Our healthcare team has been working with the University of Colorado over the past couple of years to overcome critical data challenges in healthcare… and the results are exciting. In this blog post, I’ll share how the academic medical center was able to improve security, reduce maintenance, and increase efficiency in support of the university’s mission to provide breakthrough medical advances in the field of personalized medicine with cloud integration.

Health Data Compass is a data warehouse maintained by the Colorado Center for Personalized Medicine (CCPM) at the University of Colorado Anschutz Medical Campus. CCPM is a partnership between the University of Colorado School of Medicine, UCHealth, and Children’s Hospital Colorado. CCPM mission is to bring breakthrough medical advances in the field of personalized medicine.

On-premises data warehouse was costly and non-scalable
CCPM helps physicians evaluate patients at the molecular level in order to predict their risk for disease and to develop personalized treatments based on their individual DNA.

This personalized approach requires data from thousands of patients, and includes genetic compositions and health histories. Researchers use these large-scale data sets to look for patterns that identify how and why people with particular genetic profiles acquire certain diseases and whether or not they could benefit from targeted treatments.

Securely and quickly integrating these large data sets in order to make the data usable and valuable is a considerable challenge. To address it, CCPM utilizes Health Data Compass, an enterprise health data warehouse. Health Data Compass integrates data from a variety of sources including patient clinical data, genomics data, insurance claims, public health data, and environmental data.

Initially, Health Data Compass implemented a traditional, on-premises enterprise data warehouse to store and analyze data. But this solution was too costly and could not scale to meet CCPM’s business needs. CCPM was spending too much time and money just to produce basic reports and dashboards to draw the simplest of correlations among its patient populations.

CCPM’s investment was not advancing the project to the point where it could deliver meaningful value and services to its key stakeholders. It was in need of a secure and scalable cloud solution that would reduce maintenance costs, increase efficiency, and provide the data and analytics platform and program to power its journey to translational and personalized medicine.

CCPM asked us to evaluate and recommend the cloud platform that would best meet the needs of the complex organization.

Integrating vast amounts of clinical data
After an extensive six-month pilot project, we helped Health Data Compass migrate to Google Cloud Platform, which supports federal HIPAA compliance. The cloud provides a robust, self-service platform for quickly analyzing complex data sets, compiling large data analytics, providing structured data visualization, and incorporating a data distribution environment. The multiple data sources are uploaded into Google Cloud Storage, a more affordable and scalable solution than the previously used onsite storage. Data is then routed to Google Genomics and Google BigQuery, which supports a variety of data analytics to support CCPM’s business and clinical needs.

This advanced technology allows Health Data Compass to get the data into the hands of the data scientists who are performing the analysis and data modeling, and the clinicians who will ultimately drive decisions for their patients.

Better clinical predictions with the cloud
Highlights and benefits of this massive migration of data to the cloud include:

• Integrated 6 million patient records
• Google Cloud Platform reduces operating costs by 50% and frees up funds for vital program development
• Reduced data query times by 97%
• Faster data queries accelerate research
• Scalable storage grows easily to meet research and clinical demands
• New dashboards enable CCPM to:
  • Understand prevalence of top 10 diagnosis/conditions in the state of Colorado with various drill-down/stratification capabilities to identify trends and correlation in an effort to inform, engage, and prevent
  • Conduct surveillance of patients who have a known diagnosis of influenza, over time, to identify trends and draw a correlation to allow for proactive monitoring and prevention activities
  • Incorporate environmental data, such as weather, to draw correlations

Health Data Compass supports a multi-pronged analytics initiative for breakthroughs in personalized medicine – tailored medical services based on an individual’s predicted response or risk of disease – and integrates data from two major hospital systems, a physician billing plan, and scientific laboratories at the University of Colorado Denver. Perficient helped redesign and re-platform Health Data Compass’ data warehouse, from an off-the-shelf commercial solution hosted by the University of Colorado to a cloud platform, due to inefficiencies preventing optimized use of the warehouse’s capabilities.

Health Data Compass was slowed by extensive infrastructure maintenance such as new software features, software patches, and networking issues. Watch the video to learn why Health Data Compass turned to the cloud to improve security, reduce maintenance, and increase efficiency in its mission to provide breakthrough medical advances in the field of personalized medicine.

On January 8, 2016, the FDA issued a warning letter that caught my attention. I can’t remember why I initially opened it; maybe because the company’s name had “pharm” in it, as opposed to “seafood” (which seems to be there a lot!).

Once inside the letter, I found this in the opening paragraph: “This inspection was conducted as a result of a complaint received regarding an adverse event reportedly experienced by a patient who received Trimix injection that was prepared by your firm.” I’m a sucker for stories about a single person becoming be a catalyst for positive change, so I was immediately intrigued. 

It turns out that MasterPharm, LLC is a compounding pharmacy that formulates medications for individual patient needs. They can combine multiple medications into a single dose, make icky medicines taste good so your kids will take them, or suspend medications in injectable liquids for folks with sensitive stomachs. Pretty neat, eh? Just like back in the old days before any medicines were mass-produced, except now the work is done in a state-of-the-art facility accredited by the Pharmacy Compounding Accreditation Board (PCAB).

At least, that’s what their website says.

According to the violations in the letter, MasterPharm’s facilities and procedures are severely lacking. They have issues of general cleanliness, sterile products made from non-sterile ingredients (what?), bacteria growing inside of sealed product containers (ick!), and punctured product containers(?!?!), to name a few.

Here’s a great excerpt from the letter: “For example, our investigator observed that your firm produced sterile stock solutions from non-sterile components and then stored them in stoppered containers, which were subsequently punctured multiple times throughout the assigned expiry period of up to 180 days.”

By the end of the letter, I found myself thinking that they must just not know better. Maybe they haven’t been around very long or they’re located in a country that doesn’t have a solid understanding of “sterile” just yet.

Nope and nope. They’ve been in business for 14 years and they’re located right here in the U.S. New York, no less. Plus, there’s that whole PCAB accreditation thing. How did they become accredited with the problematic facilities and practices cited in the letter?

In short, I thought the issues in the letter were worth bringing to your attention, considering the current trend toward personalized medicine. The more individualized treatments become, the more challenging it will be to maintain quality control across them, so the industry needs to stay vigilant…and patients need to keep speaking up. This warning letter shows that “just one person” has the power to make a difference!

Multiple Myeloma Research Foundation (MMRF) founder Kathy Giusti attended the Precision Medicine Initiative (PMI) summit several weeks ago, which was hosted by President Barack Obama. In a Forbes guest post, she shared five reasons why we can be optimistic about the initiative, which aims to develop better, targeted therapies that leverages one’s unique genetic makeup.

1. Patients are Ready | Patients continue to participate a variety of research programs, such as the Million Veteran Program.
2. Its Leadership is the A-Team | The folks behind the PMI are strikingly impressive – just look at their industry experience.
3. It’s Powered by Cross-Sector Partnerships | Without partnerships, the PMI wouldn’t be successful. This type of research, on such a big scale, requires collaboration among life sciences, healthcare, academic, and technology companies. Nonprofit and public organizations are also committed to supporting PMI.
4. It Has Bipartisan Support | Enough said.
5. Obama Has Every Reason to Get It Done | Aside from benefiting humankind, if the president can get this done in his last year, he’ll leave on a high note that people will always remember.

To read the guest post in Forbes, click here.

According to STAT, Vice President Joe Biden is meeting with over a dozen of the nation’s top cancer researchers today to talk about regulatory questions revolving around precision medicine. As you might recall, Biden’s son, Beau, recently died of brain cancer at the age of 46. 

Declining running for president in 2016, Biden said he wants to focus his last year in office on defeating cancer. He says,

“If I could have been anything, I would have wanted to be the president that ended cancer,” Biden added. “Because it’s possible.”

The Obama administration has put an emphasis on funding precision medicine research, beginning with President Barack Obama’s State of the Union address on January 28, 2015.

While many politicians have attempted to defeat the heterogeneous disease, time will tell if Biden’s strides will have any impact. Nonetheless, we can all agree that his cause is highly commendable and straight from the heart.

Earlier this year, I highlighted how Penn Medicine is leveraging IT to support their patient care and precision medicine programs. Several weeks ago, Oracle and Penn Medicine held a joint webinar in which the academic medical center discussed their overall IT landscape. 

Brian Wells, Penn Medicine’s Associate Vice President of Health Technology and Academic Computing, didn’t hold back; he shared what his organization is capable of doing, what they’re not able to do, and what’s planned for the future. Brian also shed light on the specific clinical, healthcare, and BI systems that are in place, some of which are from Oracle, including Oracle Health Sciences Network, Translation Research Center (includes Omics Data Bank and Cohort Explorer), and Endeca.

Based on Brian’s presentation, it’s clear that Penn Medicine has no fear of adopting new technology in the hopes improving patient care and advancing clinical research. It’s an organization that invests in technology and plans for the future.

To watch a recording of the webinar, click here.

HIT Consultant, a digital publication focused on healthcare technology, recently shared a report by Reed Smith on mergers and acquisitions (M&A) in life sciences and how personalized medicine is playing an important role in many of today’s transactions. While pharmaceutical and biotechnology companies have not abandoned the “one-size-fits all” approach to developing drugs, many have been bolstering their precision medicine programs through M&A. 

The report provides great insight into the reasons life sciences companies are interested in precision medicine, the obstacles associated with running such programs, and how companies are going about getting a piece of the pie.

You can read the full report here. I also encourage you to download our guide, which features an overview of precision medicine and real-world examples from life sciences and healthcare.

Every time I hear about precision medicine showing signs of effective disease treatment, I want to share it with you. Here’s one to add to the collection. 

AztraZeneca’s drug Lynparza (olaparib), which is used to treat women with advanced ovarian cancer, has shown positive results in patients with prostate cancer who have a specific genetic mutation.

Megan Thielking, a writer for STAT, spoke to Dr. Joaquin Mateo about the study’s findings:

How did precision medicine shape the trial?

We gave men with prostate cancer olaparib, and then we observed whether they responded to the drug. At the same time, we biopsied pieces of their tumors and sequenced the DNA to find what was in common with all the patients who responded to olaparib. Almost all of them had mutations in the same gene.

What’s the next step?

We’re now sequencing the DNA up front of every single patient with advanced prostate cancer referred to us. The idea is to get a bigger number of patients treated to get more robust information … Then, we can know how to select the right drugs for the right patients, because that’s the way we can deliver more personalized medicine.

Interested in seeing other examples of precision medicine in life sciences and healthcare? Download our guide.

Thanks to one of my LinkedIn contacts, I was introduced to a newly released “scorecard” that ranks pharmaceutical and biotechnology companies based on their precision medicine efforts. In essence, the organizations who made the cut are the ones moving precision medicine forward. They’re the ones focused on leveraging biomarkers to develop new therapies. 

The factors taken into consideration to rank companies include:

• # of precision medicine drugs on the market
• % of clinical trials that leverage biomarkers
• % of employees who have a job title relating to precision medicine

While this may be somewhat of a rudimentary method of evaluating companies, to my knowledge, it’s the first ranking of its kind.

A few days ago, I read an article in The Atlantic about precision medicine. But it wasn’t about developing drugs for individuals with specific biomarkers. Instead, it discussed a simpler form of precision medicine that can prevent serious adverse events (SAEs).

This method can actually fit in your wallet. It’s a card that houses genetic information about you. If you’re being prescribed medication, and a medical professional scans the card’s barcode, they’ll instantly know if you are at risk to certain drugs or drug doses, and can modify their treatment plan accordingly. 

This concept reminds me of a simple medical ID tag with basic emergency information, but one that has gone through an extensive digital transformation: from a tag worn on a bracelet or necklace, to a USB drive, and now to a wallet card that houses genomic data. Simple, yet so revolutionary.

We know that people can react differently to certain drugs. It could be for a variety of reasons, such as a bad interaction with another drug or something more inherent, such as specific genes that predispose them to negative reactions. So, why not focus on preventing adverse events with a solution like the “pharmacogenomic wallet card?”

Sure, it’s slightly easier said than done. Genetic tests needs to be administered, and if you want it to work seamlessly with EHR systems, some IT work would be required. That said, it could also work on a much more basic, cost-effective level.

While the FDA mentioned an increased focus on “personalized drug safety” earlier this year, I sit hear wondering why this card isn’t already in everyone’s medical wheelhouse. There’s no question we can all applaud the progress we’re making in developing more targeted and safer drugs, but it’s a mistake that we’re not leveraging the more basic tools we have at our disposable to prevent SAEs and keep everyone safe.

While pharmaceutical companies are still trying to figure out whether they should partner with companion diagnostic makers, acquire them, or simply begin developing their own tests, one thing remains certain: companion diagnostics are here to stay. 

Companion diagnostics, devices used in combination with certain drugs, have shown to be extremely valuable in pinpointing biomarkers that patients must have in order for a drug to be beneficial. According to the Tufts Center for the Study of Drug Development, “20% of new drugs winning approval in the U.S. last year were considered personalized medicines, a number that is expected to grow, based on investment plans of major drug companies.”

Luckily for all parties involved – most importantly, patients – companion diagnostics are helping to treat diseases with more precision. The one-pill-per-disease approach is no longer the best way to go.

Since President Obama’s State of the Union address in January, much has been said about precision medicine. And, rightly so. The ability to treat common and rare diseases based on genomic and patient data is showing incredible promise. However, the medical community agrees that significant changes need to be made to federal healthcare policies and, in some cases, patients’ understanding of the benefits of sharing personal data, in order for the movement to be more successful. 

Health IT Now, a coalition of patient groups, provider organizations, employers, and payers, and the Center for Data Innovation, a think tank studying the intersection of data, technology, and public policy, released a white paper that outlines three recommendations for policymakers who wish to take precision medicine to the next level. While they appear to be simple on the surface, it will literally take a nation to move things forward.

According to the white paper, here are three recommendations:

1. Improve interoperability and data sharing. Stronger federal requirements are needed to ensure that genomic and other health data can be retrieved and compared across health record systems. Bottom-up, patient-driven reforms, such as giving patients (and their providers) a right to access and share interoperable health data, would incentivize standard setting and save lives.

2. Engage patients. The public and private sectors share an interest in raising the tone of discourse on the role that genomics and other big-data applications might play in revolutionizing our expensive and underperforming health system. As the true customers of health care, consumers—especially patients desperately waiting for breakthrough cures—must be brought into this dialogue.

3. Re-think privacy law. The strict privacy requirements of the Health Information Portability and Accountability Act (HIPAA) and complementary federal and state laws, including the Common Rule, present formidable obstacles to realizing the potential of genomic medicine. It is time to reassess the costs and benefits of these policies in light of recent scientific and technical advances, and to consider less burdensome models for protecting privacy.

If your organization is interested in implementing these recommendations, Perficient can help. Our precision medicine and connected health teams are made up of experts in these areas. Drop us a line to learn more.