A World of Possibilities

Biotechnology truly is global, with some form of the industry in progress on every continent but Antarctica. Countries such as Brazil are even outpacing Europe and North America in the advancement of biofuels technology. But as in the developed world where this industry began, we see other countries looking first and foremost to the medical applications of biotech — because historically that’s where the money has been. Some countries are building their own fully integrated bioindustrial sectors.

Economic development of life-science businesses is based on the development of bioclusters in which new biotech companies can develop. Many such clusters are specializing in one aspect of the industry to work in synergy with other complementary clusters — especially when one local company reaches the point at which its capabilities become a competitive asset. This requires a “critical mass” of activities to create a self-sustaining biocluster model that assures cost savings, quality adaptability, and flexibility to the needs of small to medium enterprises.

The role of collaboration among territories is on the agenda of many regional authorities. Strategically, growth through external alliances seems to present a good development path both for new bioregions and mature bioclusters. Various approaches have been implemented to boost biomanufacturing in different parts of the European Union and the United States, but only recently has the issue of optimizing those activities been studied even there.

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Latin America is emerging as a major player in the adoption of biotech crops. Argentina’s INTA has developed disease-resistant maize. Brazil is a leader in sugarcane research and one of the first countries transforming crops such as beans, coffee, and some fruits. Chile has generated fungi-resistant grapes and has collaborated in the development of plant-made pharmaceuticals. Colombia has developed biotech sugarcane, palms, and coffee. Mexico has made important developments in plant drought tolerance and nitrogen fixation through genetically modified microorganisms.

Débora Marques of the Council for Biotech Information in Brazil is organizing a session on the topic of agricultural biotechnology in Latin America. “The panel is offering an update on recent research, industrial and regulatory advances in Latin American countries with the purpose of identifying opportunities for investment, technology transfer, and collaboration,” she explains. “Our session is intended to present a general overview of current status of the agricultural biotechnology sector of selected Latin American countries to provide an analysis of market opportunities in the region and identify technology-transfer opportunities from Latin American research institutions and to Latin American firms and farmer communities.”

Marques says the region is not only a major player in the adoption of biotechnology crops, but also in the biofuels technology development. Competitive research is being conducted in different institutions and companies all over Latin America.

“In 2009,” she adds, “the economic global situation will challenge governments and companies to creatively find new opportunities and tools to be well-succeeded and increases their results. There is no better place than the BIO International Convention to share experiences and significant biotech information, as well as to present biotech regional status.

China and Bio-Asia

China leads the world in its rate of growth, and the country is making a big play for attention at the 2009 BIO International Convention. There for the first time representatives of its State Food and Drug Administration (SFDA) will attend to introduce their country’s GLP and GCP regulatory rules to the international biotechnology community.

A fast-growing economy has attracted talent back to China from the West, where many Chinese nationals have received great education and experience in more advanced bioindustrial sectors. This has greatly improved the country’s research and development capabilities, and some multinational companies are establishing R&D and manufacturing centers in China as well as collaborating with local businesses there. They’re seeking not only low-cost business options, but also strong talent and new innovations originating in China.

A Biosimilar Future: As countries around the world begin to define their biosimilar regulatory pathways, companies including biopharmaceutical innovators and small-molecule generics makers as well as brand new start-ups have begun exploring how they can enter the biosimilar business. A biosimilar strategy can be either defensive or offensive, depending on the company’s position in the estimated US$20 billion of “at-risk” biologics. Asian countries — especially India, Korea, Singapore, and China — could be attractive locations to build biosimilar capabilities for several reasons. They are not yet committed to established innovation industries, they have invested in and developed resources and infrastructure for business, and they offer market potential of their own.

Bruce Mackler, an entrepreneur in residence at UC Davis Connect, will be presenting in a session on this topic at the 2009 BIO International Convention. “The information will be substantive,” he promises, “and we’ll discuss critical FDA issues in this regulatory environment that are likely to affect attendees’ regulatory decisions in 2009.” This will be the first time a BIO convention session will examine how companies can use (and may already) use existing resources in Asia to develop an offensive or a defensive strategy regarding biosimilars — either for their home markets or for new ones.

“Survival and growth in this economy and regulatory environment requires participation in this convention,” says Mackler.

Collaboration Is Key

Cross-border transactions are increasing in the life-sciences industry, which we at BioProcess International anticipated when we founded the magazine in 2002–2003. For example, Takeda Pharmaceutical recently acquired Millennium Pharmaceuticals in the largest overseas acquisition ever by a Japanese drug company. WuXi PharmaTech, a leading Chinese contract research supplier, acquired AppTec in the United States to add biologics capability and expand its footprint in North America. BioWa, a wholly owned subsidiary of Kyowa Hakko Kogyo in Japan, is seeking opportunities to license its antibody platform technology and acquire new antibody technologies from strategic partners. Both Pfizer and AstraZeneca have established research centers in Asia and regularly use Asian CROs for their research projects.

Initiating, creating, and maintaining successful alliances is a major aspect of biotechnology worldwide. In addition to the latest round of company buy-outs, large pharmaceutical companies are likely to continue seeking strategic alliances with the biomedical sector over the coming years, driven by the need to boost their product pipelines. Investment groups are also looking for innovative technologies that could address R&D productivity.

We’re All in This Together: Concerns about high costs and value of drugs are leading to increased restrictions on biologics by payers in the United States and other Western healthcare systems. This trend will significantly affect product and company valuations and have broad implications for patients and clinical trials. A robust pipeline of new products and expanding indications for existing therapies will only increase these decision-making pressures. Additionally, the safety and security of these drug products is vital from both the product and intellectual property perspectives. Opportunities to spend are unlimited, but resources are not, especially in the new economic climate.

Each product currently in development or anticipating additional indications will receive increasing scrutiny regarding access. As investors and executives decide on how to invest in companies, which products to pursue, and how to design clinical trials, they must now consider not only how many patients are eligible for testing, but also how many patients will ultimately gain access to their products after running the payer gauntlet.

Market access differs significantly by country. As new market access approaches are implemented and prove successful in managing the expenses of biologics for some, other countries and/or payers will take notice and could adopt aspects of those strategies.

RELATED SESSIONS AT THE BIO INTERNATIONAL CONVENTION

Global Biotechnology Issues Sessions: Monday 18 May 2009

When East Meets West: Hot to Get Deals Done and Build Enduring Relationships

Innovating for Diabetes: A #1 Priority

Global Biotechnology Issues Sessions: Tuesday 19 May 2009

Asia as the Biosimilar Launch Pad

Biomanufacturing and High-Tech Facilities: How to Share Tools Between Bio-Regions?

Global Collaboration Structures to Sustain Viable Research-Based Biomedical Industry

Global Biotechnology Issues Sessions: Wednesday 20 May 2009

Product Development for Global Health: Addressing the Resource Challenge

China: Chain to Global Multicenter Clinical Trials

International Competitiveness: Survival Guide for a Challenging Global Environment

Fast Forwarding Life Science Innovation: What Works, What Doesn’t, Where Do We Go from Here?

Global Biotechnology Issues Sessions: Thursday 21 May 2009

Challenges and Opportunities for Engaging in Global Health Product Development

The Struggle to Maintain Global Market Access for Innovative Biologic Products: Strategic, Economic, and Product Security Perspectives

Private Companies Tackling Public Health

For complete session information, visit http://convention.bio.org.

Stephanie Stiles, marketing director of Putnam Associates, is organizing a session in this topic at the 2009 BIO International Convention. “Getting a product through development and to the market is only half the battle,” she warns. “Without solid strategies to achieve and retain access to patients, there may be little gold in the pot at the end of the rainbow.”

Stiles continues, “The audience will learn how both payers and biotech companies view the challenge of achieving market access in an increasingly resource-constrained environment. Specific attention will be given to how current use is managed across the United States, United Kingdom, and French markets and how this may evolve over the next five years. An understanding of the role of product security in the access equation will also be presented.”

Session chair Kevin J. Gorman is a managing partner at Putnam Associates and author of the forthcoming book The First Twenty Years Are the Hardest. “The battle for access will demand increasingly creative designs that take into account the needs of the payer customer,” he wrote. “Forms of risk sharing and annual caps on therapy cost will be experimented with. True innovation will still command access and premium pricing, but increasingly the initial pricing decision will be a multi-dimensional affair balancing the probable reactions of many stakeholders.”

RELATED SESSIONS AT THE BIO INTERNATIONAL CONVENTION

International Sessions: Monday 18 May 2009

Global Bio-Pharmaceutical R&D Hub in China Biotechnology in Hungary: An Emerging Market

Cutting-Edge Regenerative Medicine in Japan: Establishment of a Special Zone for Advanced Medicine

Public–Private Partnerships: Translating Science into Applications

International Sessions: Tuesday 19 May 2009

Canada: Your Innovation Partner in Regenerative Medicine Mexico: New Generation Biotechnology Cancer Genomics in Spain: A Success Story

International Sessions: Wednesday 20 May 2009

Australian Biomedical Research in a Transformational Approach to Global Health The French Experience in the Field of Tropical Infectious Diseases

Russia’s Emerging Bioeconomy: New Developments in Biofuels, and Bionanotechnology

Role of Biotechnology in Improving the Bio-Economy of African Countries

Antibodies in Drug Discovery and Development and Platform Technologies Supporting the Research Activities

Building Up Research Capability for Win-Win Partnerships: Bioprospecting in Thailand Lost in Translation: Translational R&D as the Road Map to Market

International Sessions: Thursday 21 May 2009

Breakthroughs in Transgenic Animals for the Production of Biopharmaceuticals in Argentina

Recent Developments and Partnering Opportunities in Agricultural Biotechnology in Brazil

Breakthroughs in Medicinal Chemistry and Chemical Biology in the Czech Republic: Unique Opportunities for Drug Research, Development and Joint Venture

Breakthroughs in Regenerative Medicines in Germany

Accelerating the Commercialization of Nanotechnology-Based Products and Services: The Malaysian Approach

Drug Development and Gene Therapy at Krakow’s Jagiellonian University: Unique Expertise and Novel Approach

Breaking New Stemcell Research Unlocks Unknown Therapies

For complete session information, visit http://convention.bio.org.

“Attending BIO this year is especially crucial to keep abreast of the rapid changes and disruptions occurring in the biopharma industries,” Stiles says, “including the difficulty of obtaining financing impact on early stage companies, the eroding purchase prices of biotech products, pharma’s continuing need to replenish its pipelines, and pressure on national and state budgets that increase the challenges of getting new drugs covered and paid for.” She warns of increasing numbers of under and/or uninsured people that could potentially shrink the market for biologics, as well as tougher regulatory environment that could increase the difficulty of gaining approval for new treatments.

“Despite the challenges, there are a number of reasons to be optimistic,” Stiles suggests. “There are more biologics than ever in development and awaiting approval. And the general public increasingly understands the value of biologic drugs (driven by breakthroughs in oncology and autoimmune diseases). This convention will be the perfect opportunity for participants to look back and internalize the roller coaster ride they have been on for the past year and look forward to what is to come. And although there will be many obstacles and challenges, they will see a road that is filled with opportunities waiting to be captured.”

Unmet medical needs persist despite the progress of life-science innovations. Bringing innovation to fruition is a major issue. Many conferences are dedicated to examining individual aspects of the innovation chain. But the 2009 BIO International Convention’s global gathering will bring together diverse perspectives and experiences with innovation models.

Zorina Galis, president of Amplinovia and a professor at the Indiana University School of Medicine, is organizing a session on innovation. “When attending professional events, we all tend to gravitate toward those closely related to our own domain of expertise,” she says. “However, innovation thrives at the intersection of fields, an effect [our company has] dubbed constructive interference.”

Her interactive session aims to take advantage of the global event to create an open forum in which ideas will be discussed from the diverse perspectives of major stakeholders: innovators and decision makers, small and large corporations, participants from different areas of expertise and geographies. She explains, “The audience will be invited to actively participate alongside the distinguished panelists by offering their own ideas and experiences with various models of innovation. We also welcome submission of questions and opinions online ahead of time at http://constructiveinterference.wordpress.com. Look for the ‘BIO2009’ tag.

“The diverse input and open discussion should enable a better understanding and appreciation of others’ needs and wants, capabilities and constraints, which in turn will create an opportunity for collective creative problem solving to enhance innovation. The idea exchange will provide the opportunity to formulate implementable solutions to overcome the remaining hurdles, real or perceived, to innovation.”

Galis adds, “The current global economic reality accentuates the need for innovation, while at the same time limiting many of the previously available financing and development options. This challenges us to also find and create better ways to innovate. Success will likely favor those with the ability to connect and forge true partnerships that create synergy based on harmonizing capabilities, mutual appreciation, and trust.”

But Competition Is the Nature of Business: Kristen Gorts, a marketing coordinator for Pillsbury Winthrop Shaw Pittman, LLP, is organizing a session on International Competitiveness. “During this session,” she says, “industry experts will addresses important global issues that affect the way biopharmaceutical companies and their investors develop and conduct business. This knowledge is crucial given the current economic conditions. Attendees will gain critical survival skills necessary to navigate global competitiveness in today’s challenging economic climate where vital investment has ceased.”

Public Health As a Private Endeavor

Public health means different things to different people. Some look at it broadly in the capacity to study and manage threats to the health of a community. Others take a more narrow view, focusing on the subfields of epidemiology; health services; and environmental, social, behavioral, or occupational health. Biotechnology companies focusing their research on improving the lives of entire populations face unique challenges in R&D, funding, and eventual commercialization.

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Public health issues are often in the mainstream spotlight, but mainly from the patient/consumer perspective, the governmental perspective, or that of “Big Pharma” R&D. That’s why the 2009 BIO International Convention will include several sessions on public health issues, an area of biotechnology research with strong ties to the global health community.

For example, biotechnology companies are becoming more engaged in developing products targeting neglected tropical diseases. Because of substantial investment by philanthropic foundations and governments, progress has been made in treating several diseases that afflict large numbers of the world’s citizens. However, funding of global health product development is a minor fraction of the overall R&D expenditures and venture capital investments. A few companies are involved, and the chance for each potential breakthrough therapy remains small. Meanwhile, many companies in the developing world are interested in partnering with US and European biotechs but lack the contacts, funding, and expertise to do so.

Chris Dippel, principal consultant with First Founders Ltd., is organizing and chairing a convention session on Product Development for Global Health: Addressing the Resource Challenge. He says, “The US biopharma industry needs to find world markets, and individual companies need to understand the value proposition for developing products for global health. This session will be a first step in understanding the opportunity and accessing financial and managerial resources.”

Carol Nacy, chairman and CEO of Sequella, Inc., will be a presenter at the session. She adds, “Many infectious diseases that are prevalent outside the United States flow easily across porous national and international boundaries through business and personal travel to and from endemic areas. The importance of these diseases to US public health, such as multiple-drug–resistant TB, is increasing. Yet attention to new diagnostics and drugs for such diseases is scant, and venture funding is minimal. Attendees will learn how for-profit companies engaged in research and development fund their programs in global health and leverage their expertise and contacts in funding agencies at the national and international level.”

In 2009, Dippel says, “Developed world markets are cost-constrained; developing world markets have potential.” And Nacy adds, “New energy unleashed by the change in US administration, where taking care of others while we take care of ourselves will be a priority, means that companies have an opportunity to look for different markets that can benefit from their expertise and commitment to healthcare. There is no better place for them to interact than at the BIO International Convention.”