Phases of Product Development

1. Discovery: Scientists begin by choosing a biochemical mechanism involved in a disease condition, then test potential drugs on how they interact with the drug target. When they find a drug that interacts with the target, they choose one or more compounds for development.

2. Development: The potential drug then is characterized through early stage pharmacology studies, and scientists develop a formulation that they hope will deliver the needed benefits safely. Scientists perform a number of preclinical studies to analyze the bioactivity, safety, and efficacy of the formulated drug. Once the drug passes these hurdles, it undergoes Phase I (small-scale trials using healthy patients), II (small-scale trials on patients to determine safety and efficacy), and III (large-scale clinical trials for safety and efficacy in large patient populations) testing.

The development phase can take 10 to 12 years or longer. It is during this stage that advisory board meetings and “mocks” (rehearsals for presenting the drug data to the FDA) occur.

3. FDA approval: Once the data from the clinical trials is collected, the company submits the drug to the FDA for approval. It can take 10 months or longer to go through the approval process.

4. Product launch and continued marketing: The approved drug then is launched and marketed to internal sales and marketing teams and external clients.

Types of Pharmaceutical Meetings
While definitions of what constitutes different types of meetings can vary from company to company, these general definitions loosely describe some of the typical types of pharmaceutical company meetings.

Clinical trial meetings: These are usually held during the clinical trial phases to train healthcare professionals on how to administer the drug and what data to gather.

Colleague meetings: Sales and incentive meetings attended by the company’s sales and marketing teams do not have to comply with the regulations that meetings involving healthcare professionals do, such as attendance and spend-tracking, to fulfill public reporting requirements.

Endpoint adjudication committees: Usually these are one-and-a-half-day meetings of 10 to 12 paid consultants. They often have sign-in sheets to prove that the paid consultants did in fact participate.

Expert panel or medical/expert advisory board: These usually happen when a drug is in the clinical trial period and something occurs that needs to be explored. They can involve experts and consultants who may be paid an honorarium, and are usually short, one-time events that take place over a day or two.

Investigator meetings: These are usually low-profile meetings whose attendees are researchers and clinical study teams. They can be held virtually or face-to-face.

Marketing advisory boards: These meetings are held with the goal of increasing sales of a specific drug. They are promotional/commercial in nature.

Product launches: These meetings introduce the sales force to a new product, including giving them the skills, resources, and knowledge they need to market the product. They can include launch events at the national, regional, and/or local level, as well as post-event activity to help the sales force and other channels make the most of the event. Because these are colleague meetings, they do not have to comply with HCP-meeting regulations.

Speaker programs: These are promotional meetings, usually held over dinner, to introduce HCPs to the company’s products.

Steering committee meetings: These are held to steer the progress of clinical trials; they are similar to expert panels/advisory board meetings.

For more information on pharmaceutical meeting management, check out our Pharmaceutical Meeting Management Special Report.

Source: This glossary is based on information presented by Lisa Keilty, CMP, president, The Keilty Group, at the 7th Annual Pharmaceutical Meeting Management Forum, held in Philadelphia in March 2011. Keilty is an experienced meeting management consultant who provides compliance solutions that verify and validate meetings and interactions between healthcare professionals and life-sciences companies. The Keilty Group educates employees and vendors on the many global regulations included but not limited to PhRMA, AdvaMed codes, FCPA and the Sunshine Act. Among the services The Keilty Group offers are helping clients improve processes to reduce risk and legal liability when engaging healthcare professionals; developing and aligning clinical and commercial processes for audit review through collaboration with corporate compliance departments; and developing training and monitoring programs for vendors around compliance expectations. You can find Keilty on LinkedIn.