“Since its founding in 1980, EWNJ has championed the advancement of women to the most senior levels of international corporations, non profits, and public service firms. At this year’s ‘Salute to the Policy Makers’ event, we will celebrate the professional accomplishments of 36 exceptional New Jersey executives,” said EWNJ President-Elect and 2012 Salute Dinner Chair Keitha M. Lackey, who also serves as a Director for Horizon Blue Cross Blue Shield of New Jersey. “It is my honor and pleasure to serve as Chair for this year’s gala, which serves a dual purpose: Honoring an outstanding group of women and benefiting an excellent cause.”

Dr. Smaldone’s career began with Internal Medicine and Medical Oncology training at Yale University, which led her to a position at Bristol-Myers Squibb in clinical cancer research, advancing development programs through to registration. She then held a range of positions of increasing responsibility and scope in multiple disease areas, including Executive Director, HIV/AIDS; Vice President, Infectious Diseases; Senior Vice President, Global Regulatory Science; and Corporate Vice President, Business Risk Management. Dr. Smaldone was most recently CEO of a clinical phase biotechnology company, prior to joining PharmApprove as President in 2011.

Proceeds from the biennial event will fund EWNJ’s scholarship program, which has provided over $1.1 million in scholarships to more than 350 deserving New Jersey women enrolled in advanced degree programs at New Jersey institutions since instituting the program in 1986, as well as other programs that advance women.

For more information on corporate sponsorship or tickets to the Salute to the Policy Makers awards dinner, contact EWNJ at 609-249-7982 or visit EWNJ on the web at www.ewnj.org.

###

Facing the FDA? This Princeton Firm Has Your Back

by Scott Morgan

Reprinted from the November 9, 2011, issue of U.S. 1 Newspaper

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.”

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

Dr. Smaldone, formerly Senior VP of Global Regulatory Science at Bristol-Myers Squibb, will lead PharmApprove’s expert team of regulatory communications and product development specialists in expanding not only the company’s services, but its geographical reach as well, said PharmApprove founder and CEO Pete Taft.

“Laurie is a seasoned drug development and regulatory expert who brings an extraordinary range of expertise to the table,” said Taft. “She’s the perfect choice to help deepen our core business, add to our service offerings, and extend our reach into both Europe and Asia. We couldn’t be more excited to have her lead us in this new phase of growth.”

PharmApprove is an industry leader in helping to prepare drug, biologics, and device teams for high-profile regulatory hearings, including FDA Advisory Committees in the US and health authority hearings in Europe.

After completing training in Internal Medicine and Medical Oncology at Yale University, Dr. Smaldone joined Bristol-Myers Squibb in clinical cancer research, immediately advancing development programs through to registration. She then held a range of positions of increasing responsibility and scope in multiple disease areas, including Executive Director, HIV/AIDS; Vice President, Infectious Diseases; Senior Vice President, Global Regulatory Science; and Corporate Vice President, Business Risk Management.

Dr. Smaldone was most recently CEO of a clinical phase biotechnology company.

Dr. Smaldone brings to PharmApprove broad experience in global regulatory approval processes, regulatory communications, and brand development. In addition, she has prepared numerous teams for FDA Advisory Committee hearings as well as key regulatory meetings in the US, Europe, and Asia.

“PharmApprove offers real added value in assisting product development teams in sharpening complex data presentations and core messages during the most critical moments in the registrational process,” Dr. Smaldone explained.  “Having worked with PharmApprove as a client, I have experienced the power of their approach. I am thrilled to be a part of a team that has shaped and defined this consulting segment so necessary to the approval process.”

For more information, or to arrange an interview, contact Katherine Zimoulis at 609-683-0700 or Katherine@taftandpartners.com.

About PharmApprove™  
PharmApprove™ is a strategic communications consulting firm that helps drug, biologic, and devices development teams prepare and deliver their product’s key messages at critical stages of the development cycle including high-profile regulatory events in both the United States and Europe. Over the last decade, PharmApprove™ teams have helped to create and deliver over 60 drug, biologic, and device development communications programs across 18 therapeutic areas both in the US and overseas, including more than 45 Advisory Committee preparation projects. Find out more at www.pharmapprove.com.

PharmApprove™ is a division of Taft and Partners, an advertising, marketing, and digital media firm located in Princeton, NJ. Find out more at www.taftandpartners.com.

###

For more information, contact
Katherine Zimoulis
609 683 0700

Princeton, NJ – March 22, 2011 — Pete Taft, Founder and CEO of Princeton-based drug development communications firm PharmApprove™, has been asked repeat his role as co-chair of the Forum on Effective Preparation for FDA Advisory Committees.

The conference, organized by the Center For Business Intelligence (CBI), brings together diverse industry and regulatory affairs perspectives to discuss the current regulatory climate, examine trends in Advisory Committee proceedings, and share best practices for preparing to deliver sound arguments for approval of a drug, biologic, or device at these public hearings. The conference will be held on March 29-30 in Washington, DC.

“From both the Agency and the Advisory Committees perspective, the environment has become increasingly conservative for new drug approvals. The recent hearings on oncology and obesity treatments, for example, may cause sponsors to change their approach to AC hearing preparation,” says Taft, whose 12-year-old firm helped establish the field of Advisory Committee preparation.

Taft will serve as co-chair, along with Kevin P. Malobisky, Associate Vice President for Global Regulatory Affairs at sanofi-aventis.

Highlights of the conference include a discussion on the role of FDA Advisory Committee meetings, a series of presentations on best practices for successful and effective AC preparation, and Pete Taft’s keynote presentation on how Advisory Committee members approach their work, based on personal interviews with past members.

Other distinguished presenters include Michael Ortwerth, Director of Advisory Committee Oversight, FDA; Gary Appio, United States Safety and Risk Director, Novartis; and Geoffrey Levitt, Associate General Counsel, Worldwide Regulatory and Policy Law, Pfizer Inc.

About PharmApprove™

PharmApprove™ is a strategic communications consulting firm that helps pharmaceutical development teams prepare and deliver their product’s key messages at critical, high-profile regulatory events in both the United States and Europe.

PharmApprove™ works in partnership with development teams to make a clear and compelling case for approval in several public forums. Over the last decade, PharmApprove™ teams have helped to create and deliver over 60 drug, biologic and device development communications programs across 18 therapeutic areas both in the US and overseas, including more than 45 Advisory Committee preparation projects.

Currently, PharmApprove™ teams are helping to prepare four drug and device teams for upcoming Advisory Committee hearings, providing services including strategy development, medical writing, presentation coaching, slide creation, and project management.

PharmApprove™ is a division of Taft and Partners, a marketing and corporate communications firm also located in Princeton, NJ.

About Pete Taft

Pete Taft is the CEO of Taft and Partners, a communications consultancy. Pete founded the PharmApprove™ division in 1999 when pharmaceutical clients began asking him to assist in preparing global teams for critical regulatory presentations in both the US and Europe. Since then, Pete has been involved in over 60 PharmApprove™ Advisory Committee Preparation projects, providing strategic oversight and individual and group coaching services. In addition, he has conducted dozens of “lessons learned” sessions, videoconferences, workshops, seminars, and individual coaching sessions within the industry. Pete began his career covering crime, politics and law for both magazines and newspapers, winning several awards for his work. He later served as a communications executive in both the public and private sectors, advising leaders in business and government on strategic communications, public speaking, and media relations.

###

PRINCETON, NJ, December, 2010 — Princeton-based drug development communications firm PharmApprove recently played a pivotal role in helping a global pharmaceutical company win an appeal to the Committee for Medicinal Products for Human Use (CHMP) that secured a new indication for one of their products.

The victory marks PharmApprove’s first in the European regulatory theater, where such appeals are made in front of a closed-door “congress” of European Union representatives, not a public Advisory Committee, as is the case with the United States Food and Drug Administration (FDA). PharmApprove has managed 45 such US-based projects for almost 26 pharmaceutical, device and biologics companies.

Over the course of four weeks, the PharmApprove team helped the company’s team focus strategy and define messaging while preparing speakers to not only to deliver a persuasive 20-minute case for the indication, but to answer tough questions as well. PharmApprove helped the team develop both text and slides, and provided onsite support at the CHMP headquarters in London.

“We’re one of the leaders in the United States in helping drug, device and biologics teams gain positive outcomes with the FDA Advisory Committees, so to win our first victory in Europe is particularly gratifying,” said Founder and CEO Pete Taft. “It proved to us that our ‘best in class’ approach to regulatory communications is, in fact, translatable into the European theater.”

For more information about PharmApprove’s work both in the United States and in Europe, or to arrange an interview with Pete Taft, contact Katherine Zimoulis at 609-683-0700 or katherine@taftandpartners.com.

About PharmApprove™

PharmApprove™ is a drug development communications company headquartered in Princeton, New Jersey. PharmApprove™ helps development teams deliver clear, consistent and compelling key messages to regulatory bodies in both the US and Europe.

PharmApprove™ works in partnership with development teams to create the strongest argument for approval at every stage of the development process – or, as Taft says, “when they have one chance to get it right.” Over the last decade, PharmApprove™ teams have helped create and deliver more than 50 drug development communications programs across 18 therapeutic areas both in the US and overseas, including more than 40 Advisory Committee preparation projects.

Currently, PharmApprove™ teams are helping to prepare four drug and device teams for upcoming Advisory Committee hearings, providing services including strategy development, medical writing, presentation coaching, slide creation, and project management.

PharmApprove™ is a division of Taft and Partners, a marketing and corporate communications firm also located in Princeton, NJ.

About Pete Taft

Pete Taft is the Founder & CEO of PharmApprove™. Pete has been the driving force behind the creation and delivery of over 50 drug development communications programs across 18 therapeutic areas both in the US and overseas, including more than 40 Advisory Committee preparation projects. Globally, Pete is frequently called upon to prepare executives and their teams for critical, often high-profile events, both within and beyond the pharmaceutical industry. Pete brings an unmatched understanding of communications theory to his work. Trained as a journalist, he covered crime, politics and law both nationally and internationally for major magazines (Reader’s Digest, Ladies’ Home Journal, Playboy) and newspapers (the New York Times, the Philadelphia Inquirer). He later served as a senior communications executive in both the public and private sectors, advising corporate executives, governors, and members of Congress on strategic communications planning, public speaking and public/media relations.

###

PRINCETON, NJ, October 21, 2010 — Pete Taft, Founder and CEO of Princeton-based drug development communications firm PharmApprove, has been asked to present and lead a session at the largest global gathering of the pharmaceutical regulatory profession.

The 2010 Regulatory Affairs Professionals Society (RAPS) Annual Conference & Exhibition offers over 2,000 participants an opportunity to network, share expertise and attend over 70 presentations and learning sessions.

On Tuesday, October 26, Pete Taft will lead the highly anticipated session on FDA Advisory Committee Meeting Preparation. As the advisory committee process has become increasingly critical in the drug development and approval process, the session will focus on the results of a qualitative research study conducted by PharmApprove, which provides insights into how Advisory Committee members think, act and vote. Taft will also present best practices and tips he and his colleagues have amassed in their 10+ years helping prepare drug development teams for hearings in the United States and overseas.

“The Advisory Committee dynamic has changed dramatically over the last 10 years,” explains Taft, whose firm helped pioneer the field of Advisory Committee preparation. “The conference will provide industry leaders from around the world with a chance to exchange new ideas and experiences all in an effort to improve the regulatory process.”

Taft will co-lead the FDA Advisory Committee Meeting Preparation session with Robert Befus, CEO of Presentation Strategies, Inc. and Interactive Holdings, LLC.

The 2010 RAPS Conference also offers sessions from top officials from the FDA and Department of Justice in the United States, as well as from regulatory agencies from Europe, China, Japan, Brazil, Canada and more. The conference will open with a keynote presentation by Vijay Govindarajan, innovation expert and professor at Dartmouth University’s Tuck School of Business. The conference will be held from October 24-27 in San Jose, CA.

About PharmApprove™

PharmApprove™ is a drug development communications company headquartered in Princeton, New Jersey. PharmApprove™ helps development teams deliver clear, consistent and compelling key messages to regulatory bodies in both the US and Europe.

PharmApprove™ works in partnership with development teams to create the strongest argument for approval at every stage of the development process when organizations have one chance to get it right. Over the last decade, PharmApprove™ teams have helped to create and deliver over 42 drug development communications programs across 18 therapeutic areas both in the US and overseas, including more than 30 Advisory Committee preparation projects.

Currently, PharmApprove™ teams are helping to prepare four drug and device teams for upcoming Advisory Committee hearings, providing services including strategy development, medical writing, presentation coaching, slide creation, and project management.

PharmApprove™ is a division of Taft and Partners, a marketing and corporate communications firm also located in Princeton, NJ.

About Pete Taft

Pete Taft is the Founder & CEO of PharmApprove™. Pete has been the driving force behind the creation and delivery of over 42 drug development communications programs across 18 therapeutic areas both in the US and overseas, including more than 30 Advisory Committee preparation projects. Globally, Pete is frequently called upon to prepare executives and their teams for critical, often high-profile events, both within and beyond the pharmaceutical industry. Pete brings an unmatched understanding of communications theory to his work. Trained as a journalist, he covered crime, politics and law both nationally and internationally for major magazines (Reader’s Digest, Ladies’ Home Journal, Playboy) and newspapers (the New York Times, the Philadelphia Inquirer). He later served as a senior communications executive in both the public and private sectors, advising corporate executives, governors, and members of Congress on strategic communications planning, public speaking and public/media relations.

###

For more information, contact Chris Cavanaugh • 609 683 0700

Princeton, New Jersey April 6, 2010 — Pete Taft, Founder and CEO of Princeton-based drug development communications firm PharmApprove, has been asked to co-chair a first-of-its-kind conference focused on the increasingly-critical FDA Advisory Committee process.

The conference, organized by the Center For Business Intelligence (CBI), brings together a host of influential voices in the field of regulatory affairs to examine the changing rules, regulations and best practices for preparing to deliver sound arguments for a drug or device’s approval at FDA Advisory Committee hearings. It will be held on April 26-27 in Alexandria, VA.

“Advisory Committees exert enormous influence on drug development, and the vote at a hearing can make or break a drug — even a company,” says Taft, whose 11-year old firm helped pioneer the field of Advisory Committee preparation. “The conference will give leaders in the field a chance to pause and reflect on the changing nature, and increasing importance, of the committee process.”

Taft will co-chair the conference with Kevin Malobisky, MS, RAC, and Senior Director Regulatory R&D Portfolio and Global Head, Metabolism, for pharmaceutical leader sanofi-aventis.

The two-day conference covers a range of topics from heightened safety concerns and their impact on FDA Advisory Committee meetings to Taft’s presentation on best practices for successfully communicating a drug or device’s case at an FDA Advisory Committee hearing.

Other distinguished speaking faculty members will include Gabriela Gruia, M.D., Global Head and Vice President Drug Regulatory Affairs, Oncology Global Development for Novartis Pharmaceutical Corporation; and Richard Mountfield, BSc (Hons), Ph.D., CChem, MRSC, Senior Associate Director, Drug Regulatory Affairs for Boehringer Ingelheim Pharmaceuticals, Inc.

About PharmApprove™. PharmApprove™ is a drug development communications company headquartered in Princeton, New Jersey. PharmApprove™ helps development teams deliver clear, consistent and compelling key messages to regulators in both the US and Europe.

PharmApprove™ works in partnership with development teams to create the strongest argument for approval at every stage of the development process when organizations have one chance to get it right. Over the last decade, PharmApprove™ teams have helped to create and deliver over 42 drug development communications programs across 18 therapeutic areas both in the US and overseas, including more than 30 Advisory Committee preparation projects.

Currently, PharmApprove teams are helping to prepare four drug teams for upcoming Advisory Committee hearings, providing services including strategy development, medical writing, presentation coaching, slide creation, and project management.

PharmApprove is a division of Taft and Partners, a marketing and corporate communications firm also located in Princeton, NJ.

About Pete Taft. Pete Taft is the Founder & CEO of PharmApprove™. Pete has been the driving force behind the creation and delivery of over 50 drug development communications programs across 18 therapeutic areas both in the US and overseas, including more than 30 Advisory Committee preparation projects. Globally, Pete is frequently called upon to prepare executives and their teams for critical, often high-profile events, both within and beyond the pharmaceutical industry. Pete brings an unmatched understanding of communications theory to his work. Trained as a journalist, he covered crime, politics and law both nationally and internationally for major magazines (Reader’s Digest, Ladies’ Home Journal, Playboy) and newspapers (the New York Times, the Philadelphia Inquirer). He later served as a senior communications executive in both the public and private sectors, advising corporate executives, governors, and members of Congress on strategic communications planning, public speaking and public/media relations.

###

Register for the conference now or read the entire press release to learn more.

Pete Taft interviews Douglas Greene, Senior Vice President and Senior Scientific Advisor for Sanofi-Aventis about the changing landscape of FDA Advisory Committee hearings.