The Business of Life Sciences and Healthcare for Leaders

Program Overview

This five-day immersive Program, led by Life Sciences and Healthcare (LSHC) experts, provides critical insights into medical product development. Participants will hone leadership skills and develop critical-thinking skills as they navigate regulatory, commercial launch and reimbursement strategies, anticipate and mitigate risks, develop negotiation skills licensing, as they collaborate with world-renowned faculty and regulatory and industry leaders.

Through real-world case studies, expert-led sessions, and interactive discussions, participants will explore strategies to overcome industry challenges while prioritizing patient needs. The program includes:

• Expert-led sessions on key development stages.
• Small-group discussions for deeper engagement.
• 1:1 mentorship with LSHC leaders.

Capstone Projects – participants will tackle real-world challenges, applying problem-solving strategies and decision-making frameworks in collaboration with senior industry experts.

Who should join the program?

Designed for advanced professionals in pharma, biotech, medical devices, investment, health policy, business, medicine, and regulatory science, with:

• A bachelor’s degree or higher.
• 5+ years of industry experience.
• A drive to enhance leadership, strategy, and problem-solving skills.

Learning Objectives and Outcomes

• Identify major milestones, potential risks, and mitigation strategies across the medical product development lifecycle, from R&D to regulatory submission, product launch, and commercialization.
• Develop creative problem-solving tactics, lead effectively under pressure, and craft strategies to drive clinical and patient adoption.
• Understand key reimbursement requirements and leverage AI-driven decision-making to optimize product development and market success.
• Apply innovative approaches to real-world challenges through dynamic Capstone Projects, facilitated by LSHC leaders.

Experience the Power of the Smith Network

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

Dr. Marion Couch is a distinguished healthcare leader with expertise spanning health systems, federal policy, venture capital, and commercial insurance. She currently serves as 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.

Michele Dougherty, PhD

Michele Dougherty, Ph.D. has extensive expertise navigating the complex regulatory landscape associated with the biotech and pharmaceutical industries. She 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, her record includes improving FDA approval rates for client regulatory submissions by meticulously organizing filings with the appropriate level of detail and data.

Steven M. Ferguson

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 research that has also generated 48 FDA-approved drugs & vaccines.

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. She 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.

Joga Gobburu, MBA, PhD

Joga Gobburu is a world-recognized scientific leader in pharmacometrics and the area of quantitative disease models and their application to decisions. He is a professor at the School of Pharmacy and the School of Medicine, University of Maryland (UMB), Baltimore, MD, USA. Previously he 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 he 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, Esq. 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 advising on federal and state transparency reporting and licensing requirements.

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 been employed by nine (9) start-up medical device companies in a senior management capacity for the past 25+ years. Little 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.), Dr. Boris Lushniak is a renowned public health leader with extensive experience in emergency response, occupational health, and infectious disease preparedness. Prior to that he 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. Previously he held key leadership roles such as US Deputy Surgeon General and Acting Surgeon General.

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.

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.

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.

James E. Polli, PhD

James E. Polli is a distinguished expert in pharmaceutical sciences, specializing in oral drug absorption, bioequivalence, and regulatory science. As Co-Director of M-CERSI, an FDA-funded initiative, he advances research on pharmaceutical quality, drug safety, and manufacturing standards. His work focuses on maximizing oral bioavailability through formulation strategies and ensuring public quality standards for oral dosage forms.

Wendy Sanhai, PhD

Wendy Sanhai has a background that spans leadership roles in academia, regulated industry, and senior positions at the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). As the 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.

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, he specializes in innovation strategy, 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, Schlake has led 80+ major strategy projects, helping organizations navigate uncertainty and change.

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, he 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.