Following are short biographies of the members of our Regulatory Focus Board of Editors along with the reasons they joined the board. Our hope is readers will learn from these board members that they, too, can become authors of Regulatory Focus articles.
Siegfried Schmitt, chairman of the Board of Editors, has this advice for potential authors based on lessons he has learned from writing or contributing to more than a dozen books and 40 articles in various journals:
- There is always someone who is even more of a subject matter expert than you are––don't worry.
- There are many who would love to read your stories––either to learn something or to confirm their understanding of the topic.
- Always tell a story––we have grown up with stories and that is why we love reading them.
- Keep it clear and simple––your audience probably includes non-native English speakers.
- Write when you are in the mood.
- Learn from your reviews by the editors––these may range from minor edits to complete rewrites; in all cases there are good reasons for these changes.
Board member Moulakshi Roychowdhury has this to say: “Information is continuously being generated and free flowing in the regulatory world, whether through blogs, tweets or Facebook posts, akin to spokes of a wheel lacking a central hub. I joined the Regulatory Focus Board of Editors because I believe Regulatory Focus can be an invaluable hub for communications regarding regulatory developments and knowledge. Having worked in regulatory advertising and labeling, advising companies on promotional compliance with FDA regulations over the years, I've learned that keeping our fingers on the pulse of the industry is vital for success in our dynamic and continuously evolving field. For this reason, I began writing for Regulatory Focus, and I greatly look forward to reading fellow authors’ pieces and learning from their (and your) experiences. Together, let's make all the information at our fingertips work for us and help us take the regulatory world to new heights.”
Nicole D’Auteuil is vice president of regulatory and pharmacovigilance at Dyax Corp. Prior to joining Dyax, she held regulatory positions at Acusphere, Genzyme and Cambridge NeuroScience. Concurrently, D’Auteuil taught regulatory affairs and compliance at Boston University for five years. Her areas of regulatory expertise include orphan drugs, US and EU regulatory affairs for recombinant proteins, regulatory writing and investigational through commercial development. D’Auteuil began her career with NeuroCare helping traumatic brain injury patients. Describing her interest in the Regulatory Focus Board of Editors, D’Auteuil says, “The Board of Editors provides an excellent opportunity to contribute to the profession while keeping in touch with global regulatory colleagues; I also very much value the knowledge of fellow professionals and learn from their views and experiences.”She can be reached at email@example.com.
Grant S. Griffin, MS, RAC, is a doctor of regulatory science student at the University of Southern California. Previously, he worked as a patient care technician at Evanston Hospital and as a clinical research coordinator at the Chicago Institute of Neurosurgery and Neuroresearch.Currently, he coordinates daily IND, NDA and/or BLA submissions to FDA as a regulatory affairs associate at AbbVie. He holdsan MS in regulatory science from USC. Griffin joined the Regulatory Focus Board of Editors to have an opportunity to work with talented, experienced professionals and contribute to the regulatory science profession. He can be reached at firstname.lastname@example.org.
Naseem Kabir, RAC, is director, Global Regulatory Affairs, at Amgen in the hematology oncology therapeutic area. She has been in the pharmaceutical drug and device development space for 25 years and has worked in regulatory for 17, supporting pre- and postmarket stages of product development (including product defense and life cycle management activities) both in the US and international markets. Prior to Amgen, she was at Genzyme (a Sanofi company) for 17 years, most recently as senior director for the International Regulatory Affairs group. Kabir holds a master’s degree from the University of Chennai and has earned the US and EU RAC. Kabir says, “I discovered that I enjoyed thinking about, planning for and developing themes for upcoming issues that are of current interest to regulatory professionals. Becoming a board member again allows me to give back in a meaningful way to the profession that I care deeply about. Finally, I really like RF––I enjoy reading the articles as they keep me up to speed on current topics and trends and I get a feel for how my peers are dealing with common issues.” She can be reached at email@example.com.
Gautam Maitra is head of regulatory and external affairs for AC Immune, managing clinical trial applications, pre-IND meetings and interacting with regulatory agencies worldwide. He also manages regulatory and QA-related SOPs. Previously, he held positions with Roche, Novartis and OPi/EUSA. Maitra has served on the board of directors of PDA and is a member of the RAPS Board of Directors, RAPS European Advisory Committee and the RAPS Swiss Affiliate. He trained as a chemist in Sweden.Maitra said he joined the Board of Editors for several reasons. These include “the pleasure of contributing to the enhancement of the mission of RAPS with the broad and yet specialized expertise at my disposal (early phase development, biotech, vaccines, CMC); widening my own horizon of knowledge; and helping to enlarge the network and thereby help the regulatory profession.”Maitra can be reached at firstname.lastname@example.org.
Alan G. Minsk, JD, is a partner and chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP. Minsk advises pharmaceutical, medical device and food companies on all legal and regulatory matters relating to the US Food and Drug Administration, and certain matters concerning the US Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms and the Consumer Product Safety Commission. He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and lifecycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports. He was recently selected as Chambers USA: America’s Leading Lawyers in Life Sciences: Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2014.Minsk says, “I am on the Board of Editors because I enjoy seeing the depth and scope of the FDA universe and, by seeing the submissions and articles, we can educate members and editors. Personally, I also like the networking opportunities among the board members.” He can be reached at Alan.Minsk@AGG.com.
Thomas Perrone is director of CMC regulatory affairs at the oncology firm Tesaro Inc. He has 21 years of global industry experience in biopharmaceuticals, pharmaceuticals, medical devices, combination products, adhesives, paints and metallurgical testing services, with 16 years of facilitating product approval and lifecycle management. Perrone holds a PhD in analytical chemistry from Purdue University, an MS in organic chemistry from the University of Michigan, has completed Six Sigma Greenbelt training, and is RAC certified. He is actively involved in groups covering regulatory CMC, regulatory intelligence and Good Clinical Practices.Perrone said, “I am grateful for the opportunity to serve the professional community that over 12 years ago was quite influential in facilitating my transition from scientific research to regulatory science. By joining the Board of Editors, I can share my passion for developing science-based, risk-based and common sense-based regulatory solutions. I hope my contributions to Regulatory Focus will further the mission of RAPS, result in proposing meaningful standards for consideration by health authorities, be a valuable resource to regulatory practitioners, and ultimately increase availability of needed medical products.” He can be reached at email@example.com.
Linda Pollitz, RAC, is director of Regulatory Affairs, Advertising & Promotional Labeling at Alkermes Inc., where she focuses on the requirements of FDA’s Office of Prescription Drug Promotion (OPDP). She has held regulatory positions at Boston Scientific, Genzyme and AMAG Pharmaceuticals, and has been a guest lecturer at Regis College in the Masters of Science in Regulatory & Clinical Research Management for many years. The newest member of the board, Pollitz notes she has relied on RAPS and Regulatory Focus as the source of current information in the regulatory field. “We can’t always attend all the conferences we’d like to, so reading Regulatory Focus has helped me to stay current on many areas of regulatory that are outside of my daily responsibilities. As a past contributor to the magazine, it has also helped me to push outside of my comfort zone and gain broader writing experience, not to mention a bit of name recognition. I would encourage anyone at any level within regulatory to take advantage of this great opportunity.” She can be reached at firstname.lastname@example.org.
Sheryl Robinson, RAC, is worldwide director of regulatory affairs at Becton Dickinson and is a member of the Diabetes Care Leadership Team. Prior to joining BD, Robinson held regulatory positions at Advanced Bionics, Ethicon (a J&J company) and Stryker Orthopaedics working on Class I, II and III devices and combination products, as well as active implantable devices. Before entering the medical device field, Robinson was a press secretary for Congressman Joseph E. Brennan (D-ME), writing white papers, speeches and articles on legislative topics. “Being on the Board of Editors combines my love of writing and my interest and expertise in medical device regulatory affairs. In addition, I am passionate about the role of a regulatory professional as business leader and hope to increase the exposure of these topics in Regulatory Focus.” She can be reached at Sheryl_Robinson@bd.com.
Moulakshi Roychowdhury is the director of global advertising and labeling for regulatory affairs at Forest Laboratories. Previously, she worked in similar capacities at Biogen Idec, Genzyme and Bayer HealthCare Pharmaceuticals. Using her education background, she discovered a niche combining the pharmacy and legal backgrounds in regulatory advertising and labeling. Roychowdhury holds a PharmD from Rutgers University and began her career in the pharmaceutical industry in medical affairs. She also holds a JD from the Brooklyn Law School. She says, “Regardless of company or role, I've always held networking and information sharing as a high priority.” She runs a monthly teleconference to discuss current issues in the advertising and promotional compliance field. Roychowdhury can be reached at email@example.com.
Siegfried Schmitt, PhD,chairman of the Board of Editors,is a principal consultant forPAREXEL Consulting. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and competitive compliance. He is the PAREXEL practice lead for Quality by Design. Schmitt’s areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products, particularly for sterile cytostatic or cytotoxic biotech products. Previously, he held positions in industry as senior production chemist with Roche and global quality director with GE Healthcare and as validation manager with Raytheon and senior lead consultant with ABB. Schmitt holds Chartered Chemist and Chartered Scientist status. He can be reached at Siegfried.Schmitt@parexel.com.
Michael Trapani, MS, MBA,has extensive experience in regulatory affairs, new product approval, regulatory compliance and quality assurance. He has held management positions at pharmaceutical and biotech companies, clinical research organizations (CRO) and diversified medical products companies. Trapani started his career as an investigator with the US Food and Drug Administration. He is currently senior consultant with the Biologics Consulting Group Inc. a regulatory consulting company with expertise in assisting companies in developing and gaining FDA approval of biologics, drugs and medical device products.Trapani was a contributing author to the fifth edition of the RAPS publication, Fundamentals for US Regulatory Affairs .He can be reached at firstname.lastname@example.org.
Carol Vierling, RAC, is president of C L VIERLING LLC, a medical device consulting firm that focuses on developing regulatory strategies and authoring submissions for the US, Canada and the EU. Vierling has more than 25 years of experience in the cardiovascular, home healthcare and orthopedic medical device industries in both regulatory and clinical affairs. She has worked with early stage and large medical device companies, including CardioMEMS, C.R. Bard and Zimmer.“Being a member of the RAPS Board of Editors gives me an opportunity to contribute to the topics and content of articles featured in Regulatory Focus,” said Vierling. “Many of us are authors in one way or another, even though we may not all be ‘published authors’ in the true sense of the word. Being an editor encourages us as writers and improves our writing skills.” She can be reached at email@example.com.
Feng Yu is the quality assurance manager for Esteve Huayi Pharmaceutical in China. She has a deep background in CGMP guidelines and compliance. Previously, she worked in the regulatory affairs unit, where she was primarily responsible for the regulatory program for Chinese, US and EU authorities, including preparing and submitting regulatory dossiers. “By joining the Board of Editors of Regulatory Focus, I can help communicate with many regulatory professionals, and share the experience and ideas with variety of readers. “I am looking forward to a colorful and meaningful experience as an editor member of the Board of Editors.” She can be reached at firstname.lastname@example.org.