You have a groundbreaking drug that has just completed the development phase. Now you have to prove it to the federal government.

What you will have to get past are thousands of pages of data written in scientist language and a panel of experts representing the Food & Drug Administration.

The members of this panel do not want to hear jargon. They want clear, concise responses that will prove you know what you’re talking about. And, like a presidential debate or the Miss America pageant, any stumbles in your response can have disastrous effects on your chances of coming out on top.

Enter PharmApprove, a pharmaceutical communications company that specializes in getting drug companies through the last — and usually most nerve-wracking — step of the regulatory approval process. The company is a division of Taft & Partners, a communications firm based at 1 Palmer Square. PharmApprove is run by Pete Taft, the CEO of both companies.

The son of an executive with Rohm & Haas, Taft went to Dickinson College, Class of 1973, and worked as a sports writer in Santa Monica and a reporter in Vermont, with a stint teaching English in between. While freelancing for glossy magazines in New York he met his future wife, Mara Connolly, who was working at big ad agencies. Taft switched careers and opened Taft & Partners in 1999.

PharmApprove was launched in 2006 and in September hired Laurie Smaldone as its new president. Smaldone comes to PharmApprove from Bristol-Myers Squibb, where she spent 20 years in clinical development.

“When a drug goes through the regulatory process,” Smaldone says, “it’s a 10-year ordeal. At the end an organization has to translate thousands and thousands of pages of data into short statements. And be prepared for some really tough questions.”

The trouble companies run into during the pre-approval phase, Smaldone says, is that presenters — often scientists — tend to fall in love with their data. Rather than answering in English, they spend a lot of time regurgitating highly technical information.

Or a lot of presenters fall into what Smaldone calls the “slide Olympics,” a tendency to put all the information on slides and use them to answer every question asked.

But slides, she said, should be supportive, not used as responses. An FDA panel wants to hear from a presenter, not be inundated with slides.

What separates FDA panel presentations from the myriad presentations drug companies make during the investment and development phases is that FDA panels are non-scientific public hearings. “Everything is confidential until it’s not,” Smaldone says. And when you face the FDA, all your research, information, and secrets are open to an audience of interested citizens, journalists, potential investors, and your competition.

PharmApprove spends 20 to 24 weeks preparing presenters for what Smaldone calls “a very formidible event.” Everything from helping a presentation team organize its thoughts and breaking down jargon to coaching presenters on how to answer and how to stay poised.

Nerves, Smaldone says, can get the better of otherwise prepared people when they realize the weight the FDA presentation carries. After several years of discovery, development, testing, and investment, the entire operation can come to an immediate halt if the FDA doesn’t think you have good enough answers.

The last thing a company wants is a credibility problem when it steps up in front of a panel. Part of PharmApprove’s coaching is getting presenters to anticipate the questions a federal advisory panel might ask — say about side effects. “No drug has no side effects,” Smaldone says. “It’s a matter of weighing benefit versus risk.” PharmApprove helps companies understand how to present risk data so that it shows the benefit a drug will have for a particular group (stroke patients, for example) without creating undo risk.

And are there different data sets for different sub-groups? Does the drug affect men and women differently? Or older people versus younger?

A risk management plan needs to account for questions like these, and if a presenter trips over an answer, or the information is considered too slight, a promising drug can die on the panel floor. “We help rehearse teams,” Smaldone says. “But ultimately the data is the data.”

Smaldone views the FDA process as a production not unlike theater — and she should know, having been a dancer in high school and college. But when she got to Yale she found that medicine was her calling. She earned a bachelor’s in biology and philosophy in 1975 and stayed at Yale, earning her M.D. in 1979.

Smaldone was a practicing oncologist and Yale faculty member for a few years. Her original plan was to learn about clinical trials from the industry side, rather than from the medical side. But she quickly became hooked by cutting edge research happening in the pharma industry. She left Yale to take her job at Bristol-Myers Squibb.

After BMS Smaldone briefly served as president of a now-defunct pharma company named PhytoMedics, then moved into consulting with PharmApprove, already familiar with some of the most common trip-ups presenters deal with. PharmApprove offers a list of tips for anyone facing an advisory panel.

Make the panel the number one priority. Preparation for an advisory panel can take up as much as 80 percent of your team’s time. Don’t try to cram for a presentation.

Also, don’t confuse the agency with the panel. The agency will be there, but it’s not the one you need to impress. Consider not what the agency wants but what the panel needs to hear.

Build teams on performance ability. Developing a drug takes a lot of work from a lot of people over a long time. But not everyone in the development process is suited to give presentations.

Follow the axiom: “The best scientists don’t necessarily make the best presenters.” Assemble your team around who can deliver the message best, not around who put in the most hours.

Work from scripts. Don’t read from the script, but know what the script says. If it is your road map, you will not lose your way during your presentation.

You will win or lose in the Q&A. Making a succinct, informative pitch is one thing. But the panel is going to ask questions, and they’re not going to be easy ones. Learning to anticipate questions and having ready answers can spell the difference between approval and flop.

Embrace the critics early. Outsiders can offer you valuable insight by asking tough questions. Embrace this, and get the feedback early while you still have time to work on the problems.

KISS works. Keep your presentation simple. One-point-per-slide kind of simple.

Panelists are busy people uninterested in complicated technical jargon. PharmApprove recommends taking Napoleon’s advice to his troops — “Be clear, be clear, be clear.”

Rehearse, rehearse, rehearse. When you’re done doing all that, rehearse again. Know the material inside-out and upside-down. After all, Smaldone reminds, “You only get one chance.”

#b#Taft and Partners/PharmApprove#/b#, 1 Palmer Square, Suite 303, Princeton 08542; 609-683-0700; fax, 609-683-8011. Pete Taft, president. www.taftandpartners.com

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