Abstract
“Bottom line, it's a productivity issue.”
Introduction
In July 2003, ALA President Tony Beugelsdijk announced that the organization was launching a new conference: ALA LabFusion 2004 is slated to debut in Boston from June 12-16. As these dates grow near, Dr. Beugelsdijk and others share insight into why this event represents an important milestone for ALA and the field of laboratory technology and automation.
Productivity pressures
The art and science of drug discovery and development exist on a continuum that often requires an average of about 8 to 12 years to complete (Fig. 1). According to Peter Grandsard, Ph.D., of Amgen, the 2004 ALA president and associate program chair for ALA LabFusion 2004, for the past 10 years or so, most laboratory automation efforts have focused on the early stages of the process of therapeutic discovery and development. Says Dr. Grandsard, “The target discovery and high-throughput screening for small molecule hits or binding antibodies were logically the first to incorporate new technology to get more done in a shorter period of time. Expanding and speeding up hit-to-lead operations followed soon. These high-throughput functions are still essential, but today, biopharma R&D (research and development) professionals are looking for ways to use technology and automation further into the lead optimization and supporting pre-clinical processes. They're looking for ways to fail faster in order to succeed faster.”
“Bottom line, it's a productivity issue,” adds Dr. Grandsard. “Productivity, i.e., a ratio of output over input, has diminished.” For example, according to the U.S. Food and Drug Administration (FDA), the number of new drugs approved each year has increased from about 20 in 1980 to about 30 in 2002. In the meantime, according to information from the Pharmaceutical Research and Manufacturers of America (PhRMA), the amount of money spent on R&D has gone from about $2 billion to $35 billion.
The art and science of drug discovery and development exist on a continuum that often requires an average of about 8 to 12 years to complete.
“ALA members work at the front lines of these productivity challenges,” says Grandsard. “They're mission critical when it comes to productivity. Companies rely on their informed ingenuity to solve these challenges, improve operational efficiencies, or even enable new R&D processes.” The September/October 2002 Impact Report from the Tufts Center for the Study of Drug Development estimates that if more productive discovery programs or better pre-clinical screens could boost clinical success rates from one in five to one in three, the capitalized total cost per approved drug would be reduced by as much as $221 million to $242 million. In addition, it projects that shifting just 5 percent of all clinical failures in phase III/regulatory review to phase I would reduce out-of-pocket clinical costs by up to $20 million. The report goes on to recognize that, in addition to other factors such as changes in public policy and management, new technology can be a key factor in achieving new efficiencies.
The 2003 PhRMA Pharmaceutical Industry Profile points out that “more sophisticated science, more complex disease targets, a more intensive regulatory process, and a growing need for more elaborate data have increased the length, complexity and cost of the pharmaceutical research and development process.” “ALA recognizes these developments and this shift, or expansion, in the focus and priorities of its members, especially those in biopharma, and ALA LabFusion is its response,” says Dr. Beugelsdijk. “ALA LabFusion begins where ALA LabAutomation ends. Of course there is some overlap, but in general, ALA will begin its educational year in February at ALA LabAutomation with an emphasis on the front-end of the discovery process. Then, in summer, we will pick up where we left off, and focus on practical applications for the later stages at ALA LabFusion. In the meantime, throughout the year, we have JALA.”
“The educational program for ALA LabFusion 2004,” says Dr. Grandsard, “is a natural extension of the annual ALA educational menu. It is being designed in direct response to our members new and emerging interests in the later stages of discovery and pre-clinical development. For example, automation specialists will be able to learn about technology applications in process chemistry, the pharmacokinetics, drug metabolism, and toxicology labs. It delivers meaningful, first-class education, and offers attendees time and opportunities to network one-on-one with established experts in the field, or with each other.”
Fuel for the r&d fire
The focus of ALA LabFusion 2004 lies squarely on practical applications in the areas of functional screening (e.g., cell-based assays or assays in animals). Says Dr. Grandsard, “Where ALA LabAutomation exposes scientists to new and emerging technologies, ALA LabFusion explores real-life case studies of how those technologies are being successfully applied, for example, to ADME/Tox testing (i.e., absorption, distribution, metabolism, excretion, and toxicity assays including sample preparation).”
“It's more of a product-oriented approach,” adds Dr. Beugelsdijk. “Members want to learn how to increase the chances that their high-throughput screening is aimed in the right direction; to reduce time spent chasing in the wrong direction. And then, even when their science is on target, they need ideas and advice to help them introduce new technologies for validation purposes. They need to satisfy the increasingly rigorous requirements of the FDA (U.S. Food and Drug Administration).”
Another unique dimension of ALA LabFusion 2004 is that it offers a business-oriented track to complement its scientific tracks. Says Dr. Grandsard, “As ALA scientists and engineers find themselves working furiously on therapeutic discovery or development, their efforts may be insufficient to satisfy the business expectations of their company managers, boards, and shareholders. Scientific teams are under pressure from their companies to shorten time to market, fill their pipeline and sustain growth. Often, this means acquiring new compounds or entire companies that have end-stage products ready and waiting. It may also mean that technology platforms need to be added to a company's organization. This business track will discuss methods for acquiring and implementing technologies, for example, through outreach to external partners.”
“The same kind of reasoning often applies to technology,” adds Dr. Beugelsdijk. “At some point, when it's clear that a technology has matured, it may become time to incorporate that technology into a company's infrastructure. The ALA LabFusion 2004 business track explores rationale and offers insight into these types of decisions as well, including how to break new ground with the FDA.”
Why boston?
“It was easy for ALA to decide to locate ALA LabFusion in Boston. Boston, Massachusetts, and the New England corridor in general have become an impressive hotbed for biopharma,” says Dr. Beugelsdijk. Barbara Berke, Director of the Massachusetts Department of Business and Technology, a division of the Massachusetts Executive Office of Economic Affairs, made the case in a presentation to a group of laboratory automation professionals in October 2003.
According to Berke, the Massachusetts market possesses unrivaled technology strengths in software, biotechnology, sensors, plastics, precision manufacturing, and clinical research. Collectively, these strengths offer, among other things, a convenient supplier network for faster product development—all of which are being successfully leveraged by lab automation and robotics initiatives.
In recent years, Massachusetts has witnessed the highest biotech venture capital financing per capita in the U.S.: $3 billion was invested between 1995 and 2003 alone. As a result, the state is home to 320 biopharmaceutical companies, 112 medical device companies, and 55 related life science companies.
It is also home to a highly trained workforce. Massachusetts leads the nation in intellectual capital: 25 percent of its population possesses a four-year college degree, 18 percent has a graduate degree, and there are 5.4 biology Ph.D. awards per 100,000 residents. These people have been busy too. From 2000 to 2003, Massachusetts companies secured nearly a quarter of the patents granted to life sciences companies: 487 of 2264. In 2001, $1.2 billion in funding from the National Institutes of Health (NIH) and $167 million in 633 awards from the U.S. Department of Defense Small Business Innovation Research (SBIR) Program went to companies in the Boston area alone.
“Geographically, Boston is also convenient,” adds Beugelsdijk. “It's easy to access from most points in North America and it's easy for people traveling from Europe. In addition, because ALA LabAutomation traditionally is held in California, an east coast location for ALA LabFusion is a nice, balanced complement.”
A Variety of voices and visions
Members of the ALA LabFusion 2004 Scientific Committee, the team primarily responsible for shaping the event's educational program, represent a diversity of companies and interests. Members of the committee include:
Carmen Baldino, Ph.D., of Arqule in Woburn, Massachusetts.
Tony Beugelsdijk, Ph.D., M.B.A., of Los Alamos National Laboratory in Los Alamos, New Mexico.
Andrea Chow, Ph.D., of Calipher Life Sciences in Mountain View, California.
Rod Cole, Ph.D., of Arqule in Woburn, Massachusetts.
Peter Grandsard, Ph.D., of Amgen in Thousand Oaks, California.
Carol Homon, Ph.D., of Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut.
Brian Lightbody, Ph.D., of Calipher Life Sciences in Boston, Massachusetts.
Timothy Olah, Ph.D., of Bristol-Myers Squibb Pharmaceutical Research Institute of Princeton, New Jersey.
Scott Patterson, Ph.D., of Amgen in Thousand Oaks, California
Robert Pacifici, Ph.D., of Eli Lilly in Research Triangle Park, North Carolina.
John Stults, Ph.D., of BioSpect in South San Francisco, California.
Sabeth Verpoorte, Ph.D., of the University of Groningen in The Netherlands.
The primary sponsor for ALA LabFusion 2004 is Calipher Life Sciences. “At Calipher Life Sciences we believe the future of our industry lies in emerging technologies, such as microfluidics, that will change the way researchers approach biotechnology and pharmaceutical development,” says Calipher Life Sciences CEO Kevin Hrusovsky. “The creation of ALA LabFusion, which focuses on applications of up-to-date and cutting edge technologies, will facilitate adoption of these key technologies by bringing together the research scientists, manufacturers, and industry experts who are leading these changes.”
At press time, confirmed sponsors-at-large included Bristol-Myers Squibb. In addition, the Laboratory Robotics Interest Group (LRIG) and the LIMS Institute had signedon as “Friends of ALA LabFusion,” with plans to schedule complementary events for their members in conjunction with the ALA LabFusion 2004 conference.
For more information
For complete ALA LabFusion 2004 program and registration information, visit http://labautomation.org.
For ideas about things to see and do while visiting Boston, go to http://www.bostonusa.com.