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August 14 - September 25, 2020
Jim Greenwood, the CEO of the Biotechnology Innovation Organization (BIO).
we announced positive data in our Phase 2 trial in the very rare epilepsies, CDKL5 and Dup15Q. Then, on May 7, 2020, still locked down, we announced positive data in our Phase 2 trial in Fragile X. Looking to the future, we plan to deliver results from a large Phase 2 global trial in the rare epilepsies Dravet and Lenox Gastaut syndromes in the next few months, all on time. And finally, later in the year we expect to deliver results from our pivotal Phase 3 trial in Angelman syndrome.
Book seems largely like advertising so far for their various biotech ventures.
A vaccine against a novel agent and based on mostly novel platforms is complicated, and it may well be many years before a truly efficacious and safe vaccine is developed. A sobering reminder is that we are in our fourth decade of trying and still do not have an HIV vaccine.
The income inequality, already recognized as a significant social issue in this country, has now become a survival inequality. Along with new drugs and vaccines to fight the virus, we need to rethink our health care delivery system to ensure adequate access to all.
Income inequality is an overblown concern given the overall and dramatic increase in quality of life. See Steven Pinker's discussion of Gini coefficients in Enlightenment Now!. The discrepancy in survival among different ethnicity with covid-19 infection is quite possibly unrelated to differences in access to care or quality of care or differences of wealth (unless you automatically assume worse health with less wealth and even then it doesn't drill down on what is actually increasing the mortality numbers).
For example when Gilead developed a cure for hepatitis C infections, they were attacked for charging too much money for their drug. The fact that it saved society billions in future costs of liver transplants and treatment of liver cancer in patients with HCV was ignored.
In 1854,John Snow, a young English Doctor, published his new ideas on germ theory focused on the mode of communication of cholera. All the deaths from cholera were close to the Broad Street pump in London. Because of his unique view of the mechanism of disease transmission, he searched and found the well that was the water source of all the cholera cases he was investigating. Thus, Snow became the founding father of epidemiology. His search for scientific truth disproved the dominant theory, that plagues were caused by pollution or a noxious form of bad air, “miasma.”
During the 1918–19 influenza pandemic that killed over fifty million, around the world, scientists responded in ways they never had before. And because of that global pandemic, scientific institutions leaped into modern times, especially in the United States. Scientists had learned how to culture the polio virus and began to work on a vaccine, which about thirty-five years later became a savior to generations that followed. American medical schools and research centers like Rockefeller Institute (now Rockefeller University) became model centers for the world and the places for some of the
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In the 1940s, because of the discovery and synthesis of penicillin at Oxford, England, the world was changed. But it was a small chemical company in Brooklyn, New York, called Pfizer that manufactured it. Penicillin was one of the drugs that changed the lifespan of humankind. Pfizer is now one of the world’s great pharmaceutical companies working on a COVID-19 vaccine.
Oxford University is working with Astra Zeneca to try to move a new vaccine candidate forward. Abbott laboratories and Roche are helping with new diagnostics to be able to better determine who has been exposed to this virus and who has developed immunity. Jansen Pharmaceuticals, part of Johnson and Johnson, is also working on an exciting new vaccine using the spike protein of COVID-19. All of the biopharmaceutical companies that are working on new vaccines are moving things forward in record time to help society get through this pandemic.
I hope that this pandemic will teach people not to heed those who use soundbites to stoke animus against science and the industries science has spawned. I hope we come to understand that scientific innovation and scientific truth is what changes the world. It doesn’t change the world unless we in the biopharmaceutical world are encouraged to innovate and create.
Preachy scientism is pretentious and off-putting. Defend science as an epistemology and on it's practical accomplishments. Don't play veiled political games with it or hollowly virtue signal.
It is truly ironic that the sad emergence of COVID-19 has transformed the drug and biotech companies from being the bad guys (black hats) to the good guys as we try to contain and defeat this scurrilous, worldwide epidemic. It proves the fundamental raison d’être for these companies, namely, to improve the quality and longevity of life.
One in ten Americans suffers from one of 7,000 rare diseases; only 5 percent of those diseases have approved FDA treatments. Having a disease for which there is no cure is about the most tenuous, frightening way you can imagine living a life. Now, because of COVID-19, everyone in the world understands that fear—the fear of contracting a disease for which there’s no cure. It’s a psychological sea change.
am blown away by the premonition captured by a 2015 Nature Medicine paper, “A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence.” Not surprisingly, multiple authors on the manuscript were based in Wuhan, China. This may or may not have been a precursor to SARS-CoV-2, but we should have been more prepared. If you ask what we could have done, there is so much that it’s painful to even start.
And industry is doing all this for free. As in the Ebola crisis and other pandemics, biopharma companies have banded together to do what must be done, with no fanfare and no publicity. They should get full credit for their efforts. These companies are hardly perfect—just like the rest of us—but politicians who find them an easy target should open their minds and put down their cudgels. It is equally the job of reporters at mass-market business and consumer media to open their minds and understand and report on how the world really works, and who will ultimately provide the solutions to today’s
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Love in the time of corona “The world is too much with us; late and soon, Getting and spending, we lay waste our powers.… We have given our hearts away, a sordid boon!”—WILLIAM WORDSWORTH.
In the late second century AD, an estimated 10 percent of seventy-five million people in the Roman Empire died of what may have been smallpox, as the plague spurred the government and citizens to come together, adapt, and rebuild a society that emerged stronger than ever.3
together.
This piece is borderline Chinese agitprop. Bottomline is China lied and continues to lie about Covid-19, hiding its epidemiological data and intimidating its scientists to maintain whatever the party line is. The article should have been a strong denouncement of Chinese behavior concerning COVID-19.
Our world is populated by the best and the brightest, men and women who study for decades and work night and day to bring new medicines to people who need them. In the past few decades, our industry has too often been in the news for the wrong reasons and—based on a few bad actors—has been cast as a greedy industry that profits at the expense of people’s health. This poor image belies the dedication of the overwhelming majority of those who work to discover new medicines.
Cedric François is a Belgian physician-scientist and cofounder and CEO of Apellis, a global biopharmaceutical company pioneering therapies for conditions caused by the dysregulation of complement.
Absent drugs and vaccines, it will take years for sufficient herd immunity to develop so that society can resume.
This claim is possibly inaccurate. Some natural t-cell immunity exists in the population already and then there is the proportion already exposed plus those with cross-reactive immunity to SARS-CoV1 (though not really relevant to US pop.).
mAb114, which is one of the two treatments that showed some efficacy in the recent Ebola trial conducted in the Congo by NIH, and a pan-influenza-A antibody that recognizes every strain of Flu A that has arisen since the 1918 pandemic and will start Phase 2 trials for flu prophylaxis later this year. A number of years ago, we had isolated antibodies from survivors of the SARS-1 epidemic. When SARS-CoV-2 emerged, we went back to those SARS-1 antibodies to assess whether any of them were capable of cross-reacting with SARS-CoV-2. And of course we also screened antibodies from patients who
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We believe that antibodies that cross-react with an entire viral family, and therefore recognize an epitope that is highly conserved, are likely to have advantages as therapeutic agents because resistant mutants are less likely to arise.
George Scangos has been CEO of three biotechnology companies: VIR since January 2017, Biogen from 2010 through 2016, and Exelixis from 1996 to 2010.
VIR combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.
Governments around the world will try to tell their countrymen and women what a great job they have done and how things would have been so much worse without their prompt and decisive actions. As all Monday morning quarterbacks do, their critics, in the inevitable inquiries and investigations that will surely follow, will tell a different story of how unprepared and indecisive our leaders were and why, with the benefit of perfect 20/20 hindsight, our countries should have been more prepared, and should have taken bolder action sooner. The truth is likely somewhere in between, though I don’t
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As of the time of writing, there were 3,503,533 confirmed cases of COVID-19 and 247,306 recorded deaths globally.
Now approaching a million deaths though probably in excess given China's galse numbers.
Pfizer and the German biotech company BioNTech had initiated a partnership in mid-2018 to develop an mRNA vaccine for seasonal flu. This technology injects small sections of mRNA contained in tiny lipid “nanoparticles.” mRNA is the genetic material that carries instructions for a cell to make specific proteins, and if you can instruct a cell to make proteins found on the surface of a virus (an antigen), the body’s own immune system can mount a response to them and, potentially, provide immunity from any virus with that protein on its surface.
John Young is Pfizer’s chief business officer and a member of its executive leadership team.
Stéphane Bancel is chief executive officer and a member of the board of Moderna Inc.
Most viruses that have caused havoc in our lives are single-stranded RNA viruses. The list is long and includes such household names as HIV, hepatitis C, Zika, dengue, chikungunya, viral encephalitis, Ebola, and, not surprisingly, the multitude of coronoviridae culprits, led by SARS, MERS, and now SARS-CoV-2.
Most of the available effective drugs to combat RNA viruses are inhibitors of RNA polymerases, including sofosbuvir (Sovaldi), tenofovir (Viread), abacavir, 3TC, and more recently, remdesivir.
Jean-Pierre Sommadossi has spent his career battling viruses. He has built and lead companies that have successfully tackled hepatitis C, B, and HIV/AIDS, creating landmark therapeutics along the way. He is committed to world-class science, has authored over 150 papers, and holds over sixty patents. Atea is a biopharmaceutical company discovering and developing best-in-class therapies to address life-threatening viral diseases. In March 2020, the company pivoted all its efforts to develop an oral direct acting antiviral therapy for COVID-19.
John V. Oyler is BeiGene’s chair, cofounder, and CEO.
BeiGene Ltd. (Nasdaq: BGNE; HKEX: 06160) is a global biotechnology company. Its 3,800+ employees are developing novel cancer medicines to improve outcomes and access for patients worldwide.
Paul Hastings is the chief executive officer of Nkarta, a privately held biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer.
Christi Shaw is the CEO of Kite and also sits on the Gilead Leadership Team. She has full accountability for all aspects of cell therapy at Kite.
Since 2002, Dr. John Maraganore has served as the CEO and a director of Alnylam.
Pharmaceuticals and BIO Boards. Alnylam has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options.
Rachel King has spent nearly all her career in the biotechnology industry, with stints at small companies, big pharma, and venture capital. She is currently CEO of GlycoMimetics, a publicly traded company, which she cofounded. GlycoMimetics is a clinical-stage biotechnology company that uses a specialized carbohydrate-based chemistry platform to discover and develop novel drugs to address unmet medical needs. The company’s most advanced drug candidate, uproleselan, is in clinical trials treating patients with acute myeloid leukemia, or AML.
Richard Pops is the chair and CEO of Alkermes. He is member of the board of directors of Neurocrine Biosciences and Epizyme, both publicly traded biopharmaceutical companies, and also BIO and PhRMA, the industry’s principal advocacy organizations. Alkermes is a fully integrated, global biopharmaceutical company developing innovative medicines in neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders,
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Dr. Deborah Dunsire is president and CEO of H. Lundbeck A/S, the only global biopharmaceutical company singularly focused on restoring brain health so every person can be their best.
Beyond evaluating the benefits and risks of each potential medical countermeasure to treat the infected, control the spread, or prevent recurrence, many fundamental ethical questions must also be addressed. The most complex are these: Who decides the specific parameters of each clinical development pathway; how are the decisions made; and what are the near- and long-term impacts and implications of these decisions? Said differently, who decides “who shall live” and adjudicates the ethical implications of decisions that are inherent in the clinical development pathway for new medical
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What are the impacts of these risk/benefit decisions on the applicability of the resultant data to current or future patients in those other population segments? – Where in the disease progression is an experimental medical countermeasure best developed? For example, should the target patient population include only critically ill patients, those recently infected, or individuals who have never been exposed? – At what stage in the clinical or preclinical development process can a medical countermeasure be administered to humans?4 For example, is it acceptable for critically ill patients to be
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But speculation in the absence of data can be deadly. Decisions cannot be made or influenced by those who use hyperbole or promote false hope. External pressures and misstatements from private individuals (e.g. “antivaxxers”), members of the media, or government officials who do not clearly understand the complexities of and timelines for drug and vaccine development can only cause the misallocation of resources, create false hope and inappropriate actions, and harm those in true need of help.7
What level of risk should asymptomatic participants accept (or be allowed to accept) to help develop treatments for themselves or for others who are currently infected or might be in the future? Given different societal norms in different countries, will international regulators collaborate and share information to facilitate efficient approvals? And if not, can or should trial designs be altered, and what are the implications of such changes? Should some patient populations, e.g. the elderly, be asked or be willing to take higher risks to help accelerate the availability of new medicines?
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Kenneth I. Moch has been cofounder or CEO of five companies that pioneered novel therapies for life-threatening diseases,
An abhorrent lack of leadership is responsible for regression in people affected by degenerative diseases like KIF1A. Children with complex medical needs were forgotten as governments closed public schools. Special needs students who rely on services like physical therapy, occupational therapy, speech therapy, and other crucial interventions were sent home to isolation with no emergency action plan. Without consistent services, our children lose words, steps disappear, and skills vanish—skills that parents, therapists, and educators fight relentlessly to preserve. These vital therapies do more
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In developed countries, only a small percentage of the population is engaged in agricultural production. People no longer understand where their food comes from or how farmers and ranchers work diligently to provide that food. We’ve rightly heralded the many health care workers on the front lines of the pandemic, but without agricultural workers and others in the food supply chain, most of us would starve. Yet modern society seems to place little value on their efforts and ignores the challenges they face with every cycle of production.
For the agricultural biotech industry, it’s time to go on the offensive and proactively shape our future by promoting sound, science-based biotechnology innovations, a progressive and predictable regulatory framework, and transparency and engagement with consumers. These efforts will allow us to address the challenges of human, animal, and environmental well-being globally.
Sylvia Wulf is the president and CEO of AquaBounty Technologies Inc., leading its growth and commercialization efforts globally.
