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Overcoming the Challenges of Cell and Gene Therapy Facilities

Integrated Project Services describes how Inceptioneering, an early-stage planning process, can ease the shift from R&D to manufacturing.
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By Tom Piombino

For the cell and gene therapy (CGT) sector, recent years have been nothing less than phenomenal. For example, according to the Alliance for Regenerative Medicine, the sector has witnessed skyrocketing investment. The $7.5 billion raised in 2017 was more than tripled by the $22.7 billion raised in 2021.

Tom Piombino
Managing Director of the Americas, Integrated Project Services

Besides creating opportunities for CGT companies, such funding is creating a crunch for both real estate and talent. For example, in San Francisco, more than half a billion square feet of manufacturing space has been acquired by CGT companies in the past year. In Philadelphia, where academia is generating intellectual property in the CGT space at a torrid pace, more than one million square feet of new laboratory space is in development.

In North Carolina’s Research Triangle region—where vacancy rates have kept per-square-foot development in the $30’s range (as opposed to downtown Boston’s $100/square foot)—the competition for resources has placed a premium on selection and planning, as CGT programs shift from R&D, which occurs in science clusters, to manufacturing, which occurs in attractive suburban markets.

This shift is a huge challenge for CGT companies. The transition from research and preclinical development to process development and clinical manufacturing is rough. Some stakeholders underestimate the difficulties of taking their businesses to the manufacturing phase, and they end up treading water in a sea of limited options. While the pandemic significantly impacted the office market, many of the available and proposed building conversions cannot provide the rigor or meet the cost expectations of a manufacturing facility.

Site selection in today’s market goes beyond engineering and real estate. It requires bringing knowledge and talent to appreciate the perspectives of more diverse workforces and company cultures while sustaining market growth, promotion, and compliance. From an organization’s project inception, unity of the resources early in a planning process offers owners the perspectives needed to make the right decisions for their businesses while focusing on the big picture of bringing groundbreaking therapies to market. All too often, these decisions are predicated on immediate needs (2 years out) or currently available resources, instead of a vision of technological progress (10 years out).

Inceptioneering

Site selection can be daunting for the most seasoned real estate professionals, and even more so for people whose expertise is outside of the field. Selecting an attractive site—one with the proper structural capacity, heights, utilities, workforce availability, access to transportation, access to parking, and amenities—can quickly become an all-consuming task for an operating company. Additionally, predicting the needs and wants of a workforce in a transitionary state, post-pandemic, adds another dimension of complexity for people’s whose day job is attending to developing science.

Much like an engineering design process, the building out of early-stage GCT facilities requires a deliberate approach with input from experts whose knowledge in various fields benefits the project as a whole. It must start at the business case inception, utilizing a well-rounded team that can streamline the process and thoroughly explore solutions while addressing needs and challenges across the organization. While speed is incredibly important at this stage, attempts at seeing this inceptionary process as a transaction often result in a misrepresentation of the required outcome.

Using applied experience and several iterations, an experienced project team with an understanding of the business case can recognize trends, similarities, and the opportunities to quickly adapt the solutions that can be acted upon in weeks rather than months. If this approach is taken from the inception of a project, owners can realize considerable benefits and avoid distractions from their day jobs.

First, it brings into focus a clear multiyear plan addressing the operational needs of the organization: Who will need to be hired for research, quality control, manufacturing, maintenance, packaging, and shipping, among other positions? How can an organization build its culture during the growth period? What kinds of efficiencies are needed in the facility? What impact will the operational costs have on funding resources? How does residual value of the asset impact the investor appetite in a facility?

Second, it brings more value to the effort by helping owners explore costs and schedules from the outset. If owners begin months later, during conceptual design, they may belatedly discover that they could have been better positioned to seize growth opportunities.

Optionality

Planning for companies in a fast-growth period can be daunting, especially in a real estate environment as competitive as the one that currently exists. Company leaders versed in other aspects of the business such as R&D may not have a sense of how much space will be needed in the long term, or of how much effort will be needed to ensure a space meets requirements such as staying up to code.

Onboarding the project team early on can be key to making a project successful because it streamlines the iterative process. By working closely with owners at the inception of the project, team members learn what works for organizations and what does not, building upon the plan as it progresses.

It also develops trust and confidence—two elements that are especially valuable when the team needs to be flexible in the exploratory phase of project planning. Not only do these elements empower team members to present multiple options, including unconventional options, it gives them the space to learn from feedback and converge on the right solution.

Integrated Project Services biomanufacturing facility
The creation of biomanufacturing facilities, including those devoted to cell and gene therapies, can be facilitated by EPCMV companies. (EPCMV stands for Engineering, Procurement, Construction Management, and Validation.) Integrated Project Services (IPS), a leading EPCMV company, can help clients establish cell and gene therapy by leveraging its experience in cell culture, single-use systems, and process design.

When evaluating options, organizations have to focus on important factors for each element of the plan:

Site: This is about more than the location of the facility. The site plays a key role in meeting the organization’s current goals and serves its future growth. With those near-term and long-term goals prioritized, the team can address details such as the need to include multi-floor manufacturing facilities or loading docks capable of accommodating particular types of vehicles.

Also, not to be overlooked in site selection is customer access. Ensuring that an organization’s key audience can easily access these facilities—whether they are in urban areas, which may present traffic and parking difficulties, or in smaller markets, which may not be as easily accessible by commercial transportation—will be a factor in the decision-making process.

Space: The rapid growth in the CGT market puts space at the forefront of planning for small companies. How big does a new facility need to be? What features will need to be included? Can the current building stock in a market serve an organization’s needs, or will a greenfield development be required? Much of the real estate market is developer-driven rather than company-driven, which has both benefits and challenges.

In a developer-driven project, a facility may be fitted out to serve as a manufacturing nexus for cell therapies, gene therapies, and biologics. Alternatively, a facility may meet a particular manufacturing need, once the developer determines the appropriate scale reviews a few solutions. While there are few standard solutions that fit all CGT companies, by taking standard ideas and measuring the options to the needs, organizations can streamline the process by tailoring elements to their requirements.

Brand: More than being about aesthetics, a facility’s appearance has the ability to tell an organization’s story, from its culture to its future plans. While a warehouse can serve a company like Amazon quite effectively, for growing CGT companies wanting to attract top talent and top funders, the impression that a facility presents impacts the mission of the company as well as how an organization can differentiate itself from other companies in a competitive marketplace.

Expectations: There are a lot of companies that can get derailed early on in the process, as their expectations can deviate from reality.

Cost + function + strategy

For owners coming out of institutions that are not well placed, moving to a central location might put them in greater proximity to talent. It also could come with significant extra costs in rent, construction, and operations. Rents within regions, not just
between regions, can swing significantly.

However, organizations also must be honest when considering the costs. For example, is $22/square foot for rent in the suburbs more cost effective compared to $55/square foot near a city core if it means sacrificing the ability to recruit talented people who refuse to work in the suburbs?

In addition, with space at a premium, can an organization live with a real estate strategy that might require a stepped approach to growth? In the rapidly expanding CGT markets, many companies moving from research to trials to manufacturing have compromised on facilities that are too small or in the wrong location, putting growth strategies at risk.

The demands on CGT companies are different from those on other companies. Even as biopharma players have moved into the market, the competition has only increased the difficulty of coping with the market’s growth.

The move from research to preclinical trials to clinical manufacturing is occurring at such a pace that it is leaving some companies waiting at a crossroads without a complete strategy on moving forward. By engaging technical and subject matter experts as part of a project team early in the process, organizational leaders can make decisions that will position their organizations for years of growth.

 

Tom Piombino (tpiombino@ipsdb.com) is managing director of the Americas for IPS—Integrated Project Services. For more information on the Inceptioneering process, please visit www.ipsdb.com/expertise/services/inceptioneering.

The post Overcoming the Challenges of Cell and Gene Therapy Facilities appeared first on GEN - Genetic Engineering and Biotechnology News.

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Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

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Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

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The Coming Of The Police State In America

The Coming Of The Police State In America

Authored by Jeffrey Tucker via The Epoch Times,

The National Guard and the State Police are now…

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The Coming Of The Police State In America

Authored by Jeffrey Tucker via The Epoch Times,

The National Guard and the State Police are now patrolling the New York City subway system in an attempt to do something about the explosion of crime. As part of this, there are bag checks and new surveillance of all passengers. No legislation, no debate, just an edict from the mayor.

Many citizens who rely on this system for transportation might welcome this. It’s a city of strict gun control, and no one knows for sure if they have the right to defend themselves. Merchants have been harassed and even arrested for trying to stop looting and pillaging in their own shops.

The message has been sent: Only the police can do this job. Whether they do it or not is another matter.

Things on the subway system have gotten crazy. If you know it well, you can manage to travel safely, but visitors to the city who take the wrong train at the wrong time are taking grave risks.

In actual fact, it’s guaranteed that this will only end in confiscating knives and other things that people carry in order to protect themselves while leaving the actual criminals even more free to prey on citizens.

The law-abiding will suffer and the criminals will grow more numerous. It will not end well.

When you step back from the details, what we have is the dawning of a genuine police state in the United States. It only starts in New York City. Where is the Guard going to be deployed next? Anywhere is possible.

If the crime is bad enough, citizens will welcome it. It must have been this way in most times and places that when the police state arrives, the people cheer.

We will all have our own stories of how this came to be. Some might begin with the passage of the Patriot Act and the establishment of the Department of Homeland Security in 2001. Some will focus on gun control and the taking away of citizens’ rights to defend themselves.

My own version of events is closer in time. It began four years ago this month with lockdowns. That’s what shattered the capacity of civil society to function in the United States. Everything that has happened since follows like one domino tumbling after another.

It goes like this:

1) lockdown,

2) loss of moral compass and spreading of loneliness and nihilism,

3) rioting resulting from citizen frustration, 4) police absent because of ideological hectoring,

5) a rise in uncontrolled immigration/refugees,

6) an epidemic of ill health from substance abuse and otherwise,

7) businesses flee the city

8) cities fall into decay, and that results in

9) more surveillance and police state.

The 10th stage is the sacking of liberty and civilization itself.

It doesn’t fall out this way at every point in history, but this seems like a solid outline of what happened in this case. Four years is a very short period of time to see all of this unfold. But it is a fact that New York City was more-or-less civilized only four years ago. No one could have predicted that it would come to this so quickly.

But once the lockdowns happened, all bets were off. Here we had a policy that most directly trampled on all freedoms that we had taken for granted. Schools, businesses, and churches were slammed shut, with various levels of enforcement. The entire workforce was divided between essential and nonessential, and there was widespread confusion about who precisely was in charge of designating and enforcing this.

It felt like martial law at the time, as if all normal civilian law had been displaced by something else. That something had to do with public health, but there was clearly more going on, because suddenly our social media posts were censored and we were being asked to do things that made no sense, such as mask up for a virus that evaded mask protection and walk in only one direction in grocery aisles.

Vast amounts of the white-collar workforce stayed home—and their kids, too—until it became too much to bear. The city became a ghost town. Most U.S. cities were the same.

As the months of disaster rolled on, the captives were let out of their houses for the summer in order to protest racism but no other reason. As a way of excusing this, the same public health authorities said that racism was a virus as bad as COVID-19, so therefore it was permitted.

The protests had turned to riots in many cities, and the police were being defunded and discouraged to do anything about the problem. Citizens watched in horror as downtowns burned and drug-crazed freaks took over whole sections of cities. It was like every standard of decency had been zapped out of an entire swath of the population.

Meanwhile, large checks were arriving in people’s bank accounts, defying every normal economic expectation. How could people not be working and get their bank accounts more flush with cash than ever? There was a new law that didn’t even require that people pay rent. How weird was that? Even student loans didn’t need to be paid.

By the fall, recess from lockdown was over and everyone was told to go home again. But this time they had a job to do: They were supposed to vote. Not at the polling places, because going there would only spread germs, or so the media said. When the voting results finally came in, it was the absentee ballots that swung the election in favor of the opposition party that actually wanted more lockdowns and eventually pushed vaccine mandates on the whole population.

The new party in control took note of the large population movements out of cities and states that they controlled. This would have a large effect on voting patterns in the future. But they had a plan. They would open the borders to millions of people in the guise of caring for refugees. These new warm bodies would become voters in time and certainly count on the census when it came time to reapportion political power.

Meanwhile, the native population had begun to swim in ill health from substance abuse, widespread depression, and demoralization, plus vaccine injury. This increased dependency on the very institutions that had caused the problem in the first place: the medical/scientific establishment.

The rise of crime drove the small businesses out of the city. They had barely survived the lockdowns, but they certainly could not survive the crime epidemic. This undermined the tax base of the city and allowed the criminals to take further control.

The same cities became sanctuaries for the waves of migrants sacking the country, and partisan mayors actually used tax dollars to house these invaders in high-end hotels in the name of having compassion for the stranger. Citizens were pushed out to make way for rampaging migrant hordes, as incredible as this seems.

But with that, of course, crime rose ever further, inciting citizen anger and providing a pretext to bring in the police state in the form of the National Guard, now tasked with cracking down on crime in the transportation system.

What’s the next step? It’s probably already here: mass surveillance and censorship, plus ever-expanding police power. This will be accompanied by further population movements, as those with the means to do so flee the city and even the country and leave it for everyone else to suffer.

As I tell the story, all of this seems inevitable. It is not. It could have been stopped at any point. A wise and prudent political leadership could have admitted the error from the beginning and called on the country to rediscover freedom, decency, and the difference between right and wrong. But ego and pride stopped that from happening, and we are left with the consequences.

The government grows ever bigger and civil society ever less capable of managing itself in large urban centers. Disaster is unfolding in real time, mitigated only by a rising stock market and a financial system that has yet to fall apart completely.

Are we at the middle stages of total collapse, or at the point where the population and people in leadership positions wise up and decide to put an end to the downward slide? It’s hard to know. But this much we do know: There is a growing pocket of resistance out there that is fed up and refuses to sit by and watch this great country be sacked and taken over by everything it was set up to prevent.

Tyler Durden Sat, 03/09/2024 - 16:20

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