Covid updates – July, 2020

Here are some covid updates from last couple of weeks. I have gathered info from zoom sessions. For more details, accurate sources, and veracity, please research further.

• CA expecting 19000+ deaths by Nov. 1
• US covid deaths top 150,000
• More than 6,300 covid cases in the US, are linked to colleges
• After some decline in people dying, now daily death counts are rising in 21 states
• 47% (that is, almost half the population) of US adults have some underlying condition that slightly increases the chance of severe covid illness
• Blood glucose level of 7 or higher leads to 33% chance of dying 60% chance of contraction
• Spain had 2,255 more cases in last 24 or so hours.  Britain imposed quarantine on travelers from Spain
• WHO warns of new EBOLA outbreak in Congo
• China reports biggest virus spike since end of Wuhan outbreak
• India has the fastest growing coronavirus cases in the world
• 23% of Delhi residents seem to have antibodies 
• North Korea is reporting their first covid case
• Plastic visors in place of masks are NOT effective
• Israel & Japan experience huge spikes in covid cases
• Chinese study found that people with type 2 diabetes had shorter telomere length
• Study found that aerosoles in covid patients’ rooms, had live virus floating around even after 5-6 days
• Research found no transmission of covid from infected moms to newborn babies, even after 2 weeks of breast feeding with proper cleaning protocols
• In another study, pregnant women who had virus, their placenta also had virus
• Study says mosquitoes cannot pass on covid from infected patients to non infected patients
• From 3334 patients with covid in NY hospitalized, 16% had DVT, stroke or heart attacks
• Presence of virus in the gut likely means that virus takes longer to leave the system and would lead to higher risk of liver injury
• Spain study found that about 5% of those who contracted covid  in large cities had antibodies while only 3% of those of contracted covid near the coast, had antibodies
• In one study, over 50% of people who contracted covid show some heart damage
• 85 babies under age 1 tested positive in one county in Texas
• Overwhelming fatigue, palpitations, muscle aches are symptoms that linger for 4-6 weeks after recovery from covid

On potential vaccines & treatments & safety products

• There are 42 potential vaccines — Most in phase 1, 14 of them are in phase 2 and 4 are in phase 3 
• Oxford/ AZ vaccine results look good in phase 1 / 2
• China’s Sinopharm is in phase 3 trial for covid vaccine
• Cage Bio developed sanitizers that offers protection for up to 4 hours
• Steroid treatment slightly reduces the need for mechanical ventilation 
• A client has very exciting and fascinating prevention strategy. If interested in investing then let me know & I’ll put you both in contact.
• Boehringer Ingelheim identified 28 new antibodies to fight the virus

Coronavirus: Treatments and Vaccines

Recently a science teacher said that treatment for covid with remdesivir or hydroxychloroquine is better than a vaccine. I said, treatment like that is good but a vaccine is better. She said, “no. since many people get adverse reactions from vaccines, a treatment is better”. So I decided to write this blog post. First, let us consider what are drug treatments and how they are different from vaccines.

Drug treatments: Currently over 70 companies are working on various drug treatments for novel coronavirus. Although this virus is novel, not all drugs being considered are entirely novel. For instance, like the previously considered malaria drug, hydroxychloroquine, Gilead’s drug, Remdesivir, that is in the news, is not a novel drug. Remdesivir is a broad spectrum antiviral drug that has been found to successfully prevent MERS coronavirus in rhesus monkeys. Besides antiviral drugs, there are other anti-inflammatory drugs. Scientists believe that in the end, what might work may be a sort of a cocktail or some combination of antiviral and anti-inflammatory drugs.

Drug treatments do not prevent Covid-19. These drugs are offered to patients who are already suffering from coronavirus. On the other hand, vaccines prevent people from contracting the disease in the first place.  

Drug treatments are not cures. 1) there isn’t a 100% response rate among people treated with remdesivir or any other treatment. So despite many drugs showing promise, there are a few people who will respond to a drug; many still die. 2) many who suffer from the disease but go on to recover, they still utilize huge amounts of hospital resources during their illness phase. 3) during the illness phase, these sick people also spread the virus with the possibility of making others (including healthcare professionals) sick. 4) even people who may recover with the help of these drugs from covid, may have suffered substantial damage to their lungs and that may reduce their lifespan or affect them in other ways.

Vaccines:  Vaccines prevent people from getting sick. So when people don’t get sick, they don’t spread the virus, don’t utilize healthcare resources, don’t infect healthcare professionals or others in the community, and don’t get any kind of long lasting damage to their lungs. Clearly, vaccine is a far superior way to deal with coronavirus.

Why are vaccines taking much longer than drugs for covid?

As I mentioned above, many of the drugs considered currently for treatment of covid are already in existence for some other illnesses or diseases. So there are existing drugs considered for either preventing covid deaths or preventing people from becoming sicker and helping them recover faster and ending hospital stays earlier.

Vaccines on the other hand, have to be developed. There are considerable challenges at each stage of vaccine research, development and manufacturing. First of all, pharmaceutical companies have decreased vaccine research and development in the last several years, because vaccine development and manufacturing is expensive, time consuming and offers smaller payback in terms of revenues. For each new virus and for all mutations, the vaccine has to be developed and then when the virus is not active then the vaccine is not useful. Clinical studies take place during the research and development phase. Only if the studies show the vaccine to be safe and effective then the vaccine proceeds to the next phase where it has to be manufactured in large quantities required.

During a pandemic like this one, not only do we need a vaccine quickly but the world will also need  hundreds of millions of doses for the entire world population.  Fortunately, pharma companies, scientists from all over the world, billionaires like Bill Gates and Governments and countries have stepped up to tackle this challenge, with an unprecedented spirit of collaboration.  There are measured expectations for an effective vaccine to be available within 12 to 18 months. That is an unprecedented and highly aggressive timeline. Bill Gates has offered to support manufacturing of top 7 candidates during the research and development phase. That means, even without the proof of effectiveness of any of them, he will foot the bill for manufacturing all of them, in the hope that at least a couple of them will prove to be safe and effective and the world will get required doses speedily. Meanwhile, countries like India are getting ready for manufacturing of vaccines. India has proven capability and expertise to ramp up production of vaccines, while keeping costs down. Regulatory hurdles are likely to be less severe as US FDA and other regulatory bodies have promised EUA (emergency use authorization) for drugs and vaccines that may help contain covid.

If drugs like Remdesivir work then that will help some people recover and recover faster; so let us hope that any one of these drugs alone or in combination with other drugs will reduce mortality, shorten hospital stays, and help reduce spread of covid. But ultimately we need a vaccine for covid-19 and the way in which entire world is coming together, gives much hope for availability of a speedy vaccine.

Herd Immunity for Covid-19?

Have you noticed only politicians and some lay people talk about #HerdImmunity? Scientists and business people seem to be talking about #testing, cure and vaccines. Amazon is planning its own tests just for their own workforce. Some of my clients are doing the same. Chemicals for covid-19 diagnostic tests are hard to find but businesses may tap into their global connections to acquire them.

So what is herd immunity?

Herd immunity is an epidemiological concept coming from an idea that ultimately if enough people in a population are immune to a disease then it stops spreading. For instance, if 80 people out of 100 can’t get the disease than the 20 people who can get it remain protected because they may be unlikely to actually get exposed.   

Herd immunity can be achieved in a community in one of the two primary ways.

1) Vaccine access and acceptance:

If a significant number of people get access to the vaccine, they accept it and avail of the opportunity and become non carriers of the virus then even if 5% may not have gotten the vaccine, they may not get the disease because there may not be enough people to get it from. But we don’t yet have a vaccine for coronavirus.

2) Virus has a free rein: 

This is how the politicians have been speaking of herd immunity. Herd immunity is also connected to the argument that the best way to end the social distancing is to allow the virus to run free or at least almost free and in the end the population will achieve herd immunity. This sounds like a creative new idea rather than something horrifying that we should try to avoid at all costs. But let us remember that this only happens after VAST numbers in a population, get infected. So that requires us to “sacrifice the vulnerable on the altar of the economy in vast numbers.”

What kind of vast numbers of fatality might we be speaking of? As per some estimates, herd immunity for Covid-19 can occur after at least 60 to 70 percent of the population develops immunity.  That means at least 60 to 70 percent of the people have to first get infected. Moreover, these have to be random infections. That means, several people would die with a highly contagious virus running free in a society, before herd immunity is achieved.  This would overwhelm our healthcare system and several healthcare professionals would die while working in a high virus load environment.

Even with all our social distancing measures in place, we have a high death count that has brought healthcare system on the brink of overwhelm, in many places. In New York, a dense state with high international travel, there was a death count of almost 15,000 in a population of less than 10M. Healthcare professionals from several other geographical regions traveled to New York to lend help. Can you imagine every state taxed that way beyond their maximum capacity to care for the patients? And that is the reason that scientists and business leaders are not advocating herd immunity as an ultimate preventive measure. We can be lay people and choose to remain ignorant and spread the forwards and myths about herd immunity OR we can listen to what science has to say over what the politicians may be advocating.

Invention, Innovation and Entrepreneurial Thinking – Talk by Mir Imran

Mir Imran, CEO at www.incubelabs.com, spoke on “invention, innovation, and entrepreneurial thinking” at www.bio2devicegroup.org and www.eppicglaobal.org joint event at Wilson Sonsini, Goodrich & Rosati, Palo Alto.

There are many examples of innovation, in history, said Imran.  However, for the most part, innovation has been left to chance.  Imran said, it was important for him to think about how to turn innovation into a process, so that it can be made a daily practice inside an organization, and not be left to chance or a random occurrence.

Through examples and stories, Imran shared how innovation is practiced at Incube.  Incube is an applied research lab and was found in 1995.  Incube has evolved into a star incubator of companies, but is unlike other incubators, where external companies with promise, get incubated, in-house.  At Incube Labs, only in-house created companies are incubated, most of them originating from one or more of Imran’s patents.  

Imran said, “I am agnostic to technology”, and boasted of a world class multi-disciplinary team, at Incube Labs.  He said the only way one can excel while remaining agnostic to technology, is if one is a broad thinker and can embrace all technologies, so as to apply the most optimum solution for a problem.  At Incube Labs, all team members are compelled to work outside of their chosen field.  All team members pick up new skills and grow in breadth and depth, in the process.

Imran has found 28 companies, to date.  Twenty-six of them are in life science arena and 2 are in the area of security.  Despite his 400+ US patents and about 1500 foreign patents, according to Imran, filing patents, is not a measure of success, inventions don’t always translate into innovations; and even less frequently, they translate into entrepreneurial success.  Clearly, Imran has managed to translate his inventions into huge commercial success.

Some of Incube portfolio of companies

 

Imran discussed three different models of innovation.  Technology favored innovation model is frequently found in academic institutions.  The focus here is on finding applications and filing patents for a new technology that is invented, and then licensing the IP or starting a company around it.  The problem with this approach is that entire focus is on specific technology and on forcing it to fit a problem, said Imran.  Skill based innovation approach begins with applying a skill, and again it takes away from focusing on the problem.  

Imran then discussed his own need based model of innovation.  In this approach, innovation begins with identification of a poorly solved or unsolved problem.  Picking the right problem to solve, and framing it appropriately, assumes that one has the requisite broad background to understand the problem, and it is the single biggest challenge of innovation, said Imran.  Once the problem has been identified and defined, then one can focus on developing solutions and filing patents.  However, the entrepreneur must assume that an initial solution may be a partial solution.

The entrepreneur is called upon to analyze the commercial value of the solution and be prepared to “kill”, when a solution does not meet the required criteria.  Imran said, in previous models of innovation, the entire focus remains on the technology or the skill, and not on the problem.  One needs to be brutally honest when assessing the commercial viability of the identified problem, said Imran.  

Imran then discussed incremental vs. disruptive innovations.  An incremental innovation improves upon existing product or  service, resulting in an improved product or service.  In this model, there is lower risk, lower possibility of failure, and one operates in a crowded IP space.  Frequently large companies embrace this kind of innovation.  Disruptive innovation is when one develops a NEW way of describing a big problem, which may result in a highly impactful solution.  In this approach, there is higher risk, higher possibility of failure, and potential for strong IP.  Together, these two models form the innovation continuum, said Imran.  

At Incube, the process truly begins with finding worthy problems to solve.  It involves identifying the high level attributes of the problem, including the size of the problem, costs associated with the problem, identifying attributes of current solutions, including efficacy, side effects, cost, quality of life impact, understanding the progression of the disease, various biomarkers, genotypes and phenotypes that can be used for diagnosis and monitoring, and so on.   Even for viable problems, before launching a company, one must go through a focused risk analysis to identify market worthiness of solutions.  It should include detailed analysis for potential IP, efficacy and cost considerations, assessment of clinical trial length and costs involved, analysis of reimbursement issues, financing requirements, and potential for corporate partnerships.

Imran proceeded to discuss Incube’s commercialization process and how vertical integration at Incube enables efficient execution.  In recent years, because the cost of building life science companies has dramatically increased, there has been a compression of returns.  In order to reduce cost of building companies, Imran acquired Modulus, a contract manufacturing company.  This has enabled Incube companies to operate without requiring their own manufacturing capability, and has contained costs.  The venture funds, InCube Ventures and a crowd funding portal, VentureHealth, have enabled financing for the companies.

Imran shared examples and lessons learned from some of his past successes and how he has applied the lessons learned to his several current companies.  Neurolink  is focused on new pharmacologic drug therapy for epilepsy, with repurposing of an old cardiac drug.  One of his exciting new companies, Rani Therapeutics, is not focused on a specific disease, but on  delivering injectable drugs (biologics) orally, via smart pills and is thus providing a breakthrough solution for delivery of therapeutic peptides, proteins, antibodies, and vaccines and has demonstrated greater than 50% bioavailability in large animal models.  Imran said it is a truly disruptive, transformative technology, with strong patent position.  Intrapace is built around an implantable sensor based gastric pacemaker for the treatment of obesity.  Nfocus Neuromedical developed endovascular neurosurgery solutions to treat intracranial aneurysms, and was recently acquired by Covidien.  Also, Spinal Modulation, which developed a novel therapy for the treatment of chronic pain, was recently acquired by St. Jude Medical.

One of Imran’s companies, Intella Interventional, a cardiology company, ran into difficulties.  Imran managed to salvage it but he said he learned an important lesson, to not fall in love with the technology, and to not rely solely upon physicians to give the right answers.  “Also, talk to the skeptics”, said Imran.  Imran said he also learned from the failures of two of his companies.  From the failure of Surface Genesis, which had a flawed licensing model, Imran said he learned that he needed to do business modeling, earlier in the process.  His company, MDIsource was launched about 3-4 months before the market crash of early 2000, and it failed on account of bad timing.  Sometimes events outside your control can also have an impact.    

Imran said that in the course of his innovation journey, he learned several important lessons.  It is important to be current with the literature, and also listen to the naysayers.  However, entrepreneurship is a lonely journey.  In the end, an entrepreneur must be his or her own guide, and must be willing to blaze their own trail.  Despite deep knowledge and extensive literature review, successful entrepreneurs understand that published articles do not account for total truth, and they understand that 50% of scientific data is likely to be flawed or limited in some way.  Entrepreneurs must be willing to take risks, be willing to fail.  In the pursuit of innovation, failure is a constant companion and success an occasional visitor, said Imran.  He said, “question everything, including what I have said”.