IP Titan: Eyeing Israel’s Cradle of Innovation

I imagine myself zooming through space into the future programing my ship to land in a civilized highly advanced planet. Never could I have foreseen the message of leaders to their people, “Wear a mask, wash your hands, and keep 2 yards away from each other.”  Earth, your planet stands primitively still.

Titan of Innovation standing in the shadows may once again be summoned.

Russia’s Soyuz MS-16 and the Space X has successfully launched and landed in matter of hours. “Warp speed” or “light speed” space operations have sometimes resulted in catastrophes. But nothing like U.S.-Britain-Germany Warped Operations .

Success and innovation are not, however, always measured in terms of space and speed. “A company like Teva took more than 100 years to get there.” Quite a feat when compared to big pharmaceutical companies that have been around for several centuries.  

The Titan of Innovation standing in the shadows may once again be summoned. Eyeing “Pharma in Israel: building a global industry” we listen. “When you talk about pharmaceuticals in Israel, you have to talk about Teva,’ says Steven Tepper, senior research analyst for pharmaceuticals and biotechnology at Tel Aviv-based IBI Investment House.’ Teva Pharmaceutical is the company… with the richest history.”

Tepper points out that “even though they’re being marketed by Novartis or Pfizer or another company, we know that these products came from the industry here in Israel, and that would be our pride. Even though they are not coming from a so-called Israeli company, we know the IP was created and developed over here.” Right, but aren’t there both positives and negatives to not putting your name behind your product?

Did Israel sell its R&D on viruses leading to the highly coveted vaccine products only to reportedly pay Pfizer or others for it? Consider the Nature January 2017 published article Communication Between Viruses Guides Lysis-lysogeny Decisions.”  All four institute affiliations are in Israel.

Yuli Edelstein, Israel’s Minister of Health, in a recent interview on Britain’s HARDtalk seemed pleased with the percentages of Israelis vaccinated with the Pfizer vaccine. But what of the Palestinians? Edelstein, I imagine putting the R&D of viable vaccines in the hands of another “gets you off the hook” for supplying it. Either way, it’s a “win win.” Or is it?

R$D Gatekeepers

Pfizer, speaking of “win wins” and “selling out” what of the R&D on Alzheimer’s and Parkinson’s? According to Michael Hiltzik’s Los Angeles Times January article “Pfizer, pocketing a big tax cut from Trump, will end investment in Alzheimer’s and Parkinson’s research.”  Why?

Globally there are reportedly about 50 million people with Alzheimer’s and 6.5 million with Parkinson’s.  A number’s game? Johns Hopkins University  reported almost 100 million people with COVID-19 (96,823,968 global cases and 2,073, 866 global deaths). Right. More customers. Will you be “repositioning” the reported hundreds of unemployed researchers?

So here’s the Big Question, why would multiple “Big Pharma” and Biotech companies reportedly continue to conduct discovery and R&D of therapies and biosimilars for MS when reports indicate about 2.5 million people are affected globally compared to 50 million with AD?

Is it because AD life expectancy is reportedly less than 10 years? Right, MS is over a lifetime. Reminds me of “forever chemicals” attributed to corrupt chemical companies.

Interestingly, reports point to a company in the UK has conducted joint research with one such U.S. chemical company who was involved in litigation due to people incurring serious long-term adverse effects as a result from the chemical used in the manufacturing of their product(s). But aren’t pharmas and biotech just that, chemical companies?

Reading in March 2020 that “Berlin is trying to stop Washington from persuading a German company seeking a coronavirus vaccine to move its research to the United States, prompting German politicians to insist no country should have a monopoly on any future vaccine,” points to U.S. politicians’ continued failure to mandate that no company “have a monopoly on any future vaccine.”

Speaking of monopolies, let’s look at an early investor: “CureVac in 2015 and 2018 secured financial backing for development projects from its investor the Bill & Melinda Gates Foundation, working on shots to prevent malaria and influenza.” Straight path of operations between drug, tech, or biotech companies?

Mr. and Mrs. Gates, a statement is reportedly attributed to yourselves, “Like it or not, we’re in this together.” Dear Sir and Madame, does this mean we too will profit from the investment into CureVac? We like it!

Alas, the business of pharma and biotech has been criticized for controversial actions and/or market manipulation. In the health industry, it’s the “nature of the beast.” One stands out because of the deadly irony of incorporating the word “family” in the marketing of their products like bug spray and cleaners as well baby products, and now reportedly seeking approval for a vaccine.

Response to the pandemic appears to be by design – interconnectedness of lab partners.  Question is, had these partners, R$D Gatekeepers, been conducting R$D on virus vaccines all along?  

Competitors or Cartels?

Will the FIRST mRNA vaccine developer step forward and collect your prized patent: 

JOHNSON & JOHNSON (J&J) was reported in the October 3, 2013 article,  J&J’s Janssen Companies Launch a Trio of Collaborations “In the third agreement, Janssen Pharmaceuticals’ entity Crucell Holland inked a collaboration and licensing agreement with CureVac for the development of an influenza vaccine using CureVac’s RNActive® technology platform.” About a year later…

CUREVAC was highlighted in a 2014 article CureVac, Sanofi Paster in 150m-euro-plus vaccines deal “Germany’s CureVac and Sanofi Pasteur, the vaccines arm of Sanofi, have strengthened their partnership with a new deal that gives the latter rights to a new mRNA vaccine. Sanofi Pasteur has exercised its option for exclusive global rights to develop and commercialise the jab against an undisclosed pathogen…”   Let me guess, COVID-19?

GLAXOSMITHKLINE (GSK) In 04 October 2018, the article “Advances in mRNA Vaccines for Infectious Diseases was received and published in Frontiers in Immunology in March 2019 – one year before Pandemic was publicly announced.  

Is it coincidental that the authors were funded by an R&D program of China? Three of the authors, Cuiling Zhang, Hu Shan, and Junwei Li from the College of Veterinary Medicine, Qingdao Agricultural University, Qingdao, China. The fourth Giulietta Maruggi, (GM), Rockville, MD, United States.

Under the “Conflict of Interest Statement,” it reads “GM is an employee of the GSK group of companies and reports ownership of GSK shares and/or restricted GSK shares. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.”

Note: Article reads, “CZ, JL, and HS wrote this manuscript. JL and GM revised this manuscript.” 

An online search finds a Giulietta Maruggi on LinkedIn reported as “GM -Lab Head, Vector Biology Preclinical R&D US at GSK.” GSK is the acronym of a British multinational pharmaceutical company GlaxoSmithKline.

Note: Article reads, “CV7201 is an mRNA vaccine candidate under development by CureVac AG. i.d. and i.m. injection of CV7201 in mice and pigs induced potent humoral and T cell immune responses.” Does GSK have plans to join CureVac? Or Sanofi Pasteur in a vaccine partnership? Hadn’t GSK jointly ventured with Pfizer? Not be confused with the vaccine partnership, Pfizer-BioNTech.

Difficult keeping track of who’s with whom in the “Circle of BioPharma” That may be the point. And what of the reported inventor of the other vaccine, Moderna?

MODERNA was reported as a 2020 mRNA vaccine peeking the interest of both the private and public sector. President of the American Medical Association, Susan R. Bailey, M.D. shared on January 12, 2021 that we “have used this technology, mRNA, before but not at a commercial scale.”  Why is that?

Recall “More recently, live attenuated (LAV), subunit and peptide based vaccines have been developed thanks to advancements in molecular biology theory and technologies…LAVs elicit strong cellular immune responses, which are critical to eradicate many intracellular pathogens” (Zhang et al., 2019). Seems ideal to counter viruses. So what’s the problem?

It appears that “the failures that are sometimes caused by inactivated vaccines are ascribed to mutation of the surface antigens of pathogens…. the potential to cause disease in immuno-compromised individuals… the acquisition of compensatory mutations, or recombination with circulating transmissible wild-type strains”  (Zhang et al., 2019).  Anthony Fauci, Director of NIAID, recent referral to the newly found mutations as “wild types” may agree.

Dr. Fauci may have been privy to this information all along. My Academic Colleagues point to two Scholars in the U.S., State of California, Grace Lank and Jay Brewster from Pepperdine University, a 2020 alumna and a Professor of Biology, respectively. Their article, “The Promise of mRNA Vaccines” was included in the Summer 2020 Pepperdine University Magazine.

According to article, Grace Lank recently joined the research group of Anthony Fauci. If an alumna saw the “The Promise of mRNA Vaccines” as early as Spring or Summer when her paper was published, then it’s conceivable Dr. Fauci did too. Do not recall his publicly announcing it. Why?

Although some see mRNA vaccines as promising, the safety and efficacy for all participants has yet to be empirically and reliability established. Recent reports from the W.H.O. warn against the use of Moderna vaccine for pregnant women. Interestingly, for those prescribed Rebif for MS, “There are no adequate and well-controlled studies in pregnant women. Rebif should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”

Important reminder that “mRNA vaccine technology has still not extensively tested in humans… Despite the need for further optimization of manufacturing processes to generate mRNA vaccines… It is just a matter of time for RNA vaccines to be used in humans and animals(Zhang et al., 2019).   Or, “just in the knick of time” for the drug industry.

Early last Summer, Lank and Brewster argued that “The SARS-CoV-2 mRNA vaccines, if approved, would be the first to gain approval for use for vaccination of humans.” How early and right you were. Interesting, we don’t recall Fauci mentioning this to the public between March and June.

ASTRAZENECA? Reported actions by the company from nation leaders speak for themselves. To be fair, time will tell.

Clinical Trial & Error

AMA’s President Bailey stated on January 12, 2021 that centers for clinical trials for HIV were converted to conduct trials for the vaccines. This may explain in part the resurgence of two principal physicians of the 80s to address the 2020 pandemic, Anthony Fauci and Deborah Birx.

At a fraction of the U.S. population, Israel’s “high-quality research centres and a dense, genetically heterogeneous population make Israel a good candidate for hosting clinical trials, from the early-stage Phase I and Phase IIa trials ….” However, acceleration of the standard process of four phases to produce and supply a vaccine at Phase III seems to have provided a mass number of test subjects for drug trials in other countries. 

Drug companies can simply resume Phase III of the experiments in real time tracking their test subjects’ response to their product. However, “In a recent clinical trial of protamine complexed mRNA vaccine against rabies virus, the results showed that RNA complexed with protamine is safe and well-tolerated in vivo, but efficacy was highly dependent on the dose and route of administration. The efficacy of administration with a needle-free device was much better than with direct needle injection” (Zhang et al., 2019).

Candidates for clinical trials, physicians, and the public may not be privy to all the vaccine’s compounds or side effects. Drug description may not be complete or comprehensibly disclosed. Explanations typically point to proprietary rights. As a consequence, will the public be at risk of serious adverse reactions, being under or overly medicated?

In the aftermath of millions of willing participants, the drug and biotech companies are said to be able to assess “safety and side effects data” as noted by the President of the AMA.  I imagine those who dwell in cyberspace will too.

Conveniently, more data lead to more discovery. Attorneys representing clients in cases of bodily harm or death understand this nightmare. For the patient/client, it’s an endless criminal “clinical” trial.

Future: Outlicencing

In the U.S. and other leaders rush to vaccinate, the public lining up appear as cattle injected with antibiotics – strikingly similarity to those in developing countries. 

U.S. new President stated on January 25, 2021, “The Future Will Be Made in America.” Sir, Manufacturing and multinational pharma and biotech companies, regardless of their headquarters, operate across the globe. Sir, pride of products “Made in America” is something your county sold to other countries a long time ago, including to your ally, Israel.

Mr. President, not only is four years in office nowhere near the time necessary to change this but goes against your country’s interests. “Of particular importance is the lucrative US market, to which Israel is the fourth-largest supplier of pharmaceutical products.” Sir, before he set foot in the oval office, your predecessor appears to have understood this.

Sir, “The Past Was Made in America.”  The Present and the Future is in Israel and Nations who have long invested in it or recently closed deals. Financing may have been the challenge. “Israel’s Office of the Chief Scientist provides matching money in some cases, but external investors, from venture capital firms to angel investors, are still essential to get innovative biotechs off the ground, and few and far between in Israel.”

Future looks promising as one looks to the horizon as the sun rises. For pharma and biotech investors, the future is made in both the East and Middle East and sold to the West to be repackaged and sold around the globe. As Tepper reminds us, “the major model that’s working in the industry is outlicencing.” And as an old Western adage reads, “If it’s not broken, don’t fix it.”

 Man creates his beastly realities. He is his own monster and hero. MODERNITY and remedies in all their forms have taken the place of sword and shield and the primal earthly pains and pleasures of the flesh. -Leticia