Conference Faculty:

Mark Brown, Partner, King & Spaulding, LLC

Mark Brown is a partner in the firm’s FDA/Healthcare Practice.  He joined the firm after serving five years with the U.S. Food and Drug Administration (FDA) Office of the Chief Counsel.  Mr. Brown represents clients on various FDA regulatory compliance issues, including manufacturing practices, product failure investigations, factory inspections, clinical trials, adverse event reporting, recalls, product labeling, advertising and promotion issues and criminal investigations.  He also regularly advises clients on developing strategies for obtaining FDA approval and clearance for medical products.

Mr. Brown has extensive experience in FDA compliance and product approval issues that arise in products liability litigation involving medical devices and in advertising disputes between competing companies pursuant to the Lanham Act.

During his tenure at FDA, he represented the agency in both civil and criminal enforcement litigation and became the agency’s chief litigator in device enforcement actions, particularly in the area of FDA’s current Good Manufacturing Practice/Quality Systems ("GMP/QSR") regulations.  Mr. Brown represented FDA in several complex and comprehensive GMP-based enforcement actions undertaken against medical device manufacturers.

While at FDA, Mr. Brown received the Superior Achievement Award from the Department of Health and Human Services and FDA’s Commendable Service Award for superior litigation services involving human drugs and medical devices.

During 1992, Mr. Brown served as a Special Assistant United States Attorney in the U.S. Attorney’s Office in Alexandria, Virginia where he defended the United States in a variety of civil actions, including federal tort claims.

Before joining FDA in 1990, Mr. Brown was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission where he concentrated on advertising and promotional activities.  He investigated and handled the FTC’s civil fraud action against Dr. Cecil Jacobson, the Northern Virginia infertility specialist later convicted of defrauding his patients.

Mr. Brown received his A.B. degree from the University of Michigan in 1982 where he was also a member of the varsity baseball team.  Mr. Brown received his law degree from St. Louis University in 1985.

He also serves as the Hiring Partner in the firm’s Washington, D.C. office.

Ernest A. Carabillo, Jr., Founder, EXPERTech

Ernest A. Carabillo, Jr. is the Founder of EXPERTech. After selling his successful business he is limiting his practice to unique regulatory and quality challenges while he enjoys semi-retirement. He is a regulatory/quality systems strategist and an attorney, possessing a unique combination of corporate, governmental and private management experience.  He provides clients with senior level assistance in the areas of: crisis management; survival planning and administration; quality system & regulatory strategies; FDA representation; due diligence for M&A activities; organizational management review & evaluation; and corporate policy development.  An internationally recognized expert specializing in medical devices, human tissue and tobacco, his diversified background includes: extensive governmental experience with the FDA and Department of Justice culminating with an assignment as member of the White House staff. He is a Board of Directors member of several healthcare firms. He brings pragmatic issues management techniques, to the industrial strategic planning processes.

Christopher G. Chavez, President, CEO, and Director, Advanced Neuromodulation Systems, Inc.

Christopher G. Chavez joined Advanced Neuromodulation Systems as President, Chief Executive Officer, and Director in April 1998. Mr. Chavez has extensive leadership experience and has served with several Fortune 500 companies in the medical device industry. In his sixteen years with Johnson & Johnson Medical, Inc., a major division of Johnson & Johnson, he progressed through several positions in finance, strategic planning, domestic and international marketing, new business development, and general management to the position of Vice President and General Manager of the Infection Prevention Business Unit, one of four worldwide business units with approximately half a billion dollars in sales.

Prior to joining ANS, Mr. Chavez was Vice President of Worldwide Marketing and Strategic Planning for Eastman Kodak’s Health Imaging Division, where the division’s five worldwide profit centers reported to him. He received his MBA from the Harvard Graduate School of Business in 1979. Mr. Chavez currently serves as a member of the board of directors for Advanced Medical Optics, Inc. and The North Texas Visiting Nurse Association and as Chairman of the Board for the Medical Device Manufacturers Association and The Dallas/Fort Worth Health Industry Council.

Cecilia Kimberlin, Ph.D., Group Vice President of Quality Assurance and Compliance, Abbott Laboratories Medical Products Group

Cecilia Kimberlin is the Group Vice President of Quality Assurance and Compliance for Abbott Laboratories’ Medical Products Group.  This position provides quality, regulatory and compliance oversight and strategic direction for the Medical Product Group businesses.  Prior to assuming this position on August 2, 2004, Dr. Kimberlin served as Division Vice President of Quality Assurance, Regulatory, Compliance and Medical Affairs for the Abbott Diagnostics Division (ADD) since July 2002.  Dr. Kimberlin was the Division Vice President of ADD Regulatory Affairs, Compliance and Audits from September 1999 until July 2002. 

An Abbott employee since 1986, Dr. Kimberlin’s previous experience at Abbott includes Director of Corporate Compliance, Director of ADD Quality Systems, Quality Manager for Transfusion Diagnostics and Hospital Laboratory Businesses, and Manager of Research and Development.

Prior to Abbott, Dr. Kimberlin was a certified Clinical Laboratory Director in hospital and reference laboratories. She was an Assistant Professor of Microbiology at the University of Kentucky Medical School where she taught and performed research.  This followed a three-year period in an International Public Health position in Iran that was affiliated with the research efforts of WHO, the Pasteur Institute, and collaboration with the C.D.C.

Dr. Kimberlin received an MS and PhD in Microbiology from the University of Oklahoma and completed post-doctoral studies at the Harvard School of Public Health.  Her undergraduate degree is a BS in Medical Technology/Chemistry from the University of Louisville.  She maintains certifications as a regulatory professional (RAC), a Quality Manager (CQM) and Auditor (CQA) through ASQ (American Society for Quality), and a medical technologist (MT/ASCP). 

John Malloy, President, John Malloy and Associates

Mr. Malloy is President of Malloy & Associates, Inc., a consulting firm specializing in quality systems that meet the U.S. Food and Drug Administration (FDA), ISO 9000, ISO 13485 and European Medical Device and In Vitro Diagnostic Directive requirements. He has over thirty years of experience within the medical industry, having served as an FDA Investigator and having held industry management positions in manufacturing, regulatory, quality and marketing.

Mr. Malloy has worked with the Federal Food, Drug, and Cosmetic Act from both the FDA and private industry perspectives, including both domestic and international companies. His clients include companies ranging in size from less than $1,000,000 in sales to Fortune 100 companies. He has broad product line experience, having worked with all classes of medical devices, software controlled devices and processes, and all pharmaceutical dosage forms. He assists companies in the establishment of product development, manufacturing and quality systems that assure compliance with FDA and European Medical Device Directive requirements as a byproduct of good business practices.

Mr. Malloy received his MBA degree from the University of Evansville, Evansville, Indiana and holds a BS in Biology from Wheeling Jesuit University, Wheeling, West Virginia. He is the author of the articles: "The FDA's Role in the Product Development Process" published in the April, 1991 issue of Biomedical Science and Technology; "FDA Focuses on Design Practices" published in the November, 1990 issue of Medical Equipment Designer; and "Managing an Effective Complaint Resolution System" published in the October, 1987 issue of Medical Device & Diagnostic Industry. He conducts seminars that address the FDA’s Quality System Regulation, ISO 9000 standards, design controls, and auditing.

Kenneth F. Kopesky, VP Corporate Compliance and Audit, Medtronic, Inc.

Mr. Kopesky is the Vice President of Corporate Compliance and Audit for Medtronic. His responsibilities include managing the overall compliance of quality, regulatory and clinical activities through establishment of initiatives and compliance auditing. He has held management positions in quality, product performance and service, operations, manufacturing, development, regulatory and lead quality system certification for the Cardiac Rhythm Management organization. He has been involved with FDA and Notified Body inspections. He was a member of the Global Harmonization Task Force Study Grout 2 Vigilance Reporting and is a current member of Study Group 3 Quality Systems. He is an AAMI quality systems expert and a member of TC 210 Working Group 1 which wrote ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes and Medical Devices – Quality Management Systems – Guidance on the Application of ISO 13485:2003.

Jim Kozick, Principal Consultant, PARAXEL Consulting

Jim Kozick is a Principal Consultant, Regulatory and Compliance Services, PAREXEL Consulting, an international provider of regulatory compliance, validation, quality systems, and information system services to the pharmaceutical, medical device, and biopharmaceutical industries. He joined PAREXEL Consulting in 2001 after a 29 year career with the U. S. Food and Drug Administration in the Los Angeles District Office.  Mr. Kozick provides the full spectrum of compliance and regulatory consulting services to regulated industry, with a focus on medical devices.  Services include, but are not limited to, compliance assessments, regulatory strategies, FDA communications, pre and real time inspectional assistance, response to regulatory challenges/actions, and assessments under Attorney Client Privilege. 

Mr. Kozick joined PAREXEL Consulting after a 29 year career with the FDA in the Los Angeles District.  Since 1993 Jim was the Director of Domestic Investigations Branch where he directed the investigative/enforcement activities of seven Supervisory Investigators and seventy-five FDA Field Investigators comprising the largest field investigative operation within the FDA.  He developed local investigative operational policies/procedures/strategies in the enforcement of FDA statutes and regulations encompassing all FDA regulated industries.  He established and maintained effective working relationships with virtually every component within the FDA Headquarters and Field organization including, but not limited to all District Offices, all National Centers and FDA Office of Criminal Investigations.  He served on two ORA Field Committees which developed Agency policy and programs impacting on field investigations/enforcement operations.  He worked closely with local industry associations to develop and execute outreach programs, workshops/seminars, and training programs covering a wide variety of FDA-related topics.  During his last years with FDA, he served on extended temporary duty as the Acting Director, Los Angeles District, exercising ultimate responsibility and final authority for all District operations.  Jim received his Bachelor of Science degree from St. John’s University, Collegeville, Minnesota.   He is a member of the Regulatory Affairs Professional Society (RAPS), the Parenteral Drug Association PDA), the Association for the Advancement of Medical Instrumentation (AAMI), and the Orange County Regulatory Affairs Association (OCRA).

Maarten Meulenbelt, Partner, NautaDutilh, Brussels, Belgium

Maarten Meulenbelt joined the firm as a partner and head of the Life Sciences Group in March 2001. Maarten graduated from the University of Utrecht in 1992. After a five-month internship with the European Commission, he was admitted to the Dutch bar in 1992 and the Brussels bar in 1996. He has been specialising since then in European law, focusing on the life sciences industry (regulatory affairs, intellectual property, and competition law) and on EC procurement law at European and national level. He publishes and lectures regularly on these topics. Maarten represents major players in the pharmaceutical industry in the Benelux in procedures before regulatory authorities and has extensive litigation experience before national courts and the EC Commission. He has also represented clients in procedures before the EC Court of Justice.

Maarten participated in the team conducting the 2000 Audit of the EC pharmaceutical marketing authorization rules on behalf of the European Commission. He is recommended in European Counsel's Life Sciences Industry Report and Global Counsel's Life Sciences Report, for both Belgium and the Netherlands.

Julio Rivera, Senior Vice President, Corporate Compliance
Medrad, Inc.

Julio Rivera joined Medrad in 1998 with the responsibility for all Quality Assurance and Regulatory Affairs activities for new product development, suppliers and manufactured products, along with the responsibility for Regulatory Compliance.  In 2004, Mr. Rivera was promoted to Senior Vice President, Corporate Compliance, responsible for refining Medrad's performance in an increasingly complex environment of legal and regulatory compliance.

Prior to joining Medrad Julio held positions in the medical device and pharmaceutical industries with Sherwood Davis and Geck, and Baxter Health Care.  He specialized in directing quality assurance and regulatory affairs with primary focus in International Operations.  He was responsible for a number of locations world wide, including Europe, Latin America, the Pacific Rim, Central America, and the Far East, with pharmacy operations in Mexico, Brazil and Puerto Rico.  Julio's international accomplishments include the successful startup of an LVP manufacturing operation in China and a joint venture operation in Indonesia.

Armin Torres, Principal, Qualified Data Systems

Armin has over 16 years of management and engineering experience in the areas of Quality Assurance Manufacturing, Technical Support, Statistics, Validation, and Software Development within the Pharmaceutical and Medical Device Industry. Armin is also a Certified Software Quality Engineer (CQE) and certified instructor of Statistical Process Control and Design of Experiments.

Timothy A. Ulatowski, Director, Office of Compliance, Center for Devices and Radiological Health, US FDA

Timothy A. Ulatowski is the Director, Office of Compliance, Center for Devices and Radiological Health.  He manages four divisions tasked with promoting consumer health and safety, promoting product quality, and enforcing the medical device and radiological health laws and regulations.  Mr. Ulatowski has been with FDA since 1974, and with the Office of Compliance since January 2003.   

Prior to his recent appointment he was Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices.  He served as the U.S. government representative for Study Group 1 (Premarket) of the Global Harmonization Task Force and on several cross-cutting FDA committees dealing with such topics as reuse of single use devices, user fee implementation, and international standards implementation.    

Rene van de Zande, President & CEO, Emergo Group

Rene served the international commercial community as Senior Issues Coordinator for the EU Committee of the American Chamber of Commerce (www.eucommittee.be) in Brussels , Managing Director of the European-American Industrial Council in both Brussels and Geneva (www.eaic.org), and as Senior Commercial Specialist for the U.S. Foreign Commercial Service in Brussels (www.useu.be).

Having become an expert in the field of Trade and Regulatory Issues, Rene chose to serve the private sector; established Emergo Group specializing in the regulatory issues confronting manufacturers and distributors of medical devices and in-vitro diagnostics desiring to export their products to Europe or North America. As Emergo Group's client base expanded, so grew the areas of service requested by clients and fulfilled by Emergo Group's consultants, managers and associates.  Branching out from the basic service offering of Export assistance and implementation of technical and legal requirements for the European and North American markets, Emergo Group is now able to offer a wide range of European and North American regulatory and quality assurance services including the implementation of systems in accordance with CE Marking, Authorized Representation and US Agent, FDA's QSR, Canadian Medical Device Regulations CMDCAS, ISO 9001:2000 and ISO 13485/88

Rene has published numerous articles on medical device regulations-related issues. In addition, he is co-author of a series of publications on European product legislation for the US Department of Commerce and National Institute for Standards and Technology, including CE Marking for Medical Devices.

Rene was awarded a Certificate of Appreciation by U.S. Secretary of Commerce William M. Daley in June 1997 in recognition and appreciation of his outstanding effort and determination throughout the negotiation of the first Mutual Recognition Agreement with the European Union and his contribution in reaching an agreement that substantially enhances market access on both sides of the Atlantic and achieves the highest level of protection of safety and health.

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