2017 introduce you to our 2017 winners. - rebecca willumson publisher, life sciences continued...

From the publisher of Fierce Life Sciences

INNOVATION REPORT

2017

Fierce Innovation Awards 2017: Life Sciences Edition 2

CONTENTSSponsored: Next Science23

Spotlight: IsoPlexis25

Sponsored: PeerSourcing Solutions27

Spotlight: Novartis30

Sponsored: Science Exchange31

Sponsored: Tools4Patient34

Sponsored: Vanrx Pharmasystems Inc35

03 Introduction

Recognition of Best in Show Winners05

Recognition of Category Winners06

Recognition of Finalists08

Recognition of Judges10

Spotlight: Vericel13

Sponsored: 3Scan15

Spotlight: Pear Therapeutics17 Sponsored: Virogin Biotech Limited38

Sponsored: Microsystems18

Spotlight: AllazoHealth21

Sponsored: Vodori40

Directory Listings42


‘‘INTRODUCTION

The life sciences industry has been riding a wave of growth in recent years - VC groups have been investing heavily in biotech, and pharma has seen its fair share of M&A activity. At the heart of this growth lies the ever present challenge of getting drugs from the lab to the clinic faster.

This is an industry that survives through innovation and those that are winning are pushing themselves to do things that others thought could not be possible.

The Life Sciences Innovation Report showcases outstanding innovation that is driving improvements and transforming the industry. We sought the best

companies with the most innovative technologies and services that have the greatest potential to make an impact for biotech and pharma companies.

Applicants were judged in the following categories:

• Biotech Innovation - Championing innovation in the face of great competition. This category showcases products and service that are forward thinking and have the greatest opportunity to have an impact on the industry.

• Technology Innovation - Utilizing technology to shape the industry. This category highlights products and services that are using innovative technology solutions to better serve the industry and promote innovation.

• Data Analytics/Business Intelligence - Excellence in data analytics. This category recognizes greatness in business intelligence using data science, data management, and data analytics to better serve the industry.

CONTENTS

03 Introduction

05 Recognition of Best in Show Winners

06 Recognition of Category Winners

08 Recognition of Finalists

10 Recognition of Judges

13 Spotlight: Vericel

15 Sponsored: 3Scan

17 Spotlight: Pear Therapeutics

18 Sponsored: Microsystems

21 Spotlight: AllazoHealth

23 Sponsored: Next Science

25 Spotlight: IsoPlexis

27 Sponsored: PeerSourcing Solutions

30 Spotlight: Novartis

34 Sponsored: Tools4Patient

31 Sponsored: Science Exchange

35Sponsored: Vanrx Pharmasystems Inc

38 Sponsored: Virogin Biotech Limited

40 Sponsored: Vodori

42 Directory Listings


INTRODUCTION

• Digital Health Solution - Forward thinking digital innovation. This category showcases the best use of digital technology and mobile apps to better serve the industry.

• Drug Delivery Technology - Drug delivery technologies are shaping the industry. This category recognizes excellence and innovation in the latest drug delivery technologies.

Our expert panel of judges reviewed hundreds of applications to find the best of the best and now I am pleased to introduce you to our 2017 winners.

- Rebecca Willumson Publisher, Life Sciences

CONTINUED CONTENTS

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BEST IN SHOW

BEST OUTSOURCING PARTNERreSET®

BEST NEW PRODUCT/SERVICEKYMRIAH™ (tisagenlecleucel) suspension for intravenous infusion

BEST TECHNOLOGICAL INNOVATIONMACI

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WINNERS

BIOTECH INNOVATIONMACI

TECHNOLOGY INNOVATION IsoCode Chip (on the IsoLight platform)

DATA ANALYTICS/BUSINESS INTELLIGENCEThe AllazoEngine

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CONTINUED

WINNERS

DIGITAL HEALTH SOLUTIONSreSET®

DRUG DELIVERY TECHNOLOGY KYMRIAH™ (tisagenlecleucel) suspension for intravenous infusion

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FINALISTS

BIOTECH INNOVATION

Solupore - An Intracellular Delivery Technology for Next Generation Cell Therapies

REOLYSIN® QuintilesIMS Precision Site Identification for Immuno-oncology

MACI

DATA ANALYTICS/BUSINESS INTELLIGENCE

The AllazoEngine Key Pathway Advisor (KPA) The Diaceutics Method RxAnte Stars Ratings Solution

DIGITAL HEALTH SOLUTION

Clara Health: Clinical Trial Connection

MyoVista® hsECG™ Helping Reduce Post-Surgical Opioid Use with Virtual Reality

reSET®

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CONTINUED

FINALISTS

DRUG DELIVERY TECHNOLOGY

SINUVA™ Sinus Implant IDMx 1000: A Novel Drug Delivery Platform

KYMRIAH™ (tisagenlecleucel)suspension for intravenous infusion

Orbis’ Optimum® Delivery Platform; Dispersed Dosage Forms with Functional Coatings in a Single Step

TECHNOLOGY INNOVATION

Catalant On-Demand Marketplace

Oncoprex Immunogene Therapy

IsoCode Chip (on the IsoLight platform)

CarpX Percutaneous Carpal Tunnel Syndrome Device

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JUDGES

DAVID BLACKMANPPD Corporate Development & Strategy, Business Innovation Sr. Director

DIVYA CHADHA MANEK(NIHR) Clinical Research NetworkHead of Business Development & Marketing

ANUP KHARODEPwCPartner, Pharmaceutical & Life Sciences R&D Advisory Services

JOE DUSTINMedidataDirector, Mobile Health

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JUDGES

CONTINUED

SEAN ROONEYPwCPartner, Pharmaceutical & Life Science R&D Advisory Services Leader

CATHERINE PATTERSONPharmaceutical Development Group (PDG)Director of Scientific Research

DEBORAH PROFIT, PHDOtsuka PharmaceuticalsLeader, Otsuka Information Technology

JENNIFER PLUMERMedidataDirector of Marketing

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JUDGES

CONTINUED

JOHN REITESThread ResearchChief Product Officer, Partner

TIM RUCKHVerilySenior Scientist

FERRY TAMTOROFlexSr. Director, Digital Health Technology

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VERICEL

What’s the scoop: Vericel specializes in harvesting cells from a patient that is used to help them heal cartilage damaged by knee injuries. One of the company’s two main products is MACI — autologous cultured chondrocytes on porcine collagen membrane. MACI, which is the first FDA-

approved product of its kind (it’s also approved in the EU) to treat symptomatic, full-thickness cartilage in adults, uses Verciel’s tissue engineering technology to grow cells on scaffolds using healthy cartilage tissue taken from a patient’s own knee. “Unlike most other tissues in the body, cartilage doesn’t have any intrinsic healing capabilities,” Dominick Colangelo, Vericel’s chief executive, said. “Restoring cartilage is often referred to as the Holy Grail of arthroscopic surgery.” In a pivotal study that formed the basis for the FDA’s approval, the response rate for improvement in patients that underwent the process was above 90%, he said. Yet, Vericel’s Epicel appears even

IT’S NEVER A GOOD STORY WHY THEY HAVE TO BE TREATED WITH EPICEL, BUT THERE ARE A LOT OF GREAT STORIES OF THEM BEING ABLE TO GO ON WITH THEIR LIVES.

Dominick Colangelo, Vericel’s Chief Executive

more stunning in what it can do for burn victims. Epicel, which is a cultured epidermal autograft, is a permanent skin replacement for deep dermal or full thickness burns covering 30% or more of a patient’s total body surface. Epicel is also the only FDA-approved product of its kind for use with severe burns. Additionally, the company has been working on lxmyelocel-T, a multicellular therapy that could be used to treat advance heart failure due to ischemic dilated cardiomyopathy.

What makes Vericel Fierce: “Our products are life changing,” Colangelo said, pointing specifically to Epicel. “It has a profound impact on their lives,” he added. “It’s never a good story why they have to be treated with Epicel, but there are a lot of great stories of them being able to go on with their lives.”

What’s ahead for Vericel: Following very strong revenue growth in 2017, the company will be focused on commercializing MACI and Epicel next year. “Given that momentum, we are further expanding our sales force and looking for strong revenue growth in 2018 and beyond,” Colangelo said.

CEO: Dominick Colangelo

Based: Cambridge, MA

Founded: 2014

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w w w . v c e l . c o m • 6 4 S i d n e y S t r e e t , C a m b r i d g e , M A 0 2 1 3 9 • 6 1 7 - 5 8 8 - 5 5 5 5

For Me. By Me.Un ique L i f e -Enhanc ing Ce l l The rap ies


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PERSONALIZED ORGANS, MADE TO ORDER By Terri Hnatyszyn

Each year in the United States, 33,000 organ transplants are performed providing increased life expectancy and enhanced quality of life for those lucky individuals. But what about the 116,000 men, women and children in limbo on the national transplant waiting list. Appreciating this gap as both a public health issue and an opportunity to impact individual lives through tissue engineering, are a group of organizations exploring innovative ways to meet this growing need. Prellis Biologics and 3Scan, both start-up companies based in San Francisco, are combining their talents and technologies to revolutionize organ transplantation. The goal is to synthesize new organs custom built for transplant into each target recipient. Utilizing the patients’ own cells to grow the new organ tissue, this group hopes to eliminate the possibility of organ rejection and remove the costs and side effects of a lifetime of immunosuppressant drugs.

3Scan will develop a detailed 3D organ atlas in support of Prellis’ efforts to synthesize human organs for transplant. Using a proprietary imaging platform to gather microscopy data from across large volumes of tissue, 3Scan then processes the data through their custom designed algorithms to create a three-dimensional structural map of the functioning organ. This map will feed into a process called generative modeling that will ultimately generate a printable object.

Prellis will then leverage their laser-based 3D printing process to create layers of extracellular matrix containing cells, at ultra-fine resolution with near instantaneous print-speeds. These methods do not require cell-seeding or additional curing steps for the tissue matrix. With this proprietary technology, Prellis are currently printing cell-containing functional organoids and building prototype microvasculature.

“Modern medical discovery requires a sophisticated view of biological systems, and the microscopic complexity of tissues emerges larger scale than the human eye can capture.”, said Todd Huffman, CEO and Co-Founder of 3Scan. “We are excited for the opportunity to contribute technology and expertise to this compelling initiative.”

This novel and fully integrated approach to creating a spatially accurate view of human tissue biology will leverage expertise of both companies to support a common goal, to rapidly advance the development and production of an unlimited supply of organs for human transplantation.

About 3Scan3Scan is a biotechnology start up founded on the belief that tissue samples should provide comprehensive, spatially indexed information to further medical innovation and improve clinical outcomes. Our diverse group of talented engineers and scientists work to revolutionize the histology workflow through novel tools and systems that aid in decision support. The results are detailed 3D representations of anatomical structures, as well as quantitative analysis in the emerging field of volumetric pathology. www.3Scan.com

About Prellis BiologicsUsing innovations in 3D printing and stem cell development, Prellis can create tissue and organs with the microvascular systems that are critical for supporting viable human tissue. For more information, visit Prellis Biologics. Follow us on Facebook and Twitter @PrellisBio

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http://www.3Scan.com

Digitizing whole tissue samples for computational pathology / www.3scan.com

Envision new levels of discovery.


What’s the scoop: Pear Therapeutics is taking a unique pathway to treat various diseases by using a digital solution. The company develops prescription digital therapeutic software. Earlier this year, Pear received an EAP (expedited access pathway) designation from the FDA for its reSET-O product for use in treating Opioid Use Disorder. It’s an offshoot of Pear’s lead product, reSET, which is a FDA-cleared 12-week interval prescription therapy designed to treat substance abuse. It was a first of its kind for a digital player. “We’re in a space where there’s lots of noise around digital,” Corey McCann, Pear’s founder and CEO, said. “We are the only company that has taken the regulatory high road to give patients what they need.” What the company does is integrate clinically validated software applications with approved pharmaceuticals and treatment programs in an effort to gain improved outcomes for patients. That includes better patient engagement and tracking tools for providers, and a more cost-effective solution for healthcare payers. The company’s products also include Thrive, used for patients with schizophrenia, and reCALL, focused on combat-related PTSD.

What makes Pear Therapeutics Fierce: In short, the company’s clinical evidence that has supported its regulatory pathway, McCann said. “We do convergence better than anyone else out there,” he said, adding that the company is a classic tale of successfully merging biotech with technology. It’s also why Pear is co-headquartered in Boston and San Francisco.

What’s ahead for Pear Therapeutics: McCann said the company is on track to move from the EAP to FDA clearance for reSET-O in 2018 with hopes that it will become a standard for treating the opioid epidemic in the U.S. by 2019. Additionally, Pear is looking to use its technology and experience to help treat other chronic diseases in areas like hypertension, respiratory and diabetes. Oncology and inflammation are also in Pear’s sites, he added.

PEAR THERAPEUTICS

WE’RE IN A SPACE WHERE THERE’S LOTS OF NOISE AROUND DIGITAL. WE ARE THE ONLY COMPANY THAT HAS TAKEN THE REGULATORY HIGH ROAD TO GIVE PATIENTS WHAT THEY NEED.Corey McCann, Pear’s Founder and CEO

CEO: Corey McCann

Based: Boston, MA/San Francisco, CA

Founded: 2013

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SPONSORED CONTENT

MAKING DOCUMENT PROCESSING TOOLS AS SOPHISTICATED AS THE MEDICAL WRITERS WHO USE THEMBy: Matt MillerMicrosystems Senior Product Manager for Life Sciences

Medical writing is a challenging proposition, for good reason: errors in communication can be literally life threatening. Medical communicators need advanced education, specialized training, and years of experience to clearly and concisely explain complex information at an appropriate level to a wide range of audiences. Nearly 70% of medical writers report having a Ph.D. or equivalent degree to ensure that they thoroughly grasp the details and significance of their subjects. Meanwhile, globalization has increased the spread of disease just as it has dispersed medical research, development, and manufacturing operations. Due to ease of travel and immediate information sharing across national borders, “[p]ublic health and innovation are no longer purely national issues.”

And it’s not just the science that medical writers must master. The need to accurately convey research results demands that medical and regulatory writers also be skilled communicators with an excellent comprehension of language. Additionally, the International Conference on Harmonisation (ICH) has created extensive strict technical formatting and document structuring guidelines along with

an electronic common technical document (eCTD) format to encourage uniform research and reporting standards. These guidelines allow health and regulatory bodies worldwide to easily and consistently review new treatments, streamlining the process of moving potentially life-saving products to market. Documents that fail to conform to eCTD requirements risk rejection; an FDA “refusal to file” (RTF) can slow down an application substantially. Unfortunately, the survey above also reported a common frustration with “endless rounds of reviews and comments” to obtain high-quality results that conform to ICH guidelines.

To make this all the more challenging, scientific knowledge is not static: a medical writer’s education isn’t a one-and-done proposition. And in recent years ICH has begun revising its guidelines to adapt to changes in technology. Medical writers therefore must stay informed about recent developments in medicine, research, and regulatory frameworks, both domestically and globally. Staying abreast of ever-increasing regulatory and scientific complexity poses another major challenge that medical communicators must rise to.

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https://www.microsystems.com/

http://journal.emwa.org/medical-communication/writing-for-pharmaceutical-or-medical-device-companies-a-survey-of-entry-requirements-career-paths-quality-of-life-and-personal-observations/article/2481/mew-252-walker-et-al.pdf


http://stm.sciencemag.org/content/8/338/338ed6

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SPONSORED CONTENT

We believe the tools that medical and regulatory writers use should be held to the same standards of excellence.

Thankfully, in today’s world, technological innovations are progressing as quickly as medicine is, providing new tools and approaches to make medical writers’ jobs easier. We are applying automation and artificial intelligence concepts such as natural language processing and machine learning to medical writing and document processing—from the beginning stages of creating a document through review and final quality control checks. These advances allow medical communicators to save time on formatting and proofing their documents so they can focus on the heart of their work: how to coherently and correctly communicate scientific results. Innovative document software applications can do the heavy lifting of maintaining required formats and identifying internal consistency issues.

At Microsystems, we’re creating document creation tools like DocXtools for Life Sciences to be as sophisticated as the medical writers who rely on them. Shouldn’t your document software work as hard as you do?

MAKING DOCUMENT PROCESSING TOOLS AS SOPHISTICATED AS THE MEDICAL WRITERS WHO USE THEM

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https://www.microsystems.com/products/life-sciences/docxtools-for-life-sciences/

Create & Review Documents Faster

Manage Abbreviations

Find & Fix Improper Phrases

Take your eCTD reviews from hours to minutes

www.microsystems.com


ALLAZOHEALTH

What’s the scoop: The goal for AllazoHealth is to tackle one of the biggest challenges in the healthcare industry — patients not taking their medications. The problem of medication non-adherence is estimated to cost the U.S. healthcare system alone about $300 billion a year. By leveraging big data, predictive analytics and artificial

intelligence technology, the company’s AllazoEngine is designed to assess each patient’s risk of not following through on taking prescribed drugs. The technology then prioritizes patients into silos of those who will likely never follow medication instructions, those who almost always do, and the target group of patients who are the best candidates for intervention. “That group that is right on the edge of non-adherence and open to intervention is what we are looking for,” said Davin Cho, the director of strategic partnerships at AllazoHealth. From that risk assessment AllazoEngine is able to crunch a large amount of data to customize what intervention is best suited to

WE BUILT THIS PRODUCT FROM THE GROUND UP AND LEAD THE INDUSTRY IN ACCURACY AND RELIABILITY.Davin Cho, the Director of Strategic Partnerships at AllazoHealth

each patient for the best chance at medication adherence at the lowest cost. It can determine that while one patient might only need a text message as a reminder, another may need a phone call from a clinician. The data being processed for such determinations includes prescription claims, medical claims, patient demographics and numerous other factors like behavioral data that can include things like magazines subscriptions. The company is currently working with some of the leading healthcare payers in the U.S., pharmacies and drug manufacturers to further develop and improve adherence programs.

What makes AllazoHealth Fierce: “It can be embodied by one word and that’s ‘tenacity’,” Cho said. “We built this product from the ground up and lead the industry in accuracy and reliability.” And from an ROI perspective, AllazoHealth ranks 5-to1 to 10-1, he added.

What’s ahead for AllazoHealth: The company is planning on rolling out a Series A round of funding in the second quarter of 2018 as well as announcing more strategic partnerships. “As pharma moves toward patient centricity we want to move with them most efficiently and while providing the best value,” said Cho.

CEO: Clifford Jones

Based: New York, NY

Founded: 2011

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IMS Health and Quintiles are now IQVIA™ – created to advance your pursuits of human science by unleashing the power of data science and human ingenuity.

Copyright © 2017 IQVIA. All rights reserved.

HUMAN DATA SCIENCE

Research & Development | Real-World Value & Outcomes | Commercialization | Technologies


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HOW DO WE DEAL WITH GROWING ANTIMICROBIAL RESISTANCE?

The world is facing a crisis, growing antimicrobial resistance will result in excess of 10 million deaths a year by 2050, according to a recent report published in the United Kingdom. One of the leading causes for this growing resistance is the protective structures that the bacteria create around themselves, called biofilms and current treatment methods are often ineffective at dealing with them

Why biofilms? To protect themselves, bacteria come together and form colonies and when they do this they create the Biofilm, which is a physical extracellular polymeric substance (EPS). This EPS matrix acts like a force field around the bacteria – making the bacteria much more difficult to eliminate and very resistant to antibiotic therapies. Most antibiotics are either unable to penetrate the EPS matrix or unable to attack the bacteria contained within because most antibiotics are only effective against metabolically active bacteria, whereas all bacteria within the biofilm are metabolically inactive. In addition, different species of bacteria within the biofilm can communicate with each other, this is called quorum sensing and through this they can transfer resistance mechanisms to each other.

Biofilms pose a far-reaching threat to humans, animals and the environment. The continuing rise of antimicrobial resistance necessitates effective diagnosis and management of biofilm-associated infections.

Collectively, infections contribute to significant morbidity and mortality and increased health care expenditures. It has been estimated that in excess of 80% of bacterial infections, especially chronic infections are a direct result of biofilms.

Some examples of biofilm infections include Cystic Fibrosis, Chronic Wounds, Surgical Site Infection, Chronic Sinusitis, Otitis Media with effusion, Acne and Periodontal Disease. It is well known that these diseases are ever present, recurrent and extremely difficult to get rid of. In the case of Chronic Sinusitis, upwards of 15% of those patients medically managed (ie using Antibiotics) fail treatment due to the inability of those antibiotics to be effective against the biofilm infection. The same is true for surgical management of this condition, where we see as high as a 25% revision rate due to the recurrent infection.

One way to address the Biofilm ProblemNext Science’s founder and Chief Technology Officer, trained as a material scientist and used his background in material science to find a way to physically break down the EPS force field around the bacteria, thus exposing the bacteria to attack through cell lysis and defending against the recolonization of the bacteria by removing their protective structure. This contrarian approach has been shown to be more effective, gentle and sustainable than all other known approaches.

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Next Science’s platform Xbio™ Technology can be applied topically in a number of formats tailored to the infection, anatomical area and contact time required. Xbio has been shown to strongly outperform other existing antimicrobials (chlorhexidine, iodine solutions, steam, silver compounds).

Three product applications of Xbio have received regulatory clearance in the US and as a company dedicated to science and continuing to develop out the Xbio platform, we welcome any partners seeking to work with us on our novel approach to dealing with one of the leading causes of antimicrobial resistance.

SPONSORED CONTENTHOW DO WE DEAL WITH GROWING ANTIMICROBIAL RESISTANCE? CONTINUED

Judith [email protected]

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mailto:jmitchell%40nextscience.com%20%20%20%20?subject=

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of patient stratification for who these therapies are best applied to.” In addition to raising $13.5 million in Series B funding to support their work, IsoPlexis also snagged $5.6 million in NIH funding and a $1.8 million National Cancer Institute grant.

What makes IsoPlexis Fierce: Mackay said there are three elements that make IsoPlexis fierce; it’s thought leadership in technology that stems from the company’s scientific founders and advisory board; a very strong technology platform; and its employees. “All of those elements allow us to maintain our ferocity,” he said.

What’s ahead for IsoPlexis: While the company remains focused on continuing to improve on the IsoCode chip in the field of immunotherapy, Mackay said they expect to use the chip in 2018 for additional applications.

What’s the scoop: IsoPlexis has developed new technology that puts the company on the frontline of innovative immunity-based treatments of cancer. The company’s IsoCode chip system can identify and predict a patient’s response to immunotherapy at a higher rate of accuracy than conventional assays. This leap in technology allows researchers to move forward more quickly against cancer by helping them understand the role of immune cells that can determine the outcome of a patient. The IsoCode chip is capable of detecting higher amounts of critical functional data per single cell. “Our ability to measure a lot more functional data per individual patient immune cell has provided a pathway to understanding how immunotherapy works,” Sean Mackay, co-founder and CEO, said. “Its a very powerful aspect of not only uncovering some of the mechanisms of immunotherapy as well as long term in differentiating responders for the purposes

OUR ABILITY TO MEASURE A LOT MORE FUNCTIONAL DATA PER INDIVIDUAL PATIENT IMMUNE CELL HAS PROVIDED A PATHWAY TO UNDERSTANDING HOW IMMUNOTHERAPY WORKS

Sean Mackay, Co-Founder and CEO

CEO: Sean Mackay

Based: Branford, CT

Founded: 2013

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Innovative Technology forDifferentiated Products

http://www.orbisbio.com


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CAR-T TEST DRIVE

With Novartis’s recent approval for CTL019 (tisagenlecleucel) and products in development at other companies, the CAR T-cell-therapy category is poised to become an important option for patients with relapsed or refractory malignancies.

Have oncologists been swept up in all the excitement surrounding this new mechanism? How do front-line treaters feel about it? A crowd of eventual competitors compels market entrants to gain as much insight as possible into how customers think and feel about this modality now.

A new system based on artificial intelligence (AI)PeerSourcing Solutions builds distinctive brand ideas by crowdsourcing insights and direction from physician audiences via a patent-pending application. Target physicians log on, are exposed to product information, perform projective exercises and respond to direct and indirect questions. After AI analysis, the system outputs the marketing archetype indirectly specified by the physicians. The company calls this a PharmAtype® persona, one of a series of archetypes that the company has adapted specifically for health-care marketing.

As part of an extensive validation process, PeerSourcing Solutions studied pre-launch products including JCAR015 – at the time among the first CAR T-cell therapies in development. The system recruited 200 oncologists in the US and Europe, input those physicians with publicly available information, and assessed the responses.

JCAR015 Results (August 2016)The PharmAtype archetype derived from the physicians’ responses was the Disrupter. The Disrupter seeks to gain an edge by changing the rules. The Disrupter archetype seeks to overturn the status quo and usher in a new era. Despite anticipated cultural differences between the US and EU, this result was consistent across regions (Figure 1).

Artificial Intelligence provides an early peek into the hearts and minds of oncologists about the next big category By Brendan Ward, PeerSourcing Solutions (www.peer-sourcing.com)

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The need to be differentOn March 2, 2017, Juno Therapeutics announced that JCAR015 would no longer be developed. However, because JCAR015 was among the first drugs studied, we believe that its discontinuation will do little to dilute the implications of these findings for other CAR-Ts.

In this study, the science of CAR T-cells has oncologists clearly excited about significant clinical benefits. However, this enthusiasm for the category presents a challenge to marketers of individual molecules. With the same mechanism, similar data sets, and launches projected to be in quick succession, how can products stand out?

Typically, oncology marketers look at data, indications, and positioning as the tools they have to succeed. With PharmAtype personas, we add a crowdsourced brand personality to that mix. By going beyond what oncologists think, by getting under their skin to their unexpressed reactions, the system outputs the specific tone of voice that the audience connects to the brand.

Using a dataset culled from public sources and a positioning developed independent of its manufacturer, JCAR015 landed on the Disrupter PharmAtype persona. By applying different data and positioning, future CAR-T participants could access their own personas as a potent means of differentiation.

PeerSourcing Solutions is bringing artificial intelligence to medical advertising Brendan Ward may be reached [email protected].

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NOVARTIS

What’s the scoop: In what was seen by many as a huge step in the battle against cancer and for the biopharma industry, Novartis received FDA approval earlier this year for its CAR-T treatment tisagenlecleucel. Kymriah is a first-ever cell therapy for a rare form of acute lymphoblastic leukemia. The medication is made of re-engineered T cells collected from each patient, which are then infused back into the patient to attack cancer

cells. Initially, the medication is targeted for children and young adult patients. “Personalized medicine is a rapidly advancing field of treatment, which focuses on developing therapies that are specifically targeted to an individual’s unique clinical profile,” Bruno Strigini, chief executive of Novartis Oncology, said. “Novartis has been working toward personalized medicine for 20 years, leading to the development of treatments and medicines for rare diseases, including those that open new ways to approach cancer therapy by harnessing the power of a patient’s immune system.” In a unanimous 10-person vote in June and ahead of what was expected to be an October decision, one of the FDA panelists called the medication one of the most exciting treatments he’s seen in his lifetime.

PERSONALIZED MEDICINE IS A RAPIDLY ADVANCING FIELD OF TREATMENT, WHICH FOCUSES ON DEVELOPING THERAPIES THAT ARE SPECIFICALLY TARGETED TO AN INDIVIDUAL’S UNIQUE CLINICAL PROFILE

Bruno Strigini, Chief Executive of Novartis Oncology

What makes Novartis Fierce: “It is our persistence, commitment to innovation, and collaboration that has ultimately charted a course to the first successful launch of a CAR-T therapy, and makes our organization ‘fierce’,” Strigini said.

What’s ahead for Novartis: Following FDA clearance to use Kymriah to treat children and young adults with acute lymphoblastic leukemia (ALL), and after filing for an FDA nod in diffuse large B-cell lymphoma (DLBCL), the company in early November asked EU regulators to clear Kymriah to treat both diseases. Additionally, Strigini said they are working with the University of Pennsylvania to expand CAR-T cell therapy research to a broad range of hematological malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma. “The introduction of the first FDA-approved CAR-T therapy has ushered in a new era in cancer treatment, and is only the beginning of this new chapter,” he said.

CEO: Bruno Strigini, Novartis Oncology

Based: Basel, Switzerland

Founded: 1996

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SPONSORED CONTENT

R&D productivity and efficiency are key measures for evaluating the success of biotech and pharma companies. In theory, investing resources into R&D to boost those measures should yield positive results. Unfortunately, recent trends suggest a less desirable outcome.

A primary driver of the R&D productivity decline is the prolific growth in innovative therapeutic modalities. The first siRNA therapeutics, CAR-T engineered cells, and viral gene therapies have all been approved by the FDA within the past 2 years alone. This innovation in the biotech and pharma industry has enabled spectacular successes in the treatment of devastating diseases, but it comes with significant operational challenges.

In contrast to the well-known development process for small molecules, these new highly specialized therapeutics require exponentially more diverse and complex technologies and expertise. So how do biotech and pharma companies access this evolving set of technology and expertise? Increasingly, they have shifted to a reliance on an external R&D ecosystem. By outsourcing, companies can manage fixed costs while accessing specialized technologies, particularly in complex R&D areas. As of 2017, nearly half of R&D budgets are spent on outsourced scientific services and the trend is increasing.

INNOVATION DRIVES OPERATIONAL CHALLENGES THAT IMPACT R&D PRODUCTIVITYBy Elizabeth IornsPh.D., CEO and Co-Founder, Science Exchange

But, several challenges prevent companies from realizing returns on their outsourcing investments.

• First: even though outsourcing represents a rapid path to new technologies, identifying relevant and qualified service providers is a time-consuming task that can take weeks or even months.

• Second: contracts required to maintain confidentiality, protect IP, and ensure compliance can delay project initiation and add to transaction costs.

• Third: R&D organizations may have thousands of individual scientists conducting tens of thousands of outsourced R&D projects each year. Maintaining visibility, monitoring performance, measuring success represent a significant management burden.

Science Exchange directly addresses these challenges and has demonstrated a significant impact on productivity and efficiency in R&D programs around the world. The Science Exchange platform uniquely provides a marketplace of pre-qualified and pre-contracted outsourced R&D service providers to provide scientists with instant access to the innovative services necessary to advance today’s pipeline.

CONTENTS

03 Introduction






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https://endpts.com/big-pharmas-woeful-numbers-on-drug-rd-just-got-even-worse/

https://phys.org/news/2017-11-approach-reveals-collaborations-key-pharmaceutical.html?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202017-11-16%20BioPharma%20Dive%20%5Bissue:12898%5D&utm_term=BioPharma%20Dive

https://phys.org/news/2017-11-approach-reveals-collaborations-key-pharmaceutical.html?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202017-11-16%20BioPharma%20Dive%20%5Bissue:12898%5D&utm_term=BioPharma%20Dive

https://www.ncbi.nlm.nih.gov/pubmed/27118048

https://www.ncbi.nlm.nih.gov/pubmed/27118048

http://files.shareholder.com/downloads/ICLR/3717560502x0x923636/3ECDE4CD-8149-47D3-86B0-F81B69616D25/ICON_JPM_2017_10th_Jan_Final.pdf

http://files.shareholder.com/downloads/ICLR/3717560502x0x923636/3ECDE4CD-8149-47D3-86B0-F81B69616D25/ICON_JPM_2017_10th_Jan_Final.pdf


About the Author:Elizabeth Iorns, Ph.D., is the CEO and co-founder of Science Exchange, co-director of the Reproducibility Initiative, and part-time partner at Y Combinator.

Science Exchange accelerates scientific discovery by enabling instant connections to the world’s best R&D facilities through a marketplace of pre-qualified and pre-contracted scientific service providers. Today, Science Exchange serves thousands of organizations on both the supply and demand sides of outsourced R&D, including the world’s top biotech and pharmaceutical companies.

Prior to launching Science Exchange in 2011, Dr. Iorns investigated breast cancer development and progression as an assistant professor at University of Miami’s Miller

School of Medicine, where she remains an adjunct professor. She also serves on the board of directors for the Drug, Chemical & Associated Technologies Association (DCAT).

Dr. Iorns earned her doctoral degree from the Institute of Cancer Research in London, and her bachelor’s degree in biomedical science from the University of Auckland.

SPONSORED CONTENTINNOVATION DRIVES OPERATIONAL CHALLENGES THAT IMPACT R&D PRODUCTIVITY

CONTINUEDCONTENTS

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ADD A DROP OF PLACEBELL©™ TO YOUR CLINICAL RESEARCH

Placebell©™ is a tool designed to increase the sensitivity and power of your clinical trial results by characterizing Individual Placebo Responses therefore identifying true therapeutic effects.

Linkedin SlideShare Twitter Youtube

48 Rue Auguste Piccard, 6041 Gosselies, Belgium+32 (0)71 14 02 00 - www.placebell.tools


SPONSORED CONTENT

Pharmaceutical industry stakeholders agree that the lack of the ability to demonstrate efficacy greatly contributes to the high attrition rate of drug development programs and therefore can have dramatic negative financial implications. Numerous Phase II and III clinical trials fail due to the inability to demonstrate clear superiority of the tested therapy versus a placebo (false negatives).

The placebo effect is multifactorial in nature. It is a phenomenon which is powerfully influenced by different variables including patient expectation of therapeutic success, conditioning and prior experiences, observational and social learning, as well as personality traits. For accurate interpretation of clinical study results, controlling for the individual placebo response is paramount. The potentially significant impact of the individual placebo response (IPR) on the assessment of efficacy is unfortunately a major hurdle that pharmaceutical and biotechnologies companies still face until today.

Tools4Patient (T4P) has developed and validated Placebell©™ an analytical tool that improves the characterization of the IPR in certain disease states where the placebo effect can mask the true efficacy of potentially important therapies.

This unique proprietary technology, Placebell©™ has been demonstrated to increase the sensitivity and statistical power of clinical trial results in pain therapeutic areas where it demonstrated its ability to reduce the variance resulting from IPR in such a way that 1) the study power

“HOW A SINGLE DROP OF INNOVATION CAN REVERBERATE THROUGH YOUR CLINICAL TRIAL”

could be increased; and/or 2) the statistical Type II error could be reduced.

Placebell©™ has demonstrated real discrimination of patients who were either high or low placebo responders.

The Placebell©™ tool is by nature easy to use and has very limited impact on the operational conduct of clinical trials. For the investigator site, the only additional procedure required is the completion by the patient of the T4P-developed proprietary psychological questionnaire, only once at the beginning of the trial. With the outcome of that questionnaire and other information typically collected in a clinical trial, Placebell©™ will generate the IPR for use as a co-variate in the statistical analysis.

Placebell©™ pipeline is currently expanding in Parkinson’s disease, inflammatory diseases, and several other indications. In other disease states/therapeutic areas where the incidence of IPR is known to be significant (various forms of pain, other CNS/psychiatric, and respiratory/allergy etc.) Tools4Patient may work in close collaboration with sponsor to adapt Placebell©™ to their specific study requirements.

CONTENTS

03 Introduction






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https://www.youtube.com/watch?v=nYlSclbCx2E


http://www.tools4patient.com/

https://www.youtube.com/watch?v=Hrqk6vpUdTU


http://www.placebell.tools/

https://www.youtube.com/watch?v=Hrqk6vpUdTU

http://www.tools4patient.com/r-d/

http://www.tools4patient.com/research-collaborations/


SPONSORED CONTENT

Pharmaceutical leaders are being challenged to bring new drug products to market faster and at a lower cost. “Multiplexing” is a strategy currently being used by several leading biologics manufacturers and CMOs that can help you meet these goals.

“Multiplex” is a term borrowed from movie theatres, which changed from one large theatre showing blockbusters to many smaller theatres showing diverse movies. The change made them more flexible and able to match audience tastes.

A Multiplex facility duplicates smaller units of production using standard machines. For example, several smaller bioreactors or filling machines would replace the single high capacity unit used in conventional facilities. Like the movie multiplex, production schedules can shift between the blockbuster and specialized products as demand requires.

Multiplexing is a strategy for success in several scenarios, including:

• Producing multi-product commercial portfolios;• Bringing multiple development candidates through trials;• Agile contract manufacturing services; and• Duplicating production at global sites.

SPEED TO MARKET AND FLEXIBILITY USING A MULTIPLEX STRATEGYJohn HarmerDirector of Sales, Vanrx Pharmasystems

Getting to market firstMultiplexing accelerates speed to market through standardization.

Choosing standard technologies shortens initial build and validation timelines. Less space is needed to house smaller machines. Lead times are shorter. Validation requirements are well known from being used elsewhere. The process of scale-out and validation becomes a repeatable process.

As product volumes grow, a Multiplex strategy scales out by cloning units of operation. If higher volumes of existing products are needed, or new products progressed into the clinic, standardized machines and facility modules are added. Costs are spread out and timelines sped up.

Flexible production to match volatile demandThe need for flexibility is forced by the smaller patient populations and uncertain forecasts for new sterile injectables, including biologics and personalized medicines (cell & gene therapies, mRNA, ADCs).

Strategic flexibility means the ability to provide what the market wants, and pivot quickly when conditions change, providing companies with a sustainable competitive advantage.

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Operational flexibility is when facilities can deliver therapies in diverse formats at consistently high quality levels. Manufacturing systems must allow for batch size variation and fast changeovers. Single-use bioreactors and robotic aseptic filling workcells are examples of flexible technologies.

Matching production to demand is the key benefit of a Multiplex strategy. Facilities can make quantities in-line with actual market demand. Slow-selling drugs are not stuck in inventory, or successes do not leave revenue on the table.

Vanrx’s position in the MultiplexVanrx was founded by biologics experts, who saw the need for a new type of aseptic filling machine. Vanrx Aseptic Filling Workcells are gloveless robotic isolators that can fill vials, syringes and cartridges. Companies can build and validate filling capacity in only one year with Vanrx, and scale out quickly when demand requires.

For more details, please visit vanrx.com/fierce, where you can download a white paper on Multiplex strategies.

To talk about a current project, please call me at +1.604.453.8660 or e-mail [email protected]

SPONSORED CONTENTSPEED TO MARKET AND FLEXIBILITY USING A MULTIPLEX STRATEGY CONTINUED

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https://vanrx.com/fierce

mailto:jharmer%40vanrx.com?subject=

Bring drug products to market faster

Learn more at vanrx.com/fierce or call +1.604.453.8660

Bring your sterile injectables to market faster in vials, syringes or cartridges. Designed by biologics experts, Vanrx Aseptic Filling Workcells will make your manufacturing operations flexible, safe and scalable.


SPONSORED CONTENT

Cancer immunotherapy has achieved unprecedented success in treating late stage cancer patients in the past few years. However, the response rates to various forms of immunotherapy have been below 30%. A principle reason for the limited response rate is that most tumors in late stage patients are lacking immune cell infiltration, so-called “cold” tumors. An immune suppressive barrier blocks immune cells from entering the tumor mass and neither CAR-T cell therapy nor checkpoint inhibitors are effective in attacking the “cold” tumors.

Oncolytic viruses (OVs) are a group of viruses that can specifically replicate in tumor cells but not in normal cells. Replication of OVs inside tumor cells causes cell lysis and dissemination of the virus in an infected tumor. More importantly, viral infection in the tumor causes innate immune cells infiltration, which in turn kill the infected tumor cells and also present the tumor antigens to CD8+ T-cells to induce durable anti-tumor immunity. Thus, OV can change the immune microenvironment of a tumor to turn a “cold” tumor “hot”, and may significantly enhance the efficacy of current immunotherapy.

The first OV drug in North America was approved by FDA for treating melanoma in 2015 and many OVs are in clinical trials for various types of tumors. However,

BOTTLENECK BREAKTHROUGH: ONCOLYTIC VIROTHERAPY, THE NEXT GENERATION OF CANCER IMMUNOTHERAPY William JiaPhD, Virogin Biotech Ltd.

significant attenuation of virulence in current OVs have resulted in limited clinical efficacy when used alone and in most cases, OVs are only suitable for intratumoral injection.

Virogin Biotech has developed a novel oncolytic virus platform that enhances both oncolytic activity and tumor specificity simultaneously. Virogin’s technology is based on the findings that tumor specific replication of oncolytic viruses can be realized by altering the regulatory mechanisms of viral gene expression in tumor specific fashions. By applying either 5’ or 3’ translational regulatory elements in desired viral gene(s), expression of the gene(s) can be greatly suppressed in normal cells but not in tumor cells. Meanwhile, we are able to use tumor specific promoters that are stronger than endogenous viral native promoters to overexpress viral gene transcripts and to produce more virus in tumor cells. Since the translational control mechanisms override transcriptional activity, the viral protein production remains extremely low and virus replication is significantly blocked in normal cells. Due to enhanced safety and tumor specific virulence, the transcriptional and translational dual regulation (TTDR) mechanism allows us to create OVs suitable for systemic delivery.

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SPONSORED CONTENTBOTTLENECK BREAKTHROUGH: ONCOLYTIC VIROTHERAPY, THE NEXT GENERATION OF CANCER IMMUNOTHERAPY

CONTINUED

In the last three years, Virogin has created many recombinant oncolytic viruses with TTDR regulatory mechanism and carrying multiple immune regulatory factors to further change tumor immune microenvironment. Our OVs showed high efficacy in treating various tumors by systemic delivery in animal models. Often a single i.v. injection resulted in a complete tumor eradication. Virogin is on track to enter clinical stage in the near future. We are confident that our next generation of oncolytic viruses will break through current cancer immunotherapy bottlenecks to bring new hope for patients with late stage cancers.

CONTENTS

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SPONSORED CONTENT

If you work in life sciences and you’re in charge of the entire review and approval process for your promotional materials, determining the most important things to measure and optimize can be daunting. Most life sciences promotional review solutions provide basic metrics about the review and approval process of your collateral – how long it takes for a content piece to go from draft to approval in workflow, how many workflow jobs are in progress, how long it takes for each individual to review jobs in a timely manner, etc.

But unless you are truly a numbers person, even the default reports can be overwhelming. And without basic default reports, you may not have the time to scour through raw performance data or run fancy algorithms to assess the performance of your promotional review committee (PRC) process. That’s why many life sciences companies use a One Metric That Matters (OMTM) mentality to simplify performance measurement of their PRC.

OMTM represents a single metric that highlights performance against the one problem that you are trying to solve. By focusing on one metric, you can make decisions quickly and with more clarity.

We surveyed marketing operations experts who own the promotional review process and found they measure their department’s performance on:

Speed to market - 46% of respondents reported speed to market - optimizing the process for moving content from approval to publication - was a priority.

FINDING THE METRIC THAT MATTERS IN THE PRC PROCESS

Return on investment (ROI) - Everyone wants to measure ROI, but it’s easier said than done. Our respondents deconstructed ROI based on:• Cost and time saving capabilities• Measuring the quality of material submitted• Sales revenue

Promotional review systems often only provide metrics that track the review and approval process but not the performance of the content. Using a platform designed to simplify the PRC, one that enables real-time collaboration review such as Vodori Pepper Flow, can streamline the process so life sciences companies can focus on planning and executing better content. Pepper Flow makes in-flight review visible and integrates with content delivery platforms.

Keep in mind that producing a lot of content doesn’t mean that the approved content is any good. It’s important to declare a OMTM that supports and reinforces the overall goals and purpose of marketing.

Industry estimates indicate 60% of content created by marketing organizations in B2B selling environments goes unused, while content is the largest budget item for marketing.

Based on our calculations, companies produce between 1 and 15 pieces of content per $1M in revenue. Hypothetically, the marketing organization of a company with $1B in annual revenue will spend $3M on content - producing an average of 8,000 assets per year across global websites, collateral, trade show materials, etc.

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https://www.vodori.com/pepper-products/flow/

https://www.vodori.com/fixing-promotional-review-process-helps-hurts-commercial-execution/

https://www.vodori.com/fixing-promotional-review-process-helps-hurts-commercial-execution/

https://www.siriusdecisions.com/Blog/2013/May/Summit-2013-Highlights-Inciting-a-BtoB-Content-Revolution




SPONSORED CONTENTFINDING THE METRIC THAT MATTERS IN THE PRC PROCESS CONTINUED

If 60% of this content isn’t used because it was uninspiring, or it was award winning, but the sales rep, service rep, and the customer can’t find it or will never know it existed – the company just wasted $2.7 M. Moving fast and optimizing the transaction costs of collateral is important, but it doesn’t move the needle.

We can fix the real content problem by putting customers and commercial teams at the center of everything. Treat collateral development like a publishing business and find ways to test the book’s story before seeking the advance from the publisher. Let’s recognize that writing the book is only half the puzzle and that the other half depends on thoughtful promotion and distribution of the content. Finally, let’s not forget that it’s the commercial win that matters (lead generation, awareness, closed sale), not simply the completion of our annual goals.

About the author:Scott Rovegno is president & CEO of Vodori, a Chicago-based product and digital marketing agency focused on helping global B2B clients in the life sciences industries create digital customer experiences that drive measurable results. For more information, visit https://www.vodori.com/

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https://www.vodori.com/


DIRECTORY LISTINGS

3Scan is a biotech startup in San Francisco digitizing whole tissue samples through a technique that combines automation, machine learning and artificial intelligence. This innovative process is designed to revolutionize histology in support of translational medical research, pharmaceutical development and the biotech industry.

This novel approach captures high resolution images of complete tissue samples, through serial sectioning and simultaneous high resolution image capture, enabling them to compute metrics and apply mathematical models. This technique empowers scientific discovery by creating a map the related structures of the micro-environment and producing not only detailed 3D representations but providing decision support in the emerging field of computational pathology.

Could reproducible, quantified data about complex anatomical structures propel your research forward? Learn more about how 3Scan can enable greater visibility into your discovery by contacting us at [email protected] or visit http://www.3scan.com/

Avectas is a cell engineering technology company, enabling drug developers to manufacture potent engineered cell therapies at therapeutic volumes, with high efficiency and with minimal cell disruption. Our vision is to be the market leader in vector-free intracellular delivery technology for next-generation cell and gene therapies.

Avectas’ technology, Solupore™, delivers advanced molecules such as mRNA, proteins and gene editing tools to a range of cell types including T cells for immuno-oncology applications. Cells engineered with the Solupore™ technology require no recovery time, leading to a shorter, simpler, more cost effective process. Solupore™ can also enable co-delivery of cargos to cells. The Solupore™ mechanism of action allows transient permeabilization of the cell membrane, enabling diffusion of cargo into the cell. The permeabilization is reversible, the cell membrane rapidly recovers resulting in high cell viability and functionality.

The Avectas team is ready to advance commercial partnerships with industry leaders in the clinical areas of CAR-T, gene editing and advanced drug delivery. To contact us or for more information please visit our website https://www.avectas.com/.

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mailto:info%403Scan.com?subject=

http://www.3scan.com/

https://www.avectas.com/


DIRECTORY LISTINGS

Bonti, based in Newport Beach, California, is a rapidly emerging biotechnology company founded by world class neurotoxin experts with proven success at Allergan, one of the Fortune 500 fastest growing pharma companies. Bonti’s lead product candidate, EB-001, is an investigational botulinum neurotoxin serotype E (BoNT/E). EB-001 has a mechanism of action similar to the marketed botulinum neurotoxin serotype A (BoNT/A) products though it has a differentiated clinical profile. EB-001 has a fast onset of action (within 24 hours) and short duration of effect (about 4 weeks). Currently marketed BoNT/A products have an onset of action around 3-7 days and a duration of effect around 3-4 months. The unique target clinical profile of EB-001 may be well suited for a vast range of aesthetic and therapeutic uses, including for the treatment of post-surgical and non-surgical musculoskeletal pain, with currently unmet needs.

Founded in December of 2009, Genesys Spine is a growing, privately held Medical Device company headquartered in Austin, Texas with sales in the United States and internationally. Its products, including proprietary features and system-specific instruments, have garnered very positive feedback from the marketplace and remain within existing parameters for today’s current reimbursement codes.

www.genesysspine.com

[email protected]

512.381.7070 main

512.381.7076 fax

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http://www.genesysspine.com

mailto:info%40genesysspine.com?subject=


DIRECTORY LISTINGS

IsoPlexis, a privately held life sciences company, is developing novel technologies at the forefront of the revolution in immunity-based treatments of cancer. IsoPlexis has created a next-generation system, capable of identifying and predicting patient responses to immunotherapy more accurately than conventional assays. IsoPlexis enables researchers to accelerate the fight against cancer by providing a simple approach to understanding the complex role of immune cells that determine patient outcomes. IsoPlexis’ original scientific leaders from Yale, Caltech, UCLA and Memorial Sloan Kettering Cancer Center initiated research to detect cellular responses at the single-cell resolution, with much more secreted protein data per cell, to better understand how to develop potent personalized immune therapies for various cancers. More recently in 2017, researchers from Kite Pharma, the National Cancer Institute, Novartis, and Yale presented data from IsoPlexis collaborations in CAR-T, anti-PD1 and other immune therapy areas to advance predictive biomarker discovery for immunotherapy.

[email protected]

Microsystems was founded over 20 years ago to help organizations spend more time creating great documents and less time fixing them. Over the years, as we’ve learned what goes wrong with complex documents, we have proactively sought out our client’s pain points to create solutions for them. We made a simple promise: to solve our clients’ document problems and free them up to focus on what matters. We understand that software plus service is what makes the difference; so, our software has always been supported by the foremost customer service in the industry. Not only do our products support multiple parts of the document review process, but we’re also using artificial intelligence to build smart software that solves the real-life document challenges our clients face, enabling individuals to focus their time on the work they value most. For more information on our solutions for the life sciences industry, please visit www.microsystems.com.

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http://www.isoplexis.com

mailto:info%40isoplexis.com%20?subject=

http://www.microsystems.com


DIRECTORY LISTINGS

PAVmed Inc. (Nasdaq:PAVM) is a highly-differentiated, multi-product medical device company employing a unique and proven business model designed to advance products from concept to commercialization much more rapidly and with significantly less capital than the typical medical device company. Backed by a strong track record of entrepreneurship, PAVmed’s leadership team has the clinical expertise, commercial acumen and proven business model to identify, innovate, and commercialize innovative products with a focus on high-margin, single-use, interventional products encompassing a broad spectrum of clinical areas, which provide less invasive, safer, and more cost effective solutions for clinicians and their patients. PAVmed’s current pipeline consists of products with a market opportunity of over $3 billion, focused on hand surgery, medical infusion, pediatric ear infections, and tissue ablation. It’s three lead products are the CarpX Minimally Invasive Carpal Tunnel Device, PortIO Long-term Intraosseous Infusion System and DisappEAR Resorbable Antimicrobial Pediatric Ear Tube. It seeks to expand its multi-product pipeline sourced internally and from innovative clinicians and academic medical centers.

PeerSourcing Solutions (PSS; www.peer-sourcing.com) is a technology-based creative resource for the promotion of pharmaceutical and other healthcare products. PSS’s first product, PharmAtype® Branding, is a patent-pending technology that employs Artificial Intelligence and machine learning to make better branding concepts through crowdsourcing. Via this patent-pending system, target physicians indirectly specify a brand’s personality and provide in-depth, customer-intensive creative direction. Only the PharmAtype process puts the physician at the heart of the creative process. As part of extensive validation studies in support of the system, a quantitative analysis revealed that pharmaceutical ads taking a PharmAtype approach were associated with significantly better performance versus non-PharmAtype ads for content-engagement and behavioral-intention parameters. The company has also field-tested the system, completing three case studies, two of them with international audiences. PSS was founded by Maureen Regan, Richard Campbell, and Brendan Ward, industry veterans who previously started up McCann Regan Campbell Ward (RCW) at McCann Worldgroup. Adam Persing, PhD is the company’s Chief Data Scientist. For more information, please contact Maureen Regan: [email protected] 917-693-9761.

CONTENTS

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http://www.peer-sourcing.com

mailto:mregan%40peer-sourcing.com?subject=


DIRECTORY LISTINGS

Tools4Patient (T4P) personnalised medicine approaches (patient response characterization via mathematical predicitive algorithmic methodologies) up to production release, follow pre-defined development plans, peer reviews and validation protocols. Our technology called Placebell©™, which through a variety of data capture sources and analyses characterizes the individual placebo response in subjects and patients enrolled in clinical trials.

Our individual patient response characterization technology is developed to empower clinical researchers to achieve high level of reliable information. Data obtained from our development and validation studies have been published at several scientific congresses as well as presented at the FDA meeting. Tools4patient’s core team and consultants have decades of drug development expertise with both multinational pharmaceutical companies as well as biotechnologies companies and a variety of clinical research organizations. Therefore our approach includes a suite of ancillary supports such as but not limited to:

• Mathematical support to biomarker selection;• Innovative data interpretation and methodologies evaluation.

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http://www.tools4patient.com/

http://www.placebell.tools/#nutshell


DIRECTORY LISTINGS

Vanrx Pharmasystems makes the most technologically advanced aseptic filling solutions for the pharmaceutical industry. Vanrx Aseptic Filling Workcells use robotics, machine vision and gloveless isolator technologies to automate the packaging of injectable drugs into vials, syringes and cartridges.

Using Vanrx Workcells, pharmaceutical companies can bring injectable medicines to market faster. From preclinical development through clinical trials, the new Microcell Vial Filler is designed for drug development and production of clinical trial supplies. The Microcell can also support GMP manufacturing of cell & gene therapies and personalized medicines, with the ability to produce at least four patient therapies in a single shift. For late-stage clinical trials and commercial production, the SA25 Aseptic Filling Workcell can flexibly fill vials, syringes or cartridges. Short changeover times and a highly repeatable aseptic process make the SA25 ideal for multi-product manufacturing of liquid or lyophilized drug products.

Visit vanrx.com/fierce for more information.

Virogin Biotech Limited is an immuno-oncology company focusing on the discovery and development of oncolytic viruses utilizing the company’s proprietary Transcriptional and Translational Dual Regulation (TTDR) platform for the treatment of solid tumors. By combining transcriptional tumor specific promoters with translational elements to regulate viral gene expression, TTDR technology effectively solves the dilemma between oncolytic activity and safety, without the need for any attenuation. Simultaneously achieving strong tumor specific virulence and enhanced safety, TTDR-based oncolytic viruses are suitable for systemic delivery. Further equipped with multiple immune regulatory factors, Virogin’s oncolytic viruses aim to create synergy with current immunotherapy to further normalize tumor immune microenvironment, ultimately accomplishing stronger and longer-lasting efficacy, broader indications and better patient experience. Virogin’s first oncolytic virus candidate is on track to enter clinical stage by second half of 2018. Established in 2015, Virogin Biotech is headquartered in Vancouver, Canada with offices in Guangzhou and Shenzhen, China. For more information please visit www.virogin.com.

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https://vanrx.com/fierce

http://www.virogin.com

From the publisher of Fierce Life Sciences

CONGRATULATIONS TO ALL OF THE WINNERS& THANK YOU TO ALL WHO APPLIED

2017