientific expertise

Participate in and assist with preparation for key advisory board meetings

Prepare and present clinical data at internal and external meetings

Ventana Medical Systems Tucson, AZ 2004-2006

Technical Marketing Representative/Field based: NACO (Sales Department)

Present Ventana instrumentation (automated immunostainer and VIAS image analysis microscope) to clients

Install and validate Ventana instrumentation in clinical histology laboratories

Train key personal on current software, instrument usage, and maintenance

Validate antibodies for immunohistochemical staining assays

Troubleshoot staining problems (non-specific staining, inconsistencies, etc)

Repair any mechanical problems with the field instrumentation

Design marketing postcard for the American Society of Clinical Oncology (ASCO) conference

Aid in creating a booth for Ventana Medical Systems at the annual ASCO conference

Scientist: Pharmaservices (now TDX; Research Department)

Participate in Individual Project Agreements with clients

Work with major pharmaceutical companies to validate possible target proteins to bring novel diagnostics to clinical trials

Validate 3rd party antibodies and developed assays on Ventana instrumentation

Stain, analyze, and quantify tissue biopsies with pathologists

Write validation reports for clients with graphed data describing the efficacy of their potential drug targets

ADDITIONAL PROFESSIONAL EXPERIENCE

University of Washington Institutional Review Board (IRB) member -2 yrs

Obstetric-Fetal Pharmacology Research Associate: College of Pharmacy/Pharmaceutics – 1 yr

Laboratory Manager for Glaucoma Research – 1 yr

EDUCATION

Doctorate Degree in Medical Pharmacology – University of Arizona (2006-2010)

Professional Science Master’s in Applied Business – University of Arizona (2006-2009)

Bachelors of Science in Biochemistry and Molecular Biophysics –University of Arizona (2001-2004)

Certificate in Biotechnology Project management –University of Washington/UC San Diego (2017)

PUBLICATIONS

Published Manuscripts

L. Millard, D. Woodward, D. Stamer. The Role of the Prostaglandin EP4 Receptor in Regulation of Human Outflow Facility. Invest. Ophthalmol. Vis. Sci. 52 (6) 2011 (3506-3513).

E. Hoffman, K. Perkumas, L. Highstrom and W. Stamer. Regulation of Myocilin-Associated Exosome Release from Human Trabecular Meshwork Cells. Invest. Ophthalmol. Vis. Sci. 50 (3) 2009 (1313-1318).

C. Kremer, R. Klein, J. Mendelson, W. Brown, L. Samadzedeh, K. Vanpatten, L. Highstrom, G. Pestano, R. Nagle. Expression of mTOR Signaling Pathway Markers in Prostate Cancer Progression. Prostate. 66 (11) 2006 (1203-1212).

L. Samadzadeh, L. Highstrom, K.Vanpatten, E. Hughes Jr., R. Nagle, T. Grogan, P. Beresford, G. Pestano. Molecular Profiling of Solid Tumor Shows Conserved Biomarker Expression in the VEGF and EGF Signaling Pathways. J. Mol. Diag. 7 (5) 2005.

Published Abstracts

Suliman Al-Fayoumi, Sherri Amberg, Huafeng Zhou, Lindsey Millard, Jack W. Singer, James P. Dean. Cardiac Safety and Pharmacokinetics of Pacritinib: A Phase 1, Randomized, Active- and Placebo-Controlled, 3-Way Crossover Study. ACCP 2016

Suliman Al-Fayoumi, Sherri Amberg, Huafeng Zhou, Lindsey Millard, Jack W. Singer, James P. Dean. Investigation of Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Pacritinib in Healthy Subjects: A Phase 1 Study. AACR 2016.

Suliman Al-Fayoumi, Sherri Amberg, Huafeng Zhou, Lindsey Millard, Jack W. Singer, Mary Campbell. Two phase 1 clinical studies evaluating the effects of the CYP3A4 inhibitor clarithromycin and the CYP3A4 inducer rifampin on systemic exposure to pacritinib in healthy volunteers. EPHAR 2016.

Suliman Al-Fayoumi, Sherri Amberg, Huafeng Zhou, Lindsey Millard, Jack W. Singer, Mary Campbell. A Phase 1 Open Label Study to Dtermine the Pharmacokinetics of Pacritinib in Patients with Mild to Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared with Healthy Subjects. EHA 2016.

L. Millard, A. Pashko, C. Bavik, R. Kubota. Prostaglandin EP4 Increases Outflow Facility in Calf Eyes Using a Whole Eye Organ perfusion (WEOP) Model. ARVO 2014.

L. Millard, D.Woodward, and W.Stamer. Prostaglandin EP4 Receptor Activation Increases Outflow Facility in Perfused Human Eyes. Invest. Ophthalmol. Vis. Sci. 2010 51: E-Abstract 151.

L. Highstrom, D. Woodward, and W. Stamer. Characterization of Prostaglandin EP4 Receptors in Human Conventional Outflow Cells. Invest. Ophthalmol. Vis. Sci. 2009 50: E-Abstract 809.

L. Samadzadeh, L. Highstrom, G. Brunson, K. Vanpatten, E. Hughes, R. Nagle, T. Grogan, P. Beresford, and G. Pestano. Molecular pathologic identification of highly conserved VEGF and ECF responsive biomarkers in solid tumors. AACR Meeting Abstracts, 2005: 1155.

L. Highstrom, K. Vanpatten, L. Pestano, L. Samadzadeh, E. Hughes, G. Stella, P. Beresford, T. Grogan, R. Nagle and G. Pestano.Molecular Pathologic Diagnosis of the mTOR signaling Pathway Under Hypoxic Conditions. National Society of Histology (NSH) 2005.

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