With more than 70 employees and a $30 million budget, the Biotechnology Industry Organization (BIO) fulfills an unconventional
role for a trade organization. Carl Feldbaum, BIO's president, leads the charge on behalf of its 1,000 member companies with
an agenda that aims to attract investors, create a "biotech friendly" environment at FDA, and pave the way for tomorrow's
medicines and cloning technologies.
BIO opened NASDAQ on February 22, day one of its investor conference in New York (l-r): Gad Riesenfeld, Pharmos; William Huse,
Applied Molecular Evolution; Vaughn Kailian, Millennium; Carl Feldbaum, president of BIO; Henry Blair, Dyax; David Weild and
Andrea Edelstein, NASDAQ.
MM: What is BIO's focus in 2002?
Feldbaum: BIO's first order of business is to renegotiate the Prescription Drug User Fee Act, or PDUFA, with FDA and Congress. Enacted
in 1992, along with the Food and Drug Modernization Act, it streamlined biologics' review path through FDA. BIO is proposing
an increase in user fees so FDA can implement more risk management initiatives, improve communication between companies and
the agency during the first cycle of review, enhance performance of the review process, and offer independent consultants
to help sponsors design Phase III clinical trials.
MM: How does BIO hope to influence the Senate's upcoming vote on anti-cloning legislation?
Feldbaum: Like death and taxes, the cloning debate is inevitable. We are prepared to take on those who want to squelch research in
somatic cell nuclear transfer and the use of cloning technologies for therapeutic purposes.
In the meantime, we are holding conversations with religious leaders of various denominations to discuss cloning and stem
cell research-and we are prepared for a very long haul. The Vatican decided in 1869 that life begins at conception. So we
are working with Catholic bishops to re-examine that decision in light of what we now know about reproductive biology. Those
religious leaders will participate in our 2002 annual meeting in Toronto this June, both as plenary speakers and as participants
in bioethics seminars.
MM: What is your relationship with PhRMA?
Feldbaum: We work closely with PhRMA to make sure that our individual policies don't collide and that our efforts, to the extent possible,
don't conflict on Capitol Hill, because a number of companies are members of both organizations. We construct and execute
our own agendas, which are often quite similar, but our priorities tend to be different because BIO is made up largely of
small, emerging companies deeply involved in R&D, many of which do not yet have products on the market.
MM: How does BIO attract investors into the sector?
Feldbaum: We take a somewhat unorthodox role for a Washington-based trade association in that we interface between investors and the
biotech community. We host meetings around the world that involve partnering between pharmaceutical and biotech companies
and, increasingly between biotech and biotech. We also hold investor meetings to highlight new or very promising areas of
research, such as regenerative medicine, that may not have received the investor attention they deserve.
The BIO & CEO Investor Conference 2002 in New York was our largest yet. The meeting really got back to basics, focusing on
cancer therapeutics, anti-infectives, and monoclonal antibodies-the core technologies of our industry. Last year's meeting
was more a "flavor du jour," with genomics, proteomics, and bio-informatics on the agenda.
Since September 11th, there has been strong interest in increasing interaction between the biotech and national security communities.
That's a theme you will see develop throughout 2002 and beyond.
MM: Is BIO reaching out to other audiences?
Feldbaum: BIO is now engaging the judiciary branch of the government with its website Biojurist.org, which will launch in May. It will
initially focus on helping judges, law clerks, law librarians, and legal academics engaged in biotech-related intellectual
property issues. We will expand the website to include other issues, such as genetic privacy, that are percolating through
the federal judiciary.