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Synthetic Biology and the Computerization of Drug Development invivo.pharmamedtechbi.com OCTOBER 2016 Invol. 34 ❚ no. 09 Vivopharma intelligence ❚ informa Synthetic Biology And The Computerization Of Drug Development Synthetic biology oers opportunity across many industries, but the ultimate prize may be health care. BY MELANIE SENIOR ❚ Fujifilm Promises A Shake-Up Of ❚ How Immuno-Oncology Is Turning ❚ When It Comes To Pharma R&D ROI, Regenerative Medicines Market Biomarker Development On Its Head Mid Pharma Companies Outperform BY ASHLEY YEO BY OLIVIER LESUEUR, RACHEL LAING BY AMANDA MICKLUS AND MARK RATNER invivo.pharmamedtechbi.com CONTENTS ❚ In Vivo Pharma intelligence | October 2016 8 COVER ❚ Synthetic Biology And The Computerization Of Drug Development Melanie Senior Synthetic biology offers opportunity across many industries, but the ultimate prize may be health care. The millions of dollars investors have poured into companies developing CAR-T cell therapies and gene editing technologies points to growing confidence in the power of gene manipulation to generate novel, approvable therapeutics, even if for now these are just the early steps toward creating fully synthetic organisms. FEATURes 22 28 How Immuno-Oncology Is James Mazzo: 1 Turning Biomarker Growing Giant Zeiss With A Development On Its Head Small Company Mentality BY OLIVIER LESUEUR, RACHEL LAING TINA TAN AND MARK RATNER Having worked in the ophthalmic device Immuno-oncology’s challenge is to industry for more than 35 years in both orchestrate a biomarker program in a multinationals and start-ups, James highly competitive drug development Mazzo’s latest port of call is at Carl landscape knowing that prior to having Zeiss Meditec as head of the group’s significant clinical experience, the ophthalmology business. He discusses program is unlikely to yield the kinds what he views to be the strengths and of binary measurements used to define weaknesses of the global business, FUJIFILM’S TosHIKAZU BAN and select a patient population for a which he says has the broadest product targeted therapy. offering in the ophthalmic industry, and 16 how he plans to help a market giant grow even bigger. Fujifilm Promises A Shake-Up Of Regenerative 32 Medicines Market When It Comes To Pharma ASHLEY YEO R&D ROI, Mid Pharma Fujifilm has successfully transformed its Companies Outperform business strategy by expanding away from traditional photographic film and AMANDA MICKLUS toward new priority business fields – Datamonitor Healthcare’s measurement significantly in regenerative medicine. of pharma R&D productivity finds that Identifying health care as a key growth Mid Pharma companies outperform on a area, Fujifilm targets the role of being a Return on Investment index. The second comprehensive provider in the fields of in a two-part series evaluating R&D prevention, diagnosis and treatment. productivity. ©2016 Informa Business Information, Inc., an Informa company October 2016 | In Vivo ❚ CONTENTS In Vivo Pharma intelligence | October 2016 DEPARTMents EXCLUSIVE ONLINE content invivo.pharmamedtechbi.com AROUND THE INDUstRY ❚ Device/Diagnostics 4 StemCells Finds White Knight ❚ Deals In Depth Dealmaking Statistics In Microbot PETER CHARLish An overview of biopharma, medtech and Q2 2016 diagnostics dealmaking in August 2016 MAUREEN RIORDAN AND 5 In Vivo’s Deals Of The Month: AMANDA MICKLUS AMANDA MICKLUS September 2016 NANCY DVORIN ❚ Brexit, Brexit Everywhere ❚ I mmunotherapies Set 6 Commercial Considerations And Such A Lot To Think To Spark Alzheimer’s For Cell And Gene Therapies: ASHLEY YEO Drug Market Viewpoints From The 2016 NANCY DVORIN ARM Meeting Amanda MickLUS 36 ON THE MOVE Significant recent job changes in ❚ From The Editor pharma, medtech and diagnostics On October 11, Zymergen, a Bay Area start-up 2 that makes designer microbes for processes 40 DEALMAKING across numerous industries, announced it had Deals Shaping The Medical Industry, raised a $130 million Series B round led by Japa- September 2016 nese telecom conglomerate SoftBank. It’s just the latest example of a tech investor glomming onto an emerging synthetic biology play. In our You Asked...We Delivered! cover story this month, Melanie Senior surveys Relevant and exclusive online-only the history and landscape of this paradigm- content at your fingertips 24/7 shifting field. Health care applications for syn- bio have not advanced as quickly as those for Access your subscription by visiting: NANCY DVORIN other industries, but the potential for them is invivo.pharmamedtechbi.com huge once pharma figures out how to overcome and log in. the many regulatory, commercial and ethical hurdles. Elsewhere in this issue, we explore how Japan’s Fujifilm, which started its Don’t have an online user account? life in photography, has in recent years dealt its way into regenerative medi- Quickly and easily create one cine. Even though immuno-oncology developers aren’t waiting for biomark- by clicking on the “Create your ers to emerge before they commercialize their drugs, we argue that fitting a account” link at the top of the page. biomarker research component into the IO discovery/development process Contact: may well be a key element of product differentiation. And we wrap up our [email protected] two-part series on pharma R&D productivity with a look at market leaders as or call: (888) 670-8900 or +1 (908) measured by return on investment. 748-1221 for additonal information. Remember that you don’t have to wait for the print issue to see what In Vivo has been up to – we post content online throughout the month at invivo.pharmamedtechbi.com. We’ll be happy to send you an email alert whenever anything new posts. Click on the My Accounts tab on our home page to register. We’re always eager to hear from you – please send your questions, sugges- /invivo @invivo /invivo tions, concerns and comments to [email protected]. In Vivo | October 2016 invivo.pharmamedtechbi.com invivo.pharmamedtechbi.com invivo.pharmamedtechbi.com Strategic Transactions Pharma intelligence | 3 The most trusted source of health care deal intelligence You can rely on the insight and information in Strategic Transactions to carry out these and many more critical business development activities. The top pharmaceutical firms and leaders in medical devices, diagnostics, finance and consulting already do. Available via annual subscription. For more information and to request a complimentary demonstration, visit: www.Pharmamedtechbi.com/STLP ©2016 Informa Business Information, Inc., an Informa company October 2016 | In Vivo ❚ Around The Industry StemCells Finds White Knight In Microbot In May 2016, StemCells Inc., the biopharmaceutical company headquartered in Newark, found a practical application in Micro- CA, looked ready to throw in the towel. Results from a Phase II study of its only prod- bot’s Self-Cleaning Shunt (SCS), a robotic uct still in development, HuCNS-SC (a preparation of human neural stem cells for the system designed to prevent occlusions in treatment of chronic spinal cord injuries), suggested that there was little chance of the the cerebrospinal fluid shunts used in the product ever becoming a commercial success. Overnight the company’s shares, already treatment of hydrocephalus. Congenital devalued by an earlier 12-for-1 reverse stock split, plummeted over 80% to $0.57 a share. hydrocephalus affects up to five out of Then, in August, when all appeared to (life science management and holdings every 1,000 live births in the US, and is the be lost, StemCells announced that it was group), contract research organizations most common reason for brain surgery in entering a strategic merger agreement and other service companies. He is also children. It is characterized by abnormal with the Israeli company Microbot Medi- chairman of Cann 10, a medical cannabis- accumulation of cerebrospinal fluid in cal Ltd., which researches and develops focused accelerator. Mr Gadot has held the brain ventricles, leading to increased micro-robotic assisted medical technolo- a number of leadership positions in the intracranial pressure, tunnel vision, con- gies. The announcement came after an health care area including senior market- vulsions and mental disability. Normal extensive search for strategic alternatives ing roles at Johnson & Johnson, and he pressure hydrocephalus is a separate to winding up operations. Ian Massey, is currently chairman of XACT Robotics condition that can occur later in life, when StemCells’ CEO at the time, said the com- (which is developing technology for ro- it leads to symptoms such as disordered pany believed that its investors and the botic needle steering in minimally inva- gait, urinary incontinence and dementia. market at large would see the potential sive interventional procedures) and also The only effective treatment for hydro- 4 of Microbot’s robotics platform. serves as chairman and CEO of Microbot. cephalus is the insertion of a ventricu- Massey was right, it would seem, Microbot is developing two technolo- loperitoneal shunt, which drains excess because following the merger announce- gies that it states have the potential to im- cerebrospinal fluid into the peritoneal ment, StemCells’ share price soared 600% prove an individual’s health, comfort and cavity. However, the design of ventriculo- on Nasdaq. Under the terms of the merger quality of life as well as add value to other peritoneal shunts has changed very little deal, which is contingent on StemCells stakeholders such as hospitals and health over the years, and they are all vulnerable being free of debt and raising at least care systems. The first is ViRob, an auton- to complications, in particular to obstruc- $4 million by the actual merger date, omous, crawling micro-robot controlled by tion of the ventricular (proximal) part of Microbot’s shareholders will own 95% remotely applied electromagnetic fields. the shunt. Eighty-five percent of patients of the merged company, with Microbot’s The second is TipCAT, a semi-disposable, with a shunt will require two or more revi- management assuming responsibility for flexible, self-propelled endoscope provid- sion surgeries within 10 years of initial its running.
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