Renee Ambrosio is a Director in the office of Promotion and Advertising Review, Regulatory Affairs at Merck & Co., Inc. She leads a team of promotional regulatory reviewers for the oncology franchise. Renee has over twenty-seven years of experience across the healthcare spectrum; including 19 years in the pharmaceutical industry, with an emphasis in regulatory requirements and strategies, labeling, overlapping product launches for indications under accelerated approval (sub part E), as well as market development and strategies, advisory boards, sales, speaker management, and promotional resource development. Therapeutic areas include oncology, cardiology, diabetes, pediatric vaccines, respiratory, insomnia and arthritis & analgesia. Renee has a BA from Hunter College, NYC.
Jason Benagh manages the document lifecycle for promotional materials at Alkermes in Waltham, MA. This includes PRC coordination, editorial, and distribution of promotional materials for all commercial brands.
Mr. Benagh has been in marketing operations for over 15 years and has been leading companies in developing solutions that track and measure high volume initiatives. Most of his career has been in regulated environments – the last seven years in pharmaceuticals. He spent five years as an air traffic controller in the US Army and understands the need to prioritize and uses these skills to provide direction through the PRC process.
Mr. Benagh earned a Bachelor of Science degree from Embry-Riddle Aeronautical University and an MBA from Rochester Institute of Technology.
Christi joined Sanofi in 2006 and has held several roles increasing in responsibility during her time with the company. She has been responsible for the U.S. Advertising and Promotion process since 2009. Currently, she is part of the Promotional Excellence & Standards group in Global Regulatory Affairs, as the U.S. Country Lead responsible for overseeing and managing activities associated with the U.S. Commercial Materials Review Process. Along with being the subject matter expert in the US, as part of her role, she is working to harmonize processes across all threeSanofi business entities.
In her current role as Executive Director and Head of Strategic Services for Framework Solutions, Rebecca Burnett has more than 17 years of biopharmaceutical industry experience. She was most recently the Head of North America Marketing Operations for Mylan where she was responsible for leading her team in the support of five business units and more than 1,400 products.
Ms. Burnett began her career as a clinical research associate and held numerous roles in clinical research and medical affairs before finding her true passion in advertising and promotional review management in 2008. Since that time she has worked with and led teams across a spectrum of biopharmaceutical companies. Her teams have won industry awards for excellence in implementing technology solutions to drive process review efficiency and optimization. Her expertise is in diagnosing and providing recommendations to promotional review teams to ensure compliant and efficient review processes.
Ms. Burnett received her undergraduate and masters degree from the University of Colorado and has an MBA from George Washington.
Rebecca Burns, Pharm.D., Ph.D. is the Medical Affairs Manager at Arbor Pharmaceuticals LLC, a specialty pharmaceutical company headquartered in Atlanta, GA with products in the cardiovascular, neurology, hospital and pediatric markets. She enjoys handling multiple roles in Medical Affairs including acting as the medical reviewer on the Promotional Review Committee (PRC). As part of PRC, she has been involved in company and product acquisitions and multiple new product launches.
Nan Clarke has been with AbbVie (Abbott) for seven years building on prior pharma and healthcare experience with Pfizer, Pharmacia, Searle and LifeSource. Nan is currently focused on helping AbbVie increase agility and compliance related to the material review process and associated CAPA. Nan’s academic foundation includes a BFA in Stage and Theatre Management from University of Illinois and an MBA from University of Chicago. Her eclectic career spans touring theatre management, system transitions, business analysis and diverse project leadership. Nan thrives on connecting the dots between people, initiatives and systems to improve quality and streamline operations for the organizations she serves.
Steven N. Gersten is General Counsel of Dynavax Technologies. He is an accomplished legal executive with over 20 years of pharmaceutical industry experience, including advising business leaders on the promotion of drug products. Prior to joining Dynavax, he served as VP and Ethics and Compliance Officer at AbbVie, where he helped develop the pre- and post-approval communication strategy for new drug products. From 2002 to 2013, he was employed by Abbott, where he served as global VP and Chief Regulatory and Compliance Counsel, and global VP and Chief Counsel to several business units. While at Abbott, he was the primary regulatory counsel for key drug products and served on the promotional review committee. Prior to joining Abbott, Mr. Gersten worked at the U.S. DOJ, where he brought civil and criminal enforcement cases on behalf of the FDA.
I am a Program Review Operations (PRO) Manager at Genentech. I have been in this role for two years. Prior to my time in PRO I was in our Commercial Regulatory department working closely with the Program Review Committee (PRC) from a Regulatory perspective. I have worked with many different teams that go through PRC, and have gotten the opportunity to view PRC from different lenses through an operational standpoint. Every team that goes through the PRC process has their own special dynamic, size, and function and I have l learned so much from working with each. I continue to look forward to learning more as we implement processes at Genentech.
Kelcey Heman is the former Sr. Marketing Specialist at Sunovion Pharmaceuticals. At Sunovion she lead PMRC for the organization’s largest franchise, including cross-functional collaboration with all stakeholders, material forecasting and analysis, enforcement of submission process and guidelines, and strategic process enhancement. Kelcey also managed Veeva Vault PromoMats, including platform and license supervision, workflow development and maintenance, and platform optimization. Finally, Kelcey regularly reported PMRC metrics for all of Sunovion’s products to leadership in order to identify process concerns and provide high value stakeholder driven solutions to business needs. During Kelcey’s tenure at Sunovion, she managed the implementation of electronic 2253 submission process across the organization, as well as a product launch and label update.
Nancy Knickerbocker has over 19 years of Medical Device and Pharmaceutical industry experience combined, before which she gained experience in blood banking, veterinary diagnostics, clinical laboratory management and sales. She has 6 years of experience in regulatory review of advertising and promotion in medical devices with Abbott. At AbbVie, she has led regulatory review of advertising and promotion for several pharmaceutical products and successfully contributed to the launch of a new drug. In her current position, she manages a group that reviews advertising and promotion for approximately 20 products. She received her bachelor’s degree in Microbiology from DePauw University and is RAC certified.
Jeremy Lutsky has more than two decades of deep experience advising major pharmaceutical, biotech and medical device companies on a wide range of legal and regulatory matters, including FDA compliance, promotional review, regulatory guidance, M&A/transactions, advertising and sponsorships. Working in-house for ten-plus years at prominent life sciences companies, Jeremy has an intimate understanding of the needs, challenges and inner workings of the pharmaceutical and medical device industries. His first-hand knowledge equips him to understand complex issues and develop effective solutions that are compliant with relevant laws, regulations and internal policies while driving toward business goals.
Rob Masi is an Associate Program Review Operations Manager (MLR Operations) at Genentech. In this role, he supports the Ocrevus, Erivedge, Zelboraf, and Colletic brands. As a PRO manager, he helps ensure submission readiness, provides live annotations, performs all new marketer, reviewer, and agency training, and helps prioritize workload through the MLR committee. He has a passion for agency training and interactions and is involved in an internal workstream to bring low to medium complexity marketing work to a streamlined production house submission process. Prior to the MRL Operations role, Rob was a Clinical Regulatory Program Manager and also worked with the Commercial Regulatory group at Genentech. He has his BS in Neuroscience from Boston College.
Cristina is currently leading the Methods and Capability team for HEOR and Market Access at Pfizer. Cristina has extensive experience in HEOR and RWD generation and communication in Pharma (Pfizer and GSK).
Before joining the pharmaceutical industry in 2011 at GSK, Cristina was a lecturer at the London School of Economics. She led various health policy initiatives with the European Commission and OECD. Cristina holds a PhD in economics, an MSc in economics, and an MSc in Health Economics.
Nneka C. Onwudiwe, Ph.D., Pharm.D., MBA, received her doctorate in Pharmacy (Pharm.D.) from the University of Maryland School of Pharmacy, Ph.D. in Health Services Research with a specialization in Pharmacoeconomics from the University of Maryland School of Pharmacy, and an MBA (Honors) from the University of Baltimore. In addition, she received an honor of Rho Chi in Pharmacy in 2002 and an honor of Beta Gamma Sigma in Business Administration in 2012.
Dr. Onwudiwe is a Patient-reported outcomes (PRO) and Pharmacoeconomics (PE) Regulatory Review Officer at the Food and Drug Administration (FDA). Dr. Onwudiwe is the technical expert and point of contact in the review of PRO, PE, and other types of claims in prescription drug promotion for the Division of Advertising and Promotion Review II (DAPR II) within the Office of Prescription Drug Promotion.
Dr. Onwudiwe teaches Comparative Effectiveness Research (CER) & Pharmacoeconomics at the University of Maryland School of Pharmacy. Dr. Onwudiwe has received several awards and accolades over the years. She has received funding as a Principal Investigator from NIH/NHLBI. Dr. Onwudiwe currently serves on the Food and Drug Law Institute’s (FDLI) Publications Peer Review Committee as well as a member of the ISPOR Value Assessment Frameworks Stakeholder Advisory Panel.
Dr. Onwudiwe has served on several ISPOR Scientific and Health Policy Working Groups (Task Forces and Special Interest Groups) that have developed products and tools used by decision makers and researchers around the world. She is currently serving on the Value Assessment of Medical Device Special Interest Group and Statistical Methods in Health Economics and Outcomes Research Special Interest Group. In addition to this work, Dr. Onwudiwe has presented at various professional conferences and published in several peer-reviewed journals such as Value in Health Regional Issues, Spine, Journal of the American Medical Association (JAMA), Obesity, Oncologist, Cancer Medicine, and Ethnicity and Disease.
Dr. Onwudiwe holds a license in pharmacy and practices as a pharmacist in the community providing medication therapy management (MTM) and other services.
Bradford (Brad) Patrick is a Division Counsel with AbbVie Inc. in the company’s Chicago area global headquarters. He serves as legal counsel to integrated brand teams for various AbbVie pharmaceutical products that are on-market or preparing for regulatory approvals, and he focuses on compliance, coverage and reimbursement services, patient support programs, medical affairs, field sales, product labeling, and advertising and promotion. He also is lead counsel for the company’s Government Affairs team working on federal health care policy and reform issues. Brad has been with AbbVie since 2013 when it was spun off from Abbott, where he had worked since 2010. Before joining Abbott, he was Assistant General Counsel and Assistant Secretary for Invacare Corporation and began his legal career working for 8 years in a Cleveland law firm.
Bill Robinson is the Director of Commercial Content Strategy for Veeva Systems.
He has spent over 20 years in the advertising and promotion space, beginning his career developing go-to-market strategies for pre-launch and established brands. In the early 2000s, Bill transitioned to the client side. He served in various roles including global director of marketing operations at Shire, where he oversaw the review, approval, and lifecycle management of promotional materials. Most recently, as a director of regulatory affairs at Teva, he was responsible for managing the operational aspects of promotional review and approval as well as the regulatory review of content.
In his current role at Veeva, Bill is responsible for the strategic direction of the Veeva Vault PromoMats product.
Bill has a BS in Communications from Millersville University and an MBA from Holy Family University.
Michael is a FDA attorney and business counselor with a focus on advertising and promotion issues for pharmaceutical and biotechnology companies. He is currently Senior Counsel at PDL BioPharma where he supports commercial initiatives of subsidiary companies, Noden Pharma and Lensar, and business development. Michael previously held in-house positions with Mylan NV and Dendreon. He began his legal career with the FDA Drug and Biotechnology practice at Hogan Lovells in Washington, DC. Prior to his career as an attorney, Michael was a marketer with Procter & Gamble and Bristol-Myers Squibb. Michael earned Juris Doctor and Master of Public Health degrees from the University of Virginia and a Bachelor of Arts degree from the University of Notre Dame.
Keren Tenenbaum is an Assistant General Counsel at Pfizer’s Legal Division. Prior to joining Pfizer, Ms. Tenenbaum was an associate at DLA Piper’s litigation department in New York.