Dr. Hatice Bilgic Lim is a leader in medical device clinical development and regulatory writing with over 25 years of experience in research, strategy, and communication. She has held senior positions at leading MedTech companies, including Medtronic, Becton Dickinson, and Philips, where she led cross-functional teams in creating high-impact clinical and regulatory strategies that facilitated global product approvals. Her expertise lies in developing and executing effective clinical trials for innovative technologies that enhance access to care across diverse global markets.
In addition to her industry experience, Dr. Bilgic Lim has a background in academia and nonprofit leadership, emphasizing the advancement of healthcare through research, communication, and training. She is the founder of Academy HBL, where she mentors students and professionals in scientific communication and career development, and she serves as a board member for various academic nonprofits.
At the OCT Medical Devices USA 2025 conference, Dr. Bilgic Lim will lead a roundtable discussion titled “Strategic Leadership in MedTech Clinical Development: Creating Agile, High-Impact Trial Strategies.” This session will draw on her hands-on experience in designing streamlined, globally aligned clinical programs that not only meet regulatory milestones but also accelerate innovation.
Daniel Martínez studied Biochemistry at the Universidad Autónoma de Madrid and spent two years in basic research in genomics and transcriptomics. On November 2018, he started working as a CRA and, in 2022, he moved to Exeltis for globally managing Clinical Trials. Daniel focuses on implementing AI and innovative technologies throughout clinical trials to shorten timelines, improve data quality, and enhance participant experience. He collaborates with various companies and leads internal projects where AI promises to improve clinical trials.
Agustin Rodriguez is a seasoned business partner at Troutman Pepper Locke with extensive experience in guiding clients through complex regulatory landscapes in industries such as tobacco, cannabis, and gambling. As a partner in the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and its Tobacco + Nicotine and Cannabis law practices, he provides strategic counsel on complex regulatory compliance issues, including licensing, taxation, marketing, and advertising.
Before joining the firm, Agustin served as Vice President and Associate General Counsel at Altria Group, Inc., where he managed compliance, corporate governance, litigation, and transactional matters globally. Fluent in Spanish and proficient in Portuguese, Agustin has developed compliance programs across Europe, Latin America, Asia, and Africa, addressing risks related to antitrust, anticorruption, the FCPA, and corporate social responsibility.
Bryan Haynes is an experienced attorney at Troutman Pepper Locke, specializing in regulatory compliance and enforcement within the tobacco industry. As a key member of the firm’s Regulatory Investigations, Strategy + Enforcement (RISE) Practice Group and head of the Tobacco + Nicotine practice, he adeptly assists clients in navigating complex regulatory landscapes. Bryan’s expertise spans FDA requirements, tobacco taxation, and administrative disputes. He has been instrumental in advising on the Family Smoking Prevention and Tobacco Control Act and the FDA’s deeming rule. A skilled litigator, Bryan has successfully represented clients in state and federal courts, ensuring compliance and mitigating risks aligned with business objectives. His comprehensive knowledge and strategic approach make him an invaluable asset to tobacco manufacturers, distributors, retailers, and suppliers.
Karen Benson has over 20 years of experience in the pharmaceutical industry, serving in various roles including medical affairs and regulatory affairs.
Throughout her career in regulatory affairs, Karen has worked across the various phases of development (PreIND, Phase 1 through Phase 4) and has experience in Oncology, Investigational New Drug Applications (INDs) and IND submissions, clinical trial applications (CTAs) and submissions, New Drug Applications (NDAs) and post market submissions.
