Pharmaceutical contract research and manufacturing organizations (CRO/CMO) span a wide range of activities – from synthesis of isolated intermediates and active pharmaceutical ingredients (APIs) to final packaging and labeling of finished pharmaceutical products. Often, it is virtual pharmaceutical companies that request the services of these CROs and CMOs. Traditionally, virtual pharmaceutical companies are companies that rely on outsourcing almost all of their activities which require physical assets or infrastructure. Virtual pharmaceutical companies are knowledge-based companies; and typically consist of a CEO, CFO, legal counsel, and a host of business development and project management specialists.
Personnel within a virtual pharmaceutical company are responsible for managing the drug development process through the use of multiple outsourcing service providers. Since these companies are not straddled with high infrastructure costs, these companies promise a lower total cost of pharmaceutical development. While there are many variations to the business model, typically, a fully virtual pharmaceutical company in-licenses an active pharmaceutical ingredient that is approaching, or already entered clinical trials. The virtual pharmaceutical company will then contract out each stage of future clinical development of the API, including the preparation of the new drug application (NDA). If approved, and depending upon the size of the market, virtual pharmaceutical companies may either contract out the sales of the product or internally develop a sales organization. However, this is rare because at this stage the virtual pharmaceutical organization is often acquired by a big pharma company.
Often, because of the perception that the virtual organization owns no physical assets; environmental, health and safety responsibilities are ignored. These responsibilities can include, but not limited to:
- development and maintenance of a material safety data sheet;
- development and revision of a potent compound classification or potent compound categorization report; and
- environmental, health and safety auditing of contract manufacturing organizations to ensure that they can safely have your product.
The consequences of failing to perform these activities often come as a surprise to the virtual pharmaceutical company. These consequences can include expensive and time-consuming delays in the development process. Nothing stirs a virtual pharmaceutical organization up like having a multi-million dollar clinical trial batch delayed because the contract manufacturing organizations is awaiting the potent compound classification of the active pharmaceutical ingredient, or worse yet, the batch has stopped production because of adverse occupational health effects to the contract manufacturing employees.
Plan ahead. First, have an initial material safety data sheet developed for your active pharmaceutical ingredient as soon as you have in-licensed the compound…this is an OSHA legal requirement. As a virtual organization, you will be shipping compound all over the world. The last thing you want to have happen is having your compound held up in customs because the inspector didn’t like the MSDS. Secondly, have a potent compound classification report prepared just after completion of the pre-clinical studies. This classification will then need to be revised as clinical trials progress. Remember, it is your legal and ethical obligation to ensure that employees and contractors throughout the drug development process are protected.
For further information you can contact Dean Calhoun, President and CEO of Affygility Solutions at 303-884-3028. Call us and like many other pharmaceutical, biotechnology, and medical device companies we can assist you in being successful. Affygility Solutions provides EHS compliance management software, corrective action management software, potent compound safety classifications, occupational toxicology services to the life science industry.