7th CROWN Congress - The Westin Philadelphia

7th CROWN Congress
January 23 - 25, 2018
The Westin Philadelphia
Philadelphia, PA

An Elite Gathering of Clinical Decision-Makers Ready to Learn, Network and Engage on Topics Critical to the Effective Development, Execution and Management of Clinical Trials

Faculty – 7th CROWN Congress

Gail Adinamis

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Gail Adinamis provides vision, leadership, strategic planning and oversight for GlobalCare Clinical Trials. Ms. Adinamis is an accomplished executive with more than 35 years of comprehensive phase I-IV clinical trials experience, including more than 12 years of global clinical trials management at Abbott Laboratories and Astellas Pharma US. Ms. Adinamis founded the business model for centrally managed in-home and alternate site services for clinical trials in 1992.

Ms. Adinamis is an industry thought leader and has spoken at more than 30 industry conferences. She is an entrepreneur with strong business development and operational expertise along with a proven track record for success. She established and headed clinical trials divisions for three national home infusion companies. She was also the Founder and CEO for a niche clinical trials service organization providing a mobile network of clinicians to speed patient recruitment and increase compliance and retention for sponsored clinical trials.

Ms. Adinamis was recognized for two consecutive years by INC 500/5,000 as being among the leaders of the top 5,000 fastest-growing private companies in the United States and received merit-based awards for CEO of the Year and International Game Changer of the Year.

Munther Baara
Head of New Clinical Paradigm, PFIZER

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Munther Baara has over 20 years of experience in the pharmaceutical industry. He is currently Sr. Director of Development Business technology at Pfizer, a worldwide pharmaceutical company. Munther is currently the head of New Clinical Paradigm within the GPD-BT Development at Pfizer, Munther is spearheading initiatives driving innovation in development operations to align with the paradigm shift in the clinical trials execution model and emerging technologies.

In addition, Munther Led the Clinical Aggregation Layer (CAL) implementation of a high-profile, large-scale clinical private cloud of clinical and operational data. In addition, he has extensive experience in application and system strategies, best practices, and standards that work for clinical and enterprise architecture, information management, workflow/process automation and integration of both home-grown and commercial applications across mixed platforms

Peggy J. Berry, MBA, RAC

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Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

Stephen Brannan, M.D.

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Dr. Brannan is a neuroscience drug development expert who has held senior positions overseeing both clinical development and medical affairs with more than 15 years of industry experience. Previously, Dr. Brannan was the Therapeutic Head of Neuroscience at Takeda and Vice President for Clinical Research and Medical Affairs at Forum Pharmaceuticals. Dr. Brannan has been active in the development of multiple important central nervous system treatments including Cymbalta, Exelon Patch, Trintellix, and VNS for Treatment Resistant Depression while holding various senior roles at Forum, Takeda, Novartis, Cyberonics, and Eli Lilly. His experience includes drug development, registration, medical affairs, launch and lifecycle management in the areas of anxiety, depression, epilepsy, neuropathic pain, schizophrenia, migraine, cognition, and Alzheimer’s and Parkinson’s diseases. Dr. Brannan is a member of several scientific societies and groups, including ISCTM, ISCDD, AARR, IOM Neuroforum, and CNS Summit (founding member). Prior to joining the Pharmaceutical industry, Dr. Brannan worked on the faculty at the University of Texas Health Science Center at San Antonio (UTHSCSA) where he specialized in seeing Mood and Anxiety disorder patients, ran a clinical research unit, and did neuroimaging research at the Research Imaging Center. Dr. Brannan trained in psychiatry at UTHSCSA and holds a M.D. degree from the University of Texas Health Science Center at Dallas (Southwestern Medical School). He has over 40 publications and routinely gives invited talks and presentation at industry conferences.

Craig Coffman
Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS

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Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, NEKTAR THERAPEUTICS

Craig Coffman is currently Executive Director, Clinical Business Operations & Outsourcing at Nektar Therapeutics. He is focused on providing strategic direction, oversight and expertise to the organization in order to bring operational excellence to the business planning and financial management of clinical trials, and to the identification, selection and management of external service providers. Prior to his career in outsourcing, Craig held senior management and leadership positions with CROs in a variety of functions including business development, corporate marketing and clinical operations across pre-clinical, clinical and contract manufacturing service providers.

Stan Collender
Executive Vice President, MSLGROUP

Clinical Trial Participant

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Stan Collender, executive vice president for MSLGROUP, is one of the United States leading experts on the federal budget, federal spending and revenues, the national debt and the congressional budget process.

Stan is one of the most quoted pundits in the U.S. on all aspects of the federal budget and Washington’s response to economic and financial challenges and speaks to more than 100 corporate and association groups each year.

During the difficult 2011 debt ceiling debate in Washington, Stan appeared more than 200 times on television and radio including all of the broadcast networks and multiple interviews on Marketplace and other National Public Radio programs. He was also quoted regularly by the Wall Street Journal, New York Times, Washington Post and Los Angeles Times and appeared repeatedly on foreign channels including the BBC and Russian, German and Chinese television.

In the months leading up to the fiscal cliff in 2012, Stan was a regular on-air contributor to Bloomberg television and radio. Before and during the government shutdown in 2013 and for several months afterwards, Stan was a frequent guest host on Bloomberg television.

In 2009, the Wall Street Journal named Stan’s blog — “Capital Gains and Games” — one of the top 25 economic blogs in the United States. The blog is now published by Forbes.

Stan is the author of The Guide to the Federal Budget, which was one of the most assigned texts on the federal budget process during the 19 years an annual edition was published. He was also the writer of the very popular “Fiscal Fitness” column for Roll Call and “Budget Battles” for National Journal.

Stan has been involved with the congressional budget process since 1974 and is one of only a handful of people who has worked for both the House and Senate Budget Committees. As a member of the House Budget Committee staff he served as administrator of the Task Force on State and Local Government. For the Senate Budget Committee, he was responsible for analyzing defense spending. Stan also served as the administrator of the Task Force on the Budget of the Northeast-Midwest Congressional Coalition, a bipartisan group of representatives from the states in those regions.

Stan has worked for many of the major professional services firms in the world including Fleishman-Hillard and Burson-Marsteller. He was also director of federal budget policy for two major international accounting firms—Price Waterhouse and Touche Ross—and president of the Budget Research Group, a private Washington-based consulting organization.

Stan is a recipient of the Howard Award for lifetime achievement in federal budgeting from the American Society for Public Administration and was the 2012 winner of the prestigious James L. Blum Award from the American Association for Budget and Program Analysis.

In 1998, President Bill Clinton appointed Stan to the presidential commission that studied whether the U.S. should have a capital budget.

He currently teaches a course – “The Federal Budget in a time of Madness” – at the McCourt School of Public Policy at Georgetown University.

Stan holds a master’s degree in public policy from the University of California, Berkeley, and a BA from New York University. He lives in Virginia with his wife, a professional actress who has absolutely no interest in politics, public policy, or federal deficits. Because of that, they get along extremely well.

Eileen M. Daniel
Former Executive Director, Clinical Operations, NEKTAR THERAPEUTICS

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Eileen Daniel is Executive Director, Clinical Operations for Nektar Therapeutics, where she leads teams accountable for the planning, execution, oversight and delivery of clinical studies. She has done the work, written the procedures, entered the data, led the teams and built the business models over her 25+ year pursuit of making it easier to do what is necessarily complex. Her career spans all phases of clinical development and a diversity of therapeutic areas and functional domains. Eileen is insistent on walking the walk of every study team member and growing the skills to apply the modern tools of our time.

Dany DeGrave
Senior Director Innovation Programs & External Networks, SANOFI

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Dany DeGrave currently leads the implementation of various cognitive and other innovative technologies in departments like R&D and Regulatory Intelligence. He also explores and evangelizes blockchain applications in the healthcare space.

Dany is an engineer trained in biology and has over 20 years of industry experience at leading global vaccine companies GSK and Sanofi Pasteur. In various positions he contributed to the research, product and clinical development, manufacturing and regulatory submission of both companies’ line of vaccines. Next to vaccine and automation projects he developed and lead forward-looking change initiatives like “Project M: An Experiment in New Ways of Working, Inspiring Engagement, and Unleashing Talents” for which the team received multiple international awards.

Kristy Galante, M.S.
Director/External Alliances, Global Clinical Development Operations, JANSSEN RESEARCH & DEVELOPMENT, LLC

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Kristy Galante has over 17 years of experience in the clinical research industry in both the pharmaceutical and CRO arenas. At present, Kristy is a Director of External Alliance at Janssen R&D. In this role, Kristy’s primary focus is in CRO collaboration with a focus on establishing and managing process and infrastructure and driving innovation within various outsourced models. Prior to her current role, Kristy played in integral part in clinical trial leadership in several global clinical trials within Janssen R&D. Kristy holds a B.S. in Biochemistry from Mount Saint Mary’s College and a M.S. in Quality Assurance / Regulatory Affairs from Temple University School of Pharmacy.

Kenneth A. Getz, MBA
Chairman, CISCRP


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Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategies and tactics, outsourcing, and global investigative site and patient recruitment practices and policies. He is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise.  Ken is also the founder and owner of CenterWatch, a leading publisher in the clinical trials industry, and a board member of the Metrics Champion Consortium, LLC.

A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press.  He is the author of two nationally recognized books for patients and their advocates entitled Informed Consent: A Guide to the Risks and Benefits of Volunteering for Clinical Trials and The Gift of Participation, and he is the recipient of several awards for innovation and scholarship.  Ken has held a number of board appointments in the private and public sectors including serving on the Institute of Medicine’s Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative. He is on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science, writes a bi-monthly column nominated for a Neal Award in 2010 for Applied Clinical Trials, and has been twice nominated for Tufts University’s Distinguished Service award.

Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for more than seven years in management consulting where he assisted biopharmaceutical companies develop and implement business strategies to improve clinical development performance.

Jon Godshall
Director, Clinical Development Quality, Vendor Quality Lead, PFIZER

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Jon Godshall is a Director of Clinical Development Quality at Pfizer. Jon has 33 years of experience in pharmaceutical development across a number of disciplines, including statistics, clinical programming, clinical operations, and vendor quality management. In Jon’s current role within Clinical Development Quality, his responsibilities include monitoring of vendor GCP quality performance, vendor quality risk management assessment, and vendor quality planning. Jon holds M.S. degrees in Applied Statistics, and Business Management, as well as a B.A. in Mathematics.

Kevin Hudziak
Emerging Strategy Consultant, ELI LILLY & CO.

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Kevin Hudziak works in the Clinical Innovation team at Eli Lilly and Company. Kevin focuses on delivering digital solutions to meet the needs of patients and help them find clinical trials that are right for them. He has worked on industry collaborations like CTTI and TransCelerate to help deliver meaningful solutions for patients.

Mitchell Katz, Ph.D.
Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA

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Dr. Mitchell Katz is Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. In this position he is responsible for leading all operational activities across Purdue’s multinational clinical programs.

Dr. Katz has over 25 years’ experience in the pharmaceutical and biotechnology industries, including preclinical research, pharmaceutical operations, and regulatory affairs. Prior to joining Purdue, he served as Vice President of Global Clinical Operations & Data Management at Eisai Medical Research. Dr. Katz has experience working in start-up biotechnology companies, including Acorda Therapeutics, InterMune, Connetics, and NABI. He also held management positions at Ortho Biotech and Schering-Plough and participated in seven successful NDA applications in his professional career.

Dr. Katz holds a B.A. in Biology, a Ph.D. in microbiology, and served as a postdoctoral research fellow at Downstate Medical Center in NY.

Alan Kott, MUDr.
Clinical Vice President and Practice Lead, Data Analytics, BRACKET

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Dr. Kott is based in Bracket’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of data analytics in multiple large schizophrenia studies. For the past seven years, he has also provided training to investigators as an Expert Trainer.

Dr. Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty – Department of Psychiatry, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr) from Charles University.

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.

Patricia Leuchten

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With more than 25 years of experience in the pharmaceutical industry, Patricia Leuchten is a leading authority on global clinical outsourcing and strategic alliances.

In 1999, Ms. Leuchten founded The Avoca Group, a consulting and research firm specializing in quality in outsourced clinical trials. The Avoca Group has shaped the industry as the first consulting firm to track trends in clinical outsourcing and to measure the health of relationships between sponsors and CROs.

Ms. Leuchten launched the Avoca Quality Consortium in 2011 to encourage the sharing of leading clinical practices and to bring sponsors and CROs into greater alignment. Since its inception, the consortium has brokered collaborations that have improved quality, mitigated risk, and increased efficiency in outsourced clinical trials.

Maryann Livolsi, MSN, RN, RQAP-GCP
Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALS

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Maryann Livolsi, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE

Accomplished leader in R&D Quality Assurance with effective management experience worked in small, mid-sized and large pharmaceutical/bio-pharmaceutical companies, in depth knowledge in clinical trial management, GXP auditing, process gap analysis, SOP development and regulatory inspections. Effectively lead process for Quality and Performance Metrics Dashboards for R&D Compliance, adjunct professor for Drexel University Clinical Pharmacology Master’s Program, presents at industry related conferences including Linking Leaders and Exl Pharma. Over 25 years of clinical research experience. Six Sigma Graduated Rutgers University with a Bachelor’s Degree in Nursing and received a Masters of Nursing Administration from University of Pennsylvania and The Wharton School.

Zabir Macci
Clinical Operations Process Design and Analytics, IQVIA

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Zabir is a Process Design & Analytics Manager for QuintilesIMS focused on their approach to risk-based monitoring (RBM), Data-driven Trial Execution. He brings expertise spanning risk-based monitoring, business analysis, continuous process improvement, and analytics for clinical trials. He is currently a process lead for Centralized Monitoring, including advanced analytics, for clinical trial design and execution. He holds a Bachelor’s degree in Computer Science from India and has an MBA in Management and Marketing from USA.

Atul Mahableshwarkar, M.D., DFAPA
Vice President, Clinical Development, BLACKTHORN THERAPEUTICS

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After studying Medicine at the Armed Forces Medical College in India, Dr. Mahableshwarkar completed a residency in Psychiatry and a fellowship in Neuropsychiatry at the University of Health Sciences/The Chicago Medical School. During 13 years of clinical practice he ran an inpatient ward, was Director of ECT services for 8 years and ran the Consultation/Liaison services. He was chief of Mental Health Services at the North Chicago VA Medical Center and Associate Professor and Vice Chair at the Department of Psychiatry and Behavioral Sciences at the University of Health Sciences/The Chicago Medical School. During 15 years in the Pharmaceutical Industry he has designed and conducted clinical trials globally in Alzheimer’s disease, anxiety disorders, bipolar disorder, major depression and schizophrenia and has lead the development program leading to the approval of a new antidepressant. His interests are in clinical trial methodology and he has been a founding member of the ISCTM and CNS Summit and a member of the Scientific/Program Committees for both societies. He has published in all, over 140 articles/posters/abstracts/invited commentaries and book chapter.

Laura Marquis
Senior Vice President, U.S. and Canada Mid Pharma and Emerging Biopharma Sales, IQVIA

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Laura Marquis has 22 years of Clinical Research experience in pharma and CRO businesses. Throughout these years, Laura has held roles in Clinical Operations, Project Management, Alliance Management and R&D Sales Management.

Laura is currently Senior Vice President, Mid Pharma and Emerging Biopharma Sales, at IQVIA where she is responsible for driving the development of the segment’s business strategies and partnership models in the U.S. and Canada for Mid Pharma and Emerging Biopharma customers.

Prior to this role at IQVIA, Laura was the Global Head of the Emerging Biopharma Segment, responsible for the development of the business strategy, customer insights and delivery best practices of the work performed for Emerging Biopharma customers worldwide. Laura also spent six years in alliance management with responsibilities for leadership, development, and management of global strategic partnerships with services in Clinical Development, Consulting, and Commercialization.

Outside of her time at IQVIA, Laura is actively involved in the local community where she holds board positions with the Carolinas Chapter of the Cystic Fibrosis Foundation and Leadership Triangle.

Michael Martorelli

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Mr. Martorelli came to Fairmount after serving as managing director of research and senior health care analyst at Investec Inc. and its predecessor, PMG Capital. Prior to PMG Capital, Mr. Martorelli spent more than ten years at Janney Montgomery Scott as a research analyst covering companies in various segments of the health care industry.

In addition to participating in Fairmount’s healthcare industry investment banking activities, Mr. Martorelli contributes to the firm’s marketing and business development efforts with periodic industry reports and conference presentations. For the past two decades he has focused his writing and speaking efforts on pharmaceutical services companies, including those providing tools and technologies used in both pre-clinical and clinical research functions. Mr. Martorelli has participated in conferences and similar programs covering various outsourcing topics and sponsored by the Drug Information Association (DIA), the Tufts Center for the Study of Drug Development (CSDD), and other organizations. In addition to speaking, he has written for publications such as Contract Pharma, European Pharmaceutical Contractor, and Clinical Research and Regulatory Affair. He recently authored a chapter in Re-Inventing Drug Development, published by the CRC Press imprint of Taylor & Francis Group.

Mr. Martorelli received his M.B.A. and his B.S. in business administration from Drexel University. He has been an adjunct instructor or guest lecturer at Drexel, Philadelphia University, and several other colleges in the Philadelphia area.  He is a Chartered Financial Analyst (CFA) and a member of both the CFA Institute and the CFA Society of Philadelphia.

Jean Mastrangelo
Senior Manager, Clinical Operations, LUYE PHARMA

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Jean has over 13 years of experience in the Clinical Operations and Regulatory Affairs area of Clinical Research. She is a knowledgeable clinical research professional and her career path has given her well-rounded experience in Drug, Device and Biologic research, in addition to overseeing and performing clinical operations. Her credentials include a BS in Business, MS in Clinical Research Administration, proficiencies in generally accepted research practices (GCP, ICH and FDA Code of Federal Regulations) as well as management and leadership skill sets. During her career, Jean has worked on trials in the United States (US), Japan, China, Europe and South America. Her extensive experience includes the Clinical Research Organization (CRO) and Pharmaceutical side of research as well as the Regulatory Affairs side including Investigational New Drug (IND) Submissions and meetings with Federal Drug Administration (FDA).

Kelly McKee
Advisor, Clinical Innovation, ELI LILLY & CO.

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Kelly Johnston McKee is a clinical trial innovator and problem solver with a focus on patient recruitment and engagement. As a leader in the Clinical Innovation and Optimization group at Eli Lilly and Company, she is responsible for the design and successful deployment of game-changing strategies and tactics worldwide. Kelly has been in the industry for over 18 years with previous positions at Merck and Sanofi-Aventis. She has an in-depth understanding and application of novel tactics and technology in protocol feasibility, site selection, and patient recruitment. Kelly was named Pharma Times U.S. Clinical Researcher of the Year in 2012 in the clinical research team category and one of Center Watch’s 2018 Top Innovators.

Ed Miseta

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As an editor of Clinical Leader and Life Science Leader, Ed produces original articles on topics and issues related to clinical research, clinical operations and sponsor/CRO relationships. He also edits contributed articles and is instrumental in producing two weekly newsletters for Clinical Leader. In addition to his writing responsibilities, Ed also attends industry trade shows and takes part in moderating panel discussions and focus groups.

Prior to joining the Life Science Connect team at Jameson Publishing, he spent nine years covering the mass storage industry as editor for Business Solutions magazine and the newsletter Mass Storage News.

Ed also spent 10 years in the banking and financial service industries as an auditor, mortgage loan operations manager and investment consultant, in addition to spending eight years as a lecturer in economics for his Alma Mata Penn State, where he taught courses in microeconomics, macroeconomics, labor economics, and money and banking.

Ed has a B.S. degree in business economics and a master’s degree in business administration, both from The Pennsylvania State University.

Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP
Director, Quality Assurance, INSEPTION GROUP

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Dawn Niccum, Quality Manager, ENDOCYTE, INC.

Dawn Niccum is Director, Quality Assurance for the inSeption Group and responsible for all areas of QA including compliance, Policies and SOPs, and training. She was formerly with Endocyte, Inc. as Associate Director, QA. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs and Quality Compliance, certifications as a Clinical Research Associate (CCRA), Registered Quality Assurance Professional – GCP (RQAP-GCP) and Project Manager (PMP), and is a registered nurse.

Maria Palombini
Director, Communities and Initiatives Development, Emerging Technology, IEEE STANDARDS ASSOCIATION

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In 2017, Maria joined IEEE-SA with a directive to build communities and advance initiatives to develop standards for enterprise adoption of emerging technologies. Her work includes building communities of technologists, industry executives, academic researchers and industry stakeholders to educate on the benefits and challenges of technologies such as blockchain/DLTs, while building consensus on recommendations for frameworks on technical standards and recommended guidelines for protocol and policies to enhance the outcomes of technology implementation. Her primary areas of focus for blockchain adoption include the pharma, health, supply chain, energy, and agriculture sectors. In parallel to her work in blockchain standards, she is the project lead for IEEE-SA’s newest initiative, Digital Inclusion through Trust and Agency, a critical program focused on providing a solution and guidelines that gives the right to all members of the global community to be digitally included with equal right to manage and protect their digital citizenship and to be forgotten online and offline, and restore dignity to digital transactions between the individual and the entity.

In 2015, Maria left Euromoney Plc, one of the world’s leading information and event Producers. She founded DisruptiveRx™, an information company that would produce written and in-person educational programs and bring pragmatic attention on breakthrough innovations that would transform life sciences and healthcare enterprise operations.

Her career started at the prestigious IEEE (Institute for Electronic and Electrical Engineers) and moved onto highly respected media companies including Penton Media, Advanstar Communications, IIR, Reed Business Information and Nielsen Business Media. She successfully led the global branding, marketing and public relations campaign for the world’s largest mining investment networking platform, Mining Indaba™, in Cape Town, South Africa.

Maria currently holds an MBA from the Rutgers Graduate School of Business and a BA and BS from Rutgers College at Rutgers University, the State University of New Jersey. She is an accomplished leader and public speaker having presented at various industry events. You can follow her on twitter @DisruptiveRx or on LinkedIn.com/in/mpalombini.

Linda Peterson
Associate Director, Clinical Operation and Global Integration, INOVIO PHARMACEUTICALS

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Ms. Peterson is an Associate Director of Clinical Operations and Global Integration for Inovio Pharmaceuticals. In addition to her regular role, she has been working as the project manager and a Core Team member for the new Quality Risk Management System (QRMS) helping to develop and manage “perpetual compliance” within this initiative. Prior to joining Inovio, Ms. Peterson worked for Genentech as a Sr. Global Clinical Trial Leader. Ms. Peterson earned her BA in Biology from Mississippi University for Women, her MA in Management from the University of Maryland, Bowie State and a graduate certificate in QA/RA from Temple University’s School of Pharmacy.

Maryrose Petrizzo
President and Principal Consultant, CLINICAL QUALITY ASSURED, LLC.

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Maryrose Petrizzo is a Clinical Quality Assurance professional with over 21 years’ experience in good clinical practice compliance. As President and Principal Consultant for Clinical Quality Assured, LLC since 2015, she helps clients to balance the letter and spirit of the law with business needs for the conduct of clinical trials within the pharmaceutical, biopharmaceutical, and medical device industries. Maryrose is an expert in vendor management, Auditing, SOP gap analysis and SOP development, Training, Inspection Readiness, Acquisitions and Integrations, and providing ad hoc compliance assistance.

Richard Polgar
Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBB

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Rich Polgar is the Director of R&D Global Procurement at Bristol-Myers Squibb. He joined the organization in 2009 and has held positions of increasing responsibility as a category strategist for the CRO and Clinical Lab areas. Rich recently developed and implemented a strategy that has integrated central labs, biomarker labs and bioanalytical labs with internal operations at BMS. This effort reduced costs by more than 25% while bringing new technology and innovation into the organization. Rich’s efforts in logistics have achieved more than 35% savings through demand management, cost control and innovation. His efforts in the lab space have expanded beyond pricing and focused on study design optimization, reduced blood draws, integration of new technology, strategic technology transfers of assays as well as reduced cycle time through better program and enterprise-level planning of assays. This effort has saved more than 42 million dollars in three years.

Prior to BMS, Rich worked at Schering-Plough in the Vendor Strategy & Management group and at two CROs. Rich earned his B.S. in Biology and his Masters in Neuroscience from Syracuse University.

Joe Pollarine
Senior Director, GxP Systems Strategy, BioResearch Quality and Compliance, JANSSEN RESEARCH & DEVELOPMENT, LLC

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Joe Pollarine has 20 years of experience in the clinical research industry in both the pharmaceutical and CRO arenas. At present, Joe is a Sr. Director of GxP Systems Strategy at Janssen R&D. In this role, one of his key focus areas is quality oversight of outsourced clinical trials. Prior to his current role, Joe has held various leadership roles in operational quality at Janssen R&D as well as various technical roles in clinical operations and quality assurance at ICON Clinical Research. He holds a B.S. in Biology from Ursinus College.

Holly Posner, M.D., M.S.
Senior Director, Clinical Development, Global Product Development Group, PFIZER

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Dr. Posner is professionally trained in Neurology (Cornell University, New York Hospital, currently board certified) and Internal Medicine (Columbia University, Columbia Presbyterian). She also completed a fellowship in aging, cognition, dementia and behavior as well as a master’s in epidemiology, both at Columbia University.

She has raised monies from nonprofit sources to do analysis in non-proprietary data to improve the endpoints used in clinical trials of Alzheimer’s disease and its precursors. The core outcome of this was several publications and an interest in evaluating the item-level and patient-level data in clinical trials. More recently she has been the Co-Chair of the Cognitive Outcomes/Ideal Alzheimer’s prevention trial Working Group of the International Society for Clinical Trials Methodology (ISCTM). Two publications will soon be published.

She has also worked with Sid O’Bryant, Ph.D., researcher in blood-based biomarkers for AD, to bring together the perspective of pharmaceutical companies and academia. She has been a co-author on two publications with him.

She has been employed at Pfizer since 2007 and has worked on clinical trials in epilepsy with Lyrica. In the past several months she has moved over to work on Xeljanz for juvenile idiopathic arthritis.

Stephen Potter
Director, Clinical Development Quality, PFIZER

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Stephen Potter is a Director of Clinical Development Quality at Pfizer. Stephen has 23 years of experience in pharmaceutical development across a broad array of disciplines, including risk assessment and mitigation, quality assurance, clinical operations, and global feasibility. Currently, as Director of Clinical Development Quality his responsibilities include managing the operational activities for quality risk management as well as supporting clinical trial quality planning and oversight. Stephen holds an M.A. in biology as well as B.S. degrees in business administration and biology.

Scott Rauscher
Director, Global Procurement R&D, BRISTOL-MYERS SQUIBB

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Scott Rauscher is the Associate Director of Global Procurement & CRO Category Lead for BMS. Scott has a bachelor’s in engineering from Villanova University and a master’s in finance from Rutgers. He has spent the last 15 years in the pharmaceutical industry working in clinical operations and outsourcing. Prior to joining BMS he was the owner of a Pyxis Clinical Research, a specialty CRO focused on providing operational support to the biotech industry.

Jonathan Rowe, Ph.D., M.S., M.A.
Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

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Jonathan Rowe has 20 years of experience supporting pharmaceutical companies in the development of medical therapies from the clinical, operational and business perspectives. Currently, Jonathan holds the position of Executive Director, Head of Clinical Development Quality Performance and Risk Management at Pfizer, where his responsibilities include monitoring, modeling and predicting the Pfizer GCP Quality Management System, leading the analysis of Pfizer’s Clinical Trial Quality Performance and ensuring clinical trial quality risk management is built into all trials. At Pfizer he has held a number of roles including Clinical Director, with responsibility for the Phase IIIb and IV Lipitor program; Director, Intellectual Property Strategy Management; and Senior Director of Process and Performance. Jonathan spent a number of years in “small pharma” as the Head of Intellectual Property and Portfolio Strategy for Amarin and Dignity Sciences. Jonathan earned his Ph.D. and M.S. at the Albert Einstein College of Medicine and his M.A. from Binghamton University.

Karen Roycroft
Director, Clinical Quality Assurance, INOVIO PHARMACEUTICALS

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Karen Roycroft, Associate Director, Clinical Quality Management, OTSUKA

Ms. Roycroft is the Director of Clinical Quality Assurance for Inovio Pharmaceuticals. In this role she has developed and manages the GCP audit program and provides GCP expertise to the Clinical teams.  Ms. Roycroft brings more than 20 years of regulated industry experience across GMP/GLP/GCLP and GCP.  Prior to joining Inovio Ms. Roycroft worked for Otsuka America Pharmaceutical where she developed and managed the Inspection Readiness program in addition to GCP auditing and metrics reporting. Ms. Roycroft earned her BA in Biology from Augustana College.

Fabian Sandoval, M.D.

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Dr. Fabian Sandoval, CEO & Medical Director, has over 18 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine.

Before opening the doors to Emerson Clinical Research Institute (ECRI) Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease. At the NIHs’ Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center.

Dr. Sandoval served as the Supervisory Research Integrity & Compliance Officer in the Army Human Research Protections Office in the Office of the Army Surgeon General. Responsibilities included establishment, and oversight of Human Research Protection Programs across Army commands. His input has been instrumental in the review, development, and selection of protocols, in addition to education and training for resident and hospital faculty.

Outside of ECRI

In addition to his commitment to improve the representation of minorities in clinical research, Dr. Sandoval holds the following esteemed positions in the following community areas:

  • Medical News contributor on his weekly medical segment “Tu Salud Tu Familia” Telemundo WZDC Washington D.C
  • Leadership Council member, Society for Clinical Research Sites (SCRS)
  • Invited speaker/presenter to multiple pharmaceutical and clinical trial organizations; on the topic of increasing minorities’ engagement, education and participation, in clinical trials.

Bonnie Segal
Vice President & Co-Founder, SEGAL TRIALS

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Bonnie Segal is the Vice President and Co-Founder of Segal Trials, a consortium of research sites specializing in Psychiatry, Neurology, Addiction, Women’s Health and General Medicine.

Bonnie has been in medical research for 19 years and has been involved in every area of Segal Trials’ expansion and diversification. She leads the business development, operations and recruitment teams, as well as the company’s community advocacy initiatives, staff engagement and staff leadership programs. Bonnie has been a crucial part of the success of over 1,100 clinical trials conducted at seven research sites throughout South Florida and South Carolina.

Bonnie began her healthcare career in 1993 founding Positive Aging, a company specializing in psychiatric services for individuals residing in long-term care facilities. After the sale of Positive Aging, she started and sold another healthcare company, Essentials in Psychology before co-founding Segal Trials in 1998. Bonnie has a Bachelor of Science in Advertising from the University of Florida. Currently, Bonnie is on the CISCRP (The Center for Information and Study on Clinical Research Participation) Advisory Board, CNS Summit Leadership Council, Bracket Site Advisory Board, and has most recently been appointed to the Board of Directors for NAMI Broward County.

Cassandra R. Smith
Associate Director, Investigator and Patient Engagement, JANSSEN

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Cassandra Smith is currently an Associate Director of Investigator & Patient Engagement at Janssen, focusing on Patient Engagement strategies. In this role, Cassandra is currently working on Informed Consent and eConsent initiatives.

Paul Spreen
Executive Vice President and Chief Customer Officer, IQVIA

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Paul Spreen is Executive Vice President and Head of Sales, Account Management and Clinical Operations for IQVIA’s Research & Development Solutions in the U.S. Canada.

A veteran of the drug research and biopharmaceuticals industries, Paul joined Quintiles in 1996 as a business development representative. In the years that followed, Paul served in a variety of increasingly senior customer-focused roles within the company’s clinical development organization. He was formerly president, Customer Solutions Management Group, where he was responsible for all aspects of the company’s customer management, marketing, and communications efforts. Prior to taking on his new responsibilities, Paul served as EVP and Chief Customer Officer, working directly with our senior-level clients to develop groundbreaking enterprise-level opportunities across the IQVIA portfolio. Prior to joining Quintiles, Paul spent five years as a researcher with a market leader in early development services.

Paul attended Northeastern University and also completed internships at Arthur D. Little Research Laboratories and Brigham and Women’s Hospital.

Evan L. Tzanis
Senior Vice President, Clinical Development and Medical Affairs, PARATEK PHARMACEUTICALS

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Evan Tzanis joined Paratek in September 2014 and is Senior Vice President of Clinical Development and Medical Affairs. In this role, He oversees the strategic and operational deliverables for the clinical development and medical affairs functions. Mr. Tzanis brings over 20 years of global drug development experience in all aspects of clinical, operational, and regulatory processes. Prior to joining Paratek, Mr. Tzanis served as Head of Clinical Operations and Biometrics at Endo Pharmaceuticals where he also had leadership responsibility in clinical and project management. During his tenure with Endo, Mr. Tzanis was responsible for a number of late-stage development programs, including BEMA® Buprenorphine (Belbuca). Prior to joining Endo, Mr. Tzanis was the Global Clinical Program Leader at Wyeth and Pfizer for a number of successful new products on the market today to treat a range of CNS disorders including panic disorder, major depressive disorder, sleep and other medical conditions, including opioid-induced constipation and rheumatoid arthritis.

MarlaJan Wexler
Creator/Author, LUCK FUPUS

Patient Leader

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MarlaJan Wexler is 35 years old, was born with a complex congenital heart defect and had four open-heart surgeries by the time she was six. She went from pediatric cardiac ICU patient to pediatric cardiac ICU nurse until being diagnosed with systemic lupus erythematosus (lupus). Due to complications from the disease, she was forced to put her nursing career on hold. Since 2008 she’s been diagnosed with lupus and multiple overlapping autoimmune diseases, cervical cancer, and underwent a double mastectomy December 2014 after a lump was found in her breast.

She’s the creator and author of the blog Luck Fupus, www.luckfupus.com, where she writes about the day-to-day and long-term struggles of living with multiple chronic illnesses. She’s known for her humorous, non-sugar-coated, keep-it-real style of writing. Her blog was used as a platform to help her become a patient leader and influencer, and she now travels the country attending healthcare conferences, speaking publicly sharing her story, and educating and advocating for patients across the globe.

Steve Whittaker
Senior Consultant, THE AVOCA GROUP


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Steven B. Whittaker is Executive Director for The Avoca Quality Consortium and Senior Consultant for the Avoca Group, where he conducts Quality Workshops, Executive Level Consulting for Pharmaceutical Quality, Clinical Development, Project Management, Sourcing, Alliance and Relationship Management. The Avoca Group is the driving force behind the continuous improvement of outsourced clinical research. Through Avoca’s industry research expertise, 62 plus Consortium Members, and body of over 250 tools that empower and enable drug development teams, Avoca helps bring medicines to patients in a more effective manner.

Steve is an independent consultant for the pharmaceutical, biotech, and CRO industries, providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. His wealth of experience through years of drug development leadership roles and his established network with professionals across these industries provide a unique and valuable combination of insights for organizational leaders. Whittaker has served for 12 consecutive years on the Advisory Board for the annual Partnerships in Clinical Trials program, chairing the board for two years. In addition, Whittaker has moderated numerous quarterly Clinical Research Consortium forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across several top-tier pharmaceutical and biotech organizations.

Whittaker retired from Eli Lilly and Company in December 2009 where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. As the leader of the Global Clinical Research Sourcing Office, Whittaker established Lilly’s first corporate strategy, and operational design for outsourcing global clinical development to CRO preferred partners. This included the selection and initial implementation of the preferred partner approach for global, full-service CRO capabilities. Whittaker also led Lilly’s Project Management Center of Excellence, establishing standards for leaders of project development.

John Whyte, M.D., MPH
Director, Professional Affairs and Stakeholder Engagement, CDER, FDA

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John J. Whyte, MD, MPH is currently the Director of Professional Affairs and Stakeholder Engagement at the Center for Drugs Evaluation and Research at the U.S.  Food and Drug Administration.  In this role, Dr. Whyte works with health care professionals, patients, patient advocates, and others involved in the use of medicines. His office provides them with a focal point for advocacy, enhanced two-way communication, and collaboration, and assists them in navigating the FDA on issues concerning drug development, review, and drug safety. He also oversees the Safe Use program and supports the ongoing partnerships and activities under the Safe Use Initiative.

Previously, Dr. Whyte served as the Chief Medical Expert and Vice President, Health and Medical Education at Discovery Channel, the leading non-fiction television network. In this role, Dr. Whyte developed, designed and delivered educational programming that appeals to both a medical and lay audience.  This included television shows as well as online content.

Prior to Discovery, Dr. Whyte was in the Immediate Office of the Director at the Agency for Healthcare Research Quality.  He served as Medical Advisor/Director of the Council on Private Sector Initiatives to Improve the Safety, Security, and Quality of Healthcare. Prior to this assignment, Dr. Whyte was the Acting Director, Division of Medical Items and Devices in the Coverage and Analysis Group in the Centers for Medicare & Medicaid Services (CMS). In his role at CMS, Dr.Whyte made recommendations as to whether or not the Medicare program should pay for certain procedures, equipment, or services

Dr. Whyte is a board-certified internist and continues to see patients.  He completed an internal medicine residency at Duke University Medical Center as well as earned a Masters of Public Health (MPH) in Health Policy and Management at Harvard University School of Public Health.  Prior to arriving in Washington, Dr. Whyte was a health services research fellow at Stanford and attending physician in the Department of Medicine.  He has written extensively in the medical and lay press on health policy issues. His book Is This Normal? The Essential Guide to Middle Age and Beyond  has won numerous awards. His most recent book, AARP New American Diet:  Lose Weight, Live Longer is a national best-seller.

David H. Windley, CFA, CPA
Managing Director, Healthcare Equity Research, JEFFERIES LLC

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Dave Windley is a managing director and founding member of Jefferies’ Healthcare Equity Research team. Over a 20-year career in investment research, Mr. Windley has covered a broad range of healthcare product and service sectors, including managed care, healthcare information technology, pharmaceutical services, and specialty pharmaceuticals. Dave is a five-time Wall Street Journal Best on the Street honoree and a six-time Starmine award recipient.

Dave is involved in the Nashville financial and healthcare community, having served as an officer and board member of the CFA Society of Nashville, an Alumni Board Member of the Owen Graduate School of Management, and a member of Leadership Healthcare.

Mr. Windley earned his Masters of Business Administration from the Owen School at Vanderbilt University and his BA from Transylvania University. Dave is a CFA charter holder and certified public accountant.

Steve Young
Chief Operating Officer, CLUEPOINTS

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Steve holds a master’s degree in mathematics from Villanova University. He worked for three bio-pharmaceutical companies over a span of 15 years, where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor. He spent an additional six years with Medidata and then OmniComm, leading the development of analytics and risk-based monitoring (RBM) solution portfolios and providing RBM and clinical operations consulting to many organizations. He also led a pivotal RBM-related analysis in collaboration with TransCelerate, and has co-authored two patents related to RBM methods.

Beth Zaharoff
Director, Patient Focused Clinical Trial Engagement, TESARO

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Beth began work at TESARO in January 2014 when the company had approximately 75 associates. Four years later, TESARO has grown to more than 700 associates. Before that, Beth worked as the Associate Director, Medical Affairs for Spectrum Pharmaceuticals and as an MSL for MedImmune, MGI Pharma, and Allos. She spent four years as the Manager, Oncology Operations and Clinical Trials at New England Medical Center. Early in her career, Beth worked as the IRB Administrator at Boston City Hospital where she found her passion for clinical research.

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