Tracy Cole Email & Phone Number

Carlsbad, California, United States

A highly experienced strategic operator offering premier consulting services for multiple pharmaceutical and biopharma companies across the United States. Provides scientific leadership and expertise across diverse teams and functions from early discovery, target ID, and validation through early translation of First In Human (FIH) studies in the RNA therapeutic space.• Offers multiple types of consulting predicated on client goals, needs and objectives:o Audit of data.o Subject Matter expert to identify and evaluate issues to provide solutions.o Transfer knowledge to internal stakeholders to develop trust, engagement and sustainability of programs.o Facilitator of contract relationships.

Expanded role includes: Reporting directly to the CEO. Responsibility for hiring and management of scientific team of 7. Contribution of scientific and ASO platform expertise to individual case submission in-depth assessments. Creation and execution of milestone-based research-directed proposals. Management of research conducted with external collaborators, physicians, and CROs.

Leads research and development to identify personalized medicines using an antisense oligonucleotide (ASO) drug discovery platform for nano-rare nof1 diseases. Responsible for researching, recommending, and implementing data-driven efficiencies. Supports development of infrastructure. Assures regulatory requirements in research and development are met. Partners with project management to drive efficiencies in meeting milestones within individual programs. Manages case submission and external communication ensuring patient centricity throughout the process.

Leads several internal preclinical efforts to advance AAV gene therapy-based drug discovery programs for severe and rare diseases including local administration programs. Identifies and manages CDMOs/CROs virtually to conduct experiments for identified targets and diseases. Manages 1 PhD scientist to enable internal viral vector synthesis. Coordinates cross-functionally with various internal groups.

Carlsbad, California

Lead a team in major neuroscience program with $1B 10-year Biogen partnership, performing preclinical research for treatment of neurodegenerative diseases with antisense oligonucleotides. Oversee design, development, and execution of in vitro and in vivo work, coordinate with clinical, regulatory, legal, business development, and translational medicine groups. Directly manage a group of 3, including PhD level, in developing lean and strategic drug discovery plans with timelines involving in vitro and in vivo work. Write preclinical Investigational New Drug (IND) pharmacology reports. • Identified and advanced 3 compounds from exploratory research to FIH clinical studies.• Contributed to 7 patents by generating and obtaining exclusive rights to ASOs targeted to regions of 7 different genes. • Lead efforts to validate gene targets for Parkinson’s disease, Alzheimer’s disease (AD), and Spinocerebellar ataxias by generating strategic plans for drug development and managing 10+ cross-functional collaborators. • Develop external collaborations with many academic labs that contribute to in vivo proof of concept work as part of the target validation process. Publish findings in high-impact journals.• Ensure on-time delivery of multiple concurrent projects in various phases of drug development, consistent with personal and company objectives.• Interpret, summarize, and present research findings at internal and external scientific meetings.• Drive increased value for portfolio execution by proactively identifying and piloting emerging technical approaches for antisense oligonucleotides and providing team training.• Evaluate potential for therapeutic benefit by performing a wide array of in vivo techniques evaluating antisense oligonucleotide efficacy and tolerability.• Develop technical expertise and leadership potential of team members by identifying and developing individual strengths and maintaining high performance standards.

Carlsbad, California

Carlsbad, California

Irvine, Ca

Oversaw 8 undergraduate students and taught upper-level undergraduate neuroscience lab course. Studied the role of complement cascade in Alzheimer’s disease (AD). Directed animal lab work (injections, surgeries, brain extractions) and trained lab members on in vivo techniques and equipment. • Developed strong understanding of immune system and its relationship to AD through in-depth study of glial involvement in AD, with a focus on the complement cascade. • Developed SOPs for analysis of behavior data and use of behavior-specific software, as well as optimized ELISA, Western blot, and complement cascade assay protocols.• Assisted in writing a patent, IACUC protocols, and progress reports for grants, presented posters at meetings, and gave oral presentations at Society for Neuroscience annual meeting.

San Francisco, California

Berkeley, California

Doctor Of Philosophy - Phd, Neurobiology And Behavior

Bachelor Of Arts (B.A.), Biology, General