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MF-6 Sixth Microfluidics Consortium

MF-6.4

(Closed Meeting – Members Only) June 24th Cambridge, MA USA

(Open Meeting – Day Delegates + Members),

June 25th Cambridge, MA USA

Final Version

Contents:

Agenda

Delegate List

Speaker Profiles

Table-top Demonstrations

Hotel and Travel Recommendations

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Sixth Microfluidics Consortium Agenda for 6th Meeting MF-6.4

The sixth Microfluidics Consortium brings together current and future stakeholders from across a wide range of backgrounds with a shared interest in facilitating the growth of the industry through better understanding of the challenges, opportunities and choices which it faces.

Our current membership includes: Becton Dickinson (USA); CEA (F); DTU (Dk); Danaher (USA); Delta (Dk);; Philips (NL); Denz Bio Medical GmbH (A); Micronit (NL); Dolomite (UK); Fluigent (F); Invenios (NL / USA) ; IX-Factory (D); Janssen (B / USA); JSR Micro (J / B); IMT (CH), SINTEF (N) ; Dublin City University (EI); Little Things Factory / Plan Optik (D); NILT (DK); DIBA (USA/UK) and University of Cambridge (UK).

We organize closed meetings for our members on both sides of the Atlantic where we seek to promote our mission “to grow the market for microfluidics enabled products and services” by

- Finding shared interest across the landscape of applications - Championing modularity and standards where appropriate - Engaging with key industry influencers

While doing a few deals along the way.

On this occasion as well as our closed session on June 24th we are also reaching out to selected guests in the USA beyond our membership in an Open Meeting on June 25th seeking to engage them in our vision, projects and thinking.

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June 24th (Members Only Closed Day)

Location: 7

th Floor 1 Broadway (See logistics section below for Map)

10:30 am Arrivals and Networking 11:00 am Welcome – British Consulate

Anne Avidon : Head of Global Health Innovation LSO -

British Government

Anne Avidon is Head of Global Health Innovation within the Life Sciences Organization of the British Government. In this role, Anne helps shape the strategy for industry engagement with UK Life Science stakeholders and supports LSO’s work with No.10 Downing Street, Government Ministers and the Office for Life Sciences. She also leads on LSO’s strategic engagement with Britain’s National Health Service and

supports the delivery of high value inward investment projects.

House Rules and Introductions

Peter Hewkin CEO Centre for Business Innovation (CfBI)

Peter Hewkin is the Chief Executive of CfBI (www.cfbi.com) which manages a ‘stable’ of international consortia around fast moving areas of business process and technology. These include: “Medical Adherence”, “Nano-Carbon Enhanced Materials”, “Social Media for Business”, “Inclusive Design”, “Open Innovation meets Big Data”, “Corporate Venturing” as well as “Microfluidics”. Peter is the leader / facilitator of the Microfluidics Consortium which is now in its 7th year.

British Consulate General Boston

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11:30 Research Presentations: “Design for Low Cost Manufacturing of POC Microfluidic Devices” – Christine McBeth

Dr. Christine McBeth is a research scientist with the Fraunhofer

Center for Manufacturing Innovation in Boston, MA. Her current

work involves the use of microfluidic devices for an array of

biological applications including rapid antibiotic susceptibility testing,

assay miniaturization, and point-of-care diagnostics for sexually

transmitted diseases. Coming from the molecular biophysics field,

she earned her PhD at the University of Washington and Fred

Hutchinson Cancer Research Institute in 2009 followed by work as

an NRSA Postdoctoral Fellow in infectious disease at Harvard

Medical School. Dr. McBeth works with an extensive team of

engineers, scientists, and students at Fraunhofer to push biological

assays and methods of detection to become faster, smaller, and

cheaper. Fraunhofer additionally partners with research groups at Boston University and in

industry to go beyond the scope of traditional academic research to develop and deploy actual

working technologies.

“Affinity Flow Fractionation for Label-Free Cell Sorting” Suman Bose

Dr. Suman Bose is an biomedical engineer with 8 years of research

experience in microfluidics, point-of-care diagnostics, tissue

engineering and numercial modeling. He earned his S.M (2009) and

PhD (2013) from MIT in Mechanical Engineering where he worked on

developing two novel technologies for label-free cell sorting. He is

currently a JDRF Postdoctoral Scholar in the laboratory of Prof.

Robert Langer and Prof. Daniel G. Anderson at the Koch Institute of

Integrative Cancer Research at MIT, along with an appointment as

Research Fellow at Boston Children’s Hospital. He has co-authored 9

journal publications, 13 conference proceeding and is a co-inventor in

2 patent applications.

12:30 Lunch and Networking

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13:30 Scenarios and Outcomes for early stage Microfluidics companies – what can we learn? How can we make a difference? Discussion led by Sashi Murthy of Northeastern University with Cameo case studies from the Boston Cluster and Beyond.

Shashi Murthy is a Professor of Chemical Engineering and the

Founding Director of the Michael J. and Ann Sherman Center for

Engineering Entrepreneurship Education at Northeastern University.

He is also a Faculty Fellow at the Barnett Institute of Chemical &

Biological Analysis at Northeastern and holds visiting appointments

at the Massachusetts General Hospital, Shriners Hospital for

Children, and the Broad Institute of Harvard and MIT. Outside

Northeastern, Prof. Murthy is also a member of the Features

Advisory Panel of the American Chemical Society journal Analytical

Chemistry.

Prof. Murthy is the recipient of the National Science Foundation’s

Faculty Early Career Development (CAREER) Award and the Søren Buus Award for Outstanding

Research in Engineering at Northeastern University. He has co-authored over 60 publications in

the areas of microfluidic cell separation and biomaterials, is an inventor on 6 issued or pending

patents, and a founder of Quad Technologies Corp., a startup focused on commercializing cell

capture/release hydrogels designed in his laboratory.

Prof. Murthy earned his Ph.D. in Materials Science & Engineering at MIT (2003) and his B.S. in Chemical Engineering at the Johns Hopkins University (1999) and joined Northeastern in 2005 following a postdoctoral fellowship at the Harvard Medical School and Massachusetts General Hospital. He was promoted to Associate Professor with tenure in 2011 and to Full Professor in 2015. Prof. Murthy served as Associate Chair of the Chemical Engineering Department at Northeastern from August-December 2011 and as Acting Chair from January-August 2012.

15:00 Way forward for the Microfluidics Consortium – Peter Hewkin CfBI This session provides an opportunity to facilitate Member consensus on ..

- Desired Outcomes and How to handle the FDA session tomorrow - Upcoming programme for the Consortium (Dates / Venues / Content) - Focus / Themes for the Consortium Going Forward

15:30 Close and Networking The CfBI team will be on hand to assist with introductions

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June 24th Evening Joint Reception with FluidicMEMS Note this event is also open to Day Delegates who have registered for the Open Day on June 25th. Delegates will be automatically registered and received their tickets by email.

Location: 700 Main Street (See Logistics Section below for Map) Jointly Sponsored by:

FluidicMEMS

This is an opportunity for Members of the MF6 consortium to network with our colleagues and good friends from FluidicMEMs over drinks/buffet.

6:00 pm Doors Open

Networking, Drinks and Buffet

7:00 pm Address from Remi Villenauf – Emulate Bio

“July 30, 2014 | The organs-on-chips approach to

preclinical testing took another step forward this week, with the launch of Emulate, a Cambridge-based startup building pocketsize models of human organs. Although Emulate only recently completed its $12 million Series A funding round, it enters the market with a deep IP portfolio, several large industry partners, and an end-to-end platform for using its chips in the lab, thanks to a five-year incubation at Harvard’s Wyss Institute for

Biologically Inspired Engineering.”

9pm Close

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June 25th Open Day (Non-member Day Delegates please register here ) Location: Hawthorne Room - Microsoft Technology Center (See Logistics Section below for Map) Please note: Photo ID is required for access to this building – If you are not on the delegate list you will not be able to get in!!

Table-top demos will be on show in the networking area from the following MF6 member organisations:

Agenda: 8:30 Registration / Networking / Table-top demos 9:00 Welcome, Introduction to the Microfluidics Consortium and Context for the day

- Peter Hewkin, CfBI

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9:30 Research Presentations

“Towards Commercialization of Cutting Edge Technologies” Ravi Kapur – Massachusetts General

Hospital Dr. Ravi Kapur is a scientist, engineer, and entrepreneur with 20 years of experience in developing and commercializing nascent technologies from leading academic laboratories. He has commercialized cutting edge technologies impacting pharmaceutical drug development, and prenatal health care. Dr. Kapur is currently Entrepreneur-in-Residence and directs the Innovation Team at the MGH.

“Opportunities for high precision mass measurement: rapid drug susceptibility testing and exosome analysis” Scott Manalis

Andrew and Erna Viterbi Professor of Biological Engineering Koch Institute for Integrative Cancer Research Departments of Biological and Mechanical Engineering Massachusetts Institute of Technology

The Manalis laboratory develops quantitative and real-time techniques for biomolecular detection and single cell analysis. We use conventional silicon processing techniques to fabricate fluidic devices, and exploit the unique physical properties associated with micro- and nanoscale dimensions for developing precision measurement methods.

“New Approach to Pathogen Detection” Tania Konry : Assistant Professor Department of Pharmaceuticals Sciences – Northeastern University. Assistant professor of pharmaceutical sciences Tania Konry has developed a system that efficiently tests for a wide range of biological specimens. Whether you’re looking for complex cancer cell biomarkers in a sample or simple bacteria in drinking water, the system costs signifi-cantly less than standard approaches and spits out results in a fraction of the time.

11:00 Coffee and Networking break / Table-top demos

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11:30 Key Note Presentation

Yun-Fu Hu: Deputy Director, Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health, CDRH FDA

Dr. Hu completed his studies in animal sciences and veterinary medicine in China, and received his M.S. degree in reproductive endocrinology and Ph.D. degree in cancer biology from the Ohio State University. He spent 5 years at Fox Chase Cancer Center in Philadelphia initially as a postdoctoral fellow, then research associate and eventually a Staff Fellow for the last 2 years there. His research interest centers around molecular mechanisms of carcinogenesis. He then joined Becton Dickson as a Project Scientist leading the development of a molecular diagnostic test

for melanoma for 2 years before he was recruited to work at GSK as an Investigator. He was promoted to Group Manager 3 years later. His group was mainly responsible for discovery of biomarkers and development of biomarker tests in support of GSK drug development programs. After more than 6 years at GSK, he joined Metabolon as the Director of Diagnostics Development to oversee the company’s diagnostics programs including discovery of metabolomic biomarkers and development of in vitro diagnostics.

He joined FDA in 2009 as a Scientific Reviewer in the Hematology Branch of the Division of Immunology and Hematology Devices at CDRH’s Office of In Vitro Diagnostic Device Evaluation and Safety and was promoted to Associate Director in 2011 in charge of the Immunology Branch of the Division responsible for review and clearance or approval of a variety of immunology and molecular diagnostic devices such as cancer diagnostics and genetic tests as well as tests for autoimmune diseases and allergies. Upon re-organization of the Office of In Vitro Diagnostic Device Evaluation and Safety (currently known as Office of In Vitro Diagnostics and Radiological Health) in 2012, he

became the Chief of the Molecular Pathology and Cytology Branch of the Division of Molecular Genetics and Pathology providing oversight of regulatory reviews of molecular pathology and cytology devices. He is currently the Deputy Director of the Division of Molecular Genetics and Pathology.

The accepted presentation will be followed by an extended and agreed Q&A on “how the (often disruptive) microfluidics innovations which we are creating today might become the mainstream solutions of tomorrow interacting with the relevant regulatory system “, Members of the MF6 consortium have proposed a series of questions .. but there will be some time for free format questions at the end. Dr Hu will also be available during the networking session afterwards.

12:45 Lunch / Networking / Table-top Demonstrations

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13:30 Enabling Technologies and Applications for Microfluidics

Richard Gray is co-founder and commercial director of Dolomite Microfluidics. He is based in Boston.

With an engineering degree from the University of Cambridge, his early career has included posts at Mettler Toledo, TTP Group and PA Consulting.

Ronny v’ant Oever is the founder and CEO of Micronit. He is based in Holland.

Ronny van 't Oever studied applied physics at the University of Twente in Enschede, the Netherlands. He finished his study in 1999, during his study he specialised in MEMS. He realized a micro pipette in a flow cell for DNA analysis with micromachining. He has been involved in a flow cytometry project at Abbott Diagnostics where he invented a now patented way to analyse red blood cells. In 1999 he

co-founded the company Micronit. In the early days he was in charge for technology and product development. Nowadays he is responsible for new business development, sales and marketing.

“Advanced Flow Control for Microfluidics” -Robert Pelletier: Fluigent, Inc. (US) Robert is a graduate of the University of Massachusetts with a degree in Biological Sciences, as well as a Master’s in Business from Suffolk University. Prior to establishing Fluigent in the US, he was responsible for the Fluidics Business at Harvard Apparatus. His previous experience includes global, senior management roles in the scientific instrumentation

industry, as well as having started US subsidiaries for other European based companies.

“Minimizing Experimental Variability in Microfluidics: Attaining Robustness,

Reproducibility and Reliability” Tom Corso – Cor Solutions Thomas Corso, Ph.D. is Chief Technical Officer at CorSolutions, where he is responsible for the R&D and manufacturing of support instrumentation for BIOMEMS and microfluidic applications. His expertise resides in analytical instrumentation development and commercializing innovative solutions. Dr. Corso has over 35 patents and numerous publications in the

area of BioMEMs and microfluidics. He served on the user committee at the Cornell NanoScale Science and Technology Facility (CNF) for many years and as a past President of the Cornell ACS Chapter. Dr. Corso received his Ph.D. from Cornell University supported by a National Institutes of Health fellowship award.

“Room temperature bonding for microfluidics” Richard Bijlard – Invenios (US/NL) Technical-/commercial entrepreneur, with a large

international network and in-depth expertise in the high-tech industry.

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15:00 Opportunities for Collaborative Action to improve the uptake of Microfluidics

- Peter Hewkin (CfBI) Followed by Discussion 15:30 Close

Open Day Delegates will receive an email invitation to join the Open Day “Drop Box” folder, this contains the latest information about the event and e-copies of most of the presentations. If you experience difficulty with this please contact operations@cfbi.com

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Open Day Table-Top Exhibits (in the Networking Area) The LETI-HEALTH department (200 people), has been set up for micro/nano technology applications in the field of health care, life science and environment. At the frontier between micro/nano technologies and biology, the department’s knowledge lies in micromachining, microfluidics, surface chemistry, integrated optical

detection, electrochemistry and electrochemical grafting, electronics, information processing, with a strong emphasis on integration in a complete system comprising instrument, biochip and biological protocol. The exhibit is a good opportunity to present our microfluidic toolbox and our FlowPad platform based on the credit card standard.”

Since 2006, Fluigent develops, manufactures and commercializes innovative microfluidic flow control and fluid handling solutions for laboratories, research units and industrials around the world

Enabling full control of your microfluidic systems through pressure, flow and electrical monitoring, Fluigent technologies provide innovating solutions for all your microfluidic and lab-on-a-chip applications (droplet-based drug testing, chromatography, cell perfusion, flow chemistry, cells and parasites separation, dielectophoresis, highly viscous fluids and liquid air manipulations, gene expression analysis in microdroplet, etc).

Indeed, Fluigent has created the market of pressure-driven flow controllers for microfluidic applications and low volume fluid handling. The products are based on the patented FASTAB technology optimizing stability and responsiveness of the flow inside your microfluidic systems (chip, microarray, etc).

In addition to the FASTAB technology, Fluigent owns or licences a portfolio of patents worldwide covering its core technologies in microfluidic flow control, Lab-on-a-chip devices, diagnosis and life science analysis (cell capture, etc).

The Invenios group is a world leader in the manufacture of gene-sequencing bio chips, micro-fluidic devices, and high volume precision micro-manufacturing. Invenios is able to maintain total process control

of substrates from raw form to a finished product and is the only manufacturer in this field with multiple fabrication facilities on two continents (US/Eu). Invenios’ photo-structural deep etch capability (FOTURAN ®) provides very high aspect ratio structures (with straight walls). Invenios has developed a unique room temperature bonding process (without using polymer based adhesives), which provides permanent glass-to-glass bonding solutions (-plastic, -silicon, ceramics, metals, patents pending). With this unique bonding process it is possible to functionalize the substrate prior to bonding and then attach the cover slip without damaging critical micro-structures or biological treatments. The new bonding process makes it possible to bond two materials that show different thermal behavior and which therefore could not have been bonded using conventional methods. In this way Invenios can create packaging for electronics, enabling integration with novel technologies like microfluidics.

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CorSolutions offers innovative products supporting fluidic manipulation for microfluidics. Products include several models of precise, pulse-free, closed-loop, programmable fluid delivery pumps, which provide

extraordinary user control. Through a front display panel or user-friendly software these high performance pumps can generate complex fluidic waveforms using one or more fluid channels. Additionally, CorSolutions offers fluidic probe stations, flow rate meters, fluidic kits for microscopes and a variety of fluidic connection micromanipulators. These effortless connections are leak-tight, non-permanent, allow for voltage applications, and are compatible with both high and low pressures.

Established in 2005 as the world’s first microfluidic application centre, Dolomite focused on working with customers to turn their concepts for microfluidic applications into reality.

Today, Dolomite is the world leader in solving microfluidic problems. With offices in the UK, US and Japan, and distributors throughout the rest of the world, our clients range from universities developing leading-edge analytical equipment, to manufacturers of chemical, life sciences and clinical diagnostics systems. Dolomite’s key strength lies in offering a complete service to customers from problem conceptualisation and feasibility testing through to full instrument design and development. By Productizing Science™, we have enabled customers around the world to develop more compact, cost-effective and powerful instruments. Dolomite also offers a Microfluidic Consultancy to develop a variety of versatile, complex and cutting edge custom devices, available in exceptionally short lead times.

Whatever your microfluidic requirements and application, Dolomite is the right partner with the right expertise!

For more information please contact us on +44 (0)1763 242491, info@dolomite-microfluidics.com or visit our website www.dolomite-microfluidics.com.

Micronit designs and manufactures customized lab-on-chip products and will show some examples together with a microfluidic connection kit. www.micronit.com

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Open Day Delegates :

Name Surname Organisation Harry An SQZBiotech Don Arnold AB Sciex Richard Bijlard Invenios Sergey Broude Resonetics Tony Byrum Piedmont CMG Jaka Cemazar Virginia Tech Kumar Challa Millifluidica LLC Dan Chiniara

Tom Corso Cor Solutions Guillaume Delapierre CEA Chris DeMaria BD Harald Denz Denz Bio Medical GmbH Salil Desai Phenomyx Saul Felman Chiral Photonics Hubert Geisler Fluigent

Richard Gray Dolomite Neil Gupta Draper Labs Peter Hewkin CfBI Yun-Fu Hu FDA Ravi Kapur MGH Tania Konry Northeastern Darin Latimer Danaher Scot Manalis MIT Kevin McCarthy Dover Control Jeff Motschman Dolomite Roger Nassar RAN Biotechnologies Rich Parker Repco Development Technologies

Robert Pelletier Fluigent Joseph Plante Diba Edwin Roovers Micronit Ali Sahari Northeastern Nadia Sargaeva Perkin Elmer Ching-Hsuan Tsai GSK Ronny v'ant Oever Micronit Geoff Waite The Technology Partnership

Billy Wang BD David Xu BD Yosuke Yamamote JSR Micro

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Logistics: Delegates are responsible for making their own travel and accommodation arrangements. Please tell us how you plan to travel and where you will be staying so we can offer taxi/transfer shares. The information below will facilitate this. The Open and Closed Meetings take place in Cambridge, MA just across the Charles River from Boston and circa 30mins from Logan International Airport which has very good connections to Europe and the USA as well as regular shuttle flights to New York.

Hotel Recommendation Cambridge Central Cambridge hotels located within walking distance of the meeting venues are not cheap! Here is a mix of price/convenience options

Boston Marriott Cambridge (5 mins walk)

Two Cambridge Center, 50 BroadwayCambridge, MA 02142, USA 1 617-494-6600View Hotel Website

View Photos Located across the Charles River from downtown Boston, our Cambridge hotel is located in the heart of the Cambridge business district. This Cambridge, the hotel is conveniently located in Kendall Square near MIT, Harvard and Boston University. Room prices start at $299

Holiday Inn Express (10 mins cab) 69 Boston Street MA 02125

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Prices start at $199 A Friendly Inn at Harvard (Guest House)

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Rooms start at $150

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Venue for Joint Reception with FluidicMEMS

700 Main Street Cambridge, MA 02139

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Open Meeting venue Location (Cambridge MA USA): Hawthorne Room One Cambridge Center Cambridge, MA 02142 Phone: (781) 487-6400 Fax: (425) 936-7329 mtcbos@microsoft.com

Please note: Photo ID is required for access to this building – If you are not on the delegate list you will not be able to get in!!

Convenient Parking:

Parking is conveniently located at Cambridge Center West at Kendall Square, adjacent to One Cambridge Center and the Marriott Hotel. There are garage entrances off of both Broadway and Ames Street (see below). Please follow the Microsoft signs to our main entrance in the front of our building. The following parking rates currently apply: • Up to one hour $15.00 • Up to three hours $30.00 • Up to twenty four hours $40.00

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Closed Meeting Venue Location (Cambridge, MA USA)

British Consulate General Boston

1 Broadway

Cambridge

MA 02142

The consulate offices are located on the 7th floor. Photo ID will be required

on entrance.

Questions?:CfBI staff are available before or during MF-6.4 to help with

delegate queries including transfer and ride share options. ceo@cfbi.com or 07951721110