Diane E. Lifton
Senior Vice President, Head of Legal, Biopharma @Sumitomo Pharma America, Inc.
Signup · Get unlimited contacts
WORK HISTORY
Senior Vice President, Head of Legal, Biopharma @Sumitomo Pharma America, Inc.
Marlborough, MA, US
Head of Legal for the Commercial and R&D Organizations focused on Oncology, Women\'s Health, and Rare Diseases
EDUCATION
University of Michigan Law School
JD, Law
Cornell University
E-Cornell Business Management Program, Accounting and Finance
Seton Hall University School of Law
Health Law Program, Graduate Certification, Pharmaceutical and Medical Device Law and Compliance
Cornell University
BA, Government, Pre-Medical Studies
SKILLS
ABOUT DIANE E. LIFTON
I am an award-winning advocate and mentor with more than twenty-five years of experience partnering with businesses in the Life Sciences arena throughout the lifecycle of their products, including:o Transactions: Leading mergers, acquisitions, divestitures, licensing. Trusted advisor to Alliances and Collaborations. o Corporate Governance: Secretary to multiple boards. o Commercialization: Performing product risk assessments; conducting due diligence; preparing global strategic manufacturing and supply agreements; serving on promotional review committees.o Global Product Development/Clinical Operations: Drafting and negotiating clinical trial agreements, informed consent forms, master service and vendor agreements for clinical operations.o Regulatory: Counseling on FDA laws, regulations and guidance; manage responses to Phase safety signals; review of regulatory submissions (labeling, marketing); regulatory agency audit preparation. o Compliance: Conduct investigations and design compliance initiatives; draft SOPs, policies; counsel on AKA, FCA, FCPA; address GDPR and privacy issues.o Dispute Resolution: Investigate, litigate, arbitrate, and resolve disputes in the areas of commercial contracting and business relationships; product and technology acquisitions; intellectual property protection; product liability, insurance and other areas. Selected dispute resolution and investigation matters.o Management and Budgeting: Creating and leading cross-departmental teams to provide clients with budgeted and cost-effective counseling and dispute resolution services. o Talent Retention and Professional Growth: serving as a mentor, sponsor and advocate for up and coming attorneys. I also work with cross-disciplinary teams that provide additional client support in a host of areas, including the identification of potential new areas of product investment through market research and analysis; the acquisition of intellectual property, product lines and target companies through M&A, joint ventures and licensing deals; the litigation and arbitration of disputes arising out of such collaborations; the prevention and investigation of compliance-related issues; and the assessment of export controls.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.