Pharmaceutical Laboratory

Mayo Clinic did with live tweet chats.

to improve business efficiency

the breadth of their approved uses

convenience, including longer-lasting formulas and easier application

highly effective,

costly and inconclusive.

By contrast, many companies have had more success with efforts to improve the safety of products or to get them approved for use in treating additional diseases. Examples are Pfizer's Neurontin, a successful antiepilepsy medication driven predominantly by perceptions of safety differences, and the company's Celebrex, a Cox-2 inhibitor that reduces pain and inflammation and is thought to be easier on the stomach than aspirin. The breadth of approved uses for drugs can also be a significant source of differentiation. We found that nearly two-thirds of those in competitive therapeutic areas, such as depression and allergies, went on to receive regulatory approval for a broader range of treatments after they came on the market (Exhibit 2). Eli Lilly's Prozac, for example, was launched in 1987 to treat depression but has since been approved for use in a range of conditions. Today, drugs entering these competitive areas often need to have a similarly broad range of regulatory endorsements at the time of their launch, thereby raising the bar for compounds in development

pharmaceutical companies might rethink their strategies for clinical trials

oo many companies commit a disproportionate amount of their time and money to discovering first-in-class compounds when best-in-class opportunities might yield higher returns

Second, efficacy shouldn't be pursued at the expense of other sources of differentiation; claims of safety, pharmacokinetics (that is, dosing), and convenience may be as desirable and more clinically attainable

one meaningful point of differentiation and scuttle drugs that have even a single subpar attribute.

As shared solutions in clinical research and other areas are developed, TransCelerate will involve industry alliances including Clinical Data Interchange Standards Consortium (CDISC), Critical-Path Institute (C-Path), Clinical Trials Transformation Initiative (CTTI), Innovative Medicines Initiative (IMI), regulatory bodies including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Contract Research Organizations (CROs).

"We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading drug companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.