Jeff Simpson Email & Phone Number

Morrisville, Nc

Raleigh-Durham, North Carolina Area

I joined UCB Biosciences in December 2010 as a Sr. Clinical Project Manager.My primary responsibility in this role was management of clinical studies of a biologic for rheumatoid arthritis.

* I am responsible for developing complex study specific concept sheets and protocols supporting multiple clinical development programs. Duties include leading major protocol review and discussions concerning scientific and procedural aspects of study design. I have authored multiple protocols and amendments, ranging from phase 1b to phase 3 clinical trials, all completed on or ahead of schedule. * I oversee the scientific aspects of clinical trials throughout duration of study. Duties include protocol presentations/training; assisting with preparation/review of ICFs, CRFs, Data Management Manuals, Data Analysis Plans, and Statistical Analysis Plans; addressing questions regarding scientific and related procedural issues from Investigators; coordinating the collection and assimilation of ongoing data for internal analysis, review, and presentation; coordinating and managing the preparation and/or review of data listings, summary tables, study results and scientific presentations. * I manage the preparation/review of clinical research components of regulatory documents, including protocol efficacy amendments to support study approval and initiation, IND annual reports, IND safety reports, and Investigator Brochures.* I coordinated and presented at a clinical development advisory board meeting consisting of key investigators and Gilead senior management to evaluate feasibility of a potential new therapeutic indication.* I supervise a Clinical Research Scientist in the preparation and performance of the above tasks.* I have proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers.

(Note: Schwarz Biosciences was acquired by UCB Pharma)Key Tasks: * Responsible for developing, leading, and implementing the lacosamide epilepsy monotherapy clinical development program in support of registration of a line extension. * Responsible for developing, leading, and implementing the lacosamide (Vimpat®) epilepsy phase 3b clinical program 3 year strategy including protocol development and initiation of two phase 3b clinical trials.* Maintain excellent working relationships and global cross functional collaboration together with the Global Project Leader to ensure broad medical, scientific, regulatory, commercial and external input into the clinical programs.* Ensure that Protocol Summaries and derived final protocols related to the relevant development plans meet the requirements of related Clinical Development Plans and Target Product Profiles and that this is appropriately managed by the clinical study team(s).* Control operating budget up to €30 million annually.* Responsible for on-time delivery of clinical components of regulatory submissions. * With the Clinical Research Physicians and Scientists, developed and managed a network of external experts relevant to the lacosamide epilepsy monotherapy clinical development program.* With the Clinical Project Managers, ensure that clinical trial activities are executed efficiently (e.g. within agreed timelines and budget) and to a high standard, meeting all appropriate regulatory requirements. * Ensure compliance of program with all appropriate regulations, SOPs, company processes and ICH GCP and quality standards applicable to UCB.

Key Tasks:* Responsible for preparation, conduct, and reporting of clinical trials in a high quality and timely manner to support regulatory filing of lacosamide for treatment of neuropathic pain. * Trial Manager for a phase 2 proof-of-concept trial, phase 2b dose-finding trial, and phase 3 trial in subjects with painful diabetic neuropathy as well as the corresponding open-label follow-on trials. Related duties include: development of clinical trial protocol and clinical trial reports; ensure budgets and timelines are met throughout the preparation, conduct, and reporting of clinical trials; manage various vendors supporting the trial; manage the clinical trial supply; head the Clinical Trial Team and serve as team representative as member of the Clinical Subteam; monitor, track, and report trial budget and timelines and identify any issues and developing contingency plans with line management; ensure high quality of clinical trial in cooperation with line management; ensure efficient communication with and motivate Clinical Trial Team members; provide Clinical Subteam with high quality information as required in a timely fashion; serve as ad hoc member of SOP User and Peer review groups.* Author/co-author abstracts, posters, presentations, and manuscripts for scientific meetings and peer reviewed journals in support of the lacosamide publication plan* Serve as the GCP Officer representing Clinical Development in the US* Serve as member of the SOP Committee

* Serve as Clinical Scientist for a world-wide phase 3 clinical trial. Related duties include: coordinate clinical trial agreements with pharmaceutical companies (i.e., investigational product supply, adverse event reporting, publication approvals); write amendments to the protocol as necessary; present scientific overview and results at Investigator meetings; develop and maintain timelines from data retrieval through final report sign-off; coordinate and contribute to interim and final clinical study reports.* Contribute to the Integrated Summary of Safety and Integrated Summary of Effectiveness sections of the Emtriva® (emtricitabine) NDA.* Drafted a manuscript for journal publication and multiple abstracts for international meetings, presented current status of the emtricitabine clinical program for external groups.* Coordinate organization of required emtricitabine study-specific information for annual IND update; maintain and update Informed Consent template. * Serve as a Reviewer on the Triangle Pharmaceuticals Inc. (TPI) Protocol Review Committee (PRC). Responsibilities include reviewing, presenting, and leading PRC discussion of submitted protocols, amendments, and other trial-related issues with a focus on strategic development of TPI's drug candidates.

Key tasks:* Assist in coordinating phase IIIB/IV collaborative clinical trials within the HIV Market Support group by setting the agenda of study proposals for review by the International Medical Affairs (IMA) Collaborative Studies Review Committee (CSRC), participating in CSRC meetings, and presenting incoming proposals and protocols to the CSRC.* Maintain integrity of the GlaxoWellcome Collaborative Studies database and internal files by reviewing the database/files for completeness and accuracy, supervising data entry, and liaising with appropriate technical support for correcting program deficiencies or for installing program upgrades.* Request, supervise, and ensure accuracy of Clinical Trials Material contracts from GW Legal.* Request and coordinate Clinical Trial Material shipments for approved protocols and assist in forecasting future needs of Clinical Trials Material.* Assure timelines are maintained for approved protocols/studies by monitoring and reviewing data submission and presentation of interim and final study results.

Key tasks:* Serve as an assistant to the Lead CRA on an assigned project: provide assistance to the Lead CRA with project-related duties and/or conduct necessary tasks for project operation.* Develop monitoring guidelines, project specific materials, and other monitoring tools to assist team members and site staff in the performance of a clinical trial.* Participate in CRA or protocol specific training and development activities.* Participate in all phases of clinical monitoring, including site initiation visits and site close-out visits. * Oversee ongoing clinical trials of investigational drugs/devices and ensure compliance with ICH/GCP guidelines.* Assure integrity of clinical trials with respect to accuracy, accountability and documentation through review of CRFs, source documents, and medical records.* Ensure correct coding of terminology on CRFs and proper documentation and management of adverse events.

Fellowship through Univ. of North CarolinaKey tasks:Design, supervise, and participate in various research projects investigating neurodegenerative diseases (temporal lobe epilepsy, Parkinson's disease, Alzheimer's disease, AIDS-related dementia, stroke).Employ a broad spectrum of surgical, neuroanatomical, and molecular techniques including use of anti-sense oligodeoxynucleotide delivery systems, rodent stereotaxic surgeries, various modes of drug administration, immunocytochemistry, in situ hybridization histochemistry, gel-shift analysis, and DNA supershift binding analysis.Compile, analyze, and present data in oral and written formats for peer review.