Monalee S.

• Manage contracting escalations for global clinical trials, advising on research related legal, regulatory, compliance, and business matters. • Draft contract terms to manage legal and business risk issues including indemnification, subject injury, confidential information, privacy, and intellectual property. • Interface with Astellas legal specialists in intellectual property, risk management, data privacy & security (including GDPR), and compliance as required to resolve contractual issues or to draft new contract verbiage. • Update research contract templates including those for confidentiality, vendor services, and investigator-initiated studies. • Update contract playbooks and templates to comply with changing compliance, legal, and regulatory requirements. • Lead a task force consisting of in-house counsel and two global clinical research organizations to create a new clinical trial agreement (CTA) template, playbook, and over twenty country-specific templates. • Work with various task forces in winding down clinical trials and ISRs that utilize compounds that are going off patent and require IND closeout. • Maintain a system for documenting legal precedents in order to harmonize decisions made by regional legal and compliance groups. • Create new contract templates and playbooks for global use for multiple contract types, including IRB indemnification and collaborative research agreements. • Create process tools to drive efficiency (e.g. contract routing tools and checklists). • Train team members/end users about legal concepts that arise in research contracting, negotiation techniques, and balancing business and legal concerns.

Responsible for drafting, processing, execution, and management of all outsourcing and contracting activities for assigned projects. Specifically, Investigator Sponsored Research agreements (ISRs), Master Service Agreements (MSAs) amendments to ISRs, clinical trial agreements, research agreements, services agreements, collaborative agreements, health economics and outcomes research agreements, dossier developments, collaborative agreements, grants, consulting agreements, advisory board agreements, publication agreements, library agreements, amendments to MSAs, work orders, change orders, or other contracts. Manage multiple and simultaneous projects impacting the Medical Affairs, Development and Clinical divisions. Draft and negotiate contracts and contribute to more complex and broadly applied contracts. Responsible for execution of various types of contracts according to approved templates. Collaborate with legal review, general counsel, and IP counsel on complex contractual negotiations, including but not limited to complex language regarding mergers and acquisitions and future intellectual property rights. Leverage experience, precedent, and processes to develop alternate contract language for consideration and approval. Communicate with assigned stakeholders, develop relationships within assigned stakeholders, and contribute to process improvements. Ensure that language, pricing (FSP, Fixed Price, Unit Price, Fee for Service, FMV, study budget, etc.), and payment terms are appropriately protect and are in the best interests, are consistent and compliant with corporate guidelines, are well-defined, and are reasonable and customary. Analyze data and budget information as required.

Clinical Trial Development: Developed, authored, and maintained clinical trial documents including protocols, SOPs, informed consents, and case report forms (CRFs). Developed recruitment strategies in order to ensure study timeline milestones. Identified and worked closely with external vendors to develop study marketing and non-traditional recruitment initiatives. Created site clinical research coordinator (CRC) training materials. Clinical Trial Management: Trained sub-site CRCs and investigators on study protocols. Performed site monitoring including site initiation visits (SIVs), interim monitoring visits, and study site closure visits. Reviewed and assessed site-specific ICFs, local protocols, and privacy authorizations. Identified and corrected site protocol deviations and ensured ongoing protocol and regulatory compliance. Legal: Worked with university and hospital general counsel on legal issues including: licensing agreements; contracting; data use and sharing agreements; intellectual property; Anti-Kickback Statute; and False Claims Act. Worked with division physicians to maintain compliance with Sunshine Act requirements. Secured copyright licenses for use in patient literature, advertising, and marketing materials. Worked with Innovation and New Ventures (INVO) Office in the determination of patentable inventions and throughout patent prosecution. Regulatory: Oversaw, developed, and maintained all IRB protocols for the division. Ensured compliance with state and city facility licensing regulations. Conducted internal division clinical trial audits to assess regulatory compliance. Served as primary point of contact for all division FDA submissions. Generated quarterly and annual reports to Department of Defense (DoD) and FDA. Provided regulatory training and leadership to division personnel including physicians, fellows, residents, interns, and medical students.

Reviewed IRB submissions, including continuing reviews, amendments, and safety reports at convened panel meetings. Completed independent expedited reviews as directed by NU IRB staff.

Managed submission of all regulatory documents to the IRB, including development of informed consent documents and protocol review for complex studies involving more than minimal risk to research subjects. Prepared Clinical Research Unit (CRU) applications and IND/IDE applications and renewals. Corresponded with the FDA throughout the IND/IDE process. Trained, managed and evaluated the Regulatory Coordinators, whose main role was to assist with submissions in eIRB. Provided guidance on form preparation and submission and informs Regulatory Coordinators of critical process, legal, and policy issues. Conducted annual performance review for Regulatory Coordinators in keeping with institutional guidelines to manage performance excellence. Interpreted existing and/or new regulatory requirements, federal and local laws, developments and Institutional Regulatory Policies as they relate to human subjects research in order to effectively communicate regulatory requirements to the research staff. Recommended and implemented regulatory process improvements. Developed and managed the internal monitoring auditing program. Scheduled, prepared, and participated in all internal and external program audits (monitoring visits), interacted with regulatory agents, and Sponsor monitors. Tracked study approvals and expirations to ensure uninterrupted project approval. Performed preliminary prior art searchers for department-developed patents.

Researched legal issues in the fields of contract, copyright, trademark, trade secret, defamation, cyberlaw, and estates, wills, and trusts using sources such as judicial opinions, legal articles, statutes and other legal codes. Prepared demand letters, assisted with legal presentations, and reviewed contracts as directed.

Responsible for management of the clinical monitoring process and administration of clinical trials. Supervised CRCs in their function of in-house and on-site monitoring, filing, and administration of clinical trials. Oversaw assurance of adherence to SOPs, Good Clinical Practice, FDA regulations, and state and federal statutes. Reviewed and negotiated clinical trial contracts and budgets.

Performed experimental and clinical islet transplantation for human islet isolation procedures in the both the basic islet physiology laboratory and the clinical isolation facility. Performed large volume, clinical human islet isolation as part of the Human Islet Isolation Team in the cGMP facility. Analyzed and interpreted results and maintain and organize data and records for the FDA. Responsible for performing patent and prior art searches for the laboratory. Acted as the primary contact between the lab and the Technology Transfer Office in the prosecution of patents. Worked with the Technology Transfer Office in the facilitation of all laboratory Material Transfer Agreements (MTAs) and collaborative research contracts.

Responsible for all aspects of clinical trial management, including data collection and reporting, utilizing Good Clinical Practices (GCP) including maintaining all regulatory and Institutional Review Board (IRB) documentation. Served as primary liaison between department, hospital staff, and industry sponsors for various clinical trials, coordinating monitoring visits, adverse event reporting (to the FDA and Sponsors) and case report form submissions. Coordinated subject appointments, obtain informed consent from subjects for research procedures, drafted consent documents, conducted chart review, handled and processed laboratory specimens, conducted literature research, and managed department finances and clinical trial budgets.

Assisted in subject chart review, completion of research case report forms including anesthesia records, obtaining subject consent, literature research, and surgical observation. Primary studies included Parkinson's disease, high-risk stroke, aneurysm, and other neurological and spinal disorders.