Speakers

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Karen Byers, MS, RBP, CBSP

Karen became the Biosafety Officer, of Dana Farber Cancer Institute in 1989. In 2013, she was honored to receive the Rowlee “Employee of the Year Award” for leadership, outstanding work habits, and commitment to the high standards of the Dana Farber. Karen is Past-President of the American Biological Safety Association, and Co-editor of the ABSA Journal, Applied Biosafety. She was a contributor to the 2009 Biosafety in Microbiological and Biomedical Laboratories (BMBL), co-author of the chapter “Epidemiology of Laboratory-acquired Infections in the 3rd and 4th editions of Biological Safety Principles and Practices, ASM Press, and has written many articles.

As a registered and certified biosafety professional, her public service includes:

• Massachusetts State Pharmacy Advisory Board, appointed 2014.

• Indo-US workshop on Challenges of Emerging Infections and Global Health, Nov.18-20, 2014.

• Boston Biosafety Committee, appointed 2013.

• National Research Council on the National Academies Committee to assist the US Army Medical Research and Materiel Command with Preparations of a Risk Assessment for the Medical Countermeasures Test and Evaluation (MCMT&E) Facility at Fort Detrick, MD. (2011).

• Worked on the CDC and APHL on the development of biosafety competencies for laboratories working at BSL2-4 (2009-2010). MMWR 60(02); 1-6.

• Panel IV of the Transfederal Task Force on Optimizing Biosafety and Biocontainment Oversight in 2008.

Karen has provided training on biosafety for Eagleson Institute and American Biological Safety Association, Massachusetts state laboratory, and the Massachusetts Medical Research Society. In addition, she has presented talks at conferences of the African Biosafety Association, American Biological Safety Association (ABSA), American Industrial Hygiene Association (AIHA), and American Public Health Laboratory (APHL). Asian Pacific Biosafety Association, Boston Biosafety Group (BBUGS), Campus Safety, Health, and Environmental Management (CHEMSA), International Occupational Hygiene Association, Preventing and Treating Biological Exposures: a Colloquium for Occupational Medicine, Infectious Disease, and Emergency Medicine Professionals, and the United States Department of Agriculture-Agricultural Research Service. Later in 2015, she plans to develop visual training tools for APHL on the MMWR guidelines for diagnostic laboratories and illustrate the Ebola preparedness plans developed in some local clinical laboratories.

David Gillum, RBP

David Gillum is the Director of the Biological Safety and Biosecurity Programs at Arizona State University (ASU)—the largest public university in the United States. Responsibilities include oversight of over 500 laboratories using biological materials, including BSL-3 and ABSL-3 research facilities. He serves as the Institutional Biosafety Officer and Alternate Responsible Official for the ASU Select Agent and Toxin Program. With over 20 years of experience working as an effective safety partner, David has developed, implemented, and directed various safety programs at academic and research institutions.

David was elected to the ABSA International Council in 2016 and serves on two ABSA committees. He is a Registered Biosafety Professional and has been a member of ABSA International for over 15 years. In 2011, David and Kathleen Kennedy formed the Arizona Biosafety Alliance, an ABSA-affiliate, and served as President, Past-President, and Treasurer for the organization.

David is the Associate Editor of Applied Biosafety: Journal of ABSA International. He has written several research articles focusing on biosafety and biosecurity topics of interest to the biosafety community. David has served as a judge for the International Genetically Engineered Machine (iGEM) competition and has attended three iGEM safety and security meetings to discuss emergent synthetic biology matters.

David is interested in the future of synthetic biology, human genome editing, and gene drives, and the impact of these biotechnologies on society as well as the role biosafety and biosecurity professionals should play in the implementation of this new technology. David has delivered several training sessions and conference presentations regarding these topics.

Elizabeth Gilman Duane, MS, RBP, CBSP

Elizabeth Gilman Duane is the Biosafety / Laboratory Safety Service Leader with Environmental Health & Engineering, Inc., overseeing Biosafety and Environmental Health and Safety (EH&S) Programs for life science clients. She provides operational guidance and technical support and mentors a team of Biosafety and EH&S Professionals. Ms. Gilman Duane has over 25 years of experience in academia and industry, leading EH&S programs and specializing in biological safety. She is registered and certified in the professional practice of biological safety through the American Biological Safety Association (ABSA). Ms. Gilman Duane assists clients with projects involving risk assessments, permitting, program audits, interim Biosafety Officer support, training development and deployment, Institutional Biosafety Committee (IBC) and Institutional Animal Care and Use Committee (IACUC) support, and Biosafety Level Three (BSL-3) and Four (BSL-4) programs. She also provides mentoring to Biosafety Officer clients to assist them in further developing biosafety knowledge and skills.

At Wyeth Pharmaceuticals, Inc., Ms. Gilman Duane held a variety of site and corporate environmental health and safety roles. She has served as the biosafety officer for the Andover and Cambridge, Massachusetts, sites, and managed the EH&S program for the Cambridge site. She facilitated the establishment of Wyeth’s Corporate Biosafety Committee in 2001 and the Corporate Hazardous Materials Transportation Committee in 2007, and led these Committees until Pfizer’s acquisition of Wyeth in 2009. She also served as a Corporate Audit Team Member and has experience auditing R&D and manufacturing facilities for compliance with Wyeth’s Corporate EH&S Policies. She developed the Corporate Biosafety Policies that were used worldwide within Wyeth along with the Electronic Biohazard Agent Registration, a web-based project registration tool. Ms. Gilman Duane also developed programs for compliance with the U.S. Select Agent regulations and assisted Wyeth facilities with obtaining Select Agent registrations through the U.S. Department of Agriculture and Centers for Disease Control and Prevention.

While at Pfizer, Ms. Gilman Duane continued to lead the Cambridge EH&S program and in 2011 developed the EH&S program for Pfizer’s Center for Therapeutic Innovation (CTI) based in Boston with additional CTI sites in San Francisco, La Jolla, and New York City. She also established and led Pfizer’s Biotherapeutics and Biologics Safety Network Team, a committee comprised of biosafety professionals and other stakeholders representing Pfizer business units.

In 2005 Ms. Gilman Duane served as President of ABSA. She facilitated ABSA’s first Strategic Planning effort that resulted in an association that is more responsive to the needs of the membership and planned for future growth. Ms. Gilman Duane led ABSA’s role in establishing the framework for the development of the International Biorisk Management Standard, and later participated as a stakeholder while employed by Wyeth Pharmaceuticals, Inc. She has been an active member of ABSA since 1990, and in 1996 she facilitated the establishment of the New England Biosafety Association (NEBSA), an ABSA affiliate. In 2000, she received the John H. Richardson Special Recognition Award from ABSA in recognition of outstanding service on ABSA’s Training and Education Committee. She has participated in and chaired numerous ABSA committees and continues to be a dedicated member of ABSA.

Since 1997 Ms. Gilman Duane has been a member of the Board of Directors of the Eagleson Institute, a non-profit foundation in Maine working globally to promote laboratory health and safety through education. She provides direction and strategy and participates on steering committees for conferences and training programs sponsored by the Institute. Ms. Gilman Duane holds a Bachelor of Science in Biology from Rensselaer Polytechnic Institute and a Masters in Science in Biomedical Science / Toxicology from Northeastern University.

Kathryn Harris, PhD, RBP

Dr. Kathryn Harris is the Senior Outreach and Education Specialist (contractor) in the Office of Biotechnology Activities (OBA) at the National Institutes of Health (NIH). For over a decade Dr. Harris has worked at OBA developing national and regional programs of stakeholder relations, education, and outreach strategies relevant to the oversight of recombinant and synthetic nucleic acid molecules and dual use research. In addition, she advises on biosafety and biosecurity issues. She received her Ph.D. from Cornell University and completed two years of postdoctoral training at Washington University in St Louis.

Prior to joining OBA she was the Biological Safety Officer at Northwestern University. Dr. Harris is Registered Biosafety Professional and a member of the American Biological Safety Association (ABSA). She was a founding member and first president of the Midwest Area Biosafety Network (MABioN).

Chris Jenkins, PhD, MPH, RBP, CHMM

Dr. Jenkins is the Principal Partner and Chief Gene Therapy Biosafety Officer at Clinical Biosafety Services. He has performed various roles in his career, but he is best known for his work in the field of biological safety and gene transfer. His past positions have been in biosafety and include serving on hundreds of Institutional Biosafety Committees in university, private research institute and clinical organizations including the The University of Texas at Austin, University of Missouri, Scripps Research Institute and Saint Louis University. He has years of experience providing biosafety consulting and overseeing research compliance with biological materials ranging from human gene transfer to Select Agents and Toxins. Dr. Jenkins received his Doctorate of Philosophy in Public Health, with a focus on Biosecurity through the Saint Louis University School for Public Health and Social Justice as well as a Masters of Public Health in Biosecurity. He is frequently consulted for workshops, webinars, presentations, has a number of articles in print and review, and he is a Registered Biosafety Professional and Certified Hazardous Materials Manager.

Carolyn Keierleber, PhD

Carolyn Keierleber is a biosafety professional who has served in numerous capacities in her career. She has been a member of the American Biological Safety Association (ABSA) for over 20 years and is currently the Past President of BioNet, the ABSA Affiliate serving California and neighboring states. Carolyn served as the EH&S Director, Biosafety Officer, IBC manager, Responsible Official, and Occupational Safety Program manager at the Scripps Research Institute in La Jolla, CA. Prior to that she was the Biosafety Officer at the University of Florida and was involved in the IBC, the IACUC, the BSL-3 Program, the Select Agent Program, and the Occupational Medicine Program. She developed and implemented the first UF Bloodborne Pathogen Program. She received her PhD in Biological Sciences from the University of California, Irvine and completed a postdoctoral fellowship at the University of Missouri, Columbia.

Carolyn is interested in providing clear, concise, professional advice to the research community she serves. She believes that safety professionals should engage researchers to build safe working conditions in a collaborative, collegial manner. Carolyn finds solutions that allow ideas to flourish and research to advance for the benefit of all. In 2015, Dr. Keierleber joined the Environmental Health and Safety Department at the University of Southern California in Los Angeles where she serves as the Biosafety Officer.

Lois Zitzow, MS, DVM, DACLAM
 
Kenneth Oye, PhD

Kenneth Oye is a Professor in Political Science and the Institute for Data, Systems and Society at the Massachusetts Institute of Technology. He currently serves as Director of the Program on Emerging Technologies, faculty associate of the MIT Synthetic Biology Center, regulatory lead of the MIT Center for Biomedical Innovation, chair of the DARPA-Broad Institute Foundry safety committee, and co-chair of the iGEM Safety Committee. His research and teaching links the fields of technology policy and international relations.

In the last decade, he has worked on adaptive regulation of rapidly changing technologies, with emphasis on synthetic biology and pharmaceuticals. His works in synthetic biology include: “Regulating Gene Drives”(Science 2014); “Regulate Home Brew Opiates” (Nature 2015); “iGEM as a Testbed for Proactive and Adaptive Risk Management,” ACS Synthetic Biology 2014) and “Shaping Ecological Risk Research for Synthetic Biology.” (Journal of Environmental Studies and Sciences, 2014). His papers in Clinical Pharmacology and Therapeutics have treated adaptive licensing (2013, 2014), E2E trials (2014) and enhanced data utilization and integration (2015). His works in international relations include Cooperation under Anarchy, Economic Discrimination and Political Exchange and four books on American foreign policy.

Professor Oye has served as an invited expert on technology policy for the UN BWC, WHO, NSABB, PCAST, NAS and Defense Intelligence Board. His research and teaching has been funded by grants from the MacArthur Foundation, NSF IGERT, NSF Molecular and Cellular Biology, SynBERC, the Center for Global Partnership, the New Energy Development Organization and the Alliance for Global Sustainability.

Before joining the MIT faculty, he taught at Harvard University, the University of California, Princeton University and Swarthmore College. He holds a BA in Economics and Political Science with Highest Honors from Swarthmore College and a Ph.D in Political Science with the Chase Dissertation Prize from Harvard University.

Ellyn Segal, PhD

Ellyn Segal received a B.S. from McGill University in Biology/Genetics and a Ph.D. in Genetics from Stony Brook University, doing research at Cold Spring Harbor Labs in N. Y. and Scripps Research Foundation in San Diego, CA. She continued her education with a Post-doctoral position in Microbiology and Immunology at UCSF. From there she moved to Stanford University, where she was a post-doctoral scholar and Sr. Research Scientist working on bacterial pathogenesis and cellular microbiology. In 2001 she moved into her current position as Biosafety & Biosecurity Manager for Stanford University. Dr. Segal is interested in the intersection of new technologies and issues with Biosafety.

Dawn P. Wooley, PhD, SM[NRCM], RBP, CBSP

Dr. Wooley is also Director of the Biosafety Level 3 Lab., Wright State University, Dayton, OH

Her active areas of research include studying the molecular mechanisms of HIV mutation, recombination, and pathogenesis, the use of viral vectors for gene transfer, and the biosafety of viral vectors in laboratory and animal research. She is currently a member of the Board of Scientific Counselors for the Centers for Disease Control and Prevention and is a member of the Center for Retrovirus Research at Ohio State University.

She previously served as a member of the NIH Recombinant DNA Advisory Committee and Executive Board Member of the NIH/NIAID Region V “Great Lakes” Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research at the University of Chicago.

Dr. Wooley performed postdoctoral research with Nobel Laureate Howard Temin at the University of Wisconsin. She earned her Ph.D. degree in Virology from Harvard and an honors B.S. degree in Microbiology from The Pennsylvania State University.