Does pfizer have and lab contracts in Ukraine?
Biopharma Takes a Decisive Position on the Russia-Ukraine Conflict
https://www.biospace.com/article/biopharma-takes-a-decisive-position-on-the-russia-ukraine-conflict-/
Published: Mar 01, 2022 By Heather McKenzie
In normal circumstances, corporate entities tend to stay out of politics. Particularly in conflicts happening halfway around the world, companies are inclined to remain silent, hoping not to bother anybody by compromising their neutrality. These, it seems, are not normal circumstances.
On Sunday, Boehringer Ingelheim tweeted a message of support for Ukraine, and announced it was standing in solidarity with the embattled Eastern-European country.
“We condemn the military aggression against Ukraine. We will contribute EUR 2.5 million to humanitarian relief funds for Ukraine and do everything we can to help our impacted colleagues, their families and communities,” the German biopharmaceutical company said in the tweet.
In a statement provided to BioSpace by Sanofi, the global multinational stated, "Sanofi expresses profound concerns about the tragic news coming from the war in Ukraine and condemns the use of force and the outbreak of any type of armed conflict."
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"Ensuring the safety and security of our colleagues in Ukraine and abroad remains our utmost priority," continued the spokesperson, speaking on behalf of Sanofi. "As of today, we can confirm that all collaborators in Ukraine are safe and sound. Second [Sanofi] is doing our best to ensure that medicines and vaccines, as well as humanitarian aid, can be supplied to those who need them."
The statement went on to say that Sanofi has several trials currently operating in the regions, and that the company has activated business continuity plans in order to serve patients and healthcare providers as much as possible.
On Monday, a group of around 400 CEOs was represented in a conversation with Yahoo Finance Live by Jeremy Levin, the chief executive of Ovid Therapeutics. Regarding the biopharma industry, Levin spoke to the situation surrounding clinical trials. There are currently more than 250 drugs and medical devices being tested in Ukraine.
“…the Ukraine clinical trials have already been disrupted. We are supporting the Ukrainians and also, the Russians who are protesting against their government. At the same time, we will not do anything to harm ongoing clinical trials. But by and large, the Russians have already done that. They've actually actively done it,” Levin said.
While insisting that biopharma leaders would not do anything to harm ongoing clinical trials in the region, Levin said they would not be starting any new ones, and he outlined the potential impacts. “The clinical trial business is a very big business. Russia targeted biotechnology and clinical trial business as a way of starting to get their feet wet in biotech. They created businesses in this area. Many in the West went to invest in those.”
One biotech company with a lot to potentially lose is Karuna Therapeutics, which has already spoken out about a Phase III trial it is concerned will be impacted. The trial is being conducted in the United States and Ukraine. Karuna anticipates that a top-line data readout of its EMERGENT-3 study of KarXT for schizophrenia will be disrupted.
Jefferies analyst Chris Howerton noted that other smaller biotechs such as Intra-Cellular Therapies, TG Therapeutics, Veru, Inc. and Applied Molecular Transport have at least some exposure.
Veru recently launched a Phase III trial assessing enobosarm, a novel non-masculinizing hormone, in second-line breast cancer. While approximately one-third of its non-U.S. trial sites were reportedly expected to be in Ukraine, the company has been able to pivot.
"For Veru, Ukraine is an important location for excellent international clinical sites to enroll patients with advanced cancers," Veru told BioSpace in an e-mail. "Currently, however, we will not be impacted as we have not opened up any clinical sites for our current enrolling trials yet. Therefore, we will focus our efforts on initiating other international clinical trial sites."
Also on Monday, GlaxoSmithKline CEO Emma Walmsley “utterly condemned” the invasion.
“We have just huge respect for the courage and resolve of the people of Ukraine, our people and the people beyond that, and want to do everything we can to help,’ Walmsley said in a statement. She added that the company was also helping its 400 employees on the ground in Ukraine, along with making contributions to humanitarian organizations like Save the Children and the Red Cross.
Larger multinationals with a presence in Russia and Ukraine include Biogen, Incyte and Eli Lilly. Biogen reportedly has several Phase III studies running in Russia, including one for Alzheimer's drug lecanemab, which lists a location in Moscow.
Today, the biopharmaceutical industry is very much a global business, and it is very clear that the current crisis in Eastern Europe is happening to the U.S., U.K, Germany and the world. It is happening to global clinical trials and employees working for the betterment of humanity.
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>There are currently more than 250 drugs and medical devices being tested in Ukraine.
notable
March 1, 2022
CureVac establishes RNA printer-specific company as light at the end of tunnel nears
Josh Sullivan
https://endpts.com/curevac-establishes-rna-printer-specific-company-as-light-at-the-end-of-the-tunnel-nears/
When CureVac CEO Franz-Werner Haas attended the inaugural mRNA health conference in 2013, there were just 80 people in attendance, largely from Moderna, BioNTech and his own company. Nine years later, there were nearly 1,000 people there.
Five years from now, Haas says, there will be groups of people from companies whose names he’s never heard of, thanks to the recent success and rapid development of mRNA technology. But they all face a key challenge.
“It can only be sped up if you have the manufacturing as well,” he said in a call with Endpoints News Tuesday.
By way of solution, CureVac has established a separate company — CureVac RNA Printer GmbH — to develop its RNA Printer, a portable microfactory for manufacturing that can be scaled up or down when needed. The system has advanced past the prototype stages, the company said, and CureVac is now in the process of establishing GMP certification.
Markus Bergmann
“We’re still in the process, but we can see light at the end of the tunnel, in the near future,” said Markus Bergmann, the newly appointed general manager of the company.
His first day on the job was Tuesday, and he came over from ZF Group in Germany. He’s held leadership roles at Rolls-Royce and McKinsey but started his career as a doctor in Tübingen, Germany after graduating medical school with a focus on immunology.
It’s hard to say exactly when the company will reach the light at the end of that tunnel, as much of it depends on regulators. But Haas did say that they expected the microfactories to print their first molecules within the next 18 months.
CureVac’s goal is to provide a machine that can produce any RNA, not just its own products. In the future, Bergmann and Haas see its printer producing personalized cancer medicines — such as mRNA-based cancer vaccines — and to rapidly supply mRNA vaccines in future pandemics.
Its first customer is CureVac AG, but high on Bergmann’s to-do list is landing other companies to collaborate with. While companies with comparable tech — such as BioNTech and its BioNTainer, have focused on taking an already-existing manufacturing process and making it portable, CureVac’s printer is focused on an entirely different manufacturing process.
It will have the ability to be scaled up and down, the company says, making it a suitable solution for anything from clinical trials to customized treatments in a hospital or university setting. The mRNA printer could even be used as a supplement to the BioNTainer, Haas and Bergmann suggested.
Tesla and Elon Musk will continue to collaborate with the CureVac AG side of things, Bergmann and Haas said in Tuesday’s call. Musk is a noted fan of the company, tweeting in 2020 that the mRNA printer is an “important product for the world,” though he has since deleted a number of tweets about the company.
Tesla does not have a financial stake in either company, but it has been collaborating with CureVac for a few years now. In 2019, Tesla’s German division and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac’s will try to use Tesla’s operations for speeding up the process, if it gains approval.
The new effort comes during a difficult for CureVac. Its Covid-19 vaccine flopped after trials showed an efficacy of just 47%. Florian von der Mülbe, the chief production officer and 22-year veteran of the company, shifted his focus entirely to the mRNA printer after the vaccine plans were scrapped.
In October, Haas acknowledged that CureVac was no longer part of the first wave of Covid-19 vaccines, and said that the company would shift its focus to a second-generation response.
chose poorly
indeed
o7