Biotechnology is not simply about science or technology, process engineering or cell lines, corporations or regulations. It’s ultimately about the people involved in all these things — and about the people they hope to serve with their biotech aspirations. It’s about scientists and technicians, businessmen and medical professionals, patients and consumers, farmers and governments, all their lives touched in one way or another by the biotechnology industry — some admittedly more than others. Policy decisions made by legislators affect how companies can do their business. Ethical considerations affect what they do and how they communicate to the public about it. And ultimately, all these things affect how many people become interested in making biotechnology their career.
Two subjects that currently loom large in the bioethics arena, as far as most biotech companies are concerned, are genomics and clinical research. In Chapter One, we mentioned the regulatory aspects of clinical research conducted by companies from developed nations with patients in the developing world. But all clinical trial participants need protection, no matter where they live.
Many groups (ethics committees and institutional review boards as well as the companies developing drugs) are involved in such protection. Relationships between oversight committees and industry representatives can be difficult if there is little mutual understanding about the respective roles they play. Clinical trial sponsors can provide educational sessions for local IRBs to help committee members better understand drug development strategy and regulation, and they can facilitate IRB reviews of their study protocols by specifically discussing possible ethical issues in the documentation. Such opportunities for industry to talk to and understand the perspectives of bioethicists could help both groups understand each other’s goals and perspectives and thus better work together.
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How Genomics Is Changing the Landscape: Biomedical science is helping researchers and clinicians address disease more and more on its fundamental molecular level and tailor treatments to each patient’s individual genetic makeup. Already this is interesting some patients in harnessing their own clinical and genomic data.
DNA sequencing technologies have advanced rapidly: Scientists can now sequence for $60,000 what took $300 million just a few years ago. A $1,000 genome may be inevitable. New technologies will broaden the utility of genetic information in healthcare and enable revolutionary improvements in medicine. But bioethicists warn of potential pitfalls for a society that can realistically sequence the entire genome of every citizen — from insurance coverage to employment opportunities (or lack thereof).
Meanwhile, drug companies seek to connect genomics-based research with clinical care for many reasons: to accelerate identification of biomarkers, increase the efficiency of patient recruitment for clinical trials, improve trial outcomes by targeting patient selection, more quickly deliver new therapies to market, and reduce R&D costs. But along with great advances, biomedical research in support of drug discovery is facing some challenges. Delays in regulatory approval and rising development costs (as well as high-profile postmarket product recalls) are putting pressure on companies to find viable new treatments. But disconnects among both data and human organizations can slow the translation of research findings into safe and effective products.
Personalized medicine addresses diseases at their most basic levels, taking into account the genetic characteristics of each individual person. But for this to reach its full potential, biotech companies will have to find new ways to connect individuals, organizations, and institutions using 21st-century information technology. Innovative tools, resources, and incentive models encourage and support discovery and clinical development. New business models, research platforms, collaborations, and data-sharing partnerships will come from the increased role that educated and empowered consumers, patients, and healthcare providers play. Linking research to care could make this concept a reality.
Personalized medicine is also of great interest to policy makers. It’s been “on the horizon” since the turn of the century, but only now is it becoming enough of a reality to draw their attention and scrutiny. They see great potential in the idea of tailored and/or targeted therapies and companion diagnostics, but the business aspects of such a futuristic model presents the biopharmaceutical industry with many challenges, especially related to intellectual property and regulations. Scientific advances have created new business opportunities that will drive companies to find solutions to these problems.
Estelle Tsevdos, a partner with Hunton & Williams, LLP, will serve on a panel covering this topic at BIO’s 2009 International Convention. “First of all,” she says, “our panel will review progress made in bringing personalized medicine to the actively used medicinal therapies.” Panelists will discuss what hurdles are being eliminated and how companies should proceed in bringing their products to market. Then they’ll address how to face and overcome intellectual property issues. “And our FDA member will outline how the agency is dealing with the unique issues of regulating these products.” And Tsevdos adds thoughtfully, “As we face the current difficult economy in therapeutics, personalized medicine provides a look to the future. It is even more important than ever to attend this convention because a future focus is needed for individuals, companies, our nation, and internationally.”
Developing Drugs for Rare Diseases: At 2008’s BIO International Convention in San Diego, we celebrated the 25th anniversary of the Orphan Drug Act. Back in 1983, the US government recognized that policies were needed for encouraging companies to develop treatments for patients with rare diseases. Those policies have helped bring hundreds of products to millions of patients.
RELATED SESSIONS AT THE BIO INTERNATIONAL CONVENTION
Bioethics Sessions: Tuesday 19 May 2009
Building Capacity for Ethical Review of Clinical Research in Developing Countries Transforming the Research Paradigm: 21st Century Models to Unify Discovery, Research, and Clinical Care
The Ongoing Quest for a $1,000 Genome: Are We There Yet, and Are We Ready?
Protecting Human Research Subjects: What Is Industry’s Role? How Are We Doing?
Policy Sessions: Tuesday 19 May 2009
Preparing Before the Storm: The Reimbursement Policy Disaster
Biotechnology and Life Sciences in the EU: Current Developments in Regulations, Innovation, and Research Funding
The Emerging Promise of Personalized Medicine
Policy Sessions: Wednesday 20 May 2009
Developing Drugs for Rare Diseases
The 111th Congress: What’s Happened and What’s to Come in Its First Session
Europe: The Changing Dynamics of the Public Health Environment
Apples and Oranges: The Opportunities and Challenges for Implementing CER
Public/Investor Relations Sessions: Tuesday 19 May 2009
What to Say, When, and How: Navigating the Regulatory Minefield
Spreading the Word: New Technologies Mean Everyone Is a Journalist
Media Speed-Dating: Get Up Close and Personal with Biotech Journalists
Growing the Biotech Workforce Sessions: Wednesday 20 May 2009
Building a Workforce Pipeline
Developing Highly Effective Partnerships with University Workforce Development Programs
How to Grow and Retain Your Biotech Dream Team
The Brain Drain Runs Both Ways: The Global Market for Scientific and Technical Talent
Forging Scientists for the Future of Biotechn
For complete session information, visit http://convention.bio.org.
Companies developing therapies for rare diseases and conditions still face unique challenges related to regulatory approval, reimbursement, and other issues. Such problems stem from the small patient populations available for enrollment in clinical trials and the inherently small markets for resulting products. To help those companies continue meeting unmet medical needs, legislators must continue to provide incentives for research and development. As Medicare, Medicaid, private health plans, the FDA, and federal and state legislatures develop new policies on comparative effectiveness, reimbursement and drug pricing, oversight of clinical trials, the drug approval process, and other issues, they must take into account the different circumstances confronted by these companies.
Thanks to biotechnology and pharmacogenomics, more and more therapies will be targeted at smaller populations. Meanwhile, policy makers grapple with issues such as comparative effectiveness, drug safety, and drug pricing and need to understand how solutions can be tailored to help orphan drug companies address their challenges. And remember: US treatment of orphan products influences how European regulators will approach the same issues — and vice versa.
The Changing Dynamics of Europe’s Public Health Environment: When people in the United States debate the future of their healthcare system, they like to point to “Europe and Canada” as examples of universal healthcare, whether speaking positively or negatively about the subject. But people in Europe know that’s a gross oversimplification of their patchwork of programs and changing ideas. Many of these countries too are reevaluating their approaches. Several recent policy initiatives are in various stages of implementation: biosimilars legislation, an advanced therapies regulation, and the Cross-Border Healthcare initiative.
Europe’s recent Cross-Border Healthcare initiative helps a network of health agencies provide patient access to innovative treatments. At the 2009 BIO International Convention, this represents a unique chance for Europeans (and those interested in their way of doing things) to discuss the evolving dynamics of public health in Europe by linking three dimensions of regulatory, policy, and economic issues affecting the biopharmaceutical industry.
Drug Reimbursement Policies: It’s no secret that the United States is in need of new ideas when it comes to healthcare. The US system is so huge and complex that it may never be fully reformed. Both small and large biotech companies find reimbursement a concern, and many people in the industry are unsure how to approach the reimbursement process or build a dynamic strategy to successfully navigate this convoluted pathway. They wonder whether it will be easier or harder in the future.
The basic components of reimbursement policy include coding, coverage, and payment. At this year’s convention, a panel of experts representing companies, payers, and the government will address the design and implemention of an integrated reimbursement strategy within the development and commercialization processes of a new biologic. Strategies for seeking reimbursement continue to evolve as the healthcare system is challenged with cost-containment objectives.
The 111th US Congress: The first year of a US administration is an exciting time. New presidents usually enjoy the momentum and public support to drive policies forward, and the US Congress is often cooperative. In 2009, this may be the case more than ever, with a new president who is a popular advocate of “change.” Barack Obama has been described as “a policy geek.” The business of his administration, therefore, is likely to be policy first and foremost.
But what about Congress? Before long, serious health policy changes are expected to pass through its docket, affecting coverage and reimbursement as well as development and approval of new drug products. Despite the economic crisis, or maybe because of it, the 111th Congress is expected to move quickly and address healthcare reform.
Jeff Scalzi, director of marketing at Foley Hoag, LLP, is organizing a session to examine the possibilities. “To paraphrase Don Rumsfeld,” he said, “’There are known knowns, and there are known unknowns, but there are also unknown unknowns.’ In Washington biopharmaceutical policy, that especially rings true. This session will help shed light on the knowns and unknowns, review what’s seen so far, and forecast what’s to come in the 111th Congress.
“Business decisions take time to materialize, and biotech companies cannot shift course on a dime. Having a firm grasp of the rapidly shifting sands of Washington politics will assist executives and government affairs teams to better anticipate the changing landscape. When your boss asks, ‘Did you know about these new CMS rules affecting reimbursement?’ staring blankly back may not work this time around.”
Because a new US administration and Democratic-majority Congress are pursuing an aggressive, transformative healthcare agenda,” Scalzi calls 2009 “BIO’s critical year. There is no better time for biotech companies to be engaged.”
With healthcare reform near the top of the public agenda and legislative eyes from all sides on the pharmaceutical industry regarding pricing and drug safety, public relations has never been more important to the biotech industry. BIO and PhRMA continue to serve in their advocacy role, especially among policy makers, but many drug and biotech companies realize they must speak for themselves as well. Until recently, health-related biotechnology has been spared much of the public scrutiny and outcry that agricultural biotech companies have had to face, but as times change so do the winds of public perception.
Communicating Your Story, What to Say, When and How: Two panel discussions at the 2009 BIO International Convention will present communications strategies for companies seeking to tell their story to the public. One focuses on “dual-path exit strategies” for those struggling in the current unstable international financial climate. Panelists representing venture capitalists as well as life-science companies and communications experts will discuss PR challenges facing cash-strapped companies and how they can best reach a wide audience of stakeholders including investors, opinion leaders, venture capitalists, consumers, and other customers.
The second panel offers advice on “navigating the regulatory minefield” in regards to public relations. Failure to efficiently communicate clinical trial results and FDA actions can precipitate declines in stock prices, anger stockholders and employees, provoke regulatory investigations, delay future trials, and even compromise patient safety. So extreme care must be taken at each stage to manage disclosures correctly, considering all possible legal, regulatory, market, and public affairs consequences. Particular concern arises when shareholders expect details on FDA/EMEA actions, and a company can’t give out such information without jeopardizing its relationship with the agency. Good information poorly handled might keep important, ground-breaking cures from getting the attention they deserve — and in the end, patients could miss out. Bad information poorly handled can kill companies.
Organizer Karen Katz is healthcare business development director for Mintz, Levin, Cohn, Ferris, Glovsky, and Popeo, PC. She says attendees should choose her session because “maintaining management’s stellar reputation with key stakeholders requires significantly less effort than painstakingly rebuilding credibility after a botched disclosure. Attendees will hear about best and worst disclosure practices and walk away with actionable, implementable strategies and tactics for navigating murky disclosure issues.”
Katz calls BIO’s 2009 International Convention “the premier event for healthcare executives seeking to influence or stay abreast of the rapidly evolving dynamics in our industry, while also networking and exchanging ideas with peers and colleagues from across the globe.”
The Changing Face(s) of the Media: For health- and science-related communications, 2008 was a landmark year. High-profile science reporters at publications from USA Today to the Washington Post accepted buyouts and exited traditional media as new and varied voices emerged. New technologies such as microblogging and social networking have emerged while “traditional” blogging became an established technology, allowing an unprecedented level of communication among scientists, the media, and the public. One panel at the 2008 BIO International Convention focused on corporate communications; this year, the same organizers explore this new world and how researchers, academic institutions, government officials, and companies can all participate in the conversation.
Session chair Brian Reid is a senior associate and blogger for WeissCom Partners, Inc. “New media is no longer a theoretical method of communication in the life sciences,” he says, “and the reach of new media goes beyond the emerging breed of online journalists. Researchers and executives are now using these new tools to communicate directly with key audiences.” His session will feature panelists who have been “in the trenches” for years and can give first-person perspective on how patients, scientists, doctors, and the world at large will learn about biotech in the years to come.”
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“The time to get involved in new media is now,” says Reid. “Whether it’s the 150 million users of FaceBook or the billion-plus monthly video clips watched on YouTube, no one involved in the biotech world can afford to ignore the power of these tools to transmit not only corporate messages, but also key insights on everything from chemistry to regulatory hurdles.”
Reid concludes that “2009, for better or worse, will be about doing things smarter, faster and cheaper, and the new media session will help push attendees toward a communication paradigm that meets all three of those goals.”
This is not to say that the traditional media have become irrelevant. They still provide the most trusted source of information for most people. And this year’s convention presents attendees with a unique opportunity to get “up-close and personal” with biotech journalists. A media speed-dating event will make several publications with international reach (e.g., the New York Times, BioWorld Today, and Nature Biotechnology) available to attendees for networking and questions.
Organizer Trista Morrison is a staff writer for BioWorld Today. “For the first time ever,” she says, “this BIO panel will give attendees the chance to get interactive and network with biotechnology reporters from various newspapers, magazines, TV stations, and even blogs.” What will participants take away with them? “Whatever they want — that’s the beauty of it. Attendees can ask reporters anything: how they get story ideas, how best to contact them, how to work with them under embargo, what it means to go off-the-record … all the secrets of the trade.”
Morrison sees this convention as a must-attend for 2009. “Life sciences has held up better than many other sectors of the economy during the ongoing global financial crunch,” she points out, “but the impact has still been significant, and with the new administration, there are a lot of changes afoot. BIO is always a great place to keep up with the latest trends and meet with the folks who are shaping those trends.”
Building the Biotech Workforce
As biotechnology rapidly advances and changes, employment opportunities have grown, and globalization has created a high-mobility population. Competition for biotech talent exceeds the supply of it everywhere.
In the United States, the era of “No Child Left Behind” seems to have left science behind, with the country ranking near the middle to bottom of most measures of science and math literacy in the developed world. US high-school students today are more likely to say they plan to play professional sports or become a famous actor, model, or singer than go to college for science or engineering — no matter how small their chances of success in the former compared with the latter. So where will the biotech workforce come from in the future? How can the industry address its evolving talent needs?
Traditionally, one answer for US companies has been to attract the best and brightest graduates from other countries. But immigration rules have grown stricter, and now the “brain drain” runs both ways. Biotechnology companies around the world need good people. With China and India building their own biotech industries, knowledge and experience are flowing their way as natives of these countries return home from successful careers abroad. Smaller developed countries such as Ireland and New Zealand are also facing “brain drain” and immigration challenges. Technical recruiters are looking for smart people everywhere, and the Internet has made the world smaller even as physical travel becomes more costly.
Different companies are meeting these challenges with different approaches: training and promotion from within, social networking, collaborating across borders, establishing new foreign locations, and of course enticing natives back home from Europe or the United States. As local biotech hubs are established, competition is becoming ever fiercer for experienced managers, too.
One organizer for the workforce track at the 2009 BIO International Convention is Michaele Glenn of Tyler & Company. She’s put together panelists “with regional, national, and international reputations for successfully leading and operating life science companies with a world-class workforce” for a session on How to Grow and Retain Your Biotech Dream Team. She promises, “Participants will gain a renewed sense of issues around building a robust and diverse workforce. We will discuss a wide range of techniques essential to building well-rounded, high performing teams.”
Glenn cautions that “the downturn in the economy has made it more important than ever to be creative and innovative while thinking globally in this highly competitive marketplace. This convention presents an opportunity for participants to learn first-hand from industry experts about the state of the industry and what has been or looks to be successful, rather than getting snippets of information from the media and other sources.”
The Academic Answer: One secret to biotech success has always been strong academic research. Now companies are looking to academia for innovative solutions to the workforce problem.
“Lean economic times require hiring employees that can have an immediate impact,” explains consultant Scott Winston, who serves on the Professional Science Master’s (PSM) advisory board for the Council of Graduate Schools. That means universities need to turn out graduates who are ready to work, and the National Research Council has identified PSM programs as as uniquely promising for preparing biosciences talent. The US Congress agrees, having authorized $37 million for these industry-responsive graduate degree programs that combine science with management training. Several outstanding new programs have arisen across the country in biotechnology, pharmaceuticals, medical devices, medical diagnostics, clinical and regulatory affairs, medical product development, biostatistics, and bioinformatics. Industry collaborations are key to making them work. Companies can propose such partnerships with local universities in any of the 50 states because all are eligible to participate in these programs and receive federal funding for them . PSM programs are projected to receive more federal funding in 2009.
Kristie Grover is director of the BIOCOM Institute, and she’s organizing a session on PSMs for the 2009 BIO International Convention. “Universities are a key resource to biotech companies,” she says. “Attendees will take away cost-effective strategies for partnering with them in workforce preparation. Strategic action is needed to grow the biotech workforce efficiently, and this session describes approaches that can be implemented now.”
Another session, Building a Workforce Pipeline, focuses on technical training. Its organizer, Philip Gibson, is bioscience program director at Gwinnett Technical College, which is located in a suburb of the convention’s 2009 location, Atlanta, GA. The Georgia Bioscience Technology Institute (GBTI) is building a “workforce pipeline” to help biobusiness and students to come together in support of an economic development region dubbed the “Innovation Crescent.” The GBTI set out to create a workforce development pipeline extending from seventh grade to employment in the bioscience industry. Challenges of regional diversity, funding, and dramatic growth were addressed in a collaborative effort to bring biotechnology to the forefront.
Gibson says, “The challenges faced by life science curricula and workforce development are not unique to our locale. Anyone striving to improve math, science, and bioscience education from seventh grade to employment will want to attend this session. The audience will learn the process involved in biotechnological workforce development from companies to education to employees. Participants will receive detailed criteria for establishing an effective pipeline to deliver a skilled workforce to their bioscience industry base.”
Gibson also echoes the comments of others regarding the 2009 BIO International Convention: “This year, the economic and healthcare climate mandate new ideas on how to meet the demands of the market. Bioscience is a global business that must reach across traditional barriers to supply safe and effective products through a heavily regulated industry.”