I apologize if some of my columns over the years have seemed a bit negative or critical.
As a publication, we started up at a time when thought leaders pointed out the seemingly limitless potential, and need, to improve and modernize manufacturing.
Since then, we’ve had more than enough reminders of where pharma is falling short: questionable marketing practices, failures to comply with quality standards, to investigate patient reactions, to vet suppliers, embrace new technology or assess potential risk. There’s variability everywhere, from the loading of active ingredient in generic medications to the quality of raw materials, to the way operations are carried out on individual lines and at different facilities.
As we start a new year, though, perhaps it’s a good idea to take stock of the very tangible results that all of you have achieved over the past few years. Over the last eight decades, your efforts have helped move the average life expectancy for the U.S. woman from 62 to 80 years.
Your products save lives. Vaccines alone save more than 2 million lives each year, according to the International Federation of Pharmaceutical Manufacturers and Associates (IFPMA).
In the difficult war against cancer, victories can also be mentioned. Despite failures, such as Merck KGaA’s proposed vaccine, new therapies are having some impact. Cancer death rates in the United States have dropped by 18% since the early 1990s, according to the American Society of Clinical Oncology, and two of three U.S. cancer patients live at least five years after a diagnosis (in the 1970s that figure was 1 of 2). Pharma needs to take a long-term view of its individual failures, as Takeda’s EVP, Tadataka Yamada, reminded senior managers at a recent New York Pharma Forum meeting “Pharma needs a willingness to fail and to fail often because success is built on the back of failure.”
Fortunately, new technologies for plant construction and single-use processing technologies allow companies to move on, faster and with less financial risk than in the past, as this month’s cover story makes clear.
In addition to addressing its fear of failure, Dr. Yamada said, pharma needs to develop better ways to measure success. “It’s easy to measure success by the number of product launches and INDs, he said, “but how about tracking the number of lives saved and the overall advancement of society? As an industry, we’re bad at that; we’re only following surrogate markers.”
He quoted Bill Gates: “Humanity’s greatest advances lie not in its discoveries but in how they are applied to reduce inequity,” arguing that revolutionary innovation, brought about by a sense of urgency and concern for the big picture, will be the key to pharma’s future success, and to transforming its public image.
While building capacity in emerging markets, he said, pharma companies must become partners in addressing these nations’ most pressing problem: The fact that 8 million children under the age of five die each year, unnecessarily, from easily preventable and treatable diseases. He also reminded pharma of ongoing challenges in developed markets, mentioning concerns about drug-resistant strains of tuberculosis.
It is you who will solve these problems on the ground, and continue to transform drug making into the efficient and reproducible process that it can be.
Here’s hoping that you won’t shy away from change, however difficult, or discourage its agents among you. Patients ultimately depend on you, and there’s just too much evidence that doing things differently pays off, whether that’s trying a Lean or Six Sigma approach, piloting QbD, or implementing a PAT method.
On a small and personal level, I am also writing to say goodbye. It has been an honor to help chronicle all the positive changes that you have been making. Manufacturing cannot be a stepchild in the industry of tomorrow, and this publication will continue to document change, both evolutionary and revolutionary.
