Shimon Francis, Ph.D, PMP
Revere,Massachusetts
Summary
Accomplished Director at Akouos/Lilly with a strong focus on advanced gene therapy applications and proven leadership capabilities. Successfully led projects and initiatives that doubled data delivery bandwidth and contributed to a strategic acquisition exceeding $500 million. Demonstrated expertise in cross-functional collaboration and predictive project management, enhancing nonclinical studies, IND submissions, and clinical trial initiations. Career aspirations include further driving innovation in gene therapy and drug development to improve patient outcomes.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Advisor
ClearVision Therapeutics, Inc
Boston, Massachusetts
11.2024 - Current
- Proposed investment solutions based on a thorough understanding of the client's objectives.
- Drafted presentations outlining the advantages of specific investment vehicles.
- Researched current market trends and economic conditions to provide accurate advice.
- Developed strategies and study designs for preclinical in vitro and in vivo studies
Director
Akouos/Lilly
Boston, MA
12.2023 - 06.2024
- Led the program management of a potential gene therapy candidate, affecting hearing and vision
- Directed and managed projects to expand in vivo Histology and Necropsy Team spaces, capabilities, and efficiencies to double bandwidth for accelerated data delivery
- Established collaborative efforts with Lilly Genetic Medicine and Lilly Research Laboratories to evaluate alternative routes of CNS gene therapy administration in NHP, and custom antibody development for molecular detection of potential pipeline candidates
- Planned, directed, and managed several competing nonclinical in vivo studies and projects, in rodents and NHP, to develop gene-based therapies to preserve, restore, or improve hearing in people affected with monogenic or oncologic-induced hearing loss
- Directed, managed, and trained a diverse group of ten Scientists/Associate Scientists in the preparation and delivery of high-quality pharmacokinetic and pharmacodynamic (PK/PD) analysis of targeted gene delivery to meet Company timelines, advance portfolio, and achieve organizational strategic goals
- Designed study protocols for, and managed NHP studies at Contract Research Organizations (CROs), for non-GLP platform and pipeline studies
- Authored and reviewed study designs, protocols, and reports to support nonclinical documentation for pre-IND and IND submissions
- Developed and directed development of innovative high-throughput methods to produce and analyze high quality PK/PD data of AAV gene therapy expression and physiologic function, leveraging computational analysis and machine learning
- Managed the evaluation, analysis, summary, and communication of nonclinical study data to advance candidate selection and progress Company portfolio; and served as functional area lead and pre-clinical subject matter expert
Associate Director
Akouos
Boston, MA
05.2021 - 12.2023
- Company Overview: $500 million+ acquisition by Lilly
- Managed and directed In vivo Team activities to advance nonclinical studies for the development of novel gene therapies for hearing loss
- Directed the administration of gene products and gene therapies to NHPs in non-GLP studies at CROs
- Established innovative techniques for the PK/PD evaluation of gene therapies in mouse, large animal, and NHP tissues, in addition to developing SOPs and work instructions for training these techniques
- Developed study designs and study protocols to evaluate efficacy and tolerability of potential gene therapies in rodent and NHP models
- Coordinated cross-functional communication between Molecular, Physiologic, and Translational Teams to advance pre-IND and IND-enabling studies
- Authored and reviewed summary and study reports for Investigator’s Brochures (IBs), to advance pre-IND and IND submissions
- $500 million+ acquisition by Lilly
Senior Scientist II
Akouos
Boston, MA
11.2019 - 05.2021
- Developed unconventional techniques and protocols for the histologic preparation of mouse, large animal, and NHP inner ear tissues for the development of gene therapies to treat hearing loss
- Managed and trained Histology and Necropsy Team personnel in the collection and preparation of mouse, large animal, and NHP tissues for non-GLP and GLP studies
- Developed a histology and microscopy core to produce detailed images for the advancement of pre-IND and IND-enabling studies
- Established and managed the creation of a compendium for gene therapy in the inner ear to advance competitive intelligence
- Authored and reviewed protocols, SOPs, work instructions, training documents, and technical reports
Senior Scientist I
Akouos
Boston, MA
05.2018 - 11.2019
- Developed and evaluated techniques and medical devices for the administration and characterization of novel gene products to mouse, large animal, and NHP inner ears, in early nonclinical studies for the development of gene therapies to treat hearing loss
- Responsible for in vivo data collection of AAV gene therapy biomarkers and analysis for pre-IND-enabling nonclinical studies
- Responsible for the presentation and communication of data (internally and externally) to advance Executive Committee goals and timelines
Postdoctoral Fellow
NIDCD, NIH
Bethesda, MD
04.2015 - 05.2018
- Planned and performed translational studies for the prevention of antibiotic and chemotherapeutic drug-induced hearing loss, using non-traditional delivery methods (exosomes)
- Developed novel in vivo and ex-vivo techniques to explore the toxicologic cellular and molecular mechanisms of ototoxic drug-mediated hearing loss
- Responsible for training and mentoring students and fellows in molecular and histologic techniques, data analysis, and presentation
- Reviewed manuscripts as a part of the peer-review process
Postdoctoral Fellow
University of Virginia
Charlottesville, VA
05.2011 - 04.2015
- Developed and managed a cross-functional project to develop the first CRISPR mouse model at the University of Virginia
- Characterized the physiologic function and cellular/molecular phenotype for a novel CRISPR-mediated KO mouse
- Leveraged cutting edge molecular and genetic technologies to develop novel methods to study protein function and characterize genetic and toxicologic disease models associated with hearing loss
Education
Ph.D. - Pathology
Medical University of South Carolina
01.2011
B.S. - Biology, Anthropology
College of Charleston
01.2005
Skills
- Effective Team Leadership
- Predictive Project Management
- Adaptive Project Management
- PMP Best Practices
- Biotechnology Life Cycle
- Advanced Gene Therapy Applications
- Drug Development Expertise
- Non-GLP and GLP Study Management
- IND-supporting Documentation
- Understanding FDA Guidelines
- Knowledge of ICH Regulations
- Clinical Trials
- Translational Research
- Cross-functional Collaboration
- Data Reliability
- Data Integrity
- Effective Team Collaboration
- Inquisitive Mindset
- Analytical Problem Solving
- Professional Development/Mentorship
- Effective Communication
- Experimental Excellence
- Proficient in Cellular Biology
- Advanced Molecular Biology Techniques
- Histological Technique Proficiency
- Advanced Microscopy
Certification
- Project Management Professional Certification, 2024-2027
- Project Management Institute, 2024-2025
- Duke University, Office of Regulatory Affairs and Quality Training Program, 2024
- American Society for Gene & Cell Therapy, 2019-2024
- Association for Research in Otolaryngology, 2006-2024
- Wharton University of Pennsylvania, Leadership in the 21st Century Course, 2019
- Massachusetts Biotechnology Education Foundation, Transitioning to Leader Course, 2019
- NIDCD Fellows Committee, Co-Chair, 2017
- NIDCD Fellows Committee, Vice-President, 2016
- NIDCD Fellows Committee, Co-Chair Trainee Talk Committee, 2015-2016
- Association for Research in Otolaryngology Postdoctoral Fellow Travel Award, 2014
- Association for Research in Otolaryngology Postdoctoral Fellow Travel Award, 2013
- Medical University of South Carolina, Department of Pathology and Laboratory Medicine Seminar Series, 2nd Place Award, 2010
- Individual NRSA Pre-Doctoral Fellowship, Celastrol as a Co-Therapy for Inhibition of Aminoglycoside-Induced Ototoxicity (1 F31 DC010559-01), awarded by NIDCD, sponsored by Lisa Cunningham, 2009
Publications
- Protein synthesis inhibition contributes to cisplatin ototoxicity, Front Cell Neurosci., 09/27/17, 29033791
- Non-Autonomous Cellular Responses to Hair Cell Stress and Death, Front Cell Neurosci., 08/23/17, 28878625
- A short splice form of Xin actin-binding repeat containing 2 (XIRP2) lacking the Xin repeats is required for maintenance of stereocilia morphology and hearing function, J Neurosci., 02/04/15, 25653358
- Heat Shock Protein-Mediated Protection Against Cisplatin-Induced Hair Cell Death, J Assoc Res Otolaryngol., 09/27/14, 25261194
- Inner ear supporting cells protect hair cells by secreting HSP70, J Clin Invest., 08/01/13, 23863716
- A novel role of cytosolic protein synthesis inhibition in aminoglycoside ototoxicity, J Neurosci., 02/13/13, 23407963
- Celastrol Inhibits Aminoglycoside-Induced Ototoxicity via Heat Shock Protein 32 (HSP32), Cell Death Dis., 08/25/11, 21866174
- Ablation of mixed lineage kinase 3 (Mlk3) does not inhibit ototoxicity induced by acoustic trauma or aminoglycoside exposure, Hear Res., 12/01/10, 20971179
- Identification of FDA-Approved Drugs and Bioactives that Protect Hair Cells in the Zebrafish (Danio rerio) Lateral Line and Mouse (Mus musculus) Utricle, J Assoc Res Otolaryngol., 06/01/09, 19241104
- Neural Protection for a New Generation of Cochlear Implants?, Audiology Today., 09/01/08
- Mysteries of Hair Cell Mechanotransduction, Audiology Today., 03/01/08
- Antioxidants: Can They Scavenge Hearing, Audiology Today., 01/01/07
Presentations
- Demonstration of Durable Anti-VEGF Protein Expression and Otic Tolerability following Intracochlear Delivery of AK-AntiVEGF (AAVAnc80-AntiVEGF Vector) Across Multiple Doses in Non-Human Primates, Association for Research in Otolaryngology 2023 Midwinter Meeting Podium Presentation, https://akouos.com/wp-content/uploads/2023/02/Demonstration-of-Durable-Anti-VEGF-Protein-Expression-and-Otic-Tolerability-Following-Intracochlear-Delivery.pdf
- Preclinical Development of a Genetic Medicine for Otoferlin Gene-Mediated Hearing Loss: AK-OTOF, Association for Research in Otolaryngology 2023 Midwinter Meeting Podium Presentation, https://akouos.com/wp-content/uploads/2023/02/Preclinical-Development-of-a-Genetic-Medicine-for-Otoferlin-Gene-mediated-Hearing-Loss-AK-OTOF.pdf
Timeline
Advisor
ClearVision Therapeutics, Inc
11.2024 - Current
Director
Akouos/Lilly
12.2023 - 06.2024
Associate Director
Akouos
05.2021 - 12.2023
Senior Scientist II
Akouos
11.2019 - 05.2021
Senior Scientist I
Akouos
05.2018 - 11.2019
Postdoctoral Fellow
NIDCD, NIH
04.2015 - 05.2018
Postdoctoral Fellow
University of Virginia
05.2011 - 04.2015
- Project Management Professional Certification, 2024-2027
- Project Management Institute, 2024-2025
- Duke University, Office of Regulatory Affairs and Quality Training Program, 2024
- American Society for Gene & Cell Therapy, 2019-2024
- Association for Research in Otolaryngology, 2006-2024
- Wharton University of Pennsylvania, Leadership in the 21st Century Course, 2019
- Massachusetts Biotechnology Education Foundation, Transitioning to Leader Course, 2019
- NIDCD Fellows Committee, Co-Chair, 2017
- NIDCD Fellows Committee, Vice-President, 2016
- NIDCD Fellows Committee, Co-Chair Trainee Talk Committee, 2015-2016
- Association for Research in Otolaryngology Postdoctoral Fellow Travel Award, 2014
- Association for Research in Otolaryngology Postdoctoral Fellow Travel Award, 2013
- Medical University of South Carolina, Department of Pathology and Laboratory Medicine Seminar Series, 2nd Place Award, 2010
- Individual NRSA Pre-Doctoral Fellowship, Celastrol as a Co-Therapy for Inhibition of Aminoglycoside-Induced Ototoxicity (1 F31 DC010559-01), awarded by NIDCD, sponsored by Lisa Cunningham, 2009
Ph.D. - Pathology
Medical University of South Carolina
B.S. - Biology, Anthropology
College of Charleston
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