News Article 1

Safis in the News

Biotech sector's impact? Growth in consultants

By James Harper
Star correspondent
The Indianapolis Star
October 2, 2007

A long-term economic initiative, designed to build on Central Indiana's life- sciences success, is paying early dividends for a growing number of bioscience consultants. Conceived and orchestrated by BioCrossroads, the 15- to 20-year initiative is laying the foundation for growth by attracting more bioscience and medical-related startup companies whose needs are tended to by local consultants.

Since the startups lack the capital to maintain a permanent operations staff, the private consultants often serve as a research-and-development arm, marketing specialist, clinical trials manager, and business adviser to the startups as they move from product discovery through the arduous federal regulatory process.

Some of the consultants that have benefited from the initiative include:

Safis Solutions, an Indianapolis group founded by Ping Poulsen in 2001 with herself and one other employee. Today, Poulsen has more than 20 employees and a client list that embraces "all the major (life sciences) companies, as well as many startup businesses."

The Anson Group of Carmel, established 11 years ago by management adviser Gerald Richardson. It is enjoying a surge of new business centered on helping pharmaceutical clients manage clinical trials and navigate the regulatory process. Anson employs a dozen full-time consultants and 80 or so contractual employees.

Aledo Consulting, led by former Eli Lilly and Co. and Guidant employee Bob McDonald. It is carving a niche by specializing in product pricing and strategic issues that can determine a product's success once it clears regulatory hurdles.

Two of Safis' early clients, both of which moved here from overseas bases, reflect the strategy envisioned by BioCrossroads, a local organization that supports and finances regional life-sciences companies.

The clients, a pharmaceutical startup and a medical device company, have completed clinical trials, gained Food and Drug Administration approvals and have begun hiring. The pharmaceutical company has exceeded its hiring goals and the medical device firm plans to add up to 150 employees over the next three years.

Poulsen declined to identify those client companies to protect their confidentiality.

"We are especially proud of the work we did for the pharmaceutical client," she said. "The client's product had been initially blocked (from further development) by the FDA, and we were able to demonstrate during the review process that there was no fault with the drug." Success stories such as these are encouraging to David Johnson, chief executive of BioCrossroads.

"We must have some short-term successes in order to attract more talent and more funding that help drive our future efforts," said Johnson. "We need people with a lot of skills to build the new enterprises, and these are examples of what can be done as we move forward."

How crucial is the life-sciences industry to Central Indiana? Consider that more than 24,000 people in the Indianapolis area owe their livelihood to biosciences-related industries (with pharmaceuticals giant Eli Lilly and Co. accounting for more than half of that total).

A study by Battelle, a global science and technology enterprise based in Columbus, Ohio, found the Indianapolis metro area has the fourth-largest employment base in the U.S. in the pharmaceuticals sector and ninth largest for all biosciences employment.

Small wonder that Central Indiana is fertile ground for technical consultants and businesses. Reed Tarwater, director of regulatory services for the Anson Group, has worked both sides of the life-sciences fence, spending 27 years with Lilly before joining Anson. Describing the biotech sector as "a business of relationships," he is especially bullish on Central Indiana's life- sciences business model.

"During the past few years at Anson, we have probably experienced a 70 percent growth in our pharmaceuticals business sector," said Tarwater, "and all of that business has been local. I don't see any letup in the near future."

Aledo Consulting's McDonald is equally convinced that the business growth is sustainable, and his consulting company has created specialized services for those startups whose products already have received FDA approval.

Tim Parshall, founder of his one-man consultant company called Pivotal Strategies, is even more enthusiastic, saying Central Indiana is in the midst of a dynamic expansion of the medical/bioscience sector.

"For every new 'virtual company' that seeks to introduce a new product or device, there are 20 or more who are in the formative stages," Parshall said.