Mark D. Kramer, RAC Regulatory Strategies, Inc. 808 E. Fox Lane Fox Point, Wisconsin 53217 (414) 731-4257 kramer@regulatorystrategies.net Experience Regulatory Strategies, Inc. Fox Point, Wisconsin President, October 2009-present Advise medical device, pharmaceutical, and combination product companies on regulatory strategies to meet company objectives. Monitor, interpret and analyze the impact of the evolving regulatory landscape for client impact. Develop regulatory strategies to obtain and/or maintain regulatory approval/clearance of client products. Prepare regulatory submissions and responses to Agency deficiencies for IDE, 510(k), PMA, De Novo, IND, NDA and BLA applications and associated pre-submissions. Assist clients in the preparation for Agency and advisory panel meetings. Conduct due diligence activities. Assess regulatory compliance of promotional materials. Advise on the complex premarket and postmarket regulatory requirements for combination products, product jurisdiction, and current good manufacturing practice requirements for combination and single-entity products. GE Healthcare, General Electric Company Waukesha, Wisconsin Executive, Regulatory Affairs, April 2007-July 2010 Executive responsibility for the Americas regulatory affairs function for the medical device business of GE Healthcare, a $17B subsidiary of the General Electric Company. Worked closely with senior business executives, external groups and global regulatory authorities to develop and implement regulatory strategies, policies and positions consistent with business vision and global regulatory requirements. Provided regulatory advice, expertise and data to guide management and drive decisions in the USA, Canada, and Latin America. Monitored the global regulatory landscape to formulate strategies that addressed business objectives. Devised and implemented strategies to improve existing processes and champion implementation of new initiatives across the company s regulatory function to ensure growth, consistency, compliance and best practice. U.S. Food and Drug Administration Director, Office of Combination Products, December 2002-April 2007 Established and directed new FDA Office to implement the combination product provisions of the Medical Device User Fee and Modernization Act of 2002. Managed the agency s Product Jurisdiction Program, to ensure prompt assignment of drug-device, drug-biologic, and device-biologic combination products to agency Centers, and determine regulatory identity of drugs, devices and biological products for which jurisdiction is unclear or in dispute. Established programs and processes to ensure the timely and effective premarket review of combination products by coordinating and facilitating the review process when more than one agency Center is involved.
Ensured the consistent and appropriate postmarket regulation of combination products. Resolved disputes regarding the timeliness of premarket review of combination products. Developed guidance and regulations to clarify the regulation of combination products. Served as the agency s primary resource to industry and Agency staff on combination product regulation. Reported to Congress on the activities and impact of the Office. Conducted extensive outreach to industry and agency staff to communicate key combination product issues and policies. Director, Combination Products Program, Office of the Ombudsman, February 2002-December 2002 Established new FDA program to facilitate the agency s review and regulation of drug-device, drug-biologic, and device-biologic combination products. Developed policies, procedures, and processes to facilitate the intercenter review process. Monitored and provided broad oversight of the progress of premarket reviews of combination products. Served as focal point to resolve issues arising during premarket review of combination products. Developed programs to provide greater transparency and predictability to jurisdiction for combination products. Extensive interactions and outreach with senior leadership and review staff in CBER, CDER and CDRH; with industry associations and sponsors; and Congressional staff. Special Assistant to the Associate Commissioner for Planning, Office of Planning (Detail), June-November 2001 Extensively responsible for management, analysis, and communications regarding the Agency s efforts to secure satisfactory reauthorization of the Prescription Drug User Fee Act (PDUFA). Developed and implemented procedures and timelines for operations of PDUFA negotiation team. Organized and implemented strategies for communication with FDA and DHHS leadership and industry. Developed proposals and presentations for FDA positions on PDUFA reauthorization needs, including review management, financial, and information technology. Director, CDRH Staff College, Office of Health and Industry Programs, March 1999-February 2002 Directed the planning, development, implementation, and evaluation of policies, procedures, and programs for the education and training of CDRH staff. Implemented a comprehensive 360-degree training program. Ensured training and learning needs were appropriately assessed. Developed training plans and comprehensive training programs that addressed the performance gaps. Evaluated training programs to ensure program quality and maximal impact. Developed and managed departmental budget. Managed the FDA resources devoted to the PHS epidemiology training program. Worked with regulated industry to develop training programs of mutual benefit. Chief, Anesthesiology and Defibrillator Devices Branch, Office of Device Evaluation, CDRH, 1998-1999 Managed interdisciplinary team of scientists in the review of IDE, 510(k) and PMA applications for cardiovascular, anesthesiology, and respiratory therapy devices, including implantable and external defibrillators, diagnostic and interpretative electrocardiographs, implantable hemodynamic monitors, oximeters, anesthesia delivery and monitoring devices, ventilators, and other life supporting/life sustaining devices. Extensively responsible for policy development. EDAP Technomed, Inc. Burlington, Massachusetts Vice President, Regulatory Affairs, 1996-1998 Managed the company s affairs regarding the regulation and approval of its devices with the Food and Drug Administration. Specific duties included the development and implementation of strategies for approval of new or modified devices; the preparation of submissions for FDA approval of new products; the development of clinical protocols and the supervision of clinical studies; ensuring that company operations were in compliance with Good Manufacturing Practices; conducting internal audits; performing MDR assessments for product complaints; development of training programs for complaint handling and MDR reporting for company employees; and supervising the activities of department personnel.
Independent Consultant North Potomac, Maryland Independent Consultant, 1996-1998 Advised medical device companies regarding complete range of FDA regulatory matters. Specific duties included the preparation and review of IDE, 510(k) and PMA applications; development of regulatory strategies; development of clinical protocols; client representation at FDA meetings; providing advice on and interpretation of FDA regulations; and assistance with due diligence matters. C.L. McIntosh & Associates, Inc. Senior Consultant for Device Evaluation, 1995-1996 Advised medical device companies regarding complete range of FDA regulatory matters. Specific duties included the preparation and review of IDE, 510(k), and PMA applications; development of regulatory strategies; preparation of reclassification petitions and 515(i) submissions; preparation for advisory panel meetings; development of clinical protocols; data audits; review of device complaint files; preparation of medical device reports; client representation at FDA meetings; and assistance with due diligence matters. U.S. Food and Drug Administration Chief, Urology and Lithotripsy Devices Branch, Office of Device Evaluation, CDRH, 1990-1995 Managed interdisciplinary team of scientists in the review of IDE, 510(k) and PMA applications for products used in the diagnosis and management of urinary incontinence, erectile dysfunction, urinary and biliary stone disease, benign prostatic hyperplasia and prostate cancer, as well as the review of endoscopes for all uses in gastroenterology and urology. Extensively responsible for FDA policy development for urological devices, including the development of over 20 guidance documents for device reviewers and industry, and for employee training. Served as Executive Secretary of the Gastroenterology and Urology Devices Advisory Panel. Acting Associate Director for Reconstructive Devices (Detail), Office of Device Evaluation, CDRH, 1993 Second-line supervisor responsible for the management of all review activities of the Plastic and Reconstructive Surgery Devices Branch and the Dental Devices Branch. Served as the Agency s focal point for silicone gel and saline breast implants. Lead Reviewer, Pacing and Electrophysiology Devices Branch, Office of Device Evaluation, CDRH, 1987-1990 Lead reviewer for conventional and rate-adaptive dual chamber cardiac pacemakers, implantable defibrillators, implantable pacer-cardioverter-defibrillators, arrhythmia detectors and monitors, electrocardiograph monitors and electrodes, as well as the Agency s first application for pacemaker reuse. Cordis Corporation Miami, Florida Clinical Engineer, 1985-1987 Designed clinical protocols to evaluate the safety and effectiveness of new cardiac pacing products. Monitored clinical studies and analyzed study results, and prepared detailed reports for FDA review. Provided technical support and training to physician-customers and provided clinical support and training for in-house personnel. Prepared IDE, 510(k) and PMA submissions for FDA review. Reviewed and approved engineering, manufacturing, and labeling change documentation and assessed regulatory impact.
Electronic Engineer, 1984-1985 Design team leader for cardiac pacing devices. Primary engineering interface for new hybrid and integrated circuit implementation. Developed and implemented test protocols for pacemaker qualification testing that were adopted company-wide. Interacted extensively with Quality Assurance, Manufacturing, Regulatory Affairs, Clinical Research and Marketing, and supervised and coordinated all these activities as Pacing Project Manager. Education Regulatory Affairs Certification (RAC), 2008 Regulatory Affairs Professional Society, Certificate, Quality Management, 1995 The George Washington University, Washington, DC M.S. Biomedical Engineering, 1984 Rensselaer Polytechnic Institute, Troy, New York B.A. Mathematics, 1982 Rutgers College of Rutgers University, New Brunswick, New Jersey Graduated with Highest Honors, with High Distinction in Mathematics, and Phi Beta Kappa Professional Leadership Board of Directors, Regulatory Affairs Professional Society, 2009-2014 Adjunct Faculty Member, Regulatory Affairs & Services, Minnesota s St. Cloud State University, 2010-present Founder and Chair, Wisconsin Chapter, Regulatory Affairs Professional Society, 2008-2010 Named one of 100 Notable People in the Medical Device Industry, 2004
Publications Navigating the Regulatory Landscape of Combination Products, Pharmaceutical Technology, April 2014. Five Steps to Solid Regulatory Strategy Development, BoneZone Magazine, March 2014. Navigating the New GMP Rules for Combination Products in the US, Scrip Regulatory Affairs, June 2013 Challenges in Combination Product Regulation, Master Control, July 2012 5 Questions about Combination Products (Interview), MD&DI Magazine, February 2012 Combination Products (Book Chapter), Fundamentals of US Regulatory Affairs, 2011 Developing an Effective Regulatory Strategy, Regulatory Affairs Focus, December 2010 A Little Guidance for Improving Reviews of Combination Products (Interview), Medical Design, December 2008 Combination Products: Challenges and Progress, Regulatory Affairs Focus, August 2005 FDA s Office of Combination Products: Roles, Progress & Challenges, Journal of Medical Device Regulation, June 2005 Forging New Regulatory Pathways at FDA (Interview), MD&DI Magazine, September 2004