Communications During Drug Development
Helping physicians and patients get access to new drugs and medical devices requires more than showing that a product works. In this article, we focus on the hurdles that the biopharmaceutical industry faces. Similar challenges face the medical device industry; however, as they say, the devil is in the details.
Typically, the first hurdles facing the biopharmaceutical industry are demonstrating that the product is safe and effective and that it can be consistently and reliably manufactured. However, a successful product launch also requires surmounting the hurdles of reimbursement and commercialization. Continue reading
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All biopharmaceutical companies have at least three hurdles to leap before a new product can launch: safety, efficacy, and quality. Small biopharmas have an additional hurdle, however: market access (sometimes referred to as access and reimbursement). The goal of small biopharmas, where much of the drug discovery and development is now being done, is to sell or license the drug or company at the highest possible price. To accomplish this, you must develop the capability to bound right over that fourth hurdle of market access.
As a small biopharma, you should begin developing a strong market access strategy at the end of your Phase I clinical trials. The difference in how this is done can determine whether your product will launch successfully or fail miserably. Adopting a good strategy early can also significantly affect the selling price for the company or product. While safety, efficacy, and quality are critical to a product’s success, so is the integration of market access into all strategic planning. Continue reading