Elizabeth Hook Email & Phone Number

Medford, MA, US

Boston, MA, US

Head of RegulatoryStrategy for regulatory pathway to first-in-human studies.Leading a cross-functional team in preparation of regulatory submission documents.

Head of Regulatory Department, reporting to Chief Development OfficerDevelopment and implementation of global regulatory strategy for rare disease gene therapy and gene editing programs.Communicated with FDA as the main point of contact for INDs.Lead regulatory meetings with FDA and other regulatory authorities.Managed regulatory affairs, regulatory.

Tampa, Florida, US

Burlington, Massachusetts, US

Strategic development of target product profiles and product development strategies for gene therapy and small molecules to maximize regulatory success and efficiency.Commercial life cycle management: regulatory strategy for label updates, additional indications, and CMC process improvements.Lead regulatory meetings with FDA and other regulatory.

Burlington, Massachusetts, US

Commercial life cycle management: regulatory strategy for label updates, additional indications, and CMC process improvements.Regulatory strategy for gene therapy, including successful IND approval in US and Scientific Advice meetings in Europe.Manage two direct reports.

Burlington, Massachusetts, US

Direct interactions with FDA during review of NDA

Burlington, Massachusetts, US

• Filed 505(b)2 NDA in eCTD format for osteoarthritis pain treatment
• Project and timeline management for all documents in NDA
• Team leader for all Module teams
• Collaboratively write and review documents with subject matter expert teams
• Manage electronic submissions vendor
• Successful interactions with FDA, including pre-NDA meeting and face-to-face Type C CMC Meeting

US

• Regulatory lead for global Phase 3 trials in Alzheimer’s disease and Cognitive Impairment in Schizophrenia
• Worked with cross-functional team and CROs to file clinical trial applications and amendments for Phase 3 programs.
• Primary point of contact for regulatory lead at CRO.
• NDA team member supporting preparation of documents for all 5 modules for a planned 2016 filing.
• Team leader for Request for Fast Track Designation from FDA.
• Converted agreed EU PIP into a Pediatric Study Plan for US submission.

Tokyo, JP

• Global Regulatory Strategy Group member on a large oncology program.
• Participate in cross-functional team to file global marketing authorizations.
• Support post-marketing commitments to FDA and EMA.
• Support life cycle management and additional indications.
• Support alliance with external partner and parent company (Takeda)

Rockville, MD, US

Clinical and nonclinical regulatory affairs with a focus on global Phase 3 trials. In close collaboration with CRO and clinical team, filed clinical trial applications and received approvals in over 25 countries.

Rockville, MD, US

• Clinical and nonclinical regulatory affairs from pre-IND through commercialization.
• Prepared nonclinical sections investigational new drug application in CTD format for first-in-human trial.
• BLA in eCTD format: wrote nonclinical and clinical tabulated and written summaries and U.S. Module 1 documents.
• Created a working practice for collection and submission of FDA Form 1572; trained colleagues in clinical and regulatory affairs.
• Attended FDA Advisory Committee Meetings and Public Hearings on topics of interest such as direct acting antivirals for hepatitis C, REMS guidance, etc. and provided written summaries to relevant colleagues.

Rockville, MD, US

Clinical and nonclinical regulatory affairs for products in IND phase.

Regulatory Affairs support for early stage products.

Regulatory Affairs support for products in global Phase 3 trials.

Regulatory affairs support.