West Coast Editor

NEW YORK Vaughn Kailian, whose profile (given his company’s whopping $2 billion deal at the end of the year) was high at the Biotechnology Industry Organization’s CEO & Investor Conference, may have made the most pithy remark yet about recent headlines that pertain to the industry’s regulatory matters.

“You never get an I love you’ letter from the FDA,” said Kailian, vice chairman of Cambridge, Mass.-based Millennium Pharmaceuticals Inc., formerly the president and CEO of COR Therapeutics Inc., of South San Francisco. In December, Millennium said it was taking over COR in a stock deal. (See BioWorld Today, Dec. 7, 2001.)

Kailian’s remark, during the conference’s final panel session, wasn’t in direct reference to ImClone Systems Inc., of New York, which has met with FDA difficulties related to its proposed drug, Erbitux (cetuximab), for colorectal cancer.

The drug was at the center of a deal also, coincidentally, worth up to $2 billion with New York-based Bristol-Myers Squibb Co. Portions of a confidential letter, in which the FDA refused to accept ImClone’s rolling biologics license application, were published in a cancer newsletter. (See BioWorld Today, Feb. 13, 2002.)

ImClone’s woes, which came as a surprise to many, provided the subtext for much talk at the conference, including remarks made during the closing panel.

“The game is never over [with the FDA],” said Richard Pops, CEO of Alkermes Inc., of Cambridge, Mass., also speaking non-specifically. “There’s an ongoing paranoia.”

Using much more specific terms about the sensitive subject of ImClone’s imbroglio at a luncheon keynote during the conference was Michael Waldholz, reporter for The Wall Street Journal. His speech drew complaints later from some CEOs, said Carl Feldbaum, president of BIO.

“He spoke his mind, which he has every right to do,” said Feldbaum, who had invited Waldholz “weeks, if not months ago, well before the ImClone news.” Not until the night before the speech did BIO know the topic but Feldbaum said “there was absolutely nothing I was going to do or say to influence him.”

BIO is “not trying to spin’ [the ImClone problems] to people,” he added, noting his regret that, because of the speech’s format, neither ImClone nor the other companies mentioned could defend themselves.

ImClone, facing shareholder lawsuits and a government probe, could be headed to court. The issues likely would be “who knew what and when” about Erbitux, but often the legal issues are quite different, and much more scientifically complex, Feldbaum said.

BIO disclosed at the conference that it has begun The Biojudiciary Project in collaboration with Ernst & Young LLP and its Litigation Advisory Services Practice. Offering what the project calls “A Jurists’ Guide to 21st Century Biotechnology” at www.biojurist.org, organizers hope to provide judges with more information about “the impact of court decisions on the biotechnology industry and society.”

Feldbaum said U.S. Supreme Court Justice Stephen Breyer called for an “ongoing conversation” among the federal judiciary, the private sector and other stakeholders. The BIO chief said he had worked with Breyer “decades ago” in the Watergate prosecutions, and Feldbaum renewed the acquaintance.

“I wrote him a note, he invited me to his chambers, we sat by the fire and had coffee,” Feldbaum said. “He said the judiciary has not enough information and knowledge about even the scientific terms being tossed around federal courtrooms. We’ve had numerous judges complain to us that they are at the mercy of conflicting experts.”

How seriously will judges take the website, when it’s co-designed by a trade association of the industry?

“Only as seriously as it is peer reviewed and authentic,” Feldbaum said. “It starts with an annotated glossary of scientific terms, so law clerks, judges, law librarians and attorneys have a common set of language.”

There are also papers on patent law already a hot area, and likely to become more so, Feldbaum said with links to court decisions related to intellectual property. “Also, for one-stop shopping and efficiency, you can get the patents themselves,” he said.

“Unless this is objective, it’s not going to be worth a damn, frankly,” Feldbaum said. “BIO has engaged the two constitutional branches of the government, the executive and the legislative; now, it’s time to engage the judiciary. The industry has grown up, the trade association has evolved, and this is a long-term relationship. The credibility of this website is going to be its currency.”

The conference, with more than 1,500 attendees, ended Friday at the Waldorf-Astoria Hotel.

“It was just a little larger than last year, which is good, given the current environment,” Feldbaum said.

Plenty happens behind the scenes, he said.

“What you see is a small part of what they get,” Feldbaum said. “We have breakout rooms, little rabbit warrens and honeycombs, where these bees get together. What they do is their business, but there’s a lot of buzzing going on, in every nook and cranny of this hotel.”