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THE IMPORTANCE OF THE BIOTECHNOLOGY INDUSTRY AND VENTURE CAPITAL SUPPORT IN

INNOVATION

HEARING

BEFORE THE

SUBCOMMITTEE ON RURAL ENTERPRISES, 

AGRICULTURE & TECHNOLOGY

OF THE

COMMITTEE ON SMALL BUSINESS 

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

WASHINGTON, DC, JULY 27, 2005

Serial No. 109–28

Printed for the use of the Committee on Small Business

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house 

COMMITTEE ON SMALL BUSINESS 

DONALD A. MANZULLO, Illinois, Chairman 

ROSCOE BARTLETT, Maryland, Vice 

Chairman 

SUE KELLY, New York 

STEVE CHABOT, Ohio 

SAM GRAVES, Missouri 

TODD AKIN, Missouri 

BILL SHUSTER, Pennsylvania 

MARILYN MUSGRAVE, Colorado 

JEB BRADLEY, New Hampshire 

STEVE KING, Iowa 

THADDEUS MCCOTTER, Michigan 

RIC KELLER, Florida 

TED POE, Texas 

MICHAEL SODREL, Indiana 

JEFF FORTENBERRY, Nebraska 

MICHAEL FITZPATRICK, Pennsylvania 

LYNN WESTMORELAND, Georgia 

LOUIE GOHMERT, Texas 

NYDIA VELA ́ ZQUEZ, New York 

JUANITA MILLENDER-MCDONALD, 

California 

TOM UDALL, New Mexico 

DANIEL LIPINSKI, Illinois 

ENI FALEOMAVAEGA, American Samoa 

DONNA CHRISTENSEN, Virgin Islands 

DANNY DAVIS, Illinois 

ED CASE, Hawaii 

MADELEINE BORDALLO, Guam 

RAU ́ L GRIJALVA, Arizona 

MICHAEL MICHAUD, Maine 

LINDA SA ́ NCHEZ, California 

JOHN BARROW, Georgia 

MELISSA BEAN, Illinois 

GWEN MOORE, Wisconsin 

J. MATTHEW SZYMANSKI, Chief of Staff 

PHIL ESKELAND, Deputy Chief of Staff/Policy Director 

MICHAEL DAY, Minority Staff Director

SUBCOMMITTEE ON RURAL ENTERPRISES, AGRICULTURE AND 

TECHNOLOGY 

SAM GRAVES, Missouri, Chairman 

STEVE KING, Iowa 

ROSCOE BARTLETT, Maryland 

MICHAEL SODREL, Indiana 

JEFF FORTENBERRY, Nebraska 

MARILYN MUSGRAVE, Colorado 

JOHN BARROW, Georgia 

TOM UDALL, New Mexico 

MICHAEL MICHAUD, Maine 

ED CASE, Hawaii 

RAU ́ L GRIJALVA, Arizona

PIPER LARGENT, Professional Staff

(II) 

C O N T E N T S 

WITNESSES

Page 

Doerfler, Mr. Douglas A., President & CEO, MaxCyte, Inc. ................................ 4

Broderick, Mr. Daniel J., Managing Director, Mason Wells ................................ 7

Michael, Mr. Barry, President, B.A. Michael Consulting, Small Business 

Technology Council .............................................................................................. 9

Glover, Mr. Jere W., Executive Director, Small Business Technology Council, 

Brand Law Group ................................................................................................ 11

Cruz, Mr. Anthony P., Senior Vice President, Finance & Administration, 

AviGenics, Inc. ...................................................................................................... 13

APPENDIX

Opening statements: 

Graves, Hon. Sam ............................................................................................. 28

Prepared statements: 

Broderick, Mr. Daniel J., Managing Director, Mason Wells ......................... 30

Glover, Mr. Jere W., Executive Director, Small Business Technology 

Council, Brand Law Group .......................................................................... 41

Cruz, Mr. Anthony P., Senior Vice President, Finance & Administration, 

AviGenics, Inc. .............................................................................................. 60

Additional material: 

Biotechnology Industry Organization ............................................................. 63

(III) 

(1)

THE IMPORTANCE OF THE BIOTECHNOLOGY 

INDUSTRY AND VENTURE CAPITAL SUPPORT IN INNOVATION 

WEDNESDAY, JULY 27, 2005

HOUSE OF REPRESENTATIVES

SUBCOMMITTEE ON RURAL ENTERPRISES, AGRICULTURE

AND TECHNOLOGY

COMMITTEE ON SMALL BUSINESS

Washington, DC 

The Subcommittee met, pursuant to call, at 2:05 p.m. in Room 

311, Cannon House Office Building, Hon. Sam Graves [Chairman 

of the Subcommittee] presiding. 

Present: Representatives Graves, Barrow, Bartlett, Velazquez

Chairman GRAVES. Good afternoon everybody, and welcome to 

this hearing of the Subcommittee on Rural Enterprises, Agriculture 

and Technology on the Small Business Committee. I apologize for 

being a little bit late. We have got a string of votes that could happen at any time now so I thought we would go ahead and get started and get some of the opening statements out of the way. Then 

we will take our votes, and we will come back as soon as those are 

over. 

Today, we are going to be discussing the importance of the biotechnology industry and venture capital support in innovation, and 

I appreciate everybody’s support and participation, anyway, in today’s hearing. We are going to have a good hearing. I think it is 

going to reflect both sides of this issue, and we are trying to find 

out as much as possibly about venture capital when it comes to the 

biotechnology field. 

The Small Business Innovation Research program [SBIR] was 

created by Congress in 1982 to increase the participation of small 

technology firms that participate in federal research and development activities. Federal agencies with R&D budgets of over $100 

million or more are required to allocate 2.5 percent of all federal 

research and development grants to small business applicants. 

I take a particular interest in this issue since my undergraduate 

studies yielded me a degree in agronomy, particularly plant physiology. I understand the importance of and potential in biotechnology and the research these small companies do. In fact, the 

State of Missouri is slowly attracting more of these biotechnology 

firms from all across the country into our state. This means jobs 

for rural America and value-added products for farmers. 

2

Without question, the United States remains the global leader in 

the field of biotechnology. Part of this success can be attributed to 

the federal government’s role in promoting critical research and development. This program allows for cutting-edge research that may 

not, in its earliest stages, attract funding from other sources. 

Venture capital funding is critical to the small biotech companies. They provide the initial seed money to help get some of these 

innovative ideas off the ground and running. Without this investment, given the nature of the biotech industry, it would be very difficult to finance this process. These small businesses are providing 

the country with the ideas and innovation that have become the 

identity of the United States. 

The biotechnology industry is unique in that it takes hundreds 

of millions of dollars to bring a product to market from its conception. Biotechnology companies must rely on venture investment as 

well as grants for sufficient funding. 

SBA regulations require that, to be eligible, a small company 

must be at least 51 percent owned by one or more individuals. The 

SBA recently clarified the definition of an ‘‘individual’’ to include 

only actual human beings and not other forms of investment. This 

clarification now excludes many of the small biotech companies 

that participated in the SBIR program in the 20 years prior to this 

SBA clarification. 

Again, this hearing is going to examine this clarification and legislation that has been introduced, the Save America’s Biotechnology Innovation Research Act. This legislation seeks to address the eligibility issue and restore the success of the SBIR program experienced prior to the 2002 SBA ‘‘clarification.’’ The rule 

change resulted in the disqualification of many of the small biotech 

firms engaged in that research. 

It is now my pleasure to turn the mike over to Ranking Member 

Barrow for his opening statement. 

[Chairman Graves opening statement may be found in the appendix.] 

Mr. BARROW. Thank you, Mr. Chairman. Mr. Chairman, some of 

the nation’s fastest-growing and most successful small businesses 

are responsible for introducing many of America’s high-tech products, and the economic benefits of these small firms is undeniable. 

They employ almost 40 percent of the country’s high-tech workers. 

In Georgia, over half a million working men and women currently 

are employed in the high-tech industry. 

The technology boon of the 1990’s fueled the rise of these hightech firms, an industry that has changed the face of the American 

economy. From biotechnology to information sciences, these industries have created good-paying jobs, and they have provided considerable benefits to Americans of all walks of life. We all recognize 

the significance of these firms, and I believe that Congress has to 

work together to keep technological innovation at the top of our 

agenda. 

For over 20 years, one of the keys to sustaining our nation’s technology advantage has been the SBA’s Small Business Innovation 

Research program, providing between one to $2 billion a year in 

grants to start-ups and emerging firms. This program has invested 

over $14 million in Georgia companies. The SBIR program plays a 

3

critical role in technology development by providing small companies with the valuable seed funding they need to get their ventures 

off the ground. This has helped thousands of small businesses 

across the entire high-tech spectrum to grow, taking their product 

from an idea to an established technology. 

While the SBIR program provides an important source of seed 

capital, it alone cannot meet the financial needs of these emerging 

businesses. Research and development in the technology industry 

is incredibly expensive, often reaching millions upon millions of 

dollars. In order to fund new research and meet the goals of technology development and scientific advances, these businesses must 

have a healthy amount of venture capital. Without this vital source 

of financing, all of the great ideas that the SBIR program fosters 

will never have the opportunity to move from the drawing board 

to the board room. 

Today’s hearing will give us an opportunity to look at the important role that venture capital plays in the SBIR program. It will 

also allow us to review a current SBA rule that is limiting this critical source of financing for America’s small technology companies, 

a rule that needs to be revisited. 

In 2003, the SBA set an arbitrary cap on the type of investments 

that small businesses can receive, limiting the nation’s emerging 

high-tech businesses’ access to SBIR program. This rule runs contrary to the goal of the SBIR program, which is to assist in the development of technology that will have a place in the global marketplace. 

I am sure we can all agree that it is not the intention of the SBA 

to block small firms in the SBIR program form succeeding. Clearly, 

there is a need to ensure that legitimate small businesses have access to SBIR awards, but putting a rule in place that appears to 

protect small businesses on the surface but ends up only hurting 

them in the process is not good policy. There are no few industries 

that need the infusion of venture capital funding more than small 

business technology sector. If left unchanged, this current rule will 

have a chilling effect on the future of the venture capital and hightech industries. 

Today’s hearing will give us the opportunity to learn more about 

the nuances of the SBIR program. Those testifying this afternoon 

will present a firsthand account of how important the SBIR program is to small businesses, and their testimony will show that 

without proper public/private partnerships, we will be denying 

American small businesses the tools they need to grow in today’s 

economy. 

I have invited a fellow Georgian to come testify here today. His 

name is Tony Cruz, and he works for AviGenics, Inc., in Athens, 

Georgia. AviGenics is a biotechnology company that is developing 

therapeutic proteins for oncology infections and autoimmune diseases. 

Mr. Cruz, thank you for being here today, and I look forward to 

hearing your testimony. 

Thank you, Mr. Chairman. 

Chairman GRAVES. Mr. Bartlett? 

4

Mr. BARTLETT. I am very pleased to be here today to welcome an 

old friend, Jere Glover. It is good to see you again after many 

years. 

In a former life, I was a small business person. I ran a company 

for 12 years and met a payroll every Wednesday morning, so I 

know the discipline that small business goes through. I am very 

pleased to be here in Congress today helping to look after the needs 

of small business, clearly the backbone of the economy in our country. Thank you, gentlemen, for being here. 

Chairman GRAVES. We are going to break now. We have probably 

about five, six, seven minutes left on this vote, and then there are 

three, five-minute votes. We will break and then come back here 

immediately, pick up immediately after those votes are over. Then 

we should be clear for the rest of the afternoon to have a good 

hearing. But we will recess for just a few minutes, and we will be 

back. 

[Whereupon, at 2:14 p.m., a recess was taken.] 

Chairman GRAVES. We will bring the hearing back to order. I 

apologize again for the interruption with votes. Neither I nor Mr. 

Barrow make the schedule, unfortunately, so we have to abide by 

it when votes do come up, and hopefully we are going to have plenty of time this afternoon now to work through our hearings. 

I want to point out that all of the statements made by Members 

and the witnesses will be placed in the record in their entirety, just 

so everybody knows, and we will start out with Mr. Douglas 

Doerfler, President and CEO of MaxCyte, Inc., and also you are 

here to represent the Biotechnology Industry Organization from 

Gaithersburg, Maryland. 

I appreciate you being here. I know you have come not quite as 

far as some others, but I appreciate it very much. I know you all 

are very busy, and I am glad that you did take the time to testify. 

This is a very important subject. I appreciate you being here. I look 

forward to hearing your testimony. 

STATEMENT OF DOUGLAS A. DOERFLER, MAXCYTE, INC. 

Mr. DOERFLER. Thank you, Chairman Graves and Ranking Member Barrow. Thank you for the opportunity to testify today on the 

SBIR grant program. 

As you mentioned, I am Doug Doerfler. I am the president and 

CEO of MaxCyte. We are a biotechnology therapeutics company located in Gaithersburg, Maryland. I have led professionally the development of a number of successful biotechnology companies and 

products over the last 25 years. 

We founded MaxCyte in 1999. We have 20 employees and are developing novel therapeutics to treat serious diseases. We have one 

product in Phase I clinical human testing for the treatment of patients with leukemia and additional products in pre—clinical testing for the treatment of lymphoma, breast cancer, and ovarian cancer. These programs are in combination with a number of major 

universities, including Baylor College of Medicine, the University of 

Pennsylvania, and Harvard University. MaxCyte was a recipient of 

a Phase I SBIR grant in 2003, but we are no longer eligible to participate based solely on our source of investment capital. 

5

Today, I am testifying on behalf of the Biotechnology Industry 

Organization, an organization representing over 1,100 biotech companies, universities, research institutions, and state biotechnology 

associations, in all 50 states. I want to thank the Subcommittee for 

holding this hearing on the SBIR grant program and applaud the 

introduction of H.R. 2943, the Save America’s Biotechnology Innovative Research Act, by Chairman Graves. 

I ask your permission to submit for the record a letter in support 

of Chairman Graves’ legislation signed by 281 biotech CEOs from 

37 states. 

B.I.O. represents many established companies in the industry. 

Over 85 percent of BIO members are small emerging companies 

with fewer than 500 employees and half with less than 50 employees. Not surprisingly, the SBIR program has played a critical role 

in providing necessary financing for many of my fellow small biotechnology companies. 

Unfortunately, a recent interpretation by the SBA regarding eligibility requirements for the SBIR program has prevented the majority of BIO members from participating in the program. Specifically, beginning in 2003, the SBA Office of Hearings and Appeals 

ruled that companies that were venture capital backed in excess of 

50 percent were no longer eligible for SBIR grants. Prior to this 

ruling, during the 21 years the SBIR program has been in existence, the majority of venture capital-backed biotechnology companies fully participated in this program. 

H.R. 2943 would rectify this problem and allow venture-backed, 

small biotech companies to once again pursue their innovative and 

cutting-edge research under the SBIR program. 

By way of background, I would like the Committee to understand 

the unique aspects of the biotechnology industry. The average development cycle for a successful biotechnology product is 15 years, 

and only one of five make it from the start of Phase I human testing until it is approved. Therefore, before most products can become commercially available, years of research and often hundreds 

of millions of dollars are required to complete testing, gain product 

approval, and build the necessary manufacturing infrastructure. 

While there are many different funding strategies, the typical form 

of investment in promising, early stage biotechnology companies is 

venture capital. 

In our industry, even the relatively small amount of money a 

company will raise in its first round,—this is called a ‘‘Series A’’—

between five and $8 million, generally results in new investors, 

usually a collection, a syndicate, if you will, of venture capital 

funds, owning more than 50 percent of the company. 

Therefore, both SBIR and VC funding is necessary to support the 

lengthy and costly clinical development process. Limiting government support for biotech R&D risks delaying the discovery and development of promising new therapies for cancer, diabetes, Parkinson’s Disease, and, significantly, many diseases where there is less 

commercial focus, like tuberculosis or diseases that would qualify 

for orphan drug designation. 

In fact, according to a recent letter from Dr. Zerhouni, director 

of NIH, to the SBA, which I would also like to submit for the 

record, the SBA’s current eligibility rule excluding majority venture 

6

capital-backed biotech companies, and let me quote this, ‘‘undermines NIH’s ability to award SBIR funds to those applicants whom 

we believe are most likely to improve human health, which is the 

mission of the NIH.’’ That is a direct quote from his letter. 

While almost all BIO members will need to raise venture financing to advance their products toward the marketplace, many small 

biotechnology companies have come to rely upon the SBIR program 

to fund cutting-edge research in areas where venture capital and 

other sources of financing are difficult to obtain. 

For example, while a company is working on a lead research program, it often comes across a new application or new project opportunities that will need to be tested before attempting to raise additional funds. These new opportunities are precisely the type of research projects that should be eligible for SBIR grants. MaxCyte, 

my company’s, project fell into this category. 

During our fund-raising process in 2003, we submitted a proposal 

to NIH to do basic research on our technology and expand its capabilities so that one day it may be used for biodefense or for pandemic influenza vaccine development. Venture funds were not interested in this particular project, as it was too early and risky. We 

received $95,000 in funding for our Phase I and subsequently, in 

2004, closed a $10.7 million venture round. We were able to satisfy 

the rigorous milestones of our project, including breakthrough 

science to prove general concept, but we are now not eligible to participate in any further funding for this project by the SBIR program. Due to this ineligibility, this project has been suspended. 

This is extremely frustrating for us since we believe that this 

project will have potentially a major impact on biodefense and in 

preventing potentially the pandemic flu crisis. 

The legislative history makes it abundantly clear that Congress 

intended for the SBIR program to assist small businesses in commercializing their creations and products and to stimulate small, 

U.S.-owned firms to produce innovative technologies. Congress 

viewed the SBIR program as providing the necessary ‘‘proof of concept’’ to encourage venture capital investment in promising small 

businesses seeking to bring products from the lab bench to the 

marketplace. Moreover, Congress even created an SBIR Phase II 

preference for companies that attracted venture capital investment 

by providing special consideration in the funding review of Phase 

II proposals. 

B.I.O. believes that this enormous promise of biotech R&D merits 

exploration and investment on a variety of fronts and by spectrum 

of creative, dynamic, and dedicated entities. Biotechnology is a fertile field, from which patients can reap huge benefits, if it is supported by both public and private investment. The rewards of 

biotech are limitless unless we choose to limit those who can participate in this effort. I urge the Subcommittee to favorably report 

H.R. 2943. I thank you, and I am pleased to take any questions you 

may have. 

Chairman GRAVES. Thank you very much, Mr. Doerfler. 

Next, we are going to hear from Daniel Broderick, who is the 

managing director of Mason Wells. You are representing the National Venture Capital Association from Milwaukee, Wisconsin. I 

appreciate you being here. I might point out to you that we genVerDate 0ct 09 2002 20:32 Dec 19, 2005 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 G:\HEARINGS\23181.TXT MIKE
7

erally do give minutes for statements, but I do not adhere to that 

very closely, so if you go over, it is no big deal. I am not going to 

crack any whips or anything. So I look forward to hearing your testimony, and thank you for coming today. 

STATEMENT OF DANIEL J. BRODERICK, MASON WELLS 

Mr. BRODERICK. It is my pleasure to be here. Again, my name 

is Dan Broderick. I am a founding managing director of Mason 

Wells Biomedical Fund, located in Milwaukee, Wisconsin. Mason 

Wells is a small, venture capital fund focused on seed and early 

stage investing in the life sciences in companies located in midAmerica. 

Today, I respectfully submit testimony on behalf of the National 

Venture Capital Association and those venture-backed companies 

that are developing innovative technologies that improve the quality of our lives and raise our standard of living. For the last 20 

years, the dual financing sources of the SBIR program and the venture capital community have allowed many of these promising companies to conduct ground-breaking, scientific research while simultaneously building viable businesses that will bring these innovative products to the marketplace. 

Venture capital is the investment of equity to support the creation and development of new, growth-oriented businesses. In 

terms of global competitiveness, the entrepreneurial segment of the 

economy is the true differentiator in America. U.S. companies originally funded with venture capital, like Genentech and Amgen, now 

represent 11 percent of our annual GDP and employ over 10 million Americans. 

There appears to be a misunderstanding that venture capital 

firms are large corporations that control the small start-up company by having a majority control over the company’s board. It is 

important to understand the organizational structure of a venture 

capital firm, its limited partners, and the relationship between the 

VC firm and the portfolio company. 

Private venture capital funds are organized as limited partnerships and are managed by general partners. The general partners, 

like myself, are the individuals staffing the venture capital firm. 

They are responsible for and control all aspects of the fund’s operations, including making the investment decisions. The venture 

capital funds are small organizations. In fact, the average number 

of general partners in any one firm in the United States is only 10. 

The investors in these limited partnerships are usually pension 

plans, foundations, trusts, and accredited investors, and they are 

called limited partners because they are limited from liability because they exert no control in the day-to-day operations of the VC 

fund, they do not participate in setting the strategic direction of the 

fund, and they take no role in making the investment decisions. 

The limited partners’ investment in a venture capital fund is not 

a revenue stream for the fund; rather, the money that LPs invest 

in a venture fund are to make investments in portfolio companies 

and as loans to fund the day-to-day operation of the fund. These 

investment dollars and loans must be repaid by the venture capitalist before the firm can then profit. 

8

Based on my experience, the great number of companies that I 

see have established a board of three to seven members prior to 

any venture capital involvement. Members of these boards comprise founders, management, investors, and industry experts. Once 

a venture capital firm is involved, most boards slightly increase in 

size, with members representing the same groups of people. Each 

vote on the board is equal, and it is the fiduciary duty of each individual board member to act in good faith and in a manner to be 

in the best interest of the corporation. The groups involved generally do not vote as a bloc; rather, each member votes their own 

conscience. 

I would also like to briefly address the relationship between corporate venture capital and traditional venture capital firms, as outlined above. Typically, corporate venture capitalists play a different 

role than a traditional venture firm. They generally only co-invest 

alongside a traditional firm and usually do not take a board seat. 

They also generally own less than 20 percent of the portfolio company because of corporate-reporting rules. Furthermore, corporations manage only 4 percent of all venture capital under management. 

So why do venture capital firms care about SBIR grants? For the 

last two years, portfolio companies have continually alerted the 

NBCA to situations in which an SBIR grant has been denied because they have venture investors. Many of these firms were 

caught by surprise because this program has been working well for 

20 years. 

It is paramount not to confuse the role of venture capital funding 

with the role of basic R&D funding. Both are critical to bringing 

innovation to the marketplace; however, basic research funding is 

targeted at discovery and invention. It is this type of activity that 

the SBIR program has historically supported. Venture capital dollars, even those labeled early stage, are used to build a strong and 

viable business so that promising discoveries can be brought to 

market. 

Some would argue that if a company receives venture capital, 

that it has hit the lottery and does not need government funding. 

Nothing could be further from the truth. In the life sciences sectors, the cost and time associated with bringing a discovery to market is colossal. Multiple rounds of financing at millions of dollars 

per round are required. 

The cost of bringing a new drug to market is about $800 million. 

Young biotechnology companies cannot divert precious venture capital funds earmarked for business growth to embark on new research projects, although these projects may hold the next groundbreaking treatment for Alzheimer’s, cancer, or other diseases. 

Another belief is that venture investment only impacts select regions of the country. To the contrary, venture capital is a national 

phenomenon. While Massachusetts and California are the leading 

regions for venture capital investment, VC dollars have been flowing to all 50 states over the last 20 years and have directly benefitted regional economies across the country. Ironically, however, 

the SBIR program eligibility rule hurts the low-tech regions it is 

trying to support. 

9

Mid-America is one example where investing in early stage technology companies is difficult because of the smaller percentage of 

venture capital investment. From my experience as the founder of 

the Mid-America Health Care Investors Network, I know the inability of small businesses to compete for and receive SBIR funds 

is of particular concern to venture-backed companies in mid-America. The ruling that disqualified VC finance companies from competing for SBIR grants removed an essential source of financing, 

causing R&D at many technology companies located in mid-America to slow or stop altogether. 

A way to ensure the ongoing success of the SBIR program is to 

reopen it to the broadest and most qualified base of small businesses possible. This requires allowing venture finance companies 

to compete once again. 

Since SBIR’s inception some 25 years ago, venture capital and 

SBIR funding have been proven to work together to research, commercialize, and distribute innovative products on an accelerated 

basis. Recently, Congressman Graves introduced legislation that 

clarifies SBIR eligibility requirements for venture-backed, start-up 

companies. NVCA applauds this effort and encourages quick action 

on this legislation, and we look forward to working with the Committee to address this spiraling problem, and I thank you all for 

the opportunity to express my views. 

[Mr. Broderick’s testimony may be found in the appendix.] 

Chairman GRAVES. Thank you, Mr. Broderick. 

Next, we are going to hear from Barry Michael, who is President 

of B.A. Michael Consulting and here with the Small Business Technology Council from Clifton, Virginia. I appreciate you being here. 

Thank you very much. 

STATEMENT OF BARRY MICHAEL, B.A. MICHAEL CONSULTING 

Mr. MICHAEL. Good afternoon. My name is Barry Michael, and 

I head a consulting company whose primary focus is life science 

start-up companies in the Mid-Atlantic region of the U.S. 

My business career began in 1972, after serving as a Naval Supply Corps officer during Vietnam. I have been part of the health 

care industry for the last 23 years. Many of these years, I worked 

for two major Fortune 100 health care companies. However, since 

1993, I have worked primarily with start-up companies, with my 

focus including finance, strategy, tactics, and marketing. I have an 

engineering degree from Brown University and an M.B.A. from 

Wharton. 

I am here today to support the small start-up company. I believe 

that it would be bad policy to expand the current criteria for SBIRs 

to include large, venture capital, majority-controlled start-ups. 

I have worked closely with four different organizations that have 

had SBIRs awarded by the NIH. I believe that it is important to 

note their collective stories. SBIRs were critical as they formulated 

start-up strategies, developed products, and matured as businesses. 

For the purposes of perspective, I have also played a key role in 

a majority-controlled, venture-backed, biotech start-up. Therefore, I 

am at least somewhat aware of the fundamental differences, both 

financial and strategic, of these two types of start-up organizations. 

10

Venture capitalists usually think in terms of investing several 

millions of dollars. They represent very sophisticated investors who 

demand that the VCs hit their specific financial targets and have 

specific timelines for success. Early, small, science start-ups almost 

never meet these conditions and thus almost never qualify for VC 

funding in their early stages when it is most critical financially and 

strategically. Their risks are too great, their timelines too long, and 

their management teams are still too unproven. But this unproven 

group is still taking the personal risk, and they represent one of 

the crucial ways that important life science breakthroughs can 

start. 

When a person or a group of persons starts to develop their life 

science idea or invention, they are faced with daunting technology, 

market, and finance challenges. They will rely on their creativity 

and technical training to develop their idea, but usually they have 

to learn product development, business, and finance until their idea 

is proven. 

Most of these life science companies are so unproven or so clearly 

risky that established companies shy away from supporting them 

until the data show some glimmer of hope. SBIRs support the generation of that data. The NIH also provides valuable feedback to 

SBIR applicants, and if the proposal does not make it the first 

time, it may make the grade when resubmitted. Getting an SBIR 

Phase I contract award represents important validation. Getting a 

follow-on Phase II, like one of the companies that I have worked 

with, makes it possible to undertake follow-up studies, and theirs 

was a medical device clinical study. 

Many small start-ups plan to become competent enough to eventually be eligible to be financed by venture capitalists, both large 

and small. In the meantime, however, these start-ups have to rely 

on savings, spouse’s income, friends and family, second mortgages 

on their homes, angels, and, most importantly, SBIRs to provide 

critically needed seed capital. SBIRs provide a significant percentage of this early financing effort. Small start-up companies typically generate several hundred thousands of dollars in funding. 

Funding for large, VC-controlled companies, when it is available, 

would be on the order of several million dollars. 

Currently, the 2.5 percent of the NIH budget allotted to SBIRs 

creates a zero-sum game. Adding more types of eligible organizations that could threaten the current environment that very properly benefits the early, small, life science start-up company is something I would not recommend. These life science, young, start-up 

organizations represent the ongoing start of our country’s innovation process. Said another way, in three of the four start-up companies I have personally worked with, there would not have been a 

company and a development effort if it had not been for SBIRs. 

None of these organizations were even remotely mature enough to 

qualify for VC investment, but their creativity and entrepreneurial 

spirit needed a chance. 

Changing the current criteria to allow SBIR participation by 

large, venture capital-majority-controlled start-ups would be a 

major detriment to the life science start-up community. Bringing in 

new players with deep pockets will divert the current pool of money 

11

away from small start-up companies. These early stage companies 

will be faced with even greater challenges. 

Yesterday, the Small Business Technology Coalition released a 

survey of companies that received SBIR awards from the NIH. This 

survey is attached to Mr. Glover’s statement for the record. Please 

note that nine out of 10 of these companies oppose giving large VCs 

greater access to the SBIR program funds. We are told that these 

companies are among the likely beneficiaries if large VCs are allowed to play a greater role. Yet these supposed beneficiary companies clearly oppose greater large VC involvement in the program. 

While preparing this talk, I had an interesting comment from an 

expert in the public financial markets. He said, ‘‘I do not understand the issue. Venture-backed-capital companies already have 

their money.’’ In fact, as noted in my attachment, they have $53 

billion currently available to invest, and they cannot figure out how 

to invest it. Thank you. 

Chairman GRAVES. Thank you, Mr. Michael. 

Now we are going to hear from Jere Glover, who is the Executive 

Director of the Small Business Technology Council. Jere, thanks for 

being here today. I appreciate it. 

STATEMENT OF JERE W. GLOVER, SMALL BUSINESS 

TECHNOLOGY COUNCIL, BRAND LAW GROUP 

Mr. GLOVER. Thanks for inviting me, Mr. Chairman, Ranking 

Member. Jere Glover, executive director of the Small Business 

Technology Coalition. I have over 27 years of experience in small 

business innovation. I served as chief counsel for advocacy under 

President Clinton. 

Let me start by saying that prior to enactment of the SBIR program, small business was virtually excluded from the federal R&D 

funding. This is true despite clear evidence that small businesses 

were more successful and more efficient at innovating than large 

firms. 

This program is a magnificent success, widely praised, yields 

thousands of patents and billions of dollars in technology since 

1992. It has had nine favorable GAO studies. SBIR companies are 

successful in commercializing their technologies to the extent of 40 

percent, much better than even venture capitalists have been. It 

has worked so well that in its 20-plus years of existence, there 

have been very few and minor changes made to this legislation. It 

is not broken, and this fix is not needed. 

The emphasis of the SBIR program is on early stage innovations 

and technologies, an area of little interest to the venture capital 

community. Less than 2 percent of venture capital investments last 

year went to early stage and seed investments. 

There are four facts that are lost in this debate. First, Phase III 

specifically is designed to encourage and facilitate VC partnerships 

and investment in SBIR companies. Two, small venture capital 

companies can today own a majority interest in an SBIR company 

and that company remain eligible. Three, large venture capital 

companies can own 49 percent of an SBIR company without it creating a problem. And, finally, SBA is currently involved in the regulatory process on this very specific issue. 

12

Where SBA has drawn the line is on allowing venture capital to 

own and control a majority interest in a small business SBIR company. This is based on Congress’s core definition of a small business established more than half a century ago. A small business is 

one that is independently owned and controlled, 15 U.S.C. a 632. 

There are numerous laws and regulations that are driven by that 

phrase and that provision. It is a very important underpinning of 

the Small Business Act. To my knowledge, this is the first time in 

the history of the SBA that Congress has been asked to redefine 

‘‘small business’’ to include large businesses and companies that 

are owned and operated by them. 

When this issue first came up, I surveyed the SBTC Board of Directors. They were unanimously and vehemently opposed to allowing venture capitalists to own and control SBIR companies. I later 

surveyed SBTC’s membership, as well as SBIR participants, in a 

number of national SBIR meetings, always with the same results: 

Small businesses oppose the change in the definition to allow venture capital-owned and controlled companies to compete in the 

SBIR program. 

Recently, we surveyed the NIH awardees. We referred them to 

BIO, the industry association, Web site where their position paper 

was located as well as referred them to ours. We then asked them 

the questions. Ninety percent opposed. This was true even when we 

asked the question about whether it was owned by institutions and 

pension funds. 

In SBA’s rule-making proceeding, there were a number of very 

interesting questions asked. Let me just mention those. Will the 

change in allowing venture capital-owned and controlled companies 

in the SBIR program shift the program emphasis to lower-risk 

technologies that are closer to the marketplace? Will it increase 

concentration in states like California and Massachusetts? Fortysix percent of venture capital money goes to California. Will it 

change the profile of successful and unsuccessful SBIR companies, 

and will it lead to calls for other changes to allow universities and 

large businesses in the SBIR program? I think the answer to all 

of those is yes. 

These questions are very important, and I think they must be 

answered before Congress goes forward with such a radical change 

to a very successful program. 

I wonder why SBA was not asked to present its views at this 

hearing. They certainly have the expertise, and with thousands of 

comments and dozens of field hearings, I think SBA should be 

heard. 

The SBIR program is extremely competitive. For every company 

that receives an SBIR award, there are five to seven companies 

that have put in proposals that are not funded. This is especially 

true at NIH, where last year they received a thousand more proposals than the year before. There were 5,000 companies last year 

that submitted proposals to NIH that were not funded. Many 

ranked top, outstanding in science and technology, but there simply 

were not sufficient funds at the NIH to make the awards. Make no 

mistake: For every VC-owned company that receives an award, 

there will be a small business with outstanding technology that 

will go unfunded. 

13

I fear that if the Small Business Innovation program is opened 

to venture capital-controlled companies, universities and large 

firms will try to make the same arguments, thereby defeating the 

underlying purpose of the SBIR Act, which is to make sure that 

small business has access to federal R&D funding. 

The bill will result in increased geographic concentration of the 

SBIR program. As I mentioned, 46 percent of venture funds go to 

California. Ten states get 85 percent of venture funds. Having to 

compete with ventured-owned companies places small businesses 

and other states at a competitive disadvantage. 

We are not unsympathetic to the concerns raised by BIO and the 

National Venture Capital Association. We have supported programs, such as the ATP program and the MEP program, that are 

not targeted for small businesses. At the Science Committee, it was 

suggested that there needs to be a program for a large VC and 

even large businesses to use the remaining 97 and a half percent 

of federal R&D to help them commercialize new drugs and new 

technologies. We are open to such a proposal. Our objection is to 

having funds for large businesses and VC-owned firms come out of 

the very limited funds that are available exclusively for small business. Thank you for allowing me to testify. 

[Mr. Glover’s testimony may be found in the appendix.] 

Chairman GRAVES. Thank you, Mr. Glover. 

I will turn it over to Mr. Barrow to introduce Mr. Cruz. 

Mr. BARROW. Thank you, Mr. Chairman. With me today is a fellow Georgian to testify in today’s proceedings. His name is Tony 

Cruz. As indicated before, he works for AviGenics, a company in 

Athens, Georgia. AviGenics is a biotechnology company that is developing therapeutic proteins for the treatment of oncology infections and autoimmune diseases. Mr. Cruz, thank you for being with 

us. I look forward to hearing your testimony. 

STATEMENT OF ANTHONY P. CRUZ, AVIGENICS, INC. 

Mr. CRUZ. Thank you. Chairman Graves, Ranking Member 

Velazquez, Ranking Member Barrow, and Committee members, 

Good afternoon. My name is Tony Cruz. I am the senior vice president of finance and administration at AviGenics. Before my involvement with the biotech industry, I served at active duty for five 

years as a captain in the U.S. Air Force, and I am thrilled to be 

a part of this democratic process. 

On behalf of AviGenics and the biotech industry, I wish to thank 

members of this Committee for this opportunity to present my comments on the recently imposed obstacles which prohibit small biotechnology companies like AviGenics from participating in the 

SBIR program. 

AviGenics is an up-and-coming biotechnology company located in 

Athens, a small town about 90 minutes from Atlanta. Our main offices and labs are located on the University of Georgia campus, and 

we are well integrated with the university’s efforts to attract technology companies and to generate high-skilled, high-paying jobs for 

that area. AviGenics employs about 50 very highly skilled scientists, technicians, and specialized farm workers. Currently, Athens is better known for the university’s football program rather 

than its expanding base of high-technology companies. We hope 

14

that one day Athens, Georgia, will be recognized as much for its 

biotech excellence as the Georgia Bulldogs are for their football 

prowess. 

This is an urgent issue. The SBIR and access to the SBIR funding can determine the future of this and other companies within 

the Athens area, including whether or not we survive in the near 

term. 

AviGenics is not a subsidiary, nor is it a spinoff of a large pharmaceutical company. We are an independently owned and operated 

technology company dedicated to developing therapies for infectious 

diseases and cancer. The company’s core technology is targeted specifically at producing protein-based therapies which are safer, more 

effective, and more affordable than those currently available on the 

market. 

AviGenics’s approach is somewhat different from the majority of 

the biotechnology industry in that we utilize modern research tools 

as well as traditional agricultural expertise. Specifically, our technology combines state-of-the-art molecular biology with Georgia’s 

well-established poultry expertise to produce modern medicines at 

low cost in using chicken eggs as the core of our technology. 

The value-creation cycle as experienced by the company over the 

last few years is very similar to those experienced by other biotechnology start-ups. Financial support from a combination of federal grants, including the SBIR program, and venture capital funding has been critical for the survival and growth of AviGenics up 

to date. 

In the foreseeable future, SBIR funding will continue to be critical for technology development and preclinical testing of our products. SBIR funding and other federal grants make it possible for 

the company to establish a proof of concept for its base technology, 

and venture funding allows development of these specific products 

through very expensive clinical trials and the regulatory approval 

process. 

Only by demonstrating proof of concept of our technology were 

we able to attract VC investment and thus then were able to hire 

new employees, pursue activities required for development of a lead 

product, and complete human clinical trials. Future expansion of 

AviGenics relies heavily on SBIR and other federal monies being 

available to develop proof of concept for the next set of technologies 

and future product candidates. This next set of technology validation will hopefully lead to more VC funding, which, in turn, will 

further hiring and completion of other clinical studies. 

Early in the company’s history, attempts were made to secure financial backing from industry to develop and validate the core 

technology. A cross-section of large pharmaceutical companies and 

established biotechnology companies were approached with an 

unproven concept of making low-cost and improved drugs through 

an unconventional technology, i.e., production of therapeutic proteins in chicken eggs. 

The message from industry to AviGenics at that time was loud 

and clear: Come back when you can show us your technology 

works. The industry declined to fund the basic research, even when 

the promise of making drugs cheaper, better, faster, and safer was 

there. Funding from government research and a few angel invesVerDate 0ct 09 2002 20:32 Dec 19, 2005 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 G:\HEARINGS\23181.TXT MIKE
15

tors was then necessary to reach the initial proof of concept for our 

technology. Then and only then was the company able to attract 

significant funding from VC firms, eventually leading us to where 

we are now, a 50-person company about to enter Phase II clinical 

trials. 

In 2004, AviGenics completed a U.S. FDA-approved, Phase I 

human clinical trial for its lead compound to treat an insidious infectious disease. The data from the initial study suggests that our 

drug performs just as well or better and is safer than what is currently on the market. Furthermore, this drug will cost less than 

half of what it costs for a similar therapy today. Of course, more 

extensive human clinical trials are required for market authorization, but AviGenics’s technology offers a significant promise to millions of patients who do not benefit from or cannot afford the currently available therapies. 

Advancing our innovative technology to the point where we were 

able to initiate clinical evaluation was a path fully loaded with 

technical risk. This initial technology development took over four 

years as several different technical approaches had to be utilized 

without the SBIR grants or other federal funding. 

It is important to note that even with the completion of a Phase 

I study for our lead compound, federal funding continues to be necessary for the company as we must continue to develop future 

products for other disease areas. Specifically, federal research 

grants are needed for technology-improvement projects, such as developing more effective and efficient ways to apply genetic engineering techniques. 

According to the recently imposed eligibility standards, a business must be at least 51 percent owned and controlled by individuals who are citizens of the U.S., and the company may not have 

more than 500 employees, including affiliates. The SBA’s current 

interpretation of ‘‘individuals’’ excludes venture capital funds. As a 

result, AviGenics is ineligible for future SBIR funding. 

I believe AviGenics is a case study of what the SBIR program 

can do. Like I said, we currently employ close to 50 full-time employees, most of whom are highly educated and skilled. With SBIR 

and federal grants early in its history, our company was able to secure VC funding and thus initiate human clinical trials. We look 

forward to the day that our technology and hard work will result 

in affordable, effective therapies for those stricken with hepatitis, 

AIDS, cancer, or other ailments. 

AviGenics strongly supports BIO’s recommendation that the SBA 

adopt the rule that addresses the actual ownership structure of 

small biotech countries that are owned and controlled by venture 

capital companies. Since 1982, when the SBIR program was created, up until 2003, majority VC-owned, biotech companies were allowed to compete for SBIR grants. Specifically, we count on you to 

support this bill. Thank you. 

[Mr. Cruz’s testimony may be found in the appendix.] 

Chairman GRAVES. Thank you, Mr. Cruz. 

I am now going to recognize Ms. Velazquez, who is the Ranking 

Member of the full Committee. It is a pleasure to have you here. 

Thank you for coming for a statement. 

16

Ms. VELAZQUEZ. Thank you, Mr. Chairman, and I would like to 

make an opening statement so that the record reflects my concerns 

about the SBIR program and the importance of venture capital and 

the role it plays in our economy. So I want to thank you for allowing me to make my opening remark. 

We rely heavily on this nation’s technology sector to advance us 

forward and to create the next generation of innovations that will 

carry us into the next century. Over the past two decades, small 

businesses have become the dominant employer of high-tech 

innovators, producing 55 percent of all new technological developments. Clearly, if this nation is going to continue striving forward 

in the fields of science, engineering, and computers, then we must 

be investing in these businesses. This is where the SBIR program 

comes in. 

This program plays a critical role in enabling entrepreneurs with 

bright, innovative ideas in the technology field to receive the valuable seed funding they need to start and grow their businesses. The 

SBIR program is vital in empowering high-tech, small firms to obtain their end goal: to profit from its commercialization. However, 

the SBIR program needs some assistance when it comes to providing high-tech, small firms with the capital they need. That is 

why venture capital plays a vital role in turning innovative dreams 

into reality. 

There is no doubt that the applied research in the high-tech industry is an expensive one. An example of this is in biotechnology 

and drug research where it is estimated to take $800 million and 

at least a decade for product development, testing, and movement 

to the market. Clearly, this is something that the SBIR program 

cannot finance alone. We need to ensure that there is a balance in 

getting venture capital to these aspiring technology firms. It is simply not a valuable option to limit the ability of small businesses to 

access one of their most significant resources: venture capital. 

These businesses represent the next wave of innovations, and 

placing an arbitrary cap of 49 percent, as SBA proposed, on the investment they can receive will only hinder their ability to grow and 

develop. SBA’s proposal simply takes opportunity away from hightech, small firms wanting to make their way in the global marketplace. 

There are many ways to ensure that this program truly maintains its focus on this nation’s entrepreneurs without limiting their 

ability to access venture capital. These protections have already 

proven successful in other SBA programs. There is no reason why 

we cannot offer similar protections to the SBIR program. The issue 

here is that the need for venture capital within the technology sector is greater than ever. 

Our nation simply cannot afford to have a policy that withholds 

venture capital investment from high-tech, small firms. The SBIR 

program clearly plays a vital role in empowering this nation’s small 

business technology sector. However, without an adequate public/

private partnership, its capabilities will be severely hindered. That 

is why it is important that any change to this program is guaranteed to maximize technological developments. A proposal that 

would only hold small firms back and rob them of available venture 

capital investment is simply not a good policy. 

17

Without the resources offered through the SBIR program and 

adequate venture capital investment, small businesses will never 

have what they need to spur high-tech innovation and development 

in order to move this nation forward for generations to come. 

Thank you, Mr. Chairman. 

Chairman GRAVES. Thank you, Ms. Velazquez. I appreciate it 

very much. 

We are going to start with questions, and my questions, I guess, 

anyone could answer. I would be interested in hearing what all 

sides have to say about it, but one of the concerns with opening 

this back up is when a venture capitalist becomes a majority owner 

of a business, do they assume day-to-day control of the business, 

or—I might even rephrase that question—can they assume day-today control of your business? We will just start. 

Mr. DOERFLER. We just completed our first venture capital financing round, so I am pretty intimately familiar with this one. 

First of all, there was no single venture capitalist that owned 

more than 15 percent of our company at any given time. We put 

a syndicate together, and I am not aware of any company in our 

industry, the biotech industry, that is owner controlled by a single 

entity. The VCs came in as a syndicate. We were very careful, I 

think as was just mentioned, that we created a board of directors 

that was majority controlled by non-VCs to ensure that the control 

of the company was not in any group’s hands. Management controls day-to-day operations, the board controls the company itself, 

and the shareholders obviously can appoint the board members. 

Now, there is a shareholder agreement that most companies 

have—I believe virtually all companies have—that prevents any 

single VC from controlling the organization. The other members of 

the VC syndicate would not allow that to happen. So there is an 

inherent check and balance in our system to ensure that not one 

party will control the operations, certainly not control the day-today operations, of an organization. 

Mr. BRODERICK. I would like to respond as well. It certainly is 

not what the venture capitalist even wants to do, is to control the 

day-to-day operations of a corporation. What we try to do is we try 

to find talented management to take care of that responsibility. 

They have the skill sets to do that. They have the experience generally to run the day-to-day operations of the company. Were we 

to have to step in to run the company day to day, it would be a 

bad situation. It would be probably a distress situation, and we 

would probably even then hire experts to come in and take over the 

orderly dissolution of that corporation. 

As for controlling the company from the board of directors, it is 

our fiduciary responsibility as a member of the board of directors 

to act in the best interests of all of the shareholders involved for 

the purpose of increasing shareholder value. In all of the board 

memberships that I am aware of, each member has an independent 

vote. There are no side agreements: You vote my way. There are 

no club rules: I will vote for this if you will vote for that. Each 

member has a fiduciary responsibility to vote his own conscience on 

each issue as an individual. 

Chairman GRAVES. Mr. Michael? 

18

Mr. MICHAEL. I think that there are times when a VC-controlled 

or nearly controlled company is going to be frustrated about management’s desire to take on new projects, and so although that is 

not possibly your definition of ‘‘day-to-day control,’’ most energetic, 

creative scientists will often want to start new projects, and they 

will often be excluded from doing those projects unless they can get 

access to an SBIR grant. So that is a form of day-to-day control, 

and I think that happens fairly often. 

Chairman GRAVES. Mr. Glover? 

Mr. GLOVER. Most legal, underlying documents do provide the 

ability for the venture capitalist to take control if certain events do 

not happen or if certain things do not happen. To the extent the 

venture capitalist owns over 50 percent, collectively they have the 

option at any time to elect a new board, control that board, and 

make the decisions. 

The SBA’s size-determination rules for this and all other small 

businesses have always looked at the potential to exercise that control, whether it has actually been exercised or not. Legally, they 

will have the right to exercise that control, and SBA, to protect 

small businesses from that eventuality and to make sure that companies are legitimately small businesses, do look at the control 

issue, and they do look at the underlying documents, and, in most 

cases, those documents do provide sufficient opportunities for the 

majority holders to exercise those controls. 

Chairman GRAVES. Mr. Cruz? 

Mr. CRUZ. Just a short addition. In our case, at AviGenics, we 

are majority VC controlled; however, there are over 10 different 

funds that own that majority, and it is very, very difficult for any 

one fund to actually exert control over the company. As was said 

before, there are underlying legal documents that provide the distribution of decision-making throughout all of the funds, as well as 

the management team and other common shareholders. 

Chairman GRAVES. Mr. Barrow? Ms. Velazquez? 

Ms. VELAZQUEZ. Thank you, Mr. Chairman. Thank you, Mr. Barrow. 

Mr. Broderick, I have a question, in particular, about how we can 

balance the need to allow increased venture investment versus protecting small businesses. If we had a structure in place that would 

allow venture capital companies to have an interest of up to 50 percent or more, if necessary, but made it clear that the day-to-day operations of the company rested with the small business owner and 

provided the investor the ability to step in and assume operations 

only if the company was in trouble, do you think this is something 

you could support? 

Mr. BRODERICK. Thank you for the question. I believe that that 

is generally how the companies are operated today. There is a 

board of directors that is responsible for the control of the company, if you will, and we would be happy to work with you on evaluating that possibility, and, I think, look forward to doing that. 

Ms. VELAZQUEZ. Thank you. 

Mr. Doerfler, if we limit the amount of venture capital small 

biotechs can receive, where will they turn for financing? 

Mr. DOERFLER. The question is, if we limit the amount of money 

we can bring in from venture capital. Well, the venture capital inVerDate 0ct 09 2002 20:32 Dec 19, 2005 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6633 G:\HEARINGS\23181.TXT MIKE
19

dustry is perfectly suited to support the kind of work that we are 

doing because it is very high risk. 

Ms. VELAZQUEZ. I am referring specifically, if we put a cap like 

SBA wants to do. 

Mr. DOERFLER. Well, we will not be able to participate in SBIR. 

We, frankly, will not be able to do that, and investors will not come 

into the company unless they can invest as much as they want to 

and as much as the company needs to make it happen. If that cap 

continues, we will not participate in the program. It is that simple. 

It just is not worth our time to try to get around that. 

Ms. VELAZQUEZ. So will this cause small businesses to choose between the SBIR or venture capital? 

Mr. DOERFLER. Well, it will definitely be venture capital, not 

SBIR. We have no alternative. We would have to go with venture 

capital because, in my particular instance, our funding is 98 percent VC funding, and a very small amount is SBIR funding, and 

that is what we are doing for additional projects. 

Ms. VELAZQUEZ. So what will that mean in terms of the biotech 

industry regarding development? 

Mr. DOERFLER. I think that the biotech industry will walk away 

completely from the SBIR program. We are not able to participate. 

I think there is another consequence to this. If companies like 

ours, like mine, for instance, who have demonstrated the ability to 

develop technology, do not participate in the SBIR, that SBIR program will lose its competitiveness. It will not be worth what it was 

before. There is a competitive spirit there. It raises the level of 

play, and if you have got a number of players that cannot participate, it lowers the relevance of that program and the overall portfolio of companies and entities that can help NIH. 

So I think it is going to have a major effect. It will not have an 

effect on the industry as much as it is going to have an effect on 

the program and eventually NIH. 

Ms. VELAZQUEZ. Would you like to comment, Mr. Broderick? 

Mr. BRODERICK. Just one thing. Where would the biotechnology 

company go for money if they do not go to the venture capitalist? 

And I do not know. I do not think there is a choice. They would 

not be funded. They would go out of business, or they would continue to just get grant after grant after grant and never commercialize anything. 

Ms. VELAZQUEZ. Thank you, Mr. Chairman. 

Chairman GRAVES. Mr. Bartlett? 

Mr. BARTLETT. Thank you very much. For the record, let me ask, 

if I am a small business company, and I get an SBIR, and if, in 

the process of the work on that, I come up with an innovation 

which is patentable, who owns the patent? 

Mr. GLOVER. You would, sir. The SBIR company retains patent 

rights under the Small Business Innovation Act. 

Mr. BARTLETT. Okay. Thank you. If I am a small company, and 

I attract venture capital to a project, is that committed to the 

project or to my company? Can I separate the project from the company, or is it given to the company? 

Mr. BRODERICK. It is based on what is given to the company in 

general to have the company carry out the business plan, which includes a product development plan that the company has come up 

20

with, vetted, and otherwise had it reviewed by experts, and the 

venture capitalist will put the money inside the company to support that business plan— 

Mr. BARTLETT. I understand that under the present rules, if I am 

that small business company, and I have an idea that attracts venture capital money, that if more than half of my resources are venture capital money, then I cannot now apply for an SBIR for another idea I have. That is correct? 

Mr. DOERFLER. That is correct. That is my understanding. 

Mr. BARTLETT. By the way, I would like to ask Mr. Doerfler, do 

you own and control over 50 percent? I think you answered that. 

You own and control about 2 percent of it. 

Mr. DOERFLER. Do I personally? 

Mr. BARTLETT. Yes. 

Mr. DOERFLER. Less than 1 percent. 

Mr. BARTLETT. Less than 1 percent. Okay. I just wanted to get 

that on the record. 

Mr. Glover, you indicated that there is not now anywhere near 

enough money to support the good proposals that come in to NIH 

for SBIR funding. Is that correct? 

Mr. GLOVER. That is correct, sir. 

Mr. BARTLETT. Okay. So we have two things here which appear 

to be in tension. One is small companies that have one good idea 

or maybe two or three, and they acquire venture capital funding, 

which now disqualifies them for SBIR, but, you know, this engine 

of creativity is not going to be limited to one or two. 

I, in a former life, ended up with 20 patents, for instance. If I 

was pursuing one of those with venture capital money, then I could 

get no more SBIR money for one of those other ideas that I had. 

So that is on the one hand. We now have an idea that is going to 

add something of value to our economy. It is going to employ people. They cannot get any SBIR money, and the venture capital people, in spite of their name, are not really venturous, and they are 

not going to put any money out for this, and so now my idea goes 

begging because I cannot get any money. 

On the other hand, we have legitimate small businesses where 

the owner controls more than 51 percent of it, and there is not even 

enough money to go around to fund the good SBIR projects there. 

Is that correct? 

Mr. GLOVER. That is correct. 

Mr. BARTLETT. Okay. Well, it seems to me that the solution to 

this problem is not to further dilute the effectiveness of that money 

by now spreading it over a broader field. It seems to me we need 

another program or an additional pot of money to fund those entrepreneurs who happen to have been successful enough to attract 

venture capital money and now have an additional idea that they 

want funded. You know, it just does not seem to me to be productive to go to the same well which already does not have anywhere 

near enough money in it to fund those for whom the program is 

currently specified. Is that correct? 

Mr. GLOVER. That is correct, sir. 

Mr. BARTLETT. Okay. Help me understand why it makes any 

sense to try and dilute the effectiveness of that money by spreading 

it over a larger field. 

21

Mr. GLOVER. It does not, but I think, as I said, I sympathize with 

the Biotech and Venture Capital Association. There needs to be a 

program to take these companies, but it should not come out of the 

small business pot. We fought too hard to establish that small business preference. 

Mr. BARTLETT. They may still be small businesses, if I might, but 

they should not come out of this pot— 

Mr. GLOVER. That is correct. 

Mr. BARTLETT. —because this is the pot that is designated for 

small businesses, just start-up, more than 51 percent owned by the 

person. I agree that there needs to be another pot of money and 

another program somewhere for these others, but I cannot see the 

value of diluting unless we are going to pour a whole bunch more 

money into this, and then you could not be sure it is going to the 

right place because we have two very different entities here vying 

for the money, do we not? 

Mr. GLOVER. We do, indeed. 

Mr. BARTLETT. Okay. One is an itty-bitty start-up company, and 

these other companies that could be not-so-itty-bitty start-up companies. Thank you very much. 

Mr. DOERFLER. Dr. Bartlett, may I? 

Mr. BARTLETT. Yes, sir. 

Mr. DOERFLER. My company, before we received venture capital, 

was 17 employees. We are now 20 employees. So I think, by any 

measure, we are still a small company. I do not think it really 

made a difference how we got our financing, and the program 

worked fine for 21 years. 

This change that happened a few years ago changed the eligibility and forced companies like mine, who had a good idea, who 

actually invented something, based on SBIR, put in a patent application. We are very hopeful we are going to be able to get that patent, we are ready to go for a Phase II, and we think it is going to 

be important, but we cannot participate now because we have a different form of funding. And we are still, in my mind, at least my 

wife’s mind, a very itty-bitty company. 

Mr. BARTLETT. I am very sympathetic to your dilemma, and 

there ought to be a program there for you, and there ought to be 

money there for you, but if this present program does not have 

enough money for the people who are now in the program, I am 

having some trouble understanding how we make the situation better by making the field larger so that there is going to be now even 

a smaller percentage of worthy projects that get funded. 

I think that what our role ought to be, our goal ought to be, is 

trying to find more money in another program so that your second 

and third and fourth ideas can get the same kind of SBIR funding 

that your first one got. 

Thank you very much, Mr. Chairman. 

Chairman GRAVES. Mr. Barrow? 

Mr. BARROW. Thank you, Mr. Chairman. I want to pick up on Dr. 

Bartlett’s comments by coming at it from a different route because, 

on the one hand, you have got a new definition that makes the 

field of eligible participants smaller than it has been over the last 

20 years than commonly understood to be. So now, all of a sudden, 

we have got a new order of things in which a more expansive defiVerDate 0ct 09 2002 20:32 Dec 19, 2005 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 G:\HEARINGS\23181.TXT MIKE
22

nition had a larger field of eligible participants based on their internal organization structure vying for a piece of the same pie. 

I certainly agree with Dr. Bartlett that to the extent we can provide more resources, we should do so, but unless and until we are 

prepared to do that, the question then becomes, how large should 

the field of eligible participants be? And the concern that I have got 

is that for 20 years we have had an accepted definition of ‘‘eligible 

participants’’ that has evolved and been applied consistently over 

the last 20 years while something else has been going on at the 

same time. Something else that has been going on at the same time 

has been the explosion of very capital-intensive ventures that can 

be very effectively started up by very small businesses that can 

grow into very big enterprises. I have in mind a growth profile in which an infusion of $100,000 might be adequate for Phase I, an additional infusion of $750,000 

might be adequate for Phase II, and then the venture capital folks 

can get involved at Phase III. But here we have, over the last 20 

years, an explosion in the biotechnology sector, for example, in 

which it is possible for folks to do great things in small companies, 

but at Phase II you need a whole lot more than $750,000 to get 

from Phase I to Phase III. 

So now what we have got, it seems to me, is a new definition 

which does not expand the resource pool at all, does not provide 

more money, but it does dramatically and all of a sudden alter the 

definition of ‘‘eligible participants’’ so as to shrink the pool of eligible people. 

Now, in terms of picking winners and losers, I have not got much 

to say about that. It is just that it seems to me, clearly, the burden 

of proof is on folks who are supporting this change in definition to 

say that it is good public policy to shrink the eligible pool of participants so as to exclude this very valuable sector of our economy that 

has grown up in the last 20 years. The text for my message comes 

from the Book of Exodus. There rose up in Egypt a king that knew 

not Joseph. 

Things change, and we have had two patterns going on simultaneously: this growth in the sector of our economy where we are 

going to have explosive growth in very small enterprises that do 

not fit the growth profile of the criteria, the amount of money you 

can get under this new definition. I sort of feel like we want to 

make sure that we continue to make it possible for folks under the 

old definition to compete for the same resources. 

Let me follow up on that. Mr. Glover, one of the explanations 

that you offered basically in defense of this new definition which 

excludes people who have been participating up until 2003 for 

Phase II money along with venture capital firms in their structure 

is that there is a place for venture capital firms in Phase III. Well, 

how do you answer the needs of start-up firms that need a whole 

lot more than the $750,000 maximum you can get in Phase II in 

order to make the jump, make the move, from Phase I to Phase III? 

It is not enough to say that venture capital firms can come in at 

Phase III if you cannot get there from here. So help me understand 

why this definition serves that sector of our economy that we want 

to grow along with others that fit the more traditional growth profile. 

23

Mr. GLOVER. Let me first clarify the definition issue because I 

think it is important. The Small Business Act and the rules and 

regulations at SBA have used the word ‘‘individual’’ to mean, in 

fact, an individual forever, and it is specifically defined in things 

like the women’s business program, the minority business program, 

the 8[a] program, and other programs. 

In 2000, for the first time, that issue came before an administrative judge at the Small Business Administration to say what is an 

individual. It was debated, it was discussed, and the decision came 

down in that case that said ‘‘individual’’ means individual; it does 

not mean a corporation or a trust or anything else. So several people challenged that decision in subsequent years. Some looked at 

specifically, ‘‘Well, gee, I am a venture capitalist, and it should not 

apply to me,’’ and the decision came down, yes, it does. It means 

what we said it did in 2000. 

So it is not like there was a rule that the SBA changed. There 

was an understanding. Now, certainly, some companies violated 

what the SBA ruling was in 2000 and 2003, but I am sure they 

were innocent and unknowing violations. But clearly, it is not like 

SBA suddenly changed something. It was the first time they were 

asked to interpret something. 

Mr. BARROW. Do not get me wrong on that. My point is that until 

that clarification came down, there were firms that fit that were 

competing along with those that meet the new definition who do 

not meet the new definition as it exists now. They were competing, 

and they were participating in the SBIR program, and they are no 

longer eligible to do so because of this clarification. I am not at all 

being critical or attacking the means that we got from here to 

there. 

My point is, up until that point, we had the different folks who 

qualified under either definition, either the earlier understanding 

or the new clarification, participating side by side and competing 

for SBIR participation. Now only one can, and my point is, how do 

you answer the needs of those folks who have now been rendered 

ineligible as a result of the new clarification? 

Mr. GLOVER. Well, the same way we rendered the needs of these 

same companies in whole bunch of areas outside of the biotech 

area. By and large, SBIR companies have not had access to venture 

capital, with the exception of some biotech areas. Half of the program goes to defense contracting. You have not heard any small 

businesses come in and complain about this rule from the defense 

sector. We do not hear noises outside of anything than really the 

biotech area. 

The challenge to find funding for your technology is the biggest 

challenge any small business has. There is no question that that 

has been there. It is well documented, and we have had some programs in the government that tried to work at that. The advanced 

technology program, the manufacturing exchange programs, to 

varying degrees, have worked at that. There is some help there. 

Obviously, getting good funding for your ideas has always be the 

biggest challenge in America, and that is what they have to work 

hard at, whether they are a venture-backed fund or not. Some 

biotech companies actually have skipped the venture capitals altogether and gone public and done quite well. 

24

Mr. BARROW. Well, I hear what you are saying, and I want to 

work with you to try and make sure that there is enough help to 

go around. The concern I got is that we now have folks who are 

no longer eligible to participate who were in a sector of the economy that clearly is an American success story that they want to 

nurture and grow. I do not want to penalize other folks who can 

compete for opportunities to participate in this program alongside 

of folks like that. 

But it looks to me like the new clarification is what is doing the 

penalizing, and to the extent we can work it out in such a way that 

we address the legitimate concerns that big businesses not be 

masquerading as small businesses and the like, and we deal with 

the problems of effective management and control being in the 

hands of the people who are really the creative inspiration for 

these enterprises. I think that meets my concerns without penalizing this sector of the economy. 

That makes me want to turn, if I may, Mr. Chairman, to Mr. 

Cruz and ask him, but I know that Mr. Michael wants to say something. 

Mr. MICHAEL. May I make a comment, please? 

Mr. BARROW. Sure. Go ahead. 

Mr. MICHAEL. One thing that is probably helpful for the Committee to understand is that although we very often talk about the 

$800 million needed to develop a drug, the NIH SBIR programs 

also support diagnostic products, they support medical devices, 

both inside and outside of the body, and many businesses can get 

started on much less than the 20, $30 million that might be needed 

to jump start, and it needs to be part of our focus. 

Mr. BARROW. No question about it. 

Mr. Chairman, if I am not trespassing on the Committee’s time, 

I hear you on that. 

Mr. Cruz, you touched briefly, and others have as well, on the 

subject of internal management and control, and I think you just 

passed on it. Can you help us understand a little bit better what 

sorts of things are actually at work in order to make sure that 

large venture capital firms are really not able to control the management of companies such as yours? 

Mr. CRUZ. There is, as was said, the legal documentation that determines sort of the voting of each of the classes of shareholders, 

and for anything large enough that would impact the direction of 

the company, there are votes necessary across the different classes 

of shareholders. So there are, as the company progresses, different 

shareholders, different venture capital that invest throughout the 

life of the company. So inherent in that is the check and balance 

of different shareholders or different funds having control or a portion of the control for changing the direction of the country. So that 

is one level. 

Another level, the board of directors is usually defined in the bylaws of the company, and that usually takes into account, again, 

the different classes of ownership,—preferred shareholders, common shareholders, and management—and that is usually negotiated between the VCs and the management team and the previous angel shareholders to make sure that there is not one single 

25

party, one person, controlling, you know, the direction of the company. 

Mr. BARROW. Thank you. 

Chairman GRAVES. Mr. Bartlett? 

Mr. BARTLETT. Thank you very much. I just wanted to clarify for 

the record. We really never changed the rules, did we? Didn’t we 

just interpret the rules? 

Mr. GLOVER. That is my review of the case law. That is correct. 

There is no change in the rule. 

Mr. BARTLETT. It is still the same rule; it is just that before, the 

definition of ‘‘individual’’ was not clearly understood, and now that 

it has been defined, that precludes firms that have more than 51 

percent venture capital funding from participating in this program. 

That is, in fact, where we are, isn’t it? 

Mr. GLOVER. Yes, sir, with the exception that it can be a small 

venture capital firm and still be eligible at even over 51 percent. 

Mr. BARTLETT. Okay. For the record, I would just like to note 

again that there is now not enough SBIR money for the good SBIR 

proposals, as the participants are now determined by the interpretation of what an ‘‘individual’’ is. If NIH had more money, they 

could give it to more good proposals. Is that correct? 

Mr. GLOVER. Yes, sir. 

Mr. BARTLETT. Okay. And it is primarily NIH money we are talking about. 

Mr. GLOVER. Yes, sir. 

Mr. BARTLETT. Okay. If you are looking at these two different 

groups of companies,—one is the really small guy who started out, 

has no meaningful venture capital funding, and the other firm that 

has had a successful project, successful to the extent that they have 

now got venture capital funding—there are two of them now, and 

each one of them has a new proposal they are coming in with, this 

is not quite a level playing field because the firm that has already 

had enough success to get venture capital funding, they now have 

a group of investors who have confidence in them. They have already indicated that they have an idea good enough that they can 

fund. 

Now, if they cannot convince those people that this next idea is 

also good enough to fund, I do not think we have quite the level 

playing field with the new firm that has no prior history and no 

venture capital funding. And again, I am very sympathetic to that 

firm that has more than one good idea. What the heck are they 

going to do with the second and the third and the fourth good idea? 

They ought to be able to get funding for that. 

But I think, Mr. Glover, you are kind of where I am. They may 

need funding but not from this pot because this well is not even 

deep enough to fund the good proposals that come in. Is that correct? 

Mr. GLOVER. That is correct. 

Mr. BARTLETT. Okay. So I think that what the Committee ought 

to be about is finding additional funds, perhaps under an additional program, so that you do not have these two not quite on the 

same playing field, so that you do not have these two groups of 

companies competing with each other. But I agree completely that 

if we are not able to fund small companies that have more than 

26

51 percent of venture capital money and a second, a third, and a 

fourth good idea, that we are limiting the opportunities for entrepreneurship and creativity in this country. But I also agree that if 

we simply open up this program to that, that there is not enough 

money to go around now. So why would we want to spread this 

money thinner over a broader field? 

I think that we have a really great argument here for a specific 

program and additional funding, and this is the kind of thing that 

the Americans and the Congress can support because you can show 

a very good return for the taxpayer’s dollar in these programs. 

Thank you, Mr. Chairman. 

Ms. VELAZQUEZ. Mr. Chairman, I just would like to work with 

you and the Committee and the people here, and maybe what we 

could do, expanding on what you were just talking about, the pot. 

What we could do is expand the amount of money, instead of going 

from 2.5 to 5 percent, that 2.5 is the ceiling. It is the base. It is 

the floor. It is not the ceiling. So why can’t we expand the program 

and then have more people participating? 

Mr. BARTLETT. My preference would be 2.5 for this program and 

2.5 for another program because they are not quite the same population of companies. They are just not quite the same. You would 

reach the same goal you want to reach, but now you do not have 

these little guys competing with the company that is already bigger, with venture capital and maybe more consultants and so forth 

that puts them on a different playing field. 

Chairman GRAVES. Mr. Doerfler? 

Mr. DOERFLER. I am not sure how long this would take, but I 

think there is a tremendous amount of urgency around this issue. 

I mentioned a letter that we put into the record by Dr. Zerhouni, 

who said that right now it ‘‘undermines NIH’s ability to award 

SBIR funds to those applicants whom we believe are most likely to 

improve human health....’’ I think that there is a concern—at least, 

I have a concern—that the level of the applicants today—the applications are not what they were a year ago or two years ago or three 

years ago, and it is affecting public health, and that is something 

we have got to address immediately. 

I also believe that there will be more data coming in from analyses at NIH and NCI that we can put more empirical information 

around this issue so it is not something that is subject to opinion, 

but it is actually subject to someone who actually is looking at 

these applications to see if the level of the quality of the application 

is actually going up, staying the same, or going down. That is, I 

believe, a critical element of what we need to do with this program. 

Chairman GRAVES. Real quick, Mr. Glover. 

Mr. GLOVER. I have not seen this particular letter, but I can tell 

you, on 20 years’ experience with the NIH on SBIR programs, they 

have been against it from the very beginning. They fought it. They 

have announced surveys and data which looked at universities and 

rated them on a five scale and rated small businesses on a four 

scale and announced we were lower. Only after we found out, did 

they have to apologize and say they were wrong. 

They have never been strongly supportive of small business at 

the National Institutes of Health, and I would look with interest 

at whatever they did based on this long-term history, not what the 

27

current people are doing. They may be doing a fine job, but I do 

know this long history, and it has been a very embarrassing situation, and they have not done their homework. 

Chairman GRAVES. Yes, real quick. 

Mr. MICHAEL. One very quick comment. Public policy should not 

be based on just what is happening today, I think. Today, there are 

many, many people who cannot get venture capital funding. The 

flow of money, certainly in the Mid-Atlantic, is not supporting a lot 

of companies, so you are left without an option. It is very impressive to meet people who have those venture capital alliances, but 

that is not the norm certainly in the Mid-Atlantic right now. So 

SBIR has become increasingly important. 

Chairman GRAVES. I want to thank all of the witnesses for being 

here today. We do have another series of votes. But this is obviously a very important issue. I appreciate hearing both sides. We 

have exposed some very good ideas. You know, America’s technology and innovation is world renowned, and we certainly want to 

do everything we can to promote that and push it forward and provide as much resources as we possibly can from all sectors. But I 

do appreciate all of the witnesses being here. This was a great 

hearing. Thank you very much. 

[Whereupon, at 4:20 p.m., the Subcommittee was adjourned.]

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