KEY TAKEAWAY: There are numerous books on the market that skewer Big Pharma, but they really only scratch the surface of a deep-seated affliction. Find It, File It, Flog It: Big Pharma’s Crippling Addiction and How to Cure It examines an industry model that has not changed since the 1950s and offers practicable solutions for transforming it.
- First, tell us a little bit about yourself
Well, for the past ten years I have been an independent consultant in supply chain management, operating through my company PharmaFlow, principally supporting companies developing and commercializing drugs.
Prior to that, I directed supply chain management activities at a number of high profile Biotech companies, and in 2004 was supply chain lead on the successful launch of OSI Pharmaceuticals’ drug Tarceva (a drug to treat non-small cell lung cancer) in the US, in collaboration with the marketing partner, Genentech.
My days in Biotech were preceded by sixteen years at Bayer in the UK, where I joined as an industrial engineer and progressed through the various supply chain disciplines, to become the site lead for the global supply chain in 1990. During that time I was fortunate to be sponsored by Bayer through an Executive MBA at Cranfield School of Management.
As well as advising companies, I deliver presentations on the web and at international conferences. From 2010 to 2014, I served as co-chair of the annual FDA/Xavier University-sponsored PharmaLink Conference in Cincinnati.
- Why did you write this book?
It’s a long story, but I will try to keep it brief! I moved into the world of drug development in the mid 1990s, having spent early career working in other sectors. To my horror, I discovered the only thing on the minds of those running the companies was amassing clinical data to get their drugs approved to keep themselves and their investors happy; patients didn’t appear to matter, neither did health-care professionals, and certainly not the integrity of their supply chains (my specialist subject). I wrote a book, Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics published by Wiley in 2011. It highlighted a lot of the issues and aspired to catalyse change in the industry. Very few bought it as it was expensive, quite technical and presented some difficult messages for the industry.
As matters got progressively worse over the ensuing years, I resolved to write a much more explicit, easy to read book that would be difficult to ignore, because it was accessible to those crying out for change; patients, Health-care professionals and, dare I say it, politicians. Find It, File It, Flog It is the result.
- How can people who work within Pharma learn from your book?
The over-arching learning is that the present model for developing drugs is completely broken. Seeking out and patenting chemical compounds, then putting the skids under them to get them approved, and marketing the bones out of the one in 250 that is eventually approved, is not the way of the future.
A major lesson in the book is that scientific invention is confused with innovation. How many times have we seen major medical breakthroughs plastered all over the media, never to be heard of again?
This is the thing, Richard; science is only the starting point. We need people steeped in the hard yards of converting good ideas into marketed products—engineers and technologists—to turn the invention into a true innovation in the marketplace; and people with these skills are not valued in Pharma.
To address this, the final section of the book, Future Pharma, offers a totally new model for drug development. Early stage prototyping is a key component, requiring those who invented the drug molecule to stay with it and help prove it is a viable option. In doing this, we abandon the ‘discovery research’ and ‘development’ silos in favour of a single ‘design’ activity. Crucially, no prototype molecule would move into commercial production unless those responsible for converting the prototype into a marketed product agree that it has an acceptable probability of getting to market.
These are hard lessons for an industry in denial, but those learning them will reap massive reward.
- The industry, at least here in the US, is going through consolidation and change. What do you see as the challenge for Pharma?
The challenge, Richard, is that the industry is blind to the impotence of horizontal integration. What is happening now, a la Pfizer/Allegan and the many other M&As on the table, and those gone before, is merely a smokescreen for investors.
What has actually happened, over the last several decades, is that Big Pharma has divested the very people and facilities required to develop new drugs. Without that capability under their belt, they have to depend on a cadre of third parties companies working (people that used to work for them) on a fee-for-service basis to carry out the vast majority of product development. The issues of poor communication, disconnection, and lack of ownership are immense and have resulted in what is commonly known as the valley of death, which in turn gave birth to the patent cliff.
There is another challenge too. By dropping products once out of patent, the Big Pharma companies have distanced themselves from once loyal customers. Over 80% of products are now in the hands of generic companies. The current trend appears to be squeezing as much as possible from shrinking markets by charging eye-watering prices to those unlucky patients that are left.
In summary, re-integration must be the name of the game, accompanied by Big Pharma’s commitment to service their loyal customers with fit-for-purpose products.
- Do you think that most patients are becoming “consumers of health care?”
There is indeed movement from patients, patient advocacy and other stakeholder groups to place patients at the center of Pharma’s raison d’etre. However, in practice, not a lot is changing. As we learned above, the model for developing new products is as it has always been; and until that changes, we will have the same old, same old…
I should say, however, that even if Pharma were to place the patient as its central focus, this is only a small part of the problem. The main issue is that health-care professionals are generally ignored during development of drugs (aside form a small number of investigators appointed by the Pharma companies). Physicians get a fait accompli thrust upon them based upon what Pharma ‘believes’ they need. Find It, File It, Flog it spells out how both health-care professionals and patients can push back on Pharma with remarkable effect.
- Where can people purchase your book?
It is available on Amazon, Amazon Kindle and from most major booksellers