The First Annual Bio-Trac Symposium at the Bioscience Education Center at Montgomery College was sold out with attendees coming in from across the country. The two-day symposium was on Multiplex Immunofluorescence in Immune-Oncology, which is a rapidly advancing technology aiding researchers to explore the potential medical value of specific biomarkers and understand the role of the Tumor Microenvironment (TME) in Cancer Immunotherapy.
The importance of this topic was reflected by an impressive speaker line-up of world-class scientists, including a keynote lecture by Janis Taube, M.D., M.Sc., the Director for the Division of Dermatopathology at Johns Hopkins Medicine, a leading expert in the field. Wednesday devoted to lectures that included two panel discussions and several Q&As. See full Speaker lineup here.
“We get a great deal of satisfaction bringing in world renown experts to Bio-Trac events and make them available to our attendees,” shared Mark Nardone, Bio-Trac Director. “Bio-Trac provides a forum which allows researchers to gain access to current technologies while fostering an environment that promotes collaborations.”
The symposium was hosted by Bio-Trac with the sponsorship and support from MedImmune and PerkinElmer, who both also presented and moderated the day of lectures and the full day of hands-on workshops that comprised the full symposium.
Among the heavy-hitting speakers was Stephen Hewitt, M.D., Ph.D., Head of the Experimental Pathology Laboratory at NCI, and Editor in Chief of the Journal of Histochemistry and Cytochemistry. Hewitt spoke about the development and validation of multiplex IHC assays in a total test paradigm. Another highly anticipated speaker was Kurt Schalper, M.D., Ph.D. Assistant Professor of Pathology; Director, Translational Immuno-oncology Laboratory at Yale University School of Medicine. Schalper presented a lecture on the use of spatially resolved analysis for understanding the immune composition and therapeutic implication of human lung cancer. Another speaker, Adam Smith of Indica Labs, covered the use of HALO (AI) to target immune-oncology markers in the tumor microenvironment.
Hewitt agreed to lecture for two more important reasons, “I’ve spoken at Bio-Trac symposiums for years. I know the quality of the students. I know that Bio-Trac is going to provide great students and good interaction. Plus,” he added, “I was invited to talk on a topic I’m passionate about.” The symposium also allowed attendees like Louis Levy of Ultivue in Cambridge to network with others and keep his thumb on the pulse of the latest innovations in the field.
Michael Surace, Ph.D. said that MedImmune was pleased with the overbooked event and glad to be one of the sponsors because, “this approach to imaging is coming to the inflection point where it begins to move from a research tool a clinical tool, which we will begin to see in the next 5-7 years… We have fantastic modality but not the diagnostics to match it. Lots of people are looking to leverage this technology for their research but there is not a lot of guidance on how. People want guidance around the technology.”
The Course Director for the full day workshop was Jaime Rodriguez-Caneles, MD, FEBP, Senior Pathologist at MedImmune, and the workshop included hands-on training using PerkinElmer’s Vectra Polaris automated Quantitative Pathology Imaging System.
The Bioscience Education Center at Montgomery College was also a good pick. In addition to the impressive facilities, Hewitt said, “It’s a great location. You get MedImmune, you get Bethesda, you get Frederick, and you get people who will come down from Baltimore. The biotech space in Montgomery County is beginning to more actively percolate.” In part, this is due to MedImmune’s investment into the growth of the BioHealth Capital Region. The growing Immune Oncology hub is already home to well-known companies such as Immunomic Therapeutics, and high-profile startups like BeneVir (recently acquired by Jansen). Maryland has also recently attracted some big-name companies such as Kite – a Gilead Company, and Autolus Therapeutics.
Bio-Trac has provided hands-on biotechnology training workshops on a range of topics of importance to research scientists for more than thirty years. They also offer customized training for an organization’s particular research needs. In fact, the initial idea for this symposium came from a custom training Bio-Trac did earlier this year with Dr. Rodriguez at MedImmune.
There was already pre-symposium talk about making this an annual event and based off the attendance, the overall quality of the two-day event and importance of the topic, a Second Annual Bio-Trac Symposium is highly likely.
Visit www.biotrac.com for more upcoming workshops and events.
Published on BioBuzz
IPHA Oracle Survey Identifies Four Consumer Health Factors That Impact HealthTech Innovation
The Fall 2018 Inova Discover Series program showcased the Inova Personalized Health Accelerator’s (IPHA) definitive role as a driving force in the health tech innovation community. In just under one year since their official launch, IPHA has built a roadmap for identifying, cultivating, investing in and adopting healthcare innovation that has received national attention.
The Discovery Series event, held at the Inova campus on November 7th, was a great platform to bring the community together around a health tech innovation. The program consisted of a showcase for new regional health tech companies and a panel discussion on the impact of changing consumer expectations on healthcare delivery. IPHA also released the results from the IPHA Oracle Survey and explored the impact they will have on health tech Innovation as a primary theme of the program.
The event also provided an opportunity to introduce the Strategic Ventures Group to the BioHealth Capital Region’s vibrant health tech community. This group of health system venture capital investors comes from some of the most prestigious health systems from around the country that IPHA is also part of.
Rick Gordon, Director of IPHA, welcomed the audience and reinforced their mission to provide early-stage funding and mentoring. “Finding precious seed capital is increasingly more difficult, especially in this region,” he shared. The IPHA acts to fill this need and INOVA IPHA Health Tech Early Stage Funding has been instrumental in bringing pre-seed, seed, and A round financing to health tech startups by making them part of their investment portfolio. Their portfolio now includes four early-stage companies; Cyrano Therapeutics, CoverMyTest, HeMemics and Kinometrix.
Mike Thomas, Director at IPHA, unveiled the results from the IPHA Oracle Survey. Four Key Themes emerged from the findings that indicated notable opportunities for health tech innovation. The themes from the study include;
- Younger women expressed a greater interest and motivation to engage with health tech;
- NOVA is not representative of national trends of attitudes about healthcare products and services;
- Data security concerns are paramount; and
- When consumers want a health tech app or service, they want it immediately.
These findings are important for entrepreneurs to understand for the success of their ventures in the personal health tech space. For IPHA, the survey also enhances their ability to mentor and strategically advise their portfolio companies or other entrepreneurs in the space.
The program underscored the vital importance of making consumers certain that their personal health information is secure. It also made it clear that those who want personal health tech services and devices want them as soon as possible once they decide they have a need.
Molly McCartin, Partner @drivecapital shares that entrepreneurs need to find the right path in the regulatory environment to bring a product to market #InovaFunded @InovaPHA #InovaDiscoverySeries pic.twitter.com/AVartfVAcG
— BioBuzz (@BioBuzzMaryland) November 8, 2018
Ultimately, the tech put on the market must meet the needs of three different entities. “It’s not one customer,” said Molly McCartin, a partner at Drive Capital, “It’s the provider, the payor, and the consumer. The product needs to serve all three without forgetting about any of them.”
Navigating such a complicated landscape is a lot for an entrepreneur to tackle when trying to develop their idea into a viable product. Thankfully, IPHA and their community of advisors and mentors, like McCartin, are there to help. It’s a collaborative effort to support the early stage entrepreneurs, and the Discovery Series was a great example of this effort coming together.
More on Inova’s Personalized Health Accelerator
IPHA has become a beacon for early state health tech funding since launching nearly a year ago on November 30, 2017. Funding for the portfolio itself is provided by Inova health system which maintains a dual interest in both in promoting new personal health tech products and services, and realizing a return on their investment.
IPHA provides a range of services to these early startups, including working with entrepreneurs to validate their concepts to help them reach the stage of clinical evaluation. Their combination of access to advisors who have personal experiences building successful companies, and very early stage investment by health care systems provides entrepreneurs with essential funding and tools. This talent pool and focus on the individual entrepreneur is designed to minimize the investment risk while maximizing returns, with accelerator programs that are customized to each startup. By providing the initial financing and tools, the ISI (Inova Strategic Investments) ensures that more ideas are developed while giving health care systems a stake in the newest health tech innovations.
Published on BioBuzz
Abhita Batra, CEO Otomagnetics, Inc., is leading the growth of an innovative biotech startup, and bringing a drug delivery technology to market that could change the lives of childhood cancer survivors. As with many successful startups, there seems to be a winning equation when they are led by someone who brings both the industry expertise, as well as the passion for the mission.
Otomagnetics has solved that equation with CEO, Batra, who is in a role that she’s been preparing for from an early age. Growing up in India, the family business was biomanufacturing. By the time she was sixteen, she was working in production and learning the ins and outs of running a successful biotech business. After earning her Bachelors degree she took on management of the business, expanding the market from India and the United States to include SE Asia and Latin America as well. Today, the company offers about 150 products in those markets.
The family business proved to be a rewarding training ground for Batra, but she was driven to pursue her passion to work with innovative products and new technologies. That’s what brought her to the US, and to get her Masters in Pharmaceutical Biotechnology from UPENN in 2007. Following graduation, she found success at her own startup venture, followed by several executive roles at other growing biotech companies.
In 2016, Batra was introduced to an innovative new magnetic drug delivery technology, originally developed at the University of Maryland out of the Fischell Department of BIoengineering (BioE) and Institute for Systems Research (ISR) in 2013. Professor Benjamin Shapiro, now President of Otomagnetics, led the research and eventually spun out the company with co-founders Didier Depireux (ISR), David Beylin, and Irving Weinberg, M.D.
This technology, which non-invasively directs biocompatible nanoparticles and their therapeutic payloads through soft tissue, immediately captured her interest and passion. Batra was eager for the chance to work with the technology named SmartMag, which could revolutionize the future of drug delivery. The SmartMag delivery system uses a proprietary magnetic injector with degradable magnetic particles that carry drugs, proteins, or genes to the target – targets that until now have been outside the range of existing delivery systems. The initial market would be for the inner and middle ear, but there were possible applications for macular degeneration and dermatological conditions such as psoriasis.
After doing her own due diligence with leading medical experts, Batra confidently joined Otomagnetics as CBO and began working to raise funding and build a winning team. After successfully raising more than $1M in seed capital, Batra became CEO and took the lead on moving the company forward. As a platform technology, the work of forming strategic alliances and clinical trial partners became some of her top priorities alongside funding. They have been partnering with Children’s National in DC since 2013. In the future, Otomagnetics also plans to partner with clinicians with practices of their own.
The company has raised funding from a number of sources, including early seed funding from TEDCO’s MII program in 2016. In addition to the financial backing, TEDCO also provided an investment of their time and advisory support to the young company. Arti Santhanam, Director of MII, especially was someone who became a great source of advice and mentorship for Batra during these pivotal times of growth.
In 2017, Otomagnetics was awarded a $2.3 million Fast Track NIH/NCI SBIR Contract to develop a pediatric cancer drug delivery system to prevent hearing loss from chemotherapy regimens. “We are honored and excited to be working closely with the National Institutes of Health to address a pressing clinical need,” said Otomagnetics President and Co-Founder Benjamin Shapiro. “There should not have to be a choice between effective chemo and lifelong hearing loss. Our technology has the potential to allow treatment by chemotherapy without the attendant risk of hearing loss.” Earlier this year Otomagnetics also received additional investment through AngelMD’s Catalyst Fund. They received a Montgomery County Small Business Innovation Research (SBIR) Phase I Matching Grant in September.
What excites investors and clinicians alike is the potential to eliminate hearing loss for children undergoing chemotherapy and solve for an unmet clinical need.
With advancements in cancer treatment, more children survive their battle with childhood cancers. Loss of hair, nausea, and vomiting are well known secondary effects. Hearing loss is a less known secondary effect with the potential to alter the quality of life for 80% of children after treatment. If a delivery platform such as SmartMag could be used to deliver medication that would protect the inner and middle ear from damage, across the blood barrier in a non-invasive way, it could prevent hearing loss in thousands of children.
“’When a kid goes through this, even if it’s not your own, your heart breaks right away,” says Batra. “With our technology, we are able to deliver otoprotective therapy to cochlea topically. We have shown in animal studies that we can protect hearing with this non-invasive magnetic treatment. It’s a 10-minute procedure so kids can go through it with ease. It’s also offered before damage is done.”
Though Otomagnetics has a long way to go, Batra attributes their to date to having the right team. With advisory board members that include Jerome Lewis as nanoparticle advisor and both Dushyant and Neela Chipalkatty, there is a ready source of experience to tap. “That’s one of the biggest principles of success,” Batra says. “If you can bring the right people onto your team and your board, they will be the backbone of the company.”
As the next step, Batra plans to pursue Orphan Drug status, a move that is possible because the childhood cancer population they are addressing numbers less than 200,000 patients. This status will make it possible for the technology to move from Phase 1 Clinical Trials directly to Phase 3. As a result, Batra is aiming to have their platform on the market and improving patients lives by late 2021 at the latest.
For more information on Otomagnetics follow them on social media at @Otomganetics or visit their website at www.otomagnetics.com
Published on BioBuzz
First in the ‘Plug and Play’ Stem Cell Products
RoosterBio has come a long way from its days in the FITCI incubator. In 2013, five people worked in a single small space. Now there is more than enough room for the current team of thirty-five, a common area, kitchen break room, large cubicles, and a lab. Both the lab and workspace have ample natural light – a nod to those with bench experience in often windowless environments, explains Jacob Pattasseril, VP of Operations.
The layout does more than let in natural light. It makes it possible for members of the RoosterBio team to meet and work together in a variety of ways. “Our culture is very important to us,” says CEO Margot Connor. “This culture encourages open discussion, pride in the mission, and integrity.” Because the company culture is viewed as an important asset, it’s important to the team that the RoosterBio culture remain healthy and vibrant. People who are interested in a work environment based on this culture are drawn to the company.
Jon Rowley, Ph.D., Founder and Chief Product Officer, first envisioned the market for ‘plug and play’ stem cells several years before the company’s founding, Connor explains. There was a bottleneck in the path to clinical trials. Any company moving toward human trials needed cells with requisite regulatory filings such as a U.S. FDA Master File (MF). Rowley theorized that the cells could be produced by a company that specialized in just that. This would make it unnecessary for companies working toward clinical trials to first develop stem cell products of their own. They could, instead, purchase cells with an MF from RoosterBio, referencing it in regulatory filings for their own therapeutics and saving years of development and millions of dollars as a result.
Today, RoosterBio is “developing standardized stem cell products that are ‘ready to use,’ or ‘plug and play,’” says Rowley. “That greatly simplifies the process of incorporating living cells into a new medical product that is being developed. We are working on making it 10 times easier and 10 times less expensive, truly democratizing stem cell technology.” As a result, stem cell products can now be viewed as components in the same way as are parts purchased when assembling a computer or rebuilding a car engine. Currently, RoosterBio is the only company in the United States selling clinical-grade stem cell banks for use in clinical trials.
RoosterBio’s cGMP stem cell products are manufactured in a cGMP pharmaceutical manufacturing facility under stringent production controls. The current challenge, says Rowley, is to scale production at a logarithmic rate. Ultimately, trillions of stem cells will be needed, either to meet the needs of one application or to meet the needs of many smaller applications. To scale up too quickly will put them ahead of the market; to scale up too slowly will put them behind the curve.
In its first five years, RoosterBio has experienced impressive success. Connor, who will speak at the HER Story Gala hosted by Women in Bio in three weeks, attributes this success to three things: their ‘plug and play’ business model, their company culture, and the paradigm shift that is currently occurring in health tech. By envisioning and creating a company that would commercialize ‘plug and play’ stem cell systems for product development in clinical trials, Rowley took the necessary steps to eliminate that bottleneck with a viable product that meets a significant unmet need. Just last week, RoosterBio announced it had submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its CliniControl™ line of cGMP hMSC working cell banks. There’s plenty of reason to look forward to what the next five years will bring.
Published on BioBuzz
Managing diabetes, or other conditions that require knowledge of glucose levels, can be a complicated matter. Carrying glucose monitors, test strips, and lancets as part of the daily kit get old – fast. Pricking your fingers to take readings twenty times a day or more when glucose levels are fluctuating widely can leave fingertips feeling like they will bleed on demand. For babies who cannot tell an adult how they feel and for kids who are active and focused on the game or the fun, there is often no clear signal that a severe and serious low is imminent. For adults who have a long history of diabetes, it is also very likely that they are no longer aware of the signs that should interrupt their activity or awaken them in the night.
Continuous Glucose Monitors (CGMs) make use of technology that provides a solution to the glucose-reading part of the problems by automatically taking readings every five to fifteen minutes and acting on those readings in a variety of ways. Some of these FDA-approved devices make those reading available to the person wearing the device and the people assigned to track those readings through their phones or receivers.
The Dexcom G6 is one such system. It does not just track “glucose levels.” It will also sound an alarm when levels are rising rapidly, falling rapidly, or approaching dangerously low levels. It’s also thrilling for diabetics because it does not require calibration with finger-prick glucose readings.
Other CGMs take the readings but do not provide readouts unless “asked.” They also do not provide alarms. They are read when a device is held near them. The FreeStyle Libre is one such device. Whether a device is needed and which is preferable depends upon the situation.
CGMs, do not, as a matter of fact, record blood glucose levels. These devices are worn on the stomach, upper buttocks, arms, thigh, or another area of the body that has fat and muscle present. The fluid these measure is the interstitial fluid that surrounds tissue cells beneath the skin. This fluid results from glucose that moves from your blood vessels and capillaries first. As a result, the reading on the CGM rarely matches the readings on a glucose meter because they are measuring two different things.
There is generally about a fifteen minute lag between the blood-stick reading and the CGM reading, especially during a time when levels are rising or falling. Add to this the allowable margin for error of about 20% on both devices, and you see that trying to make a match is both impractical and frustrating.
The value of the CGM is that it is measuring a fluid that reflects the blood glucose levels because it is derived from those levels. The trends are the valuable part of the information recorded because they show what your glucose is doing – rising, falling, approaching a dangerously low level. They also allow people wearing these devices to see the way their bodies are reacting to their level of exertion and/or the foods they are choosing. After wearing a device for a few weeks, most people report they have been able to use their insulin in conjunction with the readings to make a meaningful change in their A1C.
~ gina
I spent the afternoon yesterday at the First Annual BioTrac Symposium. The topic was Multiplex Immunofluorescence in Immune Oncology. The speakers were very knowledgeable and spoke about Opal staining, multispectral image acquisition, and the immunophenotyping analysis with AI. It was fascinating. There are hands-on workshops today.
The training was done by Bio-Trac – a company that specializes in Biotechnology training through a schedule of sessions listed on their site, or customized training workshops for government agencies, private industry, and academic institutions. The workshop yesterday was well run, with breaks for lunch and throughout the day, as well as a reception in the evening.
Mark Nardone, the Director of Bio-Trac Training programs, was on hand to facilitate throughout the day at the Bioscience Education Center at the Montgomery County – Germantown campus. MedImmune and PerkinElmer were sponsors.
Technologies Discussed: Optimization and troubleshooting of Opal staining, multispectral image acquisition with Polaris™ scanner, immunophenotyping analysis using InForm and HALO software
Speakers: Dr. Janis Taube, Keynote, Johns Hopkins Medical Institute; Nicolas Brieu, PhD, Definiens; Stephen Hewitt, MD, PhD, NIH/NCI; Cliff Hoyt, MS, PerkinElmer; Edwin Parra, MD, PhD, MD Anderson Cancer Center; Jaime Rodriguez-Canales, M.D., MedImmune; Lorenz Rognoni, PhD, Definiens; Houssein Abdul Sater, MD, NIH/NCI; Kurt Schalper, MD, PhD, Yale University School of Medicine; Adam Smith, Indica Labs, Inc.; Michael Surace, PhD, MedImmune
You’ll find a full write-up of the day on BioBuzz.io.
~ gina