Revolutionizing Precision Medicine
An accomplished businessman, a strategic thinker and an excellent leader, Mike Klein has been responsible for raising over $50 million in private equity and venture capital financing over the years. He has drawn on a unique blend of vision, tactical thinking, communication and execution skills in the last 25 years of his career. Mike’s technical and financial backgrounds have helped him bolster businesses and meet their objectives while driving revenue growth. Excerpts from an interview with Mike Klein, CEO, Genomenon:
The Entrepreneurial Streak
A computer and electrical engineer by academic virtue, Mike Klein found his way to genomics after he joined the company Genomenon four years ago. “I knew I wanted to be an entrepreneur early in my 20’s when my brother and I both started going to inventor conferences. After spending 10 years developing products at two different Fortune 500 companies, I started my first software company – Steeplechase Software in 1993.” He reminisces how he became the undisputed leader in the market and sold the company to a large multi-national corporation in 2000. “Genomenon is the fourth software/IT company that I have either started or joined as the CEO” he states.
Growth of Genomenon
Mike notes that Genomenon was born from a brilliant team of founders to organize all the genomic discoveries found in millions of scientific reports and make that information accessible at the fingertips of doctors and researchers to quickly interpret DNA results. “Quite literally, for precision medicine to become a reality for every patient, genetic interpretation needed an entirely new platform to eliminate the roadblocks that doctors are facing” observes Mike. “For precision medicine to scale, DNA interpretation had to be sped up by a factor of 100X” notes Mike, adding that precision medicine is revolutionizing the way we think about health care and genomics is the key that powers precision medicine.
Synergizing IT and Pharma
“Today, an individual’s whole genome can be quickly and cost-effectively sequenced but making sense of the 3.2 billion nucleotides that DNA sequencing produces is a big data challenge” observes Mike. By making use of their cloud-based Mastermind platform to index and organize genomic data, the company can deliver insight into the drivers behind a patient’s cancer or genetic and rare diseases. Mike cites an example of Rady Children’s Institute, wherein usage of Mastermind has led to an accurate diagnosis, thus helping treat babies born with rare diseases.
Mike notes that scientists and doctors are a skeptical audience by nature. They do not adopt new technologies because they are cool, but they adopt them because they solve real problems, save time and can increase diagnostic yield. “It simply takes time to prove that applying new technologies in new ways can yield significant advantages in diagnosing patients or discovering new drugs. As a genomic health IT company, it’s our responsibility to demonstrate that the advantages we bring to the table are real and unmatched by any other approach,” he adds.
A New Phase for Pharma Industry
Mike believes that the pharmaceutical market will come out of the pandemic better in two ways. “As scientists are spending more time working from home, focusing on data, the ability to understand massive amounts of data to advance scientific insights is getting exercised during the pandemic, and will be a key asset that pharma companies will rely on even more in the future” notes Mike. He also predicts that the current situation will force the industry to streamline the discovery and regulatory process to get new therapies to market faster than ever before.
Knowing that their solutions play a role in saving lives and treating cancer patients is a powerful motivator for all its employees, notes Mike. “Our proudest moments are when we hear from clinicians how they diagnosed a patient using our software that would have otherwise remained undiagnosed and untreated. Our technology makes it easy for clinicians to find the answers that can save patients’ lives,” signs off Mike.
Fighting Animal Testing with Machine Learning
Jo Varshney, Founder & CEO, VeriSIM Life
Fighting Animal Testing with Machine Learning
“I believe my leadership traits are driven by how I want to represent the company and my team. One of the most important traits is valuing the time of others and myself,” says Dr. Jo Varshney, an empathetic leader, and the founder of VeriSIM Life. VeriSIM Life is a futuristic drug development company that replaces legacy methods like Animal Testing with AI. Computational tools such as in silico methods have been used traditionally for drug design and discovery. But AI/ML can take the existing processes to a new level by making it more efficient and accurate without being as expensive as animal trials. Dr. Varshney is a multi-disciplinary and celebrated pioneer in both veterinary & human health development. Even as a child, Dr. Varshney had a profound thirst to stand against animal cruelty and empower the powerless creatures by finding and developing unique methods and solutions as alternatives. Her pharmacological pedigree, her determination, and her exposure to technology led to the formation of VeriSIM Life. Being the sole founder, Dr. Varshney’s passion, and commitment helped her to accomplish more in less time. She leads by example, communicates consistently, stays on top of relevant facts, and builds trust amongst her team. So, how does Dr. Varshney manage to do all this? Let’s find out!
Dr. Varshney, a DVM and a PhD in comparative oncology and genomics have been a self-aware individual since childhood. She likes to face challenges head-on. She doesn’t let the fear of failure postpone her plans. Dr. Varshney starts her day by planning specific outcomes to achieve that day. She plans goals with enough mental space for any unexpected hindrances that may lead to course correction. She believes that the skills you learn throughout life are futile without confidence. She adds that taking a direction is always better than taking none. An important virtue that Dr. Varshney value is integrity. Since a company’s culture is a reflection of its leaders, she ensures that her company culture embodies such traits. She believes in standing up for something bigger than herself and setting a precedent within her business. These morals are the foundation of VeriSIM Life.
Against Animal Cruelty
Before VeriSIM Life, there existed a fundamental disconnect in how new medicines reach patients. Animal testing, an important link in the drug development cascade, is usually relied upon to understand how the safety and efficacy of a new drug compound will react within the human body before being used in clinical trials. This process may not be as effective for a few reasons:
- Animal physiological outcomes translate poorly in humans, and hence it leads to over 92% drug failure rate in human trials.
- Identifying a true promising drug candidate may lead to several rounds of animal testing. This drives significant time, loss of innocent lives, and costs during the drug development process.
“We, at VSL, are solving these translatability challenges by creating the framework that embodies the knowledge generated from world-class experts in machine learning, biology, mechanistic modelling, and engineering,” says Dr. Varshney. Being strongly against animal cruelty, she kept questioning herself why subject poor animals to this testing when it was not even effective. She resolved to find another way. She successfully rolled out the BIOiSIM platform. It produced models that served as ‘digital’ representations of animals and humans. This enabled simulated tests, so she could forgo animal testing altogether or significant reliance on animals during drug development.
BIOiSIM enables researchers to choose only the most applicable preclinical testing subjects. It provides outputs of species-translatable simulations. This helps in narrowing down the number of drug compounds that are potential treatments or cures of specific illness or disease. The platform can run simulations of 1000’s of experimental conditions at a time by leveraging existing datasets. Pharmaceutical firms face massive losses when their research leads to little or no gain. This results in slow speed, expense, and moral issues of testing on species such as rats and monkeys that could be eliminated with biosimulation. Drug development which normally took 10 years or more with investments of over 2 billion dollars could now be done at a shorter time with minimal errors. BIOiSIM’s approach has the potential to deliver far better outcomes than the 8% success currently seen in the medicines making it to the market. Thanks to BIOiSIM, pharma will be able to focus their development efforts on the drug combinations that are more likely to succeed in delivering the anticipated result for the treatment or cure of specific illnesses and diseases.
A Paradigm Shift
The four applications which drive the majority of the AI market in biopharma are drug discovery, precision medicine, medical imaging & diagnostics, and research. “Drug discovery is the majority shareholder,” says Dr. Varshney. Taking into account the progress in AI for Drug Discovery over the last three years, it’s reasonable to expect that really significant results could be achieved in the coming years. Thus, enabling a paradigm shift for the entire biotech industry. From a technology and data perspective, three factors, in particular, are driving progress towards the recent transformation in the biopharma world: increasing data volumes, computing power, and decreasing costs of computing.
There have been several advances in the techniques used in AI domains. Every year these techniques are improved to produce the next-generation AI methods. Biopharma companies that use these next-generation technologies in AI, Deep Learning, Big Data, reinforcement of drug discovery & production, product repurposing, and biomarker production cause significant disruption in the industry. Progressive, technologically oriented countries are reformulating their drug evaluation and approval procedures to improve the time it takes to authorize medicines.
The Fight Against COVID-19
While there are significant innovations that have been brought into the biotech sector such as gene therapy, CRISPR-Cas9, and gene sequencing, Dr. Varshney claims that there’s lots more to accomplish. “Our work is not done yet and I believe we need to continue to innovate especially in bringing drugs and vaccines to diseases such as rare diseases at a more efficient pace,” she adds. The ongoing pandemic due to COVID-19 has brought about an immensely urgent need for a cure as soon as possible. In order to do so there needs to be a significant investment in computational strategies including AI. By integrating
AI in drug development, it’s possible to accurately predict which drugs will be safe and effective for specific patient subgroups. AI can generate drug candidates for which there already exists some evidence of effectiveness. VeriSIM Life’s AI-based technology is currently reviewing the best existing drug combinations to treat COVID-19 cases. The combinations generated are based on the current literature and knowledge about the virus. VeriSIM Life hopes to find some evidence to find combinations in a matter of months rather than years. Such high throughput will also significantly reduce the costs and extensive lab testing and clinical trials. It will provide more efficient protocols for drug experiments.
“I would like to see healthcare innovations that are centered to adopt cross-functional frameworks where science and technology are married to each other to solve biological problems,” says Dr. Varshney. Immense knowledge is available at present on several biological processes and the diseases associated with them. So, making use of them efficiently is the key. Many of the current Biotech’s challenges such as reproducibility, scalability, and predictability can be solved by computationally integrated approaches. Knowledge and data are managed better by computers rather than human interventions. Software and computational resources such as ML/AI have become extensively cheaper and are easily available and are more accurate. Pharma/biotech companies would be able to maximize the utility of the huge datasets already at their disposal. In the current digital world, innovation and re-structuring biopharma will generate more drug approvals and further personalization. This is the need of the hour. Dr. Varshney feels that such a supportive, cross-functional leadership with openness to adopt new technologies would play a vital role in reforming the industry.
“From my first school prize to successful coding to winning Google’s Hackathon, I have realized every situation has its own learning curve,” says Dr. Varshney. At a Google Hackathon, patient information was shared and the team was able to identify potential drugs in 3 days. This win gave Dr. Varshney the confidence to build VeriSIM Life. Post the launch, she witnessed a spectrum of wins including getting investments from world-class investors and early testimonials from happy customers of the world’s top pharma. She also considers the opportunities to work with like-minded experts as important milestones of her success journey. VeriSIM Life is gaining a lot of traction for its tech and several manuscripts. Being recognized as a rising leader in biopharma at the JPM conference, serving on advisory boards in early-stage biotech companies to help create successful business models, and invited speaker engagements were added honors for Dr. Varshney. “Overall success is a work in progress,” says the serial achiever.
Diversity and Collaboration
Producing medicines for everyone at a large scale is expensive. This is mainly because of the highly inaccurate and inefficient drug development practices. Dr. Varshney states there is a need for a significant mind shift. We must be able to incorporate innovation and train a workforce that is capable of engaging and working hand in hand with computational resources. This will create a much-needed drug development disruption. At VeriSIM Life, Dr. Varshney strives to embrace diverse opinions. By investigating communication, problem-solving, and collaboration, she aims to create an ideal environment to focus on this important mission of solving inefficiencies and saving lives in the process. Diversity produces the rare magic needed to solve challenges and Dr. Varshney strives to include these in VeriSIM Life’s practice.
Direction of Success
Dr. Varshney’s advice for young entrepreneurs is “Cultivate an ability to persevere even when things go or can go wrong. You won’t have all the answers. You won’t always know where to move next. You’ll have your wins, and you’ll have your losses. But through it all, you can’t lose your sense of confidence and passion. Put your energy into developing top skills further. No one is good at everything. The skills at which you are not talented, or have no interest, find reliable people to take over those responsibilities. This focus points you in the direction of success”, she adds. VeriSIM Life looks forward to innovating cures for both common and rare diseases. It continues on its mission to increase human life expectancy.
Epitomizing Women Leadership
Amy Ronneberg, President & CEO, Be the Match BioTherapies
Epitomizing Women Leadership
As the CEO and President of Be The Match BioTherapies®, Amy Ronneberg juggles many roles in her life. She is at the helm of affairs for both the National Marrow Donor Program® (NMDP)/Be The Match® and Be The Match BioTherapies, the only cell and gene therapy solutions provider with customizable services to support the entire end-to-end cell therapy supply chain. As the CEO of the companies, her roles are completely synergistic, with the focus on building a strategic business plan to develop and deliver an expanded portfolio of product offerings that accelerate patient access to life-saving therapies. Amy remains an epitome of a strong female leader who can overcome many adversities, in both her personal and professional life. In an interview, she speaks on an array of topics. Excerpts from the interview:
The Biotech Journey
When the NMDP/Be The Match recognized a clear opportunity to further its mission by supporting the development of next-generation cell and gene therapies, the company extended into the space through tradename Be The Match BioTherapies. Amy says that the then CEO of NMDP/Be The Match offered her the opportunity to lead the new company, Be The Match BioTherapies, while she was concurrently serving as the CFO of NMDP/Be The Match. “Biotech, outside of blood stem cell transplants, was new to me, so I was a little taken back at first. As I thought more about it, I realized that this was one of the most exciting fields in all industries. The possibilities were endless and this could be how we, as a company, could continue to close gaps for patients in ways we never imagined. I quickly became so excited about the opportunity that any trepidation that I had was gone.” She quickly adds that she fell in love with the industry rather instantly.
Role in Be The Match BioTherapies
One of the pivotal roles Amy plays at Be The Match BioTherapies is to help ensure that patients receive the best product/cell therapy available for their particular situation. She is also leading more than 1300 professionals and 3000 volunteers who help patients receive their life-saving therapies. “The more options patients have, the better. The NMDP/Be The Match represents the patients that are in need of a blood stem cell donor, but an unrelated transplant is not always available or may not always be what is best for their situation. Through Be The Match BioTherapies, we get to serve ALL patients in need, regardless of the type of therapy,” says Amy.
As Amy was preparing for her leadership role of the NMDP/Be The Match, she was also experiencing some trying times in her personal life. Amy reminisces about her personal battle with cancer, and how upon diagnosis, she had intended to withdraw her name from the candidate pool for CFO of NMDP/Be The Match. However, the CEO at the time did not allow her to do so, and instead, the company was by Amy’s side as she fought her battle, and held the position for her when she was ready. She defeated the deadly disease but quickly points out how the disease taught her to live a more purposeful life and to do many of the things she had always wanted to do. One of the most profound realizations Amy made during her battle with cancer was that, before her diagnosis, many of her decisions in life and her career were guided by fear. After her battle with cancer, she was forced to re-evaluate her priorities. She resolved to stop living in fear and start living in the moment.
Speaking on the current Coronavirus (COVID-19) situation, Amy laments that, unfortunately, many clinical trials may be delayed, as health systems are required to turn their attention to COVID-19 patients and may therefore face difficulties in accruing patients to other studies. “This may impact how quickly new therapies can get to market. In this new industry, many companies realize that time is money and there will be companies with great potential that may exhaust their cash runway earlier in their trials than originally planned. These could be detrimental for some organizations with amazing potential.” She, however, expresses hope that many organizations have been able to pivot and will remain in the game. But, if COVID-19 continues for another year or more, there could be a real concerning impact on some organizations. Through the expertise of her teams, Be The Match BioTherapies has been able to continue ensuring that critical patients receive their therapies during this trying time. The company has also recently extended its services to support the development of therapies to treat patients suffering from the impacts of COVID-19.
Noting that the past three months have been the proudest times in her career, Amy explains how the organization has stepped up more than she could have ever imagined. “Every step of our operations were impacted by COVID-19 – country borders closed, apheresis and collection centers closing or limiting their capacity, donors unwilling or unallowed to go into healthcare facilities, commercial flights canceled and studies delayed. Yet, Be The Match BioTherapies and the NMDP/Be The Match prevailed, and quite honestly, excelled, she noted.
A Piece of Advice
A piece of advice for women who want to join the entrepreneur bandwagon, Amy says, “Don’t throw away your shot. Take every opportunity and dive headfirst into it, no matter how scary it seems, or outside your knowledge-base, you feel. Learn, learn, and learn,” she signs off.
A Dream to Democratize Healthcare
Henry Legere, CEO, Reliant Immune Diagnostics
A Dream to Democratize Healthcare
Inspiration can come from any direction. But how do you take any new concept and transform it into a reality? Dr. Henry J Legere IIIsays it is his curiosity, entrepreneurship, and his sense of fairness that stirred him to begin his success journey of designing a complete consumer-driven health platform that can provide testing, diagnosing, and monitoring solutions. Being an expert in both science and healthcare, Legere received his MD from Columbia in NYC, completed an immunology fellowship at Harvard/ Brigham & Women’s Hospital, and had clinical appointments at BWH and MIT Medical.
Living under the ethos of “if you don’t try, you will never know,” Legere was never satisfied with the healthcare provided to every person and the limited access available to large cross-sections of the population. “You would be blind if you didn’t notice the medical social economics disparities, not just globally but in our communities,” says Legere. His company, Reliant Immune Diagnostics began with an aim to democratize healthcare. Their MDBox telehealth app provides greater access to healthcare at a more affordable price utilizing technologies that are used every day.
The power of AI
AI is now reinventing modern healthcare in diagnosing and treating patients more quickly. Reliant ID incorporates AI in its MDBox app to read diagnostic tests. “The power of AI is incredible, and we’re just starting to see it being used in drug discovery,” notes Legere. During his research, Legere found that even though the human genome was sequenced almost 20 years ago, there are adults and children suffering from ancient ailments like allergies, cancer, and cystic fibrosis. “If you do a simple PubMed search, there are over 50,000 papers on cystic fibrosis from thousands of different authors from around the world. However, with the power of technology and AI, we can now come together in a new public-private collaboration.” Currently, Reliant ID has many partnerships with companies and institutions focused on many medical issues. “We combine our powers differently to provide the best healthcare available.”
Making dreams to realities
Holding fast to his dreams, Legere believes the price of success is courage, determination, and hard work. He began thinking of the MDBox app over 15 years ago, but there was no technology for it in the early 2000s. With the advent of smartphones, his dream to democratize healthcare become a reality.
A patient and a company success story
“One of our investors was very skeptical of telemedicine. While he was in town visiting his grandkids, he wanted to come to our office to do a demonstration. But he called and said he couldn’t make it because he thinks that his grandchild had given him a pink eye. And I said, ‘you know, that’s one of the things that we can take care of.’ So, he ended up downloading the app, and within a few minutes, he was given a prescription that he was able to go pick up at the pharmacy near him. Later that day, he wired funds in and invested in our company. It turned to be a patient as well as a company success story.”
From being a dreamer to a high achiever, Legere and his team are now confident to find out how they can immediately impact healthcare and strategize how they can expand health and wellness reach in the near-term future.