- Your expert scientists have created a potentially ground breaking NCE in a specialty therapeutic area.
- Your clinical and scientific teams are experts and focused on the synthesis of product and mechanisms of action.
- You’re working on getting your IND submitted in order to get the product into humans
Why you should not move ahead without input from Averitas Health:
Although you may think that planning for your Clinical Trial should only focus on clinical and scientific questions, it’s actually critical at this juncture to get solid Commercial input. Without this input it’s possible that your clinical trials could lead to weak labeling that may significantly undermine your product’s economic potential, or worst case scenario lead to delayed or denied approval, a potential economic disaster.
All too often the Clinical Trial design is undertaken without careful analysis of the market place, including barriers to entry and issues arising from product administration to physician preferences, both clinically and economically. The common practice seems to be identifying the number of patients with the disease and determining (usually through rough estimation) the number of patients that can be treated with the therapy, multiplied by an estimated price. Unfortunately more often than not that price is not stress tested in the marketplace and is, at best, a “wish” rather than a fact.
Averitas Health can help you by acting as your Commercial Team. Our Founders have more than 60 years combined experience in the Pharmaceutical Industry and have prepared dozens of products for market entry. We will sit with your Management and Clinical teams to determine the best, and most realistic forecast for your NCE. We’ll help to guide the clinical trial design through our understanding of the market place and the practice of medicine within the products specialty area. Determine if adding Health Economics Outcomes are necessary. We’ll bring together decision makers within the value chain to help determine product profile, positioning and optimal price.
Our know-how and skills range from Marketing, Sales, and Market Access, to Clinical Development, In-licensing and Life Cycle Management – including all related specialties in clinical/medical and regulatory affairs, business development, market research, operations, training and development as well as product supply.
All Partners and Management have extensive experience managing and developing brands and franchises in Specialty Pharmaceuticals. Therapeutic areas include Oncology, Neurology, Cardiology, Urology, Women’s Health, Hospital Products and Diagnostic Imaging. Averitas Health is dedicated to helping bring world class therapeutic and imaging agents to the U.S. market through our extensive expertise and commitment to our partners in the Pharmaceutical and Biotech industries.
Visit the links below to learn more about our services, at every stage of your product’s life cycle:
|EARLY STAGE||LATE STAGE||PRE-LAUNCH/RE-LAUNCH|
|Early StageNew Product or NCE|
Pre-IND and IND
|Post NDA Submission
(awaiting regulatory approval)
Phase IV (Post Launch)