REGINA BAUTISTA
Watertown,MA
Summary
Experienced attorney with a diverse background in legal and scientific fields, offering invaluable support to the biotech industry. Recognized for reliability and responsiveness as a business partner, dedicated to delivering results and solving complex challenges at all organizational levels. Firmly committed to fostering accountability, taking ownership of tasks, and promoting efficient collaboration. Possessing a strong mindset for learning and continuous improvement, consistently staying ahead of industry trends and advancements.
Overview
21
21
years of professional experience
Work History
Senior Corporate Counsel
uniQure, Inc.
Lexington, MA
01.2021 - 01.2024
- Primary transactional attorney responsible for worldwide business support which doubled its scale of employees, contracts, processes and workload within 1.5 years.
- Lead counsel for clinical stage genetic therapy of Huntingtons Disease, Amyotrophic Lateral Sclerosis, Temporal Lobe Epilepsy
- Supported executives, all functions and teams to implement $450 million Commercial License and Manufacturing Agreement for Hemophilia B which achieved FDA approval in 2022 (US) and 2023 (EU) for Hemgenix gene therapy at cost of $3.5 million per treatment
- Sole attorney integrating and supporting €46 million acquisition of Corlieve and its Temporal Lobe Epilepsy (TLE) gene therapy
- Negotiated multiple GMP manufacturing agreements valued at >$3 million for TLE
- Negotiated transfer of HD patient data under HD Consortium funded by uniQure
- Led lean legal department in conversion of operations, high volume contract requests, approvals, signature and storage to electronic management system while aligning with Finance and IT requirements
- Solely averaged 300 contracts reviewed per month such as Master Service Agreements, Clinical Trial Agreements, Supply, collaboration, research, manufacturing, quality, professional consulting agreements
- Improved legal department reputation, KPI, response time and internalized outside counsel support/spend.
- Drafted playbooks, processes, templates, guidelines and provided training to all stakeholders
Consultant Attorney
Axiom Law
Boston
03.2020 - 01.2021
- Provided contract review to Myokardia (California) and assisted with implementation of Agiloft
- Provided contract review at uniQure.
Counsel, Intellectual Property
Quest Diagnostics, Inc.
Marlborough, MA
01.2014 - 01.2019
- Provided transactional and intellectual property support to Athena Diagnostics division for in-licensed patents
- Legal support to northeast regional sales, marketing, medical and laboratory diagnostic services and healthcare compliance matters, RFPs
- Conducted re-negotiations and license for in-licensed intellectual property with $100,000 royalty fee savings
Patent Attorney II
Novartis, Inc.
Cambridge, MA
01.2003 - 01.2014
- Patent prosecution and review of intellectual property terms, freedom to operate, patentability and FAR compliance at Novartis Pharma, NIBR, Vaccines & Diagnostics.
Education
J.D. -
University of New Hampshire
Concord, NHBachelor of Science - Biochemistry
Rutgers University-Cook
New Brunswick, NJSkills
- Startup
- LEAN
- HIPAA
- GDPR
- Anti-kickback/Stark
- GxP
- Promotional Review
- Clinical Trials
- Manufacturing
License
- NJ Bar
- MA Bar
- US Patent Office Registered
Timeline
Senior Corporate Counsel
uniQure, Inc.
01.2021 - 01.2024
Consultant Attorney
Axiom Law
03.2020 - 01.2021
Counsel, Intellectual Property
Quest Diagnostics, Inc.
01.2014 - 01.2019
Patent Attorney II
Novartis, Inc.
01.2003 - 01.2014
J.D. -
University of New Hampshire
Bachelor of Science - Biochemistry
Rutgers University-Cook