Our students and alumni come from a diverse range of academic backgrounds and professions – regulatory and compliance managers, senior level FDA officers and university faculty and administrators. Each brings a unique perspective to the program and their dissertations represent original contributions to the advancement of the field.
Meet our Doctoral Program Cohorts:
Adam Cargill, MS, is the Head of Quality, Regulatory, and Clinical for MediView XR. In his role he is accountable for the oversight of all regulatory, clinical, and quality functions. Responsibilities include overseeing the company’s global regulatory, clinical, and quality strategies; provide leadership in interacting with regulatory and governmental agencies; interfacing with corporate partners to develop appropriate and compliant marketing strategies; direct the functional resources related to these areas and provide ongoing, hands-on expertise.
Adam holds his BS in Psychology and Sociology and an MS in Regulatory and Clinical Affairs from Grace College (IN). He has nine years of experience working in the medical device industry in regulatory affairs, regulatory compliance, regulatory intelligence, quality compliance, and quality management systems roles within orthopedic, cardiovascular, image guided therapy, radiology, ophthalmic, and augmented reality. Adam has previously worked at Biomet, Zimmer Biomet, OrthoPediatrics, KPMG, and Philips.
Adam has been married to his wife for nearly 15 years; they have one daughter, Everly, who is five years old. He enjoys running marathons, skiing, and traveling
Elaine Freeman is a regulatory toxicologist with the multidisciplinary consulting firm, Exponent Inc in the Center for Chemical Regulation and Food Safety and Nutrition. Ms. Freeman is a Board Certified Toxicologist (DABT) with over 20 years of experience in regulatory toxicology in the fields of pesticides, industrial chemicals, veterinary medicines, consumer products, medical devices, and food safety. She has a comprehensive knowledge of toxicological requirements as well as a thorough understanding of the nuances of toxicological testing and human health risk evaluation requirements for varied global regulations. Ms. Freeman is adept at project management and working with clients and regulators to develop strategic approaches to addressing human health concerns.
Elaine holds an MS in Pharmacology/Toxicology from Duquesne University and a BS in Microbiology from the University of Pittsburgh and is the author of multiple publications in the field of regulatory toxicology.
Holly is currently a Director, CMC Oncology and Rare Disease, at Pfizer Inc. In this role she manages design and execution of global CMC strategies for biotherapeutics from initial clinical filing through submission of the license application. Her current focus is on gene therapy products, but she has worked on monoclonal antibodies (including biosimilars) and bi-specifics as well.
Holly has over 16 years of experience in the biopharmaceutical industry, including working as part of Pfizer’s Biotherapeutics Pharmaceutical Sciences Analytical R&D group prior to transitioning to Regulatory CMC. She has extensive experience in biologic product development, including analytical method development/validation, authoring of regulatory filings, and leading discussions with regulators (both for product-specific and facility topics).
Holly has a BS in Biochemistry from the University of Nebraska, an MS in Biochemistry from Texas A&M University, and an MS in Bioscience Regulatory Affairs from Johns Hopkins University. She is an Associate Director with CASSS, and a member of both the American Society for Gene & Cell Therapies (ASGCT) and the Healthcare Businesswomen’s Association (HBA).
James Wabby, BSc., MHMS, is the Global Head, Regulatory Affairs, Center of Excellence (COE) – Emerging Technologies, Combination Products, and Medical Devices at AbbVie Inc.
He has over 20 years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Devices, Medicinal Device Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas. He regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs.
Key aspects of his regulatory responsibilities within the AbbVie Regulatory Affairs Center of Excellence (COE) include: CMC Global Dossiers/Global Device Regulatory Strategies, EU MDR/IVDR, Person Responsible for Regulatory Compliance (PRRC), 21 CFR Part 3 and Part 4 – Combination Products, CE Marking, ISO 13485:2016/MDSAP, International Regulatory Affairs, Represent AbbVie as the U.S Agent regarding FDA matters for international medical device facilities, and actively participate in industry trade organizations and serve on standards committees.
James is an internationally recognized leader as he is a member of various regulatory and quality work groups including DIA, RAPS, AFDO/RAPS, AAMI, ISPE Combination Products (CoP), OCRA, SDRAN, ASQ Orange Empire Section, and ASQ San Diego. He is an international speaker, chair, and keynote at various regulatory symposia, Chairman of the DIA Combination Products Committee, a moderator for various global regulatory panel discussions, and has various publications, interviews and podcasts. In addition, he lectures various sections for the RAPS RAC Device Certification Prep Course – SDRAN and he is an Adjunct Assistant Professor at the University of Southern California (USC) – School of Pharmacy – Regulatory and Quality Sciences.
James holds a BSc. in Biology from Duquesne University, MHMS in Health Law and Policy from Duquesne University, Certificate in Health Law and Life Science Regulatory Compliance from Seton Hall University Law School – Center for Health & Pharmaceutical Law, and Certificate, RAPS Executive Development Program from Northwestern University – Kellogg School of Management.
Olufunke Bundo (Olu), MS-RA/QA, RN, ASQ-CQA is currently the Director of Quality and Regulatory for Revision Skincare. She has been in the industry for about 15 years. She is responsible for all Domestic and International regulatory agency submissions and/or correspondence and ensuring consistency of evidence-based global product communication. Her team is responsible for compliance to all regulatory agencies that are applicable to their company. They define Regulatory and Quality strategies to support successful global product development plans for the company’s skincare brand, focusing in the US, EU, UK, Asia, Australia, North America, and South America. Her role also includes facilitating and participating in meetings and/or inspections with regulatory authorities on behalf of the company.
Olu received her Master of Science degree in Regulatory/Quality from Temple University in Pennsylvania, her Bachelor’s degree in Natural Science and Mathematics from Thomas Jefferson University in New Jersey, and a Nursing degree from Montgomery County Community College in Pennsylvania. She is passionate about what she does, as it has become a part of her life. She lives and breathes Regulatory and Quality Science and cannot see herself doing anything else.
Olu is married, and mother to two wonderful girls. She enjoys reading, watching period movies, and listening to music such as Afrobeat, Jazz, and Hip-Hop.
Scott Stirn, MS, MSJ, is currently the Director of Product Development, Early Stage at Neurocrine Biosciences Inc. In his current role, he is responsible for supporting programs as they move from research into development, leading the Preformulation, Product Development, and Materials Science functions. His group plays a critical role working with legal to build and maintain a strong intellectual property portfolio; he is an inventor on 75+ United States and International patents. In addition, he serves as Program Lead for assets moving from discovery into early clinical studies.
Scott has over 17 years of experience working on small molecules and biologics in both small and large pharmaceutical companies, all in the drug development space. He started his career working in the laboratory in the Pharmaceutical Science group at Arena Pharmaceuticals, before moving to Celgene where he began working with mAbs and other large molecules. After a few years at a contract manufacturing organization, he moved on to his current role. He enjoys building dynamic teams, promoting continued education, and mentoring scientists as they grow in their careers.
Scott holds a B.Sc. Degree in Chemistry from the University of Arizona, a M.S.J. Degree in Intellectual Property Law from Seton Hall Law School, and an M.S. Degree in Management of Drug Development from the University of Southern California.
Mr. Zhu is currently Assistant Adjunct Professor and Director of Regulatory Affairs of Nuclear Medicine within the Department of Molecular and Medical Pharmacology at University of California Los Angeles (UCLA). He received his BS and MS degrees in Biochemistry and Molecular Biology from Nankai University, China. Later, he received his MS in Regulatory Science from the University of Southern California (USC), and Regulatory Affair Certification (RAC) credential from Regulatory Affairs Professional Society (RAPS). Prior to his academic appointment with UCLA, he served as the regulatory affair director and science liaison at UCLA Department of Molecular and Medical Pharmacology.
Mr. Zhu’s work focuses regulatory science on radiopharmaceuticals for both diagnostics and therapeutics. His work includes radiopharmaceutical research and development, regulatory strategy framework, regulatory risk assessment and management, regulatory pathway planning and nonclinical radiopharmaceutical safety assessment (pharmacology and toxicology) for first-in-human use. He oversees regulatory interactions with the Food and Drug Administration (FDA) and Center for Medicare & Medicaid Service (CMS) for clinical trial clearance, radiopharmaceutical approval and reimbursement. He also advises and manages Biomedical Cyclotron PET drug current Good Manufacturing Practice (cGMP) compliance program and Nuclear Medicine Clinic Good Clinical Practice (GCP) compliance. His work resulted in successful Investigational Drug Application (IND) clearances, New Drug Application (NDA)/ Abbreviated New Drug Application (ANDA) approvals, and FDA site inspections.
Viktoria Magyar has over 15 years’ experience in law, finance, and corporate compliance. She worked for numerous small and mid-sized law firms and renewable energy companies, before launching MGC Associates LLC, a fully integrated pharmaceutical and medical device discovery and development consulting partnership.
Viktoria’s current area of focus and specialty is regulatory and quality sciences pertaining to medical devices, in vitro diagnostics, and digital health technologies in Latin American and Caribbean regions. She is a member of the Drug Information Association, the Latin American Regulatory Chapter, and the Advisory Committee for the Latin American Annual Regulatory Conference.
Eugene Babcock works in Regulatory Affairs CMC at Kite Pharma.
In his position in Regulatory Affairs at Kite, Eugene is accountable for the preparation of regulatory CMC submissions in support of the product lifecycle of commercial and developmental programs of cellular and gene therapies. He leads the development of global regulatory strategies with support from both regulatory and cross-functional representatives. He is responsible for the timely compilation of all necessary documentation and technical content for regulatory CMC submissions to global health authorities.
Eugene has over 10 years of experience working in the biopharmaceutical industry. He previously worked at Baxter BioScience in the Quality Control laboratories and was responsible for analytical method validations and technology transfers. He started his career working at Amgen in Analytical Sciences and was responsible for analytical method development and qualification to support process development, product release, and stability.
Eugene holds a B.S. in Chemistry from the University of California Irvine, a M.S. in Biotechnology and Bioinformatics from California State University, and a M.S. in Regulatory Science from the University of Southern California.
Lisa Crockett, MS, RAC has worked for more than 20 years in the pharmaceutical, biotechnology and medical device industries. She is currently the Vice President, Regulatory Affairs at Kiniksa Pharmaceuticals, a startup biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating immunological diseases with significant unmet medical need. In her role as RA VP, she is accountable for developing and executing global regulatory strategies for multiple biological products in varying stages of development. She provides leadership, direction, and input to cross-functional teams to maintain and ensure marketing applications (INDs, BLAs, etc.) are produced in a compliant manner. Previously, she was Vice President, Regulatory Affairs at InVivo Therapeutics, a startup medical device company developing groundbreaking medical device technologies for the treatment of spinal cord injuries (SCI). She has also worked at Genzyme, a Sanofi Company, supporting the development of medical devices and combination products in the orthopedic area of a global marketplace. Prior to joining Genzyme, Lisa worked at both V.I. Technologies (Vitex) and Biopure Corporation, focusing on the development of biologics of oxygen carrying solutions and viral inactivation of autologous RBCs.
Lisa is a member of the Northeastern University RGA faculty as an adjunct professor for the Regulatory Affairs Master’s Program. She holds a MS in Regulatory Affairs from Northeastern University and BS in Equine Science from Johnson & Wales University. She has also received the US Regulatory Affairs Certification (RAC) designation.
Mary Ann Del Fiorentino has over 25 years of experidence in the biopharmaceutical industry. She started her career behind the research bench in antiviral research and moved into nonclinical writing where her passion for regulatory writing was born. She has written documents across the entire drug development lifecycle from chemistry, manufacturing, and controls, nonclinical studies, and Investigational New Drug (IND) applications through New Drug Applications (NDAs) submissions in the United States and Marketing Authorisation Applications (MAAs) in the European Union for indications such as oncology, anti infectives, endometriosis, tardive dyskinesia, gout, and food allergies.
Mary Ann has worked in many different company cultures including small and large pharmaceutical companies, both as a fulltime employee and as a consultant. She is most comfortable building and leading the medical writing departments at small pharmaceutical companies particularly developing drugs to treat forms of cancer. At small pharmaceutical companies, where budgets are tight and resources are few, the Head of Medical Writing must think “outside of the box,” while working within the constraints of regulatory guidance and electronic common technical document (eCTD) structure. She loves a good challenge!
Over her career, Mary Ann has mentored many new writers, been an “expert” panelist, and provided in‑house training presentations. Lifting up the next generation of writers is important to her because the industry has changed so much, learning skills “on the job” is less possible. Her research interests include establishing medical writing best practices and guidances particularly for small pharmaceutical companies to make submissions more time efficient, accurate, and in-line with regulatory requirements.
Mary Ann is currently the Head of Medical Writing at Calithera Biosciences, a small biopharmaceutical company developing drugs for oncology, including renal cell carcinoma.
Brian Green, MS, is a Global Regulatory Lead (GRL) at AbbVie. In his role as a GRL, Brian is accountable for the development of global regulatory strategies, leading both Global Regulatory Project Teams and a cross-functional strategy team across several therapeutic areas. His current primary focus is developing global strategies and supporting AbbVie’s efforts in evaluating treatments for COVID-19. In addition, he is accountable for driving the compilation of all necessary documentation for registration dossier submissions to global health authorities.
Brian holds a B.S. in Chemistry from Rensselaer Polytechnic Institute and a M.S. in Regulatory Affairs and Public Health Policy from the Massachusetts College of Pharmacy. He has nearly 30 years’ experience working in the biopharmaceutical industry, with 25 years in the regulatory field. He has previously worked at Pfizer Global Research and Development, Astra, and several smaller companies on the East Coast. He started his career working at Eon Labs in the Analytical Laboratory.
He has been married to his wife for 24 years; they have two adult daughters and two cats. He enjoys cooking and grilling, walking, spending time with his family, listening to a wide array of music, and traveling.
Doing what is right, when no one is watching, drives her work in quality assurance and compliance.
Anjali Malhotra is a Clinical Cytogeneticist Scientist, licensed in the State of CA, an ASCP Board Certified Technologist in Cytogenetics and an ASQ Certified Quality Auditor with a BSc. Degree (Honors), in Biochemistry and Microbiology, a MBA in Health Care Administration and a MRSc. Degree from USC. She has over 30 years of experience in global quality systems for clinical trials, preclinical studies and laboratory testing.
In her current role as Director, Preclinical & Clinical Quality Assurance, ImmunityBio, Inc., she is a member of the quality leadership team, primarily responsible for the development and execution of the Quality Management Systems. She provides leadership, strategy and direction, for the quality oversight of GLP (preclinical studies), GCP (clinical trials), GCLP (a hybrid of GLP and ICH-GCP principles for early phase clinical trials) and CAP/CLIA (laboratory genetic testing). She ensures compliance with company policies/procedures, industry regulations/guidelines, and preclinical/clinical study protocols. Additionally experienced in ISO, CLSI, NYS DOH Laboratory Standards, OSHA, Risk Management, Root Cause Investigation, Six Sigma, Lean and 6S improvements; along with their application for clinical trials, laboratory testing, IVDs, biologics, and biotechnology operations. She implements applicable Healthcare laws and regulations, including but not limited to HIPAA, PHI, the Anti-Kickback Statute, Stark Law, and for government reimbursement programs like Medicare and Medicaid. She supports IND and NDA/BLA preparation, manages the Incident Management Program (CAPAs, deviations and complaints) and facilitates successful remediation and corrective action efforts, internally and externally, for sites, vendors, contractors and CROs. She diligently tracks and trends departmental metrics to improve efficiencies through continuous improvement and evaluates potential risks to compliance in a timely manner.
She has been married for 31 years to her husband and life partner of her dreams, has two adult children and 2 dogs. Spending time with family, meditating, reading, listening to audio books, paddle boating, walking, biking, swimming, cooking and soaking in nature are her favorite activities.
Dissertation: Implementation of validated electronic records and signatures: a survey of industry approaches
Sonali Namiranian is a well-established and certified clinical research professional with over 15 years of comprehensive clinical research, clinical research management and regulatory affairs experience. In addition, advisory/consulting with researchers and biotech startups for past seven years. She currently serves as the Director of the Women’s Health Clinical Research Unit (WHCRU) at UCLA’s David Geffen School of Medicine (since January 2014). Where she oversees a team of study and regulatory coordinators, research assistants and volunteers. She also wears a regulatory affairs hat for projects that need FDA submissions and approvals. In the past years she has covered ground with a full range of clinical research projects from educational, observational, translational and all phases of interventional trials. She has overseen large and small grants, Pharma trials, NIH/NCI and Cooperative group trials, and variously funded clinical research projects that need varying degrees of regulatory involvement and oversight. Through her work, she strives to make an impact – one human at a time. She knows that she was born to serve and help make this world a better place – every single day. She understands that everything she does directly or indirectly helps push the boundaries of the medico and biotech fields and this keeps her excited every day.
Every since her teens she was convinced that we were headed for some huge promises in the medico and biotechnology related fields, and thus pursued in the field and tried to find her niche. She is convinced that these are some powerful and historic times for the medico and biotech fields and therefore excited to advance her academic goals while staying abreast with hands on work. Therefore, she thinks this program is a perfect fit for her. Through this program she wants to gain Regulatory Affairs expertise and understand possibilities of optimizing the FDA approval pipelines, and ways to optimize and speed up the process without comprising safety and data.
One of her current areas of interest is to help close educational, knowledge and understanding gaps in the clinical research and regulatory field across board – from investigators, researchers, medical students all the way to laymen (study participants). She wants to help create and promote learning platforms. She has started off by writing a book on clinical research that will help close some of these gaps, she hopes to complete the book soon. She is also co-authoring an anthology to celebrate change, innovation and future of the medical and scientific field globe over, this book will be launched early next year. http://www.dearpeoplemovement.com/dear-people-book-2/
She holds a BS in Microbiology from Pune University, MBA-Biotechnology from MITCON Business school, Certificate in Project Management from UCLA Extension and several ongoing learning programs in the field to stay current. She is a compassionate human being and a compassionate leader, and seeks to tap human connections every day. She is much excited for this DRSc journey and to be part of USC and this beautiful cohort and looks forward to all that lays ahead of her.
Tayler Renshaw, MBS, is currently a Manager, Regulatory Affairs CMC at Audentes Therapeutics, an Astellas company, based in San Francisco, CA. In her current role, she supports and manages global activities for all CMC regulatory aspects of product development. This includes input into the product strategy, input and direction to the clinical teams as well as to the quality, manufacturing process development and analytical development organizations. She serves as the Regulatory CMC lead for Audentes’ gene replacement therapy candidate to treat Pompe Disease, as well as assists with the company’s lead clinical program, a gene replacement therapy candidate to treat X-Linked Myotubular Myopathy. She is also the Audentes representative on the Alliance for Regenerative Medicine (ARM) CMC Task Force. Tayler holds a Bachelor of Arts (BA) in Biology from Occidental College and Master of Business and Science (MBS) with an emphasis in Clinical & Regulatory Affairs from Keck Graduate Institute, a member of the Claremont Colleges.
Katy Rudnick is the Vice President and Head of US Regulatory Affairs for Alan Boyd ConsultantsLtd (Boyds), an established biotech and pharmaceutical consulting firm headquartered in the UK with offices in Crewe, Cambridge, Dublin and Pennsylvania. Katy is leading the US office as Boyds expands to support clients across the globe with the translation of ideas into medicines for patient benefit.
Katy holds a BS in marine biology from Millersville University, spending summers at the Marine Science Consortium in Virginia. She also earned an MS in Quality Assurance/Regulatory Affairs from Temple University. After beginning in the aquatic & veterinary industry, she transitioned to pharmaceuticals with roles at Teva Pharmaceuticals, Lannett Company, and was previously the Director of Regulatory Affairs at Lupin Pharmaceuticals.
Katy is a member of RAPs and has completed the Executive Development Program at Kellogg School of Management as well as individual executive leadership coaching through Exude.
Bridget Walton, MS, RAC is a results driven Regulatory Affairs executive with over two decades of experience, demonstrated leadership, and accomplishment in the biopharmaceutical industry spanning early and late development across multiple therapeutic areas. Bridget is currently an Executive Director of Global Regulatory Affairs at Sunovion Pharmaceuticals Inc., a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd, with offices in Marlborough, MA and Fort Lee, NJ. Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. As a Global Regulatory Affairs Group Head at Sunovion, Bridget enjoys providing support and guidance to her team on the planning and execution of global regulatory activities and submissions. She is also the Global Regulatory Lead on Global Product Steering Committees for early and late stage development projects where she develops, implements, and delivers global regulatory strategy to balance time, cost, quality, and risk. Over her 20+ years in the industry, Bridget has set global regulatory strategies (US, CAN, EU, Asia-Pac, Latin America, and GCC), met with global health authorities, performed countless submissions and obtained approvals, written global prescribing information and Company Core Data Sheets, and reviewed/approved countless promotional pieces. Bridget holds a BA in Biology/Chemistry/Premed from Immaculata University, a MS in Molecular Biology from Villanova University, and a MS in Regulatory Affairs and Quality Assurance from Temple University School of Pharmacy.
Colleen Watson, MS, RAC is currently a Senior Director of Regulatory Affairs at Vyaire Medical. She oversees both the Product Development Regulatory teams and the International Regulatory Affairs teams, as Vyaire works to manufacture and globally market products for the diagnosis, treatment, and monitoring of respiratory conditions. Previously, she has worked in Regulatory Affairs in infectious disease, oncology, and respiratory at Abbott Molecular and CareFusion/BD.
Colleen received her B.S in Biochemistry from the University of Wisconsin-Madison. After graduating, she worked at the bench level doing drug chemistry and forensic toxicology, writing methods, and testifying in court. After earning a M.S. in Biotechnology, also from Madison, focused on integrating science, law, and business – Colleen fell in love with the Regulatory Affairs field. She enjoys the challenge of building an effective team, bringing new products to the market, and seeing the direct benefit to patients.
Colleen has a large blended family with teenagers and a spirited golden retriever; in her spare time she enjoys going to the dog park, traveling, reading novels, and browsing art shops.
Cheryl Hergert, MPH has more than 20 years of experience working with start-ups as well as corporate, and is familiar with product development for medical devices, pharmaceuticals and combination products. Her experience ranges from FDA panel presentation and approval to company closure, product feasibility testing to product launch, domestic product launch as well as European Union price negotiations. She has held positions in Regulatory Affairs, Quality & Compliance, Clinical Affairs & Operations, Data Management, Statistics and Medical Writing. She currently works for Medtronic as a Principal Clinical Quality Specialist overseeing the quality and compliance of the diabetes clinical program. Patient advocacy drives her work in quality and compliance.
Her research interest includes patient data privacy and the impact of regulations pertaining to data privacy on innovation and patient participation. How regulations impact movement of clinical data, the design and implementation of clinical research in multi-regional studies, and patient consent are of interest.
Beyond product development, Cheryl is involved in several initiatives such as World Health Day, International Women’s Day, and health equity. Through her leadership, World Health Day was institutionalized as an annual event at a California State University, and food access and diabetes awareness was improved in an indigenous community representing 50 tribes. This past year, Cheryl was the program lead for International Women’s Day at her current company. Events promoting gender equality were executed across the globe impacting employees from Poland to Singapore to South Africa.
She has four adult children and two grandchildren. She enjoys hiking, yoga, tango and getting in touch with her inner child when playing with her grandchildren.
Hai Luong, M.S., has over 15 years’ experience developing Peptides, Antibodies, Antibody Drug Conjugates, and most recently Cell Therapy with growing roles in Regulatory Affairs, Analytical Sciences, Quality Operations, and Process Development. He earned a B.S. in Biochemistry and a B.S. in Microbiology, Immunology, and Molecular Genetics from the University of California, Los Angeles as a double major. He proceeded to earn a M.S. in Regulatory Science from Johns Hopkins University. He is currently a Senior Manager, Regulatory Affairs CMC at Kite, a Gilead Company in Santa Monica, California. Mr. Luong started his career working in Infectious Diseases as a researcher with a variety of scientific roles from Mass Spectrometry characterization to Solid Phase Peptide Synthesis (SPPS) within the UCLA David Geffen School of Medicine. He then transitioned into Oncology, working within Analytical Development and Quality Operations at Astellas Pharma where he led Antibody Drug Conjugate programs.
Prior to joining Kite, a Gilead Company, he continued his career in Oncology and Infectious Diseases as a Senior Associate Scientist at Gilead Sciences where he leveraged his extensive scientific, cGMP, and regulatory science knowledge to lead Analytical Transfers, Validations, and Regulatory Submissions for Gilead’s Biologics portfolio. At Kite, a Gilead Company, Mr. Luong is responsible for all operational and lifecycle management aspects of Regulatory CMC submissions (IND, IMPD, BLAA, and MAA) in support of commercial and developmental programs. As the lead for Regulatory CMC strategy program teams, he ensures technical and regulatory requirements are fulfilled for M3 contents across various applications for global harmonization and timely world-wide registration. He provides Regulatory CMC expertise and leadership during due diligence in support of new projects that are rapidly evolving due to unanticipated changes within the novel Cell Therapy landscape with adaptive strategies.
Kerry Cobb is currently a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) and in Good Clinical Practices (RQAP-GCP) and serves as the Manager of R&D Quality Assurance for the Americas for Elanco Animal Health. In her current and previous roles, she has monitored numerous GLP and GCP studies to ensure compliance with the FDA, EPA, OECD, and USDA. Mrs. Cobb received a Master of Science degree in Industrial and Physical Pharmacy Regulatory and Quality Compliance from Purdue University in December 2010 and a Master of Science degree in Forensic Toxicology from the University of Florida in December 2013.
Lequina Myles, MBA, PMP has over ten years of experience within the pharmaceutical and biotechnology industries. Lequina is currently Regional Quality Manager, providing quality oversight for international and domestic life science and clinical trial distribution. Lequina started her career in the Quality Control Laboratories and moved up through the ranks managing and supporting global projects which increased organizational efficiency, productivity, as well as improved client retention and strategic partnerships. Also, Lequina has provided expertise in project management, continuous improvement, and training and development to various organizations. Lequina holds a BS in Biochemistry from the University of California, Los Angeles (UCLA) and an MBA with a concentration in Project Management from Mount Saint Mary’s University. Lequina is passionate about learning and solving complex problems. She also enjoys traveling, mentoring others and teaching.
Lori Alquier is a Global Regulatory Leader in Infectious Disease/Global Public Health at Janssen Pharmaceuticals, a Johnson & Johnson company. She has held multiple management roles in R&D and Operations, with over 30 years of industry experience in Pharma, Medical Devices, Diagnostics and Combination Products. She is a certified Six Sigma Black Belt and a ASQ certified Biomedical Auditor with a Bachelor’s and Master’s Degree in Chemistry from the University of Vermont and Seton Hall University, respectively, and a Master’s Degree in Regulatory Science from the University of Southern California. She is an author of 17 peer-reviewed publications, 2 patents, 2 book chapters, and an invited member of United States Pharmacopoeia (USP) General Chapter Expert Panel.
Dissertation: An Industry Survey of Implementation Strategies for Clinical Supply Chain Management of Cell and Gene Therapies
Mladen Bozic is a Head & Vice President, Global Regulatory Policy and Intelligence at Shire (acquired by Takeda in January 2019), where he established processes for effective internal regulatory policy activities, external representation and meaningful regulatory intelligence surveillance, assessment and dissemination. He has built an impressive network of external stakeholders in orphan space, including industry associations, senior regulatory agency officials, influencers in policy think-tanks and others, advancing Shire’s visibility and influence. Prior to joining Shire he was with Abbott Laboratories / Hospira in various commercial roles, from sales to price analysis and territory management. After leaving Abbott / Hospira, he joined Ovation Pharmaceuticals in regulatory affairs post-approval advertising & promotion and labeling, and in 2009 he was tasked to forma US regulatory policy and intelligence group. In 2012, he joined Shire to establish Regulatory Policy and Intelligence department, which is now recognized as a center of excellence. Mladen holds a BS in Nursing and Pre-medicine from Duquesne University, MS in Regulatory Science / Bioscience from Johns Hopkins University.
Nozomi Yagi, MAS., RAC (US), is currently Sr. Regulatory Affairs Specialist at KARL STORZ Endoscopy America, based in El Segundo, CA. She has over 10 years of US and international regulatory and clinical research experience. In her current role at KARL STORZ, she is responsible for US regulatory and clinical strategies for US Class III & II devices. Nozomi holds a BSc. in Biomedical Engineering from UC Irvine and a MAS in Health Law from UC San Diego.
Ron Lillie is currently Director, Drug Safety Data Analytics at Exelixis, Inc. a California-based biopharmaceutical company. In his current role he supports Pharmacovigilance & Risk Management and Drug Safety Operations groups through development, management and implementation of interactive software applications, assuring regulatory compliance, and management of product benefit-risk. Additionally, he manages vendor selection, sponsor/vendor software development & implementation projects and software vendor relationships. Ron is a graduate of Johns Hopkins University with an M.S. in Technical Management (Innovation focus), and the University of Toronto with a BSc in Human Biology and is currently enrolled in the Doctoral program in Regulatory Sciences at the University of Southern California. Ron brings 25+ years of pharma industry experience in Clinical Development and software applications, managing the implementation of Pharmacovigilance, Medical Information and process solutions, from requirements gathering to system validation. As a software product manager, he contributed to development of Signal Management systems utilizing in-house and FDA-AERS data. In 2009 he helped launch the U.S. startup pharmacovigilance CRO APCER Life Sciences having led client services, technical operations and software implementation, and having conducted client-facing activities including workshops & webinars including being a regular contributor to drug safety user groups. Ron has taught 12+ industry training classes including DIA tutorials on MedDRA version management, a class in signal detection to Health Canada and currently is an instructor in the Biotechnology Certificate Program at San Francisco State University.
Wendy Clark is a quality executive with over 30 years of experience leading global quality systems, laboratories, and manufacturing facilities in the pharmaceutical and medical device industries. Wendy holds a BA degree in Biology from California State University Fullerton and a Master of Business Administration from Pepperdine University. Wendy is currently the Vice President, Quality, Medical Device and Combination Products, at Allergan. Allergan is a global company focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. In her current role, she is a member of the Allergan quality leadership team, reporting directly to the Senior Vice President of Quality. She provides leadership, strategy and direction for the medical device and combination product manufacturing plants globally. For the Irvine, CA site, she is Allergan’s medical device and combination product Management Representative and U.S. agent under the Quality System. Wendy also sponsors the quality culture improvement effort for Operations, has served as a mentor and is an Allergan Career Story Leader. Wendy resides in Huntington Beach, California and her office is in Irvine, California. In her personal time, Wendy enjoys spending time with her family, cooking, fitness training, museums and musical theater.
Wenny Du, MS, MBA, RAC, is Regulatory Affairs Director, JAPAC (Japan Asia Pacific) Regional Regulatory Lead for Oncology at Amgen Inc (California). In this role, which she assumed in May 2019, Wenny is responsible for integrating Asia into global development of early oncology pipeline and supporting Amgen’s innovative medicines to reach Asian patients simultaneously.
Wenny has over 25 years of experience in biopharmaceutical industry. Prior to joining Amgen, Wenny served in a variety of leadership positions in both people management and project leadership at different entities within the pharmaceuticals branch of Bayer. Wenny’s experience is diverse spanning across local (China), regional (Asia Pacific), and global (US based) levels and involving work in not only regulatory affairs (including CMC) but also clinical development, marketing, and program management. Wenny is very experienced with proven track record of success to integrate Asia into global development and achieve simultaneous submissions and approvals in multiple therapeutic areas including oncology, hematology and general medicine etc. Most notably, she successfully pioneered Bayer China’s R&D strategy to integrate China into Bayer’s global development process. As a result, Bayer’s first oncology product, sorafenib (Nexavar®) was approved in China within 2 months after the European (EU) approval, being the record of the fastest ever approval for an NCE drug in China. She also led the concurrent launch of rivaroxaban (Xarelto®) in 12 Asia-Pacific (AP) countries within one year after the EU approval. More recently, she led a global program team to create a simultaneous global submission roadmap of BLA/MAA and NDA in Japan, China and other key international countries. This roadmap guided Bayer to achieve its first global contemporaneous submissions and approvals.
Wenny holds a Bachelor of Engineering in Biopharmaceutics from the China Pharmaceutical University, a Diploma in Business Management from the China Europe International Business School (CEIBS), and a Master of Science in Regulatory Science/Biotechnology from Johns Hopkins University. She is currently pursuing a Doctorate of Regulatory Science at the University of Southern California (USC). Wenny is also a Lean Six Sigma Black Belt certified by Georgia Institute of Technology.
Monique Carter, MS, RAC is a US and Global Regulatory Lead at Pfizer, Inc in Worldwide Regulatory and Safety – Global Innovative Pharma Business in the Neuroscience & Pain therapeutic area. Prior to joining Pfizer, Monique worked as a cross-functional team leader across the drug development continuum in a number of different firms with unique business models and therapeutic area focus, including a biotech -focused investments firm, global management consulting firm, and an academic drug target identification laboratory. Monique holds a BA in Biochemistry and Physics from Baylor University and a MS in Biotechnology with a concentration in Regulatory Science from Johns Hopkins University. She is based in Collegeville, PA.
Dissertation: Global Expedited Regulatory Drug Development Pathway Utilization and Impact
Jeanne Greenwald, MS, RAC is a regulatory professional with over twenty years of pharmaceutical experience in multiple areas including global regulatory CMC (chemistry manufacturing, and controls), US regulatory affairs, quality operations, and quality assurance. Jeanne earned a B.Sc. in Chemistry from the University of Michigan and a M.S. in Regulatory Science from Johns Hopkins University. She started her career as a laboratory analyst with Merck and held a variety of roles within the Quality laboratory before moving into Regulatory Affairs CMC at Merck in human health as a regulatory scientist where she initially supported a major inline solid oral dosage product then lead CMC efforts to prepare the Quality CTD modules for a major new drug application. Afterward, Jeanne also worked briefly as a Quality Assurance Documentation Team Leader with a Pfizer manufacturing site. When the Pfizer site closed, Jeanne returned to Regulatory Affairs with Schering-Plough Animal Health (now Merck Animal Health) as a Regulatory Affairs Manager responsible for preparing and maintaining CMC information for a variety of pharmaceutical products and progressed to the Director level. Jeanne has been Director of Regulatory Affairs with Merck Animal Health for the past 9 years and currently leads the Global CMC team. In addition, as part of a development plan, Jeanne gained experience preparing all sections of the US NADA including safety, effectiveness, all other information, labeling, as well as the administrative NADA and has had the pleasure of directly receiving some new NADA approvals on behalf of the company. Jeanne lives in Whippany, NJ and enjoys spending time with her husband Ron and grown children Brianna and Robert.
Dissertation: United States Veterinary Drug Shortages
Virginia Hill, M.S, RAC (US) has 18 years of compliance and strategic experience in the international nutritional product sector. With experience in over 60 countries worldwide, she has a broad global regulatory foundation. Virginia is currently Director of Regulatory Affairs at Pharmavite, manufacturer of Nature Made dietary supplements, based in Northridge, California. She oversees the domestic and international activities of the Regulatory Affairs and Consumer Affairs departments to ensure the regulatory compliance of all products distributed to domestic and foreign markets, as well as to ensure the efficient and effective handling of consumer complaints, inquiries and adverse events. Prior to joining Pharmavite, Virginia was an Associate Director of Regulatory Affairs at Abbott Nutrition where she leveraged her extensive scientific, regulatory and business knowledge to lead global launch projects in the medical nutrition and infant formula sectors.
Virginia started her career at Herbalife, a global nutrition and cosmetic company, located in Los Angeles, California. During her 13 year tenure at Herbalife, she led several regulatory groups where she routinely interfaced with international regulatory agencies responsible for developing regulations and policies. As a member of the International Alliance of Dietary/Food Supplement Association, she gained experience in policy development by providing international regulators guidance for developing their own country policy and regulations.
Virginia earned a BA in Integrative Biology with an emphasis in Human Biology and a minor in Spanish Languages and Literature from the University of California, Berkeley and a MS in Regulatory Science from the University of Southern California. Virginia has also obtained the following certificates: a certificate in Regulatory Affairs from California State, San Diego, and two certificates in Business from the University of California, Los Angeles.
Dissertation: Substantiating Structure Function Claims
Terence Hogan, Esq., MS, holds the role of Senior Counsel II for Commercial Legal and Business Conduct for Kite Pharmaceuticals, a Gilead company, where he provides counsel to executive leadership on legal and regulatory matters pertaining to stem cell and cell technology. Prior to this role, he was the Director of Law and Compliance for Amgen’s Digital Health division. In this role Mr. Hogan worked to provide legal and compliance support for medical devices, algorithms and data mining of patient’s health information, in order to allow physicians to treat patients at the individual bio-marker level. These new technologies were often poorly anticipated by existing regulations, and required provision of creative, yet sound, solutions. Prior to this role at Amgen, Mr. Hogan was an R&D Senior Counsel at Amgen, specializing in GxP, oncology and cardiovascular pipeline drugs, early development, international and US privacy, and regulatory promotion. While in this role, Mr. Hogan worked with the CFDA in their development of GMP regulations in 2010, and has provided significant comment to the Sunshine Act portion of PPACA. He started his career as a “patent busting” litigator for a large generic company. He has a Juris Doctorate, with a concentration in Health Law from Seton Hall University; a Masters of Science from Johns Hopkins in Biotechnology, Molecular Targeting and Drug Development/Regulatory; and was once upon a time a high school biology and chemistry teacher. In his free time, Terence is an aggressively mediocre surfer, a musician, and has recently discovered the joys of stand-up paddle-boarding.
Dissertation: Sustaining Clinical Trial Transparency While Preventing the Re-Identification of Subjects
Martin Koning-Bastiaan is an expert in user-centered design of workflow applications. After receiving a Master’s Degree in Educational Theory from Stanford University, Martin worked at Apple Computer as a Research Scientist in the Advanced Technology Group. At Apple, Martin was part of a project helping educators effectively use technology in classrooms. Martin then moved on to be director of technology for MERLOT, an international consortium of universities collaborating on the use of online educational resources, originating out of the California State University system. Martin was responsible for the design and implementation of the MERLOT system. An important component of the MERLOT system was automated business process management for the review of educational materials. In 2006, Martin joined the University of Southern California as director of technology for the Institutional Review Board (IRB). Since then his responsibilities have broadened. Martin currently serves as the Director of Research Technology for USC. He is responsible for electronic workflow systems for research, including the IRB, the Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Conflicts of Interest Committees (CIRC). He designed these new systems to make it quicker and easier for researchers to obtain approval while ensuring regulatory compliance and enforcing the correct business process.
Dissertation: Institutional Review Board Implementation of the Single IRB Model for Multicenter Clinical Trials
Laura B. Kupsch, MBA, MS, is currently the Executive Director of Quality at Nutrinia, a start-up developing treatments for rare GI disorders in infants. She is primarily responsible for the development of the quality program, as well as being a member of the team planning the company strategy and growth. Prior to joining Nutrinia, Laura was the Senior Director of Quality Assurance at Ophthotech Corporation, a biotech company focused on back of the eye diseases. She also worked at Pharmasset, and was part of the team that developed a cure for Hepatitis C. Laura has over 20 years experience working in the field of clinical research and regulatory compliance. She holds an MBA from Marist College and an MS in QA/RA from Temple University, and is a registered Clinical Quality Assurance Professional with the Society of Quality Assurance. She currently resides in central New Jersey (when not traveling) and enjoys spending time with her family and completing marathons and triathlons.
Dissertation: Contract Research Organizations – A Survey of Industry Views and Outsourcing Practices
Wendi Lau, Elmhurst, IL I have over 25 years of experience in the pharmaceutical drug development industry in varying roles across the clinical development field. I started my career in the pharmaceutical industry at Astellas Pharma (formerly Fujisawa) in Data Management and then moved into Clinical Development where I managed clinical studies as well as clinical development programs for compounds in the antifungal therapeutic area. I then moved to Medical Writing where I eventually became Head of Medical Writing overseeing document preparation in support of regulatory submissions in the US and Europe. I have actively participated in supporting submissions for first in man products through marketing application across various therapeutic areas. My experience has developed in me a deep interest and appreciation for the regulations and processes which govern our ability to bring promising pharmaceuticals to the people of the world. I am currently leading an organizational improvement initiative to improve business operations efficiency within the clinical development organization.
Dissertation: A Survey of US Industry Views on Implementation of Decentralized Clinical Trials
Geoffrey Okelo is currently a lead Reviewer / Chemist at the FDA where he is responsible for evaluating submissions as relates to CMC data for product quality, recommending analytical improvements to ensure they are focused on critical quality attributes for drug product performance, safety and effectiveness, risk assessments associated with amendments and supplements, providing authoritative in put on the preparation of comprehensive summaries of regulatory recommendations, and developing policy, practices, and guidance related to review of CMC information. He is the Branch’s Super User and Representative for Panorama (recent system / interface for review and documentation) and a committee member for Panorama Reviewer User Manual Super User Review expert group. Geoffrey is a pioneer reviewer in the new approach of risk based review of regulatory submissions. As part of the team, he helped achieve a milestone of 90% review completion of over 4000 + backlog supplementary submissions in 1 year while applying a Risk – Based approach.
Geoffrey is a former Research Scientist and one of the pioneer employees at a privately held company, Rhodes Pharmaceutical L.P. Coventry, RI until 2014. His specialty area was R&D and Product Development. He was part of a team that established a fully audited FDA / GMP laboratory and Quality Documentation System from scratch. Prior to joining Rhodes Pharmaceutical in 2010, Geoffrey served as a Scientist in Pfizer’s global R&D HQ’s Groton, CT since 2007. he developed a new technology for generic sample preparation technique to improve extraction of osmotic dosage forms, evaluated stability of drug formulations using prototypes to determine shelf life and packaging, explored new analytical techniques (e.g. UV-Vis, UPLC, Fiber-Optic dissolution, etc.) to speed up the work process that improved the efficiency and productivity, and supported drug formulation screening from development through manufacturing in line with Quality -By- Design approaches.
Geoffrey holds BA (Chemistry, Magma Cum Laude Hons 2004) from Fayetteville State University NC, then proceeded to a Ph.D program and earned Master’s in chemistry (2007) from North Carolina State University, his research focused on DNA detection using radical polymerizations. He earned his MBA (2010) from the University of New Haven, Connecticut.
He is a veteran and served for 14 years in the United States Army. Geoffrey spends most of his quiet time with his family, wife (Vera) and 2 kids, daughter (Gweth) and son (Jahawi). He enjoys sports, reading and music.
Exploring Critical Elements of First Time Approval: Generic Tool for Effective High-Quality ANDA Submission
Mary Wilhelm, MS, RAC is currently Senior Director, Regulatory Affairs at Halozyme Therapeutics in San Diego, California. She has over 30 years’ experience working in a variety of quality and regulatory functions for biotechnology, pharmaceutical, agricultural biotechnology, and specialty chemical (food additives and bulk excipients) companies. At Halozyme, Mary has been involved with drug development programs from early investigational products to commercialization and post-approval activities. She is experienced in developing regulatory strategy, preparing teams for regulatory meetings, including an FDA Advisory Committee, and managing regulatory submissions (e.g., INDs, CTAs, MAAs, and BLAs). She has participated in multiple regulatory agency meetings with FDA (CBER and CDER), EMA, Health Canada, and for national scientific advice in the EU. In her current position, Mary has the unique opportunity to work with Halozyme’s partners (Roche, Baxalta, Pfizer, Janssen, AbbVie and Eli Lilly) and provide regulatory strategy for combination products utilizing Halozyme’s enzyme for investigational products for treatment in oncology and primary and specialty care indications.
Mary has a MS degree in Regulatory Affairs from San Diego State University (SDSU) and a MS in Chemistry from Purdue University. She also holds two BS degrees from Purdue University and several certifications including: Regulatory Affairs Certification (RAPS) for both the US and EU, and Certified Quality Auditor (ASQ). Mary is a member of the Regulatory Affairs Professional Society, the San Diego Regulatory Affairs Network, Athena San Diego, and is an adjunct faculty member at SDSU for the Regulatory Affairs Master’s program.
Regulatory Agreements for Drug Development Collaborations: Practices in the Medical Products Industry
Carolyn Wright, has 20+ years of experience as a process development, manufacturing, validation and quality engineer as well as department leadership roles in these areas. She started her career at Eastman Kodak in Rochester New York then moved to a transdermal development and manufacturing company in Grand Rapids, MI. She is currently with Amway Ada, Michigan and held leadership and engineering roles in the quality and regulatory departments. Carolyn is a certified Six Sigma Black Belt, has a Bachelor of Science Degree in Material Science and Engineering from Michigan State University and a Regulatory Affairs Masters Degree from Northeastern University.
Carolyn has performed the development work for several new transdermal drug/device combination products including the CMC section of multiple ANDA and NDA submission. As a validation engineer she has written and executed multiple equipment qualifications, process and packaging validations, software validations and utility qualifications. She is very familiar with the FDA regulatory requirements of 21 CFR parts 110, 111, 210, 211 and 820 and the ISO 13485 standard. Carolyn has held management responsibility for corporate new technology regulatory assessments and product safety and is currently the Quality Launch engineer for Amway’s first global medical device.
Dissertation: Using Telemetry to Ensure Safe and Reliable Medical Device Operation: Experience with Defibrillators and Infusion Pumps
Michael Yartzoff, MBA MS, is a Senior Director of Quality with approximately 20 years of experience in the pharmaceutical and medical device industries; leading teams with quality assurance, quality control and regulatory compliance oversight. Michael is a progressive leader with strong team building skills, focused on developing strategic vision, organizational capability and implementation of operational excellence across the entire organization. Michael holds a B.S. in Chemistry from Loma Linda University; an MBA from the University of Redlands and a MS in Biotechnology from Johns Hopkins University.
Michael is a Senior Director of Quality at Edwards Lifesciences; based in Irvine, California. He leads the corporate Microbiology, Biology and Chemistry laboratories supporting early phase R&D through commercial medical device manufacturing operations. Prior to 2013; and since 1999, Michael worked at Allergan Pharmaceuticals (formerly Actavis), holding various positions with increasing levels of responsibility in Quality Assurance and Quality Control. His most recent position was the Director of Laboratory Operations supporting both pre-commercial and commercial manufacturing of generic and branded solid dosage products. Michael’s professional interests include the biocompatibility of medical devices; toxicological risk assessments; early phase clinical studies; and Quality Assurance and Quality Control within the Pharmaceutical and Medical Device industries.
Current Practices in Biocompatibility Assessment of Medical Devices
Sunita Babbar, MS, DABT, is currently Senior Director of Nonclinical Research and Development at Revance Therapeutics, Inc. based in Newark, California. She has been over 18 years of experience in small and large molecule nonclinical and clinical drug development. She has an extensive background in toxicology/pharmacology/DMPK studies supporting screening, lead optimization, pre-clinical development and clinical trials to meet US and EU regulatory requirements. Her expertise include: non-clinical study design (general toxicology, safety pharmacology, reproductive toxicology, carcinogenicity, genotoxicity and PK/ADME) and execution, data interpretation and reporting; understanding of GLP regulations, FDA and ICH guidelines and experience in writing regulatory documents such as NDAs, MAAs (leading to successful approvals in the US and the European Union) INDs, IBs, Annual reports, White papers/Risk assessments, product labeling, clinical protocols and interactions with the FDA; preparation for Advisory Committee meeting; expert placement and monitoring of CROs, budget negotiation and project management; manage interactions with corporate partners, review safety data for potential candidates for in-licensing and trouble-shoot possible safety issues.Sunita was born in India and holds a Bachelor of Pharmacy degree from India. She came to the US as a graduate student (Master of Science) in Pharmacology at School of Pharmacy, Idaho State University. She is also a Board certified toxicologist.
Challenges to Implementation of Alternative Methods to Animal Testing for Drug Safety Assessment in North America
Victor Gangi MS is a senior regulatory affairs CMC professional with over 25 years of experience in the biopharmaceutical industry. He is experienced in managing teams and developing effective strategies for successful product development and lifecycle maintenance of global product portfolios for biologics, drugs, vaccines and medical devices. Victor is currently Senior Director of Regulatory Affairs CMC at TESARO in Waltham MA. He was formerly Associate Vice President of Global RA CMC at Sanofi Genzyme leading the Reg CMC function for the commercial and development portfolio of Genzyme rare disease and orphan biologic products. In addition, he led the regulatory aspects of the Consent Decree compliance activities. Prior to Genzyme Victor was Director of Global RA CMC at Wyeth Biopharma (then acquired by Pfizer) responsible for leading the function of registration and maintenance of biopharmaceutical, vaccine and device products. Prior to Wyeth he was Associate Director of Regulatory CMC at Biogen Idec. Victor started his career at the Food and Drug Administration where he held the positions of Biotechnology Specialist Investigator in the New England District and Microbiologist in the FDA regional laboratory. Victor earned a B.S. in Microbiology and an M.S. in Biology from the University of Massachusetts, as well as an MS in Regulatory Science from USC.
Examining the Regulatory Framework for Drug Compounding: Industry Views and Experiences
John Hartigan, MS, MBA, has been improving product quality and ensuring compliance to laws and standards since 1989. He is a Quality & Regulatory professional whose many years of experience and multi-disciplinary skills include a strong background in GXP operations, quality management systems, new product development, and compliance activities for chemical, manufacturing, and software processes in the biomedical industry.
Mr. Hartigan is presently enrolled as a graduate student at the University of Southern California, within the school, with a degree objective of Doctor of International Regulatory Science. He currently holds a M.S. degree in Regulatory Science from Johns Hopkins University and has earned his MBA from the University of Colorado with a concentration in finance and electives in healthcare administration. He also holds a B.S. degree in Chemistry from Sonoma State University and numerous certifications including: Certified Quality Engineer (ASQ), Certified Software Quality Engineer (ASQ), Lead Auditor, ISO 9001 with Emphasis on ISO 13485:2003 (BSI), a certification in Clinical Auditing, and a Biomedical Regulatory Affairs certificate from the University of Washington, school of Pharmacy.
Mr. Hartigan currently works at Illumina, Inc., as a Global Quality Systems Manager within the IVD and Genomic Testing industry with a primary focus on compliance oversight for FDA Pre-Inspection Audit readiness for PMA submission, conversion of IVD RUO Quality Systems to Dx GMPs, and ISO QMS site registrations and Scheme management for IVDD/R. He has also worked as a Global Compliance Manager for Philips Healthcare within the Imaging Systems Quality and Regulatory group with a primary focus of corporate quality & regulatory initiatives and compliance oversight of business units, worldwide. Formerly, John was a Sr. Quality Systems Manager for Physio-Control (Medtronic) responsible for complaints, MDR’s, internal audit, and leading QMS aspects associated with consent decree activities.
Mr. Hartigan maintains a strong commitment to health and the biomedical industry. He is a member of the American Society for Quality (ASQ), the Regulatory Affairs Professionals Society (RAPS), as well as the Organization of Regulatory and Clinical Affairs (ORCA). His passions include family, fitness, and outdoor activities.
Computerized Simulation in Clinical Trials: A Survey Analysis of Industry Progress
Michelle Mc Guinness joined AstraZeneca in July 2016 as Senior Director, Compliance Operations bringing 15+ years of experience in regulatory, quality and compliance roles within the pharmaceutical industry. At AstraZeneca, Ms. Mc Guinness supports the Diabetes and Cardiovascular Business Units and also manages the Compliance & Ethics Leaders supporting the field and working on projects. Prior to joining AstraZeneca, Ms. Mc Guinness held various positions of increasing responsibility at Janssen, Veloxis Pharmaceuticals, Mylan, PA Consulting, Accenture (formerly Octagon Research Solutions), Sanofi, Liquent (a Paraxel company) and Ranbaxy Pharmaceuticals Inc. Ms. Mc Guinness has participated in a number of joint industry-agency initiatives. She was awarded the FDA Commissioner’s Special Citation for her contribution the development of the HL7 Structured Product Labeling standard & FDA guidance. Ms. Mc Guinness holds an MSc in Quality Assurance/Regulatory Affairs from the Temple University School of Pharmacy. She holds a BA in Biology-Biotechnology from Kean University. Ms. Mc Guinness is passionate about supporting the rare diseases and orphan indication communities. She volunteers as a scientific advisor for CureCADASIL (the CADASIL Association). More details are available on her Linkedin Profile.
Investigating in Orphan Drug Development: An Analysis of the Impact of Orphan Drug Incentive Programs in the United States
Nami Migita, MBA, MS, RAC is currently Associate Director, Regulatory Affairs, Japan and Asia-Pacific (JAPAC) at AbbVie Inc. (North Chicago, IL). Ms. Migita has over 17 years of experience in the global medical device and biopharmaceutical industries based in Japan and the United States. She has performed leadership roles in marketing, project management, and international regulatory affairs in several medical devices/biopharmaceuticals companies. Before joining AbbVie Inc., she was Senior Vice President at a regulatory affairs and business consulting firm that exclusively services the medical device, pharmaceutical, and in vitro diagnostics industries. Presently, she is responsible for the development and implementation of JAPAC regulatory strategies for various new and previously marketed biopharmaceutical and medical device products at AbbVie Inc. Ms. Migita obtained a Bachelor of Arts degree in Humanities at Wako University (Japan), a Master of Business Administration degree at Emory University, and a Master of Science degree in Bioscience Regulatory Affairs from the Johns Hopkins University.
Governmental Programs to Foster Medical Product Development in Small Enterprise: A Survey Comparison of the United States and Japan
Penny Ng, MBA, MS, RAC is currently working as the Director in the Regulatory Affairs department at Celgene Corporation, focusing on biologic and small molecules development in the hematology & oncology areas. After obtaining her microbiology undergraduate degree from University of Toronto, she worked at Connaught Laboratories (currently Sanofi Pasteur) in the Quality and Control, and Research departments. Curious to understand the overall picture of biopharmaceutical product development, she transferred to regulatory affairs in 1997. In 2000, Penny earned an MBA, majoring in Finance from the Schulich School of Business, York University (Ontario, Canada) and received the Regulatory Affairs Certificate from the Regulatory Affairs Professional Society. In 2010, she completed a MS in Regulatory Affairs from San Diego State University, with a thesis on pediatric drug development with a special focus on oncology. Over the last 18 years, she worked on CMC submissions, IND/IDE/clinical trial applications, health authorities meetings (pre-IND to pre-sNDA, Scientific Advice), pre-marketing applications (including Breakthrough Therapy Designation Request, Fast-Track Designation Request, Proposed Pediatric Study Request, etc.), marketing applications, post-marketing activities, and regulatory strategies for small molecules, biologics and combination product in a global setting that spans the US, EU, Canada and APAC countries. She currently resides in Lawrence Kansas with her husband and daughter. In her spare time, she loves to cook, play the piano, paint, create imperfect but still beautiful pottery, and travel the world with family.
Regulation of Pediatric Cancer Drug Development: An Industry Perspective
Raina Olexa, MS, RAC holds a Master of Science degree in Bioscience Regulatory Affairs from Johns Hopkins University and Bachelor of Science degree in Biobehavioral Health, with a specialization in Neuroscience, from Pennsylvania State University. Ms. Olexa has worked in the medical research and pharmaceutical fields for over 15 years, gaining experience in pre-clinical, clinical and commercial manufacturing aspects of the drug development lifecycle. At Drexel University College of Medicine, Ms. Olexa conducted research to assess recovery of function in animal models of spinal cord injury. From this pre-clinical position she moved into clinical and commercial drug manufacturing, working in vaccine operations at Merck and biologic drug operations at Bristol Myers Squibb. After gaining significant GMP experience, Ms. Olexa transitioned into clinical research supporting international Phase I-IV clinical trials. She has held senior level quality assurance positions at Kendle International, Optum and Quintiles, ensuring that clinical trials are conducted ethically and in accordance with global regulations. Ms. Olexa serves as an adjunct professor for the graduate Regulatory Affairs program at Northeastern University and the undergraduate Clinical Research program at University of North Carolina, Wilmington. She is also the founder of Lakeside Regulatory, a non-profit organization dedicated to empowering the public to engage in the regulatory process.
Dissertation: Real World Evidence: Bias and Power
Darin Oppenheimer, MS is a Regulatory Affairs Director at Baxter Healthcare. Based in the Chicago Area, Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Darin leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise.
Risk Management and Recalls: A Survey of Medical Device Manufacturers
Katherine St. Martin is a United States Military Academy graduate. She served as an active duty Army intelligence officer in Germany including several developments to Baghdad, Iraq. Upon honorable discharge as a Captain, she transitioned into a corporate regulatory environment with Boston Scientific Cardiac Rhythm Management. While working as a Senior Regulatory Specialist on class III medical devices, she pursued a Masters in Bioscience for Regulatory Affairs from Johns Hopkins University. Her most recent regulatory experience is with Be the Match operated by the National Marrow Donor Program (NMDP). NMDP is a growing non-profit organization of over 1,000 employees, representing multiple stem cell product lines and extensive product development prospective and observational research. The NMDP holds several congressional contracts to facilitate unrelated stem cell donation for terminally ill cancer patients and manages proprietary DNA-matching algorithms that search worldwide bio-repositories for the best potential transplant matches. As the Regulatory Compliance Project Manager for NMDP, she advises executive staff on the regulatory impact of biologic drug product development and business process improvement related to both manufacturing and clinical trials.
Examining the Cord Blood Industry Views on the Biologic License Application Regulatory Framework
Curtis Truesdale, MS, MSE, RAC is currently the Regulatory Affairs Franchise Head for Prostate Health at Boston Scientific Urology and Pelvic Health (formerly American Medical Systems). He is based in Minneapolis MN. Prior to his current role, he served as Director of Regulatory Affairs for the Americas at Mölnlycke Health Care, a health care technology company headquartered in Gothenburg Sweden. Other previous experience consists of a variety of regulatory affairs roles at companies within the medical device industry, including Guidant Vascular Intervention (now Abbott Vascular), Stryker Spine and CareFusion. He is also a former Review Scientist and Engineer at the FDA Center for Devices and Radiological Health, Office of Device Evaluation. His combined FDA and industry experience offers him a unique perspective on the commercialization of health care products. Curtis is board certified by the Regulatory Affairs Professionals Society. He holds a Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University, Baltimore MD; a Master of Science in Engineering, with a Biomedical Engineering concentration from The Catholic University of America, Washington DC; and a Bachelor of Science in Electrical Engineering from North Carolina A&T State University, Greensboro NC. He has also completed graduate coursework in the biomedical sciences at Saint Louis University School of Medicine, St Louis MO.
Regulatory Team Development in Post-Merger Integration: A Survey of Views from Medical Product Companies
James Turner, MS, RAC is a Regulatory Affairs Manager at GE Healthcare in Waukesha, WI. He received his BS in Forensic Science from Michigan State University and MS in Quality Assurance/Regulatory Affairs from Temple University. His 15+ years of experience is in various Quality and Regulatory roles and spans the Pharmaceutical and Medical Device industries with his most recent role focused on creating internal processes and procedures to meet the new Unique Device Identification regulations and to help communication and implement the new UDI requirements across the business. He has experience in quality investigations, quality system implementation, acquisition due diligence and integration, R&D to production technology transfers, medical device premarket authorizations, advertising, promotion & labeling approvals, and the development of new processes and supporting IT solutions in an effort to meet new requirements or to simplify existing practices. Mr. Turner is a member of the Regulatory Affairs Professional Society, served two terms on the Regulatory Affairs Certification Board and is currently a member of the RAPS Annual Conference Planning Committee. He enjoys spending time outside of work with his wife and young son, and can often be found at the ice rink either officiating high school ice hockey or playing in a recreational ice hockey league.
Jennifer Wiley, M.S., RAC, is currently Associate Director of Regulatory Affairs at Alder BioPharmaceuticals, Inc., based in Bothell, WA. She has over 10 years of regulatory experience in the biopharmaceutical industry. In her current role she is responsible for developing and implementing global regulatory development strategies for oncology and neurology monoclonal antibody products manufactured in a yeast expression system. Jennifer earned a B.A. in Chemistry from Smith College and a M.S. in Epidemiology from the University of Washington.
Experience with Breakthrough Therapy Designation: An Industry Survey
Donatus Ako-Arrey, M.Sc. is Canadian citizen, born in Cameroon, Africa. Donatus earned a Bachelor of Science degree in Chemistry at the University of Buea, Cameroon. He began his graduate education at the Free University of Brussels (VUB) in Belgium where he obtained a Master of Science degree in Biomedical Sciences (option – pharmacology) and later earned another Master of Science degree in Pharmaceutical Sciences (option and – drug development) from the University of Montreal, Canada. Donatus also holds a certificate from the McGill University Post Graduate Program in Biotechnology. Donatus began his regulatory affairs career more than 10 years ago in Canada and served as Associate Director, Regulatory Affairs at Teva Pharmaceuticals USA in Horsham, PA where he is lead the design and implementation of strategies for complex injectable generics including peptide drugs, liposomal drugs and drug/device combination product development. He now serves as the Director, Regulatory Affairs CMC at Mallinckrodt Pharmaceuticals in Hazelwood, MO.
Dissertation: Effect of GDUFA Legislation on the Development and Approval of Generic Drugs: A Survey of Industry Views and Experiences
Alicia Baker, MS, is a Regulatory Consultant. Previously she was the Director of Global Regulatory Affairs at Merck & Co., Inc. She obtained her BS in Biology from St. Joseph’s University in Philadelphia, PA and MS in Regulatory Affairs/Quality Assurance from Temple University in Philadelphia, PA. She has been working at Merck for 15 years, 13 years in the regulatory organization. Throughout her career in regulatory, she has handled products in all phases of development including cardiovascular, CNS, ophthalmic, oncology, endocrine/metabolic, respiratory and immunology therapeutic areas. Her current focus is global regulatory strategy development in respiratory and immunology products. In her spare time, Alicia enjoys playing the piano, going to the theater and spending time with friends and family. She currently resides in New Jersey.
Terry David Church. As the Program Manager for Translational and Clinical Sciences at USC Norris Comprehensive Cancer Center, Terry David Church, MA, MS, is insured of a work day full of variability and creative problem-solving. The requirements of this position give him a unique arena to combine prior experience in research operations management with anthropology in the pursuit of efficient clinical, research, and resource solutions. Terry sees opportunities where others may see obstacles, whether he is working to implement survivorship planning, developing research protocols to expand the programs portfolio, or building affinity groups to help propel cancer therapeutics and diagnostics from concept to application. Terry is preparing for his next phase of his academic journey by researching topics related to his dissertation which include social policy, biorepository ethics, and collections management. In his down time, Terry enjoys unwinding with video games.
Dissertation: Continuity Management in Biobank Operations: A Survey of Biobank Professionals
Aimee Greco, is Directstyle=”margin-right: 40px; margin-bottom: 10px; width: 150px; height: 150px; object-fit: cover; border-radius: 50%;”or of Regulatory Affairs CMC Medical Devices at Shire Pharmaceuticals. Based in Los Angeles, California, Aimee is involved in many facets of medical device development for combination products and drug delivery systems, companion diagnostics and medical device software to support biologics and small molecules in oncology, immunology, hematology and genetic diseases.
With laboratories and multiple manufacturing sites all over the world, Aimee leads a team of regulatory professionals that coordinate compliance needs in R&D, regulatory submissions and strategic planning on multinational projects and clinical studies.
Her prior background as a R&D Scientist focused on clinical evaluations for pharmaceutical and medical devices in transfusion medicine and cell therapy. Aimee holds a Bachelors degree in Bioscience from California State Polytechnic University, a Masters in Regulatory Affairs from Johns Hopkins University, and a Masters in Regulatory Science from the University of Southern California.
Although Aimee has trilingual fluency in Spanish, Chinese and English, there are days when her two Yorkshire Terriers, Carey and Grant, can’t be bothered to listen to her, no matter which language she uses.
Dissertation: Implementation of Unique Device Identification in the Medical Device Industry: A Survey of the Change Management Experience
Grant S. Griffin, MS, is a native of Iowa and earned a Bachelor of Arts in Russian and history at the University of Iowa before relocating to Chicago. Grant was offered admission to the Slavic Linguistics PhD program at the University of Chicago, but instead he decided to earn phlebotomy and other allied health certifications and pursue a different career trajectory. He worked as a Patient Care Technician at Evanston Hospital and as a Clinical Research Coordinator at the Chicago Institute of Neurosurgery and Neuroresearch before joining Abbott Laboratories as a Regulatory Affairs Associate. At AbbVie Inc. he is responsible for submitting IND safety reports, information amendments, protocol amendments, general correspondence, and other submissions to FDA, updating templates, SOPs, and job aid documents, and developing metrics gathering processes in parallel with regulatory strategy. Grant is a member of the Regulatory Affairs Professionals Society Regulatory Focus Board of Editors and also holds a Master of Science in Regulatory Science from the University of Southern California. He is thrilled to live in Chicago with his wife, Sarena.
Dissertation: Sharing the Results Of Clinical Trials: Industry Views On Disclosure Of Data From Industry-Sponsored Clinical Research
Martha Kamrow has held several roles across GE Healthcare. Her current role is a Global Regulatory Affairs Director at GE Healthcare located in Waukesha, WI where she works on implementing and communicating global RA regulations, processes and procedures. Prior to that , she has held roles as Post-Market Regulatory Affairs Manager, Safety & Regulatory Engineer and Complaint Coordinator at various GE Healthcare businesses. Martha has a Master’s in Engineering from University of Wisconsin – Madison and Bachelor degrees in Mechanical Engineering and Mass Communication from University of Wisconsin – Milwaukee and Technical Communication from Milwaukee School of Engineering.
Dissertation: Organizational Communication of Regulatory Intelligence: A Survey of the Medical Device Industry
Cesar Medina, DRSc, MBA, MS, RAC is currently a Regulatory Affairs Manager at Amgen, Inc. He has over 15 years of experience in drug development from early drug discovery up to commercial market registrations. He has worked under a variety of settings including generics, CRO, small biotech, and large pharma organizations. His current role is managing global regulatory CMC (chemistry, manufacturing, controls) submissions for both biologics and small molecule drugs across several therapeutic areas. This includes leading CMC preparation for global clinical trial applications (US, EU, Asia, Latin America) as well as strategic management and implementation of CMC lifecycle activities for established commercial products. Over the years, he has contributed numerous papers in peer-reviewed journals and trade publications including the Journal of Pharmaceutical Sciences, Pharmaceutics, Handbook of Pharmaceutical Excipients, and RAPS Regulatory Focus. In 2007, Cesar earned an MBA with an emphasis in Leadership and Managing Organization Change from the Graziadio School of Business and Management at Pepperdine University. In 2010, he completed a MS in Regulatory Affairs from the Center of Bio/Pharmaceutical and Bio/Device Development at San Diego State University. Cesar’s doctoral research is focused on gaining a better understanding on the interplay between pharmaceutical manufacturing quality regulations and the biomedical marketplace.
Dissertation: Incentivizing Quality in the Manufacture of Pharmaceuticals: Manufacturers’ Views on Quality Ratings
Caroline Mosessian, DRSc is an expert in compliance and risk management; markets access; pricing and reimbursement; clinical trials and project management; health policy, economics and outcomes research”. She can be reached for consulting engagements by email: email@example.com
Value Based Purchasing: Decision-Making Processes Underlying Hospital Acquisitions of Orthopedic Devices
Vada Perkins, BSN, MSc, RN, CAPT, USPHS. Vada is an officer with the United States Public Health Service (USPHS) and serves as the Chief of Business Operations Staff with the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), Office of the Director (OD)/Review Management (RM). He previously served as a Regulatory Project Manager/Primary Reviewer with CBER’s Office of Vaccines Research and Review/Division of Vaccines and Related Products Applications. Vada is the Center lead for the implementation of electronic prescribing information and electronic drug establishment registration/product listing. He also functions as the FDA topic leader for the International Conference on Harmonization’s (ICH) M5 Expert Working Group: Data Elements and Standards for Drug Dictionaries, and represents FDA in international standards development as a US Delegate with the American National Standards Institute (ANSI) on International Organization for Standardization (ISO) activities related to the unique identification of medicinal products. Vada was a U.S. Army Officer for 9 years prior to joining the FDA and USPHS. He received his MSc. from Johns Hopkins University and his BSN from the University of Maryland, Baltimore.
Industry Views on IDMP Implementation
Dissertation: A Survey of Data Management Principles within the Pharmaceutical Industry
Susan Pusek, MS, is the Director of Education Programs for the NC Translational and Clinical Sciences (TraCS) Institute at the University of North Carolina (UNC) at Chapel Hill. She began her career in research at the University of Michigan and came to UNC in 1992 to initiate a central office of clinical trials. This office focused on facilitating the interactions between academic investigators and the pharmaceutical industry. She also ran multiple industry- sponsored clinical trials and federally funded research projects. Susan also gained experience assisting academic investigators and students who were learning how to design and conduct clinical research studies. This led to the development of training programs for investigators and research coordinators. In 2001 she formally became the Director of Training within the General Clinical Research Center at UNC. Susan obtained her MS in Clinical Research Administration from George Washington University in 2005. In 2007 she became Director of Education Programs for NC TraCS. Her responsibilities include developing education programs for various stakeholders in the research workforce, managing formal training programs and assisting researchers with career development planning. She also lectures on mentoring, grant preparation, research conduct and regulatory issues.
Dissertation: IRB Capabilities to Oversee New Technology: Social Media as a Case Study
Ali Reza Rejaei is currently Director of Regulatory Affairs and Clinical Development at POM Wonderful LLC, a division of Roll Global located in Los Angeles California. Ali has been with the company since 2007 managing medical research projects and related regulatory affairs submissions. POM medical research is focused on exploring health benefits of pomegranate polyphenols in relation to disease prevention. Prior to POM, Ali had been Manager of Regulatory Affairs with Pepsi Cola Company in Purchase, New York. He managed Regulatory Affairs of Gatorade and Propel among other products. Previously he worked at Symrise Company in Northern New Jersey managing Scientific and Technical Affairs of flavors, fragrances and cosmetic raw materials. While working, he taught Food Science courses at Montclair State University in Montclair, New Jersey for two semesters. He has published his dissertation and has been awarded for his publication in France for the novelty of research method, eliminating allerginicity of baby formula food. He currently serves as a member of IRB committee of the Los Angeles Children Hospital. He is committee member of Council for Responsible Nutrition’s Whole Food Supplement Working Group (CRN) located in Washington DC and Technical Committee member of Juice and Juice Products (TCJJP). Ali currently manages number of clinical trials in prostate and breast cancers, cognition and memory, Hemodialysis, nephrolithiasis, IUGR in pregnancy and placental dysfunction, among a few other exploratory clinical researches. He has filled and actively manages two ongoing Investigational New Drug applications with FDA in the United States.
Ali obtained his BSc. and MSc. degrees in Food Science from McGill University in Montreal, his M.B.A. degree from Fairleigh Dickenson University in Madison New Jersey. He is currently pursuing his Doctorate degree in International Regulatory Sciences in the Pharmacy Dept. of University of Southern California.
Dissertation: Establishing Clinical Efficacy of Botanical Products: A Survey of Industry Views
Catherine M. Sheehan is Senior Director of Excipients, in the Global Science and Standards Division, at the United States Pharmacopeial Convention, Rockville MD. She is responsible for development and update of USP-NF excipient monograph public standards and related general chapters in support of the USP Council of Experts. The US FD&C Act designates USP-NF as official compendia for drugs marketed in the US. She is currently part of the USP delegation to the Pharmacopeial Discussion Group’s (USP, JP and EP) compendial harmonization of excipient monographs and general chapters. As part of USPs collaboration with the FDA Monograph Modernization Task Group and other stakeholders, she is responsible for update and modernization of high priority excipients monographs at risk for adulteration. She co-authored several excipient related articles including, “Understanding the Role of Excipient Functional Category & Performance-Related Tests in a Quality-by-Design Framework”, Drug Development & Delivery, 2012. She also shared responsibility for USP’s successful launch of the Food Chemicals Codex Sixth Edition in 2008. She holds an M.S. degree in Regulatory Science and an M.S. degree in Biotechnology, both from The Johns Hopkins University, Baltimore, MD. Ms. Sheehan is active in AAPS and RAPS.
Dissertation: Views on Global Harmonization of Pharmacopeial Standards: A Survey of Key Stakeholders
Nancy Smerkanich, DRSc, MS is an Assistant Professor, Clinical Pharmacy, School of Pharmacy at the University of Southern California (USC). She served as an Educational Liaison and Instructor, International Center for Regulatory Science. Dr. Smerkanich recently completed her doctorate in Regulatory Science on the Implementation of Benefit-Risk Frameworks in Industry. She leads the clinical regulatory courses while continuing to provide regulatory guidance to her academic and industry peers. In her role at USC, she brings many years of practical regulatory knowledge and experience to academia. As the former (Executive) Vice President of Global Regulatory Affairs at Octagon Research Solutions, and a senior Consultant in Regulatory Affairs at Accenture, Dr. Smerkanich was responsible for advising sponsors on drug development, regulatory filing strategy and submissions. Prior to her joining Octagon/Accenture Dr. Smerkanich worked as an independent consultant and as a Regulatory Coordinator at Merck. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of drug development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas.
Dissertation: Benefits-Risks Frameworks: Implementation by Industry
Alexa Smith is Senior Manager, Quality and Regulatory Services – North America for Colorcon. Colorcon is a global supplier of advanced coating systems, modified release technologies and function excipients for pharmaceutical and dietary supplement industries. She has been with Colorcon since June, 1997. In addition to responsibility for Regulatory Services, she has most recently added to her role responsibility for the Quality Assurance and Quality Control organization at Colorcon’s largest site in North. Alexa is also active in IPEC’s Excipient Qualification Working Group and was the Chair of their sub-committees that developed the IPEC Excipient Information Package and Quality Agreement Template. She has participated as a member of the USP’s Compendial Process Improvement Project Team and the Joint Expert Panel on General Chapter <1197>, representing IPEC. Alexa also participates in CRN’s Regulatory Affairs Committee and participates in the SIDI Work Group. Alexa is a member of Regulatory Affairs Professional Society (RAPS) and served as President of the Philadelphia Chapter in 2005. She further holds a position as Adjunct Assistant Professor at Temple University and teaches courses in IND/NDA Submission, Regulation of Excipients and Regulation of Dietary Supplements. Alexa holds a M.S. in Quality Assurance and Regulatory Affairs from Temple University, a B.S. in Animal Sciences from Virginia Polytechnic Institute and State University and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.
Dissertation: Use of Natural Colors: Experience and Views in Pharmaceutical and Dietary Supplement Industries
Loren Wagner is the Sr. Director of Pharmaceutical Development Compliance at Allergan in Irvine, California. His responsibilities in this Research and Development role include quality assurance for all investigational materials used in Allergan clinical trials globally, the creation and approval of all CMC- related regulatory submissions for new and investigational products, and the development and transfer of manufacturing processes and analytical methods to commercial sites in support of new products. Prior to joining Allergan in 2006, he previously was employed with Baxter Healthcare and CancerVax, as well as working as an independent consultant. Loren earned his Bachelor’s degree from USC in Chemical Engineering, and recently completed a Master’s degree in Regulatory Sciences. He is a senior member of the American Society for Quality, and is certified as a Manager of Quality and Operational Excellence.
Lilit Aladadyan, MS, MPH is currently Center Director for the USC Tobacco Center of Regulatory Science (TCORS), a research center that generates scientific evidence to help inform FDA regulations on the manufacture, marketing and distribution of the diverse array of tobacco products. Prior to this, Lilit spent the previous 8 years as Director of Health Education for a community-based organization, where she developed and directed several community-wide and school-based health education programs in the areas of obesity, diabetes, asthma, and oral health. During the same time, Lilit earned her MS in Regulatory Science and is currently completing her doctorate in Regulatory Science at USC Mann. Lilit is passionate about reducing the burden of preventable diseases through effective public policy and regulations.
Dissertation: Implementation of Tobacco Regulatory Science Competencies in the Tobacco Centers of Regulatory Science (TCORS): Stakeholder Views.
Kobby Dankwah, DRSc, MS, RAC, CQE, CRE, CQA is currently Divisional Vice President, Regulatory Affairs for Abbott Diabetes Care. He received a degree in chemical engineering at the University of Science and Technology. In 1998, Kobby became the Regulatory Affairs Manager for Guidant Corporation, working on the development of a variety of devices including intravascular stents for the coronary, peripheral and cerebrovascular applications. In 2003, Kobby became the Director of Worldwide Regulatory Affairs at Abbott Vascular. Kobby helped to build a worldwide franchise through a combination of organic research, development and targeted acquisition. This experience brought him a wide breadth of knowledge of endovascular medicine and the many phases of drug development. Kobby was until March 2010, also responsible for Clinical Affairs, Statistics & Data Management and Scientific Affairs for Abbott Diabetes Care. Kobby received a Master of Science in Industrial Engineering from University of Texas, Arlington and Master of Regulatory Science in University of Southern California. He is currently a doctoral student of Regulatory Science at University of Southern California (USC).
Dissertation: Promotion of Regulated Products Using Social Media: An Industry View
Clare Elser, DRSc, MS, MBS is currently Principal Quality Product Leader for Genentech, Roche where she is responsible for management product quality lifecycle, product & process health, and quality supply of products brought to market and supplied globally. Prior to joining Genentech, Ms. Elser led Quality Systems & Compliance teams in respiratory and biologics franchises for combination products. She began her career as a research analyst in vaccines transitioning into the field of environmental health and safety during restructuring of the vaccine project. During this period of her career she held positions of increasing responsibility within the aerospace and semiconductor industries, EPA and DoD developing and implementing compliance and sustainability programs. Moving back into the pharmaceutical industry she lead global teams in the areas of supplier quality, investigations and audit for biologics, medical devices and aseptic processing product lifecycles. She also spent time in manufacturing operations overseeing quality systems & compliance, regulatory CMC, computer systems validation for API, organic synthesis, vaccines, and fermentation operations. Ms. Elser has successfully lead and managed regulatory inspections, PAIs, notified bodies and general GMP for drugs and device.
Ms. Elser holds a BS in Biochemistry from Cal State University, Long Beach, an MS in Environmental Studies from Cal State University, Fullerton, an MBA from Pepperdine University, and is finishing her doctoral dissertation in Regulatory Science from University of Southern California.
Dissertation: Validation Master Plans: Progress of Implementation within the Pharmaceutical Industry
David Locke, DRSc, MS is a Regulatory Affairs Associate at Johnson and Johnson, Ethicon Endo-Surgery where he is responsible for medical device submissions to the FDA and International Regulatory Agencies. He also manages International product registrations while providing support for New Product Development and Lifecycle products. In addition, Dave works closely with marketing partners in the review of relevant scientific literature and marketing materials. Before joining Johnson and Johnson, Dave spent nearly ten years with a contract research organization (CRO) working with transgenic research models, managing a surgical services department and participating in GLP regulated preclinical toxicology studies. Dave’s background also includes clinical experience in the area of vaccine surveillance and he has assisted in several thousand adult and pediatric surgical procedures.
Dave received his BS degree in Biology from Wright State University where he graduated Cum Laude. He received his MS degree in Bioscience Regulatory Affairs from Johns Hopkins University where he also received a graduate certificate in Biotechnology Enterprise. Dave is currently completing his Doctorate degree in Regulatory Science at the University of Southern California.
Reprocessing of Single-use Medical Devices: A Survey Investigation Comparing the Views of Three Unheard Stakeholders
Haven McCall, DRSc, MS, MBA. Haven is the Director of the Graduate Regulatory Affairs Certificate Program at Utah Valley University. He has over 14 years experience in the medical device industry working for multinational corporations, specializing in pre market and post market regulatory affairs, risk management and quality assurance. He also owns a consulting company that specializes in helping medical device companies in the areas of regulatory affairs and quality assurance. Haven has professional certifications in the areas of regulatory affairs, quality assurance and auditing. Academically, he holds a Doctorate and Master’s degree in regulatory science from the University of Southern California and a Master’s and Bachelors degree in Business Administrations from Northern Arizona University.
Risk Approaches and Standards Used in Hospitals: A Survey of Industry Views
Valerie Ramsey, DRSc, MS, RAC (US, EU, CAN, GS). Ms. Ramsey is Director of Global Regulatory Affairs at Fleet Laboratories in Lynchburg, Virginia. Her experience includes the areas of OTC drugs, cosmetics, dietary supplements, devices and prescription drugs in the United States as well as Europe, Latin America, Asia and Canada. She has worked extensively in the area of OTC drugs for more than ten years. She has been involved in many corporate global projects, facilitated global teams, and developed best regulatory practices. She has also developed global regulatory policies as well as educational and training programs. She holds a BS degree in Physics and a Doctorate of Regulatory Science.
The Impact of Incomplete Monographs on the OTC Drug Industry: A Survey Investigation of Industry Views
Chin-Wei Soo, DRSc. Global Regulatory Head, Combination Products, Devices, and Digital Health, Genentech, a member of the Roche Group
Chin-Wei Soo is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable to provide technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large (BLA) and small molecules (NDA) throughout the product lifecycle. Chin has built a global regulatory team and led the team to secure regulatory approvals for combination products globally.
Chin has 18 years of regulatory and quality experience, including strong expertise in combination products and digital health. Prior to joining Genentech, he was with Medtronic and Boston Scientific where he successfully led regulatory submissions and implemented quality management principles that resulted in approvals of IN.PACTTM drug-device coated balloon, TAXUSTM drug-device coated stent, and implantable, programmable drug infusion pumps.
Chin graduated from Iowa State University with a Bachelor degree in Industrial and Manufacturing Systems Engineering, a Master of Science in Bioscience regulatory affairs from the Johns Hopkins University, and a Doctorate in Regulatory Science from the University of Southern California School of Pharmacy.
Dissertation: Convergence of United States Regulatory and Reimbursement Policies Impacting Patient Access to Humanitarian Use Devices (HUD)
Neal Storm, DRSc, MS, MBA, RAC is currently a Director in the Global Regulatory Affairs organization at Amgen Inc. He has over 14 years of regulatory experience, advising on innovative and aligned global regulatory strategies supporting the development and life-cycle management of products in the oncology, nephrology and bone health therapeutic areas. As a Global Regulatory Leader, Neal brings experience in identifying regulatory risk mitigation and contingency plans, and in characterizing regulatory landscapes to optimize filing outcomes. He has a broad background in biopharmaceutical research and development and has held positions of increasing responsibility at Glycomed, Ligand, Genentech and Amgen, having made the career transition from basic research to regulatory affairs while at Amgen.
Neal holds a Doctorate in Regulatory Science from the school at the University of Southern California (USC). In his dissertation work, he studied “Regulatory Dissonance in the Global Development of Drug Therapies: A Case Study of Drug Development in Postmenopausal Osteoporosis.” Neal has also earned a Masters in Regulatory Science (USC), a Masters in Business Administration from Pepperdine University’s Graziadio School of Business, and undergraduate degrees in Molecular and Cell Biology (Genetics) and in German Studies from the University of California at Berkeley. Neal has also received Regulatory Affairs Certification from RAPS.
Dissertation: Regulatory Dissonance in the Global Development of Drug Therapies: A Case Study of Drug Development in Postmenopausal Osteoporosis
Simone E. Turnbull, DRSc, MS is currently a Senior Manager of Regulatory Affairs at Chattem, Inc., the U.S. consumer healthcare division of Sanofi. Chattem manages the Allegra® and Nasacort® brands, and is the platform for Sanofi Rx to OTC switches in the United States. In her role, Simone manages the regulatory activities for all of the personal care brands at Chattem including Gold Bond®, Cortizone 10®, Selsun Blue®, ACT®, Benzodent®, Herpecin L®, Sun-In® and UltraSwim®. This includes reviewing and approving labeling, advertising and promotional materials for new and existing products, providing network claim support, and regulatory due diligence activities.
Prior to joining Chattem, Simone worked as a Regulatory Affairs Associate II at Obagi Medical Products, Inc, a highly regarded, physician-dispensed skincare brand. Before joining Obagi, Simone worked as a Regulatory Analyst in the Technical Regulatory Affairs Department at Nutrilite, the global nutrition division of Amway. Simone also worked at Murad, Inc., a renowned direct to consumer seller of skincare and dietary supplement products, as their Regulatory Affairs Manager.
Simone possesses both a master’s degree and a doctorate in Regulatory Science from the University of Southern California, and a BA in Foreign Language Combination of Spanish and French from the University of Central Florida. Simone is originally from the beautiful country of Trinidad and Tobago, and in her free time loves to travel and dance.
Dissertation: Regulating Cosmeceuticals in the United States: A Cosmetic Industry View
Susan Bain, DRSc, MS has a strong background in Regulatory Affairs, Quality Assurance, Compliance and Operations, with more than 25 years of management experience at leading pharmaceutical, biotech and medical device firms, as well as at the FDA. Her corporate experience includes serving as a Vice President in charge of Quality/Regulatory Assurance and Operations at the Huntington Beach-based SpineWorks LLC, a medical device company which focuses on implant design and development, assisting people with complex spine conditions. Prior to that, she was the Manager of Regulatory Affairs and then the Manager of Corporate Quality Assurance at Watson Pharmaceuticals in Corona, CA. Her responsibilities included initiating and coordinating product recalls, ensuring product destruction met FDA guidelines and regulations, post-approval drug manufacturing changes and reporting, and reviewing and submitting labeling per FDA guidelines, among other duties. She also held management positions in Quality Assurance and Control and/or Regulatory Affairs at Techniclone Corporation (Peregrine Pharmaceuticals), Baxter Health Care Corporation and Alpha Therapeutic Corporation (Grifols) in Los Angeles. As a FDA Consumer Safety Officer based in Irvine, she investigated complaints against FDA-regulated products, conducted audit recall checks and monitored compliance to injunctions and seizures. In addition, as a certified medical device investigator, she inspected various pharmaceutical, medical device, IVD and veterinary medicine firms for compliance to all regulations for product licensure and cGMP compliance.
Currently, Dr. Bain is a Professor of Practice at Keck Graduate Institute of Applied Life Sciences (KGI) in Claremont, CA., Clinical, Regulatory and Quality; and Program Director, MBS in Clinical and Regulatory Affairs. Additionally, she’s started a Quality/Regulatory consulting firm, InCompliance Solutions.
She received a Doctorate of Regulatory Science (DRSc), a Master of Science (MSc) in Regulatory Science from the University of Southern California (USC) and a Bachelor of Science in Biology from Cal Poly, Pomona. She holds a graduate certificate in Effective Supervision from Cal Poly Pomona and is a member of the Orange County Regulatory Association and the Regulatory Affairs Professional Society (RAPS).
Dissertation: “Regulatory” Due Diligence: A Survey Investigation of Best Practices in the Medical Products Industry
Tony C. Chan, DRSc, MBA, MSQA, received his DRSc in 2012. He has seven ASQ Certifications. He is a Medical Device Staff Fellow at the Office of the Center Director, CDRH, FDA. His work includes the creation of case studies of a National Medical Device Curriculum, 510(k) modifications, safety cases, and case for quality. His expertise encompasses the research, development, training, and implementation of risk, quality and compliance management systems, system approach to total life cycle risk management, hazard analysis and critical control point programs, and unified enterprise risk management. His professional activities included:
* Advisor to the Global Harmonization Task Force, U.S. Co-Chair for the ISO/TC210, JWG1 – Risk Management, Advisor to FDA CDRH Medical Device HACCP Program, Senior advisor to Asian Harmonization Working Party, Expert Member of the IEC TC56
*Founder and trainer of the Orange County Regulatory Affairs’ Risk Management Foru
* Trainer on Risk Management to the Association for the Advancement of Medical Instrumentation, Advanced Medical Technology Association, Beijing Hua Guang Certification of Medical Devices Co. Ltd., Hong Kong Productivity Council, Taiwan Industrial Technology Research Institute, Taiwan Parenteral Drug Association, and Enhealth Sdn Bhd., Malaysia.
* Former Quality Development Advisor at a Fortune 500 Company responsible for setting up Quality Risk Management Systems; recognized by the U.S. FDA CDRH as industry standard
Dissertation: “Implementation of Risk Management in Medical Device Companies: A Survey Analysis of Current Practices”
Michael Jamieson, DRSc joined the faculty of the University of Southern California (USC) School of Pharmacy in 2008 after spending twenty five years in the pharmaceutical, biologics and medical device industry. He has been teaching in the Regulatory Science Program at USC since its inception in 2000, first as a guest lecturer from 2000 to 2007 and then as the Associate Director of the Regulatory Sciences Programs from 2008-2010. He is currently the Associate Director of the International Center for Regulatory Sciences and an Assistant Professor in the Titus Family Department of Clinical Pharmacy and Pharmaceutical Economics and Policy.
Dr. Jamieson received his Master’s from the University of Southern California in 2008 and was in the first graduating class of the Doctorate of Regulatory Sciences in 2011. Dr. Jamieson’s research interests include the regulatory/translational support of university based researchers and the development of a new model for conducting joint research projects between industry/not for profits and universities. The title of his doctoral dissertation was “The Role of Universities in the Development of Medical Products: A Survey of Industry Views” which looked at what the medical products industry in the US industry sees as the impediments to working with universities on joint research projects and the development of new products and how best to improve the current model.
Dr. Jamieson is also the Co-Founder/ Director of Clinical and Regulatory Affairs for Artenga Inc., a university spin off that has developed a drug delivery system which improves the efficacy of chemotherapy drugs and provides a platform to deliver larger sized molecules across the blood brain barrier.
Dissertation: “The Role of Universities in the Commercialization of Medical Products: A Survey of Industry Views
Duane Mauzey, MS, D-ABC, DRSc, RAC began his career in the 1970’s as a criminalist (CSI) with the California Department of Justice Bureau of Forensic Services, where he helped to put five murderers in prison for life without parole. He left the crime lab in 1985 and worked in sales as a representative for several major laboratory instrument manufacturers, including Perkin-Elmer and Waters. From there, Duane accepted a position as a scientist in a new R&D facility at McGaw, now B. Braun, where he specialized in training, analytical instrument qualification, software validation, and generic nasal spray product development. Duane migrated to Allergan in 2001, moving into Pharmaceutical Analysis where he performed a large variety of tasks associated with the chemistry and controls of drug substances and products. He retired from Allergan in the Spring of 2015 after eight years as the manager of CMC Scientific Affairs for Allergan, where he was responsible for managing the assembly, review, and QC of the Quality/CMC sections for global regulatory submissions. Duane is currently the Senior Manager for Regulatory Affairs CMC for Puma Biotechnology in Los Angeles. He provides global regulatory submission support to CMC for anti-cancer drugs in development at Puma. Duane is also President of DLM Pharmaceutical Consulting Services, Inc. (DLM Pharma CSI), a company he formed in May of 2015 to provide regulatory CMC submission support to the pharmaceutical industry in drugs, biologics, and combination products.
Duane has received an M.S. degree in Criminalistics from California State University, Los Angeles, where his thesis was entitled, “The Detection and Identification of Controlled Substances. Since joining Allergan, Duane has earned an M.S. degree in Regulatory Science from the school at the University of Southern California. In 2012, Duane completed his doctorate in Regulatory Science at USC, he now holds the degree of DRSc, Doctor of Regulatory Science. He has continued his involvement with USC by serving as an instructor in the MPTX 526 CMC class in the Regulatory Affairs Program in the school, as well as other classes at USC. Duane has passed the exam for Regulatory Affairs Certification (US) from RAPS, of which he is a member. In 2007, Duane passed the certification exam in criminalistics and is now a Diplomate of the American Board of Criminalistics. He continues his participation in the field of criminalistics as a member of the California Association of Criminalists where he lectures on the subject of Quality, and as a Fellow of the American Academy of Forensic Sciences. To the best of his knowledge, Duane is the only individual on this planet who has a dual certification in regulatory affairs and criminalistics, which explains his professional interest in pharmaceutical forensics – the study of counterfeit drugs. firstname.lastname@example.org
Dissertation: “Current Practices in Pharmaceutical Container Closure Development”
JoAnn Pfeiffer, DRSc completed her Doctorate of Regulatory Science at USC in 2013. In addition she holds Masters’ Degrees in Regulatory Science and Public Health. Dr. Pfeiffer’s expertise includes clinical trial operations, site audits, regulatory compliance, IRB submissions and reporting, global product registration, product labeling and packaging, software development and lifecycle, performance management and leadership, contract and budget review and negotiation, and staff training. She conducted the first systematic evaluation and analysis of the U.S. investigator’s relationship to the clinical trial agreements to provide a better understanding of the current practices of investigators in with clinical trial agreements and is currently doing workshop & presentations of those finding. She holds certificates in regulatory affairs and clinical research.
Dissertation: “Current Practices of U.S. Investigators in the Management of the Clinical Trial Agreement: A Survey of Knowledge, Attitudes, Perceptions, and Engagement.”