January 1, 1970 (Vol. , No. )
James C. Greenwood
This month the 2012 BIO International Convention will bring together a vastly transformed global industry poised to address the monumental public health challenges facing our world today. Since our event is taking place during a time of great change for our industry, I believe this is truly a can’t-miss opportunity to connect with industry leaders to accelerate your next breakthrough.
At this year’s Convention I personally would like to celebrate our accomplishments as an industry. Despite challenges with the funding environment and the numerous regulatory hurdles, biotechnology companies continue to move forward with promising R&D that could lead to tomorrow’s scientific breakthroughs, cures, and advanced medicines.
As an industry we need to focus on transforming the regulatory environment to ensure that we can continue to make scientific progress and encourage innovation that will lead to desperately needed cures for patients battling some of the most debilitating and life-threatening diseases.
In addition to producing the Convention, BIO educates and engages public policy leaders in Washington, in state capitols, and around the globe to advocate for policies that encourage innovation. Our overall goal is to improve the odds of success for biotech companies by encouraging investment in innovation and reforming the regulatory review process to ensure timely, science-based, and patient-focused decision-making.
Policies and a regulatory environment that encourage investment in innovation and speed discovery to scientific breakthroughs simply must be our priority.
To encourage innovation globally, harmonization of patent laws and standards throughout the world is imperative. Biotechnology companies depend on comprehensive and consistent patent rights and IP protection to create jobs and generate social and economic well-being. Enhanced international cooperation in patent procurement and enforcement provides greater incentives for the expansion of the biotechnology industry in the global marketplace. In addition, BIO continues to engage in U.S. and global trade negotiations.
The majority of industrialized countries are competing for biotechnology business development and seeking to grow the sector within their borders. Many countries and regions are showing a strong public commitment to funding basic scientific research to build and grow the industry around the world.
Despite the best efforts of industry, patient advocates, and academia, new drug approvals are not keeping up with investment in R&D. Sixty-one percent of venture capitalists now cite FDA regulatory challenges as having the highest impact on their investment decisions, and 40% expect to decrease investment in the development of new therapies, according to a recent BIO Industry Analysis survey.
The majority of drug development efforts do not succeed—less than 10% of therapies being developed for a specific condition or disease achieve regulatory approval, according to a BIO Industry Analysis/BioMedTracker study that looked at success rates between 2003 and 2010. The human suffering that is extended as a result of the length, complexity, and uncertainty of the regulatory process is unacceptable.
Perhaps the most promising signs for the U.S. industry may be the introduction of legislation that could transform the regulatory environment. Updating the Accelerated Approval process at the FDA so that it works in a transparent, predictable way for all therapies intended to treat a broader array of rare and debilitating conditions for which there is an unmet medical need is perhaps the most important legislative change that is needed right now.
Recently, Sen. Kay Hagan (D-NC) introduced S. 2113, the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act. This bill proposes to update the mission of the FDA to reflect its role in advancing medical innovation and establish a management review board to work with the Commissioner to consider structural changes at FDA. This transformation would allow the FDA to unleash the promise of 21st century medicines for patients living with debilitating diseases such as cancer, diabetes, Alzheimer’s, Parkinson’s, and HIV/AIDS.
In addition, the TREAT Act will help break the institutional barriers in order to speed new cures to patients most desperately in need. The TREAT Act also includes key elements to help the Agency integrate the most modern drug development tools and methodologies to ensure a science-based, patient-focused review process.
Senator Hagan’s TREAT Act and the recently introduced Faster Access to Specialized Treatments (FAST) Act, H.R. 4132, sponsored by Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY), would modernize and expand the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases, while preserving the FDA’s robust standards for safety and effectiveness.
Despite the challenging environment for capital formation, public policy, and regulatory issues, our industry continues to make breathtaking scientific breakthroughs. The ability of BIO members to continue our shared mission to heal, fuel, and feed the world depends on having an economic and public policy environment that supports research and development that leads to continued innovation
Jim Greenwood is president and CEO of the Biotechnology Industry Organization (BIO). For more on the 2012 BIO International Convention, click here.