The objective of Pharmaceutical industry research and development is to commercialize its products.
By Dr Stephanie-Jayne Jones
How Pharmora can help
Pharmora can provide support at any clinical stage in the product life-cycle and beyond.
Effectively this means that from the moment a potential medicinal product is considered for a clinical trial we can work with the manufacturer’s global project team to ensure the trials are designed to collect the right data and that the data are accurately entered into the database. This is especially critical in terms of assessing eligibility criteria and efficacy endpoints to demonstrate that the product works in the target population.
Pharmora can also help evaluate the safety data to identify potential safety concerns that may be either no-go criteria (stopping further development so the money can fund development of products more likely to be successful) or to further characterize the safety profile and propose risk mitigation measures.
Pharmora can support the manufacturer to interpret the data from their clinical trials to write high quality structured documents that support their applications to regulatory agencies for marketing authorisations across the world. We provide input into the documents provided to reimbursement agencies and help manufacturers design marketing materials that are compliant with the regulatory guidance.
Pharmora can continue to monitor the safety profile of the medicine once it is marketed and support the production of mandatory safety reports.
Collecting the right data
This sounds easy as clinical trials around the world tend to use the same types of methods and the same sets of investigations.
But each medicinal product is different.
Depending on the predicted safety issues it could be worth adding a specific test into early clinical trials, or performing an additional non-clinical study to explore these and prevent further investment if the product will ultimately fail.
But if the product succeeds these early additional studies will add to the body of data that support the licence application. If the regulatory agency has a concern that has not been fully explored this could delay licensing of the product. Once the patent expires multiple generic versions will become available and profits will dramatically drop, therefore the manufacturer needs to minimise the time to market and every day counts. A delay to regulatory approval could be disastrous for the company. Many patients may be waiting for this product to be approved and a delay could be disastrous for them too, especially with life-saving products the delay could mean the difference between life and death.
Considering what will be needed to support an eventual product licence is critical from the very start of development, both in terms of efficacy and safety.
Medical communications
The development of structured documentation containing data associated with medical products or interventions is called medical communications. There are countless opportunities during the life cycle of a medicinal product where there is a need for such medical communication. These range from the documentation required for routine regulatory interactions such as clinical trial applications and safety reports, to the complex set of materials incorporated into the filing for a product licence or for sales and marketing.
Pharmora can support at any stage in this clinical process. By helping to improve the type and quality of the data and documentation throughout the product life cycle Pharmora can increase the chances of success for a new product to secure its place in the global medicines market.
