New and emerging treatment options for neuropathic pain

Facilitator Notes: Over the past few years, several new prevention technologies have been proven to be effective in large-scale clinical trials.
We are going to spend some time taking a look at those tools that are either still being investigated, such as microbicides and vaccines, or that have recently been shown to be effective, such as treatment-as-prevention and pre-exposure prophylaxis).
Vaccines: A preventive vaccine is a substance that teaches the body to recognize and defend itself against bacteria and viruses that cause disease.
Pre-Exposure Prophylaxis: Pre-exposure prophylaxis (PrEP) is the ongoing use of antiretroviral (ARV) drugs, starting before an exposure and continuing afterwards. Learn More: For further information about existing prevention technologies and approaches, consult CATIE. One of the reasons for this is that the list of technologies included as NPTs evolves over time.
Therefore, today, NPTs typically refer to preventive vaccines, vaginal and rectal microbicides, pre-exposure prophylaxis, and treatment-as-prevention.
Facilitator Notes: The development of new HIV prevention technologies has increasingly relied on methods that use antiretroviral drugs (or ARVs). Some methods of using ARVs for HIV prevention are already known to work, such as post-exposure prophylaxis (or PEP) and prevention of vertical transmission, sometimes called prevention of mother-to-child transmission (or PMTCT). Some approaches have recently been proven to work or are still in the research stage, such as treatment-as-prevention, pre-exposure prophylaxis (or PrEP), and microbicides.
Here is a chart showing all of these interventions, and where the ARV-based prevention options could be used. Using treatment-as-prevention means that the HIV-positive person takes ARVs on an ongoing basis to reduce the risk of transmission during sex. Facilitator Notes: This is another visual way of representing HIV prevention options that are either ARV-based or not ARV-based. Male and female condoms, medical male circumcision, vaccines, needle exchange, and voluntary counselling and testing are all examples of prevention interventions that do not include ARVs. The tools that rely on ARVs to be effective include PEP, PrEP, and treatment-as-prevention. Some vaginal and rectal microbicides might be based on ARVs, and others might work in other ways. We know that individuals who successfully follow an ARV treatment regimen have a reduced amount of virus in their blood and other bodily fluids.
The treatment-as-prevention approach has been conceptualized in different ways and called different things. TLC+ (which stands for Treatment and Linkage to Care, Plus offering Treatment) is the name of a US pilot project that has similar goals to British Columbia. Facilitator Notes: Treatment for people who are HIV-positive could have prevention benefits in two ways. Around the world and in Canada there are demonstration projects, pilot studies and revised public health guidance that are seeking to demonstrate and capitalize on the prevention benefits of treatment. Facilitator Notes: How effective this prevention approach might be at a population level in Canada depends on having a critical mass of HIV-positive people with an undetectable viral load.
Recent studies in Ontario and the United States have shown that taking into account all of these hurdles, only an estimated 19-32% of HIV-positive individuals have undetectable viral loads. PrEP is a prevention option that could be used to reduce the risk of HIV infection from ongoing exposures to HIV.
Therefore, the goal of PrEP is to get high concentrations of antiretrovirals at places where a person may be exposed to HIV. No major safety concerns were identified in the studies AND it seems that the risk of side-effects, toxicity, and drug resistance are low. Learn More: For further information about pre-exposure prophylaxis, consult the AVAC and CATIE.
We also don’t know about the safety and effectiveness of PrEP when used outside of the tightly controlled setting of a clinical trial. Facilitator Notes: A microbicide is any substance that can substantially reduce the risk of acquiring or transmitting sexually transmitted infections, including HIV, when it is inserted in the vagina or rectum. Microbicides might look a lot like some of the over-the-counter products we already know—the gel, lube, douche or enema that have been on the shelves for years. Scientists are also working on developing new formulations that may eventually make microbicides even more user friendly than gels or creams that are inserted with an applicator. Almost all most microbicides in the research pipeline now are based on the antiretroviral drugs, or ARVs, that are used for treating people who are HIV-positive. Adapted from PowerPoint slides from Global Campaign for Microbicides and International Rectal Microbicide Advocates. Facilitator Notes: The research is still ambivalent about whether a microbicide as a vaginal gel can reduce the risk of infection among heterosexual women, when provided in combination with a package of prevention services. The research does strongly emphasize that microbicides need to be used consistently for them to work. Several acceptability studies among different populations of women and men have shown that it would be great to have different microbicides that would meet the following criteria. Second, making sure that microbicides will be affordable and accessible is a fundamental goal. Second, we must acknowledge that once a microbicide is available in gel form, it is likely to be used both vaginally and rectally.
No rectal microbicide has been tested in large-scale efficacy trials, although some ARV-based gel products are moving through the research pipeline. Facilitator Notes: A preventive vaccine is a substance (usually a part of the virus) that teaches the body to recognize and defend itself against bacteria and viruses that cause disease. Facilitator Notes: After four large-scale clinical trials, one vaccine regimen provided a slight level of protection, one increased the risk of infection in some people, and two other trials showed no protective effect. Second, animal models have not yet accurately predicted how vaccine candidates tested in labs will work in humans. Remember: Many of the questions participants will have regarding NPTs remain unknown and can only be answered through further trials, demonstration sites and real world use.
If you haven’t heard yet that Santa Cruz is fast becoming a biotech hub, it’s time to start paying attention. I asked each to share some challenges and successes and say why they think Santa Cruz is a great place to locate a biotech company.
The company was founded by three UCSC graduate students: Steve Benz, Charles Vaske, and Zack Sanborn. One of the greatest challenges we face is trying to help change the way oncologists treat their patients. Isentio founders selected Santa Cruz as home base because it’s close enough to the South San Francisco biotech hub, as well as to Silicon Valley, and also offers quality of life and a family friendly community.
They value the proximity to UC Santa Cruz because the university provides an influx of scientists with diverse backgrounds and collaboration opportunities. As a veteran of biotech startups over-the-hill, I look forward to the opportunity to build a team of world-class PhD and Masters-level scientists here in Santa Cruz.
Santa Cruz is chock-full of bright and creative people with experience in a wide variety of fields, and potential collaborators, customers, and mentors are out there with a little investment in networking.
Speaker said that since Capsulent started with a technology platform that lacked a definite application, the biggest challenge was to find the right market and segment in which their delivery system could really shine.
In its pursuit to help advance the understanding and the treatment of human diseases, the company focuses on RNA molecules as therapeutic targets and biomarkers. Johnston reports the biggest challenge has been landing large development deals with big pharma companies when their interests and company strategy change every few years. Maverix Genomics, founded by UC Santa Cruz professor Todd Lowe and featured recently by Santa Cruz Tech Beat, could have been on the list but, alas, they’re located in San Mateo. It’s no secret that local biotech companies value the proximity to cutting edge research just up the hill at UC Santa Cruz. If any of you STEALTH local biotech companies decide to un-stealth, please contact me, I would be happy to add your company to the list. Sara Isenberg curates and publishes Santa Cruz Tech Beat for the benefit of the extended business and technology community. 21-day Gamification CourseLearn the fundamentals of Gamification and Octalysis in just 21 days -- for free! With so many new technologies emerging, it’s tough to find the right one that suits your business. To facilitate this relationship with a loyal customer, many businesses are turning to rewards programs.

Lets dissect each solution and how it applies to your mainstream customer – the majority of your clientele. Mainstream use: Yes, mainstream customers use punch cards everyday at cafes or yogurt shops.
A punch card is an old form of marketing that is no longer capable of satisfying the needs of a business. Mainstream use: Like punch cards, magnetic rewards cards are commonly used by the mainstream customer. Mainstream use: If only 1 out of 100 of your customers uses a gaming app, then it is clearly not used by the mainstream customer. If you use a gaming app such as Foursquare as your main rewards program, then you’re excluding the vast majority of your customers from earning rewards at your business. Mainstream use: Will the majority of your customers use your rewards program if it was on a mobile application? In the beginning of 2011, 30% of your customers can use an app such as RewardMe; by the end of 2011, 40% of your customers will be able to use RewardMe. 2013 NFL season, league officials believe the football faithful will soon adapt without problem. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. The strategy would function as a secondary benefit of antiretroviral treatment after its primary purpose of improving an HIV-positive individual’s health. For example, up until 2007-2008, there were efficacy trials testing whether treatment of herpes simplex 2 (also called HSV-2, or genital herpes) could reduce the risk of HIV infection, and whether a diaphragm or cervical barriers could reduce the risk of acquiring HIV among women.
Their efficacy might not yet be established, or some trials may have recently demonstrated proof-of-concept, but efficacy still needs to be confirmed through further study.
Occasionally, medical male circumcision is still included in discussions of NPTs in some parts of the world, since its HIV prevention efficacy was only proven in trials in 2005-2007. Among ARV-based options alone, we know that an HIV-positive woman can receive ARVs during pregnancy and at the time of delivery to help prevent HIV transmission. ARV-based microbicides in the form of gels, suppositories, douches or enemas, for example, might have to be inserted vaginally or rectally shortly before sex, or they could possibly be used on a daily basis. People taking PEP after a potential exposure must continue a daily course of ARVs for four weeks. Prevention of vertical (or mother-to-child) transmission includes some tools that are based on ARVs, and others that are not. For each one of these four tools, we will provide a general description, give an overview of what we know about this tool’s potential for reducing the risk of HIV, and explore some of the questions that remain to be answered concerning that tool. For example, in San Francisco, public health guidelines recommend that treatment be offered immediately to anyone who tests HIV-positive.
Its goal is to diagnose those who are unaware of their HIV status, to diagnose everyone as early as possible, and to support ongoing links to care and treatment programs.
One clinical trial demonstrated a 96% reduction in risk of HIV transmission in serodiscordant couples (couples in which one partner was HIV-positive and the other was HIV-negative), when the HIV-positive partner was taking ARVs. Some people argue that doing HIV testing on a massive scale, along with providing treatment to those who test HIV-positive, could significantly reduce the number of new infections.
In San Francisco, decreases in community viral load have been associated with lower numbers of new HIV infections. The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection.
PrEP involves the ongoing use of one or two antiretroviral drugs by HIV-negative individuals – starting before an exposure and continuing afterwards. After an exposure occurs, the virus needs to spread from the site of the exposure (such as the vagina or rectum) to other parts of the body in order to cause an infection. The antiretrovirals may be able to stop HIV from spreading beyond the site of exposure to other parts of the body, thereby preventing an infection. A number of trials have tested whether PrEP, when provided in combination with a package of prevention services, can reduce the risks of HIV infection. However, the risk of these may seem to be low because of poor adherence to the drugs during the study, and we would not expect participants to experience side effects, toxicity or to develop drug resistance if they aren’t using the drug. We still don’t know the safety and effectiveness of other important types of PrEP such as non-daily dosing. PrEP may be less effective and safe if it is not provided in combination with an intensive package of prevention services such as risk-reduction counselling and monitoring of side-effects, toxicity, and HIV status. They will not contain the same chemicals as these products, but they will come in some of the same formulations. For example, they are working to make formulations that women can leave in place for long periods of time. Talking with your partner about using microbicides could be a one-time conversation, and would not have to occur right before sex. Therefore, ideally, such products should be both safe and effective when used either vaginally or rectally. They could help reduce the risk of STIs, and allow for conception, while reducing the risk of infection for serodiscordant couples.
Yet we know very little about their safety, particularly when used during anal intercourse. As of early 2012, no simple vaccine regimen has yet provided a considerable, long-term level of protection. These are the types of antibodies that could lead to effective vaccine strategies, since they could potentially neutralize HIV.
First, traditional approaches for developing vaccines have either not worked well or would be unsafe when applied to HIV vaccine development, so scientists are using newer techniques.
In other words, we don’t know much about what immune responses will protect an individual from infection. This may mean that a vaccine would not work against all strains of HIV circulating in the world. Be sure to have the relevant trial information on hand to refer to and to have a somewhat developed knowledge about these different technologies by reading up on them beforehand. This feature profiles six companies but the truth is there are more than six biotech companies that call Santa Cruz home. Five3 Genomics is a cancer genomics company specializing in analysis of individual patient tumor genomes for precision treatment guidance. Being located in Santa Cruz allows them to keep close ties with the cutting-edge genomics work being done at UC Santa Cruz. Instead of prescribing treatments based on broad categories to which a patient’s cancer belongs, we have an opportunity to utilize the genetic characteristics unique to their cancer to better inform the oncologist on what treatments may or may not succeed.
Isentio saves lives, suffering and healthcare cost through 90% faster and more accurate bacteria identification. We know we have a great working product that customers love, and that we really can change today’s diagnostics workflow and save significant healthcare cost, but we need capital to scale and get the word out. Galen Biotechnologies is an early-stage drug development company focused on the discovery of novel treatments for cancer, inflammation, and other human diseases.
We aim to revolutionize drug discovery using our proprietary technologies to address multiple unmet medical needs. Capsulent supplies charged-film microcapsules to over-the-counter pharmaceutical companies and personal care markets as a B2B raw material supplier. Additionally, Santa Cruz is culturally very innovation-supportive, the opposite of a company-town mentality, so entrepreneurially minded folks don’t have to feel isolated or lacking in community. The unexpected breakthrough in hair products has been a major success with strong domestic and international growth. SomaGenics develops innovative therapeutics and diagnostics that address unmet medical needs.
We have demonstrated efficacy of a new hepatitis C treatment in preclinical studies and established proof of concept for a new class of RNA-interference-based therapeutic agents. Santa Cruz remains attractive to SomaGenics in part because UC Santa Cruz has a strong biology and bioinformatics program, and it’s easy for them to recruit qualified graduates and post-docs from that program.
SomaGenics’ biggest success was developing the first RNA-interference-based drug candidate shown to be effective against a hepatitis C virus infection. Roger Kaspar, TransDerm CEO, considers the beauty of the area, the people, and the proximity to cutting edge science is what make Santa Cruz a great place to live and work. For more about Biotech and Genomics at UCSC, visit the Center for Biomolecular Science and Engineering’s website.

When she is not volunteering her time for the tech scene, Sara makes her living by managing software projects, web strategy planning, and providing development team services (including account management, vendor management, strategic partner management, beta project management, referrals to qualified technical team members, and more).
The tools shown in green are the ones that have been proven to be effective if they are used consistently. Today, these interventions are no longer included in the list of potential NPTs, since the trials demonstrated no prevention benefit. In some cases, the NPTs have been proven to be effective in recent trials, but they are not yet widely available or well integrated into existing HIV prevention programs. While neither non-occupational PEP nor female condoms are generally considered to be NPTs, the issues around their availability and integration into HIV prevention programs are sometimes similar, so they are occasionally included in those discussions. However, if vaginal microbicides were formulated as rings that slowly release the active ingredient, they could remain in the vagina for weeks at a time, providing protection when a woman has sex. Here you see these methods listed where the circles overlap, because they may or may not be based on ARVs. Some are not in care, either because they are not linked to care once they test positive, or because they are not retained in care. This may be because the drugs are not effective for them, because they are not achieving high levels of adherence to treatment, or because they have developed drug resistance. This is in contrast to post-exposure prophylaxis, or PEP, which is the use of antiretrovirals only AFTER a potential exposure and only for a SHORT period of time (one month). PrEP may be an option during periods where a person is at higher risk of becoming infected AND is not able to use other prevention strategies. One trial showed that daily Truvada (which is a pill containing the ARVs tenofovir and emthricitabine) can reduce the risk of infection among men who have sex with men (or MSM) and trans women. In fact, poor adherence may explain the results in the two studies among women; however, this is not yet known. For example, someone might take their pill intermittently around the time they are potentially exposed to HIV (like around sexual activity). PrEP has been submitted for regulatory approval in the United States, but as of early 2012, the FDA had not yet made its decision. One possibility is a vaginal ring—a device that could slowly release the protective substance over a month and provide round-the-clock protection.
However, no major safety concerns were identified in the trials, AND it seems that the risk of side-effects, toxicity, and drug resistance are low. This is good, because a microbicide that is not contraceptive might enable a woman to become pregnant whilst still protecting herself from HIV. Unfortunately, ARV-based microbicides will not be appropriate for use by people already living with HIV, because of the potential for drug resistance to develop. Very few studies have examined the effect of lubricants on human rectal tissue, but those that did showed mixed results.
They also work with pharmaceutical companies to identify new potential drug targets and patient groups that currently have no viable treatment options.
The university has been a source of talented employees, with most of their employees having or currently obtaining degrees from UCSC.
That leads to some of our greatest success stories where our tools have identified treatment options that obtained responses in patients who had no other options. RipSeq™ software as a service can identify the bacteria causing an infectious disease within the same day instead of 3-7 days with today’s primary method. Everybody know there will be a shift in the diagnostic market from traditional identification methods soon and that DNA technology will be the golden standard – the question is when and how. Their vision is to create vast drug-candidate libraries with such high diversity that the normal time frame for drug discovery can be dramatically shortened. Our biggest challenge has been securing proof-of-concept funding in order to commercialize our technologies.
We have also developed novel diagnostic tools to quantify micro-RNAs as biomarkers of disease and guides to treatment.
Add to that, the quality of life that all of the companies featured in this article clearly appreciate, and the resources of the SF Bay Area within a reasonable driving time. TransDerm is fortunate to have talented and dedicated employees, a partnership with a highly effective patient advocacy group, the financial support of the National Institutes of Health and terrific collaborations with leading physicians and scientists throughout the world.
Once they know their status, HIV-positive people could then reduce their risk-taking behaviours and seek treatment. Some do not want to start treatment or are not eligible for treatment according to current guidelines. Two trials showed that daily Viread (which is tenofovir in pill form) or Truvada can reduce the risk of infection when used by heterosexual men and women. However, some studies of daily PrEP suggest that occasional use of PrEP is much less protective. We also have to consider that clinical trials are relatively short and don’t tell us about the safety or effectiveness of PrEP over a longer period of time. This cannot be done with condoms, so a non-contraceptive microbicide would give women a completely new option.
Therefore, they are unlikely to protect against STIs other than HIV, without adding additional active ingredients beyond ARVs. However, given that so little research has been done so far, there is still very little information that can be usefully provided to individuals in the context of HIV prevention programmes. The Santa Cruz Chamber of Commerce  honored Five3 Genomics as Entrepreneurs of the Year in 2012. Above all our goal is to help cancer patients obtain the best possible care available, which is something we are all very passionate about. This ensures the patient correct treatment the first time, reducing the use of broad specter antibiotics, decreasing side effects, and shortening the hospital stay. Our rapid progress in the UC Santa Cruz campus Bioincubator has been invaluable in this respect.
Capsulent’s controlled-release microcapsule technology uses nature-derived materials to wrap active ingredients in a membrane-like structure just microns across. They work in partnership with the non-profit patient advocacy group PC Project and the International PC Consortium (IPCC, a group of scientists and physicians that has agreed to work together to develop therapies to relieve suffering of those afflicted with PC). The ones that are in red have recently been shown to be at least partially effective in some cases, and some trials are still ongoing to obtain further information. However, two other trials were unable to show that either daily Viread or Truvada could reduce the risk of infection when used by heterosexual women. We also don’t know the safety and effectiveness of antiretrovirals other than Viread or Truvada. The one exception to this is tenofovir gel, which in one trial reduced the risk of genital herpes (HSV-2) by half when used vaginally. More research is urgently needed to determine whether lubricants increase, decrease or have no effect on the risk of acquiring HIV or other STIs. We hope we are able to be a part of the growing presence of biotech in the Santa Cruz area. Their lead candidate is currently in clinical trials at Stanford University and a second will enter clinical trials later this year. Optofluidics is defined as the combination of microfluidics or nanofluidics and optical methods.
It’s about medication obtained legally and it doesn’t mean homemade tinctures and oils.”A commercial cannabis farm operated by Canadian licensed supplier Tweed. But many women want something that can protect them from disease and pregnancy at the same time. TransDerm also has expertise in other areas including intravital skin imaging (visualizing non-invasively what happens within the skin replacing the need for skin biopsies), preparing human skin equivalents (similar to what is used to treat burn patients) to use to test the effectiveness of drugs and evaluating the ability of formulated drugs to penetrate the skin barrier and functionally alter gene expression in various skin model systems.
Once we have an effective microbicide, it may be possible to add contraceptive ingredients to make a dual-action product—one that prevents pregnancy and reduces HIV risk. Measor is a UC Santa Cruz Ph.D graduate, and Schmidt and Deamer are UC Santa Cruz professors at the Baskin School of Engineer. Had I been in contact with Liquilume before publication, the title of this feature article may have been Seven Companies to Watch in the Emerging Santa Cruz Biotech Hub.
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