Cambridge, Massachusetts, United States
Committed to upholding the highest ethical standards and professionalism. Experienced Clinical Trial Director in global drug & device trials, all phases, regulatory, FDA compliance, subject safety, risk reduction, GDPR, HIPAA, data analytics, IND drafting, IRB, CRO, ICH, GCP, GDPR. NIH Certified. Experience from industry, law firms, medical schools and research institutions and hospitals. Trusted Clinical Trials Professional, Director, Advisor and Strategic Partner for Start Ups in Clinical Trials, Life Sciences, and Biomedical. B.U. School of Medicine, 3.9 GPA- Clinical Research Certificate in Biomedical Studies; 1 year post graduate program. NIH Cert. in Protecting Human Research Subjects; Pharmacology; IND's; NDA's; FDA; ICH; CBER, CDER; AMOR; CML; GCP; GxP; Pathology; Medical Devices: Immunology; Drug Development; Neurological Disease; Oncology ; Monoclonal Anti-Interleukin 23; tyrosine kinase; small molecule pathways, drug conjugates, metabolites; therapies; macromolecules • Patent Clerk Attorney-extern in Chambers for the Honorable Judge Rader at the U.S. Court of Appeals for the Federal Circuit, CAFC on biomedical and pharmaceutical invention disputes. • Patent appeals & Interferences trained and experienced in Washington D.C. patent law firm • Experience before 3 judge panel at the USPTO • Experienced in constructive reduction to practice, accorded benefit date, counts, claim charts, patent drafting • Patent Freedom to Operate, Validity, 3rd party review, parallel proceedings, infringement • Trained in Oncology ( neu, ras, P53, PCR, etc) in a Cambridge Biotechnology firm; Clinical Trials • Laboratory experience: ELISA, PCR, Western Blot, Molecular Biology; FDA; Pharmacovigilance • Biology & Chemistry • Large firm experience in: Hatch Waxman; Sherman Act; Clayton Act; Patent Litigation; healthcare regulatory affairs; pharma anti-kickback; licensing agreements; False Claims Act; FDA; SEC; FTC; PE; VC Education: Undergraduate: Biology and English, Thesis: Diving Apparatus of Seals Speaking Events: Concert Pharmaceuticals: In re Aqua Products Boston Patent Law Assoc. Co-Chair & Judge of the "Invented Here!" Patent Competition Boston Bar Assoc.: IP for Start Ups New England Law: Patent Law, Visiting Lecturer • Visiting Lecturer, U.S. Supreme Court Case, KSR v. Teleflex, 550 U.S. 398 (2007) • Appellate Writing Course; graded 2L Course - Judge
Optimizing contract lifecycles to accelerate site activation, study timelines and growth.
Expert in Clinical Trial Agreements, Intellectual Property and Commercial Contracts. Her scientific experience is in Biology Oncology, and Immunology. Committed to upholding the highest ethical standards and professionalism. She has additional experience brief drafting a U.S. Supreme Court matter in treaty interpretation, Roger Lin, et al v. U.S., Elaine drafted briefs on the 2012 U.S. Marines matter for the 1983 Marine Barracks Bombing in Beirut, US District Court for the District of DC. After earning her J.D., at New England Law, Elaine earned an LL.M. in IP Law at the George Washington Univ. Law School, Washington, D.C. Her theses include a Review of Patent Cases before the U.S. Federal Circuit; and a seminar capstone and presentation on the Stem Cell Patent. She lectures on Patent Law and Post Grant Proceedings. She has sat as a judge on the GW Univ Law School Patent Law Moot Court Giles Rich Competition, Elaine is a member of the Boston Patent Law Assoc where she judges for the annual “Invented Here” competition and Women in IP. Community involvement includes: BIPLA Patent Co-Chair & Lead Judge, 2019 Invented Here! Competition; Patent Judge Invented Here! Competition 2018; Speaking Events: In Re Aqua Products at Concert Pharmaceuticals, Jan 2017 for the Boston Patent Law Association; IP Basics for Start-ups with Dr. Tani Chen, June 2016 at the Boston Bar Assoc.; KSR v. Teleflex, 2011 for New England Law School.
UMass Chan Medical School Center for Clinical and Translational Science; Negotiate, draft, interpret, manage clinical research agreements on behalf of the UMASS Chan Medical School (Commonwealth of Massachusetts) with sponsor companies; mitigate risk, privacy, GDPR, compliance, regulatory, HIPAA authorizations, study letters, work orders, master agreements, amendments, interpret informed consent & review protocol; update training and templates, contract management systems, manage and complete contract life cycle; communicate with budget team, study team and principal investigators.
Trial Counsel, District Court
Provided expert legal advice and drafted Clinical Trial Agreements. Communicated daily with principal investigators, negotiated terms with finance departments, corporate sponsors, senior administrators, executives, and the Office of General Counsel at BIDMC, MGH, and the Brigham to draft and provide expert legal advice on Clinical Trials Agreements for Sponsored Cancer Research in the Office of Clinical Research Agreements.