Q: Why has there not been a push for more awareness and a new guidance regarding the concept that kinase inhibitors cause other nontargeted organ damage when used repeatedly?
I thought it best to reach out to a toxicologist, Grace Furman, Ph.D., who had this to say: “ICH [International Conference on Harmonization] safety guidelines typically will not provide guidance specific to certain molecular targets or drug classes. Since the specific molecular targets (and thus the biological effects) of tyrosine kinase inhibitors (TKIs) vary widely across members of this ‘class,’ it’s misleading to consider cardiovascular or other safety issues associated with TKIs as class effects. Drug developers should seek to understand each TKI on a case-by-case basis, focusing on the specific kinase(s) inhibited and what is known from the basic science literature which might raise concerns regarding safety.”
Jeff Evans, Ph.D., founder and CEO of Oncoholdings, previously served as president of Rondaxe, a leading pharmaceutical consultancy which he cofounded in 2003, and as director of worldwide development sourcing and planning for Bristol-Myers Squibb.
Q: Where do you see the next breakthrough in drug discovery?
The greatest challenge facing the world in terms of healthcare is in the area of Alzheimer’s disease (AD). Today there are 5.4 million Americans with AD. By 2050, that number will triple. The Alzheimer’s Association estimates that the cost of care of AD patients is over $180 billion annually.
The biopharmaceutical industry has been working for over 20 years trying to understand AD pathogenesis and develop medicines for it. Great work has been done in understanding the multiple mechanisms on how plaques form and then coming up with molecules that can stop disease progression, if not reverse it. Companies like Lilly, Pfizer, and J&J have advanced experimental medicines into the clinic and key compounds are in late-stage trials. However, the challenge in AD studies is that halting or reversing plaque progression doesn’t occur overnight. Thus, clinical trials are long, and it is not until you finish Phase 3 that you know if your drug worked.
John LaMattina, Ph.D.
Dr. John L. LaMattina is the former senior VP at Pfizer Inc. and president, Pfizer Global Research and Development. In this role, he oversaw the drug discovery and development efforts of over 12,000 colleagues in the United States, Europe, and Asia.
Q: Aside from layoffs, what are pharma companies doing to restructure their business models to be successful in the next 5 to 10 years?
Our 9th annual report of biomanufacturing shows that budgets for hiring operations staff are increasing among 29% of global facilities by 1% to 10%. The numbers are slightly rosier for hiring of new scientific staff. In fact, only 17% of companies are reducing their staffing budgets. Where companies put their budgets are an indication of short- and long-term solutions. Training for existing staff is playing a major role in the restructuring strategy, with 51% of manufacturers increasing training budgets this year. Thus, restructuring during the next 10 years is likely to include 1) hiring in the right areas, 2) laying off where core competencies are not valued, and 3) retraining of existing staff to do the critical, future work and attending various national training conferences to continuously educate on better training methods, technologies, and approaches.
Langer is president and managing partner at BioPlan Associates, Inc. He has more than 20 years experience in biotechnology and life sciences international marketing, management, market assessment, and publishing.