Summary
Overview
Work History
Education
Skills
License
Timeline
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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.
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
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.
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.
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, NH

Bachelor of Science - Biochemistry

Rutgers University-Cook
New Brunswick, NJ

Skills

  • 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

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REGINA BAUTISTA