Advisory Board

Ercem Atillasoy, MD

Chief Regulatory and Safety Officer at Jazz Pharmaceuticals

Bio

Ercem Atillasoy recently joined Jazz Pharmaceuticals in Dec 2022. Prior to joining Jazz, he was Vice President, and Therapeutic Area Head of Vaccines and Infectious Disease, in Global Regulatory Affairs and Clinical Safety. For the over 23 years, Ercem has worked in drug, biologics and vaccine development, interacting with key officials and scientists at Regulatory Agencies such as those in the United States, Europe, Japan and China. Since joining Merck in 2001, he has played an important role in the global licensure of innovative medicines and vaccines that have transformed human health, including: Ervebo (Ebola); Gardasil, Gardasil 9, Isentress, Prevymis, Recarbrio, Zepatier, Pifeltro, Delstrigo, Rotateq, Proquad, Zostavax, Zinplava and Vaxelis. He oversaw the first IND filing for Keytruda (MK-3475), and he has supported oncology products that include Keytruda, Zolinza, Pegintron, Oncotice and Emend. He has also overseen the Worldwide Product Labeling and OPAR (Promotion) groups. Prior to Merck, Ercem worked within the Medical Affairs Departments at Sandoz and Novartis Pharmaceuticals. He has taught introductory and advanced negotiation workshops at Merck for over 15 years.

Ercem is a graduate of the Yale University School of Medicine, where he was recognized as a Farr scholar, and continues to serve as a class officer. Ercem completed his medical internship at Yale-New Haven Hospital and his dermatology residency at the University of Pennsylvania. He also completed research fellowship training at the Wistar Institute, with a focus in melanoma, carcinogenesis, and gene therapy. Ercem has received executive management and leadership training at institutions such as the Wharton School of the University of Pennsylvania and the UCLA Anderson School of Management. He maintains a voluntary Clinical Associate faculty position at the University of Pennsylvania.

Marlene Bobka
President
FOI Services, Inc.

Bio

Marlene Bobka serves as the Senior Vice-President at FOI Services, Inc. In this role, she is responsible for functions that facilitate access to FDA records acquired using the Freedom of Information Act, and producing teleconferences that interpret FDA regulations, actions and expectations.

Ms. Bobka is a widely published author and speaks frequently on topics that give insight into finding and using fugitive drug, device and biologic regulatory information. She has addressed audiences worldwide for organizations including the Drug Information Association, the Regulatory Affairs Professional Association, the Special Libraries Association, the American Chemical Society, the Association of Food and Drug Officials and many others.

Before joining FOI, Ms. Bobka taught online searching strategy; conducted extensive medical, chemical, and government literature research; and designed and documented databases at Bibliographic Retrieval Services and the National Cancer Institute. She holds a B.S. in biology and chemistry and an M.L.S. with a concentration in biomedical information structure. As an undergraduate student, Ms. Bobka was awarded an AAAS research grant, and as a graduate student, she was inducted into the information science honor society, Beta Phi Mu.

Bobka has held elected office in multiple professional societies, has been named a “Thought Leader” by Pharmaceutical Executive, and was included in a listing of 100 Influential Device Executives in the publication, Medical Device & Diagnostic Industry.  She has served as a guest lecturer, adjunct faculty member and Advisory Board member for graduate programs in Library and Information Sciences and FDA Regulatory Affairs.

Paul C. Brooks
Regulatory Affairs Professional Society-Retired

Bio

Paul Brooks was executive director, RAPS (Regulatory Affairs Professionals Society) from 2016-20 and is now retired. RAPS has over 20,000 members globally.

Prior to RAPS he had completed 25 years of work experience within the medical device regulatory affairs environment during his 35-year career with the British Standards Institution (BSI), where he served as senior vice president, BSI Americas Healthcare and previously was head of the medical device EU Notified Body responsible for review and clearance of medical devices against European regulations. He also led BSI in achieving formal recognition as a recognized third party under FDA’s Center for Devices and Radiological Health (CDRH) and Health Canada’s Canadian Medical Devices Conformity Assessment System (CMDCAS) and MDSAP. He is recognized both domestically and internationally as an expert on medical device regulations and regulatory issues.

Chris Cain
VP, Clinical and Regulatory Affairs
Conformal Medical, Inc

Bio

Chris Cain serves as Vice President, Clinical and Regulatory Affairs at Conformal Medical, Inc. In this role, he has global responsibility for all aspects of clinical research and regulatory affairs for Conformal’s Class III medical device.

Prior to joining Conformal, Chris was VP, Clinical and Regulatory Affairs for Corindus Vascular Robotics, Inc. While at Corindus, he was responsible for global clinical activities supporting regulatory marketing clearances and clinical evidence generation contributing to the company’s publication portfolio. He also led global regulatory strategy resulting in marketing clearances/approvals worldwide.

Chris is a member of the Regulatory Affairs Professionals Society (RAPS), Society of Quality Assurance, and Association of Clinical Research Professional (ACRP); he holds ACRP’s Certification for Clinical Research Associates (CCRA). He also serves on the Medical Device Innovation Consortium’s (MDIC) Budgeting and Contracting Working Group; and a board member of the Medical Device Regulatory Working Group.

He earned a B.S. in Nursing from the University of Central Missouri and an MBA from University of Missouri Kansas City.

David E. Chadwick
Director, Regulatory Affairs, Regulatory Science
Cook, Inc.

Bio

Dr. David Chadwick serves as a Director, Regulatory Science for Cook Medical. In this role, he provides high-level regulatory and clinical advice on pre- and post-market safety, quality, performance, testing, compliance and marketing issues pertaining to the manufacture and supply of medical devices globally. Dr. Chadwick first joined Cook Medical in 2006.

In his regulatory affairs experience, he has been responsible for product registration, compliance and product complaints, and has served as his company’s regulatory and clinical focus person for post-market activities and customer feedback. Dr. Chadwick has also functioned as an internal auditor within the Quality System and an external auditor for vendor qualification, and has served as his company’s management representative for the Quality System. The scope of his experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, drug delivery, electrosurgery, cardiovascular stents and catheters. His main focus is medical devices and combination products, but is experienced in pharmaceutical regulation and submission.

Dr. Chadwick graduated with a B.S. in Biology from Albright College, and with a Ph.D. in Anatomy and Cell Biology from the School of Medicine, University of Pittsburgh. He holds the RAC certification from the Regulatory Affairs Professionals Society (RAPS), where he has been recognized as a Fellow. He also serves as a Board member and Treasurer of RAPS. He, additionally, serves as the Industry Representative on the Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee of the U.S. Food and Drug Administration.

Bob Darius
Head Quality Advocacy Liaison
Audit & Risk Management
GSK Vaccines

Bio

Bob Darius is currently serving as Head Quality Advocacy Liaison in GSK Vaccines. Previously, he served as the Vice President of the Quality Unit for the North American & Dresden, Germany Vaccines sites in GSK, with oversight of the Quality Assurance, Quality Control, and Validation Compliance teams. These sites manufacture Influenza Vaccines, Adjuvants, and other Vaccine products approved in Europe and Asia. Bob was a Senior Consultant at Biologics Consulting Group, then started Radius Biotechnology, LLC in 2005.

Between 1990 and 2005, served in the FDA Center for Biologics Evaluation & Research as a Microbiologist, Senior CMC / BLA reviewer, Lead Inspector and Trainer, Branch Chief, and Senior Advisor to the Center Director for Counter Bioterrorism Products. Bob has regulated, consulted on, and managed the full range of biological products and has gained experience with technical manufacturing approaches, validation, and remediation. He has lead diverse teams to qualify facilities and gain multiple regulatory approvals of sites both as a consultant and within GSK Vaccines and is an active speaker and writer within industry groups to help advance regulatory and quality knowledge, and continuous learning.

Bob graduated from George Mason University in Biology, and completed graduate work in Biotechnology at John Hopkins University.

Georgianna Harris, PhD
Global Regulatory Affairs

Bio

Dr. Harris has more than 25 years’ experience in the pharmaceutical industry at both large and mid-size companies. Most recently, she served as Senior Vice President of Regulatory Affairs at Alkermes, Inc. Prior to Alkermes, she worked at Merck & Co., Inc and took on roles of increasing responsibility within Regulatory Affairs and Basic Research.

At Alkermes, Georgianna headed the Regulatory Affairs organization which included Regulatory Strategy, Regulatory CMC, Regulatory Operations, Advertising and Promotion, and Knowledge Management Services. During her 6 ½ years with the company, she was responsible for the global team supporting psychiatry, multiple sclerosis and oncology drug development. While at Alkermes she secured approval of ARISTADA®, ARISTADA INITIO® and VUMERITY®. Georgianna was also a member of the company’s Management Committee.

Prior to Alkermes, Georgianna worked at Merck & Co. Inc. During her time in Regulatory Affairs, she served as Therapeutic Area Leader for Diabetes, Women’s Health and Oncology. Under her leadership, the teams filed numerous INDs and secured multiple NDA approvals. Prior to Regulatory Affairs she worked in Basic Research and contributed to the efforts to identify potential drug candidates for urology, metabolic diseases and infectious disease.

Dr. Harris holds a PhD in biochemistry from the University of Wisconsin Madison and a B.S. in Biology from Boston College. She was also Postdoctoral Fellow in the Chemistry Department at the Massachusetts Institute of Technology.

Debbie Henderson

Bio

Debbie Henderson is currently a consultant with more than 40 years of experience in health care, FDA, and the pharmaceutical industry. Prior to retiring from full-time work in December 2019, Debbie worked for 8 years at Merck, leading their global regulatory policy team. In that role, she managed external regulatory advocacy activities across therapeutic areas and regions to optimize their impact on product strategy. The regulatory policy team monitored and performed an ongoing strategic assessment of the regulatory environment and sought to influence proposed changes in global regulatory requirements and/or worked internally to ensure continued regulatory compliance.

Prior to joining Merck, Debbie spent many years at FDA where she directed the Office of Executive Programs in the Center for Drug Evaluation and Research (CDER). In that role and as part of the Center’s executive leadership team, she oversaw the Center’s Advisory Committee functions, the Executive Secretariat, the office of the ombudsman, and the international affairs team.

Debbie’s early career was spent at the Clinical Center at the National Institutes of Health where she worked as an intensive care nurse. She continues in her consulting role as a strong advocate of health care for all and a dedication to fostering a robust drug development ecosystem that results in safe and effective therapies.

Scott Huie
Director, Quality Compliance at Amgen

Bio

Scott Huie is currently Director, Quality Compliance at Amgen where he oversees a group that initiates QMS process improvements, hosts external audits and develops responses to regulatory agency inquiries. Previously he served as the Vice President, RA/QA at Valeritas, a company committed to developing and commercializing innovative treatment solutions for diabetes. He has written, compiled and received clearance on all of the regulatory submissions made by the company.

He has more than 40 years of experience in medical device, pharmaceutical and combination products. During his career, he has held roles in product/process development and engineering, operations, materials, facilities, regulatory, quality, compliance and post-market surveillance..

Prior to joining Valeritas, he served as the Vice President for Operations at Fusion Medical Technologies, which was acquired by Baxter Healthcare Corporation, developing and commercializing a unique hemostatic agent used in surgeries. He has also held positions at Aradigm, Cygnus Therapeutic Systems, Ciba-Geigy and 3M Corporation specializing in alternative drug delivery technologies including transdermal, buccal and aerosol delivery of pharmaceutical products. Mr. Huie received his B.S. in chemical engineering from Rensselaer Polytechnic Institute.

Kazem Kazempour
President and CEO
Amarex Clinical Research

Bio

Kazem Kazempour, Ph.D., is the co-founder, president, and CEO of Amarex Clinical Research, a full-service contract research organization providing services to the pharmaceutical, biotech and device communities.

He started his career in statistics by working at the Genetics Institute (1975) and published his first article on genetics in 1979. His experience in the industry and FDA has allowed him to understand biometrics, quality assurance/quality control from both a sponsor's perspective, as the provider of the data, and from a regulatory perspective as the reviewer of the data. Mr. Kazempour has worked in many therapeutic areas including vaccines, anti-infectives, anti-virals, AIDS, and cardiovascular, as well as devices, and has been a key contributor in the approval of these drugs/devices. Additionally, he has established, presented, and participated in many Data Safety Monitoring Boards (DSMB).

During his more than 30 years of experience in biomedical research, Mr. Kazempour has conducted research activities with the National Institutes of Health (NIH), the pharmaceutical industry and universities. While at the Food and Drug Administration (FDA) as a statistical reviewer, he received several awards for innovative problem solving and teamwork. During his tenure at the FDA, Mr. Kazempour also worked as a senior staff fellow and as a mathematical statistician responsible for supervising and conducting independent statistical analyses of clinical trials and reviewing statistical sections of submitted protocols and statistical analyses.

Mr. Kazempour has been recognized many times by the FDA for his contributions in the drug approval process. He has been active in the biomedical research community throughout his career as an organizer, a panel discussion member, and presenter at national and international meetings. He has made presentations to FDA, and FDA advisory committees on more than 30 different drugs. He is also a widely published author, having written articles, book chapters, and technical reports.

While serving as Global Biometrics Senior Director for an international pharmaceutical company, Mr. Kazempour was responsible for the global standardization of biostatistical, scientific programming, and data management procedures. He also implemented ICH guidelines and validated the programs for all biometrics offices. Additionally, he prepared and presented the biometrical aspects of study designs of Investigational New Drug Applications (IND), New Drug Application (NDA), PLA, and supplements to regulatory agencies in the United States and Europe.

Joesph Lamendola, PhD
Pharmaceutical Drug Development Strategic Advisor

Bio

Joe is a senior strategic advisor in drug development to the Pharmaceutical Industry. He is the SVP of the Biopharmaceutical Practice for Your Encore and the President of JF Lamendola Consulting, LLC. Joe serves as the senior advisor and strategic partner to pharmaceutical companies of all sizes as they work to bring medicines to patients in need.

With over 30 years of leadership experience, Joe advises biopharma and biotech companies on all key agency interactions, including pre IND, end of phase 2, pre NDA and Advisory Committee meetings. Joe also advises on regulatory structure and process as well as alignment between regulatory, clinical and commercial in the drug development process. Joe provides companies with an assessment of drug development risk and advises on strategies to mitigate these risks. He brings strategic insight to support all stages of the product development life cycle. He continues to be a trusted advisor to CEOs and R&D leaders in the biopharma and biotech industries.

Joe has held key executive positions, including: Vice President of US Regulatory affairs at Schering Plough and Vice President of US Regulatory Science and Regulatory Intelligence/Policy at Bristol Myers Squibb.

As a member of the senior management team within Global Regulatory Science as well as a member of the senior management team for the US Commercial organization, Joe participated in and led the new BMS strategy leading to the transformation of the US Regulatory Organization. In addition, he has led efforts that have resulted in the approval of over 30 NDAs in over 10 different therapeutic areas. His experiences span new chemical entities, 505B2 applications and Orphan Drugs.

While serving as Global Biometrics Senior Director for an international pharmaceutical company, Mr. Kazempour was responsible for the global standardization of biostatistical, scientific programming, and data management procedures. He also implemented ICH guidelines and validated the programs for all biometrics offices. Additionally, he prepared and presented the biometrical aspects of study designs of Investigational New Drug Applications (IND), New Drug Application (NDA), PLA, and supplements to regulatory agencies in the United States and Europe.

Steven Mandernach
Bureau Chief
Iowa Department of Inspections and Appeals Food and Consumer Safety

Bio

Steven Mandernach (Mawn-dur-knock) is the executive director of the Association of Food and Drug Officials (AFDO).  Prior to becoming executive director in 2018, Mandernach was the bureau chief for food and consumer safety at the Iowa Department of Inspections.  Mandernach is a past president of AFDO and current co-chair of the Association’s Laws and Regulations committee.  He has also served as the chair and co-chair for the Manufactured Food Regulatory Program Alliance.  He is a past president of the Mid-Continental Association of Food and Drug Officials.

Mandernach has a J.D. from Drake University Law School.  He has completed graduate work in Food Safety at Michigan State University.

Sandy Milligan
Senior Vice President

Bio

Sandra Milligan has been appointed as head of Research and Development, Organon & Co., Merck’s intended spinoff of its women’s health, legacy brands and biosimilars businesses. Prior to this role, she served as senior vice president and head of Global Regulatory Affairs and Clinical Safety (GRACS), consisting of global Regulatory, Safety and CMC functions of Merck Research Laboratories at Merck & Co., Inc. At Merck, Sandy serves as Executive Sponsor for the Veterans Employee Business Resource Group, a Trustee for the Merck Foundation, co-sponsor of the Merck Women’s Leadership Program, Global Diversity & Inclusion Line Advisor and previously as an advisory board member for the General Management Accelerator Program.

Sandy served on the board of directors and executive committee of the Drug Information Association (DIA), as program chair for the DIA’s 2013 Annual Meeting, and co-chair of the Public Policy/Health Care Compliance/ Regulatory Law Annual Meeting track. She is now a DIA fellow and serves on the Science Advisory Council of DIA. Sandy was appointed to the PhRMA industry team which negotiated PDUFA VI enacted in 2017. Prior to joining Merck, she was at Genentech/Roche (2012-2015) and Amgen (2002-2012). She is a graduate of George Washington University School of Medicine and Georgetown University Law Center, and proudly served as a General Medical Officer in the U.S. Army.

Michael C. Morton
Founder and Principal of Michael C. Morton Regulatory Consulting, LLC

Bio

Michael C. Morton is the Founder and Principal of Michael C. Morton Regulatory Consulting, LLC. The firm provides both strategic and hands-on support to the medical device industry. The firm specializes in the pre-approval process, including FDA advisory committee meetings, for high-risk devices. The firm is also experienced in a broad range of devices, including digital health, and has worked also in the 510(k), de novo, and HDE routes to market.

Michael has over thirty years of experience in the medical device industry, including quality, clinical, and regulatory affairs. Michael’s last position was Vice President for Corporate Regulatory Affairs, at Medtronic, Inc, where he was responsible for public health policy advocacy in regulatory affairs, and for internal regulatory policy. Before joining Medtronic, Inc., Michael worked for CarboMedics, Inc.; W.L. Gore and Associates; Alcon Labs; and Sorin Group.

Michael has been recognized as a Fellow of the Regulatory Affairs Professional Society (RAPS) and recently completed four years of service on the RAPS Board of Directors. He has been active in industry groups, including the Advanced Medical Technology Association (AdvaMed) where he chaired the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and was a member of the Heart Valve Task Force. Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force and remains interested in current harmonization activities. He has also served as the industry representative to the FDA Circulatory System Devices Advisory Panel.

Amra Racic

Senior Regulatory Affairs Program Manager at Medtronic

Bio

Amra Racic is currently working as a Senior Regulatory Affairs Program Manager at Medtronic's corporate office in Minneapolis, MN. She has been in the Healthcare Industry for over 20 years, most of those spent with the Medtronic Regulatory Group. She has worked on a variety of US and International submissions, leading and executing on Medtronic's global regulatory advocacy initiatives and has had responsibility for implementing and establishing regulatory policies across the strategic business units and geographies to ensure Medtronics has adequate policies to operate in accordance with global requirements. More recently, her responsibilities have shifted with leading the Global Sterilization Regulatory workstream and engaging in key partnerships with external stakeholders including the FDA Innovation Challenge Program and the FDA Ethylene Oxide Sterilization Master File Pilot. Prior to Medtronic, she has worked in Regulatory at Bayer AG and also had responsibility for Patient care management at a local hospital in Minneapolis. Amra holds a BS in Business Administration and an MBA with Management focus from Walden University.

Nancy Singer

Founder

Compliance Alliance LLC

Bio

Professor Nancy Singer founded Compliance-Alliance LLC to specialize in the professional development for FDA and industry employees in the medical device and drug industries. Previously she served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Professor Singer represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). While working on QSIT, Professor Singer received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. Professor Singer began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Professor Singer received her B.S. from Cornell University , and J.D. and LL.M. degrees from New York University Law School. She is a retired commander in the United States Naval Reserve.

Stef C. Schutte, Pharm.D., M.Sc.

Head of Regulatory Affairs, Astellas

Bio

Stef Schutte is since April 2019 Executive Vice President and Head of the Regulatory Affairs function worldwide for Astellas, he is based in Leiden in the Netherlands. In addition, Stef has been a Board member and statutory director for Astellas Pharma Europe BV and its parent company, Astellas BV.

Prior to his current role, Stef was Senior Vice President at Astellas, responsible for the Regulatory Affairs team across 23 affiliates in the Europe, Middle East and Africa region, with a focus to ensure the close collaboration and continued communication across each of the R&D functions in the region following recent globalization.

Stef achieved his M.Sc. in Pharmaceutical Sciences at the State University of Leiden and worked at ICI Pharma in Germany before earning his Pharm. D. at the State University of Utrecht in 1988. He joined Katwijk Farma for a short time before completing his military service as Head of Pharmaceutical Policy at the Ministry of Defense in The Hague.

Stef spent almost a decade at Solvay Pharmaceuticals working in the areas of CNS and infectious diseases in addition to further regulatory responsibilities for the company’s veterinary portfolio. He joined Organon in 1998 and went through the evolution of this company, first to Schering-Plough and then Merck (MSD). With initial responsibility for the Medical Biological section of Organon’s regulatory affairs department, Stef covered the reproductive health portfolio from pre-clinical to life-cycle management and later expanded his remit to include CNS and the global regulatory strategy group at Schering-Plough. In 2011, Stef was responsible for biologics and vaccines in the EMEA region at Merck (MSD), following which he led the Merck (MSD) RA organization for EMEA, based out of Brussels.

Stef has been responsible for the filing of NDAs, BLAs and MAAs and has achieved successful approvals for over 25 products worldwide. These have included small molecules, biologics and medical devices across diverse therapy areas encompassing Oncology, Neuroscience, Reproductive Medicine, Cardiovascular Disease, Infectious Diseases, Urology, Nephrology and Vaccines.

Kimberly S. Stranick, PhD

Sr. Regulatory Professional

Bio

Kim Stranick has more than 20 years of experience in global regulatory affairs in the pharmaceutical industry. Dr. Stranick has successfully led global organizations dedicated to the regulatory activities and strategic guidance for teams supporting small molecule and biologic development projects as well as combination drugs and over-the-counter (OTC) medicines. She has led global Health Authority interactions to support successful clinical trial conduct, labeling negotiations, product approvals and marketing of products across diverse therapeutic areas and product portfolios. She has participated as a senior member of global industry leadership teams for portfolio governance, business development, licensing decisions and compliance initiatives.

Dr. Stranick  has previously held senior management roles in Regulatory Affairs in large global pharmaceutical companies such as Daiichi Sankyo, Pfizer, Novartis, Johnson& Johnson, Aventis and Schering-Plough., as well in the smaller biopharmaceutical companies of Esperion Therapeutics, Symphogen Inc. and Taiho Oncology Inc.

Dr. Stranick holds a Ph.D. in Experimental Pathology from the University of Pittsburgh School of Medicine, a M.S. in Microbiology and Immunology from the University of Michigan School of Medicine, and a B.S. in Biology from Muhlenberg College in Pennsylvania. Additionally, she was a Postdoctoral Fellow of Human Immunology at Memorial Sloan-Kettering Cancer Center in New York City, and a Postdoctoral Fellow of Molecular Biology at Bristol-Myers Squibb Research Institute in New Jersey.

Janet Vessotskie, PhD, MPH

Bio

Ms. Vessotskie is currently Deputy Vice President of Science and Regulatory Advocacy at PhRMA and is responsible for the International Regulatory portfolio.

Ms. Vessotskie is a regulatory affairs professional who has expertise in both leading regulatory strategies as well as regulatory policy and intelligence activities in North America, Latin America, Africa and Asia.

Prior to joining PhRMA, Ms. Vessotskie has over 20 years’ experience in the pharmaceutical industry with various pharmaceutical companies, most recently Takeda Pharmaceuticals where she led a Global Regulatory Intelligence and Policy Network for Global Regulatory Affairs. Ms. Vessotskie has a PhD in pharmacology from the University of Pennsylvania and a Master of Public Health from New York University.