Our knowledge and advances in science and technologies have given mankind the keys to unlock the secrets of a host of life-impairing and life-threatening diseases. Translating these new discoveries into new medicines is the mission of the world’s biotechnology and pharmaceutical companies. But progress is still slow. It can take more than a decade to develop a new medicine. Many biotechs begin as small, fragile companies with limited resources and staffs. Working alongside these companies are national biotech and pharmaceutical trade groups which work as partners to help advocate for the needs of these companies. The challenges faced by drug developers can be unique in different countries which may have various regulatory and approval processes, reimbursement policies and access to investment capital.
As part of a new series WuXi AppTec has interviewed national leaders of drug development trade groups to highlight how potentially life-saving companies operate in different environments and what they can learn from each other. One of them is Jim Greenwood, president and CEO of the Biotechnology Innovation Organization (BIO) in Washington, D.C. BIO represents 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 countries worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, and industrial and environmental biotechnology products. Greenwood represented Pennsylvania’s Eighth District in the U.S. House of Representatives from 1993 to 2005. Since 2005, his deep relationships on Capitol Hill and knowledge of politics and policy have substantially raised BIO’s profile and enhanced the organization’s advocacy work.
WuXi AppTec recently talked with Greenwood about the current state of the industry, the upcoming BIO International Convention, and how China is an important partner in bringing new drugs to market.
WuXi: BIO’s International Convention is taking place this week in Boston. What can attendees expect this year?
Jim Greenwood: Boston is the world’s epicenter of biotechnology innovation and is a prime location for this year’s Convention since the city is home to nearly 1,000 biotech companies, academic centers, hospitals and life science centers. Over the last decade, Massachusetts has become a powerhouse for industry growth. There are more R&D employees in Massachusetts than in any other state. The life sciences industry has grown 20% over the last four years, adding 11,500 workers.
Attendees can look forward to a keynote address from Robin Roberts, co-anchor of ABC’s Good Morning America, an FDA Town Hall, fireside chats and dozens of breakout sessions with global biotech and pharma leaders who will discuss everything from innovation to the latest trends and topics being debated on Capitol Hill. Must-see experts include Sue Desmond-Hellmann, CEO of the Bill & Melinda Gates Foundation, and Penny Heaton, CEO of the Bill & Melinda Gates Medical Research Institute, who will discuss the mission and vision for the Institute, how they are working to advance medical breakthroughs, and championing issues that affect women around the world. Check out the agenda here. All told, I’m most looking forward to the engaging exhibits like the Patient Advocacy Pavilion, Emerging Innovators Zone, Digital Health Zone, and Start-Up Stadium – a competition where startups present to leading subject-matter experts in the industry and receive feedback in real time. Anything can happen when BIO’s One-on-One Partnering™ system is involved, which will facilitate nearly 1,300 partnering meetings per hour during at this year’s Convention.
We’re also pursuing GUINNESS WORLD RECORDS™ official attempt for the “Largest Business Partnering Meeting” ever to take place. Adding this milestone would speak volumes – literally and figuratively – about the rapid growth of the biotechnology industry since BIO was formed 25 years ago. It will be a fun, exciting, and productive event, as always, and we hope to see many of your readers there this week.
WuXi: These are, indeed, exciting times. What are some of the recent major scientific advances you’ve seen in the global industry?
Jim Greenwood: I’m proud to say that our industry has opened the doors to a new era of medicine. The therapies coming to the market and in clinical development today are unlike any we’ve seen in the history of medicine. Right now, our industry has nearly 6,000 new treatments in the pipeline for a wide range of life-threatening or debilitating diseases. We have pioneered immuno-oncology – in which we attack cancer by activating the body’s own immune system against it, while leaving healthy cells alone. Another example is cellular therapies – in which we use a patient’s own cells to develop a medicine tailored specifically for them.
Another transformational new area of biotechnology is that of genome editing techniques such as CRISPR, which allow us to revise, remove, and replace defective DNA – territory in which humans have never gone before. Genome editing research is under way with treatments for devastating diseases like sickle-cell disease, cystic fibrosis, congenital blindness, and hemophilia. Last year, the first genome editing clinical trials began to treat a rare metabolic disorder known as Hunter Syndrome. We’ve already seen the first wave of these advances reach the marketplace, and many more are moving through the FDA’s regulatory process, including novel medicines to treat childhood leukemia and other devastating diseases. We’re hopeful that the near-future delivers real results for patients in need.
WuXi: Drug discovery takes time. Does that drive investors away? Or is there enough incentive to invest in the development of new medicines and cures?
Jim Greenwood: Drug discovery is an extremely expensive, time-consuming, and risky endeavor – as The Economist put it, “creating new drugs through biotechnology is at the risky end of a business in which superhuman stamina and bottomless pockets are minimum requirements.” One fact that many people may not be aware of is that more than 90 percent of drug companies are unprofitable, and the biopharmaceutical industry ranks 36th (out of 126 industries) in terms of aggregate profitability – behind sectors such as food, retail, auto parts, and apparel/footwear. Our industry, thankfully, is in the business of saving and improving lives, which is why we continue to drive the profits we make back into the important research and development process. In fact, the biopharmaceutical industry has the highest percentage –approximately 23% – of R&D reinvestment of any US industry. To that end, biotech investors – like all investors – expect a reasonable return on their investments, free from artificial, government-imposed restrictions or erroneous assumptions about investment returns. Since drug development requires, and receives, the highest levels of R&D reinvestment of any industry, the pricing for new medicines must reflect the need to sustain this critical innovation ecosystem. Revenues from the few successes are needed to reward past investments and to attract new investments to finance future research and development programs for patients in need.
WuXi: How would you describe the biotech industry in the US?
Jim Greenwood: The United States is home to thousands of biotechnology companies – large and small – engaged in some of the most challenging, cutting-edge research in the world. They take enormous risks every day to develop the next generation of breakthrough medicines and cures for the millions of patients suffering from diseases for which there currently are no effective cures or treatments – the work they do is truly remarkable. While modern biotechnology in America is a young industry, in just a few decades, the entrepreneurs, scientists, researchers and investors working in this field have firmly established themselves at the forefront of medical innovation. In fact, our nation delivers more new drugs than the rest of the world combined, and almost 60 percent of all new medicines that treat patients across the globe are discovered and developed here in the United States. The United States has developed a public policy environment that incentivizes investment in innovation. Congress generously funds the National Institutes of Health which invests heavily in academic basic research, and we financially incentivize the transfer of patents developed in universities to private biotech companies. We provide federal grants to startup companies, protect intellectual property, and allow market-based pricing and reimbursement. Our Food and Drug Administration is well funded and staffed with highly competent and knowledgeable scientists, so that new drug applications can be thoroughly reviewed and promptly approved. These policies and institutions allow America’s biopharmaceutical industry work hard to change the way we treat and cure disease here at home and around the world.
WuXi: At this moment, is there any particular issue that you see most important for the industry to address?
Jim Greenwood: It’s estimated that more than 1,000 men and women are treated in emergency rooms daily for misusing prescription painkillers; and as a nation, we’re spending over $500 billion annually in health and social costs to combat this epidemic. Opioid abuse and addiction in America has reached epidemic heights and must be handled with urgency. Preventing addiction to pain medicine and treating various forms of addiction relies upon smart science and a regulatory environment that promotes pain management and addiction treatment alternatives. We must also ensure investments in the research and development of new, less-addictive cures and therapies is on par with other prevalent disease areas. Biotech companies are answering the call. Over 70 companies, with more than 100 clinical programs, are working on novel pain therapies with the potential to transform the standard of care for pain treatment. One such technology is an injectable that treats knee pain using capsaicin, a by-product produced by chili peppers. The evidence shows that there is a great deal of work remaining to be done. As a recent BIO report showed, over the last 10 years, venture investment in cancer treatments was about 17 times greater than investment in pain management programs, and venture capital investment in new addiction treatments has been virtually non-existent. Given the enormous personal costs of this epidemic in terms of lost lives and suffering family members, and the tremendous economic costs of this epidemic, that disparity should be unacceptable. We can innovate our way out of the opioid crisis, but to do so we must face the challenges that stand in our way. The good news is that Congress is taking action. The need for bold action to address this crisis is one of the few areas of bipartisan agreement in Washington these days. Both the House and the Senate are currently working on legislation that will address the problem from many different angles, including by encouraging increased investment and innovation, and by improving access to both safer pain treatments and to medication-assisted treatment for those suffering from addiction.
WuXi: You spoke at the 2018 WuXi Global Forum during JP Morgan week in San Francisco. How important is US and Chinese cooperation going to be in the future in bringing new medicines to market?
Jim Greenwood: China has made tremendous progress in clinical and scientific research, and its healthcare market is growing rapidly with no signs of slowing down. But neither the US, China nor the EU have a monopoly on the financial or human capital that 21st century innovation requires; and the business realities of our industry require us to be collaborators. Advances in genomics, precision medicine and regenerative biology have brought us to the doorstep of a new golden era of treatments and cures, and we must work together to bring these products to the market for our patients. That future will only come about with thoughtful and efficient regulatory policies, predictable payment systems that value innovation, and strengthened global collaborations. China can play a major global role in helping to bring new therapies to millions of people around the world. Helping countries work together to accomplish these goals is one of BIO’s top priorities in an increasingly interconnected world.