A World without R&D

I've recently been inspired by a series of events, programs, and speeches on the importance of the discovery side of our industry. Over the summer, hundreds of individuals raised nearly $1 million in one week to save the laboratory site of Nikola Tesla, the late physicist and engineer whose work in the late 1800s and early 1900s formed the foundation for wireless and X-ray technology. The funds are to be used to purchase the land where Tesla worked and to build a museum in his honor. The interest and initiative taken by donors to keep a scientific legend's work alive is more than moving.

Angie Drakulich

New legendary scientists are being discovered every day. In September, I was lucky to be able to attend the PhRMA Research & Hope Awards ceremony in Washington, DC, where nine individuals were honored for their work in the fight against Alzheimer's disease, a disease that is not only plaguing healthcare systems and distressing caregivers worldwide, but that also presents complex scientific challenges. Also in September, 10 major biopharmaceutical companies formed a nonprofit called TransCelerate BioPharma, with the aim of accelerating the development of new medicines, with an initial focus on clinical trial execution.

This month, our Executive Editor Patricia Van Arnum will be in Madrid to meet the winners of the CPhI Worldwide Pharma Awards, which recognize companies that are breaking new ground in the manufacturing of pharmaceuticals, drug delivery, and sustainable packaging. Across the Atlantic, I will be meeting the recipients of the AAPS Graduate Student, Innovation, and Research Achievement awards in Chicago. The recipients of the various awards are dedicating their studies to improving pharma analysis, formulation design, drug delivery, biotechnology, product performance, and more.

All of the individuals working to identify new disease diagnostics and therapeutics, whether or not they are recognized on the global stage, serve as the backbone to this industry. For without new products to manufacture for patients in need, where would we be?

Just where R&D lies in America's future may very well depend on federal spending and support. With the US presidential election around the corner, I thought it important to examine where the country's candidates stand on this issue. Much has been said along the campaign trails regarding manufacturing and innovation, but the candidates' specific views on R&D and related federal spending do not always make the headlines.

Here are a few goals from Obama's court based on his FY2013 presidential budget proposal, which calls for $140.8 billion in overall federal R&D spending, an increase of $2 billion over the FY2012 enacted level:

• Enhance innovation in the manufacturing sector by supporting investment in new products, processes, and industries, and by investing in cross-cutting technologies

• At NIH, level funding for biomedical research ($30.7 billion); focus more on translational studies; and to get more out of funds, aim to increase the number of new research grants by 7%

• Provide $2.2 billion for federal advanced manufacturing R&D at the National Science Foundation, and 23 other agencies, a 19% increase over 2012. This includes funding for the National Institute of Standards and Technology to advance research in smart manufacturing, nanomanufacturing, and biomanufacturing

• Improve the patent system and protect IP by giving the US Patent and Trademark Office full access to its fee collections and strengthening its efforts to improve and speed patent reviews

• Help small businesses obtain early stage financing.

Both President Obama and Governor Romney support basic stem-cell research (in addition, Obama removed the federal funding ban on broader embryonic stem-cell research in 2009), and both candidates support making the research and experimentation tax credit permanent. Obama would also like to increase the alternative simplified credit from 14% to 17%.

Romney's official website includes his plan for American jobs and economic growth. The 160-page document includes language on R&D and basic research, but that language largely focuses on clean energy spending and technologies. The core policy sections of Romney's plan—tax, regulation, trade, energy, labor, human capital, and fiscal management—do not include medical research or science policy (other than from an educational standpoint), and my email request to the Romney campaign team about his take on NIH and FDA spending was not answered.

Media reports from earlier this year note that Romney would like to shrink the NIH biomedical budget. As governor of Massachusetts, however, he did support the state's biotech and life-sciences industry.

It will be interesting to see how the winning candidate's goals are carried out given that Congress largely controls the final federal budget. Let's hope that, no matter how Election Day turns out, that R&D still has a significant role.

Angie Drakulich is editorial director of Pharmaceutical Technology. Send your thoughts and story ideas to adrakulich@advanstar.com.