The Business of Life Sciences and Healthcare for Leaders

Why attend?

• Learn from Industry Leaders: Be mentored by top CEOs, healthcare consultants, and regulatory experts tackling real-world challenges.
• Immersive Experience: Integrate thought leadership, develop critical-thinking and collaborative problem-solving skills , and benefit from expert coaching in small group settings.
• Actionable Curriculum: Use real-world case studies to master strategy across clinical development, regulatory submission, product launch, and reimbursement stages of product development.
• Build Your Network: Join a powerful community of peers and industry changemakers that lasts beyond the program.

Experience the Power of the Smith Network

Rajshree Agarwal, PhD

Rajshree Agarwal is the Rudolph Lamone Chair of Strategy and Entrepreneurship and Director of the Ed Snider Center for Enterprise and Markets at the University of Maryland. Rajshree studies the evolution of industries, firms and individual careers, as fostered by the twin engines of innovation and enterprise. Rajshree’s scholarship uses an interdisciplinary lens to provide insights on strategic innovation for new venture creation and for firm renewal. She routinely publishes in leading journals in strategy and entrepreneurship. An author of more than 60 studies, her research has been cited more than 10,000 times, received numerous best paper awards, and funded by grants from various foundations, including the Kauffman Foundation, the Rockefeller Foundation and the National Science Foundation.

Barbara Binzak Blumenfeld, PhD

Barbara Binzak Blumenfeld brings a unique combination of scientific expertise and legal acumen to FDA regulatory strategy. Holding a Ph.D. in molecular biology, she transitioned from laboratory research into Food and Drug Law, leveraging her deep scientific knowledge to create true value for clients in developing individualized regulatory strategies for drugs, biologics, biosimilars, medical devices, and combination product development programs.

Marion E. Couch, MD, PhD, MBA

Marion Couch is a distinguished healthcare leader with expertise spanning health systems, federal policy, venture capital, and commercial insurance. Dr. Couch is the former Senior Medical Advisor to CMS Administrator and currently serves as the CEO of IntoValue Inc., driving healthcare transformation through direct-to-employer partnerships. She also chairs the Executive Advisory Board at Guidehealth, an AI-powered platform advancing value-based care.

Mathias Cousin

Mathias Cousin leads Deloitte’s High Growth Biotech and MedTech practices in New England. He also heads Deloitte’s Next Gen Therapies Commercial & Corporate Strategy practice, advising pre-commercial and commercial biotech clients on scaling organizations, defining growth strategies, and leveraging technology for business transformation.

Reid D’Amico, PhD

Reid D’Amico is ex-FDA and the Principal and Leader of IQVIA’s Regulatory Science and Strategy Team. In this role, he oversees regulatory strategies across therapeutic areas and provides expert oversight for innovative, first-in-class product development. Since joining IQVIA in January 2022, Reid has expanded his team’s capabilities across drugs, biologics and devices, supporting engagements from discovery to post-market. He has led the development of new regulatory science and strategy offerings, resulting in successful regulatory outcomes, and has been a key figure in thought leadership through conferences, publications, and podcasts. Prior to IQVIA, Reid was a Life Sciences and Regulatory Specialist Master at Deloitte, managing teams addressing complex scientific and regulatory issues for the FDA’s Oncology Center of Excellence.

Michele Dougherty, PhD

Michele Dougherty has extensive expertise navigating the complex regulatory landscape associated with the biotech and pharmaceutical industries. Dr. Dougherty leverages significant experience with the US FDA’s Office of Biotechnology Products to enable companies to craft cost-effective, efficient development programs. As a CMC regulatory consultant at Eliquent Life Sciences, Michele significantly improved the approval ratio for regulatory submissions by ensuring that filings meet requirements.

Nicole Duran, BS

Nikki-Nicole Duran is ex-FDA and a manager on IQVIA’s Regulatory Science and Strategy team. Nicole has 6+ years of experience in RWD/E and life sciences, and has supported sponsors across a variety of therapeutic areas. At IQVIA, Nikki specializes in regulatory feasibility for RW studies, helping sponsors develop justifications for the relevance and reliability of RWD sources and study designs. Prior to IQVIA, Nicole was a consultant at Deloitte where she supported FDA’s Oncology Center of Excellence and the Military Health System, addressing regulatory concerns and development of high-quality electronic health record data.

Steven M. Ferguson, MBA

Steven M. Ferguson currently serves as Special Advisor at the Office of Technology Transfer at National Institutes of Health (NIH) – home of the world’s largest biomedical technology transfer program with a portfolio of 2,000 active licenses with aggregate sales exceeding $10B annually based upon NIH-funded research and market sales of FDA-approved medical products.

Judy Frels, PhD

Judy Frels is a Clinical Professor of Marketing and the Academic Director of the MS in Marketing Analytics program at the University of Maryland’s Robert H. Smith School of Business. Dr. Frels teaches courses in marketing strategy, ethical leadership, and experiential capstone projects. A dedicated advocate for inclusivity and belonging, she is a frequent recipient of both general and diversity-specific teaching awards.

Sydney Gibson, Ph.D.

Dr. Sidney Gibson is an Associate Principal with IQVIA's Real-world Regulatory Science & Strategy team. In her role, she supports life sciences companies in the design of clinical trials for FDA approval and regulatory approvals across Europe and Asia.

Dr. Gibson specializes in generating regulatory strategies for products using new and innovative technologies, including artificial intelligence. She has supported life science leaders across government affairs, regulatory affairs and business development functions in both the pharmaceutical and medical device sectors.

Her work helps clients understand the impact of evolving global law, policies, and standards on regulatory submissions. A biomedical engineer by training, she has over eight years experience in pharmaceutical and medical device development and commercialization. She previously served as a lead reviewer at FDA's Center for Devices and Regulatory Health.

Prior to FDA, Dr. Gibson earned her Ph.D. in bioengineering from Rice University and holds a B.S. in bioengineering from the University of Pittsburgh.

Joga Gobburu, PhD, MBA

Joga Gobburu is a world-recognized scientific leader in pharmacometrics and the application of quantitative disease modeling to inform decisions. Dr. Gobburu is a professor at the School of Pharmacy and the School of Medicine, University of Maryland (UMB), Baltimore, MD, USA. Previously Dr. Gobburu held key positions at the US Food and Drug Administration. Dr. Gobburu is widely recognized for transforming pharmacometrics into a critical decision-support science for drug development and regulatory evaluation.

Axel Hoos, MD, PhD

Dr. Axel Hoos is a physician-scientist, biopharma leader and entrepreneur with broad experience in drug development and building life science organizations. Most recently Dr. Hoos served as CEO of Scorpion Therapeutics, a next-generation biotechnology company focusing on Precision Oncology 2.0 for optimally designed small molecule cancer medicines.

Tina Hu-Rodgers, JD

Tina Hu-Rodgers specializes in regulatory and compliance matters related to FDA-regulated products, including drugs, medical devices, biologics, dietary supplements, and cannabis-related products. She advises clients on product approvals, labeling compliance, user fee issues, and enforcement matters. Her work also includes petitioning FDA to ensure product safety and effectiveness and advises on federal and state transparency reporting and licensing requirements.

Sandra Kweder, MD

Dr. Sandra Kweder is a distinguished physician and regulatory expert with over 30 years of experience in drug development, regulatory policy, and public health. As a Principal at ELIQUENT Life Sciences, Dr. Kweder provides strategic and technical guidance on medical product development, regulatory review, and post-market compliance.

She collaborates with global health authorities, including the European Medicines Agency (EMA) and Health Canada, to establish best practices in regulatory science. Previously, Dr. Kweder served as Deputy Director of the U.S. Food and Drug Administration’s (FDA) Office of New Drugs, where she played a pivotal role in shaping regulatory pathways, drug approvals, and post-market safety surveillance. She has been a key figure in advancing policies for rare diseases, innovative therapeutics, and global regulatory harmonization. Dr. Kweder earned her M.D. with Honors from the Uniformed Services University of the Health Sciences and holds a B.S. in Biology with Distinction from the University of Connecticut.

Juergen Klenk, PhD

Juergen Klenk brings over 25 years of experience in biomedical research, public health, and technology-driven innovation. His expertise spans AI strategy, data analytics, and technology commercialization, helping organizations leverage advanced technologies to accelerate mission-critical goals. As a Principal at Deloitte Consulting LLP, he leads the Federal Health AI & Data initiatives, overseeing a $500M portfolio dedicated to advancing AI applications in life sciences and healthcare.

Jayne Little

Jayne Little is an experienced reimbursement and market access leader having served in leadership roles in nine (9) start-up medical device companies over the past 25+ years. Jayne has extensive experience with the American Medical Association (AMA) in obtaining CPT codes for new procedures which enables physicians to be reimbursed for their work and medical products, especially minimally invasive procedures as standard of care clinical practice.

Candy Lurken, MBA

Candy Lurken is a leader in Monitor Deloitte’s Strategy Practice within the Life Sciences & Health Care industry. She has nearly 30 years of global pharmaceutical industry and strategic consulting experience, focusing on realizing growth opportunities and supporting the globalization journey for clients across the US, EU and Asia. She manages Deloitte’s Global practice’s Therapeutic Area Transformation and Launch/Portfolio Strategy Services with an offshore practice team in India.

Boris Lushniak, MD, MPH

Rear Admiral (Ret.) Boris Lushniak is a renowned public health leader with extensive experience in emergency response, occupational health, and infectious disease preparedness and current Dean, School of Public Health at UMD. Dr. Lushniak served as Professor and Chair of the Department of Preventive Medicine and Biostatistics and Professor of Dermatology, F. Edward Hébert School of Medicine at the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, Maryland. He was the US Deputy Surgeon General and Acting Surgeon General.

Jacqueline Manger, MBA

Jacqueline Manger joined the Ed Snider Center in 2018 as an executive fellow. She became managing director in 2020. Working closely with the center’s founding director, she is focused on expanding the center’s impact and is responsible for leading center activities & program operations.

Manger is passionate about the role that free markets play in society allowing for individuals to lead purpose-driven careers and lives of their own creation. She is an instructor of entrepreneurship and purposeful leadership, inspiring students from pre-college undergraduates to executive MBAs to embrace lean startup principles and work with intention and purpose to solve problems meaningful to themselves and make their world a better place. Her research activities include multiple applied research projects examining entrepreneurial strategy, decision making in early stage ventures and innovation and tech transfer.

Before joining the center, Manger was CEO of Sacramento-based consumer fintech startup New Wallet. During this time she began instructing undergraduates and taught the Lean Canvas in the center’s SELF program. Prior to her startup experience Manger spent 20 years in the investment management industry including growing two firms alongside their founders. She held CFO, COO and CCO roles with hedge fund manager West Creek Capital and private family office Rockport Capital. She began her investment career on the equity trading desk at New York-based hedge fund Caxton Corporation.

Jennifer Marr, PhD

Jennifer Marr is an award-winning professor specializing in leadership, teamwork, and ethics. As an Associate Professor and Director of the Doctorate in Business Administration (DBA) Program at the Robert H. Smith School of Business, she brings extensive expertise in organizational behavior. Her research focuses on status dynamics at work, examining how career setbacks and transitions impact employees.

Tiffany Mercado, MS

Tiffany Mercado is a regulatory science consultant with over 10 years of expertise specializing in real-world evidence (RWE). As Associate Principal for Regulatory Science at IQVIA, she advises on regulatory strategies, RWE integration, and submission packages across therapeutic areas for pharmaceuticals and medical devices. Her experience includes working with FDA’s CDRH to lead proof-of-concept RWE studies and authoring data quality frameworks. She also supported biomarker development and qualification at the Foundation for the National Institutes of Health (FNIH), collaborating with diverse stakeholders to meet complex regulatory objectives.

Kenneth I. Moch, MBA

Kenneth Moch, President of Euclidean Venture Studio, is a seasoned life sciences executive with extensive experience in founding, financing, and leading biotechnology companies focused on developing first-in-class medicines for life-threatening diseases. Ken has served as President & CEO of five companies and co-founded The Liposome Company. Ken has been responsible for the completion of over 30 public offerings and private placements, including two market opening IPOs, cumulatively raising over $1 billion in equity and non-dilutive capital.

Balaji Padmanabhan, PhD

Balaji Padmanabhan is a leading expert in artificial intelligence (AI) and machine learning (ML), specializing in their applications in business, policy, media, and healthcare. Padmanabhan is the Director of the Center for AI in Business and the Dean's Professor of Decision, Operations and Information Technologies at the Robert H. Smith School of Business at the University of Maryland.

Chirag Patel, MD

Chirag Patel is an Associate Principal with IQVIA’s Regulatory Science and Study Innovation team in Real World Solutions. With over 12 years of experience in clinical research, regulatory affairs, and industry engagement, he leads initiatives leveraging real-world data and evidence to optimize product lifecycle strategies. Prior to IQVIA, he worked at the FDA’s CDER and as a Regulatory Specialist Master at Deloitte’s Strategy and Analytics practice. He is a physician and holds a Master of Health Science in Molecular Microbiology and Immunology from Johns Hopkins Bloomberg School of Public Health.

Wendy Sanhai, PhD, MBA, LSHC Program Director

Wendy Sanhai has served in numerous leadership roles across academia, regulated industry, the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and in management consulting (Deloitte). As former Scientific Advisor in the Office of the Commissioner at the U.S. FDA, she spearheaded strategic initiatives to advance medical product development, bridge public health gaps, and improve patient care. Dr. Sanhai currently serves as a Director on multiple boards and is a Visiting Professor of Practice and Executive in Residence at UMD

Oliver Schlake, PhD

Oliver Schlake is a Clinical Professor at the Robert H. Smith School of Business, University of Maryland. An award-winning educator and consultant, Dr. Schlake specializes in developing innovation strategies, scenario planning, and corporate entrepreneurship, advising Fortune 500 companies, government agencies, and startups on future-proofing their business models. With over 25 years of experience across 15+ industries globally, Dr. Schlake led 80+ major strategy projects, helping organizations navigate uncertainty and change.

Jessica Scott, MD, JD, LSHC Program Co-Director

Jessica Scott, CEO of Legacy Health Strategies and former senior leader at GlaxoSmithKline and Takeda, is a visionary and impact-driven biopharmaceutical executive with a rare dual background in medicine and law. With over 15 years of global leadership experience across biopharma R&D, policy, and patient engagement, she has consistently catalyzed innovation and growth by integrating patient-centered approaches with operational excellence, digital innovation, and regulatory insight. A trusted advisor to C-suites, boards, and global stakeholders, Dr. Scott is known for delivering breakthrough solutions that accelerate development and improve health outcomes.

Subra Tangirala, PhD

Subra Tangirala is an expert in leadership, workplace culture, and innovation. As the Dean’s Chair of Organizational Studies and Area Chair of the Management and Organizations Department, Dr. Tangirala teaches leadership courses in the MBA and executive education programs. His research explores how organizations can foster positive workplace cultures that encourage innovation and collaboration.