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Project Alpha Expedites Search for Ideas for a Changing Military
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http://www.mitre.org/news/digest/defense_intelligence/05_04/di_project_alpha.html
May 2004
One day unmanned military vehicles can be made to swarm like ants and strike and disable enemy targets. Robots equipped with sensors will be capable of performing most combat functions—and thus will save money and lives by marching toward the battlefields of the future. And a "space elevator" that would enable surveillance vehicles or other payloads to be sent up in space via cables will improve our knowledge of troop movements and enhance warfighting capabilities.
These feats are all just ideas at the moment, but they are not as outlandish as they may sound. Not to the members of Project Alpha. And not to the Department of Defense (DOD).
By looking into new futuristic ways of conducting war, Project Alpha, (a division within the Joint Experimentation Directorate at U.S. Joint Forces Command) is helping the U.S. armed forces adapt to changing ways of defending the country against various (and often unconventional) threats. Project Alpha teams—which consist of representatives of MITRE, the military, and private industry—are working to speed up the process by which promising ideas can be identified and presented to DOD officials.
"Project Alpha has brought new ideas into the U.S. Joint Forces Command because the teams were asked to think outside the traditional paradigm of military planning," says Shane Deichman, chief of the Concept Exploration Department at the Joint Experimentation Directorate's Joint Futures Lab in Norfolk, Virginia. "By looking beyond the horizon of current concept development efforts, they are stimulating the development of new ideas to enhance the capabilities of our future joint warfighters."
Don't look for swarming entities or soldier robots just yet, though. Project Alpha teams are focusing primarily on ideas that might be ready somewhere between 2010 and 2020, though they also consider ideas of potential use outside that time frame (either sooner or later) if they're promising enough. What differentiates Project Alpha from many research efforts is that the teams are designed to work quickly. The teams identify potentially good ideas and present them to the DOD within four or five months of starting research.
"Of course the process of taking an idea from concept to acquisition typically takes at least four years. This involves developing the concept, experimenting with it, refining and validating it, developing prototypes, and getting approval to go forward with an acquisition program," says Russell Richards, the Director of Project Alpha, who operates out of MITRE's Norfolk site. "Then the acquisition program itself adds several more years to the process. The total time to field the concept can easily exceed 10 years. Project Alpha's efforts probably will not impact the actual acquisition time, but we hope to cut the time it takes to go from concept to acquisition to two years or less."
Compressing Years into Months
Because Project Alpha teams try to compress years of work—from the discovery phase to the release of a team's Rapid Analysis Process report-into four months, there's little time to waste on ideas that aren't technically feasible or that can't be refined to help the military achieve transformation. So the first step is to sort through numerous ideas from many sources and come up with the most likely successes.
"Project Alpha is not a think tank," says Richards. "Most of the good ideas that we advance are the ideas of others. We just need to be smart enough to recognize a good idea when we see one, to pull together a case in support of the idea, and to have the energy and the passion to convince others to embrace the idea."
Project Alpha members can turn to Richards, the DOD, the Joint Concept Development teams, and the Joint Vision 2020 military transformation plan to understand the context in which their ideas must fit. The staffers, who have diverse backgrounds, get ideas from industry trends, academic research, and even popular culture. The "space elevator" idea, for example, came from Arthur C. Clarke's 1978 novel, The Fountains of Paradise. With their range of knowledge and their connections, team members can quickly find the information they need.
"Despite the small group and the short amount of time, Alpha's teams are able to fan out and get a fair amount of information collected in a short period of time," says Keith Curtis, a joint experimentation analyst with MITRE who served as team leader for two Project Alpha teams.
'A Magnet, Not a Fisherman'
Project Alpha is bringing to the forefront ideas that could impact the nation's most pressing defense challenges. Of the ideas advanced thus far, three of them address detecting, identifying, and attacking mobile targets—the area Congress directed the Joint Experimentation Directorate to focus on when it was created in 1999. In that area, Project Alpha has advanced these ideas:
Swarming entities—Emulating the swarming behavior of insects by having numerous unmanned systems, working in concert with each other, converge from several locations and strike and disable targets. The unmanned systems will indeed likely be smaller than the Predator, but they may not be. In fact, the unmanned systems could represent a variety ranging from very small unmanned aerial vehicles to Predators to ground combat vehicles or underwater vehicles. The idea of swarming has been applied to all domains—air, land, and sea.
Hard-to-get signals—Project Alpha teams are using an off-the-shelf capability to improve the ability of U.S. aircraft to detect the low-probability of intercept emissions of enemy surface to air missiles and other weapons.
Pattern recognition for time critical targeting—Building software that detects patterns in the sensor tracks of ground combat vehicles, Transporter Erector Launchers, mobile Surface-to-Air Missiles, etc. If successful, friendly forces could have an enhanced ability to determine where "hide sites," reloading facilities, and forward operating bases are located, the types of weapons involved, and possibly what the enemy's plans are.
Project Alpha teams have also pushed ideas that may aid other aspects of military transformation. The Unmanned Effects (robotics) concept, for example, involves replacing humans with robots in many scenarios, which could save lives and manpower, as the robots could do several jobs more effectively and more economically than humans. With Near-space Applications, the military could use high-altitude long loiter (HALL) balloons could provide round-the-clock surveillance and theater tactical communications. Project Alpha is exploring a cellular telephone-like capability that would utilize the HALL platform like a cell tower.
Although the implementation of these ideas is still many years away, Project Alpha's team members feel they have already contributed to transformation by setting up a system whereby good ideas can be quickly assessed and then handed off to the DOD for further development.
"I think the biggest thing Project Alpha is able to do is to validate concepts. Concepts are based on certain tenants," says Curtis. "You may not be able to validate all the tenants, but if you can pick out the key ones and in some way validate them, you know you've got a viable concept that should go forward." The DOD feels Project Alpha will be successful if the teams are fed ideas from both the top down and the bottom up.
"When I briefed Project Alpha to General William Kernan, then the four-star commander of the Joint Forces Command, I described the 'discovery' efforts of the Project Alpha teams using the metaphor of 'fishing for good ideas,'' says Richards. "He said, 'No, Project Alpha would be successful when it is more like a magnet, not a fisherman.' His implication was that ideas would flow to us without us having to go out and dig for them. And this is exactly what is happening."
—by W. Russell Woolard
High-Altitude Surveillance
http://www.geointelmag.com/geointelligence/article/articleDetail.jsp?id=109348&pageID=1
Jul 1, 2004
By: Mary Ann Stewart, Lt. Col. Kevin Frisbie, Gary Trinkle
GeoIntelligence
Pages / 1 / 2
When Per Lindstrand flew his Stratoquest to an altitude of 65,000 feet, he set the world record for the greatest height ever reached by a human in a hot-air balloon. His flight also piqued the interest of military and intelligence officials seeking near-space technology solutions that could provide persistent surveillance in an operational theater.
What if the military could deploy unmanned lighter-than-air systems in the Earth's atmosphere between 60,000 and 200,000 feet -- well above an aircraft's upper limit of 60,000 feet and well below the greater than 100,000,000-foot orbits of geosynchronous satellites? For how long could such systems hover over a single area and continuously provide communications and high-resolution information products? How large would the imagery footprint be at different altitudes -- 500 miles wide, 1,000 miles? Wouldn't the time and hardware costs of deploying near-space, high-altitude platforms be significantly less expensive than launching satellites? What if this technology could be developed largely in the private sector?
Seeking answers to such questions is exactly the task that Project Alpha has undertaken. Headed by Lt. Col. Kevin Frisbie, Project Alpha is the futures investigative arm of the U.S. Joint Forces Command (USJFCOM) Joint Experimentation Directorate (J9) and is charged with quickly identifying and examining promising innovations and civil-sector technologies that have transformational potential to the military (see "Project Alpha Promotes Jointness" sidebar). One of the topic areas being assessed by Project Alpha involves advanced high-altitude platforms -- including lighter-than-air systems (balloons), high-altitude unmanned aerial vehicles (UAVs), and hybrid systems. Known as the HALL (High Altitude, Long Loiter) program, Project Alpha's evaluation of these platforms and technologies, as well as its assessment methodology, are of active interest to USJFCOM and Department of Defense (DoD) transformation activities.
Stay and Stare
A key element of the military's interest in high-altitude-capable balloons and other platforms stems from the fact that orbital mechanics deny satellites the ability to hover -- except at an altitude of 22,300 miles above the equatorial belt (geostationary). Inexpensive, unmanned lighter-than-air systems, on the other hand, are being developed that will offer sustained operations in the Earth's stratosphere 10-30 miles above the surface. These systems are said to be high-altitude and long-loiter capable. In other words, the platforms will be able to stay and stare, or station-keep.
Station-keeping refers to the ability of a HALL platform to maintain an visual footprint for long periods of time, or in some cases, to maneuver to sustain the same stratospheric location (within 2-500 kilometers). Station-keeping effectiveness is not measured in the minutes or hours of a satellite pass, but in terms of the weeks, months, and years that the system is "on-station." Stratospheric fields of view also provide large footprints -- a 60,000-foot altitude results in a 520-mile-diameter footprint -- yielding wide coverage from a few balloons (see Figure 1).
In addition, because HALL platforms would operate in the stratosphere, they would encounter little to no traffic. The Federal Aviation Administration/International Civil Aviation Organization (FAA/ICAO) airspace ceiling is 60,000 feet; thus, the platforms would not interfere with air traffic or with NASA (National Aeronautics and Space Administration) operations. Lying above the jet stream, the area is also characterized by light winds and a marked decrease in weather effects.
"This combination of high-altitude flight and station-keeping technologies potentially provide responsiveness and persistence," stated Lt. Col. Frisbie, noting that HALL technologies are well-suited to Joint Forces concepts of persistent surveillance and continuous communications.
"Project Alpha Promotes Jointness" sidebar (Click to enlarge)
The constellations of satellites currently in use do not continuously cover every place on the globe. An incredible number of traditional satellites would be required to provide that level of surveillance, whereas a station-keeping metric of days/weeks/months for a HALL vehicle really puts meaning into the term "persistence."
The cost to launch a HALL platform versus a satellite is also significantly less. Projected costs for HALL vehicle operations vary from $1,000 to $50 million -- a fraction of the price to launch orbiting bodies or fleets of aircraft.
Trucks in Space
Currently, HALL platforms are being designed independent of payload. "One could think of them as trucks," said Gary Trinkle, the project leader for Project Alpha's investigations of HALL technologies. "The trucks don't care what goes in the payload bed . . . mass and power requirements are all the platform cares about," he elaborated.
Figure 1 (Click to enlarge). Stratospheric HALL platforms can provide persistent surveillance over large areas. The higher the vehicle is deployed, the larger the diameter of its footprint. (Courtesy of Project Alpha)
During its research, Project Alpha discovered more than 300 worldwide efforts (open-source searches) adapting HALL technology for civilian uses, mostly in the fields of communications and geolocation. The technology is of particular interest to the international cell-phone industry. Like most tactical communications systems, civil-sector wireless technologies rely on line of sight. A HALL platform could provide the equivalent of a 20-mile-high cell tower.
With wireless communications providers showing great interest in HALL platforms, the U.S. military stands to benefit from the technology advances that the commercial-sector is driving. Indeed, the U.S. Army already uses tethered balloons, which it reels in for equipment updates and component swap-out to support various operations. But what greater flexibility could be provided if DoD could shed the tether and have a balloon in place for months or even years while maintaining the ability to update technology needs?
Free-Floaters, Steered-Floaters, UAVs
The benefits afforded to DoD and military operations by HALL platforms depends on the type of vehicle, where it will be deployed, and for what purposes. In particular, HALL platforms are able to achieve persistence in one of three ways: as free-floaters, steered-floaters, or high-altitude maneuvering systems, including balloons, UAVs, and hybrids.
Category 1. Free-floaters are the most rudimentary platforms and are inexpensive. They can be deployed with minimal expense and manpower when they are planned with stratospheric wind-condition forecasts. Persistence is achieved by sending a stratospheric balloon up as needed. Before a balloon bursts or drifts out of its useful perimeter, it is feasible to launch another free-floater to replace it. The payload from a burst balloon can be either blown up or brought back to Earth on a parachute or paraglider. Free-floaters can travel as high as 160,000 feet, carry as much as 8,000 pounds, and stay afloat for as long as 700 days. No single platform, however, has achieved all of these parameters in one mission.
Although stratospheric balloons are not maneuverable and are not capable of achieving powered station-keeping, they achieve persistence nonetheless. For example, if coalition forces had launched, as Trinkle describes, "Four to 12 of these platforms with a surveillance system every day for use in Iraqi Freedom, U.S. military command could have had continuous coverage of the entire country for the duration of the conflict."
Space Data Corporation's SkySite is an example of a free-floater that has been test launched and is being developed for use by the telecommunications industry. The U.S. Patent and Trademark Office has granted Chandler, Arizona-based Space Data a broad utility patent for using this technology to provide ubiquitous wireless service to cell phones, pagers, and telemetry devices. The platform will be able to provide clear, strong wireless signals from an altitude of 100,000 feet. From that height, a single SkySite can provide service to an area the size of Oklahoma.
The unique aspect of Space Data's system is that the company developed the technology to enable the creation of an entire constellation of SkySites by controlling the altitude and the relative position of each vehicle. A constellation of only 70 SkySites could provide ubiquitous service to the entire continental United States.
A SkySite balloon costs less than $100 and carries a payload worth $400 to $500. The payloads carry light beacons and phone numbers, and have been recently outfitted with GPS technology for tracking. Payload sensors are parachuted to Earth when the balloons burst. Good tracking and labeling has resulted in 95 percent of sensors being returned.
Category 2. Because free-floating HALLs could be characterized as "drifting on the wind," they must be continually replenished to ensure persistent coverage. A more sophisticated approach envisions using a constellation of long-duration, steered platforms to ensure coverage. These platforms still generally drift with the wind, but they can be controlled with a small degree of precision by a steering mechanism. Thus, although steered-floaters are capable of station-keeping, their accuracy is insufficient for effective persistence, thereby requiring deployment in large numbers.
Sponsored by the NASA Institute of Advanced Concepts, Global Aerospace Corporation of Altadena, California, developed StratoSat -- an example of a Category 2 HALL vehicle. StratoSats use superpressure ULDBs (Ultra-Long Duration Balloons), which were developed by NASA and are manufactured by Raven Industries, that float at 115,000 feet. On a 15-kilometer tether beneath the balloon is an aerobody-like device, known as the StratoSail, that takes advantage of denser air at lower altitudes of 65,000 feet to provide trajectory control to steer the balloon. The StratoSail can also contain sensors for imaging, positioning, and communications to provide surveillance that can cover an area the size of Kansas. A constellation of StratoSats would be required for persistent coverage (see Figure 2).
Another example of a steered-floater is Pufferfish, an oversized spherical balloon produced by Techsphere Systems International of Atlanta, Georgia, and demonstrated on June 28, 2004 near Washington, D.C. This vehicle is powered by as many as four propellers, with a rudder system at the back for steering. Thin-film solar cells, turbodiesel engines, and backup generators enable the craft to rise and descend. Pufferfish can cover an area the size of the state of Virginia, but it has only plus or minus 200 kilometer station-keeping accuracy. Two or three balloons would be required for certain coverage of the state.
"Hall Specifications" sidebar (Click to enlarge)
Category 3. Even more sophisticated, persistent, and responsive HALL options being developed involve stratospheric platforms that are able to maneuver through a combination of floating and flying. The high-altitude maneuvering systems -- comprising airships, aerodynamic balloon bodies, UAVs, and hybrid systems -- are thus capable of station-keeping over specified points. They have low mass, are highly aerodynamic, and are designed to fly in low-air-density conditions that do not support traditional flight.
Helios is an example of a Category 3 HALL system. Developed by AeroVironment of Monrovia, California, in cooperation with NASA's Environmental Research Aircraft and Sensor Technology program, Helios is a large, solar-electric, flexible-wing stratospheric satellite. It has 12 small engines across its wingspan. The wing flexes in the wind like that of a bird. Helios has been tested to 96,000 feet and has been involved in demonstrations using a variety of payloads designed for stratospheric altitudes.
Lockheed Martin of Bethesda, Maryland, is also developing an advanced-concept demonstration satellite for the Missile Defense Agency and U.S. Army for station-keeping use. Lockheed Martin's craft is a dirigible designed with three or four propellers and control surfaces to facilitate high-altitude flight. This concept craft is projected for its first flight demonstration in two or three years.
In addition, the Physical Science Lab at New Mexico State University is designing the Advanced High-Altitude Aerobody (AHAB). This superpressure balloon incorporates wing-like devices to give it a sleek aerodynamic shape. AHAB is designed to offset the effects of light winds by using a porpoising technique as necessary, trading altitude for horizontal motion. The craft is made up of a series of individual cells, and helium is pumped between cells to effect movement.
Many more HALL platforms are in various stages of development. The "HALL Specifications" sidebar on page 31 overviews the technical specifications for systems mentioned here as well as several others.
Operational Hurdles
Despite many successful HALL vehicle prototypes, several hurdles still must be overcome for the platforms to achieve operational functionality. For instance, a possible downside to the HALL technology occurs when a balloon transits the troposphere. A craft designed for 30-80-knot winds in near space may not be able to traverse the winds of the jet stream, which can be as fast as 250 knots.
Fortunately, NASA has been working with launch technology for quite some time. One potentially suitable application comes from the ULDB program at Wallops Island, Virginia. NASA launches the large, 1,000-foot-diameter ULDBs in semi-inflated state. Such launches, however, require a wide-open facility because the balloons' deployments are dependent on catching the wind. Another option would be to sea-launch ULDBs from the fan tail of a large ship. A third option is to have the balloon shot ballistically in a missile. At a predetermined trajectory point, the projectile releases the balloon, which self-inflates and deploys (see Figure 3). Current proposals even consider launching a rocket to Mars to deploy a balloon with research instrumentation at the fringes of the Martian atmosphere.
Figure 3 (Click to enlarge). Because a HALL platform designed for the 30-80-knot winds in near space may not be able to traverse the 250-knot winds of the jet stream, engineers are pursuing options to deploy balloons ballistically. (Courtesy of NASA)
The Project Alpha team found that there are varying degrees of launch planning and preparation required with use of the HALL platforms. Flight safety is another major consideration. It is critical to coordinate with FAA/ICAO airspace control facilities when HALL systems will transit the troposphere. Debris from HALL platforms at the end of a mission could also be an issue.
Other technological enablers for HALL systems include on-going advancements in solar film/batteries, regenerative fuel cells, and size and weight of materials, sensors, and communications equipment.
Supporting Transformation
With the technology advancing quickly and private-sector interest high, Project Alpha envisions that HALL platforms will become complementary to satellite technology. It will be possible to add data collected from balloons to other data to obtain a complete operational picture. This enhanced information will increase the U.S. warfighter's chances of distinguishing combatants from noncombatants and assist commanders in better understanding a situation and the surrounding environment.
Joint Forces is interested in HALL technology to support a number of mission areas, including anti- and counter-terrorism surveillance; tracking of high-value assets or targets; missile defense and missile warning; battlefield command, control, communications, computers, intelligence, surveillance and reconnaissance; natural-disaster response and emergency communications; homeland security; border control; and monitoring of illegal crops. The technology can also support transformation.
Transformation is the process of changing form, nature, or function. Within the U.S. military, transformation requires adaptation of our military forces to changes in the mission-set; revision in the nature of our (military) culture and doctrine that supports those forces; and streamlining of our warfighting functions to more effectively meet the complexities of the new threats challenging our nation in the new millennium.
The U.S. military has a long tradition of experimentation. From the fleet problems of the U.S. Navy in the 1930s that birthed the concepts for the use of aircraft carriers, to the Army's famous Louisiana Maneuvers of 1941 that developed the doctrine for combined arms air/ground operations -- experimentation has been at the forefront in the evolution of military affairs.
And so it is today, in the midst of information-age warfare and challenges from a new kind of adversary -- one that claims ideas rather than a state -- our military must adapt its methods to think, plan, and respond to those that would bring harm to us. As in times past, America's innovation and ingenuity will rise to the test.
Mary Ann Stewart is principal of Mary Ann Stewart Engineering, LLC and a member of the Geospatial Information & Technology Association's Annual Program Conference Committee. U.S. Air Force Lt. Col. Kevin Frisbie is military director of Project Alpha for the U.S. Joint Forces Command Joint Experimentation Directorate. Gary Trinkle is a senior military space analyst. This article stems from Lt. Col. Frisbie's participation in the Homeland Security Plenary Panel held at the Geospatial Information & Technology Association's Annual Conference, April 25-28, 2004. He was accompanied by Christian Grant, a Project Alpha project manager. They toured the exhibit hall, attended speaker presentations about technical issues, and took time to collaborate on this article. The views expressed are those of the authors and do not necessarily reflect the position of the Department of Defense or U.S. Joint Forces Command.
It appears they are in the same business lines as we are.
No Borders, Inc. Enters into Memorandum of Understanding for Acquisition of Remittance Company
Tuesday December 21, 9:55 am ET
LOS ANGELES--(BUSINESS WIRE)--Dec. 21, 2004--No Borders, Inc., (OTCBB: NBDR - News), a Nevada Corporation, announced today that it has executed a Memorandum of Understanding to acquire 100% of the common stock of Samso's Express Money Transfer, Inc., a Florida corporation. The MOU establishes a schedule which calls for negotiations of the precise terms of the acquisition to be finalized for a closing of the transaction to occur on or before the end of February, 2005. The MOU further provides that the current President and founder of Samso's, Mr. S.M. Hussein Haniff, will be engaged as No Borders' Chief Financial Officer and at the same time continue as President of Samso's which will operate as a wholly owned subsidiary of No Borders. The MOU establishes an additional schedule which calls for negotiations of the terms of Mr. Haniff's employment agreement with No Borders to be completed so that his services could commence in January, 2005
ADVERTISEMENT
Samso's is licensed as a money transmitter in California, New York, Texas, Minnesota, Florida, Georgia and Arizona, and has operations in South Carolina (where no license is required). Samso's currently sends in excess of 11,000 wires or remittances per month, has over 170 agents/delegates in the U.S., and has in excess of 6,000 payout points in Mexico, South America, and the Caribbean. The company maintains high-tech systems and information management technologies, including: a high volume, flexible, real time application processing system which enhances the initiation process; a decision support system which makes available detailed agent information and customer/beneficiary information for anti-money laundering, trend and performance analysis and on-line information procedures for customer service representatives.
Mr. Haniff, the President and founder of Samso's has an extensive background in the remittance business, accounting, banking, corporate turn-around, international trading (North America and the Caribbean), and is a Certified Public Accountant, with membership in the American Institute of Certified Public Accountants and the Florida Institute of Certified Public Accountants.
No Borders is in the business of providing a debit and stored value card platform through which a variety of financial and commercial services and products can be offered to residents of developing countries and to immigrants from those countries who reside in the United States and send money back home on a regular basis. No Borders offers significantly lower cost money transfers and long distance telephone services, initially focusing on Mexico, El Salvador and Ecuador... According to Inter-American Development Bank, Latin American immigrants in the US sent back home an estimated close to $40 Billion in 2003, and that growth for 2004, is expected to increase by over 20% The Company believes that it will accelerate its penetration into this growing market, first by reducing the excessive costs currently charged to the consumer, and second by offering a full range of financial and commercial services and products to this emerging transnational market, at significantly lower prices.
Dr. Raul Hinojosa, a co-founder, President and Chairman of No Borders, is a Professor of Public Policy at UCLA and a leading authority on the subject of the economic integration between the United States and Latin America. Dr. Hinojosa states, "Our business plan established our intent to acquire a number of companies providing money transfer services, targeting those companies which satisfy four very specific components: the company generates meaningful revenue and has increased the number of remittance transactions annually during the last two to three years; the company's deployment of our Stored Value Card Platform would facilitate a reduction in operating costs and at the same time add to its revenue generating opportunities, thus accelerating its projected rate of annual increases in market penetration and its projected rate of annual increases in revenue and profitability; and the company's current customer base includes residents of transnational communities in areas outside of Latin America; and lastly, one or more of the company's senior management personnel would add value to No Borders' own management team. Samso's satisfies each of those requirements."
Dr Hinojosa continued by stating "In following our business plan, we are currently in discussions involving the acquisition of a number of additional companies in the remittance business. It is rewarding to find that these companies like Samso's, see the value of our technology Platform and our overall business and marketing models."
For further information, contact Al Kau, Investor Relations in California at (888) 795-3166.
Certain statements in this release and other written or oral statements made by or behalf of the company are "forward looking statements" within the meaning of the federal securities laws. Statements regarding future events and developments and our future performance, as well as management's expectations, beliefs, plans estimates or projections relating to the future are forward-looking statements within the meaning of these laws. Moreover there is no guarantee that the acquisition of Samso's or that an employment agreement with Mr. Haniff will be consummated by No Borders, Inc... The forward looking statements are subject to a number of risks and uncertainties including market acceptance of the company's services and projects and the company's continued access to capital and other risks and uncertainties outlined in its filings with the Securities and Exchange Commission, which are incorporated herein by reference. The actual results the company achieves may differ materially from any forward-looking statements due to such risks and uncertainties. These statements are based on our current expectations and speak only as of the of the date of such statements. The company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of future events, new information or otherwise.
--------------------------------------------------------------------------------
Contact:
No Borders, Inc.
Al Kau, 888-795-3166
A Little Commentary
12.30.2004
http://www.pff.org/weblog/
2004 and the Digital Broadband Migration
'04 is almost over. How will it be remembered, for the purposes of this space? We’re gonna need a montage…
We’re #11 in broadband deployment! “Going Phishing” now has a far more sinister connotation than following a certain band from Vermont. Rural ILECs do pretty well with your universal service dollars, thank you. The NextWave saga ends. We’re #13 in broadband deployment! Goodbye UNE-P, hello VoIP. Broadband trumps dial-up. The Intercarrier Compensation forum. Cable a la carte. The pulver.com Order. The Vonage Order. The FCC Kidzone. BPL trials. WiMax trials. Stratellite trials. USTA II. Brand X. Muni Broadband. Triple play. ‘Net Freedom. ‘Net Neutrality. Nipple brooches. NARUC. FTTP. FTTC. Fios. VOD. DVRs. IPods. Skype. Google. Duke loses to UConn. Fade to black.
Of course, what’s a proper end-of-year retrospective without some sort of award. After consideration of several worthy nominees, the Rentseeker of the Year recipient is...
The Parents’ Television Council. Even if they are anywhere close to reportedly backing 99.8% of the indecency complaints filed at the FCC this year, this is an impressive display of rentseeking behavior. A few weeks ago, I wondered what broadcast programming would consistently look like should the PTVC run the table, and then I saw an ad for a holiday music spectacular starring Clay Aiken and Barry Manilow. That seemed about right.
Now, on to 2005. In its Top Ten Trends for 2005, Red Herring anticipates “The Death of Distance.” (David Isenberg properly blasts this header by stating that “distance is so dead its corpse stinks.”) If Red Herring can pass off forward-looking statements like this to paid subscribers, I can pass off ridiculous forward-looking statements to web surfers. Bust out the crystal ball.
1. “Stevens & Inouye” will rival Hall & Oates. Get your “Telecom reform listening tour” shirts before they’re sold out! Public hearings like these always draw the most interesting (and self-interested) people. And speaking of Hall & Oates...
2. Air Supply to headline the Aspen Summit. Maybe not, but I was quite envious to learn that Heart will be participating at an upcoming VON conference, which continues to add verve to the conference template. So, perhaps we can have our own 80's revival. Ice cream break featuring Journey? Happy hour featuring Tears for Fears? I am very serious about this.
3. President Bush will not utter the word “broadband” in public. It was worth a few points for both presidential candidates to throw out some general ideas on broadband deployment, but the Administration hasn’t shown that it is really serious about it. Had Kerry won, his name probably would have been inserted here instead. Just playing the odds.
4. Cell phone use on airplanes will be one of the most important communications issues…for public consumption. It has already begun. The FCC has posted instructions on its home page for the public to comment on the issue – which is unconventional. Leaving no stone unturned, Commissioner Copps seeks “to determine precisely what jurisdiction the FCC has over the annoying-seatmate issue." First off, the no brainer here would be the value added for users of data applications. And while I, too, worry about the annoying-seatmate, to the extent this adds yet one more option for a seatmate to be annoying, I would think that the issue can be worked out in the market.
Happy New Year to you, PFF blog readers, and to all of the folks at PFF.
- posted by Adam @ 12/30/2004 10:48:07 AM
Sunday, December 19, 2004
http://www.bloglines.com/citations?siteid=34002&itemid=653
It looks like an idea I was pitching to telecom companies back in the mid nineties is starting to gain traction. High altitude blimps. They operate at altitudes above weather paterns (which makes it easy for long-duration station keeping). At 1/27 th of the distance of a LEO satellite, these systems can easily connect to low power hand held systems and provide extremely high resolution images without expensive equipment.
IT'S A BIRD! IT'S A PLANE! IT'S A ... STRATELLITE?
http://www.defensetech.org/archives/001284.html
Ok, full disclosure: I pinched that headline from Wired.
Engadget notes that GlobeTel Communications of Ft. Lauderdale is on target to launch a prototype Stratellite early next year.
GlobeTel plans a constellation of the airships--I know you did not just call them baloons--to provide wireless services like WiFi, cellular and HDTV. GlobeTel managed to get The Economist to run a puff piece on the technology, declaring the impending death of the communications satellite industry. Engadget was skeptical, noting that GlobeTel "hasn't released any photos of the airship" and the press release "includes the usual legalese disclaimers about 'forward-looking statements'. So, we may have to wait a while to see if this is real, or if they're just full of hot air."
The whole fiery demise of the Hindenberg-thing gave blimps a bad name, so The Economist is right to take seriously today's airships, which bear little resemblance to their mid-century ancestors. The Defense Department, in particular, is considering High Altitude Airships for a variety of missions and developed a prototype solar powered airship that can fly untethered at 70,000 feet altitude with 4,000 pounds of communication and surveillance payload.
There are varying amounts of money in something like 11 seperate program elements in the budget for research and development for missions ranging from tactical communications to ballistic missile defense missions. Airships would also be a candidate platform, along with uninhabited aerial vehicles, for a constalltion of "psuedolites" to provide localized, jam-resistant GPS signals. DARPA even gets a giggle for naming its heavy lift airship ... the Walrus.
--Jeffrey Lewis
Get Your Wireless Broadband By Stratellite (before GTEL)
Contributed by Mike on Monday, December 23rd, 2002 @ 02:52PM
from the your-internet-floating-overhead dept.
There have been various attempts at offering both satellite internet feeds and fixed wirelss feeds, both of which have met with varying degrees of failure. While some have survived, none have really caught on the way the companies provided them hoped they would. Now, some companies are getting ready to combine those two ideas to try to create wireless broadband internet connections that really work. The idea is to put floating platforms up in the sky. They won't be out in space, though, they'll be up pretty damn high, so they're considered "stratellites" instead of satellites. Backers say this creates the best of both worlds, since it gets much wider coverage, while still providing fast connections. They say it can be used for any type of wireless application from basic internet access to a better system for providing 3G mobile phone service. They even plan to offer WiFi connections to consumers, which could put a damper on Cometa's hotspot plans. I still wonder, though, about the latency issue, which is the biggest complaint when it comes to satellite internet services. There's also a big question about cost. As Iridium showed, launching things into space (or near space, at least) can be a bit costly if you can't find a business model to support things.
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I used to work for Iridium
by dorpus () on Tuesday, December 24th, 2002 @ 03:37AM
Stratellites make far more sense in many ways:
1. Far cheaper to launch, maintain, and upgrade than satellites
2. Don't need a huge ugly brick antenna, since stratellites are an order of magnitude closer.
3. Latency won't be as bad, due to closer distances. Just interface with existing land lines for out-of-area calls.
Yeah, Iridium. People there said that Motorola didn't plan to make money on it; it was their way of getting into the satellite business. They were going to launch an "Iridium II." Iridium's 2,400 baud, $5/min connection, anyone?
Back then, Motorola was obsessed with "six-sigma" engineering and "metrics". No leadership, no common sense. The project started in Arizona, where they made the satellites and everything, and it should have stayed there. But Motorola wanted to curry favor with the government so they opened the MCF facility in Leesburg, VA. The (mostly) Texans who worked for Iridium hated living in Virginia. They spent millions on making this physically secure facility, where even the bathroom required a 4-digit code to be punched in. The doors had no windows so people would get smacked often. They made a big deal about "tailgating" -- you weren't supposed to follow someone else in. But then, there were only 4 unix accounts for the whole facility, and everyone knew all the passwords. They had a $10 million triply redundant electrical system, but it would have been easy for rats to chew the wire and blow it to hell anyway. And the wonder of technology called Sun workstations that had to be rebooted every time the keyboards got unplugged, which was a daily occurrence due to the shape of the console desks.
May have been posted.
http://www.apcmag.com/apc/v3.nsf/0/6C5D02F49AEC9267CA256F1E00120D7A
Thursday 30, September 2004
By APC Staff
Imagine what the Internet would be like without your clunky Net connection — no lag, no dropouts, no grainy streaming media. For a select few experimenting with futuristic broadband at speeds most of us can only dream about, this is already a reality.
This article is featured in APC September 2004 Back issues
SubscribeAt the Drysden Flight Centre in California’s Mojave Desert, the testing ground for unmanned predator drones and lunar landing vehicles, scientists are putting theories into practice. Beyond the clapped-out freighters and jumbos, you’ll find the wildest idea yet for high-speed Internet delivery. Designed as a “stratospheric” aircraft, the Proteus is capable of climbing to well over 50,000ft and has a cruise speed of mach 0.42. Oh yeah, and it also delivers your email.
Or at least it could, if the idea ever got off the ground. Proteus is just one of dozens of ideas — some outrageous, some close to fruition — designed to deliver broadband to homes and businesses so fast it will make ADSL and even cable modems seem snail-like by comparison. From tapping into the electricity grid to huge floating blimps and super-fast wireless and optic fibre, engineers are building networks capable of delivering everything from high definition video to virtual gaming worlds.
Sky high
The idea behind Proteus is truly pulled from the pages of Bold Entrepreneurial Experiments 101. First built in 1997/98 by jet designer Burt Rutan, who also helped design the cutting-edge SpaceshipOne prototype, Proteus was designed as a high altitude cross between a crop duster and a communications tower.
Flying at heights of up to 65,000ft, the plane could theoretically beam down data from its 18ft-wide antennae while flying a fixed pattern above major cities. Proteus is certainly capable of providing extremely fast connections: in demonstrations the Proteus team achieved a 52Mbit/s link for video conferencing, file transfers up to 7MB and Web browsing. They even tested a phone call while the “bird” flew overhead. By the calculations of the Proteus team, it would take only 16 seconds to transmit a 100,000 page document compared with seven hours using a 28.8Kbit/s modem, the standard technology at that time.
Marc Arnold, the CEO of backing company Angel, was keen to talk up the possibilities of the system, which the firm had dubbed HALO. “The HALO Network will provide high-speed broadband services over an area encompassing a typically large US metropolitan area, enabling individual consumers and businesses to send and receive data at multi-megabit per second rates,” Arnold enthused at the time. “HALO Network services will be replicated over metropolitan centres throughout the world.”
Sadly, geek dreams of squadrons of bandwidth-supplying jets circling overhead haven’t been realised. The idea has been stuck on the runway for years while Proteus has found other work collecting atmospheric samples for scientists, or testing collision avoidance systems.
But that’s not to say dreams of mega-speed Web downloads are over. Challenging Proteus for sheer audacity is the Stratellite, a giant airship that uses solar powered engines to sit at about 65,000ft, beaming data over a radius of about 77,700 square kilometres — think blimp meets mobile phone tower.
The Stratellite, which has been developed by a company called Sanswire, is 74.6m long, 44.2m high, and contains nearly 37 million litres of gas. Made of Kevlar, the dirigible is powered by electric motors and held in a position determined by six GPS units. In addition to Internet data, it can be fitted for mobile phone transmission, paging, fixed wireless telephony and high definition TV broadcasts. The downside is that the Stratellite can only sustain 18 months in the air without repairs.
It’s also cumbersome, but the blimp’s advantage over satellites is that it sits much lower to the ground, so it theoretically doesn’t suffer from the same data lag problems. The initial plan is to use one unmanned blimp to cover each metropolitan city.
“Our subscribers will be able to sit in their home on a laptop computer while connected to the Internet at high speed,” says Stratellite’s Web site (www.stratellite.net). “If they need to travel to another city, they simply take their laptop. . . and when they get to where they are going, they open their laptop again and they are still connected. No more finding local access numbers. No more tying up phone lines.”
Of course, getting government permission to launch giant communications balloons isn’t easy, though Sanswire reckons it is on track in the US to eventually cover the whole country and is reportedly discussing plans to bring the concept to Australia.
Light fantastic
While these wireless systems are attracting their share of sceptics, one high-speed technology is beginning to make its way off the drawing board. For decades, optic fibre was a plaything of scientists and corporations with budgets in the millions. Now it’s coming to homes.
Optic fibres are not new. Because of their reliability over long distances, the hair-thin glass tubes have been favoured by the telecom industry since the 1970s. Fibre also scales extremely well and can already deliver 40Gbit/s (science knows of no upper limit). To date, most applications of optical fibre have been in network backbones, undersea cables and other high traffic routes, largely because the equipment needed to run a fibre network has been expensive and complex to operate.
But while much demand for speedy home Internet is being met with ADSL, which has an impressive roadmap for greater bandwidth and is today’s dominant broadband medium, it’s really little better than a clever hack that squeezes extra performance from the copper wires that everyone in the telecommunications industry admits must eventually be replaced. Alternative delivery mechanisms such as cable TV networks also have promise, and wireless offers another way to boost the bandwidth available to your home. None, however, offer the bandwidth, longevity, reliability and flexibility of optic fibre.
The speeds are phenomenal. Fibre can theoretically deliver 100Mbit/s downloads, 400 times the average rate of DSL services. Best of all, there’s every chance that the connection will get faster over time.
One of the first companies to deliver optic fibre in Australia is Bright Telecommunications (www.brightonline.com.au). Bright’s service is currently available in Perth only, and while it can theoretically offer up to 100Mbit/s to each of the 200,000 homes in its coverage area, it restricts rates. A number of packages offering speeds between 100Kbit/s and 1Mbit/s and download limits from 1GB to 40GB, priced between $34.50 and $110 per month, are available. Customers can receive a bundle of Internet access, pay television and voice telephony over the two fibres.
Optic fibre allows users to drag down huge files as if they were kilobytes, not megabytes. “There’s a 34[MB file],” says Perth architect Mal Birch, trawling through his email client for some of the larger CAD files he sends home when he needs to catch up on work. “File size just isn’t a consideration any more.”
Before long, even 34MB may mean nothing to Birch, whose Internet connection already has enough bandwidth to permit him to experience fully rendered 3D representations of the buildings he designs in real time. His connection could also allow him to converse with avatars of his clients in the virtual world he creates, complete with realistic location-based sound and even physical feedback.
Australia currently has at least three fibre to the home (FTTH) projects underway. Telstra is working on an FTTH trial at Brookwater Estate, Greater Springfield, a new housing estate on the outskirts of Brisbane. The trial will include bundles of pay television, telephone and Net access, although Telstra will throttle back on fibre’s capacity in order to provide services that approximate today’s cable and ADSL offerings — no point in blowing all that capacity just yet.
Australia’s other notable fibre network is in Canberra, where TransACT Communications operates “fibre to the kerb”, an arrangement that sees the section between the home and fibre connection served with copper wire. The company’s service is capable of delivering 36Mbit/s downstream and 1.6Mbit/s upstream and includes pay television and a phone service, though once again speeds are restricted to a maximum of 1Mbit/s. There are three packages ranging in price from $59.95 to $83.45.
Similar bundles will doubtless emerge in the near future as more fibre, and other fast networks, are installed around Australia. And the networks will almost certainly get faster too as the technical difficulties that currently constrain speeds are solved.
MILITARY INTELLIGENCE
So will anyone need this capacity? Alcatel’s director of innovation, Geoff Hayden, thinks high-speed networks aren’t so far-fetched.
“Fifteen to 20 years ago, the defence sector had large screen projection systems. Now we see them at affordable prices in the mass market,” he says, advancing a theory that military technologies take 15 to 20 years to become mainstream. “One of the things we see in defence now is ‘heads-up’ displays and holographic displays. I think it is entirely reasonable to say that we will have those in the year 2020, and they will need 100Mbit/s connections to deliver content to the home.
“Over the last 20 years we have migrated from power users having 300 baud modems to today’s broadband offerings,” he continues. “If you extrapolate that trend out to 2020 you get 1Gbit/s connections to the home.”
Of course, it’s hard to predict what those services will be. “Around 75% of all applications on FTTH networks will be based on video communication,” says communications analyst Paul Budde. “We are video-driven beings. Some 75% of video will be one-to-one private communications, the rest will be video- and audio-on-demand — services we can buy.”
That same bandwidth will also change the personal computing experience by making online access to applications a much better experience, Budde says. “Seventy to 80% of apps won’t be run by you any more and you won’t have to worry about viruses and so on.”
POWER LINES FOR POWER USERS?
Another broadband technology that has failed to set the world alight is sending broadband over power lines. Tested in various countries, the idea has met with mixed success, partly because ham radio enthusiasts caused an end to some trials which interfered with their radio sets. Well, it sounded like a good idea.
But with broadband becoming an obsession for techies alongside CPU speeds and high definition TV, it won’t be long before someone comes up with another idea to takeits place.
Stratellite/Military
The military need the stratellite platform to fill a surveillance gap since we have now live in an era of unconventional warfare. Although the Predator can be deployed
anywhere, it is are limited in time on station and payload not to mention the cost. Also they can and have been shot down. Although the Stratellite and similar platforms can be taken down, it would take an aircraft (air-to-air missile) or surface-to-air missile to do so once it is on station. There is already developmental contracts with defense contrators, so we know they want it. How bad do they want it. IMO like yesterday. When the launch takes place IMO the pentagon, the White House, NSA, CIA, DIA and of course the rest of the world will be watching. What the CEO said sometime ago "this technology will change the face of telecommunications" has much truth to it. It is not as cut and dry as it appears and the CEO has his work cut out. Dealing with the government can be nerve wracking and the need for sharp lawyers is absolutely a must. I once lived in a walled city (Berlin) for a few years and now that city is no longer walled. Remember a few years back how big cell phones were. Times have changed and will continue to change. I enjoyed my intell running days and this GTEL has me spinning and grinning like the good old days.
Peace
and
Merry Christmas
"In God We Trust All Others We Monitor"
Doctors' Prescriptions Get Personal
Genetic Testing Helps Predict Whether A Drug Will Be Effective, But Brings Hard Choices
http://www.ctnow.com/news/cusom/newsat3/hc-personalizedmed1019.
artoct19,1,4651057.story?coll=hc-headlines-newsat3
October 19, 2003
By WILLIAM HATHAWAY, Courant Staff Writer
A desperate parent of a child with attention deficit disorder now can get a genetic test that may help a doctor determine the optimal dose of a promising new drug.
Hartford Hospital is developing a similar test that will help predict whether an asthma patient is likely to be helped at all by commonly prescribed medications.
Oncologists already can test the genes of some cancer patients to predict who will benefit from powerful new drugs and who won't.
The long-predicted era of personalized medicine has arrived. Even simple new DNA tests have the potential to save thousands of lives lost to adverse drug reactions. Limiting prescriptions of drugs that don't work and identifying potentially dangerous drugs early in their development could save billions of dollars in health care costs each year.
Such a revolutionary change in medicine poses a host of questions in search of answers. Should new drugs be denied to desperate patients who, because of their genetic makeup, are unlikely to benefit from them? Are small risks of adverse side effects from some drugs great enough to justify the cost of genetic tests? Will the development of new drugs be delayed because such tests might not be available to identify those who might be harmed by them?
"Everybody is watching to see who can make it work," said Gillian Woollett, vice president for science and regulatory affairs at the Biotechnology Industry Organization, which has followed the issue closely.
Doctors have long known that people exhibit a wide variety of reactions to the same drugs. The revolution in genetics holds the promise that one day medical therapies might be customized to individual patients.
However, major advances in personalized medicine have been slow in coming, in part because scientists still are struggling to understand the root causes of many diseases. The goal is not only to identify the individuals who will respond best to existing drugs, but also to design new drugs that will work best given the genetic makeup of individuals.
For instance, doctors still do not understand exactly why existing drugs seem to alleviate symptoms of many brain diseases, such as schizophrenia, depression or attention deficit/hyperactivity disorder. To their great frustration, doctors can spend months or even years trying to figure out the right drug and dose for a patient.
"It's a huge problem. I can't tell you which person will respond better to certain medications," said Dr. Robert Sahl, assistant medical director of child and adolescent psychiatry at the Institute of Living in Hartford.
Sometimes the variation in the response to drugs costs patients more than misery, money and inconvenience. Adverse drug reactions cause more than 100,000 deaths in the United States annually.
These adverse reactions have various causes, but doctors and drug companies have known about one factor for decades: People metabolize drugs differently.
Metabolic Differences
Identifying those individual metabolic differences has become the first wave of personalized medicine to hit medicine's mainstream.
People have variations in their liver enzymes that determine how much of a drug will reach its intended target. For instance, among a large family of liver enzymes known as cytochrome P-450s, one - CYP2D6 - is involved in metabolizing about a quarter of all drugs.
Most people are "extensive" metabolizers - they process most active ingredients of a drug in the liver, allowing only small amounts to escape and reach their intended target. However, about 7 percent of Caucasians lack the CYP2D6 enzyme and are known to be poor metabolizers: They let much more of a drug's ingredients pass intact through the liver. Members of this group in theory are at higher risk of adverse side effects because they receive a higher active dose of the medicine.
Poor metabolism has been implicated in adverse side effects of some anti-psychotic drugs and in other effects, such as nullifying the benefits derived from codeine. Also, many anti-depressants inhibit CYP2D6 action, in effect turning "extensive" metabolizers into poor metabolizers, a fact that has led to at least one lawsuit. The suit claimed that genetic variations led to an overdose of Prozac and the suicide of a depressed adolescent.
There are also a smaller number of "hyper-metabolizers," who allow little or none of a drug to reach its target. These patients may receive little or no benefit from many drug treatments.
With the approval of Eli Lilly's drug Strattera in November 2002, the U.S. Food and Drug Administration for the first time ordered that metabolic information should be shared with the public. Billed as the first non-stimulant to treat attention deficit/hyperactivity disorder, Strattera is also the first drug packaged with information about how people with different metabolisms respond to the medication. Also included with Strattera's labeling is a note that genetic tests are available to identify poor responders.
Clinical trial results on Strattera did show that compared to extensive metabolizers, poor metabolizers had an elevated risk for several adverse side effects, including decreased appetite, insomnia and depression.
So why wouldn't patients and doctors demand genetic tests that identify metabolic status? asks Dr. Gualberto Ruano, the scientific founder ofGenaissance Pharmaceuticals, a New Haven pharmacogenomics company, and founder of Genomas, a new biotechnology company.
"I submit that if you want the state-of-the-art treatment for attention deficit disorder, you should have the metabolic state of your child analyzed," Ruano said.
However, the value of such genetic tests is not cut and dried, say Eli Lilly scientists who developed Strattera.
No statistically significant link between poor metabolizers and a serious medical ailment was found during trials of Strattera, said Dr. David Michelson, senior medical director of Lilly Research Laboratories at Eli Lilly.
Requesting genetic tests for metabolism might make sense when the risk of a serious side effect is high, but would be of limited or no value with a safe drug like Strattera, Michelson said.
In other words, is it worth paying $100 for a test to see if a child with attention deficit disorder has a slightly higher chance of having decreased appetite?
Officials at Hartford Hospital believe that as a new generation of drugs is approved, and more is learned about genetic influences on their safety and efficacy, more doctors will demand that their patients get such tests.
These new genetic tests will not reveal underlying health risks that might become a privacy concern, but will home in on specific physiological responses, said Gregory Tsongalis, director of molecular pathology at Hartford Hospital.
"I can't stress enough that we aren't talking about tests that will tell you anything about the disease or whether you are predisposed to disease," Tsongalis said. "If it is on the label, we think it will be almost a requirement that doctors ask for these tests."
Relief Or Crushed Hopes
Hartford Hospital is part of a consortium of hospital and university laboratories that are collaborating to develop new tests capable of detecting important genetic variations among patients. The tests will help predict adverse drug episodes and the potential efficacy of the drugs.
"We want to develop some simple tests to prepare for what we think will be a big transition in how people prescribe medicine," Tsongalis said.
For instance, he said, Puerto Ricans are more likely to have a genetic variation that makes them respond poorly to a family of drugs known as beta agonists, which are commonly prescribed asthma medications.
The savings from eliminating worthless prescriptions of drugs to non-responders could "be gigantic," he said. "Why take it if it won't do any good?"
However, that question may not be so easy if the disease is cancer.
Patients with some types of cancer are already among the first to experience the relief - or crushed hope - of having a genetic test that can determine whether or not they will benefit from a lifesaving drug.
The breast cancer drug Herceptin approved in 1998 was designed to combat metastatic breast cancer, which overproduces the HER2 protein. Genetic tests can identify the 20 percent of breast cancer patients who are good candidates for treatment with Herceptin - and the 80 percent who aren't.
New cancer drugs also are being developed that target known genetic abnormalities in tumors - which means new tests can be developed to determine who will best benefit.
But those tests cannot say with certainty that a patient with a genetic makeup that is a poor match will receive no benefit from a new cancer therapy.
"If there is a lower probability of success, but no other therapies [are] available, do you deny the patient treatment?" said Woollett of the Biotechnology Industry Organization.
New Era, New Rules
That is only one of many questions that have drug companies and biotechnology firms both hopeful and leery about advances in personalized medicine.
Pharmaceutical companies in theory at least can save tens of millions of dollars in drug development costs by using genomic data to quickly identify groups of people with gene types that put them at high risk of having adverse side effects or unlikely to respond to the medication.
On the other hand, drug companies are also concerned about being forced to share genomic data with competing companies seeking to develop similar drugs, Woollett said.
Pharmaceutical companies also want to make sure that approvals of some drugs not be held up because genetic tests aren't yet available to identify poor responders. It is also not clear whether insurance companies will pay for the new generation of genetic tests, she said.
The FDA has scheduled a November meeting in Washington to begin to formulate guidelines for sharing genomic data and other questions raised by drug companies.
In many ways, the regulatory issues that arise from the advent of personalized medicine are no different than those already facing federal regulators, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
With or without genetic information, regulators must balance the potential benefits of new therapies against potential risk, she said.
"I don't believe this will be as challenging as some people believe," Woodcock said. "We've been doing this for a very long time."
No matter what guidelines the FDA eventually adopts, personalized medicine is here to stay, she predicted.
"I think the curve will be slow and flat at first and then really take off," Woodcock said. "And we're on it."