Effectively positioning your product for the right indication from early stage of development.
Have you considered the prevalence of your target indication? Have you considered the positioning of your product in the line of treatment and management care of the patients? Have you considered the competitors/predicates on the market? These questions should be addressed in the Target Product Profile (TPP) document as early as possible.
TPP is a living document that will grow alongside your product development. In addition to characterizing your product specificity regarding the Mode-of-Action, Safety and Efficacy, you will benefit from considering at very early stages the best differentiating features and potential economic value of target indication(s) and claims associated to your product. You will definitively increase your chance of success by taking into account at an early stage, via an integrated approach, all aspects of your product development, including but not limited to target population, clinical intended use, significant benefit(s) and long-term outcomes.
The TPP document is a vital tool consolidating all the relevant knowledge and information, pillars of optimized product development and a successful product launch. At VCLS, we propose an integrated approach and solutions to address all these questions and challenges.
Understanding the Market Potential
VCLS has a strong understanding of HealthTech investors’ requirements and has helped hundreds of emerging biopharmaceutical and medical technology companies build their business case and strategy.
In order to make sound investment decisions, HealthTech companies and their investors need to understand the market potential for their products. This implies understanding the environment in which a product will position itself.
We can help you:
- Understand the unmet medical need, the burden of illness, the cause & pathogenesis of the disease
- Estimate the size of the possible target populations and identify patient groups
- Understand the competition
- Understand the pricing and reimbursement potential
- Estimate the revenue potential
- Formula the value propositions and build a patient-centered value story
- Plan your pricing and market access strategy
You may also be interested in Neighborhood, the first regulatory life science innovation center.
Understanding the HTA Evidence Requirements
We have handled 1/4 of all consolidated or non-consolidated EMA/HTA parallel consultations and 1/2 of the Orphan Drugs Parallel Consultations in Europe.
Regulators’ and Health Technology Assessment Authorities’ requirements are not the same. It is critical to bridge this gap as early as possible during the product development stage to avoid the common “too little too late” outcome for products receiving a marketing authorization and trying to launch without the required evidence to support their value proposition.
We can help you:
- Prepare and conduct consolidated or non-consolidated parallel consultations with regulatory and HTA authorities
- Prepare and conduct HTA advice
- Perform gap analysis of existing versus required evidence
- Build an evidence generation roadmap
- Create and review regulatory dossier with patient insights
- Regulatory agency interactions with patient groups
- Encourage patient groups to answer calls for patient input
You may also be interested in our Regulatory Solutions.
Planning Health Economic and Outcomes Research (HEOR) Evidence Generation
VCLS outcomes researchers and health economists have collectively supported the integration of clinical, economic and humanistic endpoints into hundreds of clinical trials in Europe and the US.
In order to have the required data and evidence to obtain favorable HTA recommendations and appropriate pricing and reimbursement conditions, it is necessary to plan HEOR evidence generation alongside the clinical trial program.
We can help you:
- Perform gap analysis of available vs required evidence
- Plan the strategy for gathering data and evidence, including Real World Data (RWD) and Real World Evidence (RWE) if appropriate
- Select and integrate clinical, economic and Patient Reported Outcomes (PROs) research parameters into clinical trials and studies
- Build economic models
- Support improvement in the patient experience including treatment pathways
- Create patient information and education programs
- Patient group communication
You may also be interested in our Clinical Expertise.