Long Live the Revolution! Goodbye and May 2013 Be Filled With Positive Change for All of You

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 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 increase the average life expectancy in the U.S. by almost 20 years.

Your products save lives.  Vaccines alone save over 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 U.S. have dropped by 18% since the early 1990s, according to the American Society of Clinical Oncology, and two of three U.S. cancer patients lives at least five years after a diagnosis (in the 1970’s that figure was 1 of 2).  
http://www.cancerprogress.net/pdf/CCA_2012.pdf

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. He praised revolutionary change but urged greater tolerance of the failures that inevitably accompany it. “Pharma needs a willingness to fail and to fail often because success is built on the back of failure,” he said.

In addition, 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 IND’s, 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. 

“We need to think of this problem with the same sense of urgency that we view buyers, government, regulators and our competitors.”  
 
Do hope this doesn't sound too corny, but (organ music, please) it is you, the professionals in charge of manufacturing, development and quality operations, 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 Quality by Design for a new process or product, or implementing a process analytical technology (PAT) method.

On a small and personal level, I am also writing to say goodbye.  I'm leaving the publication to pursue a new career opportunity. It has been an honor to help chronicle all the positive changes that you have been making, for nearly 10 years.  Manufacturing cannot be a stepchild in the industry of tomorrow, and this publication will continue to document change, both evolutionary and revolutionary.  Thank you for sharing examples, despite your challenging workaday lives, and the rigors of corporate review, and please continue to do it! I remain an unabashed fan of yours, and you can reach me at agnesshanley@gmail.com. 
 
Agnes Shanley