In the Lab, Discovery As the World Changes

my story at Academic Pharmacy Now

As data science changes the way drugs are discovered and developed, pharmacy schools are exploring the possible benefits for research and patient care.

At the Quantitative Biosciences Institute at the University of California San Francisco School of Pharmacy, there were hints in January that the world was changing. As the coronavirus pandemic began to emerge on the West Coast, much of academia was on vacation. Inside the QBI scientists scrambled, trying to figure out something massive and unknown: what made the coronavirus tick. Over the next few months, the lab went full bore to examine the intricacies of the coronavirus, spilling its research across three countries and enlisting more than 200 scientists.

QBI Director Dr. Nevan Krogan formed the QBI Coronavirus Research Group, eyeing multiple research projects related to COVID-19. Researchers pooled their expertise in biochemistry, virology, and structural, computational, chemical and systems biology to understand the intricacies of how the coronavirus effectively undermines human cells to replicate itself rapidly, enabling spread to others, and what could be done to thwart it. They began to explore immense possibilities in their research: rapid diagnosis using gene-editing technology to track the spread and evolution of COVID-19, and diagnosing infected patients with no or minimal symptoms.

The researchers tapped into the world of data science, which is constantly evolving and changing the way drugs are discovered and developed and how treatments are delivered to patients. Pharmacy schools are moving forward to be part of this trend, especially in research, where data and computational methods are becoming a major part of pharmaceutical and health sciences.

For Krogan, his around-the-clock work with his research team was an opportunity to embrace research unburdened by bureaucracy and focused on a team approach welcoming to students. “We had a foundation for collaboration, which doesn’t happen overnight. It was expedited in an exciting way,” Krogan said. Noting the progress that the multidisciplinary team made, he said similar academic work “would have taken a year, but it came together in a few weeks.”

As the QBI Coronavirus Research Group set out to uncover the human proteins enabling the coronavirus to spread, it looked at how human and virus proteins interact and studied the clusters they formed. In the meantime, the team identified at least 75 over-the-counter prescription and development-stage drug compounds that they said had the potential to target cellular proteins that are possibly “hijacked” by the virus to promote its spread. The Krogan team, which included 38 scientists, made maps of cells both in healthy and disease states and disseminated the information around the world for other researchers to examine.

Data Opening Doors

“It’s all data-driven, what we piece together in this pipeline, and show how fast it can move,” Krogan said. “We interface and try to find the right targets to have an integrative suite of tools for the underlying biology. It’s sharing across the board and it is done in a more fully open way across academia.“

At the University of Florida College of Pharmacy, Dr. Steven M. Smith, assistant professor, focuses on heart disease, stroke prevention and hypertension control. He also is beginning to examine the coronavirus and possible links to hypertension and its treatment. In his research, Smith aims to “improve the way we inform treatment decisions and interact in multidisciplinary teams in the future through data visualization and clinical support.”

Smith, who is in the pharmacotherapy & translational research department and was AACP’s second NAM Fellow, also runs a family medicine fellowship at Florida and is involved in training. Data flows through many areas of healthcare. It involves interactions with patients, providers and insurers and includes medical records, administrative claims, such as billing and patient pharmacy data related to medication adherence, and even patient-reported outcomes. Fundamental issues in his work include data collection and curation, standardization, privacy and interpretation. Emerging technologies, like artificial intelligence and advanced data visualization, have to account for these issues, he said.

“If you ask 10 different people what data science is you’ll get 20 different answers,” said Smith, noting a longstanding debate over the issue. “People who call themselves data scientists don’t necessarily agree on what that means. I think pharmacy schools are recognizing that it’s important to start integrating this into the profession. Some have had this focus for a while, but others are just beginning to appreciate the importance of bringing data science into pharmacy.”

At the University of Florida, data science and related concepts are not a major focus of the professional Pharm.D. program but are taught in graduate Ph.D. and master’s programs. The graduate programs require students to get coursework in fundamentals of inferential statistics, data analysis and interpretation, all related to but not explicitly framed as data science, Smith said. The university is advancing a large-scale initiative focused on what officials say is making the school a leader in artificial intelligence research and training, including the use of supercomputer technology.

Smith is also interested in using big data sources for developing prediction models, especially related to hypertension studies. The results of blood pressure measurement may differ in so many ways, depending on where the clinicians are: in a doctor’s office, a home or a hospital. Making sense of these data can be challenging. Smith works closely with the Patient-Centered Outcome Research Institute’s PCORNet that aggregates real-world patient data, linking electronic health records, health plan data and patient-reported outcomes within a standardized common data model. PCORnet serves as a repository for data on nearly 70 million Americans receiving care across the U.S. and provides infrastructure for large-scale pragmatic clinical trials, he said. “We have started to push the boundary of the scale, speed and kinds of data that can be collected and use that to try to rapidly answer questions that weren’t previously possible, such as whether certain treatments are better or worse for patient groups that are often excluded from phase 3 clinical trials.”

Building on Existing Capability

Dr. Allen Flynn, assistant professor in the Department of Learning Health Sciences, and a research analyst and technology lead at the University of Michigan Medical School, discusses data science as “essentially the automation of algorithmic data modeling.” And that, he said, is steeped in statistics. At a place like the University of Michigan, “data science is getting a lot of attention and support campuswide these days.”

Pharmacy schools can build on their data science capability, beginning with statistical training, by adding a course in data science and machine learning, Flynn said. “One of the challenges, which is also the case in statistics courses these days, is that data science is pursued with sophisticated software tools that students also need to learn,” he pointed out. As in many areas of healthcare, data can be scattered in different uses, complicated and difficult to scrutinize. “In healthcare, because data are highly fragmented and often productized and commercialized, it can be difficult to find sufficient data to get significant value from data science studies.”

Still, substantial strides are being made, especially with large image data sets, big electronic health record data “and with enormous quantities of streaming data from physiologic monitors,” he said. Michigan Medicine is working to implement models from data science to help predict “sepsis, readmission, [electronic records] utilization and the downward trajectory of clinical worsening.”

I think pharmacy schools are recognizing that it’s important to start integrating this into the profession. Some have had this focus for a while, but others are just beginning to appreciate the importance of bringing data science into pharmacy.DR. STEVEN M. SMITH

Flynn has a long relationship with technology. After he graduated in 1993 with a Pharm.D. from the University of Michigan, Flynn studied computer science. “I am personally interested in using data science to help predict ADEs (adverse drug events) and medication issues. But finding sufficient, high-quality data about ADEs is a real challenge,” he admitted. As data science evolves, so does Flynn with the courses he teaches. He is working to change course content to incorporate data science. “I teach introduction to health informatics and I am sharing with my students what I’m seeing as data science evolves,” he noted. “My course is a survey course and I do not teach data science per se.”

While different schools work various ways through the tributaries of data science, one area is emerging that everyone seems to agree on: it is opening the door for teams to collaborate easily and produce academic studies. Whether it’s data modeling or biostatistics or data security, “I am watching what NIH is doing through the National Center for Advancing Translational Sciences (NCATS) CTSA program, as well as efforts from PCORI, the Patient-Centered Outcomes Research Institute, and OHDSI, a stakeholder collaborative that supports application of large-scale analytics to health data, what some large insurers are doing, and what ‘big tech’ is doing in these areas,” Flynn said.

Team Approaches

As Krogan worked in California with other researchers—remotely—around the world to study coronavirus, the studies bridged what had been longtime gaps. For instance, specialists in cancer and infectious diseases may not have interacted as much, but the effort to understand COVID-19 brought teams together to brainstorm ideas and share experimental information. That’s the stated vision behind the launch of the QBI by Krogan and UCSF School of Pharmacy Dean Dr. B. Joseph Guglielmo. The idea was straightforward: strengthen interdisciplinary research. QBI includes more than 100 research labs as affiliates and has earned more than $70 million in federal research funding from the National Institutes of Health for projects ranging from psychiatry to cancer.

As they explored COVID-19, the level of collaboration that resulted was eye-popping, said Krogan. The UCSF team collaborated with research groups at Mount Sinai Hospital in New York and Institut Pasteur in France and tested drug candidates that were FDA-approved or in development against live coronavirus. Krogan said the academic teams were also collaborating with pharmaceutical companies during the coronavirus studies. In a separate effort at a team approach before the outbreak, the University of California San Francisco and UC Berkeley announced a collaboration with Janssen Research and Development—part of Johnson and Johnson—for a new data science fellowship program that will “explore innovative data-driven approaches to improve human health and train the next generation of leaders in the healthcare data sciences.”

The teamwork offers great rewards in instructing students, illustrating the possibility of shared accomplishments, Krogan said. “Students look at their professors in the labs and if they work with those who are not open to collaboration and worry obsessively about who gets an asterisk on a paper, that trickles down to the student,” he said. “Students can look at what we are doing, at what can happen in collaboration, and how exciting that is. The system has to change not to just reward an individual. Let’s start rewarding groups of people, and this helps young people participating in these groups. The problem with academia is that it’s so siloed, so competitive.” The multidisciplinary team approach exhibited in the coronavirus research “is freeing, a great feeling,” he added. “We are demonstrating how fast we could move if we want it to move.”

The challenge, he acknowledged, “is keeping infrastructure in place for the next thing” beyond coronavirus. “The system can change, and attack not just COVID-19, but breast cancer and other diseases the same way. We can get exciting results.” P

Marking 9-11 Amid a Pandemic

With a complicated present, we are at the vortex of history and the future, figuring out lessons of the past and the present, and the need to recharge our imaginations toward a better, healthier country in years to come, with public health very much a key centerpiece for our direction.

The COVID-19 pandemic is our current harsh lesson. We have more than 6.3 million cases of COVID-19 in the U.S, that have resulted in nearly 200,000 deaths, testimony in part to a failure of our own thinking in evaluating the scope of the disease, trying to get over an initial slow-start response, and the nagging untruths continuing to haunt us from the top.

Bob Woodward’s new book, Rage, was the latest President Trump not-so-funny sideshow. In a Feb. 7 taped call with Woodward, Trump told what he knew about the emerging coronavirus. Much much more than he told the American people.  “You just breathe the air and that’s how it’s passed,” Trump said. “This is deadly stuff.”

Really. Americans were thinking, ok, this will be a flu, just go away, as Trump hinted many times. Left in the dark, many Americans died. Trump said he wanted to play it down. Play it down? At what point do we not tell Americans what we need to know, to survive? Do we not tell them about an impending attack from an enemy?

As we combat this virus, and the headlines rage, we will pause and mark the solemn anniversary on Sept. 11, 2011 when terrorists hatched a plot to bomb the World Trade Center, the Pentagon and a passenger airliner, resulting in more than 2,000 deaths.

The repercussions of the attacks still devastate us, and called into question our thinking of protecting our nation from outside extremists and how naïve we were that the airliner hijackings were of a distant world causing trouble  that couldn’t happen to us.

There are similarities between the COVID-19 pandemic and the 9-11 attacks, notably the immense contributions of those in public health, risking their lives every day.

Public health workers, emergency crews, first responders, physicians and nurses were front and center after the Sept. 11 attacks, working tirelessly amid the chaos of that brutal day, often at the cost of their lives after environmental exposures resulted in adverse effects on their health.

During this pandemic, public health workers are again at the forefront of responding to the relentless outbreaks, working tirelessly, jeopardizing their health and safety, risking their lives.

Since the terrorist attacks, we have taken strides to ensure more safeguards to protect the country from such threats, and some of the ways we have done so – the wealth of security checks at airports, public buildings, for example – are now second nature in our lives.

With that same mindset, we can protect ourselves against COVID-19 until a vaccine is available. We need to improve contact tracing and testing, continue to follow the known techniques to protect ourselves, like wearing a mask or practice physical distancing, and not being around large crowds.

As a country and government, however, we were  misguided in our thinking when we first confronted the COVID-19 virus. We were misguided in our thinking about how safe we were before the terror attacks.

We can change that.  – Joe Cantlupe, Health Data Buzz

Photo by Lars Mulder from Pexels

Covid-19 and the Workers’ Comp Question

From my article at Leader’s Edge Magazine

Some states have passed legislation or imposed regulations that would establish a presumption of workers compensation coverage for COVID-19 claims.

By mid-June, more than 2,800 federal employees filed workers compensation claims for contracting COVID-19 on the job, a number expected to double in a month.

Brokers may best be able to help on the risk management side at this point.

States Enact COVID-19 Workers Comp Legislation

More states are passing legislation and imposing regulations to mandate the presumption of workers compensation coverage for COVID-19, which experts say is unprecedented. Brokers and insurers say the overall situation is in a state of flux, but many predict there will be legal battles ahead.

Even the lowest of estimates of COVID-19 workers compensation claims could result in twice as many awards than in the previous year, according to the National Council on Compensation Insurance (NCCI), which analyzes workers compensation systems. For example, the Department of Labor reported in July that more than 2,800 federal workers had filed workers compensation claims for contraction of COVID-19 on the job as of mid-June, and DOL expected that number to double in a month. Families of 48 federal workers filed death claims with the agency’s Division of Federal Employees’ Compensation.

“The workers compensation system faces significant uncertainty in the years ahead because of the COVID-19 pandemic and resulting economic fallout,” according to Donna Glenn, chief actuary at NCCI, in a recent analysis. “Covid-19 is a shock to the industry, impacting almost every aspect of workers compensation,” the report says.

At a minimum, according to NCCI, “there is a reasonable likelihood for COVID-19 to result in significant [workers compensation] claims costs during the accident year 2020.”

NCCI has listed a wide range of possible workers compensation financial outcomes from the COVID-19 pandemic. For instance, claims payouts for the estimated 86.3 million workers covered by workers comp in the United States could range from $2.7 billion to $81.5 billion. An NCCI report also referred to a wide range of possible compensability rates of 20% to 60%.The presumption laws are creating lots of confusion and have preferred classes of workers,” Wilhelm says. “As the country opens up, it will raise the question of whether new COVID-19 cases arose out of employment risk.


With more people working from home, the overall number of workers compensation claims could fall. But Christine Williams, managing director for the Worker’s Compensation Center of Excellence at Marsh, says there might be “greater [COVID] claims frequency for some industries,” generating higher overall costs and even additional cost burdens of processing such claims. The industries most affected would be those that have continued operating throughout the pandemic.

A Labor Day Tribute to Those Who Work in Public Health. (Ok, Where’s the Funding?)

Day after day, the country’s public health workers – whether working a microscope in a lab or running a health clinic –  focus on encouraging healthy behaviors and wellness. The pandemic has put a greater burden on many of them who really have been engulfed in crisis mode since last winter, working long hours and often with few resources.

They are the local health department leaders, fielding calls, coordinating responses and administering tests for COVID-19,   They are the epidemiologists who map out the virus path and work diligently to put a lid on its spread in a community. They are contact workers who are checking out people worried if they have COVID-19 or other diseases, and get them help if they do. They are restaurant inspectors who make sure eateries open when they should, or shouldn’t. They are the nutritionists, educators and social workers trying to help school districts put together plans for the fall. They are the policy makers and scientific researchers planning for what’s ahead, and occupational  health and safety experts keeping watch on today’s workplace, as physicians and nurses checking our day-to-day pulse.

Public health workers’ efforts, always crucial, are now being magnified with COVID-19, and they are laboring tirelessly and often at high personal risk. As they have been on the front lines of this pandemic from day one, they continue to work in the face of shortages of lifesaving protective gear, gowns or gloves.

Indeed, hundreds of doctors and nurses, hospital administrators, paramedics and custodians  and other public health workers have died as a result of COVID-19, often because they were simply doing their jobs. Many who perished who were people of color or immigrants.

The public health workforce, beset by continual shortages. There may be a shortfall of 250,000 workers by 2020, academic papers show. Congress should pour much more federal funding, especially for state and local health departments, who are working feverishly not only to fight COVID-19 but every emergency we face.

In the U.S. per capita spending on public health is less than 3 percent of all health care expenditures, and that percentage is probably going to drop.

Everyone always calls Labor Day the unofficial end of summer. The pandemic continues, and proper precautions must be taken to prevent the spread and thwart the coronavirus by wearing a mask, be physically distant, continually wash our hands, and be careful about large gatherings.

These are the simple tools that everyone can take to thwart the pandemic.

In the meantime, public health workers are the front-and-center heroes, helping us overcome this crisis a day at a time. – Joe Cantlupe, Health Data Buzz

Photo by Karolina Grabowska from Pexels

Disease Prevention, or …Bowing to the Prez?

<The CDC action smacks of politics, not disease prevention>

The other day the Centers for Disease Control and Prevention issued a new directive that reduces testing for COVID-19 that clearly falls in line with the Trump Administration and out of step from responsible medical expertise designed to serve the public health.

In a dramatic shift of federal guidelines, the CDC disclosed that some people without symptoms of COVID-19 may not need to be tested, even though they may have been in close contact with an infected person.

Yesterday, CDC director Robert Redfield, er, tried to clarify what he was saying. “Everyone who needs a COVID-19 test can get a test,” he said. “Everyone who wants a test does not necessarily need a test: the key is to engage the needed public health community in the decision with the appropriate follow-up action.”

Experts say: wait a minute. The CDC had said previously people should be tested in part because of the possibility of asymptomatic transmission from one person to another.

The word is that the CDC, by its action  is reflecting a constant drumbeat of the Trump Administration: there are too many tests, which result in too high COVID-19 numbers.

That flies in the face of what Americans, including those who are asymptomatic with the virus, have repeatedly been told:  get tested to help halt the spread of the virus.

By recommending fewer tests, the CDC is opening the door for many more COVID-19 cases, at a time when there are millions of cases nationwide, with hundreds of thousands of deaths.

There is a constancy of pressure from the Trump Administration over the CDC, sometimes direct, sometimes subtle. Remember the Trump Administration’s pressure campaign

against the CDC about proper precautions over school openings.

The CDC’s mission is to “ “saves lives and protects people from health threats.”

The CDC cannot break from that gold standard mission by bowing to pressure from this administration. It must reverse course now. It must be the agency it was designed to be: help us be healthier and safer. — Joe Cantlupe, Health Data Buzz

MLK’s Words Resonate, a Lesson for Us All…

More than half a century after Martin Luther King Jr.’s  “I Had a Dream Speech” in Washington D.C., his words resonate more than ever, a timeless creed of indignation and hope. We embrace his words as constant reminders of some things in the past we must tear ourselves from and a future we cannot totally see.

Dr. King’s speech, in soaring rhetoric, was expert testimony of the great need for dramatic public health, judicious and societal reform as he spoke of a country that included the “lonely island of poverty” and the “unspeakable horrors of police brutality.”

As he stood Aug. 28, 1963 in the shadow of the Lincoln Memorial, Dr. King talked of what we were as a nation, what we said we were supposed to be, and the sharp distance between the two.

Today, we have made much progress since Dr. King’s speech, indeed, through a vast array of  federal regulation and civil action over the years, leading to education and housing opportunities unheard of in 1963, environmental and judicial reforms, in a society with improved overall health.

But we have a long way to go.  As we battle a paralyzing Covid-19 pandemic, Dr. King’s words constantly ring in our ears, his stirring voice echo in our hearts.  Fifty-seven years after Dr. King’s speech,  police brutality still haunts with the slaying three months ago in Minneapolis of George Floyd, an African-American man killed at the hands of a white police officer. It haunts again, repeatedly. On Aug. 23, Jacob Blake was shot seven times in the back after he walked away from officers, in Kenosha, Wis. It unleashed anger in the streets and a vast call for change through peaceful protests, the kind that Dr. King so often led. Police violence, often an outgrowth of racial profiling and structured racism, epitomizes a public health crisis.

Poverty, too, is relentless in its reach today among Blacks and other minorities with racial disparities, too often prevalent in housing, jobs and income, with its resulting widespread impact on public health.

Since Dr. King’s speech, there have been great political strides in much of American society. With Barack Obama, a Black man became president of the United States. With Sen. Kamala Harris (D-Calif.) as former Vice-President Joe Biden’s running mate in the upcoming Presidential race, there is a woman who is Black and South Asian-American running for Vice-President.

Yet Black voters face many obstacles in their hope of registering to vote, the unavailability of voting centers at a time of COVID-19, or even having their mail-in ballots counted. As we have  been overwhelmed by the pandemic, it has been more severe in Black and Hispanic communities, related to a host of factors, including housing and especially working conditions leaving them more exposed to the virus, and a public health threat.

Dr. King talked of the Declaration of Independence as the “promise that all men, yes, black men as well as white men, would be guaranteed the unalienable rights of life, liberty and the pursuit of happiness,” King said. “It is obvious today, that America has defaulted on this promissory note insofar as her citizens of color are concerned.”

Dr. King said that Black Americans and others were still waiting to “cash a check.” In some ways, they still are.

We must march ahead for justice, he said.

Today, many are gathered near the Lincoln Memorial for “Commitment March: Get Your Knee Off Our Necks.”

It is no time to turn back. – Joe Cantlupe, Health Data Buzz

Envisioning Zero

We acknowledge with a heavy heart this tragic milestone of nearly 100,000 American deaths since the COVID-19 outbreak began in late February in the U.S. where there are now 1.6 million cases.

Family, friends and other loved ones of those who have perished because of COVID-19 are constantly in our thoughts.

As we tally these numbers, we measure them in sadness but also with a resolve to overcome obstacles and early miscues that may have contributed to thousands of lives lost. We now must forge ahead with the science that guides public health every day to minimize the spread of the disease, work to reduce COVID-19 illnesses and ultimately find a vaccine.

At least 2,000 people are dying each day because of COVID-19 in the U.S., which has the most cases in the world, where more than 300,000 deaths have been recorded and more than 5 million cases.

There is no doubt that sufficient containment measures in testing, isolating or lockdowns, social distancing, wearing masks and contact tracing must continue with determination and strength.

States and cities that have resolved to take on those measures are making progress, while others who have not are struggling in their fight against the spreading infection.  Overall, infection rates are slowing in the U.S., but they remain steady in at least 25 states.

Ultimately, on this Memorial Day weekend, we begin to envision the only number that will truly matter: Zero.  It cannot be a mirage but one for which we are all in this fight together. — Joe Cantlupe, Health Data Buzz

Stepping up drug development. Oh yes, there’s that pandemic, too.

from my story at Academic Pharmacy Now

Talk to academics involved in The National Institute for Pharmaceutical Technology & Education (NIPTE) and they will tell you it’s about striving and thriving in innovation—inside and outside the walls of academia. NIPTE has collaborated with industry, academia and government, particularly the Food and Drug Administration (FDA), to identify and help solve the world’s pharmaceutical challenges, which are far-reaching and keep growing. NIPTE scientists are exploring more effective methods for the characterization of active pharmaceutical ingredients and drug products. They are identifying strategies to prevent drug opioid addictions. They are charting ways to improve dosage form design and manufacturing. They are exploring how to determine the quality of pharmaceuticals.

In addition, they are creating education and training programs that focus on evolving technology in pharmaceutical science and engineering with an eye on thwarting future workforce shortages. And they are part of the conversation in Washington on accelerated drug development plans in light of pandemics such as the coronavirus.

Most recently, NIPTE is studying plans to essentially overhaul the process for bringing generic medicines to market that its scientists say could take dramatic steps to improve safety and quality while enhancing pharmaceutical production in the U.S. “We define ourselves as a community of pharmaceutical knowledge and the scientific home for academic pharmaceutical sciences,” said Dr. Vadim J. Gurvich, executive director of NIPTE and research associate professor of medicinal chemistry at the University of Minnesota College of Pharmacy. The organization, established in 2005 and based in Minneapolis, is a coalition of academic scientists from pharmacy, education, engineering and chemistry and includes 16 universities with pharmaceutical education and research programs and one medical school. Each university member’s representative serves on the NIPTE board of directors, providing leadership and financial oversight.

“From our perspective, there is a tremendous potential to draw together subject matter experts in the academic world and being able to connect those experts to either industry or other regulatory agencies, such as the Food and Drug Administration, to address some of the grand challenges as we move forward,” said Dr. Eric Barker, dean of the Purdue University College of Pharmacy and secretary of the NIPTE board. “We’re able to have collaborations and partnerships with members to draw together on their collective expertise.”

The mission: increase science and engineering-based understanding that can lead to new drug products to move to market faster with less variability and higher predictable performance at a lower cost, said Gurvich. For example, researchers are studying abuse-deterrent protocols, intervention-based opioid technology, nanotechnology, advanced manufacturing methods and the formulation of new drug products, “which is extremely challenging, cutting-edge science that addresses a huge societal need,” he added.

Preparing the Workforce

Education and skills development in pharmaceutical science are essential elements in preparing a new workforce, according to Gurvich. At NIPTE, courses are taught based on what the organization calls a “quality and integrated review concept” involving product development, delivery, manufacturing and outcome—with collaboration as a key with schools of pharmacy and engineering. Chemistry and materials science are also included in NIPTE’s strategic roadmap.

NIPTE said its scientists organize into centers of excellence and focus groups to “more efficiently collaborate and integrate their expertise across member organizations.” The focus groups target advanced manufacturing, biologics and biosimilars, nanotechnology and translational biomarkers. The idea is to link all areas within the scope of pharmaceutical production, from development to manufacturing.

“Large data has advanced more quickly than our ability to analyze the data and that’s a challenge,” said Barker. “That we cannot go alone. We can draw and tap into (NIPTE’s) tremendous expertise in engineering and even agriculture. That’s a factor for both basic knowledge and having a program to train data scientists to upskill the existing workforce—not expecting them necessarily to be experts but competent enough to work with the data.”

NIPTE’s examination of dosages (i.e., dosage forms) and complex molecules and specialty drug technology ties into Purdue’s strategic initiatives to expand its area of pharmaceutical and biotechnology instruction from basic science to clinical science for “cutting-edge educational programming,” Barker said. NIPTE has a collection of “a close-knit group of deans,” he said.

Pharmacy a Key Component in FDA’s Drug Manufacturing Strategy

Federal officials are enlisting academia as they look toward a new generation of pharmaceutical manufacturing methods to overcome the country’s reliance on drugs produced overseas. While the U.S. is a leader in drug discovery and development, it relies heavily on drugs made in China and India. As a result, the Food and Drug Administration is encouraging investments in advanced manufacturing technology and establishing quality management systems to improve the quality of pharmaceuticals.

“FDA believes that advanced manufacturing can help regain its competitiveness with China and other foreign countries and potentially ensure a stable supply of drugs critical to the health of U.S. patients,” said Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research in testimony late last year before the House Committee on Energy and Commerce, subcommittee on Health.

Between 70 and 80 percent of active pharmaceutical ingredients and 40 percent of finished products are made outside the U.S. The FDA reported last year that 18 percent of Active Pharmaceutical Ingredients (API) manufacturing facilities are located in India and 13 percent in China. The number of Chinese manufacturing facilities has doubled since 2010. As of late 2019, only 28 percent of manufacturing facilities making APIs that supply the U.S. market are based in this country.

Vulnerable Supplies

“The fact that so many of our drug products are made overseas creates a vulnerability in the U.S. supply,” said Dr. Fernando J. Muzzio, director, National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems, and distinguished professor, chemical and biochemical engineering, Rutgers University. “The supply chain can be disrupted for lasting shortages. This is a real issue both with shortages caused by emerging quality problems and with the ability to respond quickly to emerging threats.”

Muzzio has worked for years with the National Institute for Pharmaceutical Technology & Education, a proponent of the advanced manufacturing processes with one key purpose in mind: improving the amount and quality of the U.S. drug supply. Proponents of advanced manufacturing say innovative technologies ranging from 3D printing to continuous manufacturing methods also can quickly move drugs to market. The continuous production method stands in contrast to the current predominately used batch method of drug production, which is considered inefficient and involves “breaks” or “stops” in the process.

“Advanced manufacturing offers many advantages over traditional pharmaceutical manufacturing and if the U.S. invests in this technology, it can be used to reduce the nation’s dependence on foreign sources of APIs to increase the resilience of our document manufacturing base and reduce quality issues that trigger drug shortages or recalls,” Woodcock said. Advanced manufacturing has been widely used in automotive, aerospace and semiconducting.

“The continuous state of control enables the continuous monitoring and assurance of product quality,” Muzzio told Congress. Continuous manufacturing has been embraced to replace traditional and inefficient batch methods in an era of “unprecedented innovation” following “decades of near stagnation,” Muzzio said.

Academia is playing a large role with industry and other regulatory agencies to help the FDA identify potential regulatory hurdles to adopt advanced manufacturing, according to Woodcock. In 2018, the FDA awarded eight grants to universities and nonprofit organizations to “study and recommend improvements for the continuous manufacturing of drugs and biological products as well as similar innovative monitoring and control techniques,” she said.

The FDA is working with academia and industry to identify new research areas for advanced manufacturing. FDA laboratories also have conducted advanced manufacturing research and established a Center of Excellence for Manufacturing Science and Innovation to coordinate internal advances in manufacturing research for both small molecules and biologics.

There is a tremendous potential to draw together subject matter experts in the academic world and being able to connect those experts to either industry or other regulatory agencies…to address some of the grand challenges as we move forward. We’re able to have collaborations and partnerships with members to draw together on their collective expertise.D

“Many of the NIPTE labs are doing dosage design research, and some of the information we are generating with prior knowledge may not be seen as cutting-edge research, but for pharmaceutical analysis and formulations and master’s and Ph.D. level students, this is an invaluable learning experience, both in mastering techniques and formulation design,” said Dr. Kenneth Morris, professor and director of Lachman Institute for Pharmaceutical Analysis at the Long Island University Pharmacy, which is a NIPTE member. NIPTE is also working to identify the next compounds and products likely to be important targets for the generic industry, Morris said.

As NIPTE collaborates with the FDA, the organization is also emphasizing the need to overcome workforce shortages in pharmaceutical sciences, according to Gurvich. “That was a big concern for the FDA several years ago and they couldn’t find enough qualified people with appropriate training in pharmaceutical sciences,” Gurvich recalled. “That led them to us, and they approached us to develop a training and certification program, which is very much a work in progress.”

There is irony in the work. As Gurvich and his team strive to improve pharmaceutical manufacturing in this country, “if it starts coming back to the U.S., the industry will face shortages in the workforce and that is another concern,” he said. “At NIPTE we discussed the situation, and (seek) to recalibrate education programs to solve that problem.”

More Accessible Generic Drugs

Even before the alarm over the spread of coronavirus throughout the world this past winter, NIPTE researchers began stepping up their research into improved mechanisms to manufacture and deliver generic drugs into the U.S. market. That market has been saddled by regulatory woes and much production overseas.

“The efficiency of the generic drug product system is quite low,” Gurvich said. “We noticed that about 60 percent of the drugs that are marketed by brand companies are not making it to generics. And that has caught our attention. That feeds into our priorities. It’s extremely important. It affects the drug supply, the quality of drugs, all sorts of things.”

Part of the organization’s strategy to improve access to generic drugs is wrapped around the words “new” and “prior knowledge.” Gurvich said NIPTE is pushing to highlight the distinction between the information that may involve proprietary and trade secrets and available knowledge in the public domain. Using that prior knowledge, he noted, can accelerate development and commercialization of generic drugs.

As an example of “new” and “old,” NIPTE published a paper last year titled “Pharmaceutical New Prior Knowledge: Twenty-First Century Assurance of Therapeutic Equivalence” that referred to manufacturer Apotex’s formulation of a nasal spray product, which used a different drug formulation so as not to infringe on a previous product’s unexpired patent. Years later, the situation changed: The FDA approved the generic version of the drug after the patent’s expiration. “Clearly during this review process, the FDA had access to previously disclosed” information, the paper states. Ultimately, it points to a “need for NPK (new prior knowledge) efforts to bridge the gaps between research to policy and policy to practice,” according to the authors.

Using the terms “new” and “prior knowledge,” Gurvich said, “sounds like an oxymoron. It may be a little bit provocative or paradoxical. But it needs to be taken up by public-private partnerships. NIPTE can be a partner and we had this discussion and talked to the FDA and the idea is we will have the scientific firepower to make a significant impact.”

The Surprising, Surreal, Sad and Sudden Pandemic Age: “Life is what happens to you while you’re busy making other plans” — John Lennon

Covid-19 has brought the world to its collective knees.  The novel coronavirus pandemic that began as a few cases in China now has 3.38 million cases in 187 countries and regions around the globe, and the virus has killed more than 246,000, according to the Johns Hopkins University Coronavirus Resource Center.

Civilization is a shell of its once-vibrant self. Billions of people walking far apart from each other, streets closed, buldings and businesses shuttered, playgrounds empty.  We walk outside, dodging people. Our hands are getting a bit leather. Is there such a thing as too much hand washing. Apparently not. We start noticing the colors of masks, a feature of someone’s attire.  April was dubbed by the poet TS Eliot as the “cruelest month.” This month certainly lived up to Eliot’s description.

While most people try to stay away from each other, some may be afraid that others are getting too close. Many people are obeying the social distancing, but others, not so much. A bit of a crowd hanging outside the restaurant the other day. Too many people gathering around a friend and checking a phone at a park today. The line at the grocery store a bit unnerving. Many states are now opening up. Cringeworthy, I think. It is by maintaining our distance we enhance our shared connection: to overcome the disease. Hopefully, not death by impatience.

For people who struggle with their mental health, the pandemic can worsen their problems. Social isolation and loneliness may open the door to a range of mental health and physical issues from depression to heart disease. The isolation and uncertain well being is particularly hard for the poor, disadvantaged and the elderly.

Along with financial losses, many people are suffering emotionally from home confinement. They feel alone, frustrated and anxious.

Many of the same concerns envelop essential workers, especially those working in hospitals and public health, who face the challenges of having to protect themselves while working to save lives. Workers in construction or food services also go to work, despite the threat of infection.

During this time, it’s a priority for all of us to make time for self care. It’s important to reach out to friends and family, whether by phone or online. Humans are wired for connection, and we need our circle of support. Sleep, physical exercise and a healthy diet are also essential. Going for walks and participating in nature can help reduce stress, as does taking a break from the news.

In these ways, we can develop an inner core of strength and feel we have a sense of control. That’s important, because there is still much uncertainty ahead. Once we reopen for normal activities, people may go back to their old ways, only to find the coronavirus outbreak has flared up again.

We must prepare people for the social, physical and mental health consequences of another explosion of infections. While initial orders to stay at home arrived abruptly and unexpectedly, most people complied to protect themselves and their families. They may be less willing to do so once those policies have been relaxed.

Looking to the future, together

Even as we struggle with the day-to-day realities of the pandemic, we must also look ahead. The public health field has been preparing for the realities of the next pandemic for decades, with “it’s a matter of when, not if,” a long-common refrain among preparedness and infectious disease experts. Yet when COVID-19 arrived, it exposed the gaping holes in our plans. The situation shows the need for strong public health infrastructure, necessitating enough resources and systems to mitigate future problems.

We must examine our workforce to ensure there are proper allocations of labor for the needs of communities, particularly in health care. We must also pay attention to a global supply chain, where reliance on only a few countries for medical supplies, for instance, has proven to be reckless.

Ultimately, a science-based approach is necessary to prepare for what is ahead. We must include full and open participation from our most trustworthy messengers — scientists, public health professionals and medical officials — as we retool and strengthen our health systems to stave off more outbreaks like this one.

The speed in which COVID-19 spread from a few cases in a food market to communities across the world shows that we must act faster — without presumptions that we are immune from “far-off” contagions. With the next worldwide infection only a plane ride away, we must be prepared to come together without politics or prejudice to contain disease outbreaks as soon as they occur, wherever they occur.

No less than the future of humanity is at stake – Joe Cantlupe, Health Data Buzz.