Faculty – 2nd Clinical Trial Financial Management Summit

Débora S. Araujo
Associate Director, Site Budgets and Payments, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.

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Débora S. Araujo has over a decade of experience in clinical trial operations with a special focus on the business operations aspects of clinical trials, including clinical financial management, contracting and outsourcing. Working in organizations such as Novartis Pharmaceuticals, Eisai, Inc., and Merck & Co., among others, has given Débora unique insight into the systemic blind spots sponsors have within the clinical business aspects of trials. In her current role as head of the U.S. Site Budgets and Payments group within Boehringer Ingelheim, Débora is responsible for providing leadership and strategic direction utilizing a strong customer-focused approach.

Her upcoming book, The Four Villains of Clinical Trial Agreement Delays and How to Defeat Them, explores the various factors contributing to delays in clinical trial agreement (CTA) negotiations and execution and how to comprehensively deal with these issues. Readers will get an intimate look at each of the different “villains” contributing to clinical trial agreement delays, gain strategies for dealing with each of them, and understand how addressing these villains simultaneously is necessary to truly accelerate the process and comprehensively deal with this industry-wide issue. The book will be released in early spring 2018.

Richard Brand

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Mr. Brand was an investment banker. Heading Robertson Stephens’s Private Capital, he built a number two ranked business in biotech. Mr. Brand raised VC/PE firms’ equity capital as the first broker to do so from public pensions, as a member of the team at Merrill Lynch that achieved number one ranking in the industry and as a founder at DLJ which quickly became number one. He originated and managed Merrill Lynch’s first $1 billion deal. He was an institutional investment manager. Mr. Brand was asked to be CFO and performed the external CFO functions for a public company growing 101% per annum that’s now $6 billion. Mr. Brand is on the Boards of the NYC Alumni Clubs for both the University of Chicago and its Booth School, where he earned his MBA. He graduated from the University of Iowa and was Vice President of the Council of Academic Colleges.

Jonathan Cohen
Executive Director, Business Operations, REGENERON PHARMACEUTICALS

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Jon Cohen has been Executive Director of Business Operations at Regeneron since May 2016. In his current role, Jon is responsible for Vendor Management, Cost Management, Resource Planning, and Clinical Metrics and Analytics and has been leading efforts to drive more efficiency in executing clinical trials. Prior to joining Regeneron, Jon was Executive Director Business Operations at Pfizer, where he directed a contracting organization engaged in writing and negotiating more than 3,000 contracts annually valued at $1.9 billion in annual spend while also leading an analytics and reporting group that developed and delivered a wide range of clinical portfolio, operations and vendor performance metrics. Prior to this role, Jon was in finance roles of increasing responsibility at Pfizer supporting a variety of areas in R&D, where he and his team made contributions to budgeting, forecasting, variance analysis, scenario planning, financial valuations, economic modeling and decision analysis. Jon received an MBA in finance and strategic management and a master’s degree in international affairs from Columbia University. He holds a Bachelor of Arts degree with a double major in history and political science from Tufts University.

Tara Dubois
Head of Clinical Trial Cost Management, PFIZER

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Tara Dubois is Head of Clinical Trial Cost Management within Pfizer’s Global Product Development Business Operations line. Her team was created in 2016 to bring together enhanced data and analytics on Pfizer’s clinical trial costs. Areas of focus include the establishment of novel cost analytics, assessments of the financial impact of efficiency initiatives and development of relevant training and educational materials for clinical teams. In addition, Tara serves as the Investigator Payments process owner for Pfizer and oversees oversee all related payment activity. Prior to taking on this role, Tara was the Chief of Staff of the Development Operations and spent nine years in R&D Finance supporting Development Operations, drug project teams and Financial Planning and Analysis.

Tara holds a B.S. in Accounting from New York University’s Stern School of Business and MBA from the University of Virginia’s Darden School of Business.

Jeff Kingsley

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Dr. Kingsley has been faculty with the Columbus Regional Health Family Medicine Residency as well as Director of Family Medicine and Urgent Care. He currently holds faculty appointments with the Mercer School of Medicine, Philadelphia College of Osteopathic Medicine Georgia, and Georgia Regents University.

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and nine wholly owned and integrated clinical research offices throughout Georgia. The family of companies conducts phase I through IV research in nearly every medical specialty; inpatient and outpatient; pharmaceutical, biotechnology, and medical device. He has dedicated his career to clinical research since 2006.

Dr. Kingsley currently serves as Chair of the Board of Trustees for the Association for Clinical Research Professionals, which represents more than 13,000 clinical research professionals internationally. He is the former Treasurer for ACRP and APCR, Past President of ABSAME, sits on three additional Boards, and participates on numerous other local, national, and international committees.

Jim Kremidas

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Jim Kremidas is currently the Executive Director for ACRP, a nonprofit association the represents the clinical research enterprise. Prior to that he conducted consulting services for a variety of clients, including support for investigator sites, academic institutions, sponsors and suppliers. He was the SVP of Patient Recruitment at two large CROs for more than six years, where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials. Prior to that, he spent 24 years with Eli Lilly and Company. From 1999 to 2008 he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. While in Strategic Sourcing he was responsible for the outsourcing of clinical development projects to strategic suppliers, including CROs, scientific staffing firms and patient recruitment suppliers. Before his assignment in clinical development strategic sourcing, Mr. Kremidas led Lilly’s efforts to select and establish relationships with direct to consumer and professional advertising agencies, as well as to implement standardized processes for the development and implementation of marketing materials.

He is on the advisory board of CISCRP (a nonprofit organization focused on enhancing patient participation in clinical trials) and is also a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the NIH. He is a frequent presenter at industry conferences and his articles/papers have been published in a wide variety of trade journals.

Victor Lucariello

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After college internships, Victor has worked in the pharmaceutical industry for over 15 years, initially working in the labs and progressively moving to a combination of science with finance & business. While at Celgene, during 2010–11 he was responsible for developing and implementing new procedures for site budget development to reflect current business and study needs. As process owner, he created a new site budget appendix format with a separate payment terms document, which has been in use since Jan 2012. These templates have evolved over time to improve negotiation efficiency and even to incorporate industry trends. Victor continues to lead and participate in many initiatives for process improvement within CR&D, coordinating with clinical functions as well as finance and project management.

In his current role, his main responsibilities are budget forecasting for clinical trials and development of investigator grants; from providing high-level estimates for a study concept, preparing detailed estimates for governance presentations, and to the creation and approval of global site budget templates based upon a finalized protocol. Since first working on investigator budgets in 2006, Victor has experience with investigator- and sponsor-initiated budgets for clinical pharmacology through post-marketing studies, primarily in oncology but other therapeutic areas as well. Victor graduated Rutgers University in the pre-medical track with a B.S. focusing on human biology.

Jinyong Oh
Sr. Director, Head of Finance, Global Pharm R&D Operations, JOHNSON & JOHNSON

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Jinyong Oh is Senior Director of Finance, R&D Operations and FP&A. He is responsible for providing financial leadership to the RDO business unit supporting R&D, Marketed Product Support and New Product Development activities globally. He participates in developing long-term strategy and short-term tactics to deliver cost-effective product development and clinical trials. He also provides oversight to the Janssen R&D Financial Planning & Analysis group globally. Jinyong is a member of the RDO Senior Leadership Team and JRD Finance Leadership Team.

Jinyong joined Johnson & Johnson in 2014 as Senior Director & CFO of North Asia Medical Devices and Senior Finance Director of Ethicon franchise Asia-Pac. During his tenor in Asia, he led the business turnaround in the region and the successful North Asia cross-sector ESP implementation and championed the cross-sector talent development in the region.

Prior to joining J&J, Jinyong held various finance leadership positions at Procter & Gamble in the Asia-Pacific region, including regional controller for Asia, FP&A lead, supply chain finance lead in Japan, and as country CFO for their Korea business.

He holds a Bachelor of Business Administration from Seoul National University and is a Certified Management Accountant (CMA). He is also a graduate of the AMP (Advanced Management Program) at Harvard Business School.

Phil Paone
Director of Site Budgets and Contracts, PFIZER

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I am currently the Site and Specialty Contracts Group Lead at Pfizer. I joined Pfizer as an Investigator Contracts Lead in 2008 for the C&O group. I started my career as a programmer with AT&T, became a Project Manager and eventually ended up as Project Executive in strategic outsourcing at IBM, first in the manufacturing sector and finally in the pharmaceutical sector where Covance was my last customer at IBM. After leaving IBM, I worked in law for a few years before joining Schering Plough as a site contracting specialist.

Education: BA, Computer Science, Rutgers University / JD, Rutgers Law School.

James Sacchetta
Manager, Technical Operations, PREMIER RESEARCH

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James Sacchetta has been with Premier Research for five years and held positions in Project Management and Infrastructure Management. Currently, James oversees the investigator grant and forecasting solutions for Premier Research. James leads a global team of Financial Operations Associates responsible for oversight and management of site payments throughout the lifecycle of a study. James spent the first 7 years of his career with Pharmaceutical Product Development (PPD) and held numerous positions within the Clinical Management department.

James holds a Masters of Business Administration in Pharmaceutical and Healthcare Management from the University of Sciences in Philadelphia. In addition, James holds a Bachelors of Science from Loyola University Maryland in Baltimore Maryland.

Crystal Wilmesherr
Senior Category Manager, Science and Technology Services, Specialty Generics, MALLINCKRODT PHARMACEUTICALS

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Crystal Wilmesherr is a Senior Category Manager with Mallinckrodt Pharmaceuticals. Crystal currently supports sourcing for all R&D services to meet the needs of Mallinckrodt Pharmaceuticals Specialty Generics business. She began sourcing clinical research services seven years ago when Mallinckrodt was Covidien’s Pharmaceutical business. Crystal evolved with Covidien’s divestiture of Mallinckrodt and numerous acquisitions, to support the diverse specialty pharmaceuticals company that Mallinckrodt is today.

Crystal earned her Cellular and Molecular Biology degree from University of Missouri St. Louis. She also attended Southern Illinois University Edwardsville for Project Management and is a member of Project Management Institute’s St. Louis Chapter and is a Drug Information Association member. Crystal resides in St. Louis, Missouri.

Kim Zahan
Senior Director Finance, GLAXOSMITHKLINE

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Kim Zahan is Senior Director of Finance HCP Compliance for the R&D Division of GlaxoSmithKline. He joined GSK in 2002 and has over 25 years of experience in various Finance and Compliance functions in the Pharmaceutical industry. Prior to joining GSK, Kim was the Assistant Controller worldwide for RPR/Aventis. Kim has also been the Director of Finance for the US R&D Division of RPR. At GSK, Kim created and implemented the Sarbanes-Oxley program for the research organization of GlaxoSmithKline. More recently, Kim has been responsible for the HCP monitoring and reporting for the R&D organization of GSK, including Sunshine Act, State Reporting and public disclosures of payments to HCPs as well as the European EFPIA reporting. Kim is a Business graduate of the ESCP-Europe.