[Whitepaper] It is never too early to think “drug product”

In Orphan Drug Congress, Uncategorized, Whitepapers by Freya Smale

Drug product will follow you all the way through the clinical trials and into the commercial supply to healthcare systems and the patients.

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Key features of drug product formulation:

The orphan drug product (DP) you develop is what the patients will encounter and what medicinal agencies will approve. What you develop will most probably influence patients’ lives in a tremendous way, potentially curing them and improving quality of their lives like nothing else has done before. The formulation of the DP will thus play a big role in how patients perceive the drug, how it becomes a part of their lives, and how they structure their life around it.

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The formulation you choose will influence following key features of your DP:

  •  Efficacy: DP is absorbed in a body and acts in line with its purpose
  •  Safety: DP is non-toxic for patients, minimizes risk for local side effects and may adjust for therapeutic windows of drug substance
  •  Stability: Drug substance does not decompose
  •  Uniformity of dosage: Same dosage with same effect is administered at every occasion
  •  Appearance: DP is compliant to patients
  •  Price: The cost of the final product is accepted by healthcare systems
  •  Patient acceptability: It is easy to use and dose the product both by patients and potentially healthcare providers
  •  Patentability: The formulation provides novelty, rising possibility to protect your invention for a certain part of its commercial lifetime.

We are thrilled to announce that APL are joining us as a sponsor at this year’s World Orphan Drug Congress USA 2016. Register today to meet them in D.C. on April 20-22.

World Orphan Drug Congress USA 2016