Life Sciences 2018

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LIFE SCIENCES

MAXIMIZING RESULTS THROUGH COLLABORATION AND PARTNERSHIP

OCTOBER 2018 | LIFE SCIENCES

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Sam Lohmar Accelerated Development Program Associate, Microbiology Assays

The answers are out there.

The people finding them are in here.

Sam Lohmar joined the Roche Indy Accelerated Development Program in 2017, but he’s motivated by something that happened back in 2008: his family almost lost his father to a heart attack. During the wait for test results, Sam’s dad’s heart stopped for 45 seconds.

Today, Sam deeply understands the importance of fast, accurate test results doctors need to provide a proper diagnosis for patients and their families. And he works tirelessly to support his team to make those sorts of test insights and diagnoses possible.

Learn more about Sam’s story at RocheIndy.com

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INNOVATION AND COLLABORATION ARE EMBEDDED IN CENTRAL INDIANA’S DNA.

INDIANA’S LIFE SCIENCES CATALYSTS not only bring products to the

bedside but also organize venture funds, invest in startup companies, and build corporate, academic, and philanthropic partnerships— whatever it takes to advance the industry and improve patient care.

In a 2012 speech to life-sciences leaders, Eli Lilly and Company’s then-CEO John Lechleiter challenged the group to work even more closely together and put Indiana squarely on the life sciences and innovation map. He suggested that key players support a world-class institute to bridge the gap between academia and industry.

“All of the participants in Indiana’s life-sciences hub need to think about our collaboration in new ways,” Lechleiter said in his speech.

“We need to be as innovative in the ways we work together—across disciplines and across institutions—as in the science we pursue … in order to overcome the barriers to common efforts to recruit and retain talent; fund research; create, share, and protect intellectual property; and develop economic opportunities.”

A catalyst for collaboration and partnership in the industry, BioCrossroads hosted the Indiana Life Sciences Summit where Lechleiter gave his speech. The organization remains focused on advancing the life sciences in Indiana and has maintained seed funds available to invest in startup companies.

Answering Dr. Lechleiter’s challenge and a prime example of the local innovative and collaborative environment, BioCrossroads— along with Corteva Agrisciences, Agriculture Division of DowDuPont (then Dow AgroSciences), Cook Medical, Eli Lilly and Company, Roche Diagnostics, the Lilly Endowment, the IU School of Medicine, the State of Indiana, and IU Health—created the Indiana Biosciences Research Institute, a not-for-profit independent research institute initially funded by the state of Indiana, the founding companies, and the philanthropic community.

Currently housed at the IU School of Medicine, the IBRI facilitates collaborations that could change the future of healthcare. The organization brings together research and researchers from academic and industry sectors to work together toward better treatment solutions.

Growth is on the horizon—for the IBRI as well as the local science and tech communities. Less than two miles northwest of downtown Indianapolis, 60 acres of land is ready to be transformed into the 16 Tech Innovation District. Developers will break ground in late 2018 on the community’s anchor facility, a 120,000-square-foot building, the first three floors of which will serve as the IBRI’s headquarters.

Recognizing that innovation doesn’t happen in silos and thrives when people and ideas connect, IBRI and local business, civic, and community leaders envisioned 16 Tech as a place where life sciences talent would collaborate with other scientists and—even more interestingly—with talent across the tech, engineering, and advanced manufacturing sectors. 16 Tech is where people will come to collaborate, innovate, and commercialize the next big idea. With specific programming, events, and space designed for collaboration, 16 Tech is expected to be Indianapolis’s next destination for local, national, and global talent.

“The goal is to create a location where organizations that are working on new innovative technologies can be located with each other in a way that maximizes the convergence of ideas related to the biosciences,” says Bob Coy, president of 16 Tech Community Corporation.

“Indianapolis has burnished its starting collection of life sciences companies, universities, and hospitals into a tightly honed ecosystem that acts on the global stage.”

BRUCE KATZ AND JEREMY NOWAK, AUTHORS OF THE NEW LOCALISM

When BioCrossroads hosts this year’s Indiana Life Sciences Summit, Ketan Paranjape, vice president of Diagnostic Information Systems for Roche Diagnostics, will lead the final luncheon keynote about the future of digital diagnostics. Roche has strong ties to the organizations profiled in this publication, as well as Indiana’s lifesciences community as a whole. In its products, research, and initiatives, Roche shares a common goal in the industry: using science, technology, and available data to streamline healthcare processes and ultimately improve patients’ lives.

In fact, Bruce Katz and Jeremy Nowak, authors of The New Localism, said, “Indianapolis has burnished its starting collection of life sciences companies, universities, and hospitals into a tightly honed ecosystem that acts on the global stage.”

This is the story of Indiana’s life sciences community, and how entities are working innovatively and collaboratively to impact Central Indiana’s economic future as well as the health of Hoosiers and people all over the world.

by lori roberts OCTOBER 2018 | LIFE SCIENCES

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16 TECH INNOVATION DISTRICT

Architectural rendering of the future 16 Tech Innovation District.

CREATING SPACE TO FOSTER CONNECTIONS

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AN OLD, BRICK INDUSTRIAL BUILDING sits on land nestled near the intersection of West 16th Street and Indiana Avenue near downtown Indianapolis. Citizens Energy Group once occupied this space, which is now empty. The area around it is quiet.

But if Indianapolis business, academic, government, and philanthropic leaders have their way, it won’t stay quiet for long. Collectively, these groups envision a place where innovators, entrepreneurs, and established companies come together to bring new ideas to life. Overseen by the nonprofit 16 Tech Community Corporation, plans for Central Indiana’s innovation district are quickly taking shape.

The 16 Tech Innovation District will be a central hub where creative thinkers and doers in life sciences, technology, advanced manufacturing, and engineering converge, innovate, and create. Imagine a software engineer having coffee with a medical device engineer in a 16 Tech café when the engineer suddenly realizes that an Internet of Things (IoT) application in transportation is transferrable to a medical device project she is developing. An eureka moment.

“That’s the point of an innovation community,” says Bob Coy, president of 16 Tech Community Corporation. “It brings pioneering thinkers into proximity with one another and gives them the tools and opportunities to collaborate and create.”

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BUILDING A FOUNDATION THE STORY OF 16 TECH started in 2002, when the land was zoned for innovation and entrepreneurial activity at the end of Indianapolis Mayor Bart Peterson’s term. Its location across Fall Creek from the IU School of Medicine ensures that like minds will be nearby.

16 Tech gained renewed momentum when the Indianapolis CityCounty Council approved $55.8 million in tax increment financing (TIF) in 2015, the Richard M. Fairbanks Foundation awarded a $2 million grant in 2017 to help with startup operating costs, and the Lilly Endowment Inc. announced a $38 million grant in 2018. The Lilly Endowment grant will fund many of the placemaking features of 16 Tech, including a new, iconic bridge over Fall Creek to increase connectivity to the medical school, IUPUI campus, and downtown.

The grant will also support a park and a multi-use pedestrian and cycling path connecting 16 Tech to the Indianapolis Cultural Trail.

The city TIF money and philanthropic grants help fund the infrastructure projects necessary to attract developers, Coy says. He anticipates that 16 Tech Community Corporation will become sustainable through land leases and common-area management fees paid by tenants.

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INNOVATOR SPOTLIGHT

16 Tech is coming to life because it’s connected to so many area assets—from research universities to industry giants such as Eli Lilly and Company, Cummins, Rolls-Royce, and Salesforce. And the connective tissue that will make 16 Tech a destination for talent and companies is the programming—including events, resources, and shared services that support innovation and collaboration.

DEREK SMALL

President and CEO

CREATING PURPOSE ANOTHER INDIANA MEDICAL powerhouse

is making its presence felt at 16 Tech. For the first time in its 55-year history, Bloomington-based Cook Group has operations in Indianapolis and already renovated and repurposed a building at the perimeter of 16 Tech to house its newest venture, Cook Regentec.

The facility at 1102 Indiana Avenue—once a warehouse that stored beer kegs for the Indianapolis 500—now houses 65 employees in a modern, collaborative office space with adjacent advanced laboratory facilities. Organized as a technology and entrepreneurial development center, Cook Regentec brings together scientists, innovators, engineers, physicians, and entrepreneurs to create and foster a new range of tools and medical therapies utilizing regenerative medicine.

Company leaders look forward to the development of 16 Tech and are eager to collaborate with new neighbors. Rob Lyles, president of Cook Regentec, expects to see places where employees can gather informally, whether in the common green space, at the makerspace in the renovated Citizens Energy Group building, or at a coffee shop. Good ideas can come out of these unplanned encounters, Lyles says.

“We always say innovation is a collision sport,” Lyles says. “You have to have interesting people colliding with each other in a positive setting.”

16 Tech envisions collaborations with employees from startups and established corporations as well as researchers and innovators who have started to mature a seed of an idea.

Talent at 16 Tech will come from a variety of advanced industry sectors and interact in ways that allow them to discover common interests.

That’s how KAR Auction Services sees interactions playing out in 16 Tech. The Carmel-based company, building its new

Assembly Biosciences

A PUBLICLY-LISTED COMPANY in Carmel works to bring treatments to the market for Hepatitis B, Crohn’s Disease, Irritable Bowel Syndrome, and other chronic diseases to help millions of people around the world.

Assembly Pharmaceuticals (Nasdaq: ASMB) formed five years ago to develop new medicines based on the breakthrough science of co-founder and Indiana University professor Adam Zlotnick, PhD. Initial investors included Small’s venture firm Luson Bioventures, Johnson & Johnson, and the BioCrossroads Indiana Seed Fund II. In early 2014, the startup merged with publicly listed, New York-based Ventrus Biosciences. The merger represented both an initial financing for Assembly and an IPO of sorts in the same transaction. The new Assembly Biosciences, which moved its headquarters to Indiana, now employs nearly 100 people worldwide and is in multiple clinical trials with its new drug candidates.

“It costs hundreds of millions of dollars to discover, develop, and take an innovative drug to the market,” says Derek Small, president and CEO of Assembly Biosciences.

“There are many risks in drug development; some people might call it too risky.”

It is also a process that takes years to develop. Every good hypothesis in a research lab must be tested and successfully complete multiple preclinical and clinical trials. Prospective pharmaceutical treatments must meet safety standards and be deemed efficacious for the diseases they target, and also meet the stringent standards of regulatory bodies such as the U.S. Food and Drug Administration. This is a

monumental but important task, involving hundreds of millions of dollars and years of study. Securing investment dollars to perform this work is never easy, and is one of the key risk factors beyond the science.

“BioCrossroads Indiana Seed Fund is an early investor, even a first investor that identifies promising early-stage companies,” says Brian Stemme, project director for BioCrossroads.

“The first investments are often the toughest to raise, and funds like BioCrossroads are critical to cities and states attracting talent and further investments required for building sustainable companies. And our growing early investment culture in Indiana is what made it possible for us to move the headquarters from New York City,” says Small. “Indiana has really matured in the past 10 years or so with growing life science executive talent to help foster the vibrant science and intellectual property that has always been among the strongest in the U.S.” Small has been a prolific entrepreneur.

The Indiana native started Naurex, a private, Evanston, Illinois-based company, focused on therapies for the central nervous system.

It was later sold to Allergan for $600 million up front and up to over $1.75 billion if milestones are achieved. Other launches include recently IPO’ed Aptinyx (Nasdaq: APTX) and a new local company also in the BioCrossroads portfolio called Anagin.

“The reason I became addicted to starting drug companies is the people—the quality of the people, the ethical standards, the intellect, and the ability to share all of that to make medicine to help people,” Small says.

OCTOBER 2018 | LIFE SCIENCES

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INNOVATOR SPOTLIGHT

headquarters in Hamilton County, sees benefits of working with like-minded talent in 16 Tech and having space and programming to ignite collaboration. KAR CIO Tom Fisher points out that the company is working with drone technology, in-car systems, tracking devices, and other components that translate over a wide range of industries.

“I see an opportunity for our project teams to go into a very collaborative environment that is outside the normal day-to-day environment they live in at headquarters,” Fisher says.

BRAD BOSTIC

Chairman and CEO hc1

DEVELOPING THE PLACE

BRAD BOSTIC WAS a business and infor-

mation systems major at Indiana University when he met an entrepreneurial surgeon.

Dr. R. Daniel Grossman—who eventually became Bostic’s father-in-law—encouraged Bostic to look at how healthcare could be improved through bioinformatics. And, thus, a passion was born.

“I loved the fact that you could positively impact the health and well being of people with technology,” Bostic says.

Bostic is the chairman and CEO of hc1, a company that provides precision health solutions that enable healthcare organizations to personalize treatment for individuals resulting in improved health and reduced medical spending. Founded in 2011, hc1 works with diagnostic laboratories, health systems, and public health departments to solve some of healthcare’s most critical challenges through advanced decision support and actionable analytics.

For instance, Bostic says, consider the opioid epidemic. Physicians have a limited window of time to make the best prescribing decision for each patient. hc1 offers an automated decision-support solution that acts like a smart pharmacist in the cloud who instantly and accurately assists the provider with making the optimal choice.

Additionally, the company provides a pharmacogenetic service to tailor prescribing based on each individual’s unique genetic code, preventing adverse events, improving outcomes, and reducing costs. hc1 also offers cloud-based solutions that foster high-value care—for example, its lab-utilization dashboard monitors 6

testing so individuals receive the most appropriate lab tests to render fast, accurate diagnoses while eliminating unnecessary, wasteful tests.

Bostic is borrowing from the Amazon model, in which customers are accustomed to experiences that cater to them personally based on their habits and interests.

“Ultimately everybody wins when you’re using information to drive a more personalized approach to healthcare,” Bostic says.

Bostic’s personal experience helped inspire him to create hc1. He watched his own mother battle advanced cancer in the late 1990s. Although she was fortunate to have access to great doctors at a world-class hospital, Bostic noticed that providers were not in sync and decisions were made based on incomplete information. Beyond the electronic medical record, it was clear that these individuals needed the help of advanced technology to help them make optimized decisions.

“Making healthcare personalized is incredibly important because it impacts all of us,” Bostic says. “We owe it to our families and ourselves to achieve our mission of personalizing healthcare.”

Bostic’s goal is to bring data together in a way that spotlights the best therapies for patients through applied precision medicine. That may mean avoiding medications that won’t work or encouraging preventative lifestyle changes that have shown positive benefits for specific sets of health issues. His team carries out that focus daily, with a unique intensity due to the importance of their mission.

INDIANAPOLIS-BASED Browning Investments will build the first three new buildings at 16 Tech and renovate the former Citizens Energy Group headquarters. Groundbreaking for 16 Tech’s first new building is anticipated for this November. The Indiana Biosciences Research Institute will be the anchor tenant of the five-story building. The IU School of Medicine’s new regenerative-medicine center, announced in August, will join the IBRI there. In addition to the anchor facility, Browning will construct a second office and research building and multi-family housing complex. The Citizens Energy Group building with its high-bay garage will be retrofitted for maker-space and flexible working space.

COMMUNITY COMMITMENT

16 TECH WAS ALSO FOUNDED to foster greater prosperity for residents in the Near West and Near Northwest neighborhoods.

16 Tech oversees a Community Investment Fund with the express purpose of revitalizing surrounding communities via strategic grants to benefit residents through workforce development, education, and training programs, plus neighborhood improvement projects.

The fund was seeded with $3 million from the City of Indianapolis and will be sustained through assessments paid by district tenants. An advisory committee made up of neighborhood leaders and service providers will review grant applications and recommend investments. The first round of grants is expected to be awarded in early 2019.

LIFE SCIENCES | OCTOBER 2018

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The Future of Innovation is Happening Here.

Š DEPICTION,LLC 2018

16 Tech. Central Indiana’s Innovation District. Where life sciences, tech and advanced industries will connect, collaborate and innovate. www.16tech.com info@16tech.com

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BIOCROSSROADS

INDIANA BIOSCIENCES RESEARCH INSTITUTE

Theresa Mastracci, PhD, works to find a cure for diabetes.

BUILDING BRIDGES TO ENABLE ADVANCES

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100 YEARS in starting and growing life sciences companies, including Eli Lilly and Company, Zimmer BioMet, Roche Diagnostics, and Cook Medical—all of which started with one person’s vision, grew into world leaders, and continue to have an entrepreneurial spirit today. The state’s life sciences community also includes a significant number of spinoff and startup companies, which are developing treatments for Hepatitis B, migraines, diabetes, and cancer while also inventing technologies that monitor infant breathing during surgery and instruments that improve brain surgery.

Indiana’s life sciences industry is unique in that it has depth and breadth across the entire sector: medical devices and equipment, pharmaceuticals/biotech, diagnostics, agbiosciences, and health information technology. In addition, Indiana University and its medical school (the largest in the country), Purdue University, and the University of Notre Dame all have impressive research credentials

INDIANA HAS A LEGACY OF MORE THAN

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and give Indiana academic research capacity that pursues novel ideas and collaborate with the state’s industry.

But, how do you harness all of that collective life sciences power, and what can you do with it?

BioCrossroads answers that question every day by developing collaborations with industry—the most notable and largest of which was the establishment of the Indiana Biosciences Research Institute (IBRI).

The researchers at the IBRI are not tied solely to one organization or entity, yet they hold the threads that connect the major players in the field of life sciences. Founded in 2013, the IBRI is a not-for-profit research institute that brings together scientists from across the life sciences spectrum to collaborate and share ideas that target some of Indiana’s biggest health challenges.

“We serve as a bridge between academia and industry,” says Dr. Rainer Fischer, chief executive officer and chief scientific and innovation officer for the IBRI.

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INNOVATOR SPOTLIGHT

HOW IT ALL STARTED THE IBRI’S STORY BEGAN more than 15

years ago when BioCrossroads was founded.

“BioCrossroads was developed as a catalyst to improve and accelerate positive changes in our already strong life science sector in Indiana,” says Brian Stemme, BioCrossroads project director. “Our goal is to make things happen. We try to find creative ways where we can build upon our strengths in creative ways, and hopefully make 2 and 2 equal 5.”

BioCrossroads is not a research facility, nor is it an economic-development agency, Stemme says. Rather, BioCrossroads uses many different strategies to advance life sciences in Indiana. For instance, corporations and educational institutions have historically worked in silos, keeping research close to the vest. BioCrossroads has several initiatives to foster beneficial connections, including OrthoWorx, a Warsaw, Indianabased nonprofit program supporting growth within Northern Indiana’s orthopedics industry; Datalys Center for Sports Injury Research & Prevention, a national nonprofit that provides sports injury research and surveillance; and the Indiana Health Information Exchange, Inc., the largest health information exchange in the U.S., which enables healthcare providers to share patient data for better and faster care.

BioCrossroads also maintains a for-profit arm, which invests in Indiana startup companies. Frequently, university researchers and entrepreneurs develop ideas that could lead to new medicines and medical devices, Stemme says. They want to move their products to market, but they lack the necessary funding. BioCrossroads has the capability to step in and provide early investment dollars.

Together, these seed funds have invested in more than 25 new companies, and they have in turn raised more than $100 million.

“Prior to our first Seed Fund in 2005, there was not a lot of local early stage capital,” Stemme says. “Seed funding for life sciences is very risky because it will take millions of dollars and many years to get a product to market. However, the local environment has improved, and we have several success stories from these companies—exits, partnership and co-development deals, and even products on the market.”

JOHN KANSKY

President and CEO

IHIE

JOHN KANSKY IS NOT A MAILMAN by trade, but he references the analogy when describing the work Indiana Health Information Exchange (IHIE) does.

“We kind of deliver the mail of healthcare,” says Kansky, IHIE president and CEO. One of several initiatives launched by BioCrossroads, IHIE is a nonprofit health information exchange. The organization compiles volumes of health records and puts valuable information at the fingertips of healthcare providers.

Kansky describes several examples that illustrate the need for comprehensive medical records: a woman who goes to the emergency room and forgets to tell the doctor about a drug allergy; or perhaps a man shows up at that same ER with memory issues, but he doesn’t mention a blunt trauma and CT scan he had two weeks ago. In the past, doctors either had to call other hospitals to obtain that information, or they had to rely on patients’ recollection of their own histories. Now, using IHIE’s CareWeb interface, doctors can quickly access patients’ full longitudinal care record, as well as their latest medical charts, labs, and test results.

“The American healthcare system was very used to moving information around in extremely frustrating and inefficient ways,” Kansky says. “But today, the growth of emerging electronic information technologies have allowed us to make healthcare far more efficient and less frustrating.”

IHIE was formed in 2004 by the Regenstrief Institute, BioCrossroads, private hospitals, local and state health departments, and other organizations. IHIE manages the

Indiana Network for Patient Care (INPC), a large, interorganizational clinical data repository that includes records from many Indiana hospital networks. From this data, the company develops products and services that allow physicians and healthcare professionals to access clinical records quickly and efficiently. CareWeb, developed by IHIE, is a software application doctors can use to call up patients’ medical histories. DOCS4DOCS, IHIE’s electronic clinical messaging service, delivers lab results and clinical notes via a web-based portal or directly into an electronic health record (EHR) system.

Their PopCare suite includes products and services focused on providing insight into the health of the human population.

As the steward of such a large data repository, security is of the utmost importance to IHIE. Privacy laws protect patient information, and these laws have been designed to prevent obstructions to patient care, Kansky says.

IHIE is not alone. Most other states have health information exchanges, many of which collaborate and exchange data across state lines in a national network. The value of this interstate/inter-HIE exchange has a significant impact on national healthcare interoperability. If someone’s mother were visiting from Ohio and wound up in an Indiana emergency room, doctors could access her medical records quickly and easily.

“It’s a goal to be part of something that makes the entire nation operate together in terms of healthcare,” Kansky says.

“We’re like patches in a national quilt—we have the Indiana patch covered.”

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INNOVATOR SPOTLIGHT

Research Fellow

Director, Applied Data Sciences Center

DANIEL ROBERTSON

Vice President, Digital Technology

IBRI

DANIEL ROBERTSON, PhD, has been on

both sides of the scientific research and collaboration equation. While a researcher at Indiana University-Purdue University Indianapolis in the ’90s, people around him wondered how they could interact more with local pharmaceutical giant Eli Lilly and Company. When he went to work for Lilly in 2000, the question turned around to how the research staff could better connect with academia.

Robertson’s current position at the Indiana Biosciences Research Institute allows him to answer for both sides. As an IBRI research fellow, vice president of digital technology, and director of the Applied Data Sciences Center, Robertson is now in the unique position of working with both academic institutions and large corporations on projects that benefit all participants.

“When I was offered the executive-onloan role from Lilly, my mother-in-law told me, ‘Dan, all of your career has been leading you to this,’” Robertson says.

Robertson joined the IBRI in its infancy in 2015 as a loaned executive to BioCrossroads from Lilly. He was the fourth person to work full time for the institute. Since then, he’s watched the staff grow while continuing its task of working across industries and academia, and he accepted a permanent position in 2017.

Robertson is the data guy. While some researchers spend most of their time surrounded by test tubes, Robertson’s work is computer based. He and his colleagues sift through data, looking for scientific correlations and teasing out links to connect the 10

LIFE SCIENCES | OCTOBER 2018

proverbial dots to get beneficial information.

For instance, a team from the IBRI led

by Robertson is currently working with researchers from Roche and Lilly to study Type 2 diabetes data. Using data compiled by the Regenstrief Institute, the group hopes to help medical professionals understand why people are stricken with Type 2 diabetes and better identify which patients are more likely to develop complications.

“As we analyze this data, it could lead to new treatments on the market,” Robertson says.

Data has untapped potential. It can be classified into two types: “clean data” and “dirty data,” the latter of which has been compromised by coding errors or faulty correlations. Sometimes data is compiled, but it might never be examined closely afterward. And, while data can provide answers, it can also prompt more questions.

“Sometimes the data analysis we do doesn’t give you an answer,” Robertson says. “It actually tells you what the next question is.”

Robertson understands that people might wonder why he would give up a job with Lilly, with its reputation and history, to move to a new nonprofit institute. The IBRI gives him a chance to grow with an institute that’s finding its personality and culture, he says. His enthusiasm for data and its potential implications is contagious.

He wants to succeed. He wants his staff to succeed. He knows the IBRI can’t take on every project that lands on its doorstep. He hopes the ones they do take on will benefit people beyond the IBRI laboratories.

Other BioCrossroads programs include marketing Indiana’s life sciences community, convening events and developing market knowledge through reports and studies. This month, BioCrossroads hosts the Indiana Life Sciences Summit, the largest life sciences networking and educational event for industry leaders.

“Indiana’s life sciences industry continues to be a national leader, especially when it comes to employment, industry concentration, and patents,” says David L. Johnson, president and CEO of BioCrossroads. “Our sector’s strength is a truly shared Indiana asset—from our large cities to our smaller communities and from research and development to manufacturing and distribution.

The collaborative efforts by BioCrossroads, our companies, and academic institutions are what make our state unique and help fuel the advancement of the industry.”

THE NEXT BIG STEP THE IBRI MIGHT BE BioCrossroads’s most ambitious project to date. Back in 2012, state, civic, corporate, and academic leaders wanted to see initiatives that would work with both academia and industry, accelerating and capturing game-changing research.

The not-for-profit, independent institute was formed with backing from the State of Indiana, Lilly Endowment, Eli Lilly and Company Foundation, Roche Diagnostics, Dow AgroSciences, Indiana University Health, Indiana University, and Cook Medical. The group is currently housed in 18,000 square feet of leased lab and office space in the Indiana University School of Medicine’s Biotechnology Research and Training Center on West 16th Street.

The institute started small, with only three individuals on staff at its founding.

Dan Robertson, PhD, IBRI’s vice president of digital technology and director of the Applied Data Sciences Center, came on at the beginning as a loaned executive from Eli Lilly and Company. Teresa Mastracci, PhD, was the institute’s first official scientist.

The group has since grown to 35 employees, including 11 interns over the summer.

“Our goal is to be the catalyst, to convene people, drive research, and help everyone

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be successful even though we’re very small,” Robertson says.

Robertson works on the data side of research. While lay people might associate scientific research with test tubes and white coats, Robertson’s work proves that numbers and information technology are formidable research partners. He and his staff are currently working on several projects, including a coordinated effort with Lilly and Roche to analyze Type 2 diabetes clinical data provided in collaboration with Indiana University’s Regenstrief Institute.

This project is a good example of collaboration that may not have happened without the IBRI’s involvement, Robertson says.

Large corporations cannot always come to terms on their agreements, and the IBRI was willing to assume some of the risks involved to drive the collaboration, he says. Robertson’s data-analysis project has the potential to generate new therapeutics or treatment protocols for diabetics. By studying the available data, researchers may determine which patients are more susceptible to health issues such as cardiovascular disease. Armed with this information, medical providers can take the proper steps to keep their patients healthy.

Mastracci is involved in another facet of diabetes research. She is focused on the regeneration of beta cells in the pancreas.

If Mastracci and her colleagues can determine how to regrow the beta cells that are ineffective or dying, they may be able to help diabetes patients produce their own insulin again and outsmart diabetes.

The IBRI has room to grow. The institute is slated as the anchor tenant at the planned 16 Tech Innovation Community. Groundbreaking on the 60,000-square-foot building is scheduled for late 2018, and completion is targeted for mid 2020. Until then, researchers like Robertson and Mastracci will have to make the most of their space as they work with some of the very best entities in the state to continue the commitment to life sciences.

For Robertson, it is the right place to be.

“Lilly is fantastic. It’s one of the best companies we have in the state,” Robertson says.

“But for me, the opportunity the IBRI provided was much broader than what I could do inside Lilly. I think I can provide as much or more value to Lilly at the IBRI than I did inside Lilly’s walls.”

INNOVATOR SPOTLIGHT

TERESA MASTRACCI

Senior Scientist

IBRI

WHEN TERESA MASTRACCI, PhD, was hired as the first independent investigator at the Indiana Biosciences Research Institute, she already faced several challenges. The IBRI was only about two years old then, and the seven enthusiastic individuals hired before her were still setting up. Mastracci was responsible for everything she needed, which included tasks like securing funding, hiring employees, and overseeing projects.

“All of these things are hard when you’re coming to a place that at least has the machines that you need and the equipment,” Mastracci recalls. “Coming into the institute, I was asked to build all of that, too. I walked into a space that didn’t even have refrigerators.”

Mastracci shared her colleagues’ infectious enthusiasm and contributed to the growth that has more than quadrupled the full-time staff and led to ongoing research in the fields of diabetes, nutrition, and metabolic and cardiovascular health. Mastracci’s own lab is focused on beta-cell regeneration, seeking a way to grow the beta cells in the pancreas that produce insulin. Such work could someday lead to a cure for diabetes.

Diabetes is close to Mastracci’s heart and career. She was named the Naomi Berrie Fellow in Diabetes Research and was granted postdoctoral research support by the Russell Berrie Foundation in 2007. In 2010, her postdoctoral research at Columbia University and the Naomi Berrie Center for Diabetes Research in New York was funded by the Juvenile Diabetes Research Foundation (JDRF). Her current research at the IBRI is funded in part by a prestigious

Career Development Award from the JDRF. The native Canadian also has personal ties to the disease—her father and grandfather both have Type 2 diabetes, which has been a great motivator for her work.

Diabetes researchers are a unique breed, Mastracci says. While other scientists are very protective of their findings, diabetes researchers like to talk and trade information with each other.

“I want to be able to communicate with my colleagues,” Mastracci says. “I want to be able to collaborate with my colleagues.

If I make something and it’s useful to someone else, I want to share it.”

That attitude explains what drew Mastracci to the IBRI. With its unique position as a connector, bringing companies and universities together to research diseases that affect Hoosiers disproportionately, Mastracci saw this as a good fit. The institute’s nonprofit designation was also appealing.

Mastracci’s dedication to finding a cure for diabetes doesn’t end in the lab. This August, she and a group of 12 others rode in the JDRF Ride to Cure Diabetes in La Crosse, Wisconsin. After running the Indianapolis Mini Marathon in May, she bought a bike to train with the group and prepare for what was ultimately a 100-mile ride.

Diabetes can be treated with insulin or other medication, but science has yet to provide a cure. Mastracci expects to see one in her lifetime, though. She’s willing to risk her job security to bet on this outcome.

“I would be so happy to have to find a second career because somebody cured diabetes,” she says.

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ROCHE DIAGNOSTICS

HARNESSING DATA TO TRANSFORM HEALTHCARE

I

IN THE AGE OF THE ENLIGHTENED CONSUMER, information is king. It’s the key component to making fast and effective decisions— especially in healthcare. Today concerned parents can simply click on WebMD to identify what kind of rash just showed up on their threeyear-old and what to do about it. But many conditions—like cancer— are much more complicated, and the amount of information doctors can access to determine the best treatment can be overwhelming.

What good is a glut of data if there is no practical way to sift through it all and identify what information is critical to making a decision?

This question is at the foundation of the current practice of medicine. In the past, medical care has taken a one-size-fits-all approach: giving a patient a few general tests to diagnose the condition and then trying to find the best drug or therapy, essentially by trial and error.

Today the focus is on precision medicine—gathering as much knowledge about a patient and his or her condition as possible in order to develop a personalized treatment plan. And information is the key.

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LIFE SCIENCES | OCTOBER 2018

This is why Roche Diagnostics is getting into the data business.

Its new Digital Diagnostics initiative is designed to develop solutions that gather and synthesize data in a way that lets healthcare providers make faster, better treatment decisions for their patients.

“At the end of the day, healthcare is becoming all about the data,” says Ketan Paranjape, vice president of Diagnostics Information Solutions at Roche.

HOW DATA DRIVES HEALTHCARE DATA IS THE FUEL THAT CAN DRIVE a better healthcare system.

Putting the right information in front of the right people can make a difference in effectiveness and speed of care, Paranjape says. A typical patient might go to the doctor with only scraps of information.

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The doctor recommends a specific treatment protocol, but a few days later finds that the patient’s insurance won’t cover the drug. Or, maybe the patient has used this medication in the past and had a reaction, but he forgets to disclose the incident to the doctor. On the doctor’s side, a new study might suggest that a certain treatment won’t work if given to people who are already on a different, incompatible drug.

There may be research that prompts the doctor to look for symptoms of other ailments that tend to go hand in hand with the current health issue. In the past, gathering this information could take days, weeks, or even longer. Thanks to the work of companies like Roche, this data will soon be retrievable quickly and easily.

“This is where we think the world is going,” Paranjape says. “Rather than you knocking on the door over and over again, hopefully your doctor should be able to pinpoint your disease very quickly.”

Paranjape looks toward a future where pertinent data can do more than just dictate a patient’s treatment. Various players can be connected to the patient through new technology like the software platforms Roche is developing. Suppose a patient doesn’t return to the doctor for follow-up treatment because he lacks transportation.

Instead of writing off the patient as a no show, the hospital can note the transportation issue and arrange for an Uber driver to pick up the patient for the next appointment. Insurance companies will be tied into the data-analytics model to determine necessity and cost effectiveness as physicians write their orders.

“It’s natural that all of us have to come together to make healthcare viable,” Paranjape says.

A STRATEGIC APPROACH AS THE AMOUNT OF HEALTHCARE-related information continues to grow, Roche has turned to strategic partnerships, acquisitions, and internal initiatives to connect data with the eventual end user, whether that is a healthcare professional or a patient.

In January 2018, Roche announced an agreement with GE Healthcare to jointly develop

INNOVATOR SPOTLIGHT

KETAN PARANJAPE Vice President

Diagnostics Information Solutions Roche

COMING TO INDIANA from the Pacific

Northwest, Ketan Paranjape was not previously familiar with the state’s life-sciences community. When Paranjape relocated here for a new position as vice president of Roche’s Diagnostics Information Solutions division, he quickly discovered Indiana’s extensive industry resources. Not only does the state boast industry giants like Roche, Eli Lilly and Company, Dow AgroSciences, and Cook Medical, it also has three major universities that contribute heavily to lifesciences research.

“I had no idea you had all of these universities in the state of Indiana,” Paranjape says. “Look at all of the talent that is coming out of these places.”

Paranjape oversees a staff of 32 people who work to understand healthcare data and integrate it into diagnostics solutions to help healthcare providers improve patient care. He envisions a future where all patient information can be collected and available to healthcare providers, and that information can be run against various treatment profiles and studies to determine a personalized approach to healthcare.

Instead of knocking on doors, looking for solutions, patients can leave their doctors’ offices knowing they are getting the best, most informed care.

It’s an optimistic dream for someone whose professional background includes a stint at Intel working on technology to enhance graphics in animated Disney films and improve the driving experience of BMWs. “If you can use data to bring innovation to those industries, why can’t you do that

in the life-changing space of healthcare,” Paranjape asks. “It used to take 10 days to sequence a genome. If you can sequence it in 10 minutes, you can do more for the patient.”

Paranjape’s own inspiration for bringing data-based solutions to healthcare grew from his exposure to a program that used genetic data to try to find cures for cancer in children. And his story is not unique at Roche. The company’s purpose statement, “Doing now what patients need next,” inspires the corporate research, innovation, and advancements that can affect outcomes and improve lives.

While Paranjape says his job should include motivating his staff, he finds that his employees often have their own inspirational stories about what brought them to the industry and what continues to motivate them on a daily basis. Maybe they’ve seen how the right information can be a lifesaver in a loved one’s care. Maybe they have hope for the future. Paranjape certainly does. He looks at Roche’s various acquisitions and initiatives that bring together data with the latest technology to help healthcare professionals make the right decisions for each patient. He looks for ways to combine these data sources, to ensure that mistakes aren’t made and key facts aren’t overlooked. It’s all for the patient, he says.

“Anybody who gets into healthcare now on the technology side of the world has come in with a story. They want to make a difference,” he says. “At the end of the day, it’s for the patient and the doctor.”

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The Roche Diagnostics Indianapolis campus.

and market clinical decision support software. In this cooperative arrangement, GE will provide in vivo data—information from tests performed on the body—from its medical imaging and monitoring equipment. Roche can supply in-vitro data—information from tests on blood and other types of samples collected in a test tube—from its biomarker, tissue pathology, genomics, and sequencing portfolio. This information will also be combined with patient records, research, and real-time monitoring.

NAVIFY software, launched in 2017, is a Roche platform designed to simplify the management of tumor boards—multidisciplinary meetings of healthcare professionals who review cancer patient case histories—and recommend the best courses of action. Gathering these individuals in one place with appropriate research, case histories, and test results is typically cumbersome and time consuming, Paranjape says. The Navify software puts all this information in one place, even allowing healthcare professionals to participate in tumor boards from remote locations. Eventually, the goal is to have Navify loop in information from published research studies and clinical trials, and, down the road, to help provide decision support for cardiac care and other areas.

“Navify makes the journey for the patient and the doctor that much more efficient,” Paranjape says.

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Viewics, another digital technology, was acquired in 2017 as well.

This cloud-based software analyzes laboratory processes and performance. This gives hospital networks the advantage of operating their labs more efficiently and ordering only the lab tests needed to support the best patient care, also helping them reduce unnecessary costs in the process.

Roche is also committed to sharing in data analysis with other firms in an effort to help improve patient-care outcomes, including collaboration with life sciences companies in Central Indiana. Roche was a founding partner of the Indiana Biosciences Research Institute and is currently teamed up with the IBRI and Lilly to study clinical Type 2 diabetes data compiled by the Regenstreif Institute. Roche is also one of several industry partners supporting the building of 16 Tech, an innovation community near downtown’s medical hub, where researchers will be able to work together and collaborate on potential treatments for many diseases.

Paranjape will speak at this month’s Indiana Life Sciences Summit, presented by BioCrossroads as an informative gathering of life sciences leaders from around the country. Collaboration is a growing trend in life sciences, Paranjape says, as companies discover that working together can contribute to better collective outcomes and solutions for patients and for the overall healthcare industry.

LIFE SCIENCES | OCTOBER 2018

India

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DISCOVERY WITH PURPOSE

The Indiana Biosciences Research Institute (IBRI) makes it possible for Indiana’s life sciences and IT companies and universities to work together on researching breakthroughs for health issues that disproportionately affect Hoosiers—cardiovascular disease, diabetes, obesity and nutrition.

The IBRI will continue to build a worldclass organization of researchers, innovators and entrepreneurs when it anchors the 16 Tech Innovation Community in mid-2020 with expanded research facilities and incubator spaces.

www.indianabiosciences.org

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www.biocrossroads.com BioCrossroads advances Indiana’s life sciences sector by connecting with corporate, academic and philanthropic partners; facilitating investments in promising start ups and building new enterprises; and educating through conferences, reports and market development knowledge.

Data used in graphics are the most recent available, and were compiled by the Indiana Business Research Center at the Indiana University Kelley School of Business and BioCrossroads. © Copyright BioCrossroads 2018