Opus Three operates at the nexus where innovative science meets regulatory requirements and a dynamic, rapidly changing market: we help clients assess market opportunities, maneuver the regulatory process, and design strategies to successfully position their products.
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 work 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.
STRATEGIC BUSINESS CONSULTING
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 Ortega McEachern is an Associate Partner at Opus Three. She is passionate about patients and leverages her experience to assist academic health centers, payers, biotech and pharma clients to build a robust clinical trials infrastructure. Her research experience includes running multi-million dollar Phase II-IV studies to include institutional education and training, research gap analysis, site set up and process flow integration, contracting, regulatory submissions, patient recruitment, site monitoring and audits. She has also been a member of an Institutional Review Board (IRB) and interacts regularly with institutional and central IRB’s. As a licensed and practicing Physician Assistant with twenty years of patient care experience, she is familiar with the dynamic nuances of health care delivery systems and leverages this to create enhanced patient care flows and effective communication among clinical and multidisciplinary teams. She has led system wide clinical programs that leverage provider/facility level integrated claims datasets to tailor program development, outreach and monitoring of healthcare utilization outcomes. Additionally, her work includes working with small, large, federal and union employer groups to obtain buy-in to proposed clinical initiatives.
Ms. Ortega McEachern received her Physician Assistant and Masters in Health Science degrees from Duke University Medical School in Durham, North Carolina and her Bachelor of Arts in English from Spelman College in Atlanta, Georgia. She is excited and eager to use her knowledge and skills to assist you with your healthcare and research needs.
Dr. Federico Goodsaid joined Opus Three as Associate Partner in 2018. Dr. Goodsaid has twenty years of experience in regulatory affairs including regulatory submissions for diagnostic and therapeutic products both as a sponsor as well as a primary reviewer at the FDA. He previously worked as Senior Vice President of Clinical and Regulatory Affairs at TOMA Biosciences, where he led the preclinical and clinical development and regulatory activities for the company’s next-generation sequencing (NGS)-based oncology products. Prior, Dr. Goodsaid worked as Vice President for Strategic Regulatory Intelligence at Vertex Pharmaceuticals focused on regulatory submissions for therapeutic products, as well as diagnostics and biomarker development in rare diseases. He was the Associate Director for Operations in Genomics, and Biomarker Qualification Coordinator in the Office of Clinical Pharmacology, FDA/CDER, working on the development and implementation of novel policies in genomics and biomarkers at the FDA. His particular focus included the development of a novel biomarker qualification process (now the Biomarker Qualification Program) and the development of policies for companion diagnostics. Before he joined the FDA, he was Senior Staff Scientist at Applied Biosystems and Lead for the Molecular Toxicology Group at the Schering-Plough Research Institute.
Dr. Goodsaid received his B.A. in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D. from Yale University in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University and at Washington University in St. Louis.
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We are located in San Diego, CA
+1 (800) 857-3140