PharmApprove, a Lenox Drive-based drug development consulting company, has merged with industry giant NDA, based in Sweden, creating one of the world’s largest regulatory consulting businesses.
Laurie Smaldone, at right, formerly president of PharmApprove, was made COO and chief scientific officer of NDA following the merger. She said the Lenox Drive office, and its 30 full and part-time employees, will remain open in its current location. NDA’s U.S. headquarters is located in Boston. The combined company has about 150 consultants, she said.
PharmApprove provided a number of services to large pharmaceutical companies and small biotech firms alike, centered around getting drugs through the complex and rigorous approval process demanded by government regulators. Smaldone said the company had been looking to expand into the European market and decided that a merger with NDA was a good way to do it.
“We had been looking to find a partner for European services,” she said. “We went through a systematic exploration, and felt that NDA, which is a known leader in regulatory and scientific advice, was a perfect partner. In fact, we had been in an alliance with them for over a year, which eventually led to the merger of the two organizations.”
She said the merger allowed clients to obtain “one-stop shopping” consulting services for guiding drugs through the U.S. Food and Drug Administration approval process and its European counterpart, the European Medicines Agency. While both regulators do business in English, the approval process is very different for each and requires specialized knowledge to navigate.
Smaldone grew up in the Bronx, where her mother was a French teacher and her father was a professional photographer. She is fluent in French, and said she has always had an interest in European cultures. “It’s very exciting to be able to offer that to our clients and to work with a phenomenal team in NDA group,” she said.
Smaldone has an undergraduate degree in biology from Fordham, and an MD from Yale. Before joining PharmApprove five years ago, she was senior vice president of global regulatory science at Bristol-Myers Squibb.
PharmApprove was founded in 1999 by Lenox Drive-based communications firm Taft and Partners. Pete Taft, founder and CEO of PharmApprove, will serve as a consultant to the combined company, according to a press release.
Getting a new drug approved is a complex task that often ends in failure. Because the stakes are so high, many drug companies seek outside advice for getting the job done even though they usually have internal teams that are focused on drug approval. (U.S. 1, February 1, 2012.) Smaldone said her clients have about an 85 percent success rate versus the industry average of 45 percent. “The industry often looks to expert advisors to assist them with complex scientific, clinical, or manufacturing problems that could benefit from very specific outside expertise,” she said.
Helping a client through the approval process could mean many different things. Frequently, PharmApprove helps clients prepare for the all-important public FDA advisory committee hearing, which has historically been almost synonymous with full approval. Smaldone said PharmApprove will do a “deep dive” into the data the company has gathered in its clinical trials and prepare a strong presentation. PharmApprove will anticipate the questions that the regulators will ask, and help companies prepare to answer those questions. NDA specialized in getting clients through a similar EU hearing called oral explanations, in which the applicant must defend its product against questioning from regulators.
“We also train scientists themselves to be more effective at delivering information in key meetings,” Smaldone said. “It’s hard because scientists are trained to deal with tons of minutia, but in a hearing it’s important to provide the main conclusion, then provide your supporting evidence. The key is getting to the point and delivering evidence quickly.”
PharmApprove, 2000 Lenox Drive, Suite 200, Lawrenceville 08648; 609-683-0700. www.pharmapprove.com.