Moderna, Inc.
ASSOCIATIONS - People
Stéphane J. Bancel (born 1972) - CEO (as of 2020/20201 ... [HK007R][GDrive] )
Paul Lewis Sagan (born 1959) ( "Throughout the COVID-19 pandemic, Sagan served as Senior Advisor and Executive-in-Residence at Moderna as a member of the Board of directors working on vaccine" ... [HK004K][GDrive] )
Ciaran Patrick Lawlor (born 1984) ( Scientist at Moderna in Nov 2013 - Jan 2016 , later worked at Boston Consulting Group in 2020 to provide USA COVID19 response guidance. )
Dr. Timothy "Tim" Alan Springer (born 1948)
" When [Moderna, Inc.] launched its IPO in December 2018, [Dr. Timothy "Tim" Alan Springer (born 1948)] became the company's fourth-largest shareholder and made $400 million, after investing $5 million in the startup early on " ( [HK00B2][GDrive] )
"[Dr. Derrick James Rossi (born 1966)] had developed a method of modifying mRNA first via transfection into human cells, then dedifferentiating it into bone marrow stem cells which could then be further differentiated into desired target cell types. Rossi approached fellow Harvard University faculty member [Dr. Timothy "Tim" Alan Springer (born 1948) ], who solicited co-investment from Kenneth R. Chien, [Robert Samuel Langer Jr. (born 1948)], and Venture Studio Flagship Ventures, run by [Dr. Noubar Afeyan (born 1962)]. Together they founded a company named from the combined terms "modified" and "RNA" that just happens to contain "modern". [HK007R][GDrive]
Dr. Michael S. Diamond (born 1964) - Dr. Michael Diamond was on the scientific board of Moderna, and identified in the 2018 SEC S-1 filing for Moderna ( see [HG00HU][GDrive] )
ASSOCIATIONS - Companies and Institutions
Formerly : ModeRNA Therapeutics (2010–2018)
Type : Public
Traded as :
NASDAQ-100 component
Russell 1000 Index component
Industry : Biotechnology
Founded : September 2010; 10 years ago
Founders :
Headquarters : 200 Technology Square / Cambridge, Massachusetts, U.S.
Key people
Stephen Hoge, President
David Meline, CFO
[Dr. Noubar Afeyan (born 1962)], Chairman
[Robert Samuel Langer Jr. (born 1948)], Director
[Paul Lewis Sagan (born 1959)], Director
Products : Vaccines
Revenue : US$803 million (2020)
Operating income : US$−763 million (2020)
Net income : US$−747 million (2020)
Total assets : US$7.336 billion (2020)
Total equity : US$2.561 billion (2020)
Owner (s) :
[Dr. Noubar Afeyan (born 1962)] (12.7%)
[Stéphane J. Bancel (born 1972)] (7.9%)
Robert S. Langer (2.9%)
Stephen Hoge (1.3%)
Number of employees : 1,500+ (2021)
Website : modernatx.com
Moderna, Inc (/məˈdɜːrnə/ mə-DUR-nə)[8] is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts. It focuses on vaccine technologies based on messenger RNA (mRNA).[1][9][10] Moderna's vaccine platform inserts synthetic nucleoside-modified messenger RNA (modRNA) into human cells using a coating of lipid nanoparticles. This mRNA then reprograms the cells to prompt immune responses.[11][12] Moderna develops mRNA therapeutic vaccines that are delivered in lipid nanoparticle, using mRNA with pseudouridine nucleosides. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis.[13]
The company's only commercial product is the Moderna COVID-19 vaccine. The company has 24 vaccine candidates, including vaccine candidates for seasonal flu, HIV, the Nipah virus, and a second COVID-19 vaccine that will be easier to store and administer than existing vaccines. In 2020, 65% of the company's revenues were from the Biomedical Advanced Research and Development Authority and 24% of the company's revenues were from other agencies of the federal government of the United States.[1]
[...]
History
2010–2016
In 2010, ModeRNA Therapeutics was formed to commercialize the research of stem cell biologist [Dr. Derrick James Rossi (born 1966)]. Rossi had discovered the works of Hungarian biochemist [Dr. Katalin Karikó (born 1955)] on RNA-mediated immune activation, which resulted in the co-discovery with American immunologist [Dr. Drew E. Weissman (born 1959)] of the nucleoside modifications that suppress the immunogenicity of RNA. This technology would later be licensed and used by Moderna and BioNTech to develop COVID-19 vaccines.[14]
[Dr. Derrick James Rossi (born 1966)] had developed a method of modifying mRNA first via transfection into human cells, then dedifferentiating it into bone marrow stem cells which could then be further differentiated into desired target cell types.[15][16] Rossi approached fellow Harvard University faculty member [Dr. Timothy "Tim" Alan Springer (born 1948) ], who solicited co-investment from Kenneth R. Chien, [Robert Samuel Langer Jr. (born 1948)], and Venture Studio Flagship Ventures, run by [Dr. Noubar Afeyan (born 1962)].[16][17] Together they founded a company named from the combined terms "modified" and "RNA" that just happens to contain "modern".[18]
In 2011, [Dr. Noubar Afeyan (born 1962)], the largest shareholder of Moderna, hired [Stéphane J. Bancel (born 1972)], previously an executive at BioMérieux and Eli Lilly and Company, as CEO.[16][11] Within 2 years of its founding, the company reached a unicorn valuation.[12]
In March 2013, Moderna and AstraZeneca signed a five-year exclusive option agreement to discover, develop, and commercialize mRNA for treatments in the therapeutic areas of cardiovascular, metabolic, and renal diseases, and selected targets for cancer.[11][19][20] The agreement included a $240 million upfront payment to Moderna, a payment which was "one of the largest ever initial payments in a pharmaceutical industry licensing deal that does not involve a drug already being tested in clinical trials",[19] As of May 2020, only one candidate has passed Phase I trials, a treatment for myocardial ischemia, labelled AZD8601.[a][22]
In September 2013, the company reported that it was able to improve heart function in mice and enhance their long-term survival with a "redirection of their [stem cell] differentiation toward cardiovascular cell types" in a significant step for regenerative medicine.[23][24] In October 2013, the company was awarded up to $25 million by DARPA to develop messenger RNA therapeutics.[25] In November 2013, the company raised $110 million of equity financing.[23]
In January 2014, Alexion Pharmaceuticals paid Moderna $100 million for ten product options to develop rare disease treatments, including for Crigler-Najjar syndrome, using Moderna's mRNA therapeutics platform.[26] Although CEO [Stéphane J. Bancel (born 1972)] expected the platform to enter human trials in 2016, the program with Alexion was scrapped in January 2017 after animal trials showed that Moderna's treatment would never be safe enough for humans.[11][12]
2018–2020
In 2018, the company rebranded as "Moderna Inc." and further increased its portfolio of vaccine development.[10]
In July 2018, the company opened a 200,000 square foot facility in Norwood, Massachusetts for manufacturing, preclinical and clinical work.[27][28]
In December 2018, Moderna became a public company via the largest biotech initial public offering in history, raising $621 million (27 million shares at $23 per share).[29][30][31]
Through year-end 2019, Moderna had accumulated losses of $1.5 billion since inception, with a loss of $514 million in 2019, and had raised $3.2 billion in equity since 2010.[10]
2020–2021: COVID-19 vaccine
[...]
The Moderna COVID‑19 vaccine, codenamed mRNA-1273 and sold under the brand name Spikevax,[32] is a COVID-19 vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). It is used in people aged 18 years and older to provide protection against infection by the SARS-CoV-2 virus, which causes COVID-19.[33][34] It is designed to be administered as two 0.5 mL doses given by intramuscular injection at an interval of four weeks apart.[35]
It is an RNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.
The Moderna COVID‑19 vaccine is authorized for use at some level in 53 countries including the United States, Canada, the European Union, the United Kingdom, Israel, and Singapore.[36]
In March 2020, in a White House meeting between the Trump administration and pharmaceutical executives, [Stéphane J. Bancel (born 1972)] told the president Moderna could have a COVID-19 vaccine ready in a few months.[10] The next day, the FDA approved clinical trials for the Moderna vaccine candidate, with Moderna later receiving investment of $483 million from Operation Warp Speed.[10] Moderna board member, Moncef Slaoui, was appointed head scientist for the Operation Warp Speed project.[10]
In July 2020, the Moderna COVID-19 vaccine candidate, mRNA-1273, was shown in a Phase I trial to be immunogenic in a small number of volunteers aged 18–55 years.[37]
As of November 2020, Moderna planned to sell the vaccine for $32-37 per dose.[38]
Phase III clinical trials were completed in December 2020; the vaccine had not been licensed for prophylactic use against COVID-19, although the Moderna and Pfizer COVID-19 vaccines had been approved for marketing under emergency use authorizations from the FDA and regulatory agencies in other countries.[39][40]
In November 2020, it was announced that the Moderna COVID-19 vaccine candidate (codenamed mRNA-1273), had shown preliminary evidence of 94% efficacy in preventing COVID-19 in a Phase III trial,[41] with only minor flu-like side effects. This led to its submission for emergency use authorization (EUA) as a COVID-19 vaccine in Europe, the United States, and Canada.[42][43] On December 18, 2020, mRNA-1273 was issued an EUA in the United States.[44] On December 23, 2020, it was authorized for use in Canada.[45][46] On January 6, 2021, it was authorized for use in the European Union.[47] On January 8, 2021, mRNA-1273 was authorized for use in the United Kingdom.[48]
On March 15, 2021, Moderna's second COVID-19 vaccine (mRNA-1283) was entered into Phase I clinical trials.[49]
Criticism
In February 2016, a Nature editorial criticized Moderna for not publishing any peer-reviewed papers on its technology, unlike most other emerging and established biotech companies, and compared its approach to that of the controversially failed Theranos.[50] In September 2018, Thrillist published an article titled, "Why This Secretive Tech Start-Up Could Be The Next Theranos",[51] criticizing its reputation for secrecy and the absence of scientific validation or independent peer-review of its research, though having the highest valuation of any U.S. private biotech company at more than $5 billion.[11][52] A former Moderna scientist told Stat: "It's a case of the emperor's new clothes. They're running an investment firm, and then hopefully it also develops a drug that's successful."[11]
Conflict of interest of board member
In May 2020, Moderna board member Dr. Moncef Slaoui resigned from the company to become Chief Scientist for US's "Operation Warp Speed", a group designed to accelerate the development of a COVID-19 vaccine. Slaoui continued to hold more than $10 million in stock options in the company in his new role while the federal government invested $483 million in the company to assist in COVID-19 vaccine trials. Senator Elizabeth Warren called the holding a conflict of interest and said Slaoui should have divested his options.[53]
CEO
CEO [Stéphane J. Bancel (born 1972)] has been criticized for hampering progress at Moderna because of his ego, his need to assert control and his impatience with setbacks. He has allegedly sent abusive emails and reprimanded and fired employees on the spot after failed experiments. Bancel sought employee retention techniques from the human resources departments of Facebook, Google, and Netflix. Before joining Moderna, Bancel worked in sales and did not have much of a career in the scientific fields.[11] Despite never having worked with RNA before, Bancel "is listed as a co-inventor on more than 100 of Moderna's early patent applications, unusual for a CEO who is not a PhD scientist".[11] He has been described by a former colleague as having a "warrior personality".[54]
See also
Notes
^ The relative success of AZD8601 is attributed to the fact that Moderna has been able to inject mRNA direct into the heart muscle without needing a drug delivery system. However, only the heart and some skin areas are capable of absorbing "naked mRNA".[21]
References
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- a b Pollack, Andrew (March 21, 2013). "AstraZeneca Makes a Bet on an Untested Technique". The New York Times. Archived from the original on November 16, 2020.
- ^ Weisman, Robert (March 21, 2013). "Moderna in line for $240m licensing deal". The Boston Globe. Archived from the original on November 16, 2020.
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- ^ "Our Pipeline". Moderna. Archived from the original on November 16, 2020. Retrieved May 19, 2020.
- a b Timmerman, Luke (November 20, 2013). "Moderna Vacuums Up Another $110M to Make Messenger RNA Drugs". Xconomy.
- ^ Zangi, Lior; Lui, Kathy O.; von Gise, Alexander; Ma, Qing; Ebina, Wataru; Ptaszek, Leon M.; Später, Daniela; Xu, Huansheng; Tabebordbar, Mohammadsharif; Gorbatov, Rostic; Sena, Brena; Nahrendorf, Matthias; Briscoe, David M.; Li, Ronald A.; Wagers, Amy J.; Rossi, Derrick J.; Pu, William T.; Chien, Kenneth R. (September 8, 2013). "Modified mRNA directs the fate of heart progenitor cells and induces vascular regeneration after myocardial infarction". Nature Biotechnology. 31 (10): 898–907. doi:10.1038/nbt.2682. PMC 4058317. PMID 24013197.
- ^ "DARPA Awards Moderna Therapeutics a Grant for up to $25 Million to Develop Messenger RNA Therapeutics". October 2, 2013.
- ^ Reidy, Chris (January 13, 2014). "Alexion, Moderna announce agreement to develop messenger RNA therapeutics". The Boston Globe. Archived from the original on November 16, 2020.
- ^ DeAngelis, Allison (July 17, 2018). "Moderna's $110M Norwood site built with expansion hopes". American City Business Journals.
- ^ MOLTENI, Megan (July 25, 2018). "Making Personalized Cancer Vaccines Takes an Army—of Robots". Wired.
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[...]
EVIDENCE TIMELINE
CAMBRIDGE, Mass., Jan. 8, 2015 — Moderna Therapeutics, a pioneer in the development of messenger RNA (mRNA) Therapeutics™, today announced the launch of Valera LLC, a new Moderna venture focused exclusively on the advancement of vaccines and therapeutics for the prevention and treatment of viral, bacterial and parasitic infectious diseases.
The vaccines work of Valera builds on a body of preclinical research at Moderna showing the ability of modified mRNA to express viral antigens in vivo and to induce robust immune responses. Valera’s therapeutic passive immunity programs will expand on Moderna’s research using mRNA to express antibodies that bind to viral and other targets. The robust data from these programs across a range of preclinical infectious disease models, together with the inherent, rapid turn-around time in creating novel mRNA constructs, provide Valera with a potentially powerful and versatile new platform for the creation of a broad array of vaccines and passive immunity therapies.
“We are thrilled to launch Valera to bring sharp focus to developing mRNA Therapeutics for a wide range of infectious diseases, which remain a hugely significant global health threat,” said [Stéphane J. Bancel (born 1972) , president and CEO of Moderna. “We believe that mRNA offers unique advantages when it comes to the rapid design and manufacture of new vaccines and therapies, and we have seen promising signs of efficacy in our preclinical work.”
Mr. Bancel will continue to serve as interim president of Valera. Moderna has engaged the global executive search firm Korn Ferry (NYSE:KFY) to recruit a president for Valera.
[Dr. Giuseppe "Pino" Ciaramella (born 1968)], former vice president and head of immunology and biotherapeutics at Moderna, will serve as chief scientific officer of Valera. Dr. Ciaramella has nearly two decades of global industry experience at AstraZeneca, Boeringher Ingelheim, Pfizer and Merck focused on the discovery and development of small molecule and biological clinical candidates, with a particular focus on antivirals and biotherapeutics. The plan in 2015 is for Dr. Ciaramella to hire and lead a team of 15 scientists to drive early-stage discovery and development at Valera.
Michele Keough, formerly with Moderna’s R&D strategy and operations group, will serve as head of programs and alliance management at Valera. Prior to Moderna, Ms. Keough served as senior director, program and alliance management at Genzyme, a Sanofi company, where she led several of Genzyme’s strategic partnerships with biotechnology companies.
Moderna is actively recruiting for the position of chief medical officer of Valera.
Valera will expand its team significantly in 2015 and will work out of Moderna’s Venture Labs at 320 Bent Street, Cambridge, Mass.
As [Moderna, Inc.] drew a harsh review from Stat, portrayed as a company in turmoil with an often embittered staff, the biotech unicorn named Howard Hughes investigator and University of Massachusetts Medical School Professor [Dr. Melissa Jeanne Moore (born 1962)] as its new CSO, now in command of its full mRNA development platform.
Moore was plucked from the company’s scientific advisory group at a crucial stage in Moderna’s development. The biotech has raised $1.9 billion so far — a huge amount by biotech standards — establishing a broad ranging preclinical effort to use patient cells as drug factories. That effort has now led to 11 development programs and a slate of new therapies waiting to enter the clinic.
“Melissa is an exceptional scientist whose knowledge and expertise in this area will have an enormous impact on Moderna,” said CEO [Stéphane J. Bancel (born 1972)]. “And, importantly, she shares our vision and commitment to help patients and improve lives. We could not be more thrilled.”
Thrilled is probably the last word you would hear Bancel use to describe the newly posted investigation at Stat, which claims that Moderna’s “caustic work environment” has driven away top staff at a time where “signs” have appeared that the company’s top projects are running into trouble. Bancel himself, reports Stat, is over-controlling, obsessed with secrecy and impatient with setbacks.
The story is heavy with criticism and anonymous finger pointing, but light on details. Moderna’s former CSO, Joseph Bolen, left last fall after two years at the company, which Stat used to illustrate its claims of a toxic work environment at Moderna. Bolen was pushed out, according to unnamed “insiders,” after being relegated to a small role. Bolen himself, though, declined comment. And Bancel says he tried to get him to stay on, unsuccessfully.
[Dr. Melissa Jeanne Moore (born 1962)] now gets a shot at either proving or disproving Stat’s claims at a time the company is nearing the rapids of mid-stage development, when it will have to start outlining specific proof-of-concept data on what its drugs can do. If the company can accomplish that with several programs, Bancel tells me he plans to file for an IPO.
At this stage, it’s fair to say that everyone is watching to see whether Moderna succeeds or fails. A failure would prove highly embarrassing for a lineup of top industry collaborators. Success would be groundbreaking.
[Dr. Melissa Jeanne Moore (born 1962)] herself had this to say in a prepared statement:
“As a member of Moderna’s Scientific Advisory Board, I’ve had a front row seat to experience their groundbreaking progress first-hand. And through my work at the RTI and with MassTERi, I’ve come to appreciate the power of academic-industry collaboration and entrepreneurship. My new role at Moderna is a natural next step in my own progression as a basic researcher passionate about translating our ever-increasing knowledge of RNA biology into products that improve the human condition. I look forward to working with the incredibly talented Moderna team and building stronger connections and collaborations between Moderna and academia, as we work to advance the promise of mRNA therapeutics as a completely new modality for creating the medicines of the future.”
NORWOOD, Mass., July 17, 2018 — Moderna Therapeutics, a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the opening of its state-of-the-art manufacturing facility in Norwood, Massachusetts.
The digitally-enabled and environmentally sustainable 200,000 square foot clinical development manufacturing plant was built to advance Moderna’s pipeline of mRNA-based medicines. Designed to Current Good Manufacturing Practices (cGMP) specifications, the site gives the company the capacity to develop materials for preclinical toxicology studies as well as Phase 1 and 2 clinical development programs, and to manufacture, test and run fill/finish operations for its portfolio of mRNA development candidates.
Today, Moderna has 21 programs in its mRNA pipeline, including potential treatments for different forms of cancer, rare diseases, infectious diseases and heart failure.
The new site also houses the company’s Personalized Cancer Vaccine (PCV) Unit for individualized supply batches of mRNA for potential personalized cancer vaccines. By making this direct investment in PCV next-generation manufacturing, the company can reduce the time it takes to manufacture a dedicated cancer vaccine for individual patients in clinical trials.
“The Norwood site is core to our long-term strategy, enabling us to leverage the potential of our mRNA platform, control our supply chain, and provide the necessary scale and flexibility to support the development of high-quality mRNA medicines for patients in the decades ahead,” said Stephane Bancel, CEO of Moderna. “Opening this new manufacturing facility in Massachusetts was also important as it enables close collaboration with our development and research teams in Cambridge as we advance our mRNA platform and science. We are excited to continue to work with state and local partners, leverage the remarkable innovation and talent from the Massachusetts life sciences and technology sectors, and create new biopharma manufacturing roles as we work to develop new medicines for people with serious and life-threatening diseases.”
“Our administration has reinforced our commitment to life sciences, health care and the digital health ecosystem by investing over $500 million for strategic investments to support companies in innovation and technology,” said Massachusetts Governor Charlie Baker. “Thanks to companies like Moderna, Massachusetts continues to be a global leader in the industry and we welcome their growth and investment in Norwood to support the manufacturing market here in the Commonwealth.”
Norwood Site Highlights
Workforce
More than 200 employees will work at the Norwood facility in a wide range of roles including production operations, manufacturing science and technology, quality control, engineering services, supply chain management and process development. Moderna has hired more than 150 people (full time and contractors) for Norwood-based positions since the end of 2016, and plans to add close to 50 additional manufacturing roles in 2018.
Digital Integration
The digitally-enabled site connects information systems, robotics and machinery to enable the continuous exchange of data and provide information on all manufacturing activities. Using advanced algorithms and analytics, over 7,000 events are monitored in real-time to help increase efficiency, ensure quality and maintain data integrity. Moderna has also created a paperless manufacturing environment, eliminating many manual and redundant processes.
Environmental Sustainability
As part of Moderna’s commitment to sustainability, the manufacturing facility was designed to achieve Leadership in Energy and Environmental Design (LEED) certification. Moderna is limiting energy use with advanced energy metering, LED lighting, and systems designed to reduce water usage by up to 25 percent. The site will have charging stations for nearly two dozen electric vehicles, and deploy air quality and efficient waste management systems. Next year, the Company will also add solar panels to provide renewable energy to the building.
“Our investment in Norwood brings us even closer to the industrialization of our mRNA platform,” said Juan Andres, Senior Vice President of Manufacturing for Moderna. “Norwood will allow us to own the end-to-end production of materials, run multiple programs simultaneously, and produce more than 100 cGMP batches annually in an automated and digitally-integrated environment. We believe this provides us with an important advantage as we work to develop multiple pipeline candidates for patients and to scale capacity to meet individual program demands.”
2020 (month of article unknown) - Pharmaceutical-Technology.com : "Moderna Therapeutics Clinical Manufacturing Facility, Norwood, Massachusetts ; US-based biopharmaceutical company Moderna Therapeutics opened a state-of-the-art good manufacturing practices (GMP) clinical manufacturing facility in Norwood, Massachusetts, in July 2018."
"Project Type : Clinical manufacturing facility / Location : 100 Tech Drive, Norwood, Massachusetts / Start of Construction : October 2016 / Estimated Investment : $110m"
Moderna Therapeutics' cGMP clinical manufacturing facility was built by Wise Construction. Credit: ISPE.
The facility won the ISPE’s Facility of the Year Award in 2019. Credit: Wise Construction.
The facility produces a range of mRNA therapies and vaccines for GLP toxicology, phase one and two studies. Credit: Ibbl.
US-based biopharmaceutical company Moderna Therapeutics opened a state-of-the-art good manufacturing practices (GMP) clinical manufacturing facility in Norwood, Massachusetts, in July 2018.
Moderna Therapeutics announced plans to build the facility in September 2016. The construction of the $110m facility was completed in early 2018.
The facility is located in a 200,000ft² building leased at UPLAND, a Class A office and research and development (R&D) building at 100 Tech Drive. The area was rented from real estate company Campanelli and its partner, venture capital firm TriGate Capital, for 15 years with options for renewal.
Moderna’s cGMP clinical manufacturing facility also won the International Society for Pharmacoepidemiology’s (ISPE) Facility of the Year award in 2019.
The facility manufactures a range of messenger RNA (mRNA) based drugs and vaccines for good laboratory practices (GLP) toxicology studies, as well as phase one and two studies. More than 200 jobs have been created by the manufacturing plant.
“Construction of the $110m facility was completed in early-2018.”
Details of the Moderna Therapeutics facility in Norwood
The GMP mRNA clinical facility is part of Moderna’s early development engine programme intended to advance its innovative class of mRNA drug pipeline. Apart from the facility’s construction, the programme includes collaborations with Charles River Laboratories and Pharmaceutical Product Development.
The collaboration with Charles River Laboratories helps in carrying out GLP toxicology studies and preparing investigative new drug (IND) filings to be submitted to global regulatory authorities. The collaboration with Pharmaceutical Product Development will help design and execute clinical trials to allow phase one and two clinical studies to be carried out.
Moderna is also developing an automated and digital enterprise by adopting cloud-based applications, which will help in the planning and execution of its mRNA pipeline. The company has also gained knowledge on the requirements of several regulatory authorities across the world to advance its programmes through the regulatory processes.
Details of the Moderna clinical manufacturing facility in Norwood
Covering a 200,000ft² total floor space, Moderna’s facility in Norwood offers state-of-the-art integrated end-to-end process facilities. It includes facilities for GMP manufacturing, pre-clinical operations and testing, a cancer vaccines unit and administrative offices.
The facility performs all manufacturing activities, from raw material production to active pharmaceutical ingredients (APIs), formulation, filling and finish, at one location. It produces 40 batches of GMP mRNA a year, which can be scaled up to more than 100 GMP mRNA lots in the future.
The site also has the company’s personalised cancer vaccine (PCV) unit for individual supply batches of mRNA for cancer vaccines.
Contractors involved in the project
Engineering and project management company DPS was awarded a contract to provide architectural, engineering and design services for the facility in October 2016. The contractual scope also includes construction management, commissioning, qualification and validation.
Boston-based architecture and interior design firm TRIA was awarded a contract to design clinical labs, offices, employee amenities and a conference room for the facility.
The subcontract for piping, heating, ventilation and air conditioning (HVAC) and plumbing were awarded to Kinetics and Harold Brothers.
Instrumentation and control system infrastructure was provided by Hallam-ICS, while automation and control systems were produced by Siemens.
Moderna selected Hereva Consultants to supervise the design, construction and commissioning.
Marketing commentary on Moderna Therapeutics
[...] Founded by Flagship Ventures in 2011, [Moderna Therapeutics] offers a range of therapies based on the mRNA drug technology platform targeted at areas such as oncology, immuno-oncology, cardio-metabolic, rare diseases and infectious diseases. A new class of drugs, mRNA therapeutics, generate human proteins and antibodies within patient cells to treat diseases caused by the lack of a fundamental protein.
Moderna is developing its mRNA therapeutics drug pipeline through its ventures focussed on a specific set of areas, namely Onkaido (oncology), Valera (infectious diseases), Elpidera (rare diseases) and Caperna (specific cancer vaccines).
The company has also formed strategic alliances with pharmaceutical and biotech companies such as AstraZeneca, Alexion Pharmaceuticals, Merck, Catalent and Vertex Pharmaceuticals to commercialise its drugs pipeline.
Moderna currently has 21 mRNA pipeline programmes, including treatments for multiple forms of cancer, rare diseases, infectious diseases and heart failure.
2021 (April 16) - FiercePharma : "Moderna cuts COVID-19 vaccine deliveries to Canada, U.K. amid European supply struggles"
by Noah Higgins-Dunn | Apr 16, 2021 5:02pmv / Saved PDF of source : [HW009P][GDrive]
The global COVID-19 vaccine supply is about to take another hit, but this time from Moderna. The mRNA drugmaker warned Friday that supply problems are forcing it to cut back deliveries to “a number of countries," including the U.K. and Canada.
Moderna, which has partnered with Switzerland’s Lonza to manufacture its vaccine known as mRNA-1273, pinned the reduction on deficits in its European supply chain, specifically to “human and material resources” needed to meet its production goals.
“The trajectory of vaccine manufacturing ramp-up is not linear, and despite best efforts, there is a shortfall in previously estimated doses,” a Moderna spokesperson told Fierce Pharma in an email, adding that it is maintaining close contact with national governments to plan deliveries.
While the company didn’t specify how many doses would be cut and where, Canada’s Procurement Minister Anita Anand said Friday that its shipments will contain 650,000 doses this month instead of the expected 1.2 million.
Moderna also warned up to 2 million of a planned 12.3 million shots scheduled for delivery in the second quarter would be delayed until the following quarter, according to a report from Reuters. However, a company spokesperson also told the news agency that its deliveries to the EU and Switzerland remain on track.
In its statement to Fierce Pharma, Moderna said it doesn’t stockpile doses to help smooth over delayed shipments, choosing instead to “facilitate immediacy of access by shipping doses to governments as released.”
“While this does provide the most immediate access to our vaccine, this process will by its nature result in a more variable supply on a week-to-week basis,” the company said.
Moderna noted in a supply update Tuesday that it’s delivered roughly 132 million doses globally so far, with approximately 117 million of those shots sent the U.S. through April 12. At that time, the biotech said it remained on track to deliver its second 100 million doses to the U.S. by the end of May, followed by another 100 million by the end of July. The company did not immediately respond to Fierce Pharma’s inquiry for an update on the status of its U.S. deliveries.
Moderna has previously estimated it could provide between 600 million to 1 billion doses of vaccine globally by the end of 2021 thanks to its work with Lonza. However, the Swiss CDMO's chief warned in late January that it could take a couple of months to get the company's three plants up to "cruising speed."
The reduced estimates come as countries around the globe, especially those in Europe, face crunched supply following safety concerns surrounding vaccines developed by Johnson & Johnson and AstraZeneca.
European regulators have been investigating a small number of rare and severe blood clots cropping up in some people who received J&J and AstraZeneca shots. Deliveries of J&J’s vaccine to the EU have been paused, and the use of AstraZeneca’s vaccine remains limited among individual countries.
2021 (May 04) - FiercePharma : "Moderna plans major expansion at Massachusetts manufacturing site to help boost COVID-19 vaccine supply"
by Noah Higgins-Dunn | May 4, 2021 2:45pm / Saved PDF of source : [HW009O][GDrive]
With plans to boost COVID-19 vaccine production into the billions of doses next year, Moderna is making major renovations at its Massachusetts manufacturing site that will more than double its size.
The mRNA developer on Tuesday said it plans to renovate its manufacturing site in Norwood, Massachusetts, from “a production and lab space to an industrial technology center.” That means expanding the facility, from 300,000 square feet to roughly 650,000 square feet through the acquisition of another building located on the same campus.
The expansion will boost Moderna’s COVID-19 vaccine production capacity at the facility by 50%. That increased output is expected to come into play in late 2021 and early 2022, Moderna said.
The latest renovations are part of the reasoning why Moderna recently accelerated its vaccine supply forecasts. The biotech announced late last week that it now expects to produce 800 million to 1 billion doses of its mRNA vaccine this year, with plans to grow production to 3 billion doses by 2022.
RELATED: Moderna blueprints plant upgrades to rev up vaccine supply to 3B doses a yearIn addition to a larger vaccine supply, the expansion will also support Moderna's continued mRNA vaccine development. The project will expand the company’s technical development capacity and preclinical production capability “with the goal of producing thousands of preclinical samples per month for research and development.”
It will also aid Moderna’s “focus and investment in technical capabilities, such as expansion of shelf-life stability and new pharmaceutical delivery forms such as prefilled syringes and lyophilized products,” the company said.
The Norwood facility, which first opened in July 2018, has been “core” to the company’s long-term strategy and has supported its mRNA advancement, including the technology used for its COVID-19 shot, CEO Stéphane Bancel said in a statement. Moderna did not disclose how much the expansion would cost.
While Moderna handles the bulk of its manufacturing work in the U.S., the company's European supply chain depends upon Swiss CDMO Lonza, which has struggled to hire enough specialized personnel for its vaccine production push, Bancel has previously disclosed.
Last month, Moderna had to cut back deliveries to “a number of countries," including the U.K. and Canada, following production problems in its European supply chain. However, Moderna has since said it would commit some of its cash to bolster drug substance manufacturing at its CDMO partners, including Lonza and Spain’s Rovi.
Almost all people hospitalized for Covid-19 are not vaccinated — 99.9% as of May to be exact, according to a recent Associated Press report.
Yet 13% of U.S. adults said they will “definitely not” get a COVID-19 vaccine as recently as late May, according to Kaiser Family Foundation COVID-19 Vaccine Monitor. Another 12% wanted to “wait until it has been available for a while to see how it is working for other people.”
Vaccinating the majority of the population is the best way to help avoid further surges from constantly evolving variants, like the current delta variant, which is quickly spreading in the U.S. and other countries.
Still, [Moderna, Inc.] co-founder [Dr. Noubar Afeyan (born 1962)] understands the hesitation to get a new vaccine.
“The vaccines came out in such a [short] timeframe that people assumed automatically, it can’t possibly be safe,” Afeyan said during a talk at a Solve at Massachusetts Institute of Technology event in May.
“In fact, many, many people were on television espousing the view that — experts for that matter — that if it’s done in less than five years, it’s got to be unsafe, all of which is untrue.
“Nevertheless, people get confused.”
What people might not understand is that extensive research was being done on mRNA technology and other mRNA vaccines for years. That decade plus of experience and the innovation of mRNA technology itself is what allowed Moderna to produce its Covid mRNA vaccine so quickly as the pandemic struck. And it could also change the future of medicine.
Here’s what you need to know about how the Moderna Covid-19 mRNA vaccine was developed.
The timeline: A vaccine in under a year
It is true that Moderna’s mRNA vaccine was ready remarkably fast, as was Pfizer’s.
Chinese scientists put the genetic sequence of the novel coronavirus online on Jan. 11. Over the next two days, the NIH and Moderna used it to plot out a vaccine.
Afeyan remembers getting a key call about the development of the Covid-19 vaccine. “January 21st, my daughter’s birthday.... I got a call from Davos [during The World Economic Forum] from the CEO of Moderna,” he says. [Stéphane J. Bancel (born 1972)] had been approached by a number of public health groups at the conference “urging” him to work on a vaccine.
“We literally decided overnight...to try and do this,” Afeyan said at MIT.
Moderna delivered the first doses of its Covid-19 vaccine to the NIH for testing on Feb. 24, 2020, and “the first Moderna shot went into a volunteer’s arm in Seattle on March 16, 2020,” according to Afeyan.
After testing the Moderna vaccine on 30,000 volunteers, on Dec. 18, 2020, the FDA authorized it for emergency public use, and three days after that, the first Moderna vaccines were administered to front-line health workers, according to Afeyan.
Over a decade of research to innovate mRNA as a ‘bioplatform’
One of the reasons Moderna’s mRNA Covid vaccine development moved so quickly is because scientists had been working with mRNA for years.
“Messenger RNA technologies have been in development from a basic science perspective for over 15 years,” [Kizzmekia "Kizzy" Shanta Corbett (born 1986)], the scientific lead for the Coronavirus Vaccines & Immunopathogenesis Team at NIH, who helped make the vaccine possible, told the NIH Record.
And Moderna has been working with mRNA technology “since its inception in 2010 for myriad therapeutic areas,” including cancer therapies, Afeyan tells CNBC Make It (by way of a spokesperson), and with clinical development of mRNA-based antiviral vaccines since 2015.
What Moderna did over many of those years was develop mRNA as what scientists call a bioplatform, which allows for speedier vaccine development. Bioplatforms are systems that can easily be scaled and tailored for many different diseases.
Traditionally, developing any vaccine essentially has been a bespoke effort.
“The benefits of a bioplatform is the ability to quickly redeploy the platform once established and refined — in the case of Moderna’s mRNA platform, to create and test new vaccines based on new viral sequences,” Afeyan tells CNBC Make It (by way of a spokesperson).
All of this makes mRNA vaccines virtually programable. Corbet and Bancel describe the process as “plug and play.”
“MRNA is always made of four same letters, Bancel said on the December Andreessen Horowitz podcast, “Bio Eats the World.” (MRNA is genetic material, similar to DNA, so its “code” is expressed with letters.) It’s “the four letters of life, like zeros and one in software,” said [Stéphane J. Bancel (born 1972)]. “This is like software or LEGO.”
“The only difference between” mRNA vaccines is “the order of the letter; the zeroes and ones of life,” Bancel said. “The manufacturing process is the same, the equipment is the same, with the same operators. It’s the same thing. And so this is why we could go so fast.”
Faster vaccine development in the future
Bioplatforms will effect change way beyond the Covid pandemic.
Judy Savitskaya and Jorge Conde, biotech investors for top Silicon Valley investment house Andreessen Horowitz liken how bioplatforms could change the biotechnology industry to what the advent assembly lines did for the auto industry: It “went from single ‘job shops’ in the early days of automobiles — where raw materials like steel and rubber crafted from start to finish by hand into a trickle of early cars — to assembly line production, with standard components that could be iterated for new models,” they wrote in a January blog post.
(Andreessen Horowitz is not an investor in invested in Moderna, Pfizer or BioNTech, according to a firm spokesperson.)
The Covid-19 vaccine is one example of how mRNA can be used.
Moderna has 24 mRNA vaccines and therapeutics under investigation, and 14 have begun clinical studies, according to the company’s quarterly investment documents published in May. Moderna’s pipeline of mRNA treatments include a zika vaccine, HIV vaccine and a cancer vaccine, to name a few.
The same dynamic enabled Pfizer and BioNTech, who collaborated to create the other mRNA Covid vaccine currently in use in the U.S., “to rapidly redirect its mRNA technology platform from cancer to COVID in a matter of weeks; the company estimates it can manufacture updated versions against emerging mutant strains in as little as six weeks,” Savitskaya and Conde write.
Pfizer and BioNTech are also working on an mRNA vaccine to prevent the flu.
″[T]hese programs are just the first in a long list coming that will benefit from the same underlying [bio]platforms,” wrote Savitskaya and Conde. “The rise of productive platforms will impact much more than just vaccines. It will transform all areas of biotech, from small molecule discovery, protein engineering, genome editing, gene delivery, cell therapy, and more.”
Even with all this hard work and innovation, even Afeyan says Moderna got lucky to be able to move as quickly as it did.
“I’m quite actually amazed,” Afeyan said at MIT. “Murphy’s Law was on vacation, was on sabbatical for a whole year, and so many things that could have gone wrong, simply did not.”
2021 (July 07) - TheVerge.com : "Moderna starts human trials of an mRNA-based flu shot ; It’s the next step for this vaccine technology"
By Nicole Wetsman Jul 7, 2021, 9:59am EDT / Saved PDF : [HM0073][GDrive]
Moderna gave its mRNA-based seasonal flu vaccine to the first set of volunteers in a clinical trial, the pharmaceutical company announced today. The start of the trial marks the next stage of the company’s work on this type of vaccine technology after the overwhelming success of its COVID-19 vaccine, which was built using the same strategy.
Before the COVID-19 pandemic, mRNA vaccines were still largely experimental, even as they were heralded as the future of vaccine development. People who get an mRNA vaccine are injected with tiny snippets of genetic material from the target virus. Their cells use that genetic information to build bits of the virus, which the body’s immune system learns to fight against.
The high efficacy of the mRNA COVID-19 vaccines made by Moderna and Pfizer / BioNTech was a major endorsement for this type of vaccine. Now, pharmaceutical companies plan to use this technology to fight other types of infectious diseases, including flu. The flu shots available each year in the United States are usually between 40 and 60 percent effective. The most common shots are made by growing the influenza virus in cells or chicken eggs, and then killing the virus so it’s no longer dangerous. It takes a long time to grow the virus, so companies have to start making the shots around six months ahead of time, based on predictions around which strain of the flu will be circulating that year.
Pharmaceutical companies hope that mRNA-based flu vaccines can be more effective than the traditional shots. Because they’d be faster to make, production wouldn’t have to start so far in advance, and they could theoretically be more closely matched with the type of flu spreading each season.
Moderna is the second group to start testing its mRNA flu shot in human trials — Sanofi and Translate Bio kicked off a trial this summer. Pfizer and BioNTech have been interested in mRNA flu shots for a few years, and they’re pushing forward with those plans as well.
Moderna says it hopes to eventually create combination vaccines that could protect people against flu, COVID-19, and other respiratory infections with one shot. “Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses,” Stéphane Bancel, chief executive officer of Moderna, said in a press release.
If flu shots using this technology prove to be safe and effective, it could also make us more prepared for a potential pandemic flu in the future. It’s a fairly simple process to design a shot that could target a new influenza virus. “[mRNA] gives us a very strong platform for a rapid response,” Rosemary Rochford, an immunologist at the University of Colorado, told The Verge last fall.
2022 (July) - The Moderna COVID vaccine is not available in Armenia. Why not? Their co-founder and largest shareholder is a supporter of Armenia (and is of Armenian ancestry)
https://covid19.trackvaccines.org/country/armenia/
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