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by Jim Gearhart

Big Data & the IRB: A Conference You Should Attend

If you are like me, it’s difficult to know whether a particular conference will be a worthwhile investment of time and resources. Of all the conferences out there, how do we know which one is better than the other? If you are thinking about attending the Big Data & the IRB Conference on October 24, 2014, let me present a few reasons to consider:


  1. The topics are current and important. The conference will cover the advent of Big Data could affect clinical research and how it fits within our regulatory and ethical environment. Big Data can feel like a buzzword, it can seem vague, but people say it’s changing the world.  In July, posted “The Era of Big Data and Its Implications for Pharma”, while in September the research ethics organization PRIM&R posted a collection of materials in its Knowledge Center (membership required) under, “Big Data, Research, and the Ethics of it All.” The Big Data and the IRB Conference will continue these discussions.
  2. There’s something in it for you: Educational Credit. The day-long session qualifies for a number of continuing education credits, including Continuing Medical Education (CME); Compliance Certification Board (CCB); the Association of Clinical Research Professionals (ACRP); and Certified IRB Professional (CIP). Please visit the conference page for details and a full list of available continuing education credits.
  3. It’s convenient. The conference is one day, and you can come in person in Cambridge, MA (at the Boston Cambridge Marriott), or attend online from wherever you are by viewing the live webcast.
  4. Experts will be there. “Who is speaking?” may be the most important question to ask about a conference. Judge a conference’s sessions by who is presenting and what expertise is represented. If the right people are there, you’re in the right place.

With that in mind, take a look at who will be at the Big Data and the IRB Conference. Our goal was to gather the best authorities we could for a day’s discussion on Big Data, biorepositories, clinical research, and ethics.  Here are brief profiles of some of the outside speakers who will join us in Cambridge:


Pearl O'Rourke, MDPearl O’Rourke, MD
Director of Human Research Affairs
Partners Healthcare System

Dr. O’Rourke is the Director of Human Research Affairs at Partners HealthCare Systems in Boston and an Associate Professor of Pediatrics at Harvard Medical School.  She is responsible for the systems that support the regulatory and ethical oversight of human research and human embryonic stem cell research.

Dr. O’Rourke also has been actively involved with PRIM&R (Public Responsibility in Medicine and Research), as a Board member and past president of the Board.  At PRIM&R she contributed to a comprehensive review of the storage and use of tissue samples, one our conference’s main topic.

jerrymenikoffJerry Menikoff, MD, JD
Director, Office for Human Research Protections
US Department of Health and Human Services

At the conference, the current Director of OHRP will discuss his office’s views on the regulations and ethics on biorepositories.


Anita Nelsen
Director, Genetic Sample and Data Sciences
RD Projects Clinical Platforms & Sciences

Anita Nelsen is director of GSK’s Genetic Sample and Data Sciences group, which oversees the collection, processing and management of genetics samples from clinical studies.  Ms. Nelsen also serves as deputy chair of GSK’s Informed Consent Advisory Board.

Marianna Bledsoe, MA
Independent Research Professional/Consultant
Adjunct Assistant Professor, George Washington Univ. School of Medicine

Marianna Bledsoe worked in tissue banking activities for nearly 20 years at the National Institutes of Health (NIH) and the Department of Veterans Affairs (VA). She is an Adjunct Assistant Professor in the Departments of Pathology and Clinical Laboratory Medicine at the George Washington University and an Associate Editor for the journal, Biopreservation and Biobanking.  She teaches, writes, and consults on (among other issues) the ethical, legal and social concerns around tissue banking and using human specimens in research.

Dan_NelsonDaniel Nelson, MSc
Director Human Research Protocol Office
National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency (EPA)
Adjunct Professor of Social Medicine and Pediatrics
Faculty Associate, Center for Bioethics
University of North Carolina at Chapel Hill

Daniel Nelson is a leading figure in the issues of human research protections. He is Director of the Human Research Protocol Office for the U.S. Environmental Protection Agency (EPA); Adjunct Professor of Social Medicine and Pediatrics; and Faculty Associate in the Center for Bioethics at the University of North Carolina-Chapel Hill. Professor Nelson previously held faculty appointments at the Mayo Clinic, the University of Rochester and UNC-Chapel Hill, where he directed the Institutional Review Boards for 16 years.

Ty Hoover, MD, JD
Director, Biorepository Regulatory Support
The University of Texas M.D. Anderson Cancer Center

Dr. Ty Hoover served as the Medical Director of the Total Cancer Care project and the Tissue Core Facility at the H. Lee Moffitt Cancer Center in Tampa, where he was involved in the start-up of a large-scale and multi-institutional translational biobanking effort.  He also started de novo a translational cancer biobank for a contract research organization in Tennessee.  Dr. Hoover’s current role includes facilitating the continued excellence of all aspects of biorepository efforts at the M.D. Anderson Cancer Center, including policy development, regulatory oversight, and strategic vision.

Kenneth A. Wilke
Founder and Principal
BioStrategy Solutions, LLC

After 25 years at Merck & Co., Mr. Wilke founded BioStrategy Solutions, LLC, a consulting firm providing strategy, operations and business development advice to the life sciences industry. At Merck, Mr. Wilke served as Director in the Clinical Pharmacogenomics and Specimen Management group, managing the company’s portfolio of PGx projects and directed biorepository operations.  Mr. Wilke was led the team designing and implementing Merck’s pioneering Biorepository Informatics System.

SGaurShantanu Gaur, MD
Co-founder and Chief Scientific Officer
Allurion Technologies

Dr. Shantau Gaur is a member of the Genetic Alliance Council and co-founder and Chief Scientific Officer of Allurion Technologies. On the Genetic Alliance Council, Dr. Gaur has focused on developing innovative, sustainable, and crowd sourced solutions in consumer health, including the Platform for Engaging Everyone Responsibly (PEER). He works as a medical device entrepreneur and continues exploring innovative paradigms in human genetics and, more broadly, leadership, management, and consumer health on the Genetic Alliance Council.

Michelle Ann Penny, Ph.D.
Senior Director, Tailored Therapeutics Groups
Eli Lilly and Company

Dr. Michelle Ann Penny received her PhD in Genetics from the University of Birmingham UK.  Her academic research focused on complex polygenic diseases, particularly autoimmune disease and susceptibility to infection.  Dr. Penny worked on Pfizer’s Clinical Pharmacogenomics group and then served as Oncology Molecular Medicine Lead. At Eli Lilly she led Pharmacogenomics work, and now runs the Genetics and Bioinformatics group.

Visit our conference website to see the agenda, review a complete list of who will be speaking, and to sign up.

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