This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories from BIO’s past.  To learn more about BIO’s history and our 25^thAnniversary visit our interactive historical timeline.

Reprinted from BIONews, August/September 1997

BIO ’97 was held in Houston, TX.  The opening party featured BIO staff members riding in on horseback carrying a “Biotechnology Industry Organization” flag.

We make no promises that there will be horses at BIO2018, but we can guarantee Diana Ross!

]]> https://www.biotech-now.org/corporate/2018/03/flashback-friday-bio-97-rodeo-ranch-party/feed 0 27714 https://www.biotech-now.org/corporate/2018/03/flashback-friday-how-fda-is-changing-its-regulation-of-biotechnology?utm_source=rss&utm_medium=rss&utm_campaign=flashback-friday-how-fda-is-changing-its-regulation-of-biotechnology https://www.biotech-now.org/corporate/2018/03/flashback-friday-how-fda-is-changing-its-regulation-of-biotechnology#respond Fri, 09 Mar 2018 20:11:00 +0000 http://www.biotech-now.org/?p=27631 This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories ...]]>

This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories from BIO’s past.  To learn more about BIO’s history and our 25^th Anniversary visit our interactive historical timeline.

Reprinted from BIONews, February/March 1996

HOW FDA IS CHANGING ITS REGULATION OF BIOTECHNOLOGY

By David A. Kessler, M.D.,  Commissioner, Food and Drug Administration

For the last several years, the Food and Drug Administration (FDA) has been re-examining and reforming some of the ways it regulates bio­logics, including medi­cines made through biotechnology. In the past few months, there has been considerable change in the way FDA deals with these products, and the result will be faster and more target­ed reviews that save biotech compa­nies time and money as they bring needed therapies to the public.

Many of the ideas came from pro­ductive discussion between FDA and the biotechnology community that led FDA to promise certain changes. Today, I can report that we have delivered on those promises. For the changes that have yet to be fully implemented, we are still on target for completion in the time-frames promised.

It is important to remember that everything we do as we modernize our biologic approval process builds on this agency’s fundamental mis­sion: to protect consumers from products under our jurisdiction that are not safe or do not do what they are supposed to do and, at the same time, to promote the public health by getting therapies to consumers as quickly as possible.

This commitment to high standards for safety and efficacy has served consumers well and it has served indus­try well, too. FDA-approved products are the gold standard of the world. Our second responsibility ─ to get products to patients expeditiously ─ requires that we strip away unnecessary regulatory and procedural hurdles. This not only allows industry to move promising products from the bench to the bedside efficiently but also enables FDA to use its limited resources well.

So, what have we done to achieve this? The changes started early last year when the Center for Biologics Evaluation and Research (CBER) addressed two of industry’s concerns. First was the licensure of small-scale or pilot plants. For some biologic prod­ucts, indust1y had to actually build a large-scale production plant before it could receive marketing approval. That led to a few costly mistakes when con­struction started before the drug was shown to be safe and effective. Now, for well-characterized biotech medicines, the pilot plant can be sufficient to win marketing approval.

CBER’s second decision was to sep­arate the filing of a product license application and an establishment license application-PLAs and ELAs. In the past, the FDA required that PLAs and ELAs always be submitted together from the same company, a policy that prevented indust1y from submitting one or the other application when it was ready. We modified that policy so that the two applications could come in at separate times. This could allow a company to receive earlier feedback from FDA on an application than it would have previously.

After additional study, we an­nounced several new measures in November that represent the most sig­nificant overhaul of the regulation of biotech drugs that the FDA has ever attempted. As biotechnology became more sophisticated, it became possible to characterize some biotech drugs as accurately as a traditional chemical­based medicine, suggesting that the two types of drugs could be regulated in the same way. As a result, the agency decided that it could drop the ELA requirements for well-character­ized biologics while not compromising the quality of these products. The pro­posed rule dropping that requirement was published on January 29 of this year. It must still go through a com­ment period and final rulemaking, but the process is well on its way.

In addition, FDA promised to consolidate the 21 different product and establishment license application forms that were used for biological products into a single form that could be used by both CBER and the Center for Drug Evaluation and Research (CDER). The draft form is now available for use for well-characterized biotech drugs. It is now available through CBER’s fax-on­demand system. It, too, will be going through clearance for publication in the Federal Register.

At this point, if a company has a well-characterized biologic for which it is ready to seek a PLA, and the agency agrees that the compound is well characterized, then the company only has to file the new single form. CBER is working with companies to make this transition period as smooth as possible. It is even likely that companies just entering the review process may never need to think about ELAs because they will have been eliminat­ed by the time the product is approved. Of course, if some problem shows up in the rulemaking, ELAs may last longer than any of us expects.

We made several other announce­ments in November including the decision to no longer require biotech com­panies to seek approval to release each lot of a well-characterized biotech product, and the elimination of the need for companies to submit all of their promotional labeling to FDA for pre-approval before they launched a new product. Final rules need to be written, but the process is well along.

Lastly, we promised in November that we would respond to new information submitted by companies in response to a clinical hold within 30 days. We are now doing that. Both CBER and CDER have committed to that response time and are now work­ing on needed internal procedures.

As the discussion between the agency and industry continues, we need to think beyond terms like ELAs and PLAs and focus on the science and the medicine, and then ask what we need to know to determine whether it is safe and effective, and what is the most cost-effective way for the company to submit its infor­mation so we can make good, fast decisions.

The notion that one regulatory struc­ture fits all biologics is outmoded. We simply cannot assume that the ways we have regulated biologics in the past will work for the future. And we no longer are assuming that. I think you will find that this agency recognizes that we need to be flexible enough to, as much as possible, tailor our policies to specific product lines so that safe and effica­cious medicines reach consumers as quickly and efficiently as possible.

This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories from BIO’s past.  To learn more about BIO’s history and our 25^th Anniversary visit our interactive historical timeline.

Reprinted from BIONews, April/May 1996

GETTING TO THE GRASSROOTS OF THE MATTER

By Patrick Kelly, Grassroots Manager

It was three hours before the recent Senate Labor and Human Resources Committee mark-up on Chairperson Nancy Kassebaum’s (R-Kan.) FDA reform bill. BIO learned that Senator Edward Kennedy (D-Mass.), the committee’s ranking Democrat, would offer amend­ments that could have a negative impact on our industry. Responding to this emergency both challenged BIO’s grassroots advocacy network and demonstrated its value to the industry.

What did we do? An “Urgent Alert Memorandum” was sent to BIO’s 85 advocacy liaisons in Massachusetts asking them to contact Senator Kennedy’s office and urge him not to introduce his amendments. Our liaisons responded in force, deluging the senator’s office with faxes and phone calls about the effects of the proposed amendments on his home state industry.

And Senator Kennedy listened. He agreed to hold off on his amendments and to work with other members of the committee to resolve his concerns. The bill was approved by the committee by a vote of 12-4 ( with Kennedy voting no), clearing the way for a vote by the full Senate.

This was a textbook example of how the BIO grassroots network can be mobilized at almost a moment’s notice to perform tasks critical to BIO’s legislative goals.

Since the playing field has been leveled somewhat by lobbying reform, many companies and trade associations are scrambling to organize grass­roots programs. Whether it’s by phone in the last minutes before a crucial mark-up, or face-to-face in a more relaxed district meeting, constituents command a significant amount of influence over the decision-making process.

Because BIO has been committed to this strategy since its incep­tion almost three years ago, we’re several steps ahead of the game. Now, we are fine-tuning our network to increase communications between BIO members and legislators at both the state and the federal levels.

We are also adding individual company facility information (in addition to our existing database on company­wide data) to our grassroots database to more adequately represent the biotechnology presence in states. We also recently published the “BIO Grassroots Lobbying Manual,” and the “State Captain and Advocacy Liaison Directory.” These were sent to all 300-plus advocacy liaisons.

Companies can participate in the BIO grassroots advocacy network in a variety of ways. First, designate an advocacy liaison-your company’s primary government relations person or anyone with an interest in external advocacy­and forward his or her name to us.

Second, get to know your senators and representatives. Invite them  to tour your facility and visit with your employees. You can also participate in BIO-sponsored events like the next congressional fly-in (September 18, 1996, in Washington) and the annu­al BIO Grassroots Conference (October 9-11, 1996, in San Diego).

In the coming months we plan to schedule district office meetings to inform key members of Congress about our FDA reform agenda. In September, at the BIO Fall Conference, we also plan to conduct a fly-in to Washington that will allow our members to meet with senators and representatives to discuss biotech issues. We hope you will participate.

Editor’s Note: The 21^st Century Version of this tool is called BIOAction (no faxing involved).  To sign-up text BIO to 52886 or visit www.bioaction.org. 

With the Olympic Games concluding this week in South Korea, the pomp and circumstances in Pyeongchang are certainly emblematic of the country’s place as an influencer on the global stage. However, the country has focused on more than winter sports these last few years. They have also developed a golden biotech industry focused on strong commercialization and global partnerships. With roughly 5% of the country’s GDP spent on R&D, the industry breakdown consists of 34% in the human health.

Over the past 25 years, multi-ministerial coordination and the realignment of industrial systems to facilitate R&D have bolstered the country to be a leading developer in the region. The Korean government designated biotechnology as a key component of the country’s development strategy in the early 1980s. With the support of the Ministry of Science and Technology, traditional manufacturing and research practices transitioned to focus on more advanced technologies. With this new priority, legislation supporting innovation and biotechnology flourished. The government’s passage of the Genetic Engineering Promotion Law in 1983, known today as the Biotechnology Promotion Law, reinforced South Korea’s strong foundation for the biosciences developments to come.

However, it was not just government support that formed the industry’s solid foundation. The establishment of research-based innovative associations in the 1990s, reinforced the strength of the growing industry. With associations such as Korean Genetic Engineering Research Association, known today as Korea Biotechnology Research Association (KBRA), and other institutions such as Korea Research Institute of Bioscience & Biotechnology, Bioindustry Association of Korea (BAK), and Korea Bio Venture Association (KoBioVen) paving the way, South Korea set out to make a big impact. In 2008, these three major Korean biotech associations joined forces, founding a new larger united association known as the Korea Biotechnology Industry Organization (Korea BIO) that supports both the bio-industry community and government.

Thriving academic institutions and an increased commitment to higher education also play a critical role in South Korea’s race to become a major player in the biotech field. South Korea is among the highest spenders on higher education of the Organization for Economic Co-operation and Development (OECD). The country also yields among the region’s top performers in mathematics, reading, and science- specifically in the life sciences industry. With over 5% of the country’s GDP spent on education in advanced degrees, South Korea’s education infrastructure has proven to take care of its own. Fostering an education ecosystem that privileges life science development has encouraged innovative life science breakthroughs.

The symbiotic relationship between government, local associations, and educational institutions has fueled the country’s engine for biosciences development. With the cooperation of these three forces, South Korea’s national R&D expenditure in biotechnology grew nearly 40-fold to over $311 million from the 1980s to mid-1990s.

But nothing was a bigger turning point in South Korea’s biotech history than The Basic Plan for the Promotion of Biotechnology in 1994. Despite its name, this plan was anything but basic. This national biotechnology plan shifted the tide for the country’s competitive edge. Since putting forth the Basic Plan for the Promotion of Biotechnology, government investment has increased at an average rate of over 24% annually until 2008.

This significant investment in R&D yielded powerful results. By 2004, there were over 500 South Korean companies using biotechnology in their businesses. Within these companies, there also was an interest to shift from producing generic branded drugs to increased focus on new drug discovery.

Government investment only continued to intensify moving forward. With over $5 billion invested in the industry infrastructure from 2004-2007, the country moved to rank 7^th among 59 countries and regions in the 2007 global competitiveness ranks by the International Institute for Management and Development (IMD). Investment grew even further in 2005 with the government investing an addition $1.4 billion into biotechnology.

Just when we thought there couldn’t be more investment, in 2006, the South Korean government established Bio-Vision 2016, which set the goal of making the country a global biotechnology leader. With goals to strengthen multi-ministerial coordination, develop advanced industrial infrastructure, promote a culture of research integrity and bioethics, and achieve innovative breakthroughs, the bar was set high. But with investment in biotechnology led by six Korean Ministries, including that of Education, Science and Technology; Knowledge Economy; Health and Welfare; Food, Agriculture, Forestry; Environment; and Land, Transport & Maritime Affairs, the country was well equipped to meet those goals.

The benefits of Bio-Vision 2016 were immediate. Within a year, the country’s Technology Strength (TS) index ranking improved to no. 13 in 2007, showing immediate improvement from no. 17 between 1998 and 2001. Effects of the policy also shifted industry towards regenerative medicine research, growing their medical devices industry, and expanding R&D capacity.

In March 2012, the U.S.-Korea Free Trade Agreement (KORUS FTA) was established, and with it both countries agreed to provisions to facilitate high-quality health care and improve access to safe and effective innovative and generic pharmaceutical products. Implementation of KORUS has led to various policy improvements, including regulatory data protection and intellectual property enforcement, although there remain strong concerns on South Korea’s implementation of its intellectual property rights and pricing and reimbursement commitments.

With the strengthening industrial capacity and growing support from local associations, South Korea developed a balanced regional and national system that supported biotech clusters throughout the country. These established hubs became epicenters of innovation with a goal of making regional economic development self-sustaining and self-reliant.

This environment propelled the biotech industry to what it is today. South Korea is one of the most aggressive countries in the region for the development of biosimilars, with the government setting an ambitious goal of providing 22% of global biosimilars supply by 2020. That said, ask anyone in the pharma business in South Korea what’s next and the overwhelming answer would be: expanding global partnerships and making the country a global hub of biotechnology.

BIO continues to champion the progress being made in Asia and recognizes that global collaborations are critical to not only South Korea’s success, but also those of global stakeholders seeking to find investment and licensing partners in country. To foster those cross-border partnerships, BIO is hosting its 15^th annual BIO Asia International Conference on March 19-20, 2018 in Tokyo, Japan. This year, we will feature a dedicated session entitled Market Outlook—Investor Priorities and Structuring Cross-Border Financing and look forward to welcoming Korean biotechs including:

• Eone-Diagnomics Genome Center
• 1ST Biotherapeutics, Inc.
• OliX Pharmaceuticals
• MyGenomeBox Co.,Ltd
• SIWON Intellectual Property Firm
• Y-Biologics Inc.
• Gyeongsang National University
• SPARK Korea, Korea University
• Chungnam National University
• Daewoong Pharmaceutical Co., Ltd.
• NGeneBio Co., Ltd.
• Samsung BioLogics
• IMGT Corp.
• Konkuk University
• Standigm
• Pharos I&BT Co., Ltd
• Kolon Life Science

To learn more about this exclusive partnering forum focused on doing business in the current Asia-Pacific business and policy environments, visit www.bio.org/asia.

South Korea’s rich history of support for the biotech field provides the country a favorable platform to address the challenges ahead. Accordingly, we anxiously watch as South Korea continues to help us make biotech history!

This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories from BIO’s past.  To learn more about BIO’s history and our 25^th Anniversary visit our interactive historical timeline.

 Reprinted from BIONews, April 1995

In honor of next weeks BIO CEO & Investor Conference, let’s flashback to BIO’s CEO and Senior Managers Conference, February 8-10, 1995 in Washington, D.C.

]]> https://www.biotech-now.org/corporate/2018/02/flashback-friday-bio-ceos-senior-managers-conference-1995/feed 0 27394 https://www.biotech-now.org/corporate/2018/01/flashback-friday-historical-perspective-on-health-care-reforms?utm_source=rss&utm_medium=rss&utm_campaign=flashback-friday-historical-perspective-on-health-care-reforms https://www.biotech-now.org/corporate/2018/01/flashback-friday-historical-perspective-on-health-care-reforms#respond Fri, 26 Jan 2018 18:07:44 +0000 http://www.biotech-now.org/?p=27285 This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories ...]]>

This post is part of BIO’s yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories from BIO’s past.  To learn more about BIO’s history and our 25^th Anniversary visit our interactive historical timeline.

Reprinted from BIONews, September/October 1993

REFORMING AMERICA’S HEALTH CARE SYSTEM: FIRST ASK THE RIGHT QUESTIONS

By G. Kirk Raab, Chairman, Biotechnology Industry Organization

Soon after this reaches you, President Clinton is scheduled to formally announce his health care reform plan before a joint session of Congress. Rather than predict what he will propose or what the eventual legislative outcome will be, I would like to suggest criteria by which the biotechnology industry should evaluate, the health care reform proposals that emerge from Congress.

Surely the president’s plan will address health care access and financing, and we are likely to see intense controversy on those issues. But the overarching concern for BIG is how the new health care reform plan will affect our mission: bringing to market safe, innovative and cost· effective treatments and cures for significant medical problems.

We must first ask this question: Will health care reform ultimately enhance the quality of care, promote the development of more cures and improve the quality of life?

During the last two decades the biotechnology industry has created important new treatments to fight serious medical conditions. The pipeline of biotechnology products under development promises to provide far more advances in the coming years. In fact, most experts agree that in the next several decades biotechnology will be the single largest contributor to medical progress from within the overall pharmaceutical and healthcare industries. Any health care reform plan that is designed to improve future medical outcomes needs to recognize and support the efforts of the biotechnology industry.

Second, in evaluating health care reform, the industry must ask how decisions will be made regarding the development and use of new technologies. Will doctors or government bureaucrats make these crucial decisions?

Doctors will decide the value of new technologies based on scientific and clinical evaluation. Bureaucratic decision making is more opt to reflect the uncertainties of budgetary and political compromises and thereby stifle investment in innovative research-the lifeblood of our industry.

Finally we must ask: Will incentives for innovation continue to stimulate research and development investment?

Policy makers must be willing to recognize the industry’s massive commitment to ongoing R&D because of the extraordinary opportunities it brings. But they must recognize the level of investment and risk-taking that is being made to realize the new products in human biotechnology that will bring the important clinical advances the medical community and general public won’t.

Last year the biotechnology industry spent $5.9 billion to realize the dream of medical progress. Without continuous and adequate investment capital to pay for this level of R&D expenditure, the industry will be seriously crippled. A negative impact on U.S. productivity, economic growth and competitiveness could follow.

It is crucial that policy makers understand the need to keep the spirit of capitalism alive for the biotechnology industry. Otherwise the free market incentives that stimulated the medical progress of the post will no longer spark that progress, and government restrictions and intrusion into medical decision making will blunt the effectiveness of the world’s most prolific source of medical progress.

Conversely, if we are allowed to do what we do best, our industry will significantly improve quality of life, as well as contribute ultimately to reducing the cost of health care. During this reform process, none of the decision makers should ever lose sight of the fact that as important as economics ore, saving lives and reducing suffering should be a foremost priority of this notion, and that priority should be embraced as passionately by our political leaders as it is by the medical community.

I personally believe President Clinton is well intentioned in his effort to reform health care in this country. But his recommendations and ultimately the reforms that are enacted must be thoughtfully designed so that they will actually achieve those good intentions. The immediate and pressing challenge for the industry as the new health care proposals unfold is to ask the right questions and forthrightly carry the message of our mission to our political leaders.

Editor’s Note: As part of BIO’s 25th Anniversary celebration we will be spotlighting biotechnology innovations that have made a major impact over the past 25 years.  This “Innovation Series” will publish on the 25th of every month throughout 2018. We kick-off this month with personalized medicine.

One size does not fit all when it comes to medicine. Treatments that help some patients fail to help others, and the same medicine may cause side effects in only certain patients. As a result, health systems often deliver inefficient care that fails to help large portions of the patient population — at a notable financial cost as well.

That’s where personalized medicine comes in.

Personalized medicine, sometimes called precision medicine, is an evolving field in which physicians use diagnostic tests, often genetic, that help determine which medical treatments and procedures will work best for each patient. By combining this information with an individual’s medical records, circumstances and values, personalized medicine allows doctors and patients to develop targeted treatment and prevention plans.

Personalized medicine is having a major impact on health care.

For example, one notable personalized medicine, Gleevec, approved in 2001, has transformed the treatment of chronic myeloid leukemia (CML). The American Cancer Society now credits Gleevec and other personalized medicines in large part for a five-year CML survival rate that has more than doubled over the past two decades, from 31 to 68 percent. Called “targeted therapies,” the personalized medicines used to treat CML work by disrupting the function of proteins produced only by diseased cells.

More recently in oncology, the U.S. Food and Drug Administration (FDA) approved a different kind of personalized therapy, called Keytruda, for the treatment of solid tumors anywhere in the body. Keytruda helps the body’s own immune system attack cancer, and was approved for use on any tumor that expresses “microsatellite instability” or “mismatch repair deficiency,” genetic features that make it easier for immune cells to recognize cancerous cells.

Targeted therapies are also helping patients with rare diseases. A landmark study published in The New England Journal of Medicine, for example, suggests that a targeted therapy approved by FDA in 2012 can help reduce some of the most extreme effects of cystic fibrosis by 55 percent, helping patients with this disease live longer, healthier lives.

Some of the most recently approved personalized medicines, called gene therapies, take the science a step further by correcting genetic mutations in human cells. FDA approved the first gene therapies in 2017, for the treatment of acute lymphoblastic leukemia and a genetic form of blindness.

Doctors can also use personalized medicine to help patients avoid the trial-and-error process usually associated with learning whether a treatment option that works for many patients is likely to work for them.

These approaches exemplify how personalized health care can help detect the onset of disease at earlier stages, pre-empt the progression of disease, and, at the same time, make our health system more efficient — and they underline the need for up-to-date public policies and clinical practices that keep pace with the implications of new scientific discoveries.

About Christopher Wells:

A published expert in public affairs, Christopher Wells has worked with the personalized medicine community for nearly three years to coordinate the communication of the field’s complex principles to diverse audiences. As Vice President of Public Affairs, Wells oversees the development of PMC’s marketing and communications messages and leverages a comprehensive portfolio of digital and traditional communications tools to increase awareness and understanding of personalized medicine in the United States and internationally. He also oversees content development for the Annual Personalized Medicine Conference at Harvard Medical School.

Prior to joining PMC, Wells worked as a research assistant at Binghamton University, where he graduated with a master’s degree in public administration and received the University’s Department of Public Administration Alpha Student Award. He holds a B.A. from the State University of New York at Brockport, where he was honored with Department Scholar’s Awards in both journalism and international studies.

Beginning today, BIO will be kicking off a yearlong, bi-weekly series called Flashback Friday, highlighting newsletter stories from BIO’s past.  This series is part of BIO’s 25^th Anniversary celebration.  To learn more about BIO’s history visit our interactive historical timeline.

Reprinted from BIONews, July/August 1993

BIO COMES TO LIFE, BIOTECH INDUSTRY GAINS ONE NEW VOICE ON JULY 1, 1993!

A single, strong voice for the biotechnology industry become a reality on July 1 when the Biotechnology Industry Organization (BIO), come officially into being. BIO was formed with more than 500 member companies, including the former members of the Association of Biotechnology Companies (ABC) and the Industrial Biotechnology Association (IBA), plus a number of companies that have joined since the announcement of the merger.

The new association began functioning at an organizational meeting of the BIO Board of Directors in June. G. Kirk Raab, president and CEO of Genentech, Inc., was elected to serve as the first BIO chairman. Roger Salquist, chairman of Celgene, Inc., was elected vice chairman for Food and Agriculture; Henri Termeer, chairman, president and CEO of Genzyme Corporation, was elected vice chairman for health care; David Hole, chairman, president and CEO of Gensia Pharmaceuticals, Inc., was elected secretary; and Mitchel Sayare, chairman of lmmunoGen, Inc., was elected treasurer.

The other members of the newly formed Executive Committee ore Jomes Skinner, president of EDITEK, who will serve as chairman of the Emerging Companies Section, and Robert Beckman, president and CEO of lntergen Company, who will serve as vice chairman. Elected as officers at large were Forrest Anthony, president of AVID Therapeutics, Inc., and George Masters, vice chairman and chairman of the executive committee of Serogen, Inc.

“The birth of BIO represents one of the most important steps in the industry’s evolution since its founding,” explained Raab. “It is a signal that the industry has come of age, that it has a single identity, even though it has diverse, constituent ports.”

BIO comes to life with a sum that is greater than the two separate groups from which it was formed. While its offices are in the same location as the former IBA’s, the association’s office space has been greatly expanded to accommodate former ABC staff members who have joined the combined team.

In addition to culminating the merger process, July l was also the date when the 15 member companies of the Applied Bio Treatment Association (ABTA), officially voted to dissolve and join BIO. With the addition of the companies from ABTA, BIO’s membership now includes the leading companies in the health care, agricultural, environmental, diagnostics and services areas of the industry.

“We truly hit the ground running on July 1,” explained BIO President Corl Feldbaum. “We have initiatives underway that will provide substantial benefit for the industry and, not to be shy about it, we intend to redefine the way a modern association serves its constituent industry. We’re about to go through some very exciting times.”

BIO’ s Government Relations Department has initiated a survey on the capital crisis in the industry to generate data on how uncertainty in the health care reform debate has curtailed the availability of venture capital for small biotech companies. “We’re developing the numbers to demonstrate how sensitive the industry is to public policy issues, and how easy it is for mixed messages out of Washington to affect the tempo and scope of biotech research and development,” commented Chuck Ludlam, vice president for government relations. In the works is another BIO survey to identify and coordinate state, regional and interest group contacts and resources. According to Feldbaum, “We must be prepared to identify and address issues at the local, state and regional levels, so we can deal with them when they first arise, and at their point of origin. Local issues tend to go national fast because biotechnology, like it or not, is an extremely high-profile enterprise.”

“In direct support of our national, state and local outreach efforts, we have a very ambitious schedule of 81 visits with members of the Senate and House of Representatives before the end of the year,” commented Ludlam. “We’re going to take industry leaders in to meet with the congressional leaders who will determine the final shape of the health care reform package, of small business tax incentives and other issues of concern to biotechnology. BIO will carry our industry’s message to Capitol Hill as it has never been heard before.”

BIO, through its new Special Projects Department, has begun an active and expansive effort to reach out to patients’ rights and advocacy groups. This effort has been initiated to generate support for biotechnology products from their ultimate consumers.  The Food and Agriculture Section has launched on effort designed to change the landscape of the debate about public acceptance of biotechnology food products. As a first step, the association provided training to a group of industry spokespersons to speak persuasively to general audiences about the benefits of biotechnology. The first of the two-day speaker’s training workshops took place in Philadelphia on July 19 and 20.

The association has launched two new publications to take the place of the former IBA Reports, ABC Details and IBA News. The BIO Bulletin will become a biweekly report of late­breaking events and legislative and regulatory developments. It will be faxed to member company official representatives, communications, and government relations contacts. This expanded BIO News will be the monthly newsletter to cover association activities and feature stories of broad interest to the industry.

The Meetings Department is putting the finishing touches on the first BIO Annual Committees’ Meeting, to take place September 22-24, 1993, at the Mayflower Hotel in Washington, DC. BIO will also hold its 8th Annual BIO International Meeting and Exposition to take place in Toronto, Moy 23-27, 1994.

In conjunction with the Fall Conference on September 21, the Health Core Communications Committee will host o workshop on developing educational outreach efforts as a means of building positive community relations.

This program will kick-off a major educational initiative developed to promote interest by young people in biotechnology careers. Informational kits on biotech careers will be mailed to 500 high schools nationwide this fall. These kits include a 9-minute video, a resource guide with job descriptions for entry-level jobs in the industry and a brochure that offers a description of the benefits of working in the industry.

All of this wouldn’t have been possible without people like Tom Wiggens and Steve Duzan,” Feldbaum said, “Everyone from both boards of directors who served on the joint committees, and oil of the members who mode this merger work deserve recognition. The best, believe me, is yet to come.”

Ask anyone in the life sciences field to list today’s global titans of industry and you’ll see Japan on every list. Over the past 25 years, Japan has grown to be one of the top producers of scientific knowledge in the world. With the second largest individual pharmaceutical and medical devices market, Japan spends over 10% of its annual GDP on healthcare. Further, the country has among the greatest business expenditures on R&D in the world. According to Scientific America’s 2016 Worldview Scorecard, in a search of PubMed’s papers on biotechnology, over 16,000 of them were affiliated with Japan. While recent developments have brought rich growth to the industry, Japan’s biotechnology history began well before that.

The country’s history of using fermentation processes in as early as the third century gave scientists their first understanding of biotechnology. From these ancient times until the 1870s, traditional fermentation practices had only been used in the context of the food industry. It wasn’t until the establishment of governmental colleges and science and technology research programs in the mid-1870s that the study of microorganisms popularized. As this research developed into the early 20^th century, Japanese companies expanded their portfolio outside of fermentation and traditional herbal medicine to incorporate Western-style drugs. This forever changed the Japanese market and served as a catalyst of the growth to come.

The post- WWII era, marked a leap forward for the country’s economic landscape. In the early 1950s, Japan’s Ministry of International Trade and Industry (MITI) implemented expansive measures to support industrial growth in the country, with banks serving as primary financiers. This resulted in an unprecedented level of insular economic growth. Japan’s real GDP grew so much that it averaged over 9% annually. For context, Japan’s real GDP growth over the past 15 years has hovered below 5%. The rapid growth allowed the country’s technologies to catch-up with further advanced economies. This would later mean great business opportunities for the country.

While Japan’s electronic and automobile economy developed considerably through the early 1980s, it’s biotechnology industry had yet to blossom. The industry had limited R&D focused firms and government policies that shielded Japanese companies from foreign competition. Its highly protective environment held strict capital controls and tariffs enabling the domestic industry to develop, and allowed for incremental innovation. Gradual market expansion occurred but was predominantly focused within the Asian market. While Japan had made progress in expanding foreign market access, it had yet to gain significant global momentum.

The 1990s brought a flood of government policies that shifted manufacturing-centric models to refocus on biotechnology -based R&D. This new environment, coupled with regulatory reforms in the early 1990s, expanded Japan’s global life science footprint.

This globalization accelerated the number of Japanese companies expanding abroad, and further encouraged foreign companies to enter the Japanese market. Companies such as Takeda and Eisai expanded abroad to take advantage of these new global operational capabilities and developed markets. Japan had finally made its big international debut.

The regulatory reforms in the early 1990s further supported Japan’s role in the global biomedical industry. In 1990, the Japanese government joined The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). With the founding of ICH, goals of reducing duplicative development inefficiencies in the global industry were pushed to the forefront. Japan’s role in ICH  reinforced its new global role. As a part of Japan’s international harmonization efforts, its regulatory authorities effectively streamlined drug development in Japan and upgraded the quality of the country’s clinical trials to globally accepted standards.

Not only did Japan’s role in ICH harmonize pharmaceutical regulations improve manufacturing linkages in the drug regulatory pathway, it encouraged a wave of entrepreneurship. Japan’s new collaborative approach made it easier and faster for high-quality drugs to be developed and funneled through the regulatory process. This incentivized entrepreneurs to innovate with potential for high rewards.

Further, government initiatives to facilitate technology transfer and create small and medium-sized regional enterprises led to an even greater explosion of entrepreneurship in Japan. With all this entrepreneurship, what was a country to do?

Invest, Adapt, and Discover!

And that’s just what they did.

With one of the world’s fastest growing aging populations, Japan currently faces a number challenges brought about by the demands of its demographic shift. With over 35% of the population expected to be over the age of 65 in 2030, biotechnology companies, both in Japan and abroad, are needed to provide solutions to treat chronic and long-term diseases for over 40 million people.

Current Prime Minister Shinzo Abe has highlighted aging as a national crisis. After his election victory in 2017, Abe notes that Japan’s decreasing and aging population is “the biggest challenge” for his Abenomics policy initiative. He states, “The problem is progressing by the minute, and [Japan] cannot afford waiting around.”

The political and socio-economic impacts of an aging population cannot be understated. Aside from the effects of a declined labor force, population aging will yield rising health demands that need to be addressed. Without a comprehensive and effective pricing and reimbursement framework, costs for the treatment of non-communicable diseases associated with aging will strain Japan’s economy. Addressing these challenges will require close coordination between government and the industry. The world’s top innovators are developing solutions to address these challenges, and foreign companies are seeking Japanese and global partners to collaborate with.

While the development of solutions is still underway, Japan has already demonstrated its commitment to the success of its biotechnology field. Since the late 1908s, Japan has produced four Nobel Laureates in the Physiology or Medicine category. In 2012, Shinya Yamanaka and fellow researcher, John Gurdon, won the Nobel Prize in Physiology or Medicine for their innovative work in stem cell research.  Their numerous accolades reflect Japan’s commitment to scientific research and growing the biotechnology field.

Developing these global collaborations and solutions are critical. The BIO Asia International Conference offers the avenue to do just that. In its 15^th year, the BIO Asia International Conference offers an exclusive partnering forum to bring together the global biotechnology and pharmaceutical community to understand and address these challenges. It provides the premier platform to explore licensing and research collaborations in the current Asia-Pacific business and policy environments. The conference offers further insight into the changes, challenges, and opportunities key policy leaders foresee for the Japanese market. View more on the BIO Asia International Conference program here.

Japan’s rich history of biotechnology has established a framework to address the challenges ahead. Accordingly, we look to you, the scientists, entrepreneurs, researchers, investors, and government to help shape the next 25 years of biotechnology. Help us make history!

This year the Biotechnology Innovation Organization (BIO) celebrates our 25th anniversary. It’s impossible to review BIO’s interactive historical timeline without reflecting with pride on the role we’ve played in shaping policy to save lives and promote the health of our planet.

So much of our work comes down to educating folks – policy makers, the public and each other – about the work we’re doing and its value to humanity. For 25 years, BIO has convened the biotechnology community in impressive fashion. And we’ve communicated the needs and aspirations of our scientists to Capitol Hill, state capitols and policymakers worldwide to make sure government leaders embrace thoughtful policy that helps science march forward.

I know this, because I was one of those lawmakers inspired by my BIO education. Through this organization, I came to see the miracles our industry makes possible.

I was an eighth-year U.S. Congressman representing suburban Philadelphia in March 2001, doing woodwork painting at home and watching 60 Minutes on my television. Correspondent Steve Kroft was interviewing an American fertility doctor named Dr. Panayiotis Zavos, who claimed he could clone a human being – and planned to do so within the next 24 months.

I recoiled at the thought. As a former child welfare caseworker, I felt that no child should be brought into the world as a “copy” of someone else and that every human deserved to be the unique offspring of two parents. I chaired the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigation and was confident that my colleagues on both sides of the aisle would share my deep ethical and existential objections to human cloning. So I convened a hearing with the goal of outlawing the practice.

As I prepared for that hearing, I was visited at my office by then-BIO CEO Carl Feldbaum. He told me that BIO shared my concerns about reproductive cloning. But he also explained to me the enormous promise of therapeutic cloning.  This is a process that entails the removal of a nucleus of a somatic cell – and its transfer by injection into a denucleated, unfertilized human ovum. This process enables researchers to understand how pluripotent stem cells become blood, eye, heart, skin, and brain cells, as well as every other specialized cell in the human body. This work is the basis for regenerative medicine that holds the potential to cure everything from Parkinson’s to Alzheimer’s disease.

Not only did BIO’s advocacy convince me, it made me a champion for the science. When the issue of therapeutic cloning came before the House for a vote, I gave one of the most passionate floor speeches of my political career in defense of “the most promising opportunity to cure the diseases that have plagued humanity for centuries.”

Three years later, I received a call from a headhunter asking if I was interested in interviewing for the job of BIO President and CEO. My first reaction was “thanks but no thanks.” My approval ratings were high, and who gives up a perfectly good seat in Congress anyway? But as I reflected on the opportunity, I thought about the fact that I had served as a legislator at the state and federal levels for nearly a quarter-century. Rather than be a politician for life, perhaps I could use my knowledge of Washington to help this remarkable, young industry realize its vast potential.

I decided to go for it. In my BIO job interview, I was asked if I had a passion for biotechnology. This is what I said:

“Four and a half billion years ago, when the first cell divided, life began on our planet. Since then, Darwinian evolution has led to the birth of human beings – the crown of creation – with these huge brains and opposable thumbs and amazing perceptions and abilities that allow us to literally reach into our bodies, extract our DNA, look at it under a microscope, and create something that will one day prevent a parent from burying a child. Or one day, prevent a man from looking at his wife in their twilight years and say, ‘Who are you?’

Darwinism teaches us about the survival of the fittest, but the truth is, we don’t want just the fittest to survive. So if you’ll give me this opportunity, I’d like to help you outrun Darwin.”

I got the job.

BIO is an industry organization, but I’ve always tried to put my values and the needs of patients first in our work here. Shortly after taking the helm at BIO, Congress debated the issue of biosimilars. These are medicines with no clinically meaningful differences from existing FDA-approved products – essentially a generics industry for biologic medicine. When the biosimilars debate began, it became clear to me that the heads of many Washington pharma offices didn’t want a biosimilars industry. The companies they represented had monopolies on existing biologics and raised questions as to whether biologics could be safely replicated.

I told the BIO Board that opposition to biosimilars would be a mistake. I shared my belief that the pharmaceutical industry’s initial opposition to the creation of a generics industry had cost the drug industry credibility on Capitol Hill, and I argued that we should not repeat the error.

I convinced the BIO Board that we should become the primary advocates for the creation of a safe, well-regulated biosimilars industry. In so doing, we would educate lawmakers about the science and the law. Rather than eventually having biosimilars legislation forced on us, I argued, we could instead lead the way by embracing competition – and this would put us in a strong position to advocate for the necessity of a 12-year period of data exclusivity on innovative biologics.

Biosimilars would give patients access to more affordable treatments when biologic patents expire. Adequate data exclusivity would offer biotech investors confidence that the intellectual property underlying their investment would be protected.

In the end, the Affordable Care Act created a biosimilars pathway and granted 12 years of data exclusivity for innovative biologic drugs. We even won over Democrats on the House Energy and Commerce Committee over the objections of Chairman Henry Waxman. The committee approved BIO’s position by a 47-11 vote.

As our timeline shows, we’ve won many important battles over the last 25 years. As we look forward to the next 25, there will be plenty of thorny ethical issues to debate and critical policy choices to make. The human genome has been mapped and hundreds of new treatments are in the pipeline as a result. The first gene therapies are starting to be approved by the FDA. The CRISPR gene-editing breakthrough holds transformative potential to treat and cure disease. Advanced biofuels, industrial biotech processes and genetically enhanced crops are helping reduce pollution and feed our rapidly growing global population.

Genetics today stands where chemistry did just a few decades ago: People sometimes fear that which they don’t understand. As Americans have learned more about the unintended consequences of putting chemicals in the air, we have discovered ways to utilize science without polluting our environment. When people hear about genetically modified plants, some still worry about unintended consequences. But as President Obama said of GMOs, “We must follow the science.”

Today, I spend a great deal of my time on Capitol Hill helping lawmakers understand the policy choices before them and helping them understand how manipulating genetics – ethically and responsibly – offers us our greatest hope to live longer and sustain our planet. But like all other areas of science, genetics must be appropriately regulated.

And every day BIO’s public affairs team and I work to persuade policy makers and the public that short-sighted attempts at government-imposed price controls would undermine our work to innovate life-changing and life-saving medicines for which patients and their loved ones pray.

It has been an honor to lead this organization for 13 years and counting. I’ve interviewed former U.S. Presidents on the BIO Convention stage and overseen the growth of this organization to a staff of 173 committed advocates who serve a global membership of more than 1,000 companies strong. I’ve racked up uncountable frequent flier miles visiting every corner of this country – and the world – to promote an industry that truly fuels, feeds and heals the world. But my most memorable moments have been the everyday interactions I’ve had with brilliant researchers and whip-smart entrepreneurs, knowing their hard work adds up to beating disease and bringing hope.

Congratulations to everyone who has been part of this indispensable industry for the last quarter-century. There’s no telling what the next 25 years of biotech innovation hold in store for us.