Transforming & Digitalizing Biopharma and Medtech
As a passionate healthcare innovator, Dr. Kal Patel is on a mission. Over the last 20 years, he has become a strategic leader on innovations in biopharma, medtech and regulated digital health. A medical doctor, who also holds an MBA degree, Kal is CEO & Co-Founder of BrightInsight, a leading global platform for biopharma and medtech regulated digital health solutions. Founded in 2018, the company built a compliant platform and pre-built software modules that allow biopharma and medtech companies to focus on therapeutic digital innovation instead of the underlying infrastructure. In an interview he speaks on an array of topics – from the founding of BrightInsight to challenges faced in the field of medicine, from the need to build a more holistic & methodical approach within healthcare to the challenges faced in the field. Excerpts from the interview:
Story behind Founding of BrightInsight
BrightInsight is accelerating regulated digital health innovation for biopharma and medtech customers through its scalable compliant platform. Its co-founders met while leading digital health at Amgen, one of the world’s top biopharma companies. “When trying to build a digital health platform and products within Amgen, we realized first-hand how challenging it is to launch digital innovations within a highly regulated industry.” says Dr. Patel.
This experience was the impetus for building the BrightInsight Platform.
“We replace the need for lengthy ‘build from scratch’ implementations to instead give our customers a proven platform and configurable software modules to develop and maintain secure, private, and compliant digital health solutions—even as regulations are constantly changing,” shares Dr. Patel.
With the BrightInsight Platform as their foundation, and BrightInsight as their launch partner, its customers are accelerating time to market for apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device.
“At BrightInsight, our vision is to transform patient outcomes globally by bringing the power of digital technology to healthcare.”
Innovation within Healthcare Technology
According to Dr. Patel, healthcare technology has moved rapidly to innovate new approaches that improve patient outcomes. ‘‘One unintended consequence of this fast pace has been technology siloes where several novel approaches exist that don’t allow easy or efficient sharing of data.” He cites the example of treatment offered for diabetes that elaborates this argument. “Most patients with this chronic condition are involved with multiple therapies, each involving a different manufacturer, yet none talk to each other. This is an exciting time for healthcare innovation, but a more holistic and methodical approach to building solutions is critical.”
One challenge that BrightInsight encounters is the buy versus build conundrum. Before BrightInsight, biopharma companies had no choice but to attempt to build their own custom platform from the ground up to host their digital health products. This could take several years with sky-high costs, and that’s only for one product, observes Dr. Patel.
“It is not a competitive advantage for each of these companies to have their own siloed infrastructure. The better strategy involves these companies developing differentiated intellectual property, dosing algorithms, and more, that make their therapies more effective. BrightInsight’s pre-built, comprehensive platform solves this problem as it meets the rigor these companies require- across security, privacy, quality, and regulatory requirements—that can scale across geographies and disease states.”
Most Memorable Moment of Success
“Securing our Series B round of financing in the spring of 2020—amidst a pandemic—was one of the most memorable moments of success for our company and a major achievement during a time of unprecedented uncertainty.” BrightInsight was one of the first companies to raise a substantial round of financing early into the COVID 19 pandemic. “We were able to build a rapport with our Series B lead investor, Insight Partners, over the course of many Zoom calls, since we could not travel to New York to meet in person.”
A Piece of Advice
“Leaders should adopt a philosophy of fail fast. If organizations are afraid of failure, they will invite pitfalls by paralysis. Instead, leaders should not be afraid to take risks – learning to quickly course correct as needed while innovating.” Dr. Patel notes that this is a pivotal moment for healthcare. “The industry is finally realizing its own digital revolution and those who successfully embrace this shift will be tomorrow’s leaders.”
The Future of Healthcare Lies in Decentralization
By: Pradeep Goel, Chief Executive Officer of Solve.Care
The Future of Healthcare Lies in Decentralization
The healthcare sector is one of the fastest growing industries worldwide and as such insurmountable efforts have been expended to adapt to the constant advances in technology and the needs of patient care. One of these advances that is quickly becoming the go to for new healthcare systems and solutions is blockchain. Blockchain technology has been helping to lead in the decentralization of almost every industry today. For the healthcare in particular, it can greatly streamline the administration, relationships and interactions among stakeholders, and management of logistics that health systems are built on and the overall quality of care they can provide.
The main aim of utilizing blockchain technology and decentralizing healthcare is to address the issues and problems affecting the industry. By putting patients at the center of their own healthcare journey, decentralizing the healthcare sector with the help of blockchain helps provide patients with the information, ownership, and control over their own healthcare data. This is achieved by decentralizing data into individual patient nodes. This is also useful in population health management as patients can easily provide consent for access to their health data to be shared for the creation of a shared archive of health information of any specific condition. It also allows the patient the ability to easily monetize parts of healthcare data. All this can be done anonymously, thus protecting their privacy.
It is well known that different healthcare organizations often keep fragmented records for patients, particularly when more than one organization is involved in the care. Blockchain can be used to help to eliminate this issue and ensure that there are no missing or fragmented records by creating a distributed electronic health record (EHR) ecosystem made up of individual patient nodes, where they have their complete health records. This will further help to ensure improved quality, eliminate repeated and expensive tests, reduce errors, which will provide financial and operational benefits to healthcare organizations.
Other than the aforementioned advantages of a decentralized healthcare sector with an increased concentration on the patient, the approach can be used to improve healthcare on a global scale. Blockchain frameworks will help support and strengthen disease surveillance systems in the case of outbreaks, organize research on a global scale, and even provide a consensus to what is the best method to combat specific diseases.
Blockchain technology is also immutable and traceable. This allows the user to pinpoint specific transactions or actions that have been taken, whether it be in the patient journey or when it comes to logistics of pharmaceuticals. It is the best way to minimize or even eliminate healthcare and pharmaceutical fraud and errors. Overall, blockchain and a decentralized healthcare sector is the next logical step towards a more efficient, patient focused, and better healthcare system.
AI to help kids struggling with ADHD, Autism, Asperger Syndrome , PDD-NOS & other ASD’s
Stephane Bourles, CIO, Brain Balance
By Stephane Bourles, CIO at Brain Balance
AI to help kids struggling with ADHD, Autism, Asperger Syndrome (ASD), PDD-NOS and other ASD’s
Left Brain or Right Brain?
In a properly functioning brain, both hemispheres communicate equally and at lightning speed, millions of times per minute. In a poorly functioning brain, the left and right sides of the brain only impart partial information, causing frequent miscommunication. This is called Functional Disconnection and is the root of many types of learning, behavioral and social problems found in children. The Brain Balance program puts the left and right brains back in sync using sensory motor exercises, academic skill building, and nutrition guidelines.
How does the Assessment Work?
The assessment consists of sensory, motor, and academic testing of more than 900 functions. The outcome of this assessment is a highly customized report providing parents with a complete understanding of their child’s behavioral, social, and academic skill levels.
We use AI to determine which brain hemisphere we believe to be stronger or weaker. The Machine Learning algorithm used for the assessment is not always accurate, which we know based on the feedback from our staff—yes we let them disagree with the system, which is intended as a tool to help them support their own assessment, but not to necessarily force them into a decision they don’t agree with.
But as valuable as an individual observation based on years of experience is, it still remains just the view of one individual. That is why we look at Artificial Intelligence as a new solution combining neural network architectures with massive computing power to enable our solution to learn a pattern from large datasets and make statistical predictions based on test results and feedback we already have for tens of thousands of students.
What is next?
Thanks to many product releases with different Machine Learning models we tested, we were able to improve our assessment accuracy and achieve precision, recall and F1 scores over 0.95. The limitation of this AI model is it is not 100% accurate and you don’t know for sure the source of truth. Since AI is a “black box” which can’t explain its prediction for most models, you have to trust your staff first.
Similar to clinical decision support systems helping healthcare practitioners, we believe this fast growing dataset about children, combined with new Artificial Intelligence models such as Explainable AI, will help our staff improve a child’s initial assessment, which will then improve our overall program’s results.
Read Your DNA Story
Anne Wojcicki, Co-Founder & CEO, 23andMe
Read Your DNA Story
“After 19 years of not knowing anything, and then just from spitting in a tube, I have a pile of information all about me.” “I am so grateful for the opportunity to finally have confirmation of my history.” “I have never had anyone look like me…It’s just great to find out who I am.” Well, as thrilling and amazing as these testimonies sound, understanding and decoding DNAs is the most exciting scientific discovery of all time. People have spent decades together trying to track down their lost genetic ancestry or loved ones for many years. Thanks to the “secret code” in all of us! Individuals can today get easy and affordable access to their genetic information and this is made possible by 23andMe. With an aim to help people access, understand, and benefit from the human genome, they generate the data that not only reveals ancestry insights but also enables groundbreaking research and innovative products.
“For a little bit of spit and a few hundred dollars, we can check out genetic predictions for traits we already know we have—perhaps blonde hair or blue eyes—as well as susceptibilities for diseases we may have yet to develop, such as cancer or diabetes,” notes Anne Wojcicki, the pioneer woman renowned for bringing genome mapping to the common man for tracking linage as well as medical treatment. Through her company, Anne has built one of the world’s largest databases of individual genetic information. Its novel, web-based research approach allows for the rapid recruitment of participants to many genome-wide association studies at once, reducing the time and money needed to make new discoveries, and the company has created a proven and standardized resource for finding new genetic association and confirming genetic loci discovered by others. “In a world where health is poorly understood, we use data to better understand wellness and disease. We bring science to our customers and help them use it in meaningful ways.”
As Simple As Spitting
Primarily, the company offers two Personal Genetic Services: Health + Ancestry and Ancestry. Both services require submitting a saliva sample using 23andMe’s saliva collection kit that is then sent to the lab for analysis. The Health + Ancestry Service provides insights on one’s health predispositions, carrier status, traits, wellness, and ancestry. This is done through analyzing, compiling, and distilling the information extracted from one’s DNA into 125+ reports that customers can access online and share with family and friends. This Ancestry Service helps to understand who one is, where his/her DNA comes from and his/her family story. This DNA information is then entered into the reports of 23andMe services: Ancestry Composition, Ancestry Detail Reports, Maternal & Paternal Haplogroups, Neanderthal Ancestry, DNA Family, and DNA Relatives to retrieve results. Upon receiving the sample, the company’s CLIA-certified lab extracts DNA from cells in the saliva sample and processes the DNA on a genotyping chip that reads hundreds of thousands of locations in the genome. Eventually, the genetic data is analyzed, and personalized reports are generated based on well-established scientific and medical research.
Betty’s Birthday Wish
Betty Jeannotte’s only wish when she turned 100 was to learn about her ancestry. “Years and years ago, I’d done a little research, but I never got very far,” she said. “And I was curious.” She got a 23andMe kit and a chance to work with a genealogist to find out a little bit more about her ancestry. He found 7 generations of her maternal family. The information added another layer to what she already knew. Her 23andMe Ancestry Composition showed she’s about 80 percent English and Irish with a little bit of German in the mix. That reflects accurately with what she knows about her parents’ family histories. Her mom was “of Yankee stock,” while her dad, who had been a vaudeville magician, was a Bostonian whose family originally came from Ireland.
For 23andMe, the mission is about transforming lives. They are keen to provide more regions, more connections and more ways to help people like Betty know their DNA story. Some ancestry services are records-based, which means that the data can be retrieved from historical records such as birth, death and marriage certificates, to trace a lineage. 23andMe offers genetics-based ancestry reports and tools, which means that they analyze a DNA to trace one’s lineage and learn about his/her ancestral origin through 23andMe Ancestry Composition.
Trace. Discover. Connect
Furthermore, 23andMe’s unique service, Haplogroups provides reports on one’s maternal and paternal lineage by identifying their haplogroups. A haplogroup can trace part of his/her ancestry back to a specific group of individuals in the distant past. This helps in understanding how the migration of one’s DNA tells the story of their ancestors. Alongside, one can explore genetic similarities and differences between themselves and their relatives using Share and Compare service.
“We can even point to specific Neanderthal DNA that is associated with traits that you might have, like height and back hair,” points out Anne. Even though Neanderthals vanished about 40,000 years ago, their DNA lives on. Research tells us that they interbred with humans around 60,000 years ago. 23andMe can tell how much of one’s DNA is derived from Neanderthals and how that compares to others. Moreover, 23andMe’s DNA Relative Finder helps in connecting with people who share DNA with you and message them. This enables them to meet relatives—maybe even hear new family stories, share photos and get a better understanding of their family’s’ history.
Making an Impact
Over the years, Anne’s determination and power has shocked the scientific world. As a part of her mission to change healthcare through empowering their consumers, her company also conducts its own research to try to identify new therapies for both common and rare diseases. “I am obsessed with bringing the consumer voice to healthcare.” To further this effort, 23andMe’s genetic research gives everyday people the opportunity to make a difference by participating in a new kind of research—online, from anywhere. Once participants answer online survey questions, researchers link their genetic data to study topics from ancestry, to traits, to disease. These contributions help drive scientific discoveries. On average, a customer who chooses to opt into research contributes to over 230 studies on topics that range from Parkinson’s disease to lupus to asthma and more. “With the help of our 23andMe community, we believe we can accelerate research and make an impact with our genetic data.” Alongside, all researches are governed by an Institutional Review Board (IRB). The IRB is an independent ethics panel that ensures all research is conducted in accordance with government and ethical guidelines.
For 23andMe, genetics is personal! This has in fact impacted many lives, over the years, by giving people a chance to “find family and answers”, “reveal ancestry”, “strengthen family bonds”, and “get a stronger sense of their self.” Anne calls this, “democratizing personal genetics and making it more accessible,” as she is considers each life story a pathway to connect to humanity and improve the world.