Faculty – Virtual Clinical Trials Conference

Bradley Davidson
Legal Counsel, Clinical R&D, ABBVIE

Nnamdi Ezeanochie
Senior Manager, Behavior Science, JOHNSON AND JOHNSON

Brittany Goldberg, M.D.
Medical Officer, FDA

Brian Johnson

Hassan Kadhim
Director, Head of Clinical Trial Business Capabilities, BRISTOL-MYERS SQUIBB

Dr. Daniel Karlin
Chief Medical Officer, NIGHTWARE

Chair, Advisory Board, DIME SOCIETY

Dr. Jeff Kingsley

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Dr. Jeff Kingsley received his Bachelor of Science degree from the University of Scranton in 1995 with concentrations in biology, chemistry, history, and cultural anthropology, and his Master of Science degree in 1997 in biochemistry. His medical degree was received from the Philadelphia College of Osteopathic Medicine in 2001 and his MBA was received from Emory University’s Goizueta Business School in 2011.

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

Dr. Kingsley is founder and CEO of IACT Health, a research management organization, and 15 wholly owned and integrated clinical research offices in multiple cities in two states. The family of companies conduct phase Ib 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 is the past 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. Dr. Kingsley obtained his CPI in 2009 and his FACRP in 2017.

He enjoys each day with his wife Christine and four beautiful children.Dr. Jeff Kingsley can be reached at 706-536-6619 and [email protected]

Matthew Moyer, M.S., MBA, PMP
Director, Clinical Supply Technology, MERCK

Jan Nissen
Vice President, Patient Innovation and Engagement, MERCK

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Jan leads the Patient Innovation and Engagement organization within the Office of the Chief Patient Officer at Merck. As a global team, they serve as a center of excellence in bringing forward the patient’s voice into the Merck enterprise to support business decisions that lead to better patient outcomes.

After several years working as a nurse in pediatric intensive care, Jan moved into the pharmaceutical industry where she has worked for over 33 years. She has served in sales, training, marketing, and operational leadership roles at both Abbott Laboratories in North Chicago, IL and at Merck. In 2012, Jan served as a Merck Fellow with Population Services International in Kenya setting up health care clinics in developing countries.

Jan has a Bachelor’s in Nursing from the University of Illinois Medical Center, an MBA from Lake Forest College, along with a Master’s Degree in Population Health from Thomas Jefferson University. She is an Executive Board member of Clinica Verde, a NGO in Nicaragua, along with serving on the Board of Patient Focused Medicines Development, a non-profit dedicated to developing tools and resources to support patient engagement.

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.

Isaac R. Rodriguez-Chavez, Ph.D., MH.Sc., M.Sc.
FDA Officer, Clinical Research Methodology, Regulatory Compliance and Policy Development, FDA/CDER

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Currently, Dr. Rodriguez-Chavez serves as an FDA Officer for Clinical Research Methodology, Regulatory Compliance and Medical Policy Development at CDER. He is a biomedical leader with expertise in Infectious Diseases, Virology, Microbiology, Immunology, Vaccinology, and Oncology linking oral and systemic health. Overall, he has over 20 years of professional work experience at NIH, industry and non-profit research organizations. Past positions he has held include: CEO and Founder of a biomedical consulting firm, 4Biosolutions Consulting, Rockville, MD; Vice-President for Research at the Texas Biomedical Research Institute, San Antonio, TX; Director of the AIDS and Immunosuppression Program at NIDCR, NIH, Bethesda, MD; Senior Clinical Scientist at Schering Plough Corporation, Kenilworth, NJ; and Director of Portfolio for HIV Vaccine Programs at NIAID, NIH, Bethesda, MD. Dr. Rodriguez-Chavez is an expert in science and technology, business development, pre-clinical and clinical research, development and operations, regulatory affairs, regulatory licensure of medical products, quality control and quality assurance, and securing funds for startups, non-profit organizations and universities. He has led basic, translational, pre-clinical and clinical research (phase I – IV global clinical trials). He has issued the first U.S. GCLP Guidelines and published numerous scientific and technical articles. He has been an invited speaker in multiple, international conferences and served as an associate editor of scientific journals. He leads Decentralized Clinical Trials efforts at FDA.

Kerensa Saljooqi
Associate Director, Clinical Operations, BLACKTHORN THERAPEUTICS

Dennis Salotti
Chief Operations Officer, THE AVOCA GROUP

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Dennis Salotti is COO of The Avoca Group and lead for the Diligent® Qualification Platform, the clinical research industry’s first centralized platform for clinical service provider qualification.

With more than 16 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis has experience that spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management.

Prior to joining The Avoca Group, Dennis was Director of Operations for WriteResult, an eCOA provider, where he was responsible for client delivery across the portfolio of global clinical trials. He has previously held positions in research and clinical operations for Pfizer and Merck.

Dennis is an Adjunct faculty instructor for Drexel University College of Medicine’s graduate program in Clinical Research Organization Management, and a Member of the Board of Trustees for the Diabetes Foundation. His educational credentials include an MS in Clinical Research Organization Management from Drexel University, an MBA in Technology Management from the New Jersey Institute of Technology, and a BS in Biology from Sacred Heart University.

Peter Schaeffer
TPR Analytics Director, R&D Third Party Resourcing, GSK

Alka Shaunik, M.D.
Senior Medical Director, Global Medical Affairs, SANOFI

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Dr. Alka Shaunik, is a leader in Global Medical Affairs at Sanofi with extensive experience as practicing physician and in clinical research in academia and pharmaceutical industry. She has authored numerous research publications, received industry awards, and is a peer reviewer for leading medical journals. She has experience leading phase 3 and 4 studies, and guiding launch of several successful drugs. Her current focus is real world evidence using innovative study designs and health analytics using big data, machine learning and AI methodologies. By emphasizing appropriate methods of data generation and analyses, she champions the continuum of evidence based medicine and data generation to support effectiveness and safety profile of therapies throughout their life cycle.

Michael Song
Pharmaceutical Device and Digital Health, MEDIMMUNE

Michael Sparozic
Operation Manager and Leader, Trial Supplies, SANOFI

Kelly Vaillant
Managing Expert, Clinical Center of Excellence, YOURENCORE

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Kelly is a 20+ year industry veteran with vast experience across clinical development. He has built, grown, and led global functions in the areas of Clinical Data Management (for Amgen and Novartis), Clinical Operations (for Ambit Biosciences), and most recently Clinical Trial Disclosure & Data Transparency (for Gilead Sciences). Kelly is a recognized leader; he was voted Clinical Data Management Chair for PhRMA in 2008 and is a founding member of CDISC. He is a certified Six Sigma Green Belt and describes himself as an “process and technology innovator” with a passion for improving the lives, quality of life, and well-being of patients and caregivers impacted by the products and organizations he works with.