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    Tag: regulatory affairs

    Barry M. Rosenfeld: A Strategic Legal Leader in Biopharmaceuticals and Healthcare

    Barry M. Rosenfeld is a distinguished legal executive with extensive expertise in the biopharmaceutical and healthcare industries, known for his unwavering integrity, strategic foresight, and ability to navigate complex regulatory landscapes. With a career spanning transformative roles at Oyster Point Pharma, Novartis Group Companies, and his consultancy at B. Rosenfeld LLC, Barry has driven impactful legal strategies across corporate governance, intellectual property, product development, and M&A transactions. His deep knowledge and effective communication skills have enabled him to align legal frameworks with business objectives, guide cross-functional teams, and deliver solutions that balance risk and innovation, cementing his reputation as a trusted leader in high-stakes environments.

    Nina Patel Lahanis: Senior Executive in Life Sciences, Business Development, and Operations Leadership

    Nina Patel Lahanis is a senior executive with over 30 years of experience in the biopharma industry, specializing in pharmacovigilance, regulatory affairs, and operational management. Currently serving as Vice President at PrimeVigilance, Nina leads strategic initiatives to ensure compliance across the Americas, optimizing resources and driving technological innovation. Throughout her career, she has excelled in business development, client relationship management, and cross-functional leadership, with a proven track record of driving revenue growth and operational efficiencies. Nina’s global experience spans multiple regions, including India, Canada, and the UK, and her multilingual skills enable her to build strong, diverse relationships. She is deeply committed to advancing regulatory safety and compliance and is eager to lend her expertise to boards and advisory roles in the biopharma and life sciences sectors.

    Cynthia Faught Malone: Accomplished Attorney, Strategic Leader, and Community Advocate

    Cyndy Malone is a seasoned attorney with over 40 years of experience, offering a proven track record of success in litigation, regulatory matters, business development, and strategic leadership. Throughout her distinguished career, she has held key roles at AT&T Services, Inc., where she gained extensive expertise in negotiating complex contracts, overseeing litigation teams, and providing strategic guidance across diverse business units. Cyndy’s leadership was especially evident when she served as General Counsel for AT&T Alaska, where she handled a broad range of legal, personnel, and business issues for the company’s Alaska operations. She also has a deep background in regulatory affairs, having worked in AT&T's regulatory office in Austin, Texas, to address key governmental and regulatory challenges. A passionate community advocate, Cyndy has dedicated much of her time to nonprofit organizations and local boards, including serving as the Chair of the Medina County Central Appraisal District Board and as a board member for the United Way of Metropolitan Dallas and Girl Scouts of Northeast Texas. Her approach to leadership is grounded in a logical, rational framework, with a focus on ethical decision-making, effective communication, and long-term strategic planning. Cyndy’s expertise and dedication extend beyond the courtroom, as she seeks to contribute her legal insights and business acumen to the boards of organizations that align with her values of service, leadership, and community improvement.

    Barbara Brohl: Champion of Ethical Leadership and Innovative Regulation

    Barbara Brohl is a highly accomplished executive with extensive experience in government administration, regulatory affairs, and public policy. She has a proven track record...

    Darren LaCour Jr. – Biomedical Product Development and Clinical Research Executive

    Darren LaCour Jr. is a seasoned expert in biomedical product development, with a distinguished career focused on ensuring regulatory compliance and patient safety. His extensive knowledge in clinical trial design, execution, and oversight has been pivotal in bringing innovative medical devices to market. As a strategic leader, Darren has successfully navigated the complex processes required for U.S. regulatory approval, while also dedicating himself to educating future leaders in the field. His commitment to excellence and mentorship has made him a respected figure in both industry and academia.

    Scott Oshana: Delivering Results with Precision, Expertise, and a Get-It-Done Attitude.

    I’m excited to share my professional journey and the expertise I’ve developed over 41 years in clinical research and drug development. As the President and Founder of New England Clinical Consulting (NECC), I’ve had the privilege of leading clinical operations across the biotech and pharma sectors, working on therapeutic areas ranging from oncology to infectious diseases. Throughout my career, I’ve tackled complex challenges, built high-performing teams, and delivered successful clinical trials from early-phase development to global Phase 3 studies. I’m passionate about advancing clinical research, overseeing CROs, and developing innovative drug development strategies. If you’re interested in clinical operations or collaborating on new projects, I’d love to connect and explore how we can work together to drive impactful results.

    Amy Pinette: Driving Excellence in Clinical Operations with Precision and Passion.

    I’m thrilled to share my updated executive biography, highlighting my journey and experiences in the biotech and pharma industries. With over 30 years of experience, I’ve had the privilege of leading clinical operations, managing complex programs, and working with exceptional teams to drive advancements in clinical research. My recent role as Senior Director of Clinical Operations at uniQure allowed me to deepen my expertise in clinical development, cross-functional team leadership, and strategic program management. I’m passionate about leveraging this experience to contribute to innovative projects and impactful organizations. Thank you for taking the time to read about my professional journey. I look forward to connecting and exploring new opportunities where I can bring my skills and dedication to make a difference.

    Christopher Walters: Strategic Leader in Government Relations, Public Affairs, and Strategic Planning for the Automotive, Agriculture and Construction Industries.

    Christopher Walters is an executive specializing in government relations, public affairs, and strategic planning, currently serving as Head of North America Public Affairs at Iveco Group. With extensive industry experience and expertise in energy and environmental policy, he advises on regulatory activities and strategic initiatives and plays a key role in industry trade groups.