Articles

Jerry Masoudi, former Chief Counsel for the Food and Drug Administration (FDA), highlighted the importance of assuring that inappropriate warnings are not included on drug labeling--and the importance of maintaining a national system, so "we don't have 50 different labels" for a drug.

With the biosimilar regulatory pathway in sight in markets around the world, companies from the biopharma innovators to traditional small molecule generic houses to well-funded start-ups are exploring how they can enter the biosimilar business. A biosimilar strategy can be either defensive or offensive, depending on the company's position. Countries in Asia, particularly India, Singapore, Korea and China, may be attractive locations to build biodevelopment and biomanufacturing capabilities. The panel, Asia as the Biosimilar Launch Pad, discussed the resources and infrastructure already in place in these countries, what some of the companies are already doing, and how these might impact the biologics markets of United States and Western Europe. The panel provided an overview of the current industry infrastructure, investment incentives and regulatory framework, and key participants in India, Singapore, Korea and China. In addition, speakers profiled examples of companies already building their biologics capabilities in these Asian countries. Finally, the panelists discussed the likely impact on the biologics market of Asia, the United States and Western Europe. The chair was Helen Chen, Partner and Head of China Life Sciences, LEK Consulting, LLC. Panelists included:

  • Jay Desai CEO and Founding Director, Universal Consulting
  • Bruce Mackler, PhD, JD, COO
  • Steven Lee, PhD Chief Executive Officer, A-Bio Pharma Pte Ltd, Singapore
  • Stanley Hong, PhD Senior Vice President, Celltrion, Inc

The panelists highlighted that Asia can be a launch pad for biosimilars because of one, supportive governments. Many of the countries discussed do not yet have regulatory approval pathways for biosimilars. This can slow down the decision process for approving biosimilars. However, panelists did stress that the countries discussed are supportive of an approval scheme and many will follow the WHO guidelines. Korea released a draft guidance on biosimilars for public review in April 2009, to be finalized in June 2009. This guidance will include a definition of biosimilar and clinical data requirements. Two, Asian countries have a large underserved population. And lastly, these countries have a developed clinical infrastructure. One panelist told the audience that to have a product approved in the United States, a sponsor has to know the serious adverse events. He further hypothesized that success will come to companies that develop a biosimilar that incorporates a new delivery technology. Discussion around interchangeability and data exclusivity were minimal.

--Katie McCarthy

Conflicts of interest in research and medical care is a salient topic for regulators, Congress, accrediting bodies, state legislatures, and the media.

Post by Michael Werner

Panelists:

  • Michael Werner -- Holland & Knight LLP – Moderator
  • Russell Medford – CEO, Salutria Pharmaceuticals, Inc
  • Margaret Offerman – Deputy National Vice President for Research, American Cancer Society
  • Marjorie Spears – Executive Director, Association for the Accreditation Human Research Protection Programs
  • Steve Sencer – Deputy General Counsel, Emory University

Conflicts of interest in research and medical care is a salient topic for regulators, Congress, accrediting bodies, state legislatures, and the media.  The current environment consists of the following:

  • Increased Congressional scrutiny of the relationships between institutions, physicians, and the pharmaceutical industry.  In the past year, Congress has launched investigations of research institutions, researchers, clinicians, and patient advocacy groups.
  • Senate health care reform proposals contain provisions imposing significant reporting requirements on drug and device manufacturers' interactions with researchers and physicians.
  • NIH recently published an advance notice of proposed rulemaking asking for comments about regulation of NIH grantees and the imposition of new compliance and management responsibilities on institutions. 
  • Many states are developing legislation and regulations on conflicts of interest. Several states have enacted "sunshine laws" requiring disclosure of industry payments to physicians; others are considering legislation to regulate direct to consumer advertising and the conduct of industry salespersons.
  • Several institutions are developing their own conflict policies for research, as well as interactions between faculty and industry.  Some professional and specialty societies are doing the same.

Often lost in this discussion is the recognition that relationships between industry and academia have been enormously beneficial.  Numerous discoveries and treatments for patients have resulted from the close collaborations that policy makers now find troubling.  In addition, these proposals focus on financial conflicts, ignoring non-financial conflicts that could also introduce bias into a research project.  According to the panel, industry-academic collaborations have benefits and risks.  The benefits include increased funding for research and commercial productivity.  Many parterneships are necessary for research to succeed; the commercial sector funds critically important research while other sources of funding (such as from the NIH) are insufficient.  The risks are the possibility of biased results and the loss of research integrity.  The panelists described organizational efforts to promote useful collaborations while maintaining the public's trust in medical care and research.  Disclosure of interests is a commonly-used tool and is required by federal regulations.  Nonetheless, panelists described challenges implementing a disclosure policy; especially trying to decide what information to disclose, as well as when to disclose it and to whom. Panelists agreed that public trust in research and medical care is at risk.  All stakeholders have an interest in maintaining credibility with the public and conflict of interest policies are an important tool.  Moreover, accrediting bodies require organizations to have conflict of interest policies, following FDA or Public Health Service regulations.  Commercial sponsors should make sure their collaborators have instituted appropriate policies. In addition, stakeholders are encouraged to respond to the NIH's call for comments on conflict of interest policies for NIH grantees.  Comments are due by July 7.

When Joachim Schneider (Head of Life Sciences for Bayer Crop Science and BIO’s new Chairman for Food & Ag) opened the panel on “Agricultural Production: Meeting the Sustainability Challenge,” he made it clear that today’s challenge is to increase productivity and while dealing with climate change. Will future production keep pace with demand? How can we meet food and fuel challenges? “We need to marry global science with global scale to produce global increases in yield,” says John Pierce of Du Pont Life Sciences. DuPont/Pioneer thinks yields will need to increase no less than 40 percent over the next 10 years for both corn and soybeans. We need a second green revolution. We need government, society, industry and academia to work together, and we need to use all technologies available. Biotech is an essential tool in the toolbox. Biotech presents the greatest opportunity to improve crop yields in Africa, Brazil, East and Southern Asian. But biotech acceptance must remain a global effort. Global food security remains an objective, not an accomplishment. There are multiple benefits of biofuels production: It reduces the need for imported petroleum – which has national security implications – and helps reduce the trade deficit. It can also offset the use of petroleum and chemical-based fuels. For biofuels production, the United States has an advantage in land area and technology. The next generation of biofuels will improve existing ethanol production by increasing feedstocks yields. New fuels (including cellulosics, advanced cellulosic from corn stover and switchgrass) will improve performance. And technological- driven improvements will help increase crop yields. We’ll see massive improvements over the next five years, and we’ll need predictable policy to ensure progress.

--Val Giddings

Sustainable agriculture is the basis for sustainable biofuels, says John Pierce, VP, DuPont Applied Biosciences - Technology. Biotechnology applications can help to reduce energy costs and increase yields in biofuel production

Welcome to this special edition of the IP Think Tank podcast for Monday the 18th of May 2009.  In this call Duncan speaks to Gregory Glover, a panelist at the 2009 BIO International Convention about the pending Biosimilar legislation and concerns over situations where a follow on product might avoid patent claims but still be able to rely on innovatory regulatory data.

By Terri Somers - In these serious times, up to 15,000 biotechnology executives from around the globe are descending upon Atlanta today to do some serious business at the 2009 BIO International Convention. In this difficult economic climate, with a new administration focusing on healthcare reform and the world getting a glimpse of what a flu pandemic could look like, there are plenty of issues for the biotechnology industry to tackle.

The Biotechnology Industry Organization's international convention comes to town amid global economic woes - not to mention trailing fears of the H1N1 swine flu epidemic - yet the industry's enthusiasm for the annual event remains as high as ever, perhaps even more so in the face of tough challenges ahead. As many predicted, attendance for this year's meeting is down about 35 percent to 40 percent from the number of people that attended last year's convention in San Diego.

Last night research, industry and politics got together at Dailey's in Atlanta for a little meeting. It was actually a networking reception but let's face it, we were all about ensuring the wheels of biotechnology kept turning in Canada.

Author:  Dr. Carolyn Britton, President, National Medical Association