Click on down arrow for biographical information about each individual. Note that additional faculty from industry and government will be invited to teach courses periodically.
Faculty from the College of Business Administration
Dr. Gretchen Vik has taught at San Diego State University since 1975 in the Management and Information Systems Department of the College of Business Administration.
Professor Vik’s publications range from major Irwin texts (Business Communication with Jeanette Gilsdorf and the ninth and tenth editions of Writing and Speaking in Business with C. W. Wilkinson and Dorothy Wilkinson) to articles on basic business communication testing programs, training package development, collaborative writing projects, internship programs and other experiential learning, and computer screen design. Her current research interests focus on accounting communication and e-mail format and style.
President of the Association for Business Communication in 1989 – 1990, she has served on many committees for that organization, as well as serving on the board of the Association for Business Simulation and Experiential Learning.
Faculty from the College of Arts and Letters
Linn K. Bekins has over a decade of experience in providing training and documentation to pharmaceutical, medical device, and biotech organizations. As a consultant, she specializes in scientific writing training, project management, and process management. Dr. Bekins has worked as a consultant to the FDA performing quality audits of NDAs and working to improve the communications between medical officers and pharmaceutical companies. She conducts writing and project management workshops to help scientists develop their communication skills on-site at such organizations as Gen-Probe, Metabasis Therapeutics, and U.S. Geological Survey. She provides documentation services to healthcare organizations, such as American Specialty Health.
Dr. Bekins earned her Ph.D. in Education, emphasizing rhetoric and composition, from the University of Utah, Salt Lake City. Currently, she directs the Professional Writing Certificate Program at San Diego State University (SDSU) and is an Associate Professor in the Department of Rhetoric and Writing Studies. Her research interests consider the rhetoric of science, user experience design, scientific and technical communication, and adult learning strategies. She is also a faculty advisor for the Entrepreneurial Management Center at SDSU. In addition to her responsibilities at SDSU, she continues to serve as an industry consultant and committee member for industry trade organizations.
[expand title=”Lorah Bodie, Ed.D., San Diego State University”]
Dr. Bodie recently retired from her position as the Associate Director/Graduate Advisor for the SDSU Regulatory Science Programs. She has over twenty years of leadership experience in strategic planning, organizational development, partnership development, and program management, complemented by a varied background and training in change management and continuous quality improvement.
Lorah earned her doctoral degree from the SDSU – University of San Diego Joint Doctoral Program in Education with an emphasis in online teaching and learning. Prior to working at SDSU, she was the Manager of Research and Development at the San Diego Workforce Partnership, and a Research Analyst in the Strategic Development Department at Scripps Health.
[expand title=”Scott Harris, M.S., Chief Operating Officer, Cleave Therapeutics Inc.”]
Scott Harris, MS, RAC is currently Chief Operating Officer at Cleave Therapeutics Inc. Mr. Harris started his career as a bench scientist before moving out of the lab and into the field of Regulatory Affairs. His career in the biopharmaceutical industry has spanned 15 years, and has included positions of increasing responsibility at companies such as Biosite Inc., Angstrom Pharmaceutical, Attenuon, BioMarin Pharmaceutical, Adynxx Inc. and his own independent consulting business. Most recently he was head of Regulatory Affairs and Quality Assurance for Corthera Inc., until its acquisition by Novartis Pharmaceutical Corp.
Mr. Harris obtained a M.S. in Regulatory Affairs from SDSU and a BS in Biochemistry and Cell Biology from UCSD. He also holds academic appointments at SDSU and CSUSM, where he teaches undergraduate and graduate courses in healthcare product regulation.
Dr. King is Principal of Macnas Consulting International, Inc., a firm providing consulting services to pharmaceutical, biotechnology, medical device, and venture capital companies in the areas of corporate strategy, leadership development, change management and strategic product development.
Dr. King has over 15 years experience managing business and development operations in the pharmaceutical, medical device, biotechnology and CRO (Contract Research Organization) industries. Prior to founding Macnas Consulting, Dr. King was President and CEO of Predict, Inc. an information technology firm; Vice-President and General Manager for San Diego Operations for PAREXEL and Head of PAREXEL’s Emerging Growth Opportunities Group; President and COO at Advanced Bioresearch Associates; EVP for Biological Sciences and Medical Affairs at Trega Biosciences (and President of ChromoXome after its acquisition by Trega); President of Segenix, a spinout of Advanced Tissue Sciences, where Dr. King had previously headed Research and Development; VP Worldwide Medical and Regulatory Affairs for ConvaTec, a BristolMyers Squibb subsidiary; and, Director of Clinical Investigation at SmithKline.
Dr. King’s broad background gives him deep and significant insights into the processes and constraints of product development within highly entrepreneurial environments.
Dr. King graduated cum laude from the University of Notre Dame, majoring in English and Preprofessional Studies, and received his MD from the Ohio State University College of Medicine. Following completion of residency training in Medicine and Pathology at Ohio State and his Cardiology fellowship training at the Mt. Sinai Medical Center in New York, he was an Assistant Professor in Medicine (Cardiology) and Physiology at New York Medical College. He is board certified in Cardiology and Internal Medicine. He received his MBA from the Wharton School of the University of Pennsylvania.
Barney is married to Kathleen Marek-King and has four children: bookend boys, ages 34 and 21, and daughters, ages 27 and 26. He is usually fine as long as he takes all of his psychoactive medications.
[expand title=”Gautam Maitra, Fil.Lic., M.S., Global Regulatory Strategy and External Affairs, AC Immune”]
Gautam Maitra is a Sweden-trained chemist and regulatory affairs professional with over 14 years of experience in two of Forbes top-ranked pharmaceutical companies, Roche and Novartis. At Novartis, he was in charge of regulatory support for both marketed and early development products. Since 2007, he has been the Head of Regulatory and External Affairs at AC Immune. He has conducted pre-IND meetings with FDA and Scientific Advice meetings with numerous international regulatory agencies. Under his leadership, the AC Immune regulatory department filed clinical study applications in Austria, Denmark, Sweden, UK and Finland, and an IND in the US.
Gautam served as the European Director of the Parenteral Drug Association (PDA). Until 2015, he was a member of the Board of Directors of RAPS and the President of the RAPS Swiss Affiliate. Gautam has a M.Sc. degree in Analytical Chemistry and Fil.Lic. in Organic Analytical Chemistry from the University of Stockholm, Sweden. In addition to being adjunct faculty for the SDSU Regulatory Science program, he also serves as a regular instructor in Regulatory Affairs at the Swiss Federal Institute of Technology.
[expand title=”Darrel Moellendorf, Ph.D., Emeritus Professor of Philosophy at SDSU; Professor of International Political Theory, Goethe University, Frankfurt, Germany; Former Director of the SDSU Institute for Ethics and Public Affairs”]
Darrel Moellendorf is a Professor of International Political Theory and Professor of Philosophy at Goethe University, Frankfurt, Germany. He is Emeritus Professor of Philosophy at San Diego State University and former Director of the SDSU Institute for Ethics and Public Affairs. He has been teaching ethics in the Regulatory Affairs program since 2005. His research interests are in the areas of moral and political philosophy. He is the author of several articles and chapters in books, and of three books: Cosmopolitan Justice (Westview Press, 2002), Global Inequality Matters (Palgrave Macmillan, 2009), and The Moral Challenge of Dangerous Climate Change (Cambridge University Press, 2014). He is also a private consultant on regulatory affairs. He is married and has a son. He enjoys the outdoors, especially skiing in the Alps. But he misses the San Diego sunshine!
Norma Schafer, MS, MT(ASCP), RAC is Vice President of Regulatory Affairs and Quality Assurance for SteadMed Medical in Fort Worth, Texas, where she is responsible for multiple regulatory and quality activities for Medical Devices.
In the course of her Regulatory career, she has successfully shepherded various drug applications in the US FDA system including New Drug, 505(b)(2) and Abbreviated New Drug Applications for ophthalmic, otic, nasal and renal products. Her experience includes working with medical devices (regulated by the Center for Devices and Radiological Health), pharmaceuticals (regulated by Center for Drug Evaluation and Research) and over-the-counter products. She has also prepared and filed Investigational New Drug Applications (INDs) in the US and registered Medical Devices both internationally and domestically. In addition, she has had the opportunity to work with Medical Devices registered through the National Institutes for Safety and Occupational Health. She has worked extensively in Regulatory Operations, submitting electronic Common Technical Document applications to the FDA and EU.
In parallel with the US applications, Norma has prepared and filed pharmaceutical Clinical Trial Applications (CTAs) and Marketing Authorization Applications (MAAs) in the EU. She has also worked with U.S. Customs on classification and clearance of products coming into the U.S.
Norma has held various positions with companies in many medical areas, including Abbott Diagnostics Division of Abbott Laboratories; Alcon Laboratories, a Subsidiary of Novartis; and ZS Pharma, an Affiliate of AstraZeneca. She received degrees from Texas Woman’s University in Biology and Chemistry (BS) and Baylor Medical Center in Medical Technology (MT), becoming certified by the American Society of Clinical Pathology (ASCP) prior to receiving her MS in Regulatory Affairs from SDSU. Norma is Regulatory Affairs Certified (RAC) and a member of the Regulatory Affairs Professional Society (RAPS).
Through his company R&D Advisors, Dr. Seymour provides regulatory affairs outsourcing services for industry and academia. Regulatory experience includes regulatory writing and regulatory submissions, FDA meeting preparation and engagement, regulatory strategy, regulatory intelligence, and regulatory due diligence. As a life scientist, he has over 20 years experience in basic science and clinical research in industrial and academic settings. Dr. Seymour is also Faculty at the University of Michigan and works as a Regulatory Project Manager in the Michigan Institute for Clinical and Health Research (MICHR) in their IND/IDE Assistance Program. Pertinent to this course, he serves as MICHRs Lead Publisher for eCTD and eCopy submissions to FDA. He teaches the “Introduction to Electronic Submissions” course at SDSU, and has lecturered in both beginning and advanced eCTD through the Drug Information Association and the Regulatory Affairs Professional Society.
Dr. Seymour earned his BS in Biology from the University of Notre Dame and his PhD in Biochemical and Molecular Nutrition from Michigan State University.
Yekaterina Sharikova, M.S. has years of extensive experience in data management, proposal development, and budgetary negotiations in the global pharmaceutical industry.
Her positions with Novartis (Fortune 500 Company, Forbes Magazine-rated Best Pharmaceutical Company of the Decade) enabled her to help manage Scientific Operations departmental multi-million dollar budget and conduct contractual negotiations with distributors worldwide. She has served as Project Manager on a variety of construction projects (both scientific and commercial facilities) and is now part of the Operations Committee to launch the new Biologics Device Business Unit for Novartis Institute of Biomedical Research.
Yekaterina’s successful cross-functional project portfolio is closely connected to her scientific background and attention to developing communication skills. She holds a B.S. in Chemistry and an M.S. in Regulatory Affairs from San Diego State University.
Yekaterina currently resides in San Diego, California, and is an avid Pilates’ practitioner and enjoys golfing. Her personal motto is “In it to win it.”
Ajit Simh has over 30 years of multidisciplinary experience in the medical device, chemical, pharmaceutical, and bio-pharmaceutical industry. He earned his bachelor’s degree in Biology and Chemistry from Bangalore University, India and his Master’s degree in Cell Biology from St. Louis University, St. Louis, Missouri. He has excellent technical knowledge in the manufacture and control of class I and II medical devices, drugs, biologics, and active pharmaceutical ingredients.
Ajit began his career with Mallinckrodt Medical and has held increasingly senior positions in R&D, manufacturing, operations, and quality systems with Arena Pharmaceuticals, Cytel Corporation, Abbott Laboratories, Baxter Healthcare Corporation, and Cambridge Medical. Most recently he spearheaded the successful completion of a US FDA Pre-Approval Inspection (PAI) in Europe.
During his career, Ajit has frequently interacted with the US FDA on inspections, submissions, and reviews of product applications. In addition, he has shared the speaker’s panel with FDA and industry leaders at several national meetings in the areas of API’s, finished pharmaceuticals, and biologics. Ajit has audited and advised companies within the US, Europe, Japan, China and India on operating in compliance with US FDA and ICH requirements.
In order to keep up with cutting edge technologies and current compliance trends, Ajit became an instructor at the University of California, San Diego in the biomedical-manufacturing program in 1994. He is a member of the university advisory committee and was recently appointed adjunct professor at San Diego State University in the Bio-device and Biomedical graduate studies program offering a Master’s degree in Regulatory Affairs. He is a member of the advisory committee to the Bio-Pharm Journal. He is affiliated with the Parenteral Drug Association (PDA) and IBC offering short courses in cGMP requirements and auditing foreign API manufacturers.
Rita Tomlin is a consultant who provides medical writing and editing services to pharmaceutical companies. In her 16 years in pharmaceuticals, she has contributed to a broad spectrum of documents, including Investigational New Drug (IND) submisstions, clinical development plans, protocols, Informed Consents Forms, Case Report Forms, Clinical Study Reports, manuscripts, posters, slide presentations, and 4 New Drug Applications (NDAs)/ Common Technical Documents (CTDs) including managing the US submission of Rituxin® in rheumatoid arthritis.
In addition to RA605, Ms Tomlin teaches RWS 508, Scientific Writing at San Diego State University, as well as an accredited workshop for the American Medical Writers Association in their core curriculum program. Ms Tomlin specializes in establishing team-based writing processes to optimize the development of cohesive documents throughout a project to carry well reasoned, consistent messages through to submission to regulatory agencies.
Prior to becoming a Medical Writer/Editor, Ms Tomlin was a Medical Technologist in hospitals in Cincinnati, Ohio, for 11 years. She performed clinical laboratory testing in chemistry, hematology, microbiology, and blood banking and taught courses in Medical Technology internship programs at two hospitals. She coordinated Phase 1 clinical trials at a CRO for 2 years, which lead to her career in Medical Writing.
Ms Tomlin holds a Bachelor’s of Science degree in Medical Technology from the University of Nebraska, 1985; a Graduate Certificate in Science and Technical Writing from SDSU, 2004; and a Master’s of Arts degree in Rhetoric and Writing Studies at SDSU, 2007.
Kim Walker is an independent Global Regulatory Affairs and Quality Assurance Consultant since 2006. She has over 21 years of industry experience and over 18 years of regulatory affairs experience. In her consulting practice, she assists clients with pre- and post-market regulatory and quality system needs. Her work experience includes environmental chemistry, veterinary science, blood banking, clinical laboratory science, infectious disease assay research, microbiology, surgical assistant, IVDs, biologics, pharmaceuticals, combination products, and medical devices in university, start-up company, and large company environments. Kim has served on the OCRA Program Committee since 2003, served on the OCRA Board of Directors 2004-2010, and was the 2008-2009 President. Kim participated on the CLSI Point of Care Testing, Quality Systems, EP9, and Process Improvement working groups and was listed as one of the authors for CLSI GP22-A3. Quality Management System: Continual Improvement. She has managed, presented at, and/or moderated at several professional conferences and educational institutions on clinical, regulatory, and quality topics. Additionally, she has participated in the SDRAN Mentoring Program since 2009 and the OCRA Mentoring Program since 2012. Kim participated on the CSUPERB Advisory Committee and Development Team for the Project Management in Clinical Trials certificate program through the California State University system. She was the instructor for the “Pre-Market Submission” course and co-instructor for the “Regulatory Requirements for Medical Products” course in the certificate program. Kim was also an instructor for the “Regulatory Requirements for Pharmaceutical Products” course and a co-instructor for the “Technical Writing for the Medical Product Industry” course at UCI Extension. She is one of the originators of the Quality Leadership Network between industry and FDA; an organization dedicated to establishing more effective ways for FDA and industry to communicate and work together more effectively. Kim achieved both the US and EU RAPS Regulatory Affairs Certifications. She received the 2008 Leonard Stauffer Award from RAPS in recognition of her contributions to mentoring and furthering regulatory professional education development. She graduated from an SEC university with a Bachelor of Science degree in Bio-Medical Sciences and graduated with a Master of Science degree in Regulatory Affairs from San Diego State University.
Mary Wilhelm is currently a Director, Regulatory Affairs for Halozyme Therapeutics, Inc. in San Diego with responsibilities in both clinical and post approval activities for investigational and commercial drug products. Mary’s experience includes developing regulatory intelligence and strategy, preparing regulatory submissions, interacting with domestic and international regulatory agencies and providing regulatory support to Halozyme’s partners. Previously, Mary was a manager for the Regulatory Affairs and Quality Assurance departments at CP Kelco in San Diego where she focused on issues associated with the manufacture of bulk excipients and food additives. She has also held various Quality Assurance/Quality Control positions within Monsanto/Pharmacia and Eli Lilly and Company.
Mary holds degrees from Purdue University in Indiana: Textile Science (BS), Chemistry (BS), and Analytical Chemistry (MS). She has also received a MS in Regulatory Affairs from SDSU. Mary has achieved Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS), for both the EU and US, and Quality Auditor Certification from Society of Quality Assurance (SQA). She served on the San Diego Regulatory Affairs Network (SDRAN) Board and is currently a member of SDRAN and RAPS.
Kristin Godfredsen, MS, RAC, is Associate Director, Regulatory Affairs for Gen-Probe Incorporated in San Diego, California. She is responsible for the regulatory activities supporting licensure of blood screening assays (regulated by CBER) and approval / clearance of other in vitro diagnostic medical devices and instrumentation (regulated by CDRH). She is also responsible for obtaining the CE mark and ensuring world wide marketing approvals for these products. Her experience includes facilitating meetings with FDA, preparation and filing of Investigation New Drug (INDs) Applications and Biologics License Applications (BLAs) in electronic format and submission of dossiers supporting CE marking activities in the European Union. Previously, Kristin was a manager for the Quality and Regulatory Department at Scantibodies Laboratory, Inc. in Santee, California where she focused on issues associated with the development and production of in vitro diagnostic (IVD) medical devices, establishing Quality Systems and ensuring compliance with the Quality System Regulations (QSR) through internal audits and audits of contract manufacturers. Kristin holds a BS in Animal Physiology and Neuroscience from University of California, San Diego and received a MS in Regulatory Affairs from SDSU. Kristin is Regulatory Affairs Certified (RAC). She is a member of the San Diego Regulatory Affairs Network (SDRAN) and the Regulatory Affairs Professionals Society (RAPS).
Tonya Saheli, JD, MS, is Legal Mediator and Regulatory Consultant. She received her training as an Attorney from John F. Kennedy University. Currently, she owns a Legal Mediation Practice and Consulting business and also sits on several Alternative Dispute Resolution panels with Alameda County and Contra Costa County Courts.
In her capacity as a Regulatory/Legal Consultant, she advises doctors, other health care professionals and scientists on how to open and maintain health clinics, laboratories, and research facilities while remaining in compliance with health care regulations and FDA regulations. Additionally, she performs internal audits for clinics to help them get prepared for audits. Tonya has also held research positions with Stanford University Department of Genetics-Human Genome Project, where she was published in Science Magazine for her work. She has also held a host of other positions in many medical areas.
In addition to her JD/law degree from John F. Kennedy University, Tonya also has a MS degree in Regulatory Affairs from San Diego State University and a BS in Biology from the University of San Francisco.
Chris Santos, MS is currently an independent consultant focused on providing regulatory affairs and quality assurance support to the pharmaceutical industry.
Chris’ prior role was Senior Director of Regulatory and Quality Affairs for Victory Pharma, Inc., until its acquisition by Shionogi, Inc. In this role, he expanded Victory’s development operations, leading to a recent NDA submission for an internally-developed small molecule program. He also had oversight for Victory’s commercial products, including DDMAC submissions, post-approval supplements, annual reports, and safety updates. Prior to Victory, Chris was with Kalypsys, Inc., where he focused on transitioning new chemical entities (NCEs) from late discovery to early development. This work lead to FDA acceptance of NCE INDs and successful First-in-Human clinical studies in the areas of pain management and metabolic disorders. Chris also held research positions at Illumina, Inc. and Discovery Partners International, Inc. (acquired by Galapagos NV).
Chris has a BS in Biochemistry from the University of California, San Diego and an MS in Regulatory Affairs from San Diego State University.
Michelle Sands worked for the majority of her career in the pharmaceutical industry as a bioanalytical chemist in drug metabolism for Pfizer, both in Connecticut as well as in California. In 2009, she moved from the lab into a “document specialist role.” Since 2011, she has been working in Regulatory Affairs in small biotech companies.
Michelle received degrees from the University of California, Irvine in both Biology and Chemistry (BS) and from the University of Rhode Island in Analytical Chemistry (MS) prior to receiving her MS degree in Regulatory Affairs from SDSU. She is very involved with the San Diego Regulatory Affairs Network (SDRAN), where she is a member of the Board and the VP of Member Relations.
Janis Smoke is currently a Quality Assurance Auditor for Takeda Vaccines (Montana) in Bozeman, Montana. While she focuses primarily on auditing of contract manufacturers and suppliers for GMP compliance, additional responsibilities include review of regulatory submissions and control of quality systems documentation. Previously, she worked as a QA manager for a GLP contract testing organization and as a high school chemistry teacher.
Janis holds a BS in Chemistry from University of Washington, a secondary teaching certificate from the University of Alaska Fairbanks, and a MS in Regulatory Affairs from SDSU. She also recently became a grandmother, so feel free to ask her about that any time!