Attendees
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Paul J. Anderson, M.D., Ph.D.
Chief Academic Officer
Brigham and Women's Hospital
K. Frank Austen Professor of Medicine, Harvard Medical School
panderson@partners.org
Paul J. Anderson, M.D., Ph.D., is the K. Frank Austen Professor of Medicine at Harvard Medical School, and Associate Chief of the Division of Rheumatology, Immunology, and Allergy at the Brigham and Women's Hospital (BWH). He is a member of the American Society for Clinical Investigation and the Association of American Physicians, and serves on the Scientific Advisory Committee at the American College of Rheumatology.
Before graduating from the medical scientist training program at the New York University School of Medicine, Dr. Anderson trained with Jan Vilcek, the inventor of Remicaid, the first biologic therapy for patients with autoimmune disease. He then came to the Brigham where he completed an internship and residency in Internal Medicine and a fellowship in Rheumatology. In 1990 he started in own research laboratory at BWH focusing on the role that post-transcriptional control of gene expression plays in the regulation of inflammatory and stress response programs. His laboratory has been funded by the NIH and by various foundations and industry collaborations, and has hosted over 30 M.D. and/or Ph.D. research fellows. He has authored or co-authored over 175 publications and is on the editorial boards of a number of journals including Cellular Immunology and Modern Rheumatology.
In addition, Dr. Anderson is a Senior Physician at BWH and sees patients in the Brigham Arthritis Center ambulatory clinic and attends on the Rheumatology Consult Service.
For the past five years, he has been a member of the Rheumatology Division Fellowship Selection Committee, which interviews all applicants for the Rheumatology Fellowship Program and makes recommendations for ranking these candidates.
Dr. Anderson received a B.S. in Biology from SUNY Stony Brook, and received both M.D. and Ph.D. (Microbiology) degrees from New York University School of Medicine.
Maria N. Berdella, MD
Co-Director, Cystic Fibrosis Center
Mount Sinai Beth Israel
mberdella@chpnet.org
Maria N. Berdella, MD is the Co-Director of the Cystic Fibrosis Center in the Department of Pediatrics and Pulmonary Medicine at Beth Israel Medical Center. The center relocated from Saint Vincent’s Hospital and Medical Center in June 2010 and received full Accreditation from the Cystic Fibrosis Foundation as well as a designation of a specialized center for Cystic Fibrosis Newborn Screening from the Department of Health. It is also a Designated Cystic Fibrosis Research Center. The Cystic Fibrosis Center has been in existence since 1977.
Dr. Berdella did her Pediatric and Post graduate training at Saint Vincents Hospital and Medical Center and has been Co-Director of the Center since 1998. She specialized in the care of patients with Cystic Fibrosis.
Dr. Berdella has been involved in many Cystic Fibrosis research trials to help move the science forward. She is currently the Principal Investigator at Beth Israel for Vertex 770, a new drug that targets the genetic defect in patients with Cystic Fibrosis, which has given great hope to this population of patients. Dr. Berdella lectures on Cystic Fibrosis at many local and international meetings, is a member of the Newborn Screening Consortium for NY State and sits on the Board of the Cystic Fibrosis New York Chapter
David Bergquist
Chief Campus Counsel
University of California
David Bergquist is the Chief Campus Counsel at University of California, Riverside. During the past twelve years Mr. Bergquist has served in various functions on UC campuses and at the Office of General Counsel in Oakland, California. Prior to his tenure at the University of California, David was an equity partner in the San Diego office of McKenna, Long & Aldridge where he represented a number of the largest public and private entities in the region, on a wide variety of matters. David is a graduate of Gustavus Adolphus College in Minnesota and University of Minnesota Law School, where he served as Managing Editor of the Journal of Law & Inequality. David is a frequent author and lecturer for various local, state and national publications and trade organizations.
Jason T. Briody, CISSP, CCE, ACE, and CCFP
Director
Atlantic Data Forensics
jason.briody@atlanticdf.com
Jason T. Briody is a Director at Atlantic Data Forensics and specializes in in-depth forensic analysis and reporting. He has worked on hundreds of matters including homicide, intellectual property theft, patent interference, employment disputes, research misconduct, industrial espionage, insurance fraud, and more, and has a wide range of experience with clients that range from business on the Fortune 50, to the nation’s leading universities, to local and national law firms.
Mr. Briody is a CISSP, CCE, ACE, and CCFP, and graduated Summa Cum Laude from the NSA-, DHS-, and NIJ-recognized Champlain College in Burlington, VT with a Bachelor of Science degree in Computer & Digital Forensics. He regularly speaks and writes on the intersection of technology and law, and has been featured as a speaker at numerous venues and groups, including the Association of Research Integrity Officers, the Maryland State and American Bar Associations, national CLE providers such as Lawline.com, and on Edward R. Murrow Award-winning live news radio.
Van Cherington, Ph.D.
Director, Science Administration
The Wistar Institute
vcherington@wistar.org
Van Cherington, Ph.D. is the Director of Science Administration at The Wistar Institute. He provides leadership for the Office of Science Administration and serves as the Institute’s Research Integrity Officer, Institutional Official for the animal care and use program, and the IRB Administrator. The Office of Science Administration is responsible for administration and oversight of research compliance programming at Wistar related to research conduct, integrity, and ethics. Programming includes mandatory training, administration of boards conducting review and approval of research involving human or animal subjects and biohazards, post-approval monitoring, and audits of regulated research activities. The Office of Science Administration is also responsible for the administration of research space allocation and oversight of research resources such as staffed core facilities and unstaffed shared resources including common use equipment. Environmental Health and Safety (EHS) is located within the Office of Science Administration and reports to the Director. EHS staff provide comprehensive health and safety orientation, training, workplace safety programming, and support services for laboratory research and all other Institute operations.
Prior to joining Wistar in 2007, Dr. Cherington served as the Departmental Administrator for the Cancer Immunology and AIDS department at the Dana-Farber Cancer Institute and as a Project Administrator in Research Administration at Dana-Farber. He also served previously as a senior research scientist at ALG Company in Marlborough, Mass., and on the faculties at Dana-Farber/Harvard Medical School and Tufts University School of Medicine as an Instructor and Assistant Professor of Pathology, respectively. Dr. Cherington received his doctorate in Pharmacology from Harvard University, Division of Medical Sciences.
The Wistar Institute (www.wistar.org) is located in University City in Philadelphia and is the nation’s first independent institution devoted to medical research and training. It has evolved from its beginnings in 1892 as an anatomical teaching museum to its present-day status as an international leader in basic biomedical research. In 1972, The Wistar Institute was designated a National Cancer Institute Cancer Center in basic research—a distinction it holds to this day. It is also a member of the Association of Independent Research Institutes (AIRI). Wistar discoveries have led to the development of vaccines for rabies, rubella, and rotavirus, the identification of genes associated with breast, lung, and prostate cancer, and the development of monoclonal antibodies and other significant research technologies and tools.
Yafang Deng
Assistant General Counsel
Mount Sinai Health System
yafang.deng@mountsinai.org
Yafang Deng is Assistant General Counsel for the Mount Sinai Health System. The Mount Sinai Health System Office of the General Counsel provides a broad range of legal representation to seven hospital campuses, a medical school, and other health system components in the New York metropolitan area.
Stephanie Marshall-Guzik, MBA, RN, BSN, CHRC
Research Integrity Officer
Rush University Medical Center
Stephanie_gusik@rush.edu
Stephanie is the Director of Research Compliance and the Research Integrity Officer at Rush University Medical Center located in Chicago. Stephanie’s staff audits research activities to assure compliance with federal, state and university policy to ensure the conduct of research operates in compliance. Stephanie assesses research education needs, compliance risks and opportunities for improvement. Her team provides onboarding training for all new researchers. In her role, Stephanie is responsible for review and adjudication of financial conflicts of interest in research for the university. Stephanie has over 15 years in research administration and serves as an institution-wide resource serving on multiple campus compliance and research committees. She also develops research compliance policies and procedures in response to the rapidly evolving state and federal laws and regulations. She has substantial experience in internal investigations, external audits (e.g., FDA) and interpreting/applying complex federal and state statutes. In addition, Stephanie investigates allegations of scientific misconduct.
Richard Karalus, Ph.D
Director, Office of Research Compliance
University at Buffalo
Office of Research Compliance
karalus@buffalo.edu
Richard Karalus serves as the Director of Research Compliance at the University at Buffalo. Karalus has over 25 years of experience in the field of scientific research. The Office of Research Compliance is responsible for maintaining the high ethical standards and compliance of the Universities scientific research programs. This includes research using both human and animal subjects, conflict of interest, and data and export controls.
Karalus has worked in both the private sector and academic community. He has served as the Director of Microbiology for CUBRC, Inc. for 13 years where he operated a Select Agent Laboratory performed biodefense related studies. He was responsible for managing compliance with the Select Agent program which included safety, security, and personnel reliability. He also holds a patent for the development of a simple protein sample preparation method for use in the field.
Karalus joined the University in 2012 where he served as the Building Manager for the newly built Clinical and Translational Research Center until 2015. He was responsible for setting up the initial operations of the facility and supervising the setup of the research laboratories. This included developing the safety program and providing training for the investigators.
Karalus received his BS in biotechnology from the Rochester Institute of Technology and his MS and PhD in medical microbiology from the University at Buffalo. He also serves on numerous committees including the Western New York VA Research Safety Committee and the Universities Institutional Biosafety Committee.
Farida Lada
Director for Research Compliance
The City University of New York
farida.lada@cuny.edu
Farida is the University Director for Research Compliance at The City University of New York (CUNY), where she is responsible for the oversight and management of research compliance programs across CUNY’s 24 colleges. Previously, Farida was the Director of Research Compliance at Weill Cornell Medical College in Qatar (WCMC-Q), where she established WCMC-Q’s first research compliance program. In this role, she also worked closely with the Qatari Supreme Council of Health in developing the local regulations for protecting human and animal subjects in research. Prior to that, she served as Assistant Director – Human Subject Research at University of California Los Angeles (UCLA). Farida is also a PhD Fellow at Maastricht Graduate School of Governance/United Nations University MERIT. She holds a MBA from University of Louisville and a BS in Biology from University of Texas at Arlington.
Michael R. Ludwig
Research Integrity Officer/Associate Vice President for Research Administration
University of Chicago
mrludwig@uchicago.edu
Michael R. Ludwig is Associate Vice President for Research Administration and Director of University Research Administration, a team of more than 25 professionals responsible for grant and contract management, research compliance, and review and institutional endorsement of all applications for sponsored funding, including clinical studies and trials and Material Transfer Agreements. The group also provides sponsored project information services and overall guidance, support, and research administration training.
Previously, Ludwig was Director of Sponsored Program Services at Purdue. During his 26-year tenure at Purdue, he served for nine years as Associate Director of Sponsored Program Services (SPS) and six years as Director overseeing a staff of 75 with broad, pre- and post-award responsibility including most areas of financial administration and reporting. As Director, Ludwig led the team responsible for pre- and post-award support to faculty, including approval of sponsored program proposals; negotiation and acceptance of awards and other agreements affecting research activities; subcontract issuance and monitoring; account set up, invoicing, reporting and audits. Together with senior administrators at the university, Ludwig developed and implemented policies and procedures to enhance services and assure compliance with Federal regulations. As Associate Director for Sponsored Program Administration at Purdue from 1999-2008, Ludwig led a staff of 65 professionals and implemented an effective new organizational structure and pre- and post-award process to better serve faculty in response to significant growth in sponsored research funding that had growth 250 percent in nine years. He also oversaw the implementation of a new research administration system.
Prior to that position, Ludwig served as Director of Academic Business Managers from 1993-1999 and directed a staff of 200 providing business services support such as budgeting, payroll, purchasing and account management, to business managers in the schools, divisions and departments. He also led the development of new systems and procedures to enhance business services provided to faculty and staff. During this time, Ludwig participated in the development of the University’s annual budget plan that exceeded $1 billion; served as Purdue’ Public Records Officer; and served as Interim Director of Personnel Services from 1995-1996. Since 1987, he held various positions of increased responsibility at Purdue.
Ludwig received his Bachelor of Science in Agricultural Economics at Purdue University West Lafayette.
A prominent and respected leader in his field, Ludwig is a member of the Federal Demonstration Partnership (FDP), the Council on Governmental Relations (COGR) and National Council of University Administrators (NCURA). He is a also a member of COGR Board of Directors and serves on the Research Compliance and Administration Committee and the Steering Committee for Administrative Computing. Ludwig has served as committee member and presented and participated in workshops at NCURA Financial Research Administration’s annual conferences.
Carolyn B. Levine
Deputy General Counsel and Corporate Secretary
Memorial Sloan Kettering Cancer Center
levinec@mskcc.org
Carolyn Levine is Deputy General Counsel and Corporate Secretary of Memorial Sloan Kettering Cancer Center where she assists in the oversight of transactional matters, risk management, and regulatory affairs. Before joining the Office of General Counsel at MSK, Ms. Levine was a partner in the law firm of Hughes Hubbard & Reed in New York with a concentration in corporate practice. Ms. Levine is a graduate of Tufts University and Fordham University School of Law.
Andrew Mahler, JD, CIPP/US, CHPC, CHRC
HIPAA Privacy Officer
The University of Arizona
amahler@email.arizona.edu
Andrew lives in Tucson, Arizona, where he serves as the HIPAA Privacy Officer for The University of Arizona. Prior to joining the University, Andrew was a federal investigator with the U.S. Department of Health and Human Services, Office for Civil Rights (OCR). Andrew is experienced in a broad array of matters primarily related to HIPAA and research compliance, including policy development, investigations, compliance reviews, and training. Andrew in licensed to practice law in the states of Arizona and Georgia. Andrew holds CIPP/US, CHPC, and CHRC designations.
Alison Ng
Compliance Manager
San Francisco State University
Office of Research and Sponsored Programs
alisonng@sfsu.edu
Alison Ng is the Compliance Manager in the Office of Research and Sponsored Programs for San Francisco State University. She received her Masters of Science in Community Development from University of California, Davis and has continued to serve her local neighborhood. She is also a Certified Institutional Review Board Professional and familiar with ethical and financial compliance issues in research. She spends time leading a children’s enrichment program on the weekends and tries very hard not to chase after her three children.
Dr. Robert Quinn
Associate Vice President for Research Integrity/Director, Dept. of Lab. Animal Resources
SUNY Upstate Medical University
quinnr@upstate.edu
Dr. Quinn is currently Director of Animal Resources at SUNY Upstate Medical University in Syracuse. He received a bachelor’s degree from Utah State University and then his D.V.M. from Colorado State University in 1991. From there he did a 3-year residency in laboratory animal medicine at the University of Michigan. He is a diplomat of the American College of Laboratory Animal Medicine (ACLAM). He has been a member of national AALAS for more than 20 years. He has been active on many committees at the national level for AALAS, ACLAM, ASLAP and currently serves on AAALAC Council.
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Susan Ross
Director, Research Integrity and Compliance/RIO
NYU Langone Medical Center
Susan.Ross@nyumc.org
Susan Ross is the designated RIO for NYU Langone Medical Center, having served in this role since July 2014. Prior to joining NYU Langone, she led sponsored project pre-award offices at both Northwestern University and Columbia University. Her current role at NYU Langone focuses on Research Integrity and Compliance, including risk assessment, policy development, investigations, audits, and training. She is also responsible for all conflict of interest matters at the medical center.
Toni Russo
Research Integrity Officer
The Office of the Vice President for Research
The George Washington University
trusso@gwu.edu
Toni Russo serves as a Research Compliance Officer within the Research Integrity Compliance Office at the George Washington University. As a transplant from Washington state, Toni began her career in research administration at GW five years ago as a contracts specialist, negotiating grants and contracts with the federal government and industry in a research portfolio of almost $200M. Her current role allows her to focus on central compliance issues including research misconduct and conflicts of interest. Outside of work, Toni enjoys going on adventures with her daughter, rooting on her beloved Seattle Seahawks, and reading.
Erik Schneebeck
Research and Regulatory Compliance Manager
Memorial Sloan Kettering Cancer Center
schneebe@mskcc.org
Erik joined Memorial Sloan Kettering Cancer Center in 2013 and serves as the Research and Regulatory Compliance Manager in the Office of Research Outreach and Compliance. In this position, he is responsible for the development and oversight of a regulatory compliance quality assurance program for research grants and contracts. Erik also serves as the administrator for the Institutional Biosafety Committee and MSK’s new export control compliance program. He is a non-scientist member of the IACUC and the Tri-SCI ESCRO administrative committee. Prior to joining MSK, Erik worked at Rutgers University, where he served as an administrator for the IRB and IACUC. He received his JD in 2010 from Brooklyn Law School with a focus on health law and bioethics. He received his Bachelor's degree in Art History from Bowdoin College in 2004.
Lacey Smith, M.D.
Professor of Medicine & Director of Office of Research Integrity
University of Tennessee Health Science
lacey.smith@uthsc.edu
In RIO capacity for 2 years, strong clinical-educator background, (with a distant start in research). Served the administrative functions as Chief of Medicine (VAMC), 2+ years each interim stents as Chairman of Medicine, and Dean of College of Medicine, then as permanent Chief Medical Officer of the academic practice group (a position with some of the parallel professional responsibilities as RIO, professional misconduct and malpractice), and then as CEO of that practice group. Since the virtual dissolution of that practice group, I have returned to primary clinical and teaching duties, assuming the RIO function as well.
Kristin Sommer
Research Integrity Officer
Baruch College, CUNY
Department of Psychology
kristin.sommer@baruch.cuny.edu
Kristin Sommer is a Professor of Psychology at Baruch College, City University of New York. She also holds appointments on the doctoral faculties in Basic and Applied Social Psychology and Industrial/Organizational Psychology at the Graduate Center. Dr. Sommer's main program of research explores the effects of interpersonal rejection on affiliation and avoidance behaviors within novel social interactions. She teaches undergraduate and doctoral courses in research methods and social psychology, and a course on research design in work organizations as part of Baruch College’s International Executive Master’s Program in Management of Human Resource and Global Leadership. She has been the College's Research Integrity Officer since October, 2014.
Tung-Tien (Henry) Sun
Chair the Standing Inquiry Committee
New York University Medical School
tung-tien.sun@nyumc.org
Position: Prof Cell Biology, Pharmacology, Urology, and Rudolf Baer Prof Dermatology, NYU Med School since 1982.
Research: Epithelial growth & differentiation - discovered keratins as epithelial markers, uroplakins as urothelial markers, and corneal and hair follicle stem cells (230 papers; H index 86).
Honors and Awards: AAAS Fellow; Member of Academia Sinica, Taiwan (2002); named lectureship Stanford (1987), Harvard (1991) & Hopkins (2001); Montagna Award in dermatological research (1989); Alcon Award in ophthalmological research (1993); Wu Award in urological research (1999); adjunct and honorary professorship Cornell, Upenn and Univ Queensland.
Bob Winston
Senior Associate Provost of Academic Affairs
Dickinson College, Academic Affairs
winston@dickinson.edu
"I began my tenure at Dickinson College in 1979 with an appointment in English. Although hired to teach early American literature, a liberal arts college like Dickinson always provides opportunities for growth, and my teaching and scholarship evolved to include the relationship between popular literatures, especially detective fiction and national cultures as well as contemporary Scottish fiction. In 1988-90 I was the first director of Dickinson’s Norwich Humanities Program, located at the University of East Anglia in Norwich, England and had the opportunity to do a second tour from 1998-2000.
I began doing more administrative work when I became Assistant Provost for First-Year Programs in 2008 and went into administrative work full-time in 2011 when I was appointed Associate Provost for Personnel and Assessment. This appointment included working as the College’s RIO. I am currently Senior Associate Provost for Academic Affairs and continue as Dickinson’s RIO."
- Syllabus
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