FIERCE INNOVATION AWARDS - Life Sciences Edition 2020 INNOVATION REPORT
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FIERCE INNOVATION AWARDS Life Sciences Edition 2020 INNOVATION REPORT
About the only positive way to describe APPLICANTS WERE JUDGED IN THE FOLLOWING CATEGORIES:
this past year is as one that has been Biotech Innovation
Championing innovation in the face of great competition. This category
challenging. showcases products and service that are forward thinking and have the
A global pandemic not seen for more than a hundred years shuttered countries greatest opportunity to have an impact on the industry.
and communities, disrupted daily lives and cast a sense of uncertainty on the
future. Though obstacles remain in the face of Covid-19, the Life Sciences Technology Innovation
industry has not only overcome tremendous hurdles in just a few months it has Utilizing technology to shape the industry. This category highlights products
begun to map out what we can expected when the crisis subsides. and services that are using innovative technology solutions to better serve
the industry and promote innovation.
Rebecca Willumson Initially seen as an industry that was slowly adopting digital technology,
Publisher, Life Sciences Life Sciences organizations fully embraced it in just a few weeks in order to Data Analytics/Business Intelligence
maintain functional operations as well as leverage and streamline everything Excellence in data analytics. This category recognizes greatness in business
from drug development and clinical trials to treating and communicating with intelligence using data science, data management, and data analytics to
patients, customers and employees. better serve the industry.
The constant in all this change continues to be a patient-centric focus. Digital Health Solution
Treatments initially targeting unrelated diseases were found to be effective Forward thinking digital innovation. This category showcases the best use of
in helping patients suffering from the effects of Covid-19 and were quickly digital technology and mobile apps to better serve the industry.
channeled to meet that need. Government regulators also responded by
Drug Delivery Technology
streamlining requirements to get the most effective treatments to patients
Drug delivery technologies are shaping the industry. This category recognizes
while also aiding researchers looking for a viable vaccine.
excellence and innovation in the latest drug delivery technologies.
This year’s Life Sciences Innovation Report reflects those trends as the
Medical Device Innovation
industry responds to the global crisis and looks toward the future. Each year
Advancing science through device innovation. This category showcases the
we uncover cutting edge organizations that have or are in the process of
best medical device innovations that have the greatest opportunity to have
launching new technologies and services that are reinventing what it means to
an impact on the industry.
be focused on the ultimate goal—helping people. Each year it gets harder for
our judges because there are so many more companies doing great work and Our expert panel of judges reviewed hundreds of applications to find the best
making huge strides toward that goal. of the best and now I am pleased to introduce you to our 2020 winners.
Fierce Innovation Report Healthcare Edition 2020 | 2
MEET THE JUDGES
Katarzyna Bernacki, Ph.D. David Blackman Tim Ruckh Catherine Patterson, PhD
Associate Director of Patient Experience Business Innovation Senior Director Associate Principal Scientist, Precision Medicine, Chief Scientific Officer
ASTELLAS PPD CORPORATE DEVELOPMENT & STRATEGY R&D Oncology BIOTECH RESEARCH GROUP
ASTRAZENECA
Divya Chadha Manek John Klacking, Ph.D. Rob Saiter Joe Dustin
Head of Business Development & Marketing Co-Founder Managing Director, Life Sciences R&D Solution Director, Digital Health
(NIHR) CLINICAL RESEARCH NETWORK ANGIOCRINE BIOSCIENCE ACCENTURE MEDIDATA SOLUTIONS
Fierce Innovation Report Healthcare Edition 2020 | 3
BEST IN SHOW
BIOTECH INNOVATION TECHNOLOGY INNOVATION
Mesoblast NJ Sharing Network
Remestemcel-L NJSN IgG Subtype Assay
DATA ANALYTICS/BUSINESS INTELLIGENCE
TriNetX
TriNetX Platform for Protocol Design and Feasibility
DIGITAL HEALTH SOLUTIONS
IQVIA
IQVIA eCOA
DRUG DELIVERY TECHNOLOGY
RenovoRx
RenovoGem™ (intra-arterial gemcitabine + RenovoCath®)
treatment of locally advanced pancreatic cancer via the Trans-
Arterial Micro-Perfusion (TAMP™) procedure
MEDICAL DEVICE INNOVATION
miR Scientific, LLC
miR Sentinel Test
Fierce Innovation Report Healthcare Edition 2020 | 4
SPOTLIGHT
WHAT’S THE SCOOP: WHAT MAKES IT FIERCE:
Mesoblast, which is focused on cellular medicines for the Itescu put it simply: Innovation and vision. “We have been
treatment of inflammatory diseases, has been developing ahead of the curve the whole way through,” he said.
BIOTECH INNOVATION
Remestemcel-L, which goes under the brand name Ryoncil. “We’ve known how to harness it and how to deliver. Our
CEO: SILVIU ITESCU It is designed for the treatment of excessive inflammation understanding of the power of technology and using it
BASED: MELBOURNE, AUSTRALIA such as graft versus host disease (GVHD), chronic obstructive strategically to address unmet needs is what has allowed us to
FOUNDED: 2004
pulmonary disease associated with elevated levels of create the right business model.”
REMESTEMCEL-L
inflammation and biologic resistant Crohn’s Disease. Of the
more than 30,000 patients globally that receive an allogeneic WHAT TO LOOK FOR:
bone marrow transplant each year, primarily for the treatment In the near term the company’s focus will be on ramping up
of blood cancers, about half of them develop acute GVHD with and rolling out Remestemcel-L as well and completing the
Mesoblast – Leader
in Allogeneic Cellular
mortality rates reaching as high as 90 percent despite high Phase 3 study of the treatment’s use on Covid-19 patients. In
Medicines
standards of care. Remestemcel-L has the ability to counteract the coming years, Itescu expects they will be looking at other
the inflammatory course by down-regulating the production areas such as treating heartburn and pain.
Markets Opportunities for Lead Products
of pro-inflammatory cytokines, elevating the production of
Mesoblast (ASX:MSB; Nasdaq:MESO) is developing and commercializing allogeneic cellular
anti-inflammatory cytokines and helping trigger naturally
medicines to treat serious and life-threatening inflammatory diseases with significant,
unmet medical needs.
Acute Graft Versus Advanced Heart Chronic Low Back Pain
occurring anti-inflammatory cells in the involved tissues. “We
call it taming the cytokine storm,” Silviu Itescu, Mesoblast
The Company’s Phase 3 off-the-shelf mesenchymal lineage cell The United States Food and Drug Administration (FDA) has
product candidates are:
Host Disease
accepted for priority review Mesoblast’s Biologics License
Failure Due to Disc Degeneration
• RYONCIL™ (remestemcel-L) for steroid-refractory acute graft Application (BLA) to
• >30,000 seek approval
allogeneic boneofmarrow
RYONCIL to treat steroid-
• U.S. healthcare costs for NYHA class • MPC-06-ID development focused
versus host disease (acute GVHD) refractorytransplants
acute GVHDperformed
in children.globally
The FDA has set a Prescription
II-IV patients $115bn/year on over ~3.2m patients in U.S. alone
chief executive, said. The treatment is currently under priority
Drug User(>20K
Fee Act (PDUFA)
US/EU) action ~20%
annually, date of September 30, 2020,
• Hospitalizations account for ~69% • U.S. market opportunity
• Remestemcel-L for moderate to severe acute respiratory and if approved, Mesoblast will make RYONCIL immediately of expenditure
pediatric
distress syndrome (ARDS) due to COVID-19 infection >USD $1 billion
available in the United States.
• Steroid-refractory aGVHD • Multi-billion dollar annual market
• REVASCOR® for advanced chronic heart failure, and represents
The Company’s >USD manufacturing
proprietary $700m U.S./EUprocesses yield opportunity in in the U.S.
review by the FDA and is expected to be approved for use in
• MPC-06-ID for chronic low back pain due to degenerative marketcryopreserved,
industrial-scale, opportunity off-the-shelf, cellular medicines.
disc disease. These cell therapies, with defined pharmaceutical release criteria,
are planned to be readily available to patients worldwide upon
receiving marketing authorizations.
Phase 3 Product Candidates
PRODUCT
CANDIDATE
THERAPEUTIC
AREA PHASE 1/2
Corporate History
PHASE 3 REGISTRATION
MESOBLAST
COMMERCIAL
RIGHTS
COMMERCIAL
PARTNERS
children under 12 with GVHD in September. A similar cytokine
storm in patients suffering from Covid-19 was observed
Acute GVHD – Pediatric
RYONCIL™
(Remestemcel-L)
Mesoblast has more than a decade of scientific, manufacturing, clinical development and corporate development experience targeted
Global
ex-Japan
Acute GVHD – Adult at bringing to market allogeneic, off-the-shelf cellular medicines for inflammatory diseases.
Chronic GVHD
during the outbreak of the pandemic and the U.S. regulatory
Global
Pediatric &
adult systemic
2011 2016 2019
Acute Respiratory Distress Syndrome (COVID-19; Influenza; Bacterial)
inflammatory
diseases Entered into TEMCELL® HS Inj Entered into strategic
REMESTEMCEL-L Hypoxic Ischemic Encephalopathy* 2004 manufacturing 2014 (MSC medicine) 2018 partnership with
partnership withGlobal launched in Japan Grünenthal for chronic
Mesoblast founded Lonza Group in ex-Japan Granted manufacturing by Mesoblast Entered into low back pain asset in
agency approved the use of Remestemcel-L under expanded
Epidermolysis Bullosa* in Melbourne, pioneer status by strategic partnership
Singapore for MPC licensee JCR Europe & Latin America
Australia and listed medicines Economic Development agreement with Tasly
Biologic-refractory Crohn’s Disease on the ASX Global Board of Singapore for cardiovascular
assets in China
Advanced Heart Failure
REVASCOR® Global
access under its compassionate care clause. “We straight
(Rexlemestrocel) Localized ex-China
inflammatory End-Stage Ischemic Heart Failure
diseases
Entered into Mesoblast receives Smith & Nephew
MPC-06-ID Chronic Low Back Pain strategic alliance Global royalty income from its acquired Osiris
ex-EUR, LATAM
(Rexlemestrocel)
with Cephalon to patent licensee TiGenix, Therapeutics, and Filed first BLA
develop and S.A.U., a wholly owned will receive future submission to US
The Company also has a promising pipeline of product candidates and next generation technologies.
*Mesoblast has the right to use data generated by JCR Pharmaceuticals Co Ltd in Japan to support its development and commercialization plans for remestemcel-L in the US and other major healthcare markets, including for GVHD, HIE and EB.
commercialize Dual listed on the subsidiary of Takeda, on earn-outs on MSC FDA; RYONCIL™
away figured if our cells are able to do that then there was no
This chart is figurative and does not purport to show individual trial progress within a clinical program.
MPC therapeutics Acquired MSC Nasdaq its worldwide sales of its business (remestemcel-L) for
business from product Alofisel® for the steroid-refractory acute
Osiris Therapeutics
www.mesoblast.com treatment of complex graft versus host
2010 with future earnouts 2015 perianal fistulas in adult
2019 disease in children
patients with Crohn’s
2013 disease, as well as
2020
reason they wouldn’t do the same thing for the lungs,” said
milestone payments.
2017
Itescu. Initially, 12 Covid-19 patients at Mount Sinai Hospital in
New York were treated with Remestemcel-L, resulting in an 83
percent survival rate. The study was quickly expanded to 300
patients and is currently in the middle of a Phase 3 study.
United States Australia Asia
505 Fifth Avenue Level 38 20 Biopolis Way
Third Floor 55 Collins Street #05-01 Centros
New York, NY 10017 Melbourne, Victoria 3000 Biopreneur 3
USA AUSTRALIA SINGAPORE 138668
T +1 212 880 2060 T +61 3 9639 6036 T +65 6570 0635
F +1 212 880 2061 F +61 3 9639 6030 F +65 6570 0176
www.mesoblast.com E info@mesoblast.com E info@mesoblast.com E info@mesoblast.com
Fierce Innovation Report Healthcare Edition 2020 | 5
SPOTLIGHT
WHAT’S THE SCOOP: WHAT MAKES IT FIERCE:
TriNetX is a global health research organization that has Clarehout says two things make TriNetX Fierce. The first is the
developed a platform that connects the arena of drug performance that the company has shown in building a unique
discovery and development in the pharmaceutical industry network in a short time. The second is creating data access
with clinical trial sites around the world. The platform aids for the industry and academic researchers with breadth and
DATA ANALYTICS/BUSINESS INTELLIGENCE
the industry in addressing flawed protocols and expensive depth. “We are building networks in Asia and Latin America,
CEO: GADI LACHMAN and often avoidable amendments through real-time access and that truly makes us Fierce,” he said.
BASED: CAMBRIDGE, MA to clinical data and cutting-edge analytics. It also provides
FOUNDED: 2013 companies with the understanding of study viability and WHAT TO LOOK FOR:
TRINETX PLATFORM FOR PROTOCOL DESIGN AND FEASIBILITY
the ways inclusion and exclusion criteria can affect the size Growing the data platform and expanding its geographic
of the anticipated eligible patient population. That kind of reach. “Finding more data and enriching the data we have
information developed during the design process can reduce so we have a complete picture and it becomes even more
TRINETX LIVE™ the risks of too much restrictive criteria that down the road important to research,” he said.
Apply a Data-Driven
Approach to Clinical can lead to protocol amendments that equate to higher trial
Research costs and delays in bringing new drugs to market. TriNetX’s
platform features continuously-refreshed clinical data collected
TriNetX Live™
from the company’s network of more than 150 healthcare
As a result of its reach and rapidly expanding network,
TriNetX has become the market leader in protocol design and TriNetX Live enables researchers to analyze patient
feasibility. Researchers have leveraged the TriNetX network to populations and perform “what-if” analyses in real-time.
analyze over 13,500 protocols, presented over 2900 clinical Researchers are presented with aggregate views, but each
organizations and health data partners located in 29 countries
trial opportunities to its healthcare members, and reduced the data point in the TriNetX network can be traced to healthcare
Design Successful Protocols Improving Planning and time to find Have
trial sites by 50%.
a Path to Real Patients organizations who are able to identify individual patients.
This enables clinical researchers to develop virtual patient
Design feasible protocols with Site Selection Identify sites that have eligible patients cohorts that can be re-identified for potential recruitment
basedFaster Site Gain
on real data. Identification
a path back
that serve an estimated 400 million patients. Through the
self-service access to de-identified, into a clinical trial.
Instantly see a list of sites with the
clinical and genomic data. to the identity of the patient if the
number of patients that match your
healthcare
n=591 organization TriNetX
responses decides to Industry
criteria and a comprehensive Best of all, what previously took days to weeks to determine, can
participate in your trial.
aggregated picture of the cohort. now be done in minutes.
platform, research teams are able to investigate attributes and
Industry
*42 Days
Answer Questions Confidently
TriNetX is the global health research network that optimizes Mapped & Harmonized Data Protocol Design & Feasibility
comorbidities of the eligible cohort. “Without such a platform
clinical research and enables discoveries through the creation TriNetX works extensively
TriNetX to map all data to a master clinical
of real-world evidence. TriNetX combines real-time access to terminology which is a consistent set of standardized clinical • Self-service access to continuously-refreshed clinical data
longitudinal clinical data allowing pharmaceutical companies coding ontologies (e.g., ICD, CPT, *14.6 Days
RxNorm, LOINC, HGVS). • Investigate all attributes and comorbidities of the
and Contract Research Organizations (CROs) to understand TriNetX’s highly acclaimed user interface (UI) known for its
eligible cohort
you would have to spend months of modeling and looking
study viability and the ways in which inclusion and exclusion speed and ease of use allows users to seamlessly work with
• Determine if a sufficient patient population matches
criteria impact the size of the anticipated indicated patient the globally mapped data coming from the EMR, tumor
a protocol
population. These insights can be used to help refine inclusion registries, molecular labs, and NLP processing. Once the data40
and exclusion criteria, reducing the time and costs required
0 10 20 30 50 • Analyze inclusion / exclusion criteria and the impact
is mapped, it is curated through a series of quality
Days control of protocol changes
for data sources figuring out whether your actual protocol will
to fully recruit the study and increasing the speed to tests to ensure it is reasonable and representative.
market access.
Per Tufts Center for Drug Development Impact Report, Site identification is defined
The data within TriNetX comes from both inpatient and Path Back to the Patient
as: “Process to identify a list of suitable sites to approach to participate in a clinical Identify Sites Quickly
All patient information
study.” available through the TriNetX network
give you enough patients to run that trial,” Brecht Claerhout,
outpatient settings and includes diagnoses, medications, Site Identification
procedures, lab results, vitals, advanced tumor information, is re-identifiable by the contributing healthcare organization.
* Industry Site ID typically takes 6 weeks (42 days)
and genomic variants. In addition to the highly curated data The healthcare organization has the ability to contact patients • Locate study sites based upon their volume of patients
* TriNetX Site ID takes approximately 2 weeks (14.6 days) – less than
in our network, TriNetX clients bring additional datasets, who meet the eligibility criteria for clinical trials, provided they
half the industry standard of 42 days matching a protocol
have appropriate IRB approval.
chief data officer for TriNetX, said. “With our platform you just
including datasets they license from 3rd-party data vendors, • Engage the right contact within the clinical trials office
to access them through the TriNetX platform. at the right site
“Pfizer is using TriNetX for real-time access to • Predict the number of newly eligible patients at each site
clinical, genomic and oncology data to design in the next 12 months
put in your clinical criteria, push a button and you know what
• Work with sites that can instantly generate identified
clinical trial protocols with greater efficiency.
patient lists to commence recruitment
We hope to reduce avoidable amendments by
identifying and correcting overly restrictive
About TriNetX, Inc.
the population in the real world out there looks like.”
inclusion and exclusion criteria early in the TriNetX is the global health research network that
Copyright © 2019 TriNetX • 125 Cambridgepark Drive, Suite 500 • Cambridge, MA 02140 USA
www.trinetx.com • join@trinetx.com • 857.285.6037 design process.” revolutionizes clinical research and enables discoveries
through the creation of real-world evidence. TriNetX
Dr. Mohanish Anand combines real-time access to longitudinal clinical data
with state-of-the-art analytics to answer complex research
Head of Study Optimization, Pfizer
questions at the speed of thought. The TriNetX platform is
HIPAA and GDPR compliant. For more information, visit
www.trinetx.com or follow @TriNetX on Twitter.
Copyright © 2019 TriNetX • 125 Cambridgepark Drive, Suite 500 • Cambridge, MA 02140 USA
www.trinetx.com • join@trinetx.com • 857.285.6037
Fierce Innovation Report Healthcare Edition 2020 | 6
SPOTLIGHT
WHAT’S THE SCOOP: WHAT MAKES IT FIERCE:
IQVIA is a repeat winner with Fierce, having taken the Data Its sense of purpose. “We have always been very laser
Analytics/Business Intelligence category last year with its focused on the patient,” Gustafson said. “They are the ultimate
DIGITAL HEALTH SOLUTIONS Natural Language Processing platform. This year, IQVIA customer and or goal is to ensure each patient is at the center
is being recognized for its electronic Clinical Outcome of care, so we created tools to make it simpler for them to
CEO: ARI BOUSBIB
Assessment (eCOA) platform. The eCOA platform can trim share their stories.”
BASED: DURHAM, NC
up to three months off the drug development time line while
FOUNDED: 2016
IQVIA ECOA also employing artificial intelligence supported design tools WHAT TO LOOK FOR:
that lets sponsors launch trials faster and with confidence One thing the Covid-19 pandemic has reinforced at IQVIA is
assessments that track real-time insights on trial progress the need for virtual trials. “Our roadmap is really focused on
Fact Sheet
and results. At the core of the platform is IQVIA’s Sculptor tool the continued adoption of and enablement of mobile health
ELECTRONIC CLINICAL OUTCOME that features a drag-and-drop interface and global library of care within virtual trials,” Gustafson said. “Our future in the
ASSESSMENT (eCOA) SOLUTION
Simplifying patient engagement and amplifying their voice
more than 800 pre-built, pre-validated assessments. It gives next six months to five years is the continued integration of
to advance outcomes for life science companies
sponsors finger-tip access to scientific expertise that record wearable devices.”
Real-time and quality patient insights can accelerate your study timelines and lead to better
HOW (eCOA)
outcomes. With IQVIA’s electronic Clinical Outcome Assessment IQVIAplatform,
eCOA CAN WORK
you can
transform your approach to patient data collection for more reliable and insightful clinical
FOR YOU
a patient’s perspective in any given study. It also allows for a
preview of assessments on multiple devices simultaneously
research and real world applications.
that can identify potential design errors in real-time. The
THE OPPORTUNITY THE CHALLENGES
BUILD AND DEPLOY YOUR MANAGE YOUR STUDY AND SIMPLE, INTUITIVE, AND
Traditional paper-based patient data collection makes OWN SOLUTION WITH EASE VIEW RESPONSE DATA RESPONSIVE PATIENT INTERFACE
real-time insight impossible to gather and understand.
• Simple ‘drag and drop’ interface • Powerful reporting and • Engage patients and
patient facing application of the platform is IQVIA’s Scribe tool,
There’s a clear need for a more effective and efficient
• Library of pre-built assessments integration improve compliance with
solution that allows us to overcome the most tasking
Outdated Rising cost Increasing Lack of
• Quickly set up and administer alerts and reminders
patient engagement challenges. technology • Auto-generate
of drug specifi cation
cycle times transparency
development
documents studies and accounts
and control • Supports iOS and
which is a user-friendly design that encourage interaction
• Control access to studies Android devices
• View diary workflow and spot
potential errors in real-time and study data • Available with BYOD or IQVIA
managed devices
FASTER, SMARTER, RELIABLE DATA – DIRECT•FROM
Model your diary in real-time
PATIENTS
and can be used on or offline and is compatible with iOS and
on multiple devices • Works online or offline
Easy to use and accessible to patients via their smart devices, the
IQVIA™ eCOA platform enables you to build and deploy real-time patient
Android devices. “What we do is cut the overall average time
data collection solutions in clinical research and real world studies.
The simple and intuitive interface provides advanced patient
assessments that enhance the patient experience and improve data
quality – amplifying the patient’s voice to accelerate outcomes.
from building an assessment,” said Kris Gustafson, VP Global
IQVIA eCOA IN ACTION
COA PLATFORM OFFERS LIFE SCIENCE COMPANIES:
SHIFTING TO AN eCOA
AN ENHANCED USER EXPERIENCE
Reduced cycle times – 3x faster set up times than traditional methods.
Head of Patient Center Technologies. The industry average for
The IQVIA eCOA platform provides a superior
Increased efficiency – eliminates manual efforts through user experience for both you and your patients.
auto-generated accurate project documentation.
The dynamic building tool makes it easy for
such a build is between 12 to 6 weeks. “We can do that same
Improved endpoint data – enhanced reliability and protocol you to create and deploy your own eCOA
compliance through proven patient engagement strategies. solution and view a functioning version
Real-time insights – cloud-based visual eCOA configuration of your design on multiple devices
for greater transparency, control, and collaboration. simultaneously. For patients, the app
features a simple, user-friendly design
that encourages interaction. build in two to four weeks,” he said. “That’s a pretty significant
Copyright © 2019 IQVIA. All rights reserved. FS.0122-1-03.2019
THE FUTURE OF THE PATIENT EXPERIENCE – IT’S IN YOUR HANDS
If you’re looking to transform your patient data collection, improve the
time savings from a deployment perspective.” Trimming
the time of such studies and the remote capture of patient
experience for you and your patients, and accelerate study outcomes,
contact IQVIA: ecoa.rfp@iqvia.com
information has become even more important in the midst
CONTACT US
ecoa.rfp@iqvia.com
of the Covid-19 pandemic. Gustafson said IQVIA is currently
engaged in multiple Covid-19 studies and that is primarily due
to the company’s ability to ramp up quickly.
Fierce Innovation Report Healthcare Edition 2020 | 7
SPOTLIGHT
WHAT’S THE SCOOP: WHAT MAKES IT FIERCE:
RenovoRx is focused on developing technology that uses The ability of its core team to look at problems from a different
fluids targeted at delivering diagnostic and therapeutic agents perspective and develop new solutions. “We’ve been able
to specific sites in the peripheral vascular system through to take a generic drug and find a better way to get it to the
DRUG DELIVERY TECHNOLOGY
its Trans-Arterial Micro-Perfusion therapy (TAMPTM). The tumor,” Bagai said. “We’re a small and adept company that
CEO: SHUAN BAGAI company has leveraged RenovoGem (gemcitabine) for the pays attention and is able to shift and adjust quickly.”
BASED: LOS ALTOS, CA treatment of locally advanced pancreatic cancer through its
FOUNDED: 2009 delivery technology. Pancreatic cancer tumors are unlike other WHAT TO LOOK FOR:
RENOVOGEM™ (INTRA-ARTERIAL GEMCITABINE + RENOVOCATH®)
tumors in the body because they have fewer blood vessels In the next six months the company will continue to drive
TREATMENT OF LOCALLY ADVANCED PANCREATIC CANCER VIA THE TRANS-
that prevent current therapies from being as effective. By forward on its pancreatic cancer study by opening its last
ARTERIAL MICRO-PERFUSION (TAMP™) PROCEDURE
using RenovoRx’s TEMPTM system that combines RenovoGem couple of sites and enrolling new patients. Beyond that,
with its RenovoCath delivery system (a double balloon infusion Bagai said, RenovRx has decided to expand its technology
catheter) a pressure head is created during the procedure that to other tumors. It’s also in the process of wrapping up its
forces the small-molecule chemotherapy through the vessel Series C funding. “It takes a village to make things happen
wall that bathes the adjacent tissue containing the tumor. “By and I’m really happy with the support from our employees,
forcing chemotherapy and actually getting to the tumor we investigators, physician and investors, and we’re having a real
found that patients were feeling a lot better because they patient effect,” he said. “We have a bigger mission than just
were not getting systemic chemotherapy exposure,” Shuan going to work every day.”
Bagai, RenvoRx chief executive, said. “But more importantly,
we found patients were living almost twice as long.” With its
therapy, RenovoRx is seeing patients live up to a year to year-
and-a-half longer. The FDA has already granted Orphan Drug
Designation to the company for use of RenovoGem for the
treatment of pancreatic cancer and bile duct cancer. Its Phase
3/pivotal study for pancreatic cancer is showing strong data,
Bagai said, and a Phase 2 study is in process for the treatment
of bile duct cancer.
Fierce Innovation Report Healthcare Edition 2020 | 8
SPOTLIGHT
WHAT’S THE SCOOP: WHAT MAKES IT FIERCE:
The detection and treatment of prostate cancer is looking “We are Fierce because we dared define the problem at
at a game changer. miR Scientific has developed a non- its most fundamental way and nature and to innovate with
MEDICAL DEVICE INNOVATION
invasive liquid biopsy urine test that can detect, grade and what we believe to be truly game changing approaches,”
CEO: SAM SALMAN monitor prostate cancer with a 90 percent sensitivity and Salman said. “And that is to measure the problem at its most
BASED: RENSSELAER, NY specificity. Dubbed the miR Sentinel, the test can accurately fundamental level. Once that’s done, we can then build upon
FOUNDED: 2014 detect the presence of prostate cancer. For those diagnosed that foundation to create all kinds of tools. “Some of which
MIR SENTINEL TEST it can identify patients with aggressive cancer that requires we have already developed and some of which we plan on
immediate treatment. Additionally, the test can monitor developing in the next few years.”
patients with moderate grade prostate cancer. Prostate
cancer is the second leading cause of cancer-related deaths WHAT TO LOOK FOR:
miR Scientific LLC
of men globally. The current diagnostic standard of care for miR Scientific will remain focused on ways they can direct the
Transforming Cancer Management ® the disease and treatment is based on the PSA test, which pathways for patient care from early detection to management
June 2020
requires intrusive needle biopsies that can result in non- of prostate and bladder cancer. Two to three years down
negligible false negatives. “The Sentinel test eliminates all the road, Salman said, they are targeting the combination of
Prostate Cancer Treatment: Annual Costs that,” Sam Salman, miR Scientific’s chief executive, said. “Any early detection and the ability to select the most responsive
Indolent Aggressive
person from any walk of life can simply have a urine test and treatments for prostate, bladder and kidney cancers.
Total expected annual
© 2020 miR Scientific, LLC - Proprietary & Confidential
we can definitely tell them if they have no cancer, or what
worldwide
$20B
kind of (prostate) cancer they have so they have actionable
expenditures
by 2025*
$12B
Most patients (whether they have indolent or aggressive cancers)
are treated as though they have aggressive disease:
Surgery, Radiation, Chemotherapy, Biologics, etc
Annual
over-treatment cost
estimate
information to make informed treatment decisions.” The
test examines the levels of hundreds of small, non-coding
(e.g biopsies, surgery)
Costs of treating side
$1.3B
RNAs (sncRNAs) that are isolated from urinary exosomes
effects e.g.
urinary incontinence,
impotence
from a single urine sample. The test has been validated and
*excluding likely increases due to new personalized medicine and immunotherapy options
7
7
© 2020 miR Scientific, LLC - Proprietary & Confidential
presented in a number of peer-reviewed venues that include
the American Society for Clinical Oncology, the European
Association of Urology and is scheduled to be published in
September in the Journal of Urology.
Fierce Innovation Report Healthcare Edition 2020 | 9
SPOTLIGHT
WHAT’S THE SCOOP: WHAT MAKES IT FIERCE:
Almost 3,000 New Jersey residents are currently awaiting “We have a fantastic core group of people,” Rao said. “Every
organ and tissue transplants and look to NJ Sharing Network day we become more efficient in helping people.” He added
for a lifeline. The organization is part of the national recovery that a key to the organization’s drive is an open and very
system that has about 110,000 people on its waiting list and communicative environment focused on saving lives.
has developed an IgG subtype assay that can identify and
distinguish between the presence of complement activating WHAT TO LOOK FOR:
and non-complement activating antibodies. In order to In the next six months NJ Sharing expects its work will be
facilitate an organ transplant two methodologies are currently reinforced and they will begin to use the assay as an early-
TECHNOLOGY INNOVATION used to help detect a match: Cell Dependent Cytotoxicity warning system in post-transplant patients. “If there is a
crossmatch (CDCXM) and Flow Cytometric crossmatch (FCXM). rejection the IgG subtype assay could help us detect that,”
CEO: JOSEPH S. ROTH
While CDCXM can detect complement activating antibodies Rao said. In the coming years the organization hopes the
BASED: NEW PROVIDENCE, NJ
in patients, it is not very sensitive or specific and may result in assay becomes a standard practice.
FOUNDED: 1987
NJSN IGG SUBTYPE ASSAY
a false negative result. FXCM is a highly sensitive assay, but it
can’t differentiate between complement and non-complement
activity that can give a false positive result. Being able to make
a proper crossmatch between donor and patient is a very
critical test. “We invented a cocktail reagent that we can now
use in the crossmatch,” Prakash Rao, vice president and chief
laboratory officer for diagnostics and research, said. “With it,
donor cells are allowed to say hello to a recipient’s blood—we
are the eHarmony of transplants.” The validity of the assay was
confirmed in a small study of twenty kidneys, eight hearts and
one lung of patients that under standard testing, would not
have been considered suitable for a transplant. All of those
patients are now doing well. NJ Sharing’s technology has
been reviewed, a U.S. patent issued with international patents
currently in process. With widespread adoption, Rao expects
about 9,000 additional lives can be saved each year.
Fierce Innovation Report Healthcare Edition 2020 | 10FINALISTS
BIOTECH INNOVATION DATA ANALYTICS/BUSINESS INTELLIGENCE
AMT-101 TENAPANOR REMESTEMCEL-L XCELLERATE MEDICAL REVIEW PATIENT NETWORK EXPLORER / REAL TRINETX PLATFORM FOR PROTOCOL
WORLD DATA SOLUTIONS DESIGN AND FEASIBILITY
DIGITAL HEALTH SOLUTIONS DRUG DELIVERY TECHNOLOGY
SNAPCLINICAL VIRTUAL PRE-SITE IQVIA ECOA AEROSOL DELIVERY SYSTEM FOR EDV (ENGENEIC DREAM VECTOR) – RENOVOGEM™ (INTRA-ARTERIAL GEMCITABINE
PREMATURE INFANTS AND OTHER BASED CANCER THERAPEUTICS + RENOVOCATH®) TREATMENT OF LOCALLY
ADVANCED PANCREATIC CANCER VIA THE
POTENTIAL INDICATIONS
TRANS-ARTERIAL MICRO-PERFUSION
(TAMP™) PROCEDURE
MEDICAL DEVICE INNOVATION TECHNOLOGY INNOVATION
BIOINTELLISENSE FDA-CLEARED TRIA™ HEART VALVE MADE WITH MIR SENTINEL TEST EVOZYNE, DATA-DRIVEN MOLECULAR XT-VIVO NJSN IGG SUBTYPE ASSAY
BIOSTICKER™ MEDICAL DEVICE AND LIFEPOLYMER™ ENGINEERING TECHNOLOGY
MULTI-PARAMETER DATA SERVICES
Fierce Innovation Report Healthcare Edition 2020 | 11You can also read
