SOLUTIONS

Ontogenes offers specialized products, practical and innovative solutions to complex business issues, and consultancy for startup or commercial stage companies. We work with clients to optimize strategic decision-making at the product, business unit, operation, financial and enterprise level. We partner with clients in developing and delivering specialized healthcare products, solutions, pharmaceutical products and, AI/ML, emerging technologies and IT solutions.

• Innovations strategies from product to delivery of healthcare and outcome
• Specialized Product—Planning, development and providing to portfolio
• AI/ML based innovative solutions to increase effectiveness in new product development and patients outcome
• Product and Market access, pricing, and reimbursement 
• Product—Commercialization 
• Franchise and business unit strategy 
• Corporate strategy 
• Regulatory and Compliance 

Ontogenes's experienced consultants bring decades of experience in market development, new product planning, and the development of innovative life sciences products. 

Product planning and development solutions 

• Developing specialized product to differentiate and stay competitive 
• Clinical development planning/clinical trial strategy 
• Strategic Market planning and execution  
• Product life cycle 

Global Regulatory and Compliance

• Regulatory Strategy and Regulatory Operations
• Regulatory and Medical Contents
• Clinical Quality and Compliance
• Submission and Agency Communications

Global commercialization solutions 

• Strategic Market Assessment (SMA) 
• Stakeholder/key opinion leader mapping 
• Competitive planning/war gaming/capability benchmarking 
• Product revenue forecasting 
• Sales force planning 
• Geography planning 
• Launch excellence 
• Brand plan support 
• Project management/resource support 
• Loss of exclusivity strategy 

If customers can’t find it, it doesn’t exist. Clearly list and describe the services you offer. Also, be sure to showcase a premium service.

Our team includes leading experts—including many MDs and PhDs—with deep experience in: 

• Cardiology 
• Chronic disease 
• Diagnostics 
• CNS/Neurology 
• Immunology 
• Infectious disease 
• Oncology 
• Rare/orphan diseases 

For life sciences innovators, today’s dynamic healthcare environment offers tremendous opportunities, especially given technological advancements and rapidly improving clinical outcomes. However, challenges to success are significant in complex and evolving global environments: 

• With revolutionary changes in healthcare delivery models, innovators must deal with uncertainty and be ready to adapt quickly; 
• The market simply won’t accept marginal improvements— instead, life sciences companies are challenged to transform treatment paradigms in ways that demonstrate truly significant clinical and/or economic value; 
• Hurdles to successful innovation and commercial success are increasing. They span shifting regulatory requirements, tightening access, increasingly restrictive budgets, and competitive pressures that vary significantly across therapeutic areas and global markets;
• Achieving corporate growth and financial goals demands accelerated commercialization of innovative products and therapies while deriving maximum value from existing assets, leveraging into smart adjacencies, and optimizing the value and return on investment across the entire portfolio. 
• Increased enforcement, coupled with massive fines and penalties, can cripple any organization and only those that invest in effective compliance programs reduce the risk of improper behavior allowing the organization to focus on their core values and beliefs; helping treat patients in the highest ethical manner.