Jennifer L. Daily
New York,NY
Summary
Professional leader with executive experience ready to drive impactful change. Proven ability to implement strategic initiatives and enhance operational performance. Valued for collaborative team leadership and adaptability to evolving business needs. Highly motivated neuroscientist with extensive experience working in academic pre-clinical research labs as well as the clinical research and drug development sector of industry. Results-oriented individual with an accomplished publication record who consistently meets deadlines and builds professional relationships with industry leaders in both pre-clinical and clinical fields. Experience driving multiple programs from preclinical stage through IND approval. Candidate thrives in high-pressure professional environments and has significant experience in both the development and management of research projects. Expertise in gene therapy and the emerging clinical trial space, with a specialty in gene therapy for rare disorders. Respected member of the largest Angelman syndrome non-profit advocacy group for over 13 years with extensive experience working with patients, caregivers, and KOLs to support the patient experience in drug development.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Vice President, Preclinical Development
ModuLight.bio
08.2022 - Current
- Synopsis: ModuLight.bio is developing a novel optogenetic platform for the treatment of CNS indications such as epilepsy and Parkinson’s disease. Responsible for leading the gene therapy aspect of the program development, such as the IND-enabling pharmacology and toxicology studies, regulatory interactions, and manufacturing.
- Skills:
- Identify and evaluate potential manufacturers for research grade AAV material, process development, and GMP material
- Lead preclinical studies to evaluate the efficacy of product in target indications, including the study design, management, and analysis
- Lead regulatory interactions, including authoring relevant documents and liaising with agency personnel
- Oversee and manage vendors performing preclinical studies
- Identify and evaluate potential CROs for clinical development and operations
Executive Director, Preclinical Development
Neurogene Inc.
01.2020 - 07.2022
- Synopsis: Reporting directly to the CSO, I am leading the preclinical programs, including all efficacy and pharmacology studies, as well as safety and toxicology studies to support first-in-human trials with novel gene therapy products in the Neurogene pipeline. I manage the preclinical team who are supporting the IND enabling studies as well as early discovery proof-of-concept studies to further expand the company’s portfolio.
- Skills:
- Manage a team responsible for completing IND-enabling pharmacology studies and evaluation of novels constructs
- Represent the company during regulatory interactions to present and discuss the preclinical programs
- Manage and coordinate numerous preclinical vendors to support pharmacology and toxicology studies
- Coordinate cross-functional workflows to ensure that preclinical studies are supportive of clinical plans and aligned with manufacturing timelines
Sr. Director of Preclinical Development
Prevail Therapeutics
08.2019 - 01.2020
- Synopsis: As the Sr. Director of Preclinical Development, I led the toxicology program and oversaw the completion of safety studies to support first-in-human trials with gene therapy pipeline products for multiple indications. I was also responsible for authoring all the safety summaries for FDA-ready documents, clinical documents, and communications with outside parties. I represented Prevail during interactions with the FDA when discussing the toxicology program and data. Because the toxicology program is very dependent on data from the preclinical studies, I worked with the scientists to develop informative preclinical efficacy studies and assisted with data review to ensure meaningful readouts.
- Skills:
- Lead the toxicology program for all pipeline products, including designing studies, managing CROs and vendors, and reviewing/authoring study reports
- Effectively work with a cross-functional team (e.g. preclinical, manufacturing, clinical, etc.) to ensure that safety studies are representative of the efficacy work and support the initiation of a clinical trial with patients
- Guide the bioanalytical plan for the evaluation of toxicology samples to determine transduction and expression in nonclinical models
- Author the toxicology sections for pre-IND and IND meetings with the FDA
- Create presentations detailing the safety data for board meetings and investor meetings
- Manage and coordinate global vendors to facilitate nonhuman primate studies, sample testing and analysis, and report completion
- Effectively present study data to governance in weekly project meetings and frequent ad hoc meetings with the CEO and COO
- Manage and oversee an annual budget of approximately $10 million, including completion of SOWs, reviewing invoices, providing prospective budgets
- Communicate with regulatory experts in gene therapy to ensure effective study designs consistent with FDA expectations and requirements
- Expertise in guidelines and requirements for GLP toxicology studies to support FDA submissions
Director of Research
Agilis Biotherapeutics
09.2017 - 06.2018
- Synopsis: As the Director of Research, I was co-leading the pre-clinical research for multiple gene therapy programs at Agilis, including Friedreich ataxia (FA) and Angelman syndrome (AS). I was responsible for managing and overseeing the collaboration with outside academic partners and ensuring that all timelines were met as required in the completion of the pre-clinical work leading to the development and initiation of clinical trials.
- Skills:
- Manage and oversee the collaboration with outside academic partners and vendors
- Lead the design and development of pre-clinical studies to support and inform the clinical program for Angelman syndrome; co-lead the preclinical program for Friedreich ataxia
- Design and oversee the completion of the IND-enabling toxicology studies in both rodents and nonhuman primates
- Cultivate relationships with KOLs and families in the AS and FA fields
- Collaborate closely with families and researchers in AS to identify and optimize appropriate outcome assessments for a clinical trial
- Create and present Powerpoint presentations at board meetings, scientific conferences, and investor meetings
Clinical Scientist
Ovid Therapeutics
03.2017 - 09.2017
- Synopsis: As a clinical scientist at Ovid Therapeutics, I was co-leading the design, development, and implementation of a phase 2 clinical trial of OV101 in individuals with fragile X syndrome. My responsibilities included reviewing pre-clinical data both independently and with the pre-clinical biology team to ensure all current information was incorporated appropriately into the design and development of the OV101 FXS trial, literature review of previous trials and qualitative assessments, and engagement of vendors to assist with study operational aspects. In addition, I performed an in-depth analysis of previous FXS clinical trials and the outcome measures utilized to better understand and address the drivers and barriers to a clinical trial in this indication. I worked closely with regulatory to better understand the FDA process for drug studies and labeling requirements, and to ensure that timelines were met in preparation for FDA meetings.
- Skills:
- Co-lead preliminary meetings with key stakeholders to identify issues with previous FXS trials and strategize ways to improve OV101 FXS study
- Co-lead face-to-face meetings with KOLs to review protocol synopsis draft and proposed strategies and outcome measures for OV101 FXS study
- Work closely with parents and caregivers of individuals with FXS to identify challenges of previous FXS trials, parent expectations for future studies, and strategies to address gaps in previous studies
- Cultivate relationships with KOLs and families in the FXS community to build trust and respect as an individual in the FXS field and overall with Ovid
- Manage and oversee the completion of CDAs and contracts with key stakeholders and outside vendors
- Effectively collaborate with cross-functional teams (e.g. Legal, Regulatory, Clinical Operations) to ensure efficient development and implementation of study protocol
- Manage relationships with external vendors to ensure deliverables are completed within the agreed upon timeframe and within budget
- Oversee the adaptation of assessment scales, such as the CGI, for use in individuals with FXS by external vendors and relaying pertinent information obtained from discussions with KOLs
Clinical Research Associate
Medpace, Inc.
06.2014 - 03.2017
- Synopsis: As a CRA, my role was to monitor clinical trial data and assist with study-start-up processes. I have experience with trials across various fields, including oncology, cardiology, and neuroscience, that are in Phase I-III of clinical development. It was my responsibility to ensure sites were trained properly and conducting the studies appropriately per protocol and regulatory guidelines. As Lead CRA on multiple oncology studies, I was responsible for generating the site materials used by CRAs, ensuring the CRA team receives study training, ensuring site issues are addressed and resolved, and acting as a liaison between the CRAs and sponsor.
- Skills:
- Lead meetings with both internal study personnel as well as external sponsor personnel regarding study status and data management
- Managed 10+ clinical trial sites across 3-4 different clinical trials in varying indications in cardiology, neurology, and oncology
- Proficiency with clinical trial regulatory guidelines, such as Good Clinical Practices and Good Laboratory Practices
- Experience managing clinical trial sites, including ensuring recruitment goals are met, study personnel are adequately trained, and studies are completed according to the protocol requirements
- Developing and maintaining professional relationships with principle investigators at the sites, coordinators, and the sponsor company study team
- Maintain professional and appropriate communication with the study teams at the sponsor pharmaceutical companies
- Oversee the generation of site study materials that were used by CRAs and ensure both internal and external study personnel were trained with the material
- Managed responsibilities as Lead CRA, and assisted the other CRAs on the study team with development of monitoring tools, assistance with co-monitoring, and answering study-related questions
Postdoctoral Research Fellow
Cincinnati Children’s Hospital
10.2012 - 06.2014
- Synopsis: While completing my postdoctoral training, my main focus was continuing my work in Angelman syndrome (AS) and developing a research program at the hospital that was focused on furthering the work in this field. I examined potential mechanisms for activating a gene that is typically silenced in the brain due to imprinting in an effort to rectify the symptoms characteristic of AS. In addition, I was working in collaboration with other faculty at the hospital to develop a clinical trial to better understand language acquisition and processing in children with AS using neuroimaging techniques. Although I am no longer at Children’s, I have maintained the professional relationships previously developed and continue to assist with the development and implementation of a neuroimaging clinical trial in children with AS.
- Skills:
- Mentoring graduate students, undergraduates, and lab volunteers
- Developing original research projects and implementing them independently
- Grant writing and submission, including the generation of budget proposals
- Forming and maintaining collaborations with other experts in the field, as well as seeking out connections in novel fields that were beneficial to my project goals
- Mouse colony maintenance, including genotyping and breeding paradigms, and behavioral testing
- Experience with FDA-approved pharmaceutical testing for off-label use
Ph.D. Candidate
University of South Florida
08.2007 - 09.2012
- Synopsis: The main goal of the lab was to investigate the underlying mechanisms of learning and memory, with an emphasis on the role of UBE3A. Varying methods of increasing Ube3a protein in the AS mouse brain were investigated, such as hippocampal drug screenings with pharmacological agents, in vivo electroporation of UBE3A plasmid, and viral-conjugated UBE3A vectors injected directly into the brain. For my thesis, I examined the potential of using a viral vector to rescue the phenotype of an AS mouse. The main focus of my project was conjugating an exogenous UBE3A gene to an adeno-associated viral vector. The recombinant gene was injected directly into the hippocampus of adult AS mice. Behavior testing and electrophysiology were used to determine improvements in hippocampal-dependent learning. In addition to recovering the cognitive deficits by specifically targeting the hippocampus, I examined the potential to recover the motor coordination defect by administering the recombinant gene early in development to achieve a more widespread transduction. I also examined the potential to use a TAT peptide-conjugated Ube3a protein for non-invasive systemic administration.
- Skills:
- Independently developed and implemented original research projects
- Generated and submitted publication-quality manuscripts for peer review
- Mentored and trained undergraduate students and new graduate students joining the lab
- Spearheaded the testing and analysis of FDA-approved drugs for off-label usage for the treatment of Angelman syndrome
- Oversaw the use of a small-molecule compound library for the investigation of novel drug products, including optimizing high-throughput screening techniques
- Proficiency with DNA cloning and adeno-associated virus production and purification for novel viral-mediated gene therapy treatment in an AS mouse model
- Independently researched and coordinated with experts in the field to implement in vivo bilateral electroporation of mouse hippocampus to investigate novel drug delivery systems targeting the CNS
- Rodent behavior testing: open field, elevated plus maze, rotorod, Morris water maze, radial arm water maze, fear conditioning
- Data collection and analysis, and data presentation with manuscript development and presentations at scientific conferences
- Developing collaborations with leading experts in the field of AS genetics, gene therapy, and cognitive behavioral analysis
- Knowledge of federal and internal research policies, regulations and guidelines.
Education
Ph.D. - Neuroscience
University of South Florida
Tampa, FLB.S. - Biology
University of South Florida
Tampa, FLSkills
- Regulatory agencies guidelines and expectations
- Drug development pathway from bench to clinic
- Decision-making
- Critical thinking
- Team leadership
- Coaching and mentoring
- Complex problem-solving
- KOL relationship building
- Strategic planning
- Business development
- Results-driven
- Training and mentoring
- Presentations
- Data analysis
- Corporate communications and board presentations
- Public speaking at industry conferences
Certification
Patent Application No. JP2017-556744; Modified UBE3A Gene for a Gene Therapy Approach for Angelman Syndrome
Affiliations
- Foundation for Angelman Syndrome Therapeutics (2008-Current)
- Angelman Syndrome Alliance of Greater Cincinnati (2012-Current)
- Current Position: Vice President
- Society for Neuroscience (2007-2014)
- American Association for Laboratory Animal Science (2006-2008)
Publications
- JL Daily, AG Smith, EJ Weeber (2012). “Spatial and Temporal Silencing of the Human Maternal UBE3A gene.” Eur J Pediatr Neuro 16(6): 587-591.
- JL Daily, K Nash, J Jinwal, T Golde, J Rogers, MM Peters, RD Burdine, C Dickey, JL Banko, EJ Weeber (2011). “Adeno-associated virus-mediated rescue of the cognitive defects in a mouse model for Angelman syndrome.” PLoS ONE 6(12): e27221.
- RM Gustin, TJ Bichell, M Bubser, JL Daily, I Filonova, D Mrelashvili, AY Deutch, RJ Colbran, EJ Weeber, KF Haas (2010). “Tissue-specific variation of Ube3a protein expression in rodents and in a mouse model of Angelman syndrome.” Neurobiology of Disease 39(3): 283-291.
- S Garbuzova-Davis, SJ Gografe, CD Sanberg, AE Willing, S Saporta, DF Cameron, T Desjarlasi, JL Daily, N Kuzmin-Nichols, W Chamizo, SK Klasko, PR Sanberg. “Maternal transplantation of human umbilical cord blood cells provides prenatal therapy in Sanfilippo type B mouse model”. FASEB J 20(3): 485-487.
Timeline
Vice President, Preclinical Development
ModuLight.bio
08.2022 - Current
Executive Director, Preclinical Development
Neurogene Inc.
01.2020 - 07.2022
Sr. Director of Preclinical Development
Prevail Therapeutics
08.2019 - 01.2020
Director of Research
Agilis Biotherapeutics
09.2017 - 06.2018
Clinical Scientist
Ovid Therapeutics
03.2017 - 09.2017
Clinical Research Associate
Medpace, Inc.
06.2014 - 03.2017
Postdoctoral Research Fellow
Cincinnati Children’s Hospital
10.2012 - 06.2014
Ph.D. Candidate
University of South Florida
08.2007 - 09.2012
B.S. - Biology
University of South Florida
Ph.D. - Neuroscience
University of South Florida
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