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Sheraton Pentagon City Hotel

Mar 12, 2024 7:30 AM - Mar 13, 2024 3:55 PM

900 South Orme Street, Arlington, VA 22204, USA

Advertising and Promotion Regulatory Affairs Conference

Explore the current state of compliance for marketing both biopharmaceuticals and medical devices.


Alyson  Andrikanich, PharmD

Alyson Andrikanich, PharmD

Senior Director, Advertising and Promotion, Regulatory Affairs Americas, Bayer Pharmaceuticals, United States

Alyson Andrikanich is a Senior Director in Regulatory Advertising and Promotion at Bayer Pharmaceuticals. She has over 14 years experience in the pharmaceutical industry, specializing in advertising and promotion in regulatory affairs. Alyson completed a post-doctoral industry fellowship program through Rutgers University and Bayer in Medical Communications/Medical Affairs.

Lynn  Bowen, PhD

Lynn Bowen, PhD

Vice President, Regulatory Affairs Advertising Promotion & Labeling, Alkermes, Inc., United States

Lynn Bowen, PhD is currently the Vice President, Regulatory Advertising Promotion & Labeling at Alkermes. Prior to joining Alkermes, she was the Senior Director and US Head of Regulatory Advertising & Promotion at Vertex Pharmaceuticals. Lynn has over 15 years of pharmaceutical industry experience including prior roles in both regulatory and medical affairs. Lynn received her BS in Biotechnology from Rochester Institute of Technology and her PhD in Microbiology from Boston University School of Medicine.

Bob  Dean, MBA

Bob Dean, MBA

Head of Global Labeling Strategy & Ad/Promo, EMD Serono, United States

Bob is currently the Vice President of Commercial Regulatory at Myovant Sciences. Prior to that, he was Director/Team Lead at Merck & Co., Inc. in the Office of Advertising and Promotion Review. Prior to joining Merck, Bob was the Director of the Division of Advertising and Promotional Review 2 in the Office of Prescription Drug Promotion (OPDP). During his 15 years at OPDP, he oversaw core functions within FDA including advisory and labeling reviews, as well as investigations and enforcement actions. He co-developed new FDA Policies, Regulations and Guidance documents and led the efforts of the educational outreach program (Bad Ad) to help engage stakeholders in the medical community.

Anthony  Genovese, PharmD

Anthony Genovese, PharmD

Group Leader, Regulatory Advertising and Promotion, Johnson and Johnson, United States

Anthony Genovese is the Group Leader, Regulatory Advertising and Promotion at Johnson and Johnson. Prior to joining Johnson & Johnson, he held roles at Bayer Healthcare Pharmaceuticals, most recently serving as the Director of Regulatory Affairs – Advertising and Promotion and Head of Regulatory Advertising and Promotion Operations. Anthony has over 15 years of pharmaceutical industry experience including roles in medical affairs, external scientific affairs, and regulatory strategy.

Nicol Lorraine George, PharmD, RPh

Nicol Lorraine George, PharmD, RPh

Vice President, Promotional Review & Labeling Services, ProPharma Group, United States

Nicol George, Pharm.D., R.Ph., is the Vice President, Promotional Review Services & Labeling at OneSource Regulatory (OSR) a ProPharma Group Company, where she manages the Regulatory & Medical Review staff, provides executive level consulting services including leadership mentoring,process improvements, electronic review system implementations & Advertising and Promotion Training. Before joining OSR, Nicol was at Baxter Healthcare where she held the position of Director, Global Regulatory Affairs Labeling, Advertising & Promotion & led an international team for 5 years (2012-2017). Nicol has been in the industry for over 20 years with pharma, biologic & device experience in Medical (Med Info & Medical Science Liaison) & Regulatory Affairs.

Catherine  Gray, PharmD

Catherine Gray, PharmD

Director, Office of Prescription Drug Promotion, OMP, CDER , FDA, United States

Catherine Gray leads the Office of Prescription Drug Promotion (OPDP) at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy and operational issues pertaining to the promotion of prescription drugs. She oversees policy development, social science research, regulatory counseling, compliance activities, labeling recommendations, stakeholder engagement, and operational support to the office as it realizes its mission to protect the public. Her over twenty years of experience include roles in clinical pharmacy and the pharmaceutical industry. Dr. Gray received a B.S. from the University of Notre Dame and a Doctor of Pharmacy from Campbell University and completed several fellowships.

Joanne  Hawana, JD, MS

Joanne Hawana, JD, MS

Member, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States

Joanne Hawana is a Member at the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, practicing in the Health Law/FDA Group and based in the firm’s Washington D.C. office. She counsels global clients on the business impact of new U.S. federal and state actions related to drugs, biologics, cellular therapies, foods, and medical devices. Her counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, both pre-market and post-market, and including enforcement matters. Joanne has a masters degree in molecular genetics from UMDNJ and a bachelors degree in biology from the College of William & Mary. She received her JD from the University of Maryland Francis King Cary School of Law in 2007.

Georgina  Lee, PharmD

Georgina Lee, PharmD

Executive Director, Regulatory Advertising and Promotion, Sage Therapeutics, United States

Georgina Lee is currently the Head of Regulatory Advertising and Promotion at Sage Therapeutics. She has over 10 years of experience in the industry specializing in advertising and promotion, labeling development, and MLR operations. She received her Pharm.D. from the University of Southern California and is the co-chair of the DIA Advertising and Promotion Committee this year.

Amy  Muhlberg, PhD

Amy Muhlberg, PhD

Deputy Director, OPDP’s Division of Promotion Policy, Research and Operations, FDA, United States

Amy Muhlberg is Deputy Director of the Division of Promotion Policy, Research, and Operations in the Office of Prescription Drug Promotion (OPDP). She joined OPDP in 2021 as a Staff Fellow leading the development of guidance documents, regulations, and citizen petition responses related to prescription drug promotion. She held a similar role in FDA’s Office of Policy for Pharmaceutical Quality, working on drug product quality and manufacturing issues across the product lifecycle. She has over two decades of FDA policy experience in trade associations, regulated industry, and on Capitol Hill. Amy earned her Ph.D. in Biochemistry from The Scripps Research Institute, and received her undergraduate degree from McGill University.

Moulakshi  Roychowdhury, JD, PharmD

Moulakshi Roychowdhury, JD, PharmD

Global Head, Regulatory Affairs, Advertising & Promotion, Allergan Aesthetics, AbbVie, United States

Moulakshi Roychowdhury, PharmD, JD is Global Head of Regulatory Advertising & Promotion at Allergan Aesthetics, an AbbVie Company and leads a team of professionals who advise the company on how to comply with regulations while being competitive & exceeding business goals. She is passionate about finding creative & compliant ways to communicate with customers to optimize their knowledge in making healthcare decisions and believes if intentions are ethical and in support of public health, compliant paths forward must exist. She is dedicated to growing and empowering the next generation of professionals. Moulakshi’s favorite saying is by Pablo Picasso: “Learn the rules like a pro, so you can break them like an artist.”

Dale  Cooke, JD, MA

Dale Cooke, JD, MA

President, PhillyCooke Consulting , United States

Dale Cooke is president of PhillyCooke Consulting, which helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Dale is the author of Effective Review & Approval of Digital Promotional Tactics, now in its second edition, which was published by the Food & Drug Law Institute.

Mark  Gaydos

Mark Gaydos

Global Head, Advertising & Promotion, Global Regulatory Affairs, Sanofi, United States

Mark is Vice President and Global Head of Advertising & Promotion within Sanofi's Global Regulatory Affairs organization, with responsibility spanning the General Medicine, Specialty Care, and Vaccine portfolios. In this role, Mark is accountable for regulatory leadership and strategy in developing competitive labeling, supporting impactful product promotion and maintaining strict regulatory compliance in the interest of promoting and protecting patient health. During 30 years in industry, Mark has held leadership roles across numerous therapeutic areas, including responsibility for regulatory strategies across the product lifecycle.

Micheline  Awad, MBA

Micheline Awad, MBA

Sr. Director, Regulatory Advertising, Promotion, and Labeling, Day One Biopharmaceuticals, United States

Micheline leads the Advertising & Promotion and Labeling functions at Day One Biopharmaceuticals. Her experience includes Regulatory Affairs Strategy, Advertising & Promotion, and Labeling for Biologics, Drugs, and Devices. Her expertise in product launches is driven by strategic planning, risk assessment, and maintaining regulatory compliance while fostering innovation and growth. She is passionate about collaborating with cross-functional partners to drive successful product launches while ensuring adherence to complex regulations and guidances. She received her MBA from University of Southern California with a focus on Strategy and Marketing, and her BS in Biology specializing in Biotechnology from George Mason University.

Representative Invited

Representative Invited

DIA, United States

Sorcha  McCrohan, MSc

Sorcha McCrohan, MSc

Specialist, Scientific Programs, DIA, United States

Sorcha McCrohan is a Specialist of Scientific Programs for the Americas Region at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics. Before joining DIA, she conducted COVID-19 research in Chiapas, Mexico, and worked in marketing within Pfizer's Global Vaccines Meningococcal franchise. Sorcha holds a BA in Sociology from Mount Holyoke College and an MSc in Global Health, Disease Prevention & Control from Georgetown University.

  Sponsored Sessions

Sponsored Sessions

, United States

Victoria  Gemme, MBA, MS

Victoria Gemme, MBA, MS

Policy Research Associate, Duke-Margolis Center For Health Policy, United States

Victoria Gemme is a research associate at the Duke-Margolis Center for Health Policy, where she works on a range of policy topics related to medical product development and regulation. Prior to Duke-Margolis, Victoria worked at the Cystic Fibrosis Foundation where she oversaw a diverse policy portfolio covering basic science research, drug development, antimicrobial resistance, and organ transplant among other topics. Victoria graduated from Vassar College with a Bachelor's degree in neuroscience, from Suffolk University with a Master’s in Ethics and Public Policy, and from Quantic School of Business and Technology with a Master’s in Business Administration.

Jason  Cober, MPA

Jason Cober, MPA

Lead Project Manager, OPDP | OMP | CDER | FDA, United States

Jason Cober is the Lead Project Manager in the FDA's Office of Prescription Drug Promotion. He leads OPDP's eCTD outreach efforts and has 15 years experience with the Agency's eCTD specification and guidance development process.

Zoe  Dunn

Zoe Dunn

President & CEO, Hale Advisors, Inc., United States

Zoe Dunn, President & CEO of Hale Advisors, is a digital marketing and communications specialist with 20+ years of experience in life sciences industries, driving results for clients’ business with multi-channel strategies. Zoe has worked with most of the top 25 Pharmaceutical and Biotech companies and regularly speaks at pharmaceutical and healthcare conferences about organizational readiness in multichannel marketing. Hale Advisors specializes in digital governance and competency solutions.

Nazeer  Ahmed, MS

Nazeer Ahmed, MS

Sr. Technical Program Manager (Data Science), Allergan, United States

Nazeer leads the AI product development at Allergan's Data Science and Engineering division, spearheading its evolution into a next-generation AI organization. Six of his 20 years in the tech industry was in all four AI types: rule-based, machine learning, deep learning, and gen AI. Notably, he launched Arabic as Amazon Alexa's 9th language and has applied similar AI (NLP) techniques in regulatory reviews at Allergan, with a publication forthcoming in RAPS journal in early 2024. Beyond Allergan, Nazeer serves on advisory panels for various organizations (non-profits and for-profits), guiding them in building their data infrastructure, unlocking millions in new revenue, and developing AI capabilities.

Kimberly  Belsky, MS

Kimberly Belsky, MS

Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States

Kimberly (Kim) Belsky is a regulatory professional with expertise in Regulatory Policy & Intelligence and AdPromo. With over 30 years of global experience in the medical product industry, including 20+ years in regulatory affairs, Kim's diverse experience including scale up and tech transfer, quality/compliance, advertising & promotion, labeling, and regulatory policy and intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim is the co-chair of the DIA AdPromo WG (part of the RegAffairs Community) and is an active member in RAPS. Kim is passionate about networking, learning, and collaboration.

Laura  Brett

Laura Brett

Vice President, National Advertising Division, BBB National Programs, United States

Laura Brett leads the National Advertising Division of BBB National Programs and its New York office. The National Advertising Division (NAD) is the centerpiece of the U.S. advertising industry’s system of self-regulation. In over 100 cases each year, the NAD reviews advertising and upholds advertising law standards that are set by the Federal Trade Commission (FTC). Laura speaks regularly on advertising law in the U.S. and internationally and has published articles and been interviewed on emerging issues in advertising law like the use of consumer reviews, influencer marketing, “green” claims, and dark patterns.

Rachel  Imam, MBA

Rachel Imam, MBA

Senior Regulatory Specialist, US WorldMeds, United States

Rachel Imam specializes in regulatory affairs for pre-approval and commercialized drug products. She manages product labeling from inception through NDA/BLA approval for drugs, biologics, combination products, and medical devices and has negotiated labeling for five major applications as well as numerous labeling supplements. She serves as the lead regulatory reviewer on the company’s Promotional Review Committee (PRC/MLR) and has facilitated several new product launches. Her advertising and promotional review experience is in the areas of hemophilia, oncology, recovery, and central nervous system disorders, among others, and she has unique experience with boxed warning products, combination products, and co-promotion of drug products.

Richard  Lem, PharmD

Richard Lem, PharmD

Director, International Regulatory Affairs Advertising and Promotion, Abbvie, United States

Richard Lem is the Director of International Regulatory Affairs Advertising and Promotion at Allergan Aesthetics, an AbbVie Company. In this role, he leads a team that provides regulatory guidance on ex-US commercial activities and advises country and area level review teams on compliant promotional activities. Prior to joining Allergan Aesthetics, an AbbVie Company, Richard was Head of Global Regulatory Affairs Advertising and Promotion at TG Therapeutics, where he implemented policies to support the company’s transition from a clinical stage to commercial organization and established the Global Regulatory Affairs Advertising and Promotion team to support compliant commercialization activities.

Amy  Toscano, PharmD, CPA, RPh, RAC

Amy Toscano, PharmD, CPA, RPh, RAC

Senior Director, Sumitomo Pharma America, Inc., United States

Amy Toscano, PharmD, RAC, is a Senior Director in Regulatory Advertising & Promotion at Sumitomo Pharma America, Inc. She has over nine years of experience in the pharmaceutical industry , specializing in advertising and promotion in regulatory affairs. Prior to working in the pharmaceutical industry, she worked for over ten years as a reviewer and a team leader at the FDA’s Office of Prescription Drug Promotion. Dr. Toscano completed a post-doctoral industry fellowship through Rutgers University and Bristol Myers Squibb Toscano in Medical Information. She holds a B.S. in accounting and a PharmD, both from Rutgers University.

Renee  Ambrosio

Renee Ambrosio

Executive Director, Office of Promotion and Advertising Review, Merck & Co., Inc., United States

Renee Ambrosio is the Executive Director and Department Head for U.S. Advertising and Promotion, Regulatory Affairs at Merck & Co., Inc. Renee oversees the regulatory review, approval, submission, and promotional regulatory strategy for all U.S. pharmaceuticals and biologic products. Renee has over thirty years of experience across the healthcare spectrum; including 25-years in the pharmaceutical industry, with an emphasis in complex regulatory strategies, overlapping product launches for indications under accelerated approval, as well as sales and marketing, she brings these valuable insights to the industry. Renee is also the current DIA Ad/Promo Working Group Co-Chairperson.

Audrey  Athlani Jorno, PharmD, MS

Audrey Athlani Jorno, PharmD, MS

Associate Director, Promotional Materials & Compliance, Pharmalex, France

Audrey Athlani Jorno is Doctor of Pharmacy with a Master Degree in Regulatory Affairs. She brings more than 10 years of experience in Promotional Materials and Healthcare compliance activities for wide range of products. Working in pharmaceutical and consulting companies provided her an extensive experience in the global evaluation of external communication spanning from corporate documents to the local affiliates’ adaptation. Audrey Athlani Jorno has gained experience as project manager and coordinator though many diverse international projects in Promotional materials and Healthcare compliance activities, from the strategy to the operational phases.

Heather  Banuelos, JD

Heather Banuelos, JD

Counsel, King & Spalding LLP, United States

Heather Bañuelos is Counsel in King & Spalding’s FDA & Life Sciences practice group. She advises clients on regulatory strategies and initiatives for the labeling, promotion, and advertising of FDA-regulated products, as well as non-promotional communications, with particular focus on prescription drugs. She routinely serves on promotional review committees and medical/scientific review committees, providing practical and insightful advice and recommendations. Heather has over 20 years of experience in food and drug law, including as a former Associate Chief Counsel in FDA’s Office of the Chief Counsel and as senior in-house regulatory counsel for Fortune 500 pharmaceutical companies.

Eugenia  Blackmon, JD, LLM

Eugenia Blackmon, JD, LLM

Executive Director of Legal and OEC (Office of Ethics and Compliance) EEDI Strat, AbbVie, United States

Attorney & community leader, Eugenia Blackmon, Esq. is a high-functioning professional that values relationships. Prior to joining AbbVie, Eugenia was General Counsel and Compliance Director for UniWorld Group Inc., head quartered in Brooklyn, New York. Before working in advertising law, Eugenia was a Corporate Mergers & Acquisitions Senior Associate for the national office of PriceWaterhouseCoopers in Washington, DC. Upon joining AbbVie, Eugenia expanded her expertise in Digital Marketing and led a digital transformation initiative for Allergan Aesthetics and Women’s Health. Now, Eugenia sits within AbbVie Legal & Compliance as Executive Director of EEDI Strategy.

Kathleen  David, BSN

Kathleen David, BSN

Division Director, Division of Promotion Policy, Research, and Operations, OPDP, FDA, United States

Kathleen (Katie) David is the Division Director for the Division of Promotion Policy, Research, and Operations in the Office of Prescription Drug Promotion (OPDP) at the Food and Drug Administration (FDA). Katie joined OPDP in 2012 as a Regulatory Review Officer and has also held the position of Team Leader and Deputy Supervisor for Policy, Research and Operations. Prior to joining FDA, Katie worked in the fields of corporate intelligence and oncology nursing. She has a B.A. in history from Washington University in St. Louis and a BSN from University of Maryland.

Adam  George, PharmD

Adam George, PharmD

President and Founder, ANG Regulatory Consulting, United States

Adam is the Founder of ANG Regulatory Consulting, LLC. He has 18 years experience in regulatory affairs and clinical development focused on oncology. He uses his experience working at FDA, and in industry, to assist clients in developing regulatory strategies for product development programs and prepare clients for interactions with regulators. Prior to ANG, he was the Vice President of Regulatory Affairs at PureTech Health and regulatory affairs therapeutic area head for oncology and respiratory at Teva Pharmaceuticals. At FDA, Adam was a clinical reviewer in the Division of Hematology Products and a senior reviewer in the Office of Prescription Drug Promotion. At OPDP Adam served as the subject matter expert in clinical trials.

Lynette  Hopkinson

Lynette Hopkinson

Principal, CoRA Consulting LLC, United States

Lyn Hopkinson is a Regulatory Affairs executive with twenty-five years of experience in the pharmaceutical/biotech industry leading global teams previously as Sr Vice President, Regulatory and Quality, Imara; Vice President, Global Regulatory Strategy Cystic Fibrosis and Commercial Regulatory Affairs, Vertex Pharmaceuticals; Sr Director, Commercial Regulatory Affairs, Eisai. As Principal of CoRA Consulting LLC, Lyn leverages her significant experience in Regulatory Advertising and Promotion, Labeling and Clinical Strategy (early and late-stage development, regulatory submission and approval, launch and life-cycle management) to guide and support a broad range of clients across the pharmaceutical and biotechnology industry.

Jia-Huey  Huey, PharmD, RPh

Jia-Huey Huey, PharmD, RPh

Group Leader, Regulatory Advertising and Promotion, Johnson & Johnson Office of Health Care Compliance & Privacy, United States

Jia-Huey Huey is Group Leader of Regulatory Advertising and Promotion, within Health Care Compliance organization at Johnson & Johnson with responsibility for providing regulatory and compliance advice to the commercial, medical, research and development teams on a wide-range of matters. Jia currently manages a team and have overall responsibility for setting strategic direction and developing and managing a robust regulatory compliance program. Jia is a licensed New Jersey pharmacist with both a Doctor of Pharmacy and a BS in Pharmacy from the Ernest Mario School of Pharmacy at Rutgers University. She is a Certified Compliance and Ethics Professional and holds the Seton Hall Law School Health Care Compliance Certification.

Alan G. Minsk, JD

Alan G. Minsk, JD

Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP, United States

Alan G. Minsk is a partner in the Food and Drug and Government and Regulatory Practices. Mr. Minsk was recognized in Chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and was selected for inclusion in the International Who’s Who of Life Sciences Lawyers 2013-2018. Mr. Minsk focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic and food companies, on all legal and regulatory matters relating to the U.S. Food and Drug Administration (FDA).

Denise  Sanchez, JD, MA, MS

Denise Sanchez, JD, MA, MS

Principal Consultant, Opus Regulatory Inc., United States

Denise has worked in the regulatory space for close to 20 years with combined industry, government and law firm experience. Industry roles include Regulatory overview of commercial promotion and practices at Allergan Aesthetics, Ironwood, Celgene, & Cubist. At the law firm Hughes, Hubbard, and Reed, Denise worked on drug off-label promotion & product liability litigation. Denise’s federal government tenure focused in the public health service, as Regulatory Counsel for CDRH and CBER, FDA and congressional policy at the National Cancer Institute, NIH. Denise completed undergraduate & public health graduate study at Columbia University, biomedical sciences graduate work at Rutgers, & law study at Georgetown University Law Center.

Shelby  Buettner, JD

Shelby Buettner, JD

Assistant General Counsel and Compliance Officer, Becton Dickinson (BD), United States

Shelby has advised pharmaceutical and medical device manufacturers, healthcare and technology companies, hospitals, and healthcare providers on a variety of regulatory and compliance matters. Shelby previously served as Principal Legal Counsel, Enterprise Legal Regulatory and Acting Lead Counsel, Mechanical Circulatory Support Operating Unit at Medtronic; Associate Chief Counsel at the Food and Drug Administration; and before that, was in private practice. Shelby also has experience coordinating clinical research at an academic medical center and managing biomedical projects funded by the Department of Defense and the National Aeronautics and Space Administration.

Kellie B. Combs, JD

Kellie B. Combs, JD

Partner, Ropes & Gray LLP, United States

Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She serves as co-counsel to the Medical Information Working Group, represented Pacira in its litigation against FDA, and has extensive experience handling matters implicating FDA promotional rules and the First Amendment.

Janet  Gottlieb, PhD

Janet Gottlieb, PhD

Head of Medical Review Solutions, Canopy Life Sciences, United States

Dr. Janet Gottlieb’s experience in research, diagnostics, medical devices, and pharmaceuticals in a career spanning over two decades provides critical insight into medical review. She is adept in the formation, expansion, and training of centralized Medical Promotional Review teams, resulting in greater efficiencies via improved turnaround times, consistency in guidance, enhanced communication, and successful commercial launches. She is a recognized subject matter expert in the field, presenting as an invited speaker at multiple industry conferences. Dr. Gottlieb holds an undergraduate degree in Biological Sciences and Ph.D. in Medical Microbiology and Molecular Virology from the University of California, Irvine.

Kristen  Heinlein, PharmD

Kristen Heinlein, PharmD

VP, US Advertising and Promotion Regulatory, Takeda, United States

Kristen Heinlein has almost 20 years’ experience in pharmaceutical industry, having spent the past 12 years in various leadership roles in Advertising & Promotion Regulatory. She is currently Vice President, U.S. Advertising & Promotion Regulatory, supporting the U.S. Business Unit portfolio at Takeda. Prior to joining the Regulatory team, Kristen held various positions of increasing responsibility in Medical Communications at Shire, which also included an international assignment. Preceding her time in industry, Kristen was a Clinical/Staff Pharmacist at Peninsula Regional Medical Center in Salisbury, MD.

Kristine T. Khuc, PharmD

Kristine T. Khuc, PharmD

Consumer Safety Officer, CBER, FDA, United States

Kristine T. Khuc has been with the FDA, Center for Biologics Evaluation and Research (CBER) since 2011, where she is a Consumer Safety Officer in the Office of Compliance and Biologics Quality (OCBQ), Advertising and Promotional Labeling Branch (APLB). In her current position, she has experience in reviewing and evaluating advertising and promotional labeling. She came from the Center for Drug Evaluation and Research (CDER) in the Division of Advisory Committee and Consultant Management. She received a Doctor of Pharmacy degree from Howard University and completed a drug information residency program at Washington Hospital Center. Prior to FDA, she practiced as a pharmacist at the Fairfax Health Center and at the Andrew Rader Health Clinic.

Shakshi  Kshatriya

Shakshi Kshatriya

Associate Director, Advertising and Promotion, Abbvie, United States

I am an Associate Director at AbbVie, a global biopharmaceutical company, where I lead the US advertising and promotion, digital and corporate communications compliance for the company's products and services. With over eight years of experience in regulatory affairs and compliance management, I have a deep understanding of the complex and dynamic regulatory environment in the pharmaceutical industry, and the ability to ensure alignment between business objectives and regulatory requirements.

Anne K. Walsh, JD

Anne K. Walsh, JD

Director, Hyman, Phelps & McNamara, PC, United States

With more than 27 years of experience in private practice and government, Ms. Walsh helps pharmaceutical and medical device companies comply with, and defend against, FDA regulation. She regularly counsels clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls. She has specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and has investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General.

M. Jason  Brooke, JD, MS

M. Jason Brooke, JD, MS

Attorney & Managing Member, Brooke & Associates, United States

M. Jason Brooke, MSE, JD, CSQE is an attorney and the Managing Member at Brooke & Associates—a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant, bringing a focused expertise in the medical device industry that combines 20 years of experience ranging from science and technology development to business strategy and operations to legal and regulatory compliance.

Dara S. Katcher Levy, JD

Dara S. Katcher Levy, JD

Director, Hyman Phelps & McNamara P.C., United States

Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective disease awareness initiatives. At launch and in the post-marketing stage, Dara works closely with corporate communications and marketing to help achieve their goals. Dara serves as the legal reviewer on promotional review committees and conducts company training programs.

Deborah  Wolf, JD

Deborah Wolf, JD

Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States

Deborah Wolf has been a regulatory counsel in CDRH since 1995, focusing primarily on issues related to labeling and advertising. She advises staff in many parts of CDRH on a broad range of device-related policy and regulatory issues and engages with the other medical product centers on Agency policy discussions and document development.

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