Sept 22

Serial entrepreneur Alfred E. Mann presented a primer on business success as well as a fascinating look into his own career at the CURE/Yale BioHaven seminar September 16 in New Haven. 

Mann has founded and largely funded 17 companies in his career. Nine were acquired at an overall total of almost $8 billion, and two became public companies. 

He is currently chairman and CEO of MannKind Corporation. Its lead investigational product candidate, AFREZZA™, is an ultra rapid-acting insulin. The facility constructed in Danbury, CT for the commercial production of AFREZZA™ has won numerous accolades, including the CURE 2010 New Operations Award and Facility of the Year awards for process and equipment innovation from ISPE/INTERPHEX. 

Introduced by Paul Pescatello, the president and CEO of CURE, Mann was the first speaker this season in the CURE/Yale BioHaven seminar series, which showcases both the science and business side of biotech operations.

Mann’s presentation, Creating a Successful Medical Device Enterprise, included a ten-point model for starting a new medical device company: 

1. Select a target market
2. Identify underserved needs
3. Evaluate barriers to entry
4. Establish product specifications
5. Create business model
6. Allocate development resources
7. Organize marketing, sales, reimbursement and support infrastructure
8. Validate, qualify and transfer to manufacturing
9. Pursue clinical trials and regulatory approval
10. Unleash sales/marketing and service 

In a nutshell, Mann said, the key is to “take on a technical challenge in an untapped, fast-growing market with few competitors, and produce a superior product.” He said that he did not like to start with a product and try to find a market for it, but rather to first identify a market and then consider what products could be developed to serve it. 

Mann’s presentation also included his checklist of the ten most essential ingredients for business success: 

1. Capital
2. Capital
3. Capital
4. Leadership
5. Management
6. People
7. People
8. Marketing
9. Manufacuring
10. Product

“Notice how far down the list Manufacturing, Marketing, and yes, the Product itself, are,” Mann said. Capital appears on the list three times because “you need to figure out how much money you’re going to need, double it, and then don’t go into business unless you have thrice that.” 

He said that People made the list at least twice, and he distinguished between Management and Leadership. “You need to have somebody with vision who can inspire the team and keep them moving forward, and they’ve got to buy into the vision; and that is more than just management.” 

After tracing his early success with aerospace and medical device businesses, Mann focused on the project that is currently taking most of his time, MannKind Corporation, which is developing an ultra rapid-acting inhalable insulin for treatment of diabetes. 

Showing a series of technical slides, Mann said that the key characteristic of the new AFREZZA™ insulin was that in the body its profile more closely mimicked the profile of naturally occurring insulin than did the other artificial insulins currently available. 

“This is my current passion,” Mann said. He called diabetes the number one health threat facing the world and said “we’ve go to do something about it.” He said he had already put $925 million of his own money into the project. 

Presented by CURE and the Yale Office of Cooperative Research, the BioHaven Series thanks its lead sponsors, Wiggin and Dana and PricewaterhouseCoopers. The series is also sponsored by Elm Street Ventures, with additional support from the Yale Entrepreneurial Institute and the Yale Biotechnology & Pharmaceutical Society.