Archive for category Biotech – Medical Device – Life Science – Healthcare
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on March 29, 2020
Recently, CABS, the Chinese American Biopharmaceutical Society hosted a webinar on the topic, “COVID-19 Clinical Treatment and Research Experiences from China”, with Dr. Wenhong Zhang. Dr. Zhang is Director of the Department of Infectious Diseases in Shanghai and leader of Anti-Covid-19 team. He is also on Chinese Society of Infectious Disease and with Chinese Association of Internal Medicine. During the fight against Covid-19, Dr. Zhang led the Shanghai team to formulate a clinical treatment and containment plan.
An article in scientific publication Lancet predicted in late January that after Wuhan, Shanghai can be the epicenter of the virus with as many as 800,000 cases. However, with very early focus on containment and reasonable social distancing (even without complete lockdown measures), Shanghai managed to restrict the spread to about 4,000 cases. The key was that the healthcare system went on full alert when they had their very first case of a person traveling from Wuhan.
Dr. Zhang shared many details of their process for containing the spread and answered questions sent by the audience members. I have captured a few of the nuggets from his talk and I am sharing them below.
Diagnosis: Immediately they optimized diagnostics and did all needed tests for suspected patients. Shanghai made separate fever clinics and all patients who met 1 epidemiology criteria plus one clinical criteria were encouraged to go to these clinics. Suspected Covid-19 patients were sent to separate quarantine wards for full testing, and while they awaited results. If the results came back positive, they were sent to separate hospitals for quarantine stay and were tested again, before release.
Further, while in the US some hospitals first tested for flu and other viruses and if the patient tested positive for any of them then they were not tested for coronavirus, Shanghai tested all suspect cases for coronavirus. Dr. Zhang said that they have found that there are a lot of co-infections so a person can have regular flu virus plus coronavirus. Additionally, they found a high negative rate in PCR testing, while a positive rate was around 70%. Therefore, despite negative test results, if the patient was highly suspect than they did more testing. They did not rely on CT scans because they found that a chest CT cannot precisely confirm Covid and all cases needed molecular diagnosis.
Detailed process in place: Shanghai had a very detailed process in place for the steps to be taken for patients in the first screen, then first test, then when tested positive, if tested negative, and for followup. Timely diagnosis and timely distancing and quarantine is very important, said Dr. Zhang. Immediate separation and early control of local transmission is the key to stop the Covid-19 disease spread, said Dr. Zhang. This is something that did not happen in Italy. Almost all of their early cases were of foreigners. Eventually all of their cases and high death toll has been among the local population.
Treatment Options: Dr. Zhang shared that over 95% of the patients recovered and eventually were released. One patient died. There has been debate around anti-viral treatments. Dr. Zhang said, these treatments don’t seem to be effective. China also used hydroxychloroquine (widely touted malaria drug) to treat Covid patients and did not find it to be effective. However, it can have compassionate use since it shows little lasting side effects, said Dr. Zhang. Although he did not observe clinical evidence of anticoagulants, he said, it is possible that early anticoagulation may block clotting and eventually reduce the risk of major organ damage.
Respiratory Treatment: Dr. Zhang shared that the most fundamental treatment in keeping patients alive is respiratory treatment. We have a narrow window to stop progression from mild symptoms to severe symptoms, said Dr. Zhang. Low and short duration corticosteroids may stop progression and we need more studies to find that out. Life support for critically ill patients is crucial. Timely intervention with mask oxygen inhalation, nasal cannula oxygen therapy, mechanical ventilation etc. can prolong life until the body’s immune system gets critical time to fight off the virus.
Medical Personnel: In Shanghai, strict following of protocol, translated into not a single infection spreading into the healthcare professionals. Highly qualified and standardized process included appropriate PPE (personal protective equipment) with gowns, goggles, masks, double layer gloves and shoe covers. Healthcare professionals were asked to never share a meal with others at home, during the time this contagion was active. As far as possible, the patients were kept in negative pressure wards and surfaces were cleaned with disinfectants every 4 hours.
Stay tuned for my next article on how China effectively used high tech, specifically big data and coupled it with public awareness and public participation to contain the virus. Please note: I am not a fan of, or in any way endorsing communism or authoritarianism. And yet, perhaps there are lessons even for Western democracies, to pay heed to early signs and implement containment strategies. And that is exactly what Bill Gates was referring in 2015, when he spoke at TedTalks and warned us about a virus pandemic that can possibly kill millions. That is what various scientists have been warning of, for years.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on March 23, 2020
The looming threat of Covid-19 and the grim reality of the toll that novel coronavirus takes on humankind, makes it imperative that we find a way to prevent the spread faster and with less cost. Currently nine out of ten drug therapies fail mostly between phase 1 trials and regulatory approval. The estimated cost of developing a new treatment is around staggering US $2.6 billion. While this article won’t address it, I want to mention that many bio/pharma companies are working with repurposed drugs to find a cure and at least 69 drugs have been identified as treatment possibilities. Drugs also have side effects and need to be tested for safety. Let us focus for a while on search for the vaccine.
Many companies including Moderna, CureVac and BioNTech are working on vaccines. With the help of Machine Learning, Artificial Intelligence and other technologies the hunt for new pharmaceuticals and appropriate chemicals is expected to be quicker, cheaper and more effective. Novel coronavirus presents the most unprecedented challenge to date because of the speed with which it spreads.
Who better than a supercomputer made by a company that has been on the cutting edge of innovation for over a century, to take on this speed challenge? IBM scientists instructed the world’s fastest computer to tackle this challenge at its Oak Ridge National Laboratory in Tennessee. Summit can run 200 quadrillion computations per second. The scientists ran thousands of simulations to analyse which drug compounds could stop the coronavirus from infecting the host cells.
Summit, an IBM supercomputer equipped with the “brain of AI” identified 77 compounds (from over 8000 compounds) that could be efficacious in preventing coronavirus from spreading in the host. This is promising news in humanity’s quest for an effective vaccine against the virus. These findings are published in the journal ChemRxiv and give us hope although road is still long to get there.
With increasing computer processing power and advanced algorithms, AI has been employed to analyze large data sets with greater efficiency and will likely lead to many exciting innovations. While AI and ML show promise to change every industry sector for the better, artificial intelligence, machine learning and deep learning have become the most widely discussed topics in the healthcare sector and the excitement keeps growing.
I will be looking forward to hearing about new innovations AI/ML at #TiEcon2020. Stay tuned for new dates for the conference at http://www.tiecon.org and on this blog.
Artificial Intelligence emphasizes the development of machines that think and reason like humans. As this technology is becoming more and more sophisticated where machines are acquiring an ability to learn, reason and self-correct, the applications of Artificial Intelligence and Machine Learning are expanding and are becoming relevant to almost all professional areas.
At TieCon 2020, a bootcamp focused on AI/ML will provide an overview of the methodologies and its implications in many professions. Experts in the field will share information on deploying and monetizing AI applications.
Dr. Ronjan Nag will lead the workshop. Dr. Nag co-founded the technology company Lexicus that was acquired by Motorola in 1993 and Cellmania that was acquired by Research in Motion in 2010. Later, he served as Vice-President of both Motorola and Blackberry, and served as Chairman of Eratz Labs, which specializes in ML. Currently, Dr. Nag is a Fellow at Stanford Distinguished Careers Institute and is founder and managing director of R42 Group.
In addition to Dr. Nag, AI/ML bootcamp speakers will include several experts. Dr. David Stevens is an IP attorney specializing in patent prosecution, due diligence, infringement, right-to-practice, freedom-to-operate, licensing and litigation. Dr. Eric Saund, Principal of Saund Laboratories has over 50 patents, is widely published and his prototypes have served thousands of users. Vaidhi Nathan has 30+ years of experience as an entrepreneur and business leader and was founder and CEO of IntelliVision, an AI/Analytics focused company for videos and cameras that was acquired by Nortek Security and Control. Matteo Colombo has 18 years of information technology and consulting experience and is currently senior executive at KPMG.
In this bootcamp, attendees will learn the basics of how AI techniques work so they can effectively lead data science teams, evaluate business potential of AI projects before investing and critically evaluate AI products for business deals. This is a not-to-miss workshop for professionals who are attending #TiEcon2020 and work in AI/ML related field and need to expand their knowledge base. Registration is open at www.tiecon.org
As coronavirus is raging on, entrepreneurs and scientists are called upon to come up with innovative ways to deal with this deadly virus. For instance, after 11 Israelis were quarantined after disembarking from a cruise ship in Japan, Israel has become a “Living Lab” for technologies to treat the virus. Israel, which has a large digital health sector, put out calls to entrepreneurs for proposals for new solutions to contain and combat the disease. Meanwhile, China is also taking a lead in exploring how futuristic technologies powered by artificial intelligence can help identify coronavirus symptoms, find new treatments, and track the spread of the disease. Chinese scientists sequenced its genome and shared around the world within weeks.
Unlike MERS, but more like SARS, Coronavirus is very contagious and has a long incubation period when people feel fine as they unknowingly walk around, infecting others. After identifying infected people, it is challenging to care for them while trying to contain the disease. Some healthcare workers who cared for coronavirus patients have themselves died of infection. We also heard that even after learning of highly contagious and deadly CD-19 coronavirus, some healthcare workers from the USA were “improperly deployed” when sent to assist in bringing home the patients infected in China.
In caring for coronavirus patients, human touch needs to be avoided and assistance should be provided remotely. Robots and automated technologies are of great help here. Robots are being used to disinfect rooms, take laundry items, help check for symptoms and disease progression, deliver medications and communicate with family and healthcare providers. Robots help disinfect surfaces and help in killing viruses and bacteria by emitting ultraviolet light. Drones and self-driving vehicles can deliver medications and supplies, petrol public places, spray disinfectants and do general surveillance.
Silicon Valley’s largest entrepreneurship conference, TiEcon 2020 has a dedicated track on health technologies. Amidst growing fears of coronavirus becoming a pandemic, emerging technologies like drones, robots, Artificial Intelligence, Machine Learning Digital Health and TeleHealth are likely to be game changers. Investors and entrepreneurs alike are focusing on the space with great interest. There will likely be exciting conversations as entrepreneurs from several countries (depending on travel restrictions), converge at TiEcon 2020, at Santa Clara Convention Center in CA, on May 8 and 9. If interested, you can register for the conference at www.TiEcon.org
Speedy identification of pathogens: saves lives, reduces cost & lowers antibiotic resistance problem
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on September 24, 2019
At a recent Bio2DeviceGroup (www.bio2devicegroup.org) event, Kevin Hacker, CEO of BioAffinity Sciences talked about their new technology that when fully developed will identify pathogens more than 100 times faster than the traditional blood culture and related technologies currently in use.
Every year, in the US, 500 thousand people die due to sepsis related complications. Sepsis is a final common pathway for many infections, particularly when an individual’s immunity is low. Body normally releases chemicals into the bloodstream to fight an infection. When the body’s response to these chemicals is out of balance, it results in Sepsis. That is when body’s immune system launches a massive counter attack that harms body’s own tissues and organs. The triggering changes begin to damage body’s vital organ systems that results in dramatic drop in the blood pressure, ultimately leading to death.
Sepsis and septic shock are more common if the individual is very young or very old, have a compromised immune system, have diabetes or cirrhosis, is already sick and frequently in a hospital intensive care unit, have wounds or injuries or severe burns, have invasive devices inserted into the body, and have previously received antibiotics or corticosteroids. Often people can recover from mild sepsis. However, if the body goes into septic shock, the average mortality rate for septic shock is about 40%. Additionally, an episode of severe sepsis may place a person at higher risk of future infections.
Given that widespread infections can progress to Sepsis and Sepsis shock in a matter of few hours, it is imperative that such infections be treated immediately with antibiotics. When given the right antibiotics, there is often a dramatic improvement and speed of cure.
Problem with speedy identification of pathogens
Given that early treatment of sepsis is associated with vastly improved outcomes, rapid diagnosis is essential. However blood culture work is slow and often takes 1-3 days. The diagnosis of sepsis in critically ill patients, housed in hospitals is also challenging because it can be complicated by the presence of inflammation resulting from other underlying diseases and from prior use of antibiotics, making cultures negative. Most testing is done through mass spectrometry that gives mass to charge ratio of ions. Since culture-dependent diagnosis of infection is slow, sometimes patients are given antibiotics, before the results of the culture are available. Patients are given broad spectrum antibiotics and 40% are not effective. In such instances, antibiotics are withdrawn after one cycle of treatment, when the cause of the illness is found to be something else and this can lead to antibiotic resistance.
Bioaffinity Sciences solution will be able to identify pathogens within 10 minutes, 430 fold faster than blood culture. This is cell affinity based, low cost technology. Pathogens are run through microchannels comprising of a surface- grafted scaffold of reactive polymer onto which affinity molecules (sugars, aptamers, vancomycin, and methicillin) have been bio-conjugated. High capacity of the channels allows low numbers of microbes to be quickly identified. The unknown pathogen’s pattern of binding to the channels is recorded, and this pattern is compared to a library of known pathogens. When a match is made, the identity of the pathogen is reported. In addition to speed, this is also more sensitive in terms of the number of different pathogens detected than blood culture.
Disease burden to the healthcare system in the US due to Sepsis
Sepsis management is a major challenge and results in disproportionately high burden in terms of hospital utilization. The average length of stay for sepsis patients in the US is approximately 75% greater than for other conditions. The cost of sepsis management ranks highest among hospital admissions for all disease states. The cost is estimated to be between $25 billion and $27 billion, and represents 13% of total US hospital costs.
Considering that poor sepsis outcomes are directly tied to the delay in diagnosis and treatment, such a dramatic improvement in speed and accuracy of diagnosis leading to speedy and accurate treatment can not only dramatically improve outcome and quality of patient care but also significantly reduce cost of care for hospitals.
The talk was followed by Q&A.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on September 17, 2019
Andre Bessette, CEO & Co-founder at Eclipse Regenesis talked about Short Bowel Syndrome at an event by Bio2DeviceGroup (www.bio2devicegroup.org) held at Wilson Sonsini (WSGR) in Palo Alto. Bessette shared information on prevalence of the disease, it’s impact, and the new technology that offers hope for restoration.
Feel free to skip the short tutorial below and jump to SBS and the technology solutions for treatment of SBS
Movement of the food
Typically digestion begins in the mouth where chewing and saliva begin to break down the food. As it passes through the esophagus, the contractions in the esophagus moves the food forward towards the stomach. In the stomach, the food breaks down further into liquid or paste and is mixed with acids and enzymes. The stomach slowly empties the contents, called chyme, into the small intestine.
It is the tube shaped organ and is located between the stomach and large intestine. The small intestine is regarded as the workhorse of the digestive system. It is 20 FEET LONG and includes the duodenum, jejunum, and ileum.
Duodenum is the first part of the small intestine where typically iron and other minerals are absorbed.
Jejunum is the middle section where cabs, proteins, fat and most vitamins are absorbed.
Ileum is the lower end of the small intestine where bile acids and vitamin B12 are absorbed.
From small intestine the food travels to the large intestine which is about 5 feet long in adults and helps in absorption of water and other remaining nutrients. It then changes waste from liquid to a solid matter called stool.
Short Bowel Syndrome (SBS)
Short Bowel Syndrome or SBS is a devastating condition where the small intestine is simply too short. The inadequate length of the small intestine leads to a whole host of problems primarily related to malabsorption of nutrients and depending on the degree of shortness, sometimes it drastically shortens lifespan. Typically SBS is diagnosed when people have at least half of their small intestine removed and sometimes all or part of their large intestine removed due to disease or injury and significant damage of the small intestine. Sometimes it is a congenital abnormality, where a baby is born with very short small intestine. Depending on the length, SBS may be mild, moderate or severe.
People with SBS cannot absorb enough water, vitamins, minerals, protein, fat, calories and other nutrients from food. Difficulty in absorbing nutrients depends upon the area of small intestine that is removed or non-existent. This inability to absorb nutrients and water causes severe and frequent diarrhea, weight loss and other symptoms related to loss of essential vitamins and minerals.
There are about 8 thousand new cases of SBS in the US, each year. About 65% of them are due to congenital or acquired defect. Typically pediatric patients die before they reach 3 years of age. Their short life is marked with TPN (Total Parenteral Nutrition) treatment where by nutrients are given directly into the bloodstream bypassing the gastrointestinal tract. Gattex (teduglutide) is a prescription medicine given through intravenous (IV) feeding or subcutaneous injection. Not only is it a costly treatment, averaging around 200-300K annually without much improvement but a baby would need to continuously be wearing or accompanying a backpack. Surgical treatment costs 150K to 400K and transplants cost over a million dollars and require life long care, possibility of rejection and infections and has about 5 year mortality for 50% of patients. NONE OF THE CURRENT TREATMENT OPTIONS RESTORE FULL BOWEL FUNCTION.
Eclipse Regenesis Solution
The Eclipse XL1 therapy is a restorative solution designed to grow a longer, healthy intestine rapidly in the course of 2-3 weeks. The solution is entirely mechanical and repeatable, without any harmful or toxic effects. Eclipse has devised a nitinol coil that is introduced into the small intestine via a stoma. Plication sutures are then applied outside the intestine to hold it in place. During the course of the therapy of 2-3 weeks, while the device is in place, nutrients continue to flow through the intestine. Over 2-3 weeks period, the coil gradually expands. As it expands, it gently pulls the small intestine, stimulating new tissue growth and lengthening the treated region 2 to 3 times. The solution is striking in its simplicity and beautiful uncomplicated. After expansion, the sutures dissolve, allowing the coil to move forward and finally get passed out naturally.
Besssette shared information on the team of co-founders with impressive credentials and answered various questions from the audience. Yes, the contractile function continues in the newly lengthened intestine, no the length sustains and does not snap back and the process is repeatable to produce clinical significant length of the intestine and all of these is indicated by the animal trials.
Small Bowel Syndrome is an orphan disease and as such the Eclipse XL1 has received a HUD designation (which requires incidence rate of less than 8000 new cases a year, in the US). Eclipse is anticipating using the HDE regulatory pathway which requires safety and probable benefit data. Eclipse plans to commercialize in pediatric market, in the near future.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on January 12, 2018
JPM 2018 and concurrent events just ended with what may be one of its biggest draws. As many as 10,000 people from life science industry and its related sectors are likely to have descended upon the city, during last four days. In addition to JPM event itself, everything health was under review and up for discussion at various conferences including at EBD Group & Demy Colten’s #BiotechShowcase #DigitalMedicine #BTS18 and #WuXiGlobalForum2018 . Networking and deal making continued late in the nights at various receptions held across the city. Receptions by legal firms like #WilsonSonsini #MoFoLLP #ReedSmithLLP attracted some of the biggest crowds.
Overall the tone for 2018, seemed highly optimistic. BiotechShowcase held a media roundup and echoes of optimism were heard from almost all panelists @barbara_ryan12 @TriangleInsight @CarolineYLChen @adamfeuerstein @statnews @SFBIZronleuty @BrittanyMeiling @endpts @juliet_preston @medcitynews @ldtimmerman .
There is a general agreement that the pace of #innovation in biotech greatly accelerated in 2017 and is likely to continue. According to Luke Timmeerman, “sheer velocity of news in healthtech innovation is fascinating”. Transformative therapies across huge and diverse range of diseases are increasingly focusing on cures and going beyond the short term treatment focus. The surge of innovation has been led by focus on oncology although concern was also raised in one of the panels that we still continue to get stymied and realize how friggin smart the disease of cancer is and if we will truly crack the code on cancer in the immediate upcoming years. All signs are however, that next year we may see critical data from some clinical trials in immuno-oncology space that can cause market spikes.
Here are some areas of concern raised in some of the panels. In 2017, a slight dip was observed in the areas of orphan and rare diseases. Also there seemed to be a general consensus that we need smart policies that incentivize new anti microbial drugs and other treatments for infectious diseases. Due to increasing resistance of antibiotics, there is an ongoing and real fear for some of the infectious diseases to turn into pandemics. These are areas that bold entrepreneurs may focus on. Also medical devices continues to remain somewhat underfunded. Discussions around accelerating healthcare costs and drug pricing issues creeped over into many panels. Entrepreneurs with disruptive pricing innovation in product development as well as healthcare can easily have a tremendous leverage. It can’t be overstressed that finding effective pricing solutions holds key to continued and sustainable growth in healthcare sector.
Discussion in one of the panels focused for a few minutes around large investments in life sciences and if that indicated a healthtech bubble that may be due for a crash. Indeed, some experts observed that pace of 2017 is unlikely to continue and there may well be a slight dip in 2018. But overall the consensus seemed to be, that a steep and deep pipeline of innovation in R&D is likely to prevent a crash, and the venture funding blizzard is likely to continue. Overall, the feeling among investors and healthcare experts was that among the industry, there is a strong focus on science and people are pursuing innovation with discipline that will ensure unprecedented mechanisms and novel medicines. All this activity is taking healthcare to a new level of cures and sustainability and stability from temporary treatment focus. Exciting indeed to be living in this era of amazing healthcare innovation.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on December 26, 2017
Biotech Showcase taking place concurrently with the J P Morgan event in San Francisco in January 2018, is an investor and networking conference. Many partnerships and collaborations will be forged with over over 7000 one on one meetings, with opportunities for eager innovators to seek out enthusiastic investors. Besides one on one meetings, general sessions will focus on a number of disease areas that are significantly expected to impact the healthcare arena. More blogs to follow and will highlight focus on new treatment modalities.
A panel led by Jennifer Goldstein from Silicon Valley Bank will focus on body’s largest organ that is often misunderstood and frequently underrated, the skin. Panelists Alan Dunton from Purdue Pharma, David Giljohann from Exicure, Jennifer Good from Trevi Therapeutics, Shelley Harman from Aegle and Mark Wilson from MatriSys will discuss early signs and symptoms on the skin that often signal infectious and internal diseases.
Antimicrobial resistance or (AMR) is increasingly a prominent public health concern and has been highlighted by both WHO and CDC. Since the discovery of first antibiotic penicillin in 1928, more than 100 compounds have been created but no new class has been found. In panel moderated by Bibhash Mukhopadhyay at New Enterprise Associates, leading anti-microbial drug development experts, Alan Carr of Needham, Julia Gregory from Contrafect, Kenneth Hillan from Achaogen, Gregory Mario from Taxis Pharma, John Rex from F2G, and Chris Stevens from Arsanis will discuss the tailwinds and headwinds in this space that is getting a fresh second look from both experts and investors.
Current epidemic of metabolic syndrome will be the focus in a panel moderated by Philip Kenner from ClearView with panelists Deborah Dunsire from DTuit, Tomas Landh from Novo Nordisk, Harith Rajagopalan from Fractyl Labs, and Wendye Robbins from Blade Therapeutics. Having any one of the risk factors like high blood pressure, high blood sugar, obesity, high cholesterol, or high triglycerides can greatly increase health risk. However having a cluster of these conditions together indicate metabolic syndrome and vastly increase health risk. Metabolic syndrome is on the rise, reaching epidemic proportions according to some health experts.
While JPM conference is by invitation only event, registration is open for Biotech Showcase at email@example.com or at https://ebdgroup.knect365.com/biotech-showcase/agenda/1