Marek Kania, M.D., M.B.A.
Founder and Principal
About
Biopharmaceutical Executive Leader, committed to build effective and efficient startup organizations, drug development programs and product commercialization, which are focused on highest value creation for patients, physicians and payors. Most recently Dr. Kania served in a dual role as Executive VP, Managing Director and Chief Medical Officer for HUTCHMED Int., member of the C-Suite, Executive Committee of 2.5-3bio USD market cap company. Dr. Kania designed, built and led International, which focused on driving portfolio development, launching new products and creating high value for patients, providers and payors. Within 4.5 years he attracted and built the entire organization from zero, to approx.150 individuals across all functions, opened 6 global clinical programs, more than 20 trials from phase 1 to phase 3s. Dr. Kania managed the entire entity P&L. He was responsible for building capabilities from a ground up and leading company’s global organization across the entire international enterprise, across all functions. Several new US INDs were submitted, and programs initiated, with two late phase programs including global regulatory NDA/MAA submissions. Fruquitinib global registration phase 3 study, FRESCO 2 designed and executed in record time during most restrictive global pandemic related limitations. Trial resulted in global practice change results in metastatic colorectal cancer, with US, EU and Japan approvals. FRESCO2 Positive results led to a global licensing deal with Takeda Oncology, with 400mio USD upfront payment and potential to generate 1.13bio USD in milestones payments. Previous to this position, during 25 years’ experience at Eli Lilly and Company held several senior management roles, last few as Vice President of Medical Policy and Strategy across the enterprise and VP of Global Med. Affairs and Late Phase Product Development for Lilly Oncology and Global Oncology Product development Leader. At Eli Lilly and Company main areas of Dr. Kania experience spanned across general management, global oncology clinical research and development, and global regulatory and medical affairs, leading teams to launch multiple new oncology brands; corporate enterprise-wide medical policy and strategy, quality assurance, global strategic commercial, marketing. Specialties: General Management of the Startup Organization, CMO, Oncology Global Clinical Research & Development, Global Medical and Regulatory Affairs Leadership, New Product Launch Capabilities. Leading Leaders, Corporate Leadership, Enterprise level Medical Policies and Procedures
United States
Naples
Biotechnology
Business Strategy, Project Management, Medical Research, Business Development, Executive Management, Investigational New Drug Application (IND), Protocol Design, Product Lifecycle Management, Clinical Development, Oncology, Medical Affairs, Drug Development, Pharmaceutical Industry, Clinical Trials, FDA, Market Access, Clinical Research, GCP, Immunology, Cancer
Experience

Founder and Principal
Marek Kania & Partners Biotech Consulting
Assisting oncology, small and medium Biotech, oncology Startups, Private Equity and CRO industry to set the global oncology drug development strategy, both from a regulatory and commercial perspective. In addition building right sized R&D and Commercial capabilities, industry and academic partnerships and the execution of plans. Main goal is to create high value to patients, providers and investors with highest efficiency. Mentor and Coach for senior top Talent across the industry.

Staff Physician, Anaesthesiology and Intensive Care Unit
Tarnow Regional Hospital
Poland
Marek Kania, M.D., M.B.A.'s Contact Information
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