Taking Regulatory and Market Access milestones into considerations

Through this multi-disciplinary approach, this breakfast proposes to focus on the key elements that deserve to be closely challenged during a due diligence of a small biotech.

Importance of regulatory aspects:
Maximizing the chances for a successful investment requires a scrutinized analysis of key factors such as IP protection and fulfillment of unmet medical need.

Care should be taken to avoid risky investments linked to inadequate development plans or defective regulatory strategy including, but not limited to, key specificities and characteristics of the product, as well as the choice of the targeted indication.


Importance of market access aspects:
The emergence of influential payers as a core customer has seen an increased focus on cost containment and, as a result, arrays of more stringent reimbursement mechanisms have emerged.

In the past few years, many cases have occurred where regulatory agencies have approved an innovation but the payers responsible for reimbursement of the therapy have rejected to pay for the treatment.

As such it is now imperative that both Small Biotech companies and investors alike consider the market Access, pricing and reimbursement conditions as part of a robust Due Diligence.

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