Clinical Research Fastrack

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Innovation in Healthcare – Clinical Research Fastrack MD News Feature

“I think we’ve built a very unique and disruptive medical ecosystem.”

From left to right: Aaron Ali, MD, CEO of MedtoMarket; Holly Bain, Founder and CEO of Paramount Research Network; Mario Sierra, Business Strategist with Paramount Research Network

Aaron Ali, MD, anesthesiologist and CEO of MedtoMarket, is tired of the status quo in health care and is looking to shake things up. His 31,683-square-foot medical training and co-working facility, located in south-central Austin’s St. Elmo District, is just the place to do it.

Innovation Station

MedtoMarket, which was founded by practicing physicians, has a mission of helping medical innovators get to market faster — by doing things in a new way.

The facility, which contains 35 offices filled with everything from bioskills research and training, to physician access, to multi-use space, allows MedtoMarket to provide the resources a startup company needs to bring their visions to life. The facility includes a wet lab, mock OR and large skills labs, plus the kinds of amenities found in typical tech incubator spaces, such as meeting spaces, a large pitch room for presentations, a lounge area and even a free workout facility.

It’s an ecosystem where all the different elements, from the big medical device companies to those who sponsor clinical trials, all work side-by-side with physicians, nurses and patients. Add a large dose of entrepreneurial spirit, and something magic seems to happen.

“When I walk through there, I see different companies talking to each other, and they’re sharing resources or sharing personnel,” Dr. Ali notes. “They’re sharing stories, which I think that’s one of the coolest things. It gives me a big smile to see that. They’re kind of creating their own value amongst each other.”

Streamlining Success

One success story to which Dr. Ali proudly points is TVA Medical, a group in Austin that developed a novel type of arterial-venous fistula for dialysis. TVA came to MedtoMarket to collect data for its FDA approval.

“During the process of [TVA] coming in, using our facilities and asking us questions, we ended up giving them even more ideas about how they can enhance their procedure,” Dr. Ali says. “As physicians and anesthesiologists who have been doing these cases, we had a couple of ideas for them, and they took those and put them in the process. They actually started using our ideas in their clinical trials.”

Within weeks of gaining FDA clearance for their everlinQ endoAVF System for hemodialysis, TVA was acquired by Becton, Dickinson, and Company. According to Dr. Ali, “We were a very integral part of creating a more efficient process and letting them get to the finish line a little faster.”

“These are unprecedented times with the COVID-19 pandemic. As a physician, as a father of three sons, as a husband and as an entrepreneur, the reality of what this pandemic has done to us physically, mentally and economically is difficult to take in without being depressed or fearful. Fear and panic are not the answer. One thing I have learned over the years is we are a resilient country. It will be the scientists, doctors, nurses and entrepreneurs who will bring us out of these dark times with the support of the hospitals, clinics and surgical centers. It will be the wet labs, clinical trial specialists and pharmaceutical companies that will bring medicines to the people who need them most. Though this article was written prior to the COVID-19 pandemic, it could not have come out at a better time. The collaboration between entities across our healthcare ecosystem is more important than ever. Stay safe, stay healthy — but more importantly, stay optimistic.”
— Aaron Ali, MD, anesthesiologist and CEO of MedtoMarket

Embracing New Ideas and Technology

Another medical startup making a positive impact is San Antonio’s Paramount Research Network (PRN), which partners with physicians and clinics to facilitate the conduct of phase 2–4 clinical trials and deliver high-quality data to sponsors.

Holly Bain, Founder and CEO of Paramount Research Network

Mario Sierra, Business Strategist with Paramount Research Network and graduate of Clinical Research Fastrack’s training program

“We are a clinical research company that is focused on maximizing physicians’ flexibility and profit, utilizing automation in the clinical research industry,” says Holly Bain, PRN’s founder.

PRN will negotiate contracts and budgets, as well as fully equip existing practices with certified research staff, administration support, research equipment, training, regulatory submissions, pharmacists and continuous sponsor representation.

“It’s a turnkey process for physicians and an important source of alternative treatment for patients,” Bain says. “We’ve been able to bring therapies to patients that are not currently on the market.”

One such treatment is PRN’s ongoing nonalcoholic steatohepatitis (NASH) trial to treat fibrosis of the liver in patients with fatty liver disease, which currently has no available treatment.

One of the challenges that PRN tackles is a reluctance on the part of the medical establishment to embrace new ideas and technology when it comes to performing clinical trials.

“I think because the space is so highly regulated, people are intimidated,” Bain says.

PRN looks to find technologies that can be easily and effectively adapted to clinical trials. They look for inefficiencies and apply technology to streamline and simplify the process. For example, time spent doing monotonous tasks is replaced with scalable technologies. Using software and continuous monitoring devices to automate repetitive work and reporting — for example, using Ideal Science’s TempStick technology for real-time temperature tracking — can reduce the labor involved in the trial process and increase accuracy.

One such idea is the implementation of virtual clinical trial visits, otherwise known as telemedicine, which leverage the abundant access to internet-capable devices many of us have. This technology allows for trials and regular doctor’s appointments to continue in the most dire circumstances, such as what we are facing with the COVID-19 global pandemic. PRN is virtual-certified through its partnership with VirTrial and plans to expand use of the technology with the looming health crisis.

“We are seeing many obstacles taken down in the area of telemedicine in an attempt to keep communication of the virus down,” Bain says.

For Bain, it’s more than a business; it’s a mission to advance medicine.

“We want to help people,” Bain says. “We want to make the trial process more accessible so physicians can expand their practices. We want to give the patients more treatment options. We want to help medicine move forward.”

And partnering with incubators like MedtoMarket is key to that.

“They’re very forward-thinking and they’re trying to solve a problem in the industry. It’s all about innovation,” she says. “They are providing a launchpad for biotechs and standardized training to make everything more efficient and, in the long run, drive down the cost of drugs and the cost of health care.”

In MedtoMarket, PRN found another partner looking to improve upon the traditional we’ve-always-done-it-that-way thinking.

“We’ve decided to team up with Clinical Research Fastrack in an effort to staff our sites with highly trained personnel,” Bain says. “Their training program is one of the most comprehensive out there, providing both in-class and field training from industry experts. It’s bringing standards to our industry.”

From left to right: Jamaica Cundiff, Associate Program Director with Fastrack; David Silberman, Co-Founder and CEO of Fastrack; Lauren Ballina Chang, MS, CCRP, National Program Director with Fastrack

Answering Questions Better and Faster

Lauren Ballina Chang, National Program Director for Clinical Research Fastrack, thinks she knows the reason there are shortages of trained clinical researchers.

“No one grows up thinking, ‘I want to be a clinical researcher.’” she says. “In fact, that isn’t even something most people know is a career option.”

Clinical Research Fastrack is designed to address that. From their headquarters in Arizona, they train aspiring clinical research professionals, physicians and other study staff who want to bring new devices, drugs, and therapies to market.

“I think a lot of people get into medicine because they want to help people. Well, clinical research is always working on the future of medicine,” Chang says. “They get to work on cutting-edge new devices or therapies or medications, as well as offer new options to their patients. If the goal is to help people, I can’t think of a better way to reach well beyond just one patient at a time.”

Mario Sierra, business strategist with PRN and a graduate of the Clinical Research Fastrack training program, is a prime example of what is possible with this new training methodology.

“I had a good educational background for research, but no practical experience to land me a job in the industry. Fastrack solved that problem for me and put me in front of people who were looking for quality candidates,” Sierra says. “I capitalized on the opportunity and was fortunate enough to have a job lined up before training was even over. That’s the power of Clinical Research Fastrack.”

Ultimately, clinical research is trying to find the answer to such questions as, “Is this new intervention safe?” “Is it effective?” When questions like these are answered, the entire medical community greatly benefits.

Conducting clinical trials is a way for physicians to generate more revenue for their practices while staying at the forefront of their field of medicine. However, if you haven’t had training in clinical research, it can be difficult to get your very first trial.

“Clinical research is like its own specialty. You couldn’t be a practicing surgeon without the proper residency and, just the same, you can’t be a practicing principal investigator without the proper training,” Chang says. “Physicians have extensive medical knowledge and expertise but lack the understanding of clinical research operations. Clinical Research Fastrack is able to fill this gap so that all parties involved are able to oversee trials successfully.”

Chang notes that one of the key issues with trials is noncompliance with the FDA’s regulations regarding the Statement of Investigator Form 1572, a binding agreement between the investigator and the FDA. As she sees it, “a lot of it goes back to a lack of training, inadequate training or just not the right training. It’s not that it is difficult, it’s just that you don’t know what you don’t know, and that’s where mistakes happen, delays happen, trials are lost and subjects are put at risk.”

The 1572 regulations are in place to ensure that all protocols are adhered to and the investigators or clinicians are qualified and that the results delivered to the sponsor are accurate and that FDA rules are followed, protecting the safety and well-being of participants and collecting clean, credible data. There’s an extensive amount of paperwork and protocol to follow. The physician oversees this, but much of it is delegated to other study staff. This is where a company like PRN comes in — to take care of the day-to-day, nitty-gritty details of running the trials, Chang says.

A traditional clinical training program can take up to two years to complete, valuable time that is has been seen as the industry standard. Clinical Research Fastrack is disrupting the norm with its crash-course training methodology.

“Our PI training, designed for physicians, is 16 hours, and our clinical research fundamentals training is 228 hours. We do a lot of hands-on in-classroom didactics where we can practice before we play,” says Chang. Physician training also includes personalized, one-on-one guidance. “We give them the training, but then also guidance on how to be successful in acquiring their first trial and beyond.”

As Chang sees it, “We are changing the industry by elevating the individuals getting into [clinical trials], whether it’s the physicians overseeing the studies, the principal investigators, the coordinators running the protocols or the data management team or regulatory teams — whomever it is, we can elevate them all. This translates to an acceleration in the speed and the quality with which these trials are run.”

Classes at Clinical Research Fastrack are led by professionals in the industry, and students are provided with site-level exposure through externships that help them prepare for their new roles.

“It’s not enough to just have knowledge in this world,” Chang says. “If you can’t translate it or can’t put it into action, then it’s not worth much.”

Theater and training bay at MedtoMarket

Lowering Barriers to Entry

This is exactly the kind of innovative thinking that Dr. Ali and his partners had in mind when they started MedtoMarket.

“PRN and Clinical Research Fastrack are in the same area as us — we each aim to do it better, faster, smarter. They have their expertise, we have ours. We work well together.”

MedtoMarket is quickly becoming the place to be to get up and running faster for small healthcare/medical startups. It aligns well with the mission of the 21st Century Cures Act, a 2016 law designed to speed the process of medical product development so these advances and innovations to patients can be more efficiently provided to patients who need them. MedtoMarket checks all of the boxes of the Cures Act. The facilities, the ability to share ideas with like-minded innovators and the access to the right people — investors, major medical device manufacturers, pharmaceutical companies, and leading names in healthcare innovation — all help lower the barriers to entry.

Historically, most innovation in medicine has been controlled by academic centers. While valuable, they can also be plodding, laden with bureaucracy that is the opposite of entrepreneurship.

Paramount Research Network’s Behind the Science podcast is available on Soundcloud, Apple Podcasts and Spotify.

“It’s those things that have always kept healthcare innovation held down a little bit and made it a little bit tougher,” Dr. Ali says. “That long route has always been like that, and people have just accepted that it’s going to take seven to eight years to get something out there to market. We want to disrupt that and say, ‘you know what, we think we can do it faster, and we think we can do it smarter and we think we can do it more economically.’”

That’s not to say that Dr. Ali dismisses the role of academic research.

“We look at our cause as a very nice, synergistic partnership with the medical school and the academic center and the hospitals,” he says. “As a matter of fact, they’ve all visited, they all love it, and they’re all trying to figure out ways to bring their physicians and nurses and students here. We look at ourselves almost like the third leg to the barstool. You’ve got your academic centers, your hospitals and then you have us, which allows you to go off into a neutral off-campus site.”

As far as he knows, there is no other facility like MedtoMarket anywhere in the world.

So, what makes Austin a successful location?

“It does take a special city to be able to support something such as ours,” Dr. Ali says. “No. 1, you have to have a vibrant city where you have an incredible amount of intelligent people. I go to my kid’s school, and I can’t tell you how many parents are PhDs or doctors. It’s just an incredible base of educated people.”

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