Major Statement, Major Impact: FDA’s Rule Refinement for DTC Advertising
Authored by Bahar Ameri, Jessica Tsalikis, Jagpreet Kaur Maker, Kevin Pickering, Kaitlyn Delano, Jen Wild, Tim Balvers, Julie Turnbull
Authors
Bahar Ameri
Managing Medical Editor, Science + Regulatory
Bahar Ameri, Managing Medical Editor, Klick Health, has years of experience and expertise in FDA marketing guidelines plus a rich history in pharmacy. With three years of experience in the pharmaceutical marketing and regulatory fields, Bahar has successfully helmed over 15 website launches in the current year alone, alongside managing a multitude of diverse and high-profile projects. Her training as a pharmacist and innate leadership qualities have been pivotal in driving complex initiatives to fruition. Admired for her project management acumen, Bahar upholds a standard of excellence in every endeavor, cementing a reputation for effective cross-disciplinary coordination and meticulous attention to detail within the ever-evolving landscape of healthcare marketing. Bahar’s relentless pursuit of process innovation to enhance efficiency and cost-effectiveness ensures that her team not only meets but exceeds the challenging demands of the industry without compromising on quality.
Jessica Tsalikis
Director, Science + Regulatory
Jessica is currently Director, Science + Regulatory, at Klick Health, and is responsible for ensuring regulatory compliance and scientific accuracy within a wide range of digital and print promotional assets. Before joining Klick, Jessica received a PhD from the University of Toronto in laboratory medicine and molecular biology, and completed a postdoctoral fellowship while collaborating with pharmaceutical partners and leading research into novel therapies. She has published nine peer-reviewed papers and presented at various national and international scientific conferences. With over five years of experience in promotional advertising and regulatory compliance, Jessica has been involved in branded and unbranded campaigns in various therapeutic areas including cystic fibrosis, diabetes, depression, psoriatic arthritis, and sleep disorders. Jessica has experience with new product launches and is passionate about working with MLR and client teams to streamline processes and drive efficiencies.
Jagpreet Kaur Maker
Medical Editor, Science + Regulatory
Jagpreet, currently excelling as Medical Editor, Klick Health, since June 2021, has gained extensive editing experience over the last five years. With a master’s degree in science communication from Laurentian University and a background in industrial biotechnology, she has demonstrated her commitment to effective communication. At Klick Health, her role encompasses editing and fact checking regulatory submissions, emphasizing precision in clinical- and patient-focused content. She actively engages in regulatory review meetings and client calls, and she also maintains style guides. Jagpreet’s diverse editing background, coupled with her educational facility, positions her as a valuable asset, ensuring impactful communication at Klick Health.
Kevin Pickering
Vice President, Science + Regulatory
Kevin Pickering has nearly two decades of healthcare advertising experience with a specialized focus in promotional compliance. His tenure in the industry is marked by consistent collaboration with both U.S. and global MLR teams, ensuring that promotional materials meet exacting standards of accuracy and compliance. Well-informed on FDA-enforcement trends and guidelines, Kevin’s role expands beyond oversight—he actively aids in shaping strategies for promotional submissions, especially for launch products. Before his current venture with Klick, Kevin made significant strides as the Director of Regulatory Review for a worldwide healthcare communications group. In this capacity, he managed the submission of promotional materials across varied platforms and played a key role in several high-profile projects. Beyond this, Kevin’s diverse experience includes over five years as a writer and content strategist, where he crafted and steered notable marketing campaigns in various therapeutic areas, including autoimmune diseases, oncology, and infectious diseases. When called upon, Kevin’s depth of experience becomes a crucial asset, enabling him to assist in fine-tuning content that resonates with audiences while meticulously adhering to regulatory standards.
Kaitlyn Delano
Director, Science + Regulatory
With a PhD in pharmacology from the University of Toronto, Kaitlyn Delano brings her expertise to the forefront as Director, Science + Regulatory, at Klick Health. Her contributions are extensive, spanning more than eight years, delivering significant impact in therapeutic areas such as oncology, rare diseases, and respiratory health. She has also won a Cannes Lion – Gold for The Congregation in 2023. Kaitlyn has extensive experience in bringing new therapeutic products to market and demonstrates a thorough understanding of launch dynamics alongside a proactive stance on regulatory guidelines. She works closely with MLR teams, ensuring the integration of compliance standards and efficient submission processes; she also plays a key role in optimizing and establishing MLR approval processes. Kaitlyn leads a team of medical editors and managers, driving the creation of engaging and compliant healthcare communication materials that serve the needs of healthcare professionals and patients alike.
Jen Wild
Director, Science + Regulatory
With over 5 years of experience in promotional advertising across diverse therapeutic categories, including oncology, neurology, and men’s and women's health, Jen currently serves as Director, Science + Regulatory, at Klick Health. In this capacity, she leads a dedicated team of medical editors and regulatory experts, overseeing multiple client portfolios throughout the entire campaign lifecycle—from concept to launch and beyond—for vaccines, pharmaceuticals, and medical devices. Jen excels in cultivating robust relationships with MLR teams, collaborating seamlessly to optimize submission strategies to ensure compliance and efficiency. Leveraging her extensive regulatory and agency experience, she is dedicated to elevating life sciences promotion, aiming for award-winning, impactful campaigns that optimize patient outcomes and contribute to the evolution of industry standards. Jen’s academic background includes an MSc in chemical biology from McMaster University, where she specialized in metabolomics related to rare genetic diseases and women’s health.
Tim Balvers
Managing Medical Editor, Science + Regulatory
Tim Balvers, Managing Medical Editor, Klick Health, brings a tenure of three years in promotional pharmaceutical advertising. An MSc graduate in applied clinical pharmacology from the University of Toronto, Tim merges his academic acumen with hands-on experience in oncology, addictions, and the orchestration of clinical trials. At Klick, Tim coordinates editorial operations across multiple high-stakes pharmaceutical and medical-device portfolios. Tim has a passion for creating clear, compliant, and compelling content, and works continuously towards this goal by forging strong bonds with client MLR teams.
Julie Turnbull
Vice President, Science + Regulatory
Julie Turnbull expertly guides the team in medical quality and regulatory excellence as Vice President, Science + Regulatory, at Klick Health. A seasoned leader with a PhD in molecular genetics, Julie has over 15 years of expertise in the healthcare sector. Her early career involved fostering collaborations across the scientific and medical communities and advancing patient-centric communication, authoring over 35 peer-reviewed publications in neurology and rare diseases, and actively participating and presenting at scientific and advocacy conferences. During her tenure at Klick, she has directly impacted numerous launches across multiple therapeutic areas for healthcare professionals and consumers alike. Julie’s scientific knowledge goes hand-in-hand with her deep experience with medical, regulatory, and legal teams. At Klick, she was pivotal in the development of a comprehensive in-house regulatory affairs program, ensuring company-wide adherence to the highest standards. Julie’s unique blend of academic achievements and professional engagements positions her at the forefront of medical-quality and regulatory-compliance leadership within the organization.
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