The R&D Tax Credit Aspects of Cryogenics



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Cryogenics
        Recent developments in cryogenics research have shed light on a promising duet: low temperature, high performance. Capable of modifying the physical properties of various materials, preserving living systems, and controlling temperature during a wide range of industrial processes, cryogenic systems can serve as the basis for innovation in a virtually unlimited number of areas. The present article will discuss the potential applications of extremely low temperatures and present the R&D tax credit opportunities available for companies investing in cryogenics.

The Research & Development Tax Credit

        Enacted in 1981, the Federal Research and Development (R&D) Tax Credit allows a credit of up to 13 percent of eligible spending for new and improved products and processes. Qualified research must meet the following four criteria:

  • New or improved products, processes, or software
  • Technological in nature
  • Elimination of uncertainty
  • Process of experimentation

        Eligible costs include employee wages, cost of supplies, cost of testing, contract research expenses, and costs associated with developing a patent. On December 18, 2015 President Obama signed the bill making the R&D Tax Credit permanent.  Beginning in 2016, the R&D credit can be used to offset Alternative Minimum tax and startup businesses can utilize the credit against $250,000 per year in payroll taxes.


Cryogenic Research & Cryopreservation

        Cryogenics is the science that studies the production and application of very low temperatures. Cryogenic temperatures are significantly lower than those normally experienced in everyday physical events, usually ranging from -238°F to absolute zero, or approximately -460°F - a theoretical temperature at which molecules reach their lowest energy state.

        Temperature reduction has two contradictory effects. On the one hand, there is a decline in the rate of deterioration of biological systems. On the other hand, however, there is an increase in their rate of destruction, as the same systems lose their abilities to sustain self-maintenance functions. Designed for surviving at higher temperatures, living systems are susceptible to low-temperature injuries, which can include phase changes in membrane lipids or cold-induced protein denaturation. These kinds of destructive effects are limited to a range of hazardous subzero temperatures, variable to each system, beyond which preservation effects predominate. Cryobiological preservation technologies aim to limit the damaging effects of low temperatures during cooling as a means to letting the protective effects of even lower temperatures to prevail.
 
        In other words, cryogenics intends to explore the benefits of low temperatures while protecting cells from freezing and thawing damage. It does so through a process called vitrification, which is based on the fact that temperature is a measure of internal energy in physical systems and indicates the intensity of molecular motion. In most systems, reduced temperatures are accompanied by decreased molecular mobility, which leads to solidification. Other systems, however, do not experience solidification even at extremely low temperatures. Instead, they loose fluidity through a process called vitrification and become “solid liquids”, also known as “glasses”. After reaching glass-transition temperatures, these systems remain liquid but their molecular arrangements stay virtually unchanged.

        In systems that do not vitrify naturally, the process is made possible by an extremely fast drop in temperature combined with high concentrations of cryoprotective agents, as explained by Fontana, California-based 21st Century Medicine (21CM): “When a cell is permeated by cryoprotectants in concentrations high enough to allow for vitrification, all of the cell’s molecular constituents become locked into the glass as it forms and therefore become unable to change over time.”  

        Vitrification is key to avoiding the potential damages of ice formation, as it allows water, which normally freezes, to vitrify. It is a well-known fact that water expands when it freezes. This gain in volume can have several damaging consequences to adjacent tissues, such as the mechanical disruption of extracellular structures. Since most living systems contain water, preventing ice formation is crucial to taking advantage of the protective effects of low temperatures while preserving the system’s viability.

    Cryopreservation is already used for some medical purposes, including the preservation of sperm, red blood cells, and even early-stage embryos. Future applications could revolutionize the worlds of drug discovery and organ transplantation, as discussed below:


Cryopreservation and Drug Development
        For biopharmaceutical companies, cryopreserved tissues can extend the viable period in which to test investigational treatments. Cryopreservation technology is particularly helpful when it comes to absorption, distribution, metabolism, excretion (ADME), and toxicology studies, which are used to define how a drug compound interacts with the body. So-called ADME/Toxicology profiles are traditionally constructed using any number of in vitro and in vivo model systems, which are generally unstable, expensive, poorly preserved, and unfit to be kept in inventory. Even though billions of dollars are spent in ADME/Toxicology profiles every year, inaccuracies in these studies are among the most common causes of failure for new drug candidates. According to the U.S. Food and Drug Administration, liver toxicity is the leading cause for discontinuation of clinical trials as well as for the withdrawal of drugs from the marketplace.  

        Aiming to optimize costs and accuracy of ADME/Toxicology studies, various innovative companies are working on cryopreserved liver slices that reproduce in vivo human hepatic function. Achieving consistent cell quality upon thawing remains, however, remains a challenge. American multinational biotechnology company Thermo Fischer Scientific, for instance, provides ready-to-use human and animal cryopreserved hepatocytes for in vitro metabolism testing. Cryogenics allows for high viabilities, in vivo-like enzyme expression levels, and proper cell morphology, which opens the way for more accurate in vitro/in vivo correlations. The company underlines that, if properly stored, cryopreserved hepatocytes remain viable for several years, making them ideal for series of experiments.  

        Cryopreservation is also important to enable the development of “organs-on-a-chip”, a groundbreaking technology that is expected to allow for significantly more accurate predictions of drug responses than those provided by commonly used cell culture systems and animal models. “Organs-on-a-chip” consist of microfluidic chambers containing human cells cultured under conditions that mimic native tissues or organs. Their viability, however, is dependent on long-term cell storage, a field in which cryogenics can play a revolutionary role.

        A widespread implementation of cryopreservation technology will require advancements in various areas, including the toxicity of cryoprotectants.  Though crucial to the preservation process, these substances can be highly toxic, potentially damaging or killing the very cells they are intended to protect. In November 2015, researchers in the College of Engineering at Oregon State University unveiled a new approach to vitrification that minimizes negative effects. It begins by exposing cells to low concentrations of cryoprotectants and allowing them time to swell. This initial process is then followed by a rapid addition of high concentrations of the protective substance. The optimized procedure has raised healthy cell survival rate to more than 80 percent, from only 10 percent in conventional approaches.


Organ Transplantation
        According to the U.S. Department of Health and Human Services, an average of 22 people die each day waiting for organ transplantation. Data from the World Health Organization show that, at a global scale, less than 10 percent of the demand for transplantable organs is being met.  The absence of long-term storage capabilities is one of the most significant obstacles to a more effective system. Currently available technologies limit the life span of donated organs to a few hours, condemning precious resources to waste.  

        Innovative cryopreservation techniques could revolutionize the world of organ transplantation, allowing for the creation of actual organ banks, capable of responding to the exact needs of each recipient with off-the-shelf availability. In addition to extending the lives of harvested organs, cryopreservation could give doctors the necessary time to repair otherwise non-viable donations. Also, it could allow for transplantations to be planned in advance, enabling recipients to gradually acclimatize to the new organ’s cells thus reducing the incidence of rejection.

        On January 15, 2015, the Department of Defense (DoD) launched three programs devoted to advancing organ-banking research. According to the Organ Preservation Alliance (OPA), a non-profit organization located in NASA's Research Park in Silicon Valley, this pioneering initiative could fund over 20 research teams, which could potentially receive $3-3.5 million in business innovation grants. Dr. Sebastian Giwa, CEO of the OPA underlines that “35 percent of all deaths in the U.S. could be prevented or substantially delayed by organ transplantation, and this exciting move by the DoD could be a true game changer.”  

        Aiming to advance the field of organ cryopreservation, with particular focus on preventing the damages of ice formation, researchers at the Institute of Biomedical Technology at Binghamton University are trying to emulate species that naturally “freeze” and thaw. This is the case of the North American wood frog, which “freezes” several times during an average winter. It does so by substituting most of the water in its body with glucose, thereby allowing its insides to turn into glass and preventing the damages of ice formation.  

        Also inspired by this amphibian example, Dr. Mehmet Toner of Harvard Medical School has pioneered the use of trehalose, which is also a sugar, as a vitrifying cryoprotectant. In June 2015, Dr. Toner and his colleagues were able to “freeze” and subsequently revive rat cells using acetyl groups that made trehalose more absorbable.  

        Another attempt to avoid the damages of ice formation is the use of an alternative method called isochoric cooling. Developed by researchers at UC Berkeley and the U.S. Military Academy at West Point the innovative approach “lowers temperatures in a preservation chamber by increasing pressure while retaining the same volume.”  

        The ability to prevent the hazardous effects of low temperatures is, however, just one side of the coin. Researchers must also face the challenges of “reviving” organs, which can include potentially irreversible damages caused by thermal stress. Paradoxically enough, ice formation remains an obstacle during the thawing process and, therefore, the heating up of cryopreserved tissue must be done rapidly and uniformly. Aiming to overcome these hurdles, researchers at the University of Minnesota are experimenting with an innovative cryoprotectant, which is infused with magnetic nanoparticles. When exposed to radio frequency waves, the vibration of these particles would warm the cryopreserved organ from within, heating it up by over 212°F per minute and preventing damages to the tissue. Recent experiments have shown great promise in applying this method to heart valves and arteries.

        A growing number of innovative companies are also engaged in organ cryopreservation research. Based in Charleston, South Carolina, Tissue Testing Technologies (T3) is working on ice-free and stress-free cryopreservation methods for complex systems. Among other innovative efforts, the company proposes the combination of synthetic ice modulators (SIMs) with established cryoprotective agent (CPA) cocktails to create more favorable conditions for cryopreservation in the vitrification process. T3 advocates that “The application of SIMs enables lowering the CPA concentration, thereby reducing the toxicity potential, while decreasing the critical cooling and rewarming rates, thereby reducing the risk of structural destruction to the tissue as a consequence of thermo-mechanical stress.” This initiative was recently awarded $149,999 in funding by the DoD.  

        Also dedicated to advancing cryopreservation technologies, Sylvatica Biotech, focuses on the development of innovative cryoprotectants. Founded in 2015, the Brooklyn, New York-based company was also awarded a DoD grant to develop a non-toxic, multi-component, next generation cryostasis cocktail. With the objective of accomplishing storage times of several months, Sylvatica is working on a protocol for organ preservation in a frozen state using high subzero cryogenic storage temperatures combined with metabolic depression.

        Located in San Francisco, California, X-Therma is using biomimetic nanoscience to develop unique peptidomimetic polymers that will emulate the ice-inhibiting effects of naturally occurring antifreeze proteins, found in cold-resistant creatures, such as hibernating mammals. The innovative nanomaterial is intended to become a non-toxic, hyperactive, cost-effective alternative to conventional cryoprotectants.


Industrial Applications of Cryogenic Technology

        Most industrial applications of cryogenic technology are made possible by the use of liquefied gases, also known as cryogenic liquids or cryogens. With boiling points bellow -238°F, cryogenic liquids are extremely cold and can thus be used as refrigerants. Examples of commonly liquefied gases include nitrogen, helium, oxygen, and hydrogen.

        Typically supported by an on-site liquid gas supply, cryogenic systems use different thermodynamic techniques and cycles to maintain interior temperatures of about -238°F or less. Demand for cryogenic equipment has increased considerably due to a growing number of potential applications in a variety of sectors, including energy, military, healthcare, aerospace, and transportation. According to a recent report by Grand View Research, the global cryogenic equipment market will be worth $25.5 billion by 2022.  Examples of industrial applications of cryogenic technology include:


Cold Chain Logistics
        Transportation of temperature-sensitive material is an important field for cryogenic technology, particularly when it comes to the life sciences industry. For instance, Irvine, California-based Cryoport, Inc. provides worldwide cryogenic logistics solutions to the biopharma, reproductive medicine, and animal health markets. The company’s proprietary Cryoport Express uses liquid nitrogen dry vapor shippers that maintain below -238°F temperature for up to 10 days of dynamic shipment. This technology is arguably superior to those used by many other cold chain logistics suppliers, which often resort to dry ice (and are thus unable to reach cryogenic temperatures). Cryoport works with a range of biologic materials such as immunotherapies, stem cells, CAR T-cells, and reproductive cells. Its list of clients include points-of-care, CRO’s, central laboratories, pharmaceutical companies, contract manufacturers, and university researchers

        With a 34 percent year-over-year revenue growth, 28 new clients in the biopharmaceutical industry, and $3.5 million in new funding for growth and development initiatives in the first quarter of FY 2017, Cryoport is a vivid illustration of the fast-paced expansion of cryogenic logistics. The company offers increasing support to biopharmaceutical innovation, currently assisting 23 out of the 28 leading clinical-stage CAR T-Cell programs and more than 90 clinical trials, including 14 phase III projects.

        Recent innovative efforts from Cryoport shed light on some promising ways in which cold chain logistics can move forward. Examples include a biostorage solution for comprehensive storage and fulfillment services, as well as a monitoring system that provides real-time conditions and location data on critical biological commodities.


Cryogenic Machining
        Temperature is a major concern in cutting tools. Tool wear is often accelerated by heat. Even the slightest dulling intensifies friction and consequently raises temperatures. Higher temperatures mean softer tool materials, which are more prone to degradation. More dulling means more friction, and the vicious circle continues.

        Though intended to prevent this self-accelerating phenomenon, traditional coolants, which work at about 70°F, offer limited effectiveness due to their common inability to reach the exact spot where heat is generated. Cryogenic machining, on the contrary, delivers liquid nitrogen through the tool directly to the cutting zone. They work at -321°F, a difference of nearly 400°F that turns the tool into a thermal sponge and significantly increases productivity. According to MoldMaking Technology Magazine, cryogenic methods not only enable more parts to be cut in the same amount of time with the same machine but increase tool life by up to a factor of 30. Virtually all machines can be retrofitted to incorporate cryo functionalities, serving as a means to increase productivity without requiring investments in new machinery.  

        German machine tool supplier MAG underscores that even though the use of nitrogen itself is not a new technique, previous methods required a much higher volume of the cryogen - as they often involved spraying the tool or submerging the entire work area. Using a through-tool approach, MAG’s solutions are classified as  “minimum quantity” cryogenic machining, in other words, they maximize the cryogen/cooling ratio.

        Headquartered in Cincinnati, Ohio, 5ME has developed patented cryogenic machining technology with programmable flow rates of liquid nitrogen that can fit different cutting tool types. In 2015, Lockheed Martin acquired 5ME’s cryogenic system to perform roughing and finishing operations on large titanium airframe components. In addition to improved surface integrity and part quality, initial tests revealed a 52 percent increase in cutting speeds (21 hours with 5ME cryogenics vs. 44 hours with coolant), with equal cutter consumption. The new technology is expected to reduce part costs by 30 percent.

        Cryogenic machining can be particularly beneficial for mold suppliers, who must respond to a growing demand for more durable and reusable molds. Made of metals and alloys, longer-lasting molds are harder and more expensive to cut. Also, the production of reusable molds requires a careful control of temperature, as excessive heat can cause tool failure, which increases tooling costs and downtime. Cryogenic technology is an innovative way to overcome these challenges and increase efficiency and affordability of mold making.


Military
        Examples of applications of cryogenic temperatures in the military sector include infrared sensors installed in night vision-based systems, satellite-based surveillance, and missile guidance. In July 2016, officials of the Space and Naval Warfare (SPAWAR) Systems Center Pacific in San Diego, California announced contracts with two companies as part of the Emerging Cryogenic devices, Electronics, and Systems program. Mountain View, California-based Out of the Fog Research LLC and Elmsford, New York-based Hypres Inc. will carry out research and development activities aimed at advancing cryogenic radio frequency technology for tactical signals intelligence  (SIGINT) systems. Together the contracts are worth $90.8 million and, with options, can reach up to $159.1 million.


Healthcare
        Cryogenic systems are gaining prominence in the healthcare sector, particularly due their extensive utilization in proton therapy, cryosurgery, MRI systems, and liquefaction of oxygen in hospitals. In cryosurgery, for instance, extreme cold is used to destroy diseased tissues. It can be used to treat a variety of conditions, including prostate and liver cancers, early stage skin cancer, and other noncancerous ailments. Ongoing studies aim to assess the viability of expanding the applications of cryosurgery to breast, colon, and kidney cancer treatment. Researchers also envision its use in combination with other, more traditional approaches. In comparison to other treatment options, cryosurgery offers minimal pain and scarring, lower costs, and faster recovery times.  

        Cryogenics also play a key role in enabling advanced MRI technology and proton therapy, both of which rely on high-powered magnets that need to be cooled in order to activate their superconducting properties. Capable of targeting tumors with sub-millimeter precision, proton therapy is a type of radiation treatment that spares healthy, nearby tissues and minimizes side effects. Cryogenic technology has been crucial to enabling the emergence of more compact and affordable proton therapy systems that promise to replace traditional, multi-room equipment that are inaccessible to many healthcare facilities due to investment and space requirements. Headquartered in Palo Alto, California, Varian Medical Systems has developed a single-room proton therapy system that combines speed, flexibility, and cost efficiency. With contracts for system installations at 12 locations around the globe, Varian’s innovative proton therapy technology is already being used at the Cincinnati Children’s/UC Health Proton Therapy Center, the Scripps Proton Therapy Center in San Diego, Maryland Proton Therapy Center in Baltimore, the Rinecker Proton Therapy Center in Munich, and at the Paul Scherrer Institute in Switzerland.  


Superconductivity
        Even though electrical resistance lowers as temperature decreases, ordinary conductors are unable to reach zero resistance, due to impurities and defects. A special category of materials, however, present superconducting properties and, thus, when cooled below a certain critical temperature, offer exactly zero electrical resistance.

        Superconductivity was initially made possible in 1911 through the use of liquid helium, which enables extremely low temperatures. So-called “high-temperature superconductivity” (HTS) was subsequently discovered in 1986 and raised critical temperature to around -320°F, allowing for the use of liquid nitrogen as a refrigerant.

        An increasing number of superconductivity applications underscore the importance of innovative cryogenic refrigeration systems that provide economical and reliable long-term operations.  HTS is at the basis of high-impact technological innovations in various areas, including biology, condensed matter physics, chemistry, magnetic resonance, material sciences, particle accelerators, colliders, and fusion devices.

        Superconducting wires are an example of how cryogenics can enable major technological breakthroughs. Headquartered in Austin, Texas, Superconductor Technologies, Inc. (STI) is the creator of the Conductus superconducting wire platform, a high current carrying coated conductor with 100 times the current carrying capacity of traditional copper and aluminum wires.

    Designed to operate across a broad range of cryogenic temperatures (from around -450°F to -321°F) STI’s Conductus offer major performance improvements, higher power density, smaller size, and significant cost benefits over their conventional counterparts. Not only can they revolutionize electric power transmission and distribution, but they can also enable much smaller and more powerful magnets for motors, generators, energy storage, and medical equipment.


Cryogenic Food Processing
        Food processing activities can greatly benefit from cryogenic technology. In addition to contributing to food preservation and safety, high-efficiency cryogenic systems can help maintain food quality, while boosting productivity and streamlining operations.

        Advanced cryogenic solutions are much faster than traditional freeze/chill methods and can thus increase the volume and speed of production while reducing overall freezing costs. Other potential benefits include reduced evaporation and dehydration losses on cooked poultry and red meat products, texture and freshness preservation in seafood, and structure continuity in parbaked goods. Cryogenic processing can also help prevent losses due to bacterial contamination as, when combined with the necessary hygienic conditions, it acts as a shield against Salmonella, E. coli, and other pathogens.

        According to German multinational industrial gases and engineering conglomerate The Linde Group, many high-volume food processors have been able to save $2-3 million per year due to the adoption of cryogenic solutions, such as tunnel freezers, individually quick freezing (IQF) freezers, immersion freezers, spiral freezers, immersion spiral freezers, impingement freezers, pellet freezers, and cryo-mechanical freezing systems.

        Data from the Cryogenic Society of America show that, in the bakery industry, production time can be reduced by more than 50 percent. For example, cookies that take 13 minutes to cool from 130°F to 75°F using traditional methods are cooled in no more than one minute with liquid nitrogen. Consistent temperatures also improve product quality, reduce waste, and eliminate excess moisture, unreliable timing, and labor costs associated with ice.  
    
        In the case of proteins, which can consist of up to 75 percent water, challenges involving ice formation are critical. Conventional methods often lead to uneven freezing as the location of water molecules influence their freezing temperature. Also, changes in pressure and crystal formation can damage cell walls and harm the structure of the meat. Cryogenic processes overcome these challenges by enabling virtually instantaneous freezing that is harmless to the internal fiber structure. 


Natural Gas
        The liquefaction of natural gas occurs at approximately -260°F at atmospheric pressure. Once liquefied, natural gas takes up about 1/600th of the volume that it would have in its gaseous state.  

        For decades, the cost of production and the need for sophisticated cryogenic storage have hampered a more widespread, commercial use of liquefied natural gas (LNG). However, both economic and environmental issues have led natural gas to gain prominence all over the globe, and particularly in the U.S. energy supply. Though more commonly used for transportation and storage purposes, LNG is rapidly finding its way into new applications. Examples include the LNG bunkering (or marine fuel) market, which is expected to experience a 20 percent compound annual growth rate between 2016 and 2023, according to Global Market Insights Inc.

        Headquartered in Allentown, Pennsylvania, Air Products & Chemicals has been at the forefront of cryogenic natural gas liquefaction technology and equipment. On September 9, the company rolled out the first LNG cryogenic heat exchanger produced in its Manatee County, Florida facility. Aiming to achieve economies of scale, Air Products produces heat exchangers as large as over 15 feet in diameter and 180 feet long. The production and transportation of such large equipment requires innovative efforts, which included the construction of the 300,000-square-foot Florida facility. Jim Solomon, Director of LNG at Air Products underscores that “as the world's energy needs continue to increase, demand for cleaner energy is at the forefront, and natural gas is the cleanest of all the fossil fuels. In order to achieve the greatest economies of scale, even larger capacity LNG heat exchangers for LNG plants are being required."  

        The potential benefits of LNG use have spurred innovation in various related fields. Working in partnership with Japanese producer of cryogenic LNG tanks Hitachi High-Tech AW Cryo., the Alaska Railroad Corporation will soon became the first railroad in the country to ship LNG. Even though moving LNG by rail has been common practice for decades in countries as Japan, it has never been done in the U.S. This innovative means of transportation could significantly reduce the prices related to LNG use, therefore opening the way for more widespread applications.  


Low Temperatures, High Impact

        Cryogenic systems can change the way various industries work. From healthcare and the military to logistics and food processing, cryogenic technology has already enabled major technological breakthroughs in a variety of fields. Ongoing R&D efforts point to an exciting future with revolutionary applications that include organ banking. R&D tax credits are available to support companies engaged in low-temperature, high-impact innovation.

Article Citation List

   


Authors

Charles R Goulding Attorney/CPA, is the President of R&D Tax Savers.

Andressa Bonafé is a Tax Analyst with R&D Tax Savers.

Tricia Genova is a Tax Analyst with R&D Tax Savers.


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