by Craig Shimasaki
7 steps for biotech
What do you do First?
     Most would-be entrepreneurs know they will eventually start a company, however they usually do not know how?  Beginning a company cannot be haphazard.  Starting a company requires significant planning and many events must simultaneously converge in order to be successful.  Some describe this successful convergence as “serendipity” others call it “chance” or “luck”.  Whatever you call it, heed the words of Louis Pasteur who said, “chance only favors the prepared mind”. Knowing what to do first can be the most challenging aspect since there are so many things that need to be accomplished.  Here is a checklist of 7 items that are essential for starting a biotechnology company.

1.         Make absolutely sure the idea has a true market need
     Good ideas are just that…good ideas, however, not all good ideas yield needed products.  Recognize that there are many exciting technologies that are still in search of a market need.  Be absolutely sure that there is a real market need for this future product (see BioBlog “The Deception of Marketing a High Tech Product 9/30/09 post).  Also, be sure that the technology of interest is protected by intellectual property (IP).  Next, secure the assets, IP rights and commitments from the inventors and key personnel (if you are not one) who have the know-how required to make the technology successful.

2.         Identify Founders and Key Personnel
     Good people are critical to any company’s success.  Carefully identify these individuals and understand their interest and commitment to a future organization.  Not all individuals with interest at this stage will be founders of the company; nor should all founders be equally compensated with identical amounts of stock unless all intend to work full-time in the organization once it is funded.  Determining percentage ownership is a difficult issue.  However, you do not want one founder receiving identical equity ownership who will not be working with the new organization yet keeps a secure position receiving a good paycheck and rides on the coat-tail of other founders.

3.         Find a Good Attorney
     This individual will be a key partner.  Your attorney will be the individual you go to for advice, guidance, counsel, and of course, legal answers.  They will help you navigate through the corporate and business issues during all stages of establishing and growing your company. Within the first week of starting your company, you will have this person’s phone number committed to memory.  Therefore, they need to be someone you trust and someone with whom you work well, and above all, a professional with many years of experience advising start-up biotechnology companies. 

4.         Incorporate your company as a C Corporation
     Your next objective will be to raise money and/or secure federal SBIR (Small Business Innovative Research) grants.  Without an incorporated company you won’t be able to do either.  There are many reasons to incorporate early, one reason is that you can then issue founders stock without having to pay exorbitant amounts of money for shares (or have large tax consequences) since the valuation of the company at this stage is extremely small.  The majority of all biotech companies should be C Corporations rather than an S Corporation or an LLC.  Serious investors know this difference and may decline to invest because they do not want to go through the trouble to change an incorrect business structure.

5.         Conceive a well-planned marketing and business strategy
     It is impossible to raise money without a well-written plan that clearly describes the market problem and need, how your product will solve it, how much money your product will generate, what you intend to do with the cash, what the return and exit is for the investor, and who the key personnel are within the company.  Write the business plan with the guidance of your attorney.  He/She will help convert this into a fundraising document (private placement memorandum).  You will then seek audience with the appropriate investor groups for your stage and sector of business. 

6.         Operate as a virtual company
                 Keep your day job!  Build the company carefully while minimizing your risk.  At this early stage, brick and mortar is not necessary when you possess a computer, a cell phone and have an internet connection.  However, be sure to have access to a conference room or meeting room but don’t spend money on rent at this stage.  As you work on your new enterprise, be careful about performing any work for the new enterprise while remaining at your current place of employment. There can be legal issues with ownership if you use company time and/or facilities while starting your new business venture. Be sure to discuss these issues with your attorney.

7.         After raising seed capital, advance the technology consistently through successive product development milestones
                 Be sure to outline key value-increasing product development milestones throughout the entire product development pathway.  Then demonstrate consistent progress by meeting the projections for the first few of these milestones.  New investors like to hear about companies making steady progress along a planned development pathway.  By timely meeting key milestones, you increase the value of your company and decrease the investment risk.  Consistency in meeting planned milestones increases the likelihood of securing subsequent funding. 

The Takeaway Tidbit
These 7 steps are important basics for the biotech entrepreneur.  The time it may take to complete these steps can be anywhere from two months to two years.   There are many more steps to starting a biotechnology company than presented here, and this brevity is not meant to trivialize the process but rather to clarify what is involved in reaching this goal.

by Craig Shimasaki
        When starting a company, it is absolutely essential to find a good attorney experienced in biotechnology start-ups!  Yes, there are boilerplate forms you can use for most every type of document, which can be found on the internet — sometimes free.  However, remember you are paying for expertise and sound advice, therefore, find someone you can work with that has plenty of experience in the biotechnology industry.  A good attorney will give strategic advice to avoid problematic issues in the future.  You will need advice about issuing founders stock and tax implications, the best corporate structure, invention disclosure and employment agreements, to name a few.  For those that want more information check out: Biotechnology and the Law by Wellons and Ewing, and The Entrepreneur's Guide to Business Law by Bagley and Dauchy.

        The Takeaway Tidbit
Save time and expense by ensuring the legal structure and necessary agreements are done right the first time!
        For those just starting, avail yourself to seminars and webinars to familiarize yourself with the basics of starting a company.  For example, The New York Academy of Sciences is hosting a three part series titled: Entrepreneurship 101: Essentials for Innovators and the Young Technology Company on September 21, September 29 and October 13, 2009.  These can be joined via webinar or in-person (for $20 or less). Find venues such as these that focus on the basics of starting a technology business such as intellectual property protection, business structure and organization, venture capital and angel financing, as well as all the required documents.

by Craig Shimasaki
Discouraging news was announced about the unlawful practices of Pfizer in marketing its drugs to physician's using free golf, massages, and resort junkets, along with promoting off-label uses for several of their drugs (read complete story).  The Justice Department said that Pfizer's sales people created sham requests from physicians asking about unapproved drug uses and then the company mailed the information to doctors.  This $2.3 billion settlement is the largest ever paid by a drug company.  Government attorneys noted that this is actually the fourth settlement over illegal marketing with Pfizer or one of its subsidiaries since 2002.  Associated Press reports that the Massachusetts U.S. attorney said while Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.

The TakeAway Tidbit 
          Every Industry is in Need of Value-Based Leadership!  
          This is true for the biotechnology and pharmaceutical industry since they seek to cure, treat and diagnose some of the world's most devastating illnesses that still plague the world.  Trust and credibility are the intangibles of a biotech entrepreneur, yet these are the currencies upon which a successful business is built, grown and sustained (See Nature Biotechnology Article, Credibility: Your Most Important Asset).  All choices and decisions emanate from an individual's core values.  When the goal of generating profits is sought irrespective of the method, then symptoms such as seen with Pfizer's marketing practices will surface throughout an organization.  Holding to core values during challenging financial times provides a compass rather than a map and gives a company the direction it needs in the midst of the storm.  Possessing enduring core values can steer one clear of many potential pitfalls in business and in life.  Be sure to hold on to, and ascribe to, those core values that are supportive of successful business practices.  Your company will then be built upon a strong and enduring foundation from which to grow and it will provide you and your organization the best chance for success.  For those interested in more about this topic, two good books to read are Jim Collin's book, Good to Great, and Hal Urban's book, Life's Greatest Lessons: 20 Things that Matter