Managed and Produced by:
Healthcare Committee Chair: James E. Quinn, MBA, Senior Business Administrator for the Department of Dermatology in the University of Pennsylvania Health System. The UPHS dermatology practice is one of the largest academic departments of dermatology in the world. Very high patient volumes and the distributed operations of an integrated, regional health system present major security obstacles. Mr. Quinn will guide the Healthcare track and lecture on information infrastructure assurance from a senior hospital administrator's perspective. Mr. Quinn is also advising the Program Committee, based on his experience as the US Navy officer responsible for disaster and mass medical emergency planning for the Port of Philadelphia and the US Naval Hospital and Shipyard. In this role, Lieutenant Quinn received a Senior Naval Citation and recognition by the Secretary of Defense for his disaster network planning, preparations, and successful exercises.
LIFE SCIENCES CHAIR: Peter Villax, Vice President, Pharma Division, Hovione SA, a leading manufacturer of Active Pharmaceutical Ingredients. Mr. Villax will discuss an executive's view of the appropriate balance between regulatory requirements and pragmatic approaches to securing a high-value facility. He will also describe the challenge of responding to multiple agencies from multiple nations, many of which have divergent policies for (and interpretations of) information infrastructure assurance and computer system validation requirements.
Mark R. Anderson, CPHIMS, FHIMSS, Healthcare IT Futurist and CEO, AC Group, Inc., is one of the nation's premier IT research futurists dedicated to health care. He is one of the leading national speakers on healthcare and has spoken at more than 300 conferences and meetings since 2000. He has spent the last 30 years focusing on Healthcare – not just technology questions, but strategic, policy, and organizational considerations. He tracks industry trends, conducts member surveys and case studies, assesses best practices, and performs benchmarking studies. He also assists vendors in their Business Strategies, Market and Customer Strategies, Competitive Analysis, and Product Profiling.
M. Brenckle, CIO, University of Pennsylvania Health System
Eric Begun, Esq. is a partner in the multi-practice national law firm of Blank Rome LLP. Mr. Begun advises clients extensively on intellectual property and technology matters, including data privacy and security, computer law, and high technology. Mr. Begun will speak about the current state of legal thinking regarding data and computer security, and he will provide a novel perspective on the sources of regulations and legal requirements in the area and the potentially overwhelming task of managing the myriad of associated legal risks presented by these regulations and requirements.
Col. Thomas P. Collins Army G-3 (HQ) is the recently out-cycled Commander, Combined Joint Task Force, Consequence Management, Kuwait / Iraq. In this role, Col. Collins was responsible for a six-country, four-service, chem / bio consequence management plan and its execution during Operation Iraqi Freedom. Col. Collins will discuss the physical, financial, and societal impacts of cleaning up after a chemical or biological attack. His comments will include labor, equipment, supplies, and schedule requirements for such an undertaking. With this knowledge, attendees will be able to include accurate WMD risk estimates in threat enumeration and evaluation sections of their disaster contingency plans.
(NOTE: The Program Committee has had several consultations with leading experts in the field of WMD remediation. For national security reasons, all of these experts have been recalled to active duty. These officers and their commanders are dedicated to disseminating their critically-needed infrastructure assurance knowledge and are committed to supplying a lecturer. The Program Committee will let attendees know as soon as feasible if deployment schedules affect any US Army lecturer's attendance at the conference.)
Pierre DeHail is the Chief Security Officer of MedAire, Inc., the internationally known remote site medical provisioning and emergency medical extraction / treatment firm. Mr. DeHail is a former security section chief for the French Government. Mr. DeHail will discuss the problems encountered with medical records management during international emergencies and the physical security of Life Science/ Healthcare facilities.
Anthony Fiorito, is the Senior Systems Engineer / VMS Architect for Quest Diagnostics, the largest healthcare laboratory services company in the world. Mr. Fiorito will discuss the challenges of securing the infrastructure underlying such a massive and vital system against multiple threats. He will also describe the advantages that a “non-Windows” infrastructure provides to infrastructure engineers and architects, particularly in being able to provide “fault-resilient” systems.
Special Agent (SA) Matthew W. Fine, FBI, has been a Special Agent with the Federal Bureau of Investigation for five years. He is currently assigned to the Cyber Crime Squad for the Philadelphia Division of the FBI, where he primarily investigates computer intrusions. SA Fine attended the College of William and Mary (VA) where he received his B.A. in Government and was commissioned a Second Lieutenant in the United States Army in 1994. SA served as an Infantry Platoon Leader, Company Executive Officer, and Assistant Battalion Operations Officer with the 101st Airborne Division (Air Assault), Ft. Campbell, KY. SA Fine worked as a computer network engineer at the National Institute of Health (NIH), Bethesda, MD, prior to his appointment to the FBI in 1999. SA Fine is also currently assigned to the Philadelphia Division FBI Evidence Response Team.
Agent Fine currently works with the InfraGard initiative, a concept that was developed to encourage the exchange of infrastructure protection information between the government and the private sector members. Agent Fine will be discussing this unique partnership and how federal law enforcement can be part of companies' integrated infrastructure assurance plans.
Linda Forstedt, Validation Manager, Amgen B.V.
Brian Hausner, General Manager, Micron Technologies, Inc. Mr. Hausner is one of several people presenting a victim's case study. Micron Technologies is one of the world's foremost nexuses in active pharmaceutical ingredient (API) micronization theory and practice. (Micronization is the reduction of APIs to very small and very consistent particle size, a key process in "weaponizing" chemical and biological agents.) Micron Technologies was the victim of armed robbery of its computer systems, including the data center hard disk storage arrays. Mr. Hausner will present a brief overview of the crime and discuss the follow-on disaster recovery and Micron's security upgrades to prevent future occurrences.
Victoria V. Lander is Market Development Manager at NuGenesis Technologies Corporation. She is responsible for marketing and market development for NuGenesis software products focused on the pharmaceutical industry. Victoria also sits on the PDA 21 CFR Part 11 Task Group (adjourned) in Bethesda, MD, and has given many conference presentations on Part 11.
L. Bruce McCulley, CISSP, Managing Director, Cybernet Security, LLC, will discuss defenses against the only security threat that has a 100% probability of occurrence and a 100% scope of effect: Obsolescence. A member of Digital Equipment Corporation’s original PDP-11 / RSX-11 operating system design team, Mr. McCulley has an unparalleled expertise in regulated industry legacy system rescue and remediation.
James McIntosh, Senior Special Agent, FBI, (retired) Based upon his extensive law enforcement experience, Mr. McIntosh will focus on the benefits to business of being "law enforcement friendly." He will discuss the advantages of involving law enforcement early in any investigation, describe the Federal, State, and Local resources available to help businesses in security planning, and offer some sage advice on how to avoid becoming a information crime victim.
Kathleen McDermott, Esq., a Partner in Blank Rome's Health Law and White Collar Practice Groups, represents health care providers and government contractors in the areas of compliance counseling, internal investigations, government investigations and health care business litigation. Ms. McDermott brings to the conference her experience as an Assistant U.S. Attorney and Health Care Fraud Coordinator for the U.S. Attorney's Office in Maryland from 1991-1999, where she investigated government fraud matters and was responsible for coordinating the federal health care fraud task force. Ms. McDermott will lead a Plenary Panel Discussion reviewing federal criminal and regulatory statutes that impact corporate strategies for compliance and protecting critical information from falling into the wrong hands.
VP / Quality Services, AccuLogix
Andrew Milligan, PhD, President and Chief Executive Officer, Bionix Development Corp., will present a victim's case study. Bionix, a specialty medical device manufacturer, employs a senior engineer who is the principal investigator on a project, funded by an NCI grant, to develop novel electro-mechanical cancer treatment devices. Concerned for the security of this proprietary and confidential research, the P.I. reported irregularities in her corporate e-mail accounts. A subsequent investigation revealed an insider as the culprit. An electronics repair technician, working in another company department, had masqueraded as a company official, convinced an ISP to supply passwords, and became an "e-mail snoop" and an Internet pornography fan. Dr. Milligan will discuss the real-life problems that this scenario caused, including how it jeopardized a landmark research program, resulted in serious sexual harassment liability, and consumed vast amounts of senior management time.
Acting Supervisory Special Agent (A/SSA) John C Narvaez, has been a Special Agent with the Federal Bureau of Investigation for 24 years and since 1989 been assigned to the White Collar Crime Squad that became the first designated Health Care Fraud Squad in the Bureau. During his tenure on the Health Care Fraud Squad, A/SSA Narvaez has had the distinction of being invited to testify before the Senate Sub-Committee on Aging on one of his major investigations that was cited by Senator William A. Cohen in support of the Health Insurance Portability and Accountability Act (HIPAA) Bill. A/SSA Narvaez was also nominated for Investigator of the Year-Public Sector for that investigation. In addition to his investigative and managerial responsibilities, A/SSA Narvaez is an 18 year veteran of the Philadelphia Division FBI Hostage Negotiation Team.
Agent Narvaez will be participating in a Plenary Panel Discussion on the subject of “Partnerships Between the FBI and Corporate America.” Agent Narvaez will bring his particular expertise in Healthcare and Life Sciences law enforcement to this discussion.
Chief Privacy Officer, University of Pennsylvania Health System.
George Robertson, PhD., VP Science and Technology, PDA. Dr. Robertson has considerable experience in the biodefense industry, including service as a member of the United Nations' biological weapons inspection team in Iraq (1995) and as a participant in the U.S. Department of Defense teams searching for biological weapons in the former Soviet Union. He served on the Defense Intelligence Agency Advisory Committee of Experts, evaluating future chemical and biological weapon threats. Dr. Robertson will address the probabilities of realized WMD threats against high value targets in the US Life Sciences and Healthcare sectors.
Col. David Ruff, CM, USAR, CMA Operations, President and owner of wmd consulting group LLC, is on a temporary hiatus: currently mobilized on active duty serving as an Operations Officer with the U.S. Army Chemical Materials Agency. Col. Ruff has advanced training and experience in access and disablement of improvised nuclear, chemical, biological and radiological dispersal devices.
Dale Yeager, President of SERAPH, Inc. Mr. Yeager is an internationally acclaimed expert in criminal profiling, forensic psychology, sex crime investigation, and crime scene forensics/procedures and terrorism analysis. His experience includes crimes involving Child on Child Violence, Workplace Violence, and violent crimes committed by Religious, Eco-Terrorism and White Supremacy organizations. He is the creator of and lead instructor for a dramatically effective program of "Human Threat Psychological Evaluation," that allows hiring managers to screen for behaviors that indicate trouble ahead. Mr. Yeager will describe techniques that working managers can use to avoid Dr. Milligan's situation.
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