OncoProtein based Program for Early Detection of HPV induced Cervical Cancers

Dr Johannes Schweizer, VP of R&D at Arbor Vita Corporation talked about Arbor Vita’s proprietary OncoE6™ Cervical Test that Predicts Development of Cervical Cancer at www.bio2devicegroup.org event.  Information on 3 great upcoming conferences EPPIC, TiEcon, and HealthTechForum with great speakers on healthcare tracks, is posted at the end of the article.

Arbor Vita was found by Dr. Peter Lu, in 1998 with an aim to apply discoveries of the role of PDZ proteins to the development of novel therapeutics and diagnostics.  Numerous pathogens have been found to cause diseases by binding to a PDZ protein and thereby disrupting normal cell signaling.  The ability to regulate PDZ/PL interactions represents new opportunities in controlling multiple signaling cascades in complex diseases and have recently been a focus for human drug targets.  Arbor Vita has identified nearly all of the PDZ domains in the human proteome and has decoded most of them.  Arbor Vita’s platform technology is targeted towards several diseases.  Its stroke treatment asset was recently sold to NoNO, Inc.  Avian flu Dx is the first FDA cleared rapid Dx test.  At this event, Dr Schweizer discussed Arbor Vita’s diagnostic and treatment technology for HPV induced cancers.

Cervical cancer is a leading cause of mortality, worldwide.  HPV induced cancers are transmitted through sexual contact and kill over 275,000 women, every year.  These do not receive as much attention because the mortality rates are lower in the US and other developed countries.  But mortality from slow progressive cervical cancers peak in developing countries.  In India for instance, every 7 minutes, a woman dies from this disease.  The current mode of detection is through pap smears, which have poor sensitivity and poor specificity.  In the US, out of 100,000 women tested, 23,000 are likely to be hr-HPV positive.  But from these, only 6 women are likely to have cancer.  This indicates that the current screening methods are sensitive but are not sufficiently specific to detect pre-cancerous and cancerous activity and low specificity leads to over treatment.  Pap tests give about 20% false positive and false negative results.  The only reason it still work is because of the frequency of testing in the case of this very slow moving cancer, said Schweizer.  Also pap tests require lot of infrastructure and set up that is often not easily available in developing regions.

Arbor Vita’s OncoE6TM Test is the only test that specifically identifies the viral E6 oncoprotein that causes cervical cancer.  And it is simple to administer with specimen captured with a polyester tipped cervical swab, which can also be captured by the woman on her own as well.  Elevated E6 oncoprotein correlates to cancerous activity and development of high-affinity anti E6 mAb is a key to feasibility.  There are 15 HPV types that cause cancer.  Among these, HPV 16 and HPV 18 are leading causes of cervical cancers, worldwide.  This test is specific to these two viruses.  Further this test is robust and lends to easy storage at ambient temperature.  The entire process from sample collection to getting the results can be completed in 2.5 hours.

Schweizer shared some of the data from its clinical trials.  The data indicates that in a head to head comparison with OncoE6TM, the DNA test results in nine fold over treatment including colposcopies and biopsies.   OncoE6 Cervical Test on the other hand, has high specificity for women with high grade disease cancers.  OncoE6 Cervical Test efficiently identifies women in need of clinical follow-up, among the many more with clinically irrelevant HPV infections.  In a one year follow up, E6TM promised to be a solid predictive marker as high specificity and high PPV are keys to lower referral rates and clinical follow-up.  This was very interesting talk and was followed by Q&A.

_______________________________________XXXXXXXXX________________________________________

Please see below information on some excellent conferences and events coming up in the Bay Area, in next couple of months.

March 29, 2014 (day after tomorrow) EPPIC (www.eppicglobal.org) is hosting annual conference at SF, Westin.  Panels include Neglected & Rare Diseases – http://bit.ly/1c1vvTR, Innovations in clinical Development of Novel Agents, Point of Care gold rush and there will be speed pitch and SIG networking opportunities.  Promises to be a great conference.

May 16, 17, 2014 TiE SV (www.tiesv.org) will host TiEcon (www.tiecon.org) , the largest entrepreneurship conference.  This year it will feature #healthcare track with focus on Disruptive Technologies in Healthcare.

May 20, 2014 HealthTech Forum (www.healthtechnologyforum.com) will host annual conference around the theme “Pathways to Sustainable Health” at Parc 55 Wyndham, SF and will feature excellent panels and speakers on Medical Research in the Cloud, Patient Engagement in Behavioral Health, Improving Health in Global Underserved Communities and more.

www.bio2devicegroup.org meets every Tuesday and next Tuesday Dr. Russell Pachynski, co-founder, CombImmune, will talk about “Novel approaches to Immune Therapy and Monitoring”.

Check out new job opportunities 1) Embedded Software Engineer – Mountain View, CA 2) Quality manager – Mt Laurel, NJ – http://bit.ly/P1H0QK

 

Enabling Physician Adoption of new Medical Technologies

Dr. Akhil Saklecha, General Partner at Artiman Ventures talked about understanding the challenges of physician adoption of new technologies and discussed ways of overcoming resistance and enable adoption of new medical and heatlhcare technologies by physicians, at www.bio2devicegroup.org event. (See below, at the end of the article, more info on bio2devicegroup, EPPICon, TiEcon, & HTF conf.)

Entrepreneurs in the health technology sector, must first understand physicians, the environment they work in, and the nature of the work flow.  Physicians have to be patient advocates, they often control the purse strings and make decisions on allocation of scare resources, and there is a potential to impact their adoption of new technologies by exercising influence upon them.  Physicians generally have competitive, type A personalities and they do not want to lag behind in adoption of useful technologies, said Saklecha.

So what are drivers for adoption of new technologies?  Technologies that solve problems that drive doctors crazy, get their attention.  Entrepreneurs with “must have” technology, will find it easier to get it adopted.  Entrepreneurs must focus on solving their problems, said Saklecha.  In addition to understanding physician’s work challenges, it is also important to understand every single stakeholder, in the healthcare setting.  For instance, Saklecha said he has seen some GI tools that solve a smaller problem but take up additional time of the scrub technician, general nurse, and GI nurse.  All this would add to the expenses and if the technology does not offset the cost, it will be rejected.  In fact, there is an early shift towards disposable colonoscopy devices because it saves set up and clean up time.

When it comes to money, “ignore it at your own peril”, said Saklecha.  His advice was that entrepreneurs must map out the flow of money, very early on.  They should get an understanding of where the revenue is generated and who makes the money and who loses the money.  Given the tremendous pressure to save costs, it is extremely important that new technology does not add costs to the system, unless it is a huge value add in terms of quality of health.  Entrepreneurs must know the flow of the money, direct and indirect costs and savings and they should understand CPT codes and reimbursement rules.  Obtaining CPT code does not necessarily translate into reimbursement, warned Saklecha.

Entrepreneurs must focus on enhancing quality and patient safety, said Saklecha.  Quality drives revenues and safety keeps patients alive and providers’ revenues are increasingly tied to performance.  A thorough understanding of work flow and how it impacts all various service providers including nurses, physicians, clerks etc. is very important.

One of the valuable advice Saklecha gave was with regard to timing and specific point of insertion of new technology.  Find a point of least friction for insertion of new techology, said Saklecha.  With regards to timing, it is important to keep in mind that no benefits will be seen during the first month, and instead there may be adverse effects.  Most inefficiencies will dissipate in the following 3-6 months and only then will the benefits begin to appear.  So this may be a time to keenly observe and understand the impact and every little nuance of the new technology on the work flow.  In the past decade, electronic medical records or EMR has been all the rage.  However, data entry and management takes physicians’ time away from patient care.  This is a challenge that is not yet effectively tackled, said Saklecha.   Voice recognition and scribes are used but the both have challenges of cost and errors.

Saklecha gave examples of several medical technologies and how they overcame physician adoption challenge by solving their key pressure point.  For instance, iRhythm cardiac monitoring device allows for remote monitoring of minimally “at risk” patients and it enables ER doctors to read the data and generate revenues.  Insurance companies also like it because instead of sending the patients over for hospital stays, they can be sent home and patients enjoy the convenience.  Minimally invasive blood test offered by Cardio Dx replaces cardiac stress test and it was a great improvement in saving costs.  The company directly marketed it to primary care physicians.  However, they misjudged and found that these doctors were slow to adopt because they were looking for validation from the cardiologists.  That was an important lesson in physician adoption of new technologies.  Now the company has pivoted and changed their marketing strategy and they are finding traction.

Another example is GI Dynamics which has a medical device that targets obesity.  Bariatric surgery is complex and there is high morbidity population.  The company has a fairly simple procedure that was found to simultaneously solve issues around hypertension and diabetes, while treating obesity.  GI physicians loved the technology since it offered them a whole new class of patients.  Just like GI physicians, cardiologists are also a competitive and procedure driven specialty, and they are quickly adopting new technologies in cardiac stents and percutaneous valves.  The talk was highly interactive and generated lot of discussion.
X                   ____________________________________                  X
Please mark 3 great conferences focused on life science, medtech, & healthcare, in the next two months, in San Francisco Bay Area, on your calendar, & see info on life science networking group that meets every week.

www.eppicglobal.org EPPICon annual conference is on March, 29, at Westin, SF and it features a panel on “Neglected & Rare Diseases” http://bit.ly/1c1vvTR, on “Point of Care”, on “Innovations in Clinical Development of Novel Agents” and more. Excellent event to network with VCs, panelists, speakers & other professionals.

www.tiecon.org is on May 16 & 17 at Santa Clara Convention Center.  On day 2, May 17th, it will feature a Life Science track with keynote and a distinguished panel on “Disruptions in Healthcare”. Great to network with entrepreneurs working inside and on the boundaries of various disciplines.

www.healthtechnologyforum.com  annual conference is on May, 20 at Parc 55, Wyndham, SF and it has excellent lineup of speakers and panels with a broad focus on “pathways to sustainable health”. More specific panels will focus on patient engagement, medical ethics, IoT, health apps, building resilient communities and more. Excellent to network with physicians, non profits & other entrepreneurs.

www.bio2devicegroup.org meets every Tuesday & covers a broad range of topics pertaining to biotech, medical device and pharmaceutical industries. On Tuesday, March 22, at 8:30am Johannes Schweizer, Arbor Vita will talk on OncoE6™ Cervical Test that Predicts Development of Cervical Cancer www.bio2devicegroup.org – Free event, all are welcome. Become a member and network with diverse range of life science industry professionals.