Moya Daniels
San Diego,CA
Summary
Dynamic leader with a proven track record at Osiris Therapeutics, Inc., adept in biotechnology and regulatory strategic planning. Spearheaded groundbreaking approvals and fostered global partnerships, showcasing exceptional strategic thinking and cross-functional team management. Renowned for advancing regulatory compliance and driving innovative product development strategies.
Overview
38
38
years of professional experience
1
1
Certification
Work History
Board Member
Alliance for Regenerative Medicine Board of Directors
Rockville, MD
10.2023 - Current
- Responsible for collaborating with industry leading experts in the field of Cell, Gene Therapy and Tissue Repair for the development and enhancement of innovative technologies
- Serve on the CMC Regulatory Committee to address the challenges and draft policies and procedures to help guide the industry with their product development and commercialization strategies
- Participant and stakeholder in Congressional-Fly In to meet and lobby with Congressional leaders regarding laws to facilitate the acceleration of approval of cell and gene therapies for the treatment of rare pediatric diseases
- Interaction with government policy makers for reimbursement of regenerative medicines intended for the treatment/cure of rare and unmet medical need
- Member of the Alliance for Regenerative Medicine Women's Executive Forum
Founder
Gaia BioScience Solutions, LLC
San Diego, CA
01.2019 - Current
- Delivers worldwide regulatory and operational services for biotechnology clients.
- Identified potential uses of emerging technologies within organizational processes.
- Maintained conformity with applicable laws and guidelines within the operational scope.
- Optimized operations by negotiating mutually beneficial terms with external entities.
- Oversaw performance metrics, ensuring adherence to quality standards.
- Transformed business processes by leveraging current industry trends and strategic planning.
- Monitored regulatory changes and industry advancements.
- Managed cross-functional collaboration to achieve punctual and superior product releases.
- Streamlined procedures to achieve greater efficiency and lower costs.
- Fostered a positive company culture that encourages teamwork, innovation, and excellence.
Senior Vice President, Regulatory Science and Quality Assurance
Aruvant, Inc. (Closed operations)
Millburn, NJ
11.2021 - 08.2022
- Company Overview: (Company closed operations)
- Executive team leader for Regulatory Science and Quality Assurance
- Lead for the 3 disciplines of Regulatory Science (Non-Clinical, CMC and Clinical)
- Responsible for global regulatory interactions and filings
- Management of external regulatory operations
- Establishment of Quality Management System and compliance for all GxP activities including IT compliance
- Implementation of Pharmacovigilance/Drug Safety policies and procedures
- Key participant in investor and partnering activities
- Cultivated teamwork for development of fresh strategies.
- Created standardized procedures to optimize departmental productivity.
- Demonstrated organizational leadership by steering strategic goal-setting initiatives.
- Analyzed possible risks and devised contingency strategies.
- Oversaw partnerships with external entities, vendors, and stakeholders to secure successful alliances.
- Defined key metrics for monitoring progress in alignment with organizational goals.
- Advised executive team with insights for making informed operational decisions and launching initiatives.
- Worked alongside senior management on long-term strategic planning.
- Orchestrated team efforts to deliver innovative solutions spanning various departments.
- Streamlined team communication through the arrangement of regular sessions and workshops.
- Directed technological advancements, achieving waste reduction and removing business bottlenecks.
- Led execution teams in implementing strategies to support product development.
- Tracked competitor strategies to anticipate market shifts.
- Supported the creation of strategic collaborations within the sector.
- Monitored critical performance indicators to gauge success of initiatives and adjust focus.
- Secured favorable contract terms with suppliers to drive cost efficiency.
- Authorized and endorsed budgets for new funding and program initiatives.
- Optimized team effectiveness through recruitment, training, mentoring, and evaluation.
- Managed execution of corrective action plans to address issues.
Executive Vice President, Head of Regulatory Science, Quality and Clinical Operations and Company Officer
Histogen, Inc.
San Diego, CA
10.2020 - 08.2021
- Executive team leader for Regulatory Science, Quality and Clinical Operations
- Led the 3 disciplines of Non-Clinical, CMC and Clinical
- Direct negotiator with FDA reviewers
- Enhancement of Quality department operations and processes
- Built a Regulatory, Clinical Operations and Quality functional unit
- Highest achievement was removal of IND clinical hold for CMC information that did not exist due to past history
- Received clearance of clinical sites by Department of Defense (DoD) Human Research Protection Office (HRPO) for DoD grant award for orthopedic clinical trial and served as Principal Investigator (PI) for the trial
Senior Vice President, Global Quality Assurance & CMC Regulatory Science
San Bio, Inc.
Mountain View, CA
03.2020 - 10.2020
- Executive team leader for Global Quality Assurance in U.S
- And Japan
- Primary interface with FDA for U.S
- CMC related topics
- Built a Global Quality Assurance team in U.S
- And Japan
- Enhancement of document quality management system to fulfill U.S
- And Japan requirements
- Quality and CMC Regulatory lead for Japanese Biologic License Application (JBLA)
- Global Regulatory lead for interactions with Contract Manufacturing Organizations (CMOs)
- Quality assessor of Module 3 sections of BLA filing
- Responsible for company pre-approval inspection readiness and licensure
Senior Vice President, Global Quality Assurance & GxP Compliance & Regulatory Science
Orchard Therapeutics, Ltd
Menlo Park, CA
01.2019 - 12.2019
- Executive team leader for Global Quality Assurance
- Primary interface with FDA for project specific CMC issues
- Building a Global Quality Assurance team
- Implementation of document management and training tools such as Master Control
- Member of the Joint Steering Committees for Contract Manufacturing Organizations
- Chartered and organized a company Quality Committee consisting of executive leadership representatives
- CMC Team member of in-license of GSK rare disease programs
- Quality assessor of Module 3 sections of regulatory filings
- CMC Regulatory and Global Quality Team member of EMA MAA filing for approval of MAA for Metachromatic Leukodystrophy (MLD) indication
- Responsible for company global pre-approval GxP Quality inspection readiness and licensure
- Establishment and execution of global Quality Executive Leadership Team
Senior Vice President, Regulatory Science & Quality Assurance
Orchard Therapeutics, Ltd
Menlo Park, CA
07.2017 - 01.2019
- Executive team leader for global Regulatory Science and Quality Assurance
- Primary interface and negotiation of Regulatory Science issues with FDA
- Site Head for Menlo Park (CMC) location
- Navigation of the developing cell and gene therapy regulations and integrating the requirements into the regulatory Science and quality assurance division
- Quality Assurance and Regulatory lead on Joint Steering Committee with Contract Development Manufacturing Organizations (CDMOs)
- Member of team responsible for due diligence and in-licensure of three late-stage gene therapy products and one commercial product
- Regulatory and Quality contributor to the pre-IPO activities, i.e
- Addressing analyst and investor questions
- Development, implementation and maintenance of quality systems to support compliance with GXPs, i.e
- GMP, GCP, GLP, GDPs and Pharmacovigilance
- Responsible for USAN and INN filings for pipeline indications
- Regulatory document lifecycle management in support of therapeutic products, e.g
- IND, CTAs/IMPDs, BLA, NDS, MAA
- Working closely with research, product development, manufacturing operations team and clinical to develop and implement sound regulatory and quality strategies
Vice President, Regulatory Science, CMC & Quality
Fate Therapeutics, Inc.
San Diego, California
01.2014 - 07.2017
- Executive team leader for global Regulatory Science, Chemistry, Manufacturing & Controls (CMC) and Quality
- Provides quarterly reports to the Board of Directors
- Lead for interactions and negotiations with regulatory authorities
- Navigation of the developing cell therapy regulations and integrating the requirements into the regulatory Science division
- Development and implementation of quality systems to support compliance with GXPs
- Directing the development of global regulatory strategy to deliver product approvals for the cell therapy platform
- Regulatory lifecycle management of therapeutic products globally
- Managing the regulatory issues related to the compilation of high-quality Common Technical Document (CTD) regulatory submissions
- Working closely with research, product development, manufacturing operations team and clinical to develop and implement sound regulatory strategies
- Program Management lead for product candidate-ProTmune-(November 2015-June 2016)
- Interim Head of Manufacturing and Quality Control-(May 2015-December 2015); led the manufacturing and quality control department in support of the onsite manufacture and release of a transplant product
- Interim Head of Clinical Operations-(November 2015-June 2016); responsible for the design and development of protocols, identification and management of Clinical Research Organization (CRO); study startup activities such as clinical site identification in US and EU; development and submission of regulatory filings to regulatory authorities in the US and EU
- Co-lead in Medical Science interactions and engagement of clinical investigators
- Regulatory Advisory Board planning and successful meeting execution to garner relevant nonclinical, clinical and CMC input and recommendations in support of the Fate clinical development programs
- Regulatory and Quality representative in due diligence discussions
- Accomplishments: Successful Pre-IND meeting for first in class ex vivo genetically engineered Induced Pluripotent Stem Cell derived Natural Killer Cell product candidate (cell and gene therapy product)
- Obtained EMA Advanced Therapy Medicinal Product (ATMP) classification
- Obtained EMA small-medium sized enterprise (SME) status
- Received US and EU Orphan Drug Designations
- Successfully filed and cleared eINDs
- Received FDA Fast Track Designation
Vice President, Regulatory Science & Quality Assurance
Macrocure, Ltd
Tekva, Israel
03.2013 - 01.2014
- Global Regulatory Science lead in support of North America, EU and Israel strategic development and regulatory submissions
- Accomplishments: Obtained EMA Advanced Therapy Medicinal Product (ATMP) classification for activated leukocytes
- Obtained FDA agreement to conduct a single phase 3 trial in diabetic foot ulcers and venous leg ulcers to support a future broad label indication for both diseases
Senior Director, Regulatory Science/Quality Assurance
Osiris Therapeutics, Inc.
Columbia, MD
03.2009 - 03.2013
- Lead the Osiris regulatory team to receive the first approvals for an allogeneic adult stem cell therapy product-Prochymal and first approved allogeneic cell therapy indicated for the treatment of acute Graft Versus Host Disease in Canada and New Zealand
- Primary lead in the planning of Regulatory and Quality launch activities for the launch of the first approved adult stem cell product
- Responsible for Global (including North America; Europe; Australia and New Zealand) quality and regulatory strategic planning and execution in support of commercialization
- Lead the daily operations of the regulatory and quality assurance department, including mentoring, training, supervising, and evaluating staff to achieve project goals
- Primary lead on the planning and publishing of electronic Common Technical Document (eCTD) and non-eCTD electronic submissions (NeeS) for global regulatory filings
- Primary interface with regulatory agencies in support of product development and license applications
- Primary contact with outside consultants for regulatory publishing
- Primary contact for local sponsors/representatives in various countries where authorization/consent is sought
- Lead in all regulatory agency inspections
- Responsible for the management of pharmacovigilance reporting and signal detection in collaboration with CRO and Medical Monitor
- Lead the compilation and submission of IND Annual reports/DSURs
- Regulatory and Quality Assurance lead in due diligence meetings
- Regulatory and Quality Assurance representative for the Osiris/Lonza/Genzyme Manufacturing Steering Committee
- Clinical and Regulatory representative for the Osiris/Genzyme Joint Steering Committee
- Regulatory and Quality representative for the Osiris/JCR Pharmaceuticals Partnership
- Accomplishments: Received Health Canada and MedSafe New Zealand approval for the world's first approved off-the-shelf adult stem cell product, Prochymal
- Alliance Management and primary regulatory and clinical interface with partner JCR Pharmaceuticals in the development of Prochymal (referred to as TEMCELL) in Japan
- TEMCELL received approval in 2015
- Successfully compiled and filed 3 global license applications (Canada, New Zealand and Australia);
- Orphan Drug Designations/Priority Review Status obtained in 5 countries
- FDA inspection with no reported 483s
Director, Prochymal Business Unit
Osiris Therapeutics, Inc.
Baltimore, MD
12.2005 - 03.2009
- Successfully executed the completion of the first phase 3 and largest acute Graft versus Host Disease trial with a stem cell product
- Responsible for Global Clinical Operations in support of Expanded Access/Compassionate Use Program, Phase 2 and 3 clinical trials
- Provided leadership in the implementation of clinical initiatives and business processes, achievement of management goals and objectives within the framework of the company mission
- Responsible for mentoring, training, supervising, and evaluating staff to achieve project goals
- Developed and implemented regulatory strategic plans in support of commercialization
- Developed the training module for training clinical site staff on the preparation of the investigational agent
- Lead the planning for investigator meetings and nurse coordinator meetings
- Primary interface with the Food and Drug Administration
- Led the development and filing of the US and EU Orphan Drug application for Prochymal
- Organized the execution of a cGMP audit which led to EU Manufacturing Certification
- Established global drug distribution for clinical trials
- Led the development of processes to support Pharmacovigilance, such as medical monitoring review for signal detection, tracking of adverse events and reporting to regulatory agencies
- Clinical and Regulatory Science lead in due diligence meetings
- Alliance Management Lead for co-development of product with JCR Pharmaceuticals (approved product TemCell)
Director, Provacel Business Unit
Osiris Therapeutics, Inc.
Baltimore, MD
08.2004 - 11.2005
- Successfully completed a phase 1 study in acute myocardial infarction utilizing allogeneic adult mesenchymal stem cells as a treatment therapy to aid in the repair of the damaged heart tissue and to improve contractility of the heart
- Lead the planning for investigator meetings and nurse coordinator meetings
- Hired, trained and mentored a clinical operations team
- Developed and trained clinical site hospital staff on the preparation of the investigational agent
- Simultaneously led the Regulatory Science activities for the company
- Osiris Clinical and Regulatory Science representative to the Osiris/Boston Scientific Steering Committee
- Clinical and Regulatory Science lead in due diligence meetings
Director, Quality Assurance and Regulatory Science/Associate Director, Quality Assurance and Regulatory Science/Manager, Quality Assurance/Manager, Quality Control
Osiris Therapeutics, Inc.
Baltimore, MD
12.2000 - 08.2004
- Managed receipt and release testing of raw material products
- Developed components of the regulatory and licensing strategy
- Led the drafting, editing, compiling and submitted regulatory filings to FDA, which included identification of resource implications and time-line development
- Arranged, participated in, and/or led interactions and negotiations with FDA
- Specialized in Chemistry, Manufacturing and Controls
- Interfaced with functions within the regulatory Science department, other company departments, and regions to assure alignment and achievement of goals
- Regulatory Science and Quality Assurance lead in due diligence meetings
- Partnered with counterparts and project management to assure representation and implementation of global strategy components
- Instrumental in completion of process Failure Modes Affect Analysis (FMEA)
- Prepared quality assurance training program for visiting Japanese cellular therapy technicians
- Assisted Japanese corporate partners in drafting regulatory submission to their Japanese Ministry of Health Labor and Welfare
- Coordinated team efforts to obtain FDA Fast Track Designation for lead product
- Established educational training program for clinical sites to perform cell preparation and infusion procedure for bone marrow transplant program
Supervisor, Quality Control
BioWhittaker, Inc.
Walkersville, MD
06.2000 - 12.2000
- Supervised quality control department and 3 analysts
- Supervised the conduct of QC testing and release of Limulus Amebocyte Lysate test kits
- Supervised the routine testing and release of raw materials
- Generated and approved certificates of analysis for test kits
- Authored and/or revised several Standard Operating Procedures
Manager, Laboratory Operations
In Vitro Technologies, Inc.
Catonsville, MD
02.1999 - 06.2000
- Managed all facets of purchasing; validation and calibration, supplies and inventory, maintenance, facilities, safety and waste management
- Supervised 2 materials management personnel
- Saved the company over $180K in fiscal year of 1999-2000 by establishing special contract pricing with vendors
- Obtained bids and negotiated contracts with vendors for supplies and other contract services
Quality Control Analyst
MedImmune, Inc.
Gaithersburg, MD
10.1997 - 12.1998
- Conducted assays pertinent to the critical routine studies of the quality control department
- Trained and supervised 2 other analysts in the performance of various plant sampling and testing methods
- Authored and/or revised several Standard Operating Procedures
- Conducted a quality audits of vial fill and finish vendor
- Assisted in Quality readiness for Pre-Approval Inspection for BLA approval of Synagis
Transcriptionist/Medical Records Clerk
Medical Personnel
Silver Spring, MD
01.1996 - 01.1997
Medical Student; Completed coursework equivalent to Medical Masters
Ross University School of Medicine
Dominica, West Indies
01.1994 - 01.1996
Assistant Microbiologist, Toxicology Assistant
BioReliance, Inc.
Bethesda, MD
01.1993 - 01.1994
Regulatory Auditor, Pesticide, Rodenticide and Herbicide Labeling
Systems Integration
Crystal City, VA
01.1992 - 01.1993
Biological Assistant, Neurotoxicology Division
U.S. Environmental Protection Agency
RTP, NC
01.1987 - 01.1990
Education
Masters degree - Health Care Administration
University of Maryland
College Park, MarylandMedical Student - Completed 2 Years of Medical School Academic And Clinical Training
Ross University School of Medicine
Dominica, West IndiesBachelor of Science degree - Biology
Saint Augustine University (formerly College)
Raleigh, North CarolinaSkills
- Biotechnology stealth/startup and technology development
- New Product Development Strategy
- Early & Late-Stage Product Development
- Regulatory Strategic Planning including leveraging and development of global accelerated pathways to approval
- Regulatory Operations
- Project Management
- Leadership & Team Building
- Cross-functional Team Management
- Principal Interface with US and ex-US with Regulatory Authorities
- Pre-Approval Inspection Preparation & Oversight
- Budget Projections and Oversight
- Resource Planning
- GxP Quality Management System Development & Oversight
- Alliance Management
- In/Out Licensing Technology Due Diligence
- Regulatory Submissions, ie INDs, CTA/CTX, BLA, MAA, NDS, Orphan Drug, Fast Track, PRIME (EMA), Pediatric Investigational Plans (EMA)
- Vendor Selection, Qualification & Management
- Policy evaluation
- Global perspective
- Leadership experience
- Strategic thinking
- Diversity and inclusion
- Financial acumen
- Industry expertise
- Strategic planning
- Regulatory compliance
- Policy development
- Operations management
- Organizational leadership
- Business consulting
Memberships Certifications
- Regulatory Science Professional Society (RAPS)
- Alliance for Regenerative Medicine
- American Society for Quality (ASQ)
- Previously Regulatory Science Certified (RAC)
- Previously Certified Clinical Research Professional (CCRP)
Publications
- A double-blind, randomized, placebo controlled human clinical trial of allogeneic mesenchymal stem cells for the treatment of acute myocardial infarction., Hare, J., Dib, N., Traverse, J., Henry, T., Hermiller, J., Daniels, M., Archambault, M., Abstract presented at American Heart Association Meeting 2007.
- Health Services and Outcomes Research - Malignant Diseases: Economic Burden of Infections Following Allogeneic Hematopoietic Cell Transplant for Hematologic Malignancies., Ariel Berger, MPH, Walter W Grubb, MS, Samuel Huse, Maitreyee Mohanty, MPharm PhD, John Ferraro, MBA, Moya Daniels, MS, Wendy J. Levin, MD MS
Management Experience
- Phases I, II, and III
- Biologics (cell (autologous and allogeneic) and autologous gene therapy and combination products (mAbs, vaccines, and medical devices)
- Various delivery routes (transdermal, IV, and surgical)
Indication Experience
- Acute Myelocytic Leukemia (Leukemias)
- Multiple Myeloma
- Non-Hodgkins Lymphoma
- Glioblastoma
- Pancreatic Ductal Adenocarcinoma
- Sarcoma (Oncology)
- COVID (Infectious Disease)
- Sickle Cell and Beta-Thalassemia (Anemias)
- Orthopedics
- Cardiology
- Epilepsy
- Leukodystrophy
- Parkinson's
- Adult-onset leukoencephalopathy (Neurodegenerative Diseases)
- Wound care
Affiliations
- Hiking
- Reading
- Traveling
Accomplishments
- Achieved the approval of the first allogeneic stem cell product.
Certification
- Previous Regulatory Affairs Certification (RAC)
Timeline
Board Member
Alliance for Regenerative Medicine Board of Directors
10.2023 - Current
Senior Vice President, Regulatory Science and Quality Assurance
Aruvant, Inc. (Closed operations)
11.2021 - 08.2022
Executive Vice President, Head of Regulatory Science, Quality and Clinical Operations and Company Officer
Histogen, Inc.
10.2020 - 08.2021
Senior Vice President, Global Quality Assurance & CMC Regulatory Science
San Bio, Inc.
03.2020 - 10.2020
Founder
Gaia BioScience Solutions, LLC
01.2019 - Current
Senior Vice President, Global Quality Assurance & GxP Compliance & Regulatory Science
Orchard Therapeutics, Ltd
01.2019 - 12.2019
Senior Vice President, Regulatory Science & Quality Assurance
Orchard Therapeutics, Ltd
07.2017 - 01.2019
Vice President, Regulatory Science, CMC & Quality
Fate Therapeutics, Inc.
01.2014 - 07.2017
Vice President, Regulatory Science & Quality Assurance
Macrocure, Ltd
03.2013 - 01.2014
Senior Director, Regulatory Science/Quality Assurance
Osiris Therapeutics, Inc.
03.2009 - 03.2013
Director, Prochymal Business Unit
Osiris Therapeutics, Inc.
12.2005 - 03.2009
Director, Provacel Business Unit
Osiris Therapeutics, Inc.
08.2004 - 11.2005
Director, Quality Assurance and Regulatory Science/Associate Director, Quality Assurance and Regulatory Science/Manager, Quality Assurance/Manager, Quality Control
Osiris Therapeutics, Inc.
12.2000 - 08.2004
Supervisor, Quality Control
BioWhittaker, Inc.
06.2000 - 12.2000
Manager, Laboratory Operations
In Vitro Technologies, Inc.
02.1999 - 06.2000
Quality Control Analyst
MedImmune, Inc.
10.1997 - 12.1998
Transcriptionist/Medical Records Clerk
Medical Personnel
01.1996 - 01.1997
Medical Student; Completed coursework equivalent to Medical Masters
Ross University School of Medicine
01.1994 - 01.1996
Assistant Microbiologist, Toxicology Assistant
BioReliance, Inc.
01.1993 - 01.1994
Regulatory Auditor, Pesticide, Rodenticide and Herbicide Labeling
Systems Integration
01.1992 - 01.1993
Biological Assistant, Neurotoxicology Division
U.S. Environmental Protection Agency
01.1987 - 01.1990
- Previous Regulatory Affairs Certification (RAC)
Masters degree - Health Care Administration
University of Maryland
Medical Student - Completed 2 Years of Medical School Academic And Clinical Training
Ross University School of Medicine
Bachelor of Science degree - Biology
Saint Augustine University (formerly College)
Similar Profiles
RYLIE BUTLERRYLIE BUTLER
Clinical Coordinator at Regenerative Medicine and Pain ManagementClinical Coordinator at Regenerative Medicine and Pain Management
Ashley PenningtonAshley Pennington
Family Nurse Practitioner at Southern Pain & Regenerative Medicine/Southern VIP Vascular and Interventional Pain ManagementFamily Nurse Practitioner at Southern Pain & Regenerative Medicine/Southern VIP Vascular and Interventional Pain Management
Karina Gonzalez GutierrezKarina Gonzalez Gutierrez
Clinic Manager at Leucadia Chiropractic & Regenerative MedicineClinic Manager at Leucadia Chiropractic & Regenerative Medicine