Translational Medicine aspects will also have an added value in launch preparations by linking the underlying science to current clinical practice and existing unmet medical needs.

 

Importantly, the work on the positioning of your product and the story that you would like to communicate needs to start early in Research.

 

Building your Story means that you already from Day One need to start generate “the right evidence” to support your positioning, build your Regulatory File and your Payers Dossier and satisfy your Clinical Users.

 

TM Bridges have solid experience from product launches and what it takes to build a solid, convincing and clinically successful case.

The Regulatory demands have risen significantly over the latest decade with a shift towards risk-avoidance. Thus, it is crucial to understand exactly what the regulatory authorities require to get it right.

 

Meanwhile it has also become increasingly important to intensify the dialogue with the regulatory authorities on how to balance risks and clinical benefits in more streamlined development programs.

 

TM Bridges could through its network of partners provide you with expertise encompassing:

 

• Claims substantiation

• Documentation requirements from regulatory authorities

• Initial scientific advice meetings

• Writing of Common Technical Document modules

• Answering regulatory questions and preparing for CHMP or FDA hearings

• Driving clinical and regulatory guidelines to support innovations

Over the latest decade the power balance has shifted from leading physicians and thought leaders to regulatory decision-makers and health care payers. Thus, a positive opinion from your Payers is crucial for success.

 

YOUR value strategies need to take Market Access beyond clinical performance and explore how the existing evidence can target and exceed Payer needs. Importantly, Payers Needs is not all about cost savings.

 

YOUR Payers Dossier should contain information about the burden of the disease, the health benefits of your drug, its economic value, and its budget impact. Not the least, the dossier needs to be focused and appealing.

 

TM Bridges have experience from developing Value Dossiers based on its preparatory Payers Value Propositions.

Stakeholders are partners in achieving shared goals. Many stakeholders will also become your advocates, based on mutual values, interests and beliefs. Thus, YOUR concept will also become their concept.

 

The advocates perceived as most reliable are those who keep their integrity and stay independent. Thus, professional relationships need to be built on mutual credibility, trust and commitment.

 

TM Bridges has extensive experience from working with thought leaders and advocates and will assist you in outlining effective plans including:

 

• Elements needed to drive Market Access for YOUR Product

• Inventory of YOUR target groups and YOUR objectives

• Selection of Advocates and Shaping of their Training

• Designing of Awareness initiatives and Health Care education

• Integration of your new product into best practice and relevant guidelines