Bionics & Beyond

Pre-conference: Monday 13 May 2019

Pre conference workshop – MCEC Room 207 Morning session Regulatory affairs workshop Full day event providing attendees with an 09:00 – 12:30 Arthur Brandwood overview of the regulatory system in Australia, Founder and Principal – Brandwood and what manufacturers need to know to Biomedical successfully navigate the various requirements. Afternoon session Health economics and Reimbursement 13:30 – 17:00 The session will also cover reimbursement strategy advice for the Australian workshop economy and inform attendees what to watch out for. Sarah Griffin Principal Consultant for Reimbursement – Brandwood Biomedical Registration available through the conference registration form or as a standalone event here

Pre-conference tours and site visit

Option 1 RMIT Advanced Manufacturing Precinct Address: 58 Cardigan Street, Carlton, VIC 3083 Location: Melbourne City campus , Building 55 Website: www.rmit.edu.au/.../advanced-manufacturing-precinct Time: 11.00am – 12.00pm

Visit the Advanced Manufacturing Precinct the largest additive manufacturing facility in Australia which combines RMIT's expertise in technology and design innovation with a focus on additive manufacturing. Witness how the next generation of engineers, designers and technicians working closely with industry both in Australia and internationally to be the leader in the implementation of the next wave of additive manufacturing in Australia. Lunch: 12.00pm – 12.45pm (hosted by RMIT) RMIT Micro Nano Research Facility Address: Bowen Street, Melbourne, VIC 3000 Location: Melbourne City campus , Building 7 , Level 4 Website: www.rmit.edu.au/.../micronano-research-facility Time: 1.00pm – 1.45pm The Micro Nano Research Facility (MNRF) at RMIT University enables the transformation of discoveries into technology. With capabilities in manipulating light, electronics, and fluids at scales from a single atom in size to the width of a human hear, we undertake full prototype lifecycle development from design, fabrication, characterisation and packaging. Visit us to experience medical technologies at various stages of the commercialisation path from using light to measure molecules, electronic skin that measures things within and around you, droplets that target lung cancer cells, to capsules you swallow to under the gut microbiome.

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Pre-conference: Monday 13 May 2019 (continued)

Pre-conference tour and site visit

Option 2 BioFab3D Address: 1st Floor, Clinical Sciences Building, 29 Regent St, Fitzroy, VIC 3065, Website: www.biofab3d.org Time: 10.00am – 11.00am

Visit BioFab3D@ACMD, Australia's first robotics and biomedical engineering centre, embedded within a hospital. Here, researchers, clinicians, engineers and industry partners work to build biological structures such as cartilage, muscle, bone, nerves and organs: almost anything that requires repair through disease and physical trauma.

CAREN - Computer Assisted Rehabilitation Environment System Address: Corner of Grattan and Bouverie Streets, Carlton VIC 3053|G01 Engineering Workshops Building (169) Website: https://ourcampus.unimelb.edu.au/engineering-precinct-refurbishment/caren-opening Time: 11.30am – 12.30pm The Computer Assisted Rehabilitation Environment System (CAREN) is a fully-integrated motion platform and treadmill, surrounded by an immersive virtual reality with high-speed motion capture cameras. A truly ‘field-in-a-lab’ system with real-time feedback, it evaluates human cognitive and physical responses and provides quantitative neuromusculoskeletal information. It enables researchers to measure human motor learning and decision-making processes in a fully immersive virtual environment, opening up new capabilities in bringing field testing to the laboratory. High impact research disciplines that will benefit from the CAREN system are biomedical engineering, rehabilitation engineering, sports technology and defense.

Pre-conference event Partnerships for life-changing technologies When: Monday 13 May 2019, 2:00pm – 3:30pm Where: Goods Shed North, 710 Collins Street, Docklands VIC 3008 RSVP: Register here via an external site or contact [email protected]

Be one of the first to hear about new support for HealthTech startups in Victoria We’re excited to invite you to the announcement of the collaboration between Johnson & Johnson, the MedTech Actuator and the Victorian Government in the Victorian innovation ecosystem. Executive leaders in healthcare will be discussing partnership support, strategic collaborations and investment opportunities that Johnson & Johnson can offer Victorian HealthTech startups. Drinks and canapés are provided. Website https://www.eventbrite.com.au/e/partnerships-for-life-changing-technologies-tickets-59682074692

Post-conference: Thursday 16 May 2019

Post-conference workshop

ANDHealth Winter Digital Health Summit When: Thursday 16 May, Summit from 8:00am-5:30pm followed by Networking Drinks Where: Melbourne CBD Cost: Summit Ticket: $495 | ANDHealth Ecosystem Partners: $395 (Including BioMelbourne Network, MTAA, MSIA and AusBiotech Members) RSVP: Register here via an external site

Post-conference workshop

SME Assist TGA workshop - Meeting Your Obligations Workshop When: Thursday 16 May 2019, 9:00am – 2:30pm Where: MCEC 1 Convention Centre Pl, South Warf, VIC RSVP: By Friday 26 April 2019 – Register here via an external site Navigating the regulatory maze can be a challenge, especially if you're new to regulation. The Therapeutic Goods Administration’s SME Assist service, together with AusBiotech, presents 'Meeting Your Obligations': a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation. If you are making therapeutic claims about a product or have a product that is likely to be considered a therapeutic good, this workshop will help you understand your responsibilities at different stages of the regulation process.

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Pre-conference Welcome Reception: Monday 13 May 2019

18.00 – 19.30 Pre-Conference welcome reception Melbourne Room 2 Welcome reception MCEC Brett Lunn Melbourne 2 room Managing Partner, FB RICE

Graciously supported by FB RICE and the Victorian Government

Tuesday 14 May 2019

08.00 – 09.00 Delegate registration Melbourne Room 2 Foyer

09.00 – 9.30 Opening Session Room 203/204 Conference welcome address Lorraine Chiroiu CEO – AusBiotech Victorian Government address The Hon. Martin Pakula Minister for Jobs, Innovation and Trade - Government of Victoria

09.30 – 10.00 Plenary Session Room 203/204 Minimally invasive surgery, robotics and digitally enabled medical devices With nearly two decades of experience in healthcare, Dr. Dutta is a pioneer in minimally invasive and robotic surgery, Dr. Dutta offers insights on the development of and investment in disruptive medical technologies , including robotics, artificial intelligence, and advanced imaging. Dr Sanjeev Dutta VP External Innovation & Digital Surgery, Medical Devices - Johnson & Johnson

Chair: Kathy Connell, Senior Director, New Ventures ANZ – Johnson & Johnson Innovation 10.00 – 10.30 Plenary Session Room 203/204 Medical device regulation: the revolution continues Adjunct Professor John Skerritt Deputy Secretary, Health Products Regulation Group – Therapeutic Goods Administration

Chair: Lusia Guthrie, Chair, BioMelbourne Network 10.30 – 11.00 Morning Tea break Melbourne Room 2

11.00 – 12.00 Plenary Session Room 203/204 Harnessing the pipeline: Key opportunities for big medtech Across the ecosystem for medtech companies commercialising biomedical research, there is an interdependent relationship between small and large companies. Multinational companies are a critical part of the Australian landscape and facilitate access to devices and diagnostics in development. This panel seeks an update from big medtechs about their partnering, prospecting and support work in the Australian environment. Renee Compton Ryan Vice President Venture Investments – Johnson & Johnson Development Corporation Dr Tim O’Meara Regional Research Leader – GE Healthcare Prajni Sadananda Business Development and Strategy Manager – Medtronic Stuart Elliott Co-CEO and Co-founder – Planet Innovation Barry Thomas Director Asia Pacific, Vice President – Cook Medical Chair: Lorraine Chiroiu, CEO - AusBiotech

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Tuesday 14 May 2019 (continued)

12.00 – 13.00 Lunch Melbourne Room 2 12.00 – 13.00 AusMedtech committees meeting (closed meeting) Room 205

13.00 – 14.00 Session A Room 207 Session B Room 208 Regulation: Adapting to current and Getting paid: Ensuring reimbursement future needs Greg Roger Danielle Humphrey Advisory Member –Prostheses List Advisory Committee Counsel– Hogan Lovells US LLP Beth Roberts Dr Frederic Bustos Partner – Hogan Lovells US LLP Vice President of Regulatory Affairs – Nanosoncis Andrew Maxwell Tracey Duffy Managing Director – Chatsworth Associates First Assistant Secretary, Medical Devices and Product Andrew Carter Quality Division – Therapeutic Goods Administration CEO - Commercial Eyes Damian Hine A/Prof Strategy, Director, Asia Pacific Enterprise Initiative – UQ Business School Chair: Peter Bradley, VP Global Business Development – Chair: Mandi Jacobson, Partner – Dentons Australia LBT Innovations

14.00 – 15.00 Session C Room 207 Session D Room 208 Market access & distribution: Accessing international The product development of

markets personalised medical devices Dr Anabela Correia Paul Skevington CEO – LiVac Vice President R&D and Elisabethann Wright manufacturing – Rex Bionics Partner – Hogan Lovells US LLP Dr Rachel De Las Heras Sacha Dopheide Ultrasound Product Development Manager – Queensland Brain CEO – Lumos Diagnostics Institute Colin Denver Dr Ben Kloeck CEO – SpeeDx Technology Director – Flanders Investment & Trade Chris Jeffery CEO – Field Orthopaedics Chair: Michael Heyl, Partner – Hogan Lovells US LLP Chair: Paul Carboon, CEO – Solentropy

15.00 – 15.30 Afternoon Tea break Melbourne Room 2

15.30 – 16.15 Plenary Session Room 203/204 The brain-machine interface in the treatment of Parkinson’s and epilepsy Prof Mark Cook Director – Graeme Clark Institute for Biomedical Engineering, University of Melbourne Dr Wesley Thevathasan Neurologist – Melbourne Deep Brain Stimulation

Chair: Eddie Walker, Partner – FB Rice

16:15 – 16:45 Plenary Session Room 203/204 The Australian bionic eye – Improving independence for the blind Brian Gordon Chief Scientist Officer – Bionic Vision Technologies

Chair: Dr Dimity Dornan, Chair and Founder – Bionics Queensland

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19.00 – 19.30 Pre-dinner Drinks Room 109/110 19.30 – 22.00 AusMedtech Conference Dinner Barry Thomas Director Asia Pacific, Vice President – Cook Medical Mr Frank McGuire, Parliamentary Secretary for Medical Research, MP for Broadmeadows, Victorian Government

Graciously supported by Cook Medical and the Victorian Government

Wednesday 15 May 2019

08.00 – 09.00 Delegate registration Melbourne Room 2 Foyer

09.00 – 09.20 Plenary Session Room 203/204 Healthcare 2025: The Future of Smart Healthcare Rising healthcare costs, aging populations, and the rise in chronic disease incidence, along with governments dedicating more funds to public health, will result in healthcare expenditure rising to $13.92 trillion by 2025. The healthcare industry has been a laggard in Big Data adoption as compared to other verticals. However, the intent to leverage the power of Big Data is evident across all industry stakeholders, including governments, payers, providers, suppliers and consumers. The goal is to make healthcare more predictive and prescriptive through meaningful information and insights. Solutions that apply cutting-edge digital technologies such as AI, Big Data and analytics, cloud, Blockchain, and Internet of Things (IoT) provide impetus for change while a variety of market and regulatory requirements will drive the adoption of medical technologies associated with digital health. Mark Dougan Consulting Director, Australia & New Zealand – Frost & Sullivan

Chair: Lis Boyce, Partner – Dentons 09.20 – 09.50 Plenary Session Room 203/204 Good science, industry leadership and a lifetime of commitment; Cochlear's history of innovation continues to lead life-changing solutions for the future Dig Howitt CEO – Cochlear

Chair: Dr Jia-Yee Lee, Director, Industry Engagement – Graeme Clark Institute for Biomedical Engineering, University of Melbourne 09.50 – 10.20 Plenary Session Room 203/204 Digital health future is a reality in the start-up nation! Dr Yossi Bahagon Clinician and Entrepreneur – Qure Ventures Dr Yossi Bahagon is a world leader in digital healthcare and has led the digitisation vision of the Israeli healthcare system. He will cover ethics, lessons learned, data sensitivity and security in the set-up of a huge healthcare database to create an innovative ecosystem, bridging the start-up spirit with healthcare traditionalism. Dr Bahagon will address a patient’s partnership role in the future of their personalised medicine and the relevance of the Israeli digital health revolution to the Australian healthcare system. Chair: Bronwyn Le Grice, CEO & Founder – ANDHealth

10.20 – 11.00 Morning Tea break Melbourne Room 2

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Wednesday 15 May 2019 (continued)

11.00 – 12.00 Session G Room 207 Session H Room 208 De-risking medical Investors: Through the looking-glass device clinical Join us as we ask leading investors to give their 6 minute pitch on why development: The companies should choose them over their colleagues as the source of their case for highly integrated commercial and clinical next funding. The reverse-pitches will be followed by free-flowing Q&A. development strategy planning Amanda Gillon Hear from a diverse skillset discuss how commercial, clinical and COO Investments – BioScience Managers scientific teams supporting the development of a product need to Natasha Rawlings interact closely to ensure excellence in clinical development Investment Manager – Uniseed execution, and how robust clinical development plans have spin-off Jarred Shein benefits during capital raising efforts. Investment Manager – Qure Ventures Anita Van Der Meer Ingmar Wahlqvist Manager, Clinical Trials Support Unit – NSW Office of Investment Manager – Brandon Capital Partners Health and Medical Research, Ministry of Health Renee Compton Ryan Matt McNamara Vice President Venture Investments – Johnson & Johnson Chief Investment Officer – BioScience Managers Development Corporation Alastair Hodges Former Chief Scientific Officer – Universal Biosensors Berneen Gardiner Director of clinical affairs, APAC – Cook Medical

Chair: Dr Andre Tan, Business Development Manager, Chair: Bronwyn Le Grice, CEO & Founder – ANDHealth Medical Devices & Diagnostics (ANZ) – IQVIA 12.00 – 13.00 Session I Room 207 Session J Room 208 Demystifying AI The Australian eco-system – Incubators and accelerators Brent Barnes Warren Bingham CEO & Managing Director – LBT Innovations General Manager, Medlab – Cicada Katherine Bailey Peta Ellis Senior Principal, Artificial Intelligence – Accenture CEO – River City Labs Sammi Bhatia Sabeen Shaikh CEO – Medius Health AI COO – The Actuator, Australia’s National MedTech Catalyst Bronwyn Le Grice CEO & Founder – ANDHealth Prof Karen Reynolds Director – Medical Device Partnering Program

Chair: Chris Nave, Managing Director, Brandon Capital Chair: Andrea Ruhrmann, Senior Counsel - FB Rice Partners 13.00 – 13.50 Lunch Melbourne Room 2

13.50 – 14.20 Plenary Session Room 203/204 Space MedTech: A timely Australian opportunity Biomedical technologies are a crucial element of the Australian Space Industry. They not only enable human space flight for all future (wo)manned missions, but the scientific spin-off benefits will provide terrific economic and public health benefits to Australia through improved health care and novel development of devices and diagnostics. Areas with short term Earth-based opportunities include miniaturization of devices, telehealth and remote medical technologies and 3D printing of novel materials. Hear from two experts on: Building a Space MedTech Industry in Australia, and Commercialisation of Frontier MedTech. Dr James Waldie Human Aerospace Ben Wright Program Director MDCTP, Chief Innovation Officer – Cicada

Chair: Dr Ilana Feain, Space BioMed Lead and Commercialisation Specialist CSIRO Astronomy and Space Science

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Wednesday 15 May 2019 (continued)

14:20 – 15:30 Future Forum Room 203/204 Future Forum This 70-minute session will focus on the future of Medtech. Panellists will talk about the future of various areas, followed by an interactive discussion with the audience, looking at what is on the horizon in terms of technologies, trends and the issues they create. Kathy Connell Senior Director, New Ventures ANZ – Johnson & Johnson Innovation Alison Coutts Executive Chairman – Memphasys Tracey Duffy First Assistant Secretary, Medical Devices & Product Quality Division – Therapeutic Goods Administration Brent Barnes CEO and Managing Director – LBT Innovations Bronwyn Le Grice CEO & Founder – ANDHealth Robert Klupacs CEO – Bionics Institute Dr John Heasman Program Manager: Epi-Minder – Cochlear

Chair: Professor Jan Tennent, CEO – Biomedical Research Victoria Audience facilitator: Peter Bradley, VP Global Business Development – LBT Innovations 15.30 – 16.30 Closing reception Melbourne Room 2

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