Advice from the Experts on Boostrapping a Life Science Company

Scale Finance and First Flight Venture Center are joining together for a timely, and useful discussion on no-dilutive funding for life science companies. A distinguished panel of local successes will be gathered at American Underground in Durham on Oct. 8 to give startups insight, and ideas, on how to start and grow life science endeavors with limited cash flow.

Bootstrapping for a period of time allows companies to raise capital in the future and at better terms. The trick for life science and medical device companies is to identify early sources of alternative non-dilutive capital to move the business as far as you can before seeking the larger amounts of capital that will eventually be needed.

The forum panel includes the following well-known leaders:

• Rich West, currently co-founder and CEO of his fourth life sciences startup, which is focused on newborn screening (www.baebies.com)
• Peyton Anderson, CEO of Affinergy, a Duke spinout commercializing medical devices and is Chairman of Powered Research, a preclinical CRO 
• Sam Tetlow, CEO of EpiCypher 
• Dr. Eva Garland, VP of R&D for Agile Sciences 
• Gary Hayes, COO and Co-Founder of Scale Finance

Register for the event here 

Read the full press release here

Tapping into Biodefense Spending

Originally posted by Edward R. Ergenzinger, Ph.D. via Ward and Smith, P.A.  It has been shared with permission (original article here).

The 2014 Biodefense Summit
On August 26, 2014, the North Carolina Biotechnology Center held a summit on biodefense – a term that generally refers to methods for preventing, detecting, or managing an attack involving biological weapons.  The summit provided a platform for decision makers from federal funding agencies to engage with academic and industry leaders in North Carolina's life sciences sector.  The impetus for the summit was the recognition that the level of biodefense spending in North Carolina is disproportionately low given that the state is home to the third largest life sciences cluster and the fourth largest military presence in the United States.  In a nutshell, the summit was organized to kick start strategies to leverage those strengths and expand the number of biodefense government contracts awarded in North Carolina.

The summit emphasized the cutting-edge life sciences work being done in North Carolina, some of which would have been considered science fiction just a short while ago.  Mike Wanner, CFO and Executive Vice President of Operations at Medicago Inc., described  his company's work using genetically-engineered tobacco to produce vaccines much faster and simpler than traditional methods (Medicago's commercial-scale facility in Research Triangle Park is targeted to produce 10 million doses of pandemic influenza vaccine per month).  Dr. Anthony Atala, Director and Chair of the Wake Forest Institute for Regenerative Medicine and Director of the Armed Forces Institute for Regenerative Medicine, showed a video clip in which he and his team use a 3-D printer loaded with living human cells to make a transplantable kidney in about seven hours.  An earlier iteration of this technology used ink-jet printers to make bladders that were first successfully used in human patients over ten years ago.

Grants vs. Contracts
One of the takeaways from the summit was the importance of becoming familiar with all aspects of the federal contracting process.  First off, federal grants and federal contracts must be distinguished from one another.  Federal grants are typically awarded to states, local governments, universities, and non-profit organizations to accomplish some public purpose or stimulate a desired activity.  Grants are relatively flexible in terms of the scope of work required and the ability to make amendments when changes are needed.  Reports are usually only required on an annual basis and failure to perform is not likely to result in legal action or financial consequences.

By contrast, federal contracts are designed to acquire goods and services, with an emphasis placed on delivery and performance.  Contracts are more typically awarded to commercial enterprises, though states, local governments, universities, and non-profit organizations can and do receive federal contracts as well.  Contracts are relatively rigorous regarding their terms and conditions and many include set asides for small businesses, minorities, or special classes of competitors.  Frequent reports are usually required and a failure to perform and achieve the promised results or product will result in potential legal action and financial consequences.

Federal contracts are governed by the federal acquisition laws contained in the Code of Federal Regulations ("CFR").  These laws are implemented through an extensive set of rules codified in Title 48 of the CFR known as the Federal Acquisition Regulation ("FAR"), which attempt to establish uniform policies and procedures for acquisition by all federal agencies.  However, each federal agency with contracting authority can augment the FAR with its own additional regulations, known as FAR Supplements, which are codified as separate chapters under Title 48 of the CFR (e.g., additional rules unique to the Department of Defense are set forth in the Defense FAR Supplement, known as the "DFARS").  
It is the FAR clauses contained or referenced in federal contracts that are the source of the relatively rigid terms and conditions mentioned above.  For example, FAR provisions may include requirements for changing the scope of work, terminating contracts, making payments, conducting inspections and testing, accepting delivered goods and services, and intellectual property rights.  Even if a particular contract does not appear to explicitly list or incorporate by reference certain FAR clauses, other FAR and/or DFARS regulations may dictate that certain clauses should have been incorporated and they will thus be deemed by courts as implicitly incorporated, even if omitted.  Furthermore, if the prime contract recipient recruits subcontractors, many of these FAR clauses must be "flowed down" and included in the agreement between the prime contractor and the subcontractor. 

The Federal Contracting Procedure
Federal agencies typically post Request for Proposal ("RFP") solicitations for contracts on the Federal Business Opportunities website (http://www.fbo.gov/) or their own websites.  Interested companies prepare offers in response to the requirements laid out in the RFP and in accordance with applicable provisions of the FAR.  Following the submission deadline, government agency personnel evaluate all vendor submissions using the source selection method and criteria described in the RFP.  In some cases, potential federal vendors may submit unsolicited proposals for new ideas and innovative concepts pertaining to a given agency's program areas.  Such unsolicited proposals must comply with the requirements of FAR Subpart 15.6.

A key to success in securing government contracts is matching a specific product or service to the needs of a particular agency.  If it is a stretch to justify the match, the potential vendor is likely wasting its time.  In addition to searching the Federal Business Opportunities website for available RFPs, potential vendors can attend "matchmaking" events with federal agency contracting officers and follow-up with them regularly to stay apprised of agency needs.

For newcomers to the world of federal contracting, an alternative to seeking prime contracts is to explore subcontracting opportunities.  This strategy was cited at the biodefense summit by a number of panelists from companies that initially waded into the waters as subcontractors but that are now successful in securing government contracts.  By subcontracting with an experienced prime contractor, a vendor can gain familiarity with the process and gain experience to become ready to competitively bid for prime contracts.

Conclusion
With billions of dollars awarded to biodefense contractors annually, government contracts can be a lucrative source of opportunities for life sciences businesses.  However, there are many potentially costly pitfalls, especially if the provisions of a federal contract, including those that appear only in an unreferenced FAR, are not understood.  Potential federal government vendors considering venturing into the world of federal contracts would be well advised to seek expert counsel to help navigate the waters.

When Does Hiring an Outside Marketing Consultant Make Sense?

Guest Post by Christina Motley, Christina Motley LLC
 

As a business owner or entrepreneur there comes a time when you face a tough decision – deciding whether to outsource your marketing to a consultant or keep it in-house.

To make an informed decision, follow these tips.

1. Perform an internal audit.
The purpose of the audit is to evaluate a number of factors. What is the importance of this strategic initiative and its alignment to your business and marketing plan? What level of in-house expertise is available? Or, do you have limited resources (staff) for leading and implementing the initiative? What tools and funds are allocated to the project? How will this initiative impact your customer growth and retention?

 2. Who do you know and trust?
Referrals are a great place to start when considering outside consultants. Tap into your team’s network for contacts and referrals. If time is not of the essence, you can also send out an RFP. In the end, trust in the consultant’s ability to perform and complete the project is crucial to achieving your desired goals.

3. Speak with several individuals, agencies or firms.
Understand that different people and firms possess unique skill sets and approaches to the work. By talking with a variety of individuals or firms, you open yourself to generating additional ideas or asking questions you may not have thought of previously.

4. Review their work, credentials and previous projects.
Upon reviewing the consultants’ work and credentials, you should be able to answer these questions:

▪   Do the potential candidates have a proven track record for completing similar projects? 

▪   What results were produced on similar, previous projects?  

▪   How quickly can they learn about your organization and industry?  

▪   What is their approach and process?  

5. Request a proposal.
At a minimum, the proposal should include a timeline and rough estimate of the project cost. (For especially complex projects, Ghantt or PERT charts can be very useful in determining expertise and proficiency.) The proposal provides enough objective data to share with your team and executive leadership to allow for cross-functional input.

6. Interview the top 2-3 contenders.
Treat the interview with prospective consultants as if you’re interviewing a candidate to join your company. Even though the project may be on a short-term basis, it’s important to feel good about and like the person (or firm) with whom you will work. While trust and talent are important, the chemistry may be stronger with one candidate when compared to others. 

7. Ask for a Statement of Work Agreement (SOW.)
SOWs define the project specifics – what is to be done within a defined scope, the number of allowable revisions, key deliverables, client expectations and estimated compensation. The purpose of a well-defined SOW is to protect your organization as well as the consultant.

Advice for Startups: 3 Lessons I Wish I’d Known 20 Years Ago

By David Spitz

Editor’s Note

David Spitz is president and chief operating officer of ChannelAdvisor and 2014 chairman of the Council for Entrepreneurial Development (CED).

I am what they call a “serial entrepreneur.” Before joining ChannelAdvisor and taking it public last year, I built two software companies in the Triangle and sold them both. I’ve been lucky to have success. And I’ve learned a lot along the way.

Recently I was asked what advice I’d give to entrepreneurs just starting out. There’s so much to say on that front, but let me boil it down to three major lessons that have served me well. In fact, I wish somebody had told me these 20 years ago!

No. 1: Listen to your customers. 
Over many years of starting companies and making mistakes and having some success, I learned that a lot of entrepreneurs get focused on fundraising or other business milestones that are interesting, but may not necessarily create value.

It’s also easy to get “heads down” in the trenches, laboring in pursuit of a perfect product. Striving for excellence is a good thing. But the perfect is definitely the enemy of the good in entrepreneurship.

It’s better to build a product relatively quickly, get it into the hands of customers and start gathering feedback. You need this “airing out” so you can make adjustments and truly meet the needs of the market. Especially when you’re starting out, you don’t have a lot of resources to waste going down the wrong path for too long.

Listening to customers and getting market validation early and often is critical.

No. 2: Don’t neglect sales and marketing.
I'm a technologist and a self-described “nerd.” I like to play with technology just for fun. That’s great. It’s what sparks innovation. But technologists like me can sometimes assume that if we build a great product, the world will beat a path to our doors. Not so.

It took me a few years to realize that no matter how good a product is, you have to market it. You have to sell it. You have to really put forth that effort to get it into the hands of your customers – and on the radar screen of all the thought leaders and opinion makers who can generate buzz.

Don’t underestimate the importance of sales and marketing. Having talented sales reps and marketers on your team is every bit as important as has having great engineering talent.

No. 3: Build your network. 
There’s a myth out there of the heroic entrepreneur who does it all on his or her own. But that’s just what it is: a myth. Most of us need a lot of help from people around us to be successful.

You need to build your network.

Having a mentor can be an enormous boost. Early in my career, I benefited from a couple of people whose accumulated wisdom was a great resource for me. I could turn to them in total trust if I had questions about how to deal with something or what path to take.

Peers and entrepreneurial support groups can also help keep you on the straight and narrow. I feel so strongly about the power of “the network” that this year I am chairing the Council for Entrepreneurial Development (CED).

If an entrepreneur wants to really plug into a deep pool of experience, CED is a great one-stop shop for that. It is the connective tissue that helps entrepreneurs get the resources they need in the Triangle.
 

To see “the network” in action, be sure to check out the CED Tech Venture Conference 2014 this Sept. 16-17 at the Raleigh Convention Center. You’ll be amazed at the conversations you’ll strike up and the amazing people you’ll meet.

CED website: www.cednc.org 

Conference website: www.cednc.org/techventure

Innovate Raleigh Announces 3rd Annual Summit and Inaugural Startup Crawl

Innovate Raleigh has announced details for the third annual Innovation Summit on Wednesday, September 10^th, 2014 at Marbles Kids Museum.

The Summit convenes community thinkers, makers, and doers to look at our region’s entrepreneurial landscape, identify what’s missing, and generate ideas to fill the gaps.  Previous events inspired the creation of HQ Raleigh, the TriangulateNC site, and a direct flight to San Francisco.

This year’s event will feature talks by Lyle Estill, Founder of Piedmont Biofuels, a Triangle coop offering clean renewable fuels, and Troy Henikoff, Managing Director of Chicago’s TechStars, one of the world’s leading startup accelerators.

Says Henikoff, “As an entrepreneur and investor, I’m constantly looking for what’s next not just for Chicago, but across the nation.  I’m excited to be part of the entrepreneurial momentum created by Innovate Raleigh, to have the chance to share insight from my experiences in Chicago, and to return home with new ideas and energy!”

The day will also include three breakout sessions, hosted at Artspace, 214 Martin, and the Stockroom. These working groups are an opportunity for entrepreneurial and civic leaders to collaborate and drive innovation at a citywide and regional level.

In addition to the Summit, Innovate Raleigh has also announced plans for Raleigh’s first-ever Startup Crawl. The Crawl will showcase innovative spaces throughout downtown, including HQ Raleigh, American Underground, DesignBox, and more. Similar to an art walk, participants will embark on a self-guided tour through the Warehouse District and the Fayetteville Street Business District. Each space will have networking opportunities with local startups and investors.

Both events are presented by Wells Fargo and sponsored by Rex Healthcare, Big Pixel, Red Hat, Raleigh Economic Development, NC State, Wake County Economic Development, and Blackstone Entrepreneurs Network.

All those interested in attending can learn more here: www.innovateraleigh.com/the-summit/

Please contact Allyson Sutton at 919-300-6917 with any questions.

Continuity Control raises $10 million to fund growth

River Cities Capital Fund leads investment round for provider of banking compliance management technology

New Haven, CT – August 21, 2014 – Continuity Control^™, a New Haven, Conn.-based provider of a compliance management system for community financial institutions, announced today that it has raised $10 million in growth funding to continue extending its industry-leading technology platform and regulatory intelligence.

The round, which resulted in double the $5 million funding Continuity Control was originally seeking, was led by River Cities Capital Funds, a growth equity firm investing in information technology and healthcare companies. Additional investments came from BancVue, a national provider of banking products, marketing solutions and consulting services for community financial institutions, and the family of IBM founder Thomas Watson. Rik Vandevenne, a director with River Cities, will join the Continuity Control board.

“We are very excited to welcome River Cities, BancVue and the Watson family to our team of investors. The interest generated in this round of investment further validates our vision for compliance management and the opportunity it represents in the community financial industry,” said Andy Greenawalt, co-founder and CEO of Continuity Control. “This funding will allow us to accelerate functionality enhancements to our industry-leading platform, so we can continue to reinvent the way compliance management is handled.”

“Continuity Control empowers community financial institutions to streamline the complex and burdensome regulatory compliance process, freeing them up to focus on what they do best,” says Vandevenne. “The company’s rapid growth and innovative solution is a true testament to the stellar management team – we are eager to be a part of the opportunity to further expand the company’s reach.”

Founded in 2008 by a group of technology, banking and compliance experts, Continuity Control raised $5.2 million in earlier rounds. The company has expanded quickly, experiencing revenue growth of more than 300 percent between 2013 and 2014 alone. With more than 23,000 users currently on its cloud-based platform, Continuity Control plans to hire 40 additional staff members in the coming year to support the company’s growth.

“This funding will fuel significant investments in research and development,” Greenawalt added. “The faster we progress, the sooner we’ll fulfill our mission to eliminate the tedious, manual effort historically involved with compliance management, allowing community financial institutions to get back to the business of banking.”

To learn more about Continuity Control, take an online tour and register for compliance-related webinars, visit www.continuity.net/rethink.

About Continuity Control
Continuity Control is a compliance management system for community banks and credit unions that has been engineered to reduce the time, cost and risk impacts of regulation. This single, unified system automates the entire regulatory lifecycle — managing regulatory updates, policies, procedures, risks, vendors, audits, business continuity and exam preparation along with compliance strategy and planning. Built by bankers and former examiners, the system's advanced software has been coupled with expert personalized service to help community financial institutions quickly adapt to regulatory change, streamline the workload and ensure compliance.
Contact Information:
Britney Grimmelsman
River Cities Capital Funds
bg@rccf.com
513-345-2338