Age Is Just a Number: Considerations for Older Adults in Cancer Clinical Trials

Older adults continue to be underrepresented in cancer clinical trials, despite most cancer occurrence peaking in the later decades of life. Consequently, diagnostic and management strategies are commonly extrapolated from data on younger patients, thus challenging the delivery of informed cancer care in this patient population. Several recommendations and calls to action have been released by cancer societies, advocacy organizations, and regulatory agencies to guide inclusion of older adults in clinical trials. Effective implementation, however, requires awareness and close collaboration between all stakeholders involved in the clinical trial journey. We herein provide insights and experience from a drug developer on key considerations to optimize participation and retention of older adults in cancer clinical trials and discuss those under four key domains: trial eligibility and design, assessments and endpoints, patients and oncologists, and data reporting.

ICN pharmaceuticals: corporate governance analysis

ICN Pharmaceuticals, Inc. (today Valeant Pharmaceuticals International) was a drug developer and manufacturer, known in the medical field for its development of Ribavirin, an antiviral compound used to treat various viral infections. However, ICN will probably be remembered mostly as an example of problematic and inefficient corporate governance. Changes in the management structure of ICN occurred almost at the same time when corporations, like Enron, WorldCom, Tyco, were dealing with financial scandals caused by problems in corporate governance. Since ICN was not a powerful corporation and found a way to deal with its problems, it was not subject of any big financial scandal. Nevertheless, it is interesting how ICN managed to operate, in some years even successfully, with so many corporate governance problems and how Milan Panic managed to stay at the top of ICN for 42 years, in spite of his numerous expensive law suits, scandals and bad decisions.

A Follow-On Biological Drug is not a Biogeneric: Lessons from Omnitrope and Valtropin

Recent years have seen the approvals, more so in the EU than the United States, of follow-on biological drugs. These products have been new formulations of recombinant therapeutic proteins, developed to compete with the marketed originator products. Intended to closely mimic the originator products in terms of chemistry and therapeutic properties, these so-called ‘biosimilar’ products were initially conceived to be developed according to abbreviated development programmes, presumably at a substantial cost savings to both the drug developer and the consumer. With several such products now recently approved, however, it has become clear that their development programmes have been quite extensive and not particularly abbreviated. Accordingly, cost savings to consumers appear to be relatively modest.