Our first-hand experience in regulatory and payer environments allows us to provide a unique mix of services that integrate scientific and clinical needs with regulatory and market access considerations. The results are genuine and actionable strategies that can be successfully implemented in a dynamic and rapidly evolving health care market.
We prefer working with clients in a hands-on fashion and offer support from conception to commercialization: we not only help developing a successful strategy but also support the translation into practice.
Management consulting for life sciences and health care companies
Strategic planning, priority setting, due-diligence
Evaluation of pre- and post-market strategies
Companion diagnostic development (strategic partnering, project planning and oversight)
Product development and positioning support, identification of market access opportunities
Design and planning for clinical trials, including alignment with diagnostic partner
Creation of tral protocols, IRB submissions, and other clinical documents
Patient-facing documents, including surbeys, patient-reported outcomes forms
Trial site identification, setup and management, patient identification and recruitment strategies
Clinical reports and regulatory documentation
Regulatory strategy and copetitive intelligence
Planning of interactions with regulatory authorities
Identification of regulatory pathways for drugs and (companion) diagnostics
Preparation, writing and/or review of regulatory documentation and submissions
Creating value proposition relevant for payers
Design of health economics and outcomes-based research projects
Identification of real-world, payer focused research sites and opportunities
Evaluation of reimbursement environment
Market access strategies
Dr. Felix Frueh is a respected thought leader in personalized medicine with twenty-five years of R&D, management, and policy experience. He founded Opus Three in 2012 after spending several years at the FDA and in the payer environment working closely with the pharmaceutical and diagnostic industry.
Dr. Frueh is also an entrepreneur, having founded or supported the founding of several startup companies. He is a mentor at the Institute for the Global Entrepreneur at the University of California San Diego (UCSD) and worked as entrepreneur-in-residence at Third Rock Ventures in Boston and San Francisco.
He was Chief Scientific Officer at Human Longevity, Inc. and was President of the Medco Research Institute, leading the PBM’s clinical research initiatives in health economics and outcomes research after having formed Medco’s personalized medicine R&D organization. Prior, he was the first Associate Director for Genomics at FDA/CDER, where he oversaw the development and implementation of policies around biomarker qualification and companion diagnostics.
Dr. Frueh is a Board member at Selva Therapeutics, Enterome Biosciences, Ariana Pharma, Intellos Health, and CredibleMeds, and also served on the Boards of TcLand Expression and the Personalized Medicine Coalition. He serves (or served) on several scientific advisory boards to pharma companies.
He is a Fellow of the American College of Clinical Pharmacology and held faculty positions at Georgetown University in Washington, DC and at the University of North Carolina. Dr. Frueh received his education at Stanford University and the University of Basel in Switzerland, where he graduated magna cum laude in biochemistry.
Julia McEachern is an Associate Partner at Opus Three. Over twenty-five years, she has honed her background in research and patient care to assist clients in the design and conduct of clinical programs and research studies, emphasizing on utilizing data for targeted patient populations and results oriented interventions.
Julia has worked nationally with numerous healthcare integrated systems to develop approaches to implementing Accountable Care Organizations (ACOs), Clinical Programs, Research Trial Management, and also programs for under- and over-utilization of medication and healthcare resources. Her data management, payer, and research experience includes work with Ingenix (now Optum), United Health Group, Aetna, Medco, and more recently, Blue Shield of California. She was also the Head of Alliance Management at Human Longevity, Inc.
Julia attributes her passion for helping individuals with chronic disease from her experience for over twelve years as a physician assistant in Internal Medicine and Geriatrics. She began her research career at Social and Scientific Systems in Rockville, MD with the AIDS Clinical Trials Group (ACTG) and at the Henry M. Jackson Foundation for the Advancement of Military Medicine where she participated on the Walter Reed Army Institute Investigational Review Board. She received her Physician Assistant and Master’s degrees in Health Science from Duke University in Durham, NC and her Bachelor of Arts degree from Spelman College in Atlanta, GA.
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We are located in San Diego, CA
+1 (800) 857-3140