Journalist Resources

Read Mr. Avellanet in Pharmaceutical Manufacturing in a FDA data integrity, validation, and litigation interview (PDF) or listen to the interview with PharmaQbD.

Suggested Interview Questions for John Avellanet:

• You claim to have designed a new medicinal product process – your 21st century new medicinal product development funnel – but realistically, how can you make drug discovery or device engineering “new”?

• Market analyses and reimbursement considerations are common activities as new medicines approach market launch, yet you encourage firms to assess these as early as possible, preferably before they even started testing the new medicine in humans.  Won’t this lead to potential new medicines being shelved because of concerns over profitability?  How will executives avoid accusations of putting profits before patients?

• Shareholder lawsuits and activist investors are often seen as distractions to companies trying to follow the science and engineering to come up with new medicines.  Aren’t the processes and frameworks your proposing – the voice of the customer, the increasing role of reimbursement, and so on – going to give shareholders and investors a greater chance of disrupting innovation inside those companies who adopt this new development framework?

• FDA approval processes seem, at best, a mystery to anyone outside the agency.  Yet you claim that companies who’ve followed your advice have seen better approval success rates and faster time to market.  How can you substantiate this?

• We all know that people use the Internet more and more for health research, but you claim that companies should – instead of fearing this – embrace this and ask people – “pre-informed patients” as you call them – to help design and develop new medicines.  Won’t this run afoul of FDA rules prohibiting marketing unapproved medicines?

• The FDA is stepping up its enforcement, particularly under Commissioner Hamburg.  You’ve argued that firms can minimize their risks of noncompliance by taking a more cross-functional, more holistic view of compliance.  How does that actually work?  Aren’t you stretching it?

Potential Story Angles

• Healthcare Costs Can be Lowered with Advice from Get to Market Now! Because healthcare costs are driven in large part by the high cost of developing new medicines – and paying for those new medicines that did not pan out – pharmaceutical and device firms can help contribute to a lowering of healthcare costs while still retaining or even improving their profit margins by adopting advice from the new book Get to Market Now!

• Improving New Drug Development Pipelines. Biopharmaceutical industry news is full of the decline in R&D productivity in big pharma.  FDA staffers claim their approval numbers are down because “less new drugs are being submitted.”  Author John Avellanet’s new book, Get to Market Now!, offers solid advice, research, and insights on specific steps executives can take to improve their new drug development pipelines without searching for one merger after another.

• Get to Market Now! Provides Executives Advice on Minimizing Risks of Shareholder and Investor Lawsuits. Investors and shareholders are increasingly claiming that FDA compliance related issues are “material information” that need to be disclosed by companies to investors.  When executives downplay or otherwise ignore this to issue rosy predictions, a lawsuit is sure to follow.  Nor does it help that investment firms are increasingly realizing the link between a firm’s compliance status and its ability to get new medicines on the market (and thus profitability).  Get to Market Now! provides executives strategies to manage compliance and balance practicalities with profitability.

To arrange an interview, you may contact Logos Press, the publisher of Get to Market Now!, or contact the author directly.