MCC Model Can Save Health Care Industry Billions Annually in Drug Development Costs

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Medical Communication Consultants, Inc. (MCC) , a fast-growing Cincinnati medical writing firm, speeds up and streamlines the process of getting new drug documents and reports approved by the Food and Drug Administration, saving a pharmaceutical company up to $100 million in development costs. MCC's Writers Initiative Network (WIN) selects the most expert medical writers nationwide and assigns them specific drug development projects based on experience and drug or medical device expertise.

"If the drug development industry as a whole adapted some of our practices, billions of dollars could be saved in drug development and health care costs a year."

A fast-growing Cincinnati medical writing company is helping cut the high costs of new drug development-- by taking advantage of technology and outsourcing trends.

Medical Communication Consultants (MCC) of Cincinnati is a six-year-old medical writing firm headed by founder Keith Kleeman. MCC currently employs 57 outsourced medical writers located throughout the U.S. whose talents are solicited as needed to help drug companies fulfill FDA regulations regarding new drug development and approval. Last year the firm reported revenue growth of 46 percent.

MCC plans to double or even triple its stable of writers this year as it takes on more specialized pharmaceutical drug development projects. But freelance writers needn't update resumes just yet: successful candidates will have advanced degrees and at least three years experience in writing for specialized medical areas such as oncology, endocrinology, or the central nervous system.

"If the drug development industry as a whole adapted some of our practices ranging from discovery, to research and development and documentation, billions of dollars could be saved in drug development and health care costs a year," said Kleeman.

The cost to develop a new drug in the U.S. is estimated to be nearly $900 million over 20 years, according to the Journal of Health Economics. About 15 of those years are spent in invention, clinical trials, and the development of documents related to Food and Drug Administration (FDA) approval. By the time a drug has FDA approval and is ready for public consumption, it's not uncommon to have only five years left to market the drug before the patent expires and generics erode drug company profits.

MCC president Kleeman saw that if documents and reports related to FDA drug approval could be created faster, smarter and better, it was possible to shave off months of the time usually associated with drug development and the FDA application process-- saving a pharma company up to $100 million in development costs.

To address this, in October 2009, Kleeman announced to the American Medical Writers Association the formation of the industry's first creative resource coalition, the Writers Initiative Network™ (WIN). WIN is an organization of expert medical writers who are assigned to specific drug development projects based on experience and drug or medical device expertise.

Competitors typically assign writers on the basis of availability, not expertise. WIN ranks each writer based on the number of projects worked on in specific therapeutic areas, and matches writers according to project specifications. Writers are also required to pass a battery of ethics and writing exams before being accepted into the MCC stable.

Medical writing assignments are closely managed by MCC and doled out to writers living in geographic areas as diverse as Pittsburgh, Portland, and Prescott. Despite having writers located across the country, Kleeman said, project work streams, including management and oversight, are very similar to those at other corporations.

Kleeman outlined three benefits of his WIN working model:

  • Affordability-- MCC retains the services of the best, most experienced writers in the industry, not just the ones available in the next cubicle-- which reduces or eliminates learning curves and saves the customer money. MCC writers are paid per document, not for the amount of time spent in an office.
  • Flexibility-- MCC has a single point of contact with customers, becoming part of a customer's development team. Modest to large-scale projects can be easily scaled up or down.
  • Manageability-- MCC manages every part of the drug development process from beginning to end, integrating fully into a customer's development team and allowing principals to focus on their businesses, not the minutia of the drug development process.

Under a traditional business model, medical writing companies can't afford the best writers because they have to seek work for each employee on an ongoing basis, said Kleeman.

"Because of MCC's business model, we can afford to hire the best writers in the nation for every drug development project.

"Each writer in WIN is compensated on a per project basis without the burden of unneeded overhead," he added. "We can engage in instant scalability to make certain each project has the best writers with the most talent and expertise in the needed area of research-- which means more nuanced observations and troubleshooting as we develop documents."

The WIN model dovetails with drug companies' emerging 21st Century way of doing business-- streamlining the drug development process through technology and outsourcing.

It used to be that pharmaceutical companies owned nearly every part of drug development-- from research and development to manufacturing to marketing, said Kleeman. "That proved to be expensive and time-consuming," he said. "Drug companies are beginning to move toward establishing networks of independent companies that aid them in each of these areas of development."

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