YOUR Market Access preparations should preferably start already with your Project idea and will, in addition to the services listed here, also include the designing and planning of your clinical trials and health economic studies.

 

The steps necessary to finally gain Market Access at the Right Price and endorsement in clinical practice are inter-dependent and should follow a logical flow with Translational Medicine as a key element.

 

Your success is dependent on a proactive, multifunctional working model where the global and the local activities are well coordinated.

How would you like your product to be perceived? Most often positioning is not given sufficient attention in early development since research, medical, regulatory and marketing are not properly connected.

 

TM Bridges will bring a Translational Medicine culture into your company and give long-term positioning more attention from the very start; in itself, in Target Product Profiling and in outlining your Payers Value Proposition.

 

Some key questions essential for YOUR product positioning:

 

• What are the present therapeutic beliefs and experiences in the area?

• What are the advantages of your product compared to existing therapies?

• Will these advantages be considered important to patients, prescribers and payers?

• What kind of evidence would substantially contribute to shape the identity and image of your product and to make its benefits understandable?

A successful launch requires more than a regulatory approval. You also need to get your product reimbursed at the right price.

 

To reach this goal you need to present a product rationale that appeals to your Payers and contains the evidence they would like to see. Thus, to get YOUR Payer Value Proposition right you need to know your stakeholders and their needs and present your evidence in a targeted and structured way.

 

This work needs to start early in YOUR Project and must then proceed through the entire R&D chain to ultimately result in Market Access at the Right Price.

 

Developing your Payers Value Proposition also provides an opportunity to align your Company’s views with the Payer’s perspectives and identify risks and gaps including implications for your clinical trials and then set YOUR priorities.

 

TM Bridges are prepared to provide you with full support in this process.

Risks cannot be avoided but they can be proactively managed.

 

The spectrum of risks is wide and could range from technical feasibility, toxicological issues and intellectual property risks to significant competition, legal issues and skepticism from the payers.

 

The ability to translate early findings into potential projects risks is crucial to avoid unpleasant and costly surprises later on in the R&D process.

 

TM Bridges will guide and support you in:

 

• Identifying risks and bottlenecks at all steps of YOUR Project

• Categorizing the identified risks into inter-related clusters

• Characterize the risks in terms of likelihood and impact

• Work out an Action Plan for each of the prioritized issues

Product labeling is largely driven by the interpretation of pre-registration efficacy and safety surveillance data.

 

By proactively addressing regulatory requirements and questions expected to be asked by the authorities already early in the R&D process the chances for a smooth regulatory process and a favorable label increases markedly.

 

Through its professional network TM Bridges provide regulatory expertise encompassing specific aspects and documentation which preferably should be addressed already by the start of the project.

 

The interests of TM Bridges also include clinical and regulatory guidelines which could facilitate development and approval of breakthrough products.

Effective Project Execution requires:

 

• Routine use of advanced analytics and adaptive trial designs

• Solid and structured “critical chain” project management

• A flexible mindset and preparedness to address also unexpected events

• Being one step ahead with the contingency planning

 

TM Bridges will help you leverage your project for growth by drawing your Roadmap and unleashing the power of Your Team:

 

• Identify and address gaps and obstacles throughout the R&D process

• Decide on priorities, actions, timelines and resources required

• Secure alignment on all decisions between the functions involved

• Outline and kick-off the Execution Plan agreed

• Monitor progress and make corrections along the road as needed