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Bio Connections Australia

Optimising Clinical Trials | Commercialising Great Science | Partnering for Growth

13-14 November 2018 | Pullman Melbourne on the Park

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overview

Australia is well positioned to be a leading destination for early phase clinical trials, commencing over 1000 new trials each year. But how can we, and the rest of the world, further capitalise on this opportunity?

Bio Connections Australia is a brand new event designed to foster the growth of early phase clinical research in Australia. As a unique platform for networking and discussion, the conference will explore drug development, early phase clinical trials, translational research and expediting Australia’s great science into commercialisation.

Bringing together a mix of the nation’s industry executives, researchers, and academics, the two-day event will also be attended by international pharmaceutical and biotechnology companies looking to conduct clinical trial activity in Australia.

Conference agenda topics & features:

  • The opportunities and obstacles to early phase clinical trials in Australia vs International
  • Aussie biotech success stories & the path to commercial success
  • Optimising drug development in Australia
  • Global best practice tools & techniques for designing a clinical development programme
  • Leveraging Emerging Technologies Including Machine Learning & Deep Sequencing for Clinical Development
  • Medical device trials in Australia
  • Assessing partnerships in clinical trials
  • Translational research and expediting research into commercialization
  • Models for turning discovery into drugs
  • Finding the funding – navigating challenges and getting ahead of the pack
  • Government incentives for biotech, pharma and medtech companies in Australia
  • Recruitment and engagement in clinical trials across Australia
  • Mitigating risk and ensuring patient safety
  • Australia as a springboard into Asia – regional partnership opportunities
  • The regulatory environment in Australia & comparing international regulatory pathways
  • Governance, bureaucracy, ethics: How we cultivate innovation rather than stifling it
  • Driving greater collaboration across academia and industry

sponsors

exhibitors

Partners

agenda

8:30 am

Morning Coffee on Arrival

8:50 am

OPENING | Opening remarks from the Chair

Kevin Wightman, ARCS Board Director, Senior Industry Executive & Clinical Development Solutions Consultant

9:00 am

  • A US company’s experience working with Australian Investigators and Australian CROs
  • How this US company set up an Australian Fully Owned Entity
  • Planning for future Australian studies and work
  • US company with Australian data getting funding from United States Investors

9:25 am

INTERNATIONAL KEYNOTE | Early Phase Studies in Australia

Xiaowei Shi, Executive Director, Clinical Operations, Asia-Pacific, BeiGene

9:45 am

  • CSL competes alongside the world best businesses to develop and deliver lifesaving drugs
  • Conducting early phase studies in Australia enables CSL to leverage relationships with local collaborators
  • Minimising “white space”, maximizing opportunities, overcoming obstacles

10:45 am

Networking Break

11:15 am

  • Afamelanotide: a first-in-class melanocortin-1 receptor agonist
  • Novel clinical use in photoprotection and repigmentation
  • Clinical development, regulatory pathways and post-authorisation management in EPP, a neglected orphan disease

(EU marketing authorisation in 2014, US NDA filed in 2018)

12:15 pm

  • How is the landscape for phase 1 studies in both Australia and abroad changing and shifting?
  • What are the challenges you see in implementing phase 1 studies in modern day?
  • How are phase 1 units adapting and addressing these issues?
  • What are Australia’s strengths and why is collaboration important?
  • What can be done to attract more early phase trials to Australia?

1:00 pm

Networking Lunch

Chair: Michelle Gallaher, Managing Director, The Social Science

2:00 pm

  • How is Australia raising awareness of clinical trials in Australia?
  • What are the new approaches to recruitment internationally and what works here in Australia?
  • How can we improve expertise in trial methodology to meet the latest recruitment challenges?
  • How can we more effectively using existing data sets?
  • What role can emerging technologies play in patient recruitment?
  • Ensuring effective patient engagement in clinical trials

2:45 pm

A Chinese Biotech’s Experiences & Future Plans for Early Phase Studies in Australia

Chris Huang MD, CMO, Phagelux Inc & Phagelux Australia Pty Ltd

3:05 pm

Networking & Refreshment Break

Chair Mary Nteris, PhD, GAICD, Director and Consultant, Regulatory and Related Services

3:35 pm

In response to a rapidly evolving scientific landscape and increased stakeholders expectations regulatory authorities worldwide are developing new pathways to facilitate patients’ access to novel therapies.

This panel discussion will use some case studies to illustrate the challenges and opportunities facing industry and regulators in diverse therapeutic areas and across several jurisdictions.

4:15 pm

  • Cancer Genomics offers exciting opportunities for cancer detection and surveillance, monitoring drug response and studying evolution of chemo-resistance, using liquid biopsies.
  • International programs of genome mapping through the International Cancer Genome Consortium (ICGC) aims to unravel the genomic changes present in many forms of cancer that contribute to the burden of disease in people throughout the world.
  • Whole genome sequencing costs continue to drop dramatically. Professor Grimmond’s lab is working on how to crystallise clinically relevant information from cancer genomes and transcriptomes (messenger RNA) and to prove their value in a clinical setting.

4:40 pm

Closing remarks from Chair

4:50 pm

Networking Reception

7:30 pm

BioPalooza Dinner - Hosted By CharterNet

8:00 am

Morning Coffee

8:50 am

OPENING | Opening Remarks from Chair

Tam Nguyen, Executive Officer Research, St Vincent's Hospital Melbourne

9:00 am

KEYNOTE | From Discovery to Commercialisation

Dr Dan Grant, CEO, MTP Connect

9:25 am

The challenges in taking academic discoveries and turning them into drugs – what is typically required by industry but is seldom part of any academic research program.

9:50 am

  • How do we partner effectively?
  • How do we support the translational pathway?
  • What does collaboration across disciplines really mean?
  • How do we nurture our ability for creative discovery without sacrificing economic benefit?
  • How do we stand out in a global environment?
  • How do we leverage Australian capabilities and translate into successful projects?
  • How do we collaborate with existing capabilities such that all stakeholders have a voice?
  • How do you translate one project into many collaborations?

10:35 am

Networking Break

11:15 am

Finding the Funding - Navigating the Commercial Challenges & Getting Ahead of the Pack

Dr Chris Nave, Managing Director, Brandon Capital Partners & CEO, Medical Research Commercialisation Fund

11:40 am

  • Navigating regulatory pathways for fast and efficient options to market
  • Creative use of intellectual property
  • Appointing a CRO and other service providers
  • Messaging your story to investors
  • Designing a commercially attractive development program

12:05 pm

  • Medical device research is the fast growing sector of the industry in Australia
  • How is medical device research different – what are the challenges and considerations in undertaking a successful device clinical development program?
  • Utilising Australia’s capabilities in early phase research for medical device development – from pre-clinical research to first-in-human implants and beyond
  • What are the current and future opportunities for device research in Australia’s innovation ecosystem?

12:30 pm

  • Where are the key funding gaps in Australia?
  • What can be done to address the Valley of Death and help innovative companies grow?
  • What are the stumbling blocks?
  • How do you prepare for and navigate them?
  • Industry/academia funding and collaboration

How do we build connectivity in the system to facilitate trust and allow the support for new ideas which are industry ready?

1:15 pm

Networking Lunch

2:30 pm

  • Basics of machine learning and its use in drug design
  • Utilising clinical deep sequencing without getting lost in the data
  • What’s all the excitement in immuno-oncology and how can Australia capitalise on this
  • Growth opportunities in attraction of vaccine early phase trials to Australia
  • Vaccine-Exchange – an MTPConnect initiative to advance Australian vaccine development

2:55 pm

  • Understanding the value of industry trials for all stakeholders
  • Putting trials on the agenda for a clinical service driven environment
  • Barriers to running trials efficiently and effectively
  • Ways we have sought to overcome those barriers

4:00 pm

Closing Remarks from Chair

4:05 pm

Networking Afternoon Tea

pricing

Packages Price
Two Day Conference$2795+GSTEarly Bird
Two Day Conference + Site Tour$3095+GSTEarly Bird
Extras Price
Dinner (13 Nov 2018) $150+GST
Packages Price
Two Day Conference$1795+GSTEarly Bird
Two Day Conference + Site Tour$2095+GSTEarly Bird
Extras Price
Dinner (13 Nov 2018) $150+GST

All prices are in AU$

Site Visits

MORNING SITE VISIT

Site Visit to BioFab3D@ACMD (biofab3d.org), St Vincent’s Hospital, Melbourne
Thursday 15th November, 2018 | 10:30am – 12:00pm

Located at St Vincent’s Hospital, Melbourne, BioFab3D@ACMD is Australia’s first hospital-based biofabrication, robotics and biomedical engineering research centre. Here, researchers, clinicians, engineers and industry partners are working to build biological structures such as cartilage, muscle, bone, nerves and organs: almost anything that requires repair through disease and physical trauma. Work is highly geared towards clinical translation and commercialisation.

On this tour, you will get a behind the scenes look at some of the most exciting biomedical research programs in Australia, including the development of a Biopen device for handheld surgical bioprinting (twice listed on the Timeline of Key Australian Medical Technologies), and the development of a robotic hand controlled by the patient’s thoughts.

More information can be found here: www.biofab3d.org & www.svhm.org.au/research

Provisional program for the visit:

– 10.00am Bus leaves the hotel
– 10:15am Arrival at the site
– 10:30am Presentation
– 10:50am Visit
– 11:40am Q&A
– 12:00pm Departure from site

 

AFTERNOON SITE VISIT

Site Visit to Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre building in Parkville, Melbourne.
Thursday 15th November, 2018 | 2:30pm – 4:00pm

Networking Highlights

  • BioPalooza Dinner – A relaxed evening offering the opportunity to meet your partners and peers in one of Melbourne’s well loved venues
  • Networking Drinks Reception – A not to be missed opportunity to mix and mingle over a beer or glass of bubbles
  • See the Sites! Check out clinical trial sites with our organised visits to Australia’s leading clinical trial sites
  • Networking Breakfast – Debrief on the previous day’s activities and make new connections over a coffee and your pastry of choice
  • Expert Clinics – A great opportunity for delegates to get 5 minutes of one on one airtime with a market or industry expert on clinical trials in Australia. It enables delegates to establish connections for future planning & gain new insights in a fast and efficient way.
  • Night at the Crown – Join us for a night of entertainment at the largest casino in the Southern Hemisphere

speakers

Kevin Wightman

ARCS Board Director, Senior Industry Executive & Clinical Development Solutions Consultant

Dr Dan Abrams

CEO, Cerebral Therapeutics, USA

Xiaowei Shi

Executive Director, Clinical Operations, Asia-Pacific, BeiGene

Jolanta Airey

Early Clinical Development Physician, Clinical Pharmacology Translational Development, CSL Limited

Sharon Charles

Director of Medical Affairs, Mesoblast

Brad Joblin

Chief Scientific Officer, Q-Pharm Pty Limited

Phil Kearney

Director External Licensing, MSD

Megan Ford

Senior Director Research & Development, IQVIA

Nicoletta Muner

Director, Global Regulatory Affairs, Clinuvel Pharmaceuticals Ltd

Dr Kilian Kelly

VP Product Development, Cynata Theraputics Ltd

Sameer Kassam

Partner, CharterNet

Michelle Gallaher

Managing Director, The Social Science

Roslyn Ristuccia

Co-Founder & CEO, ClinTrial Refer

Professor Lisa Askie

Director, Systematic Reviews & Health Technology Assessment, Manager, Australian New Zealand Clinical Trials Registry, NHMRC Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney

Tam Nguyen

Executive Officer Research, St Vincent's Hospital Melbourne

Pip Palmer

Therapeutic Area Head, MSD Australia and New Zealand

Chris Huang MD

CMO, Phagelux Inc & Phagelux Australia Pty Ltd

Mary Nteris

PhD, GAICD, Director and Consultant, Regulatory and Related Services

Professor Sean Grimmond

Director of Cancer Research & Bertalli Chair of Cancer Medicine, University of Melbourne Centre for Cancer Research

Dr Dan Grant

CEO, MTP Connect

Glenn Begley

Chief Executive Officer, BioCurate Pty Ltd

Karyn Joyner

Chief Operating Officer "Maridulu Budyari Gumal", Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)

Brett Roberts

Head of Strategic Partnerships, Novartis Pharmaceuticals Australia Pty Ltd

Dr Tina Soulis

Chief Executive Officer, Neuroscience Trials Australia

Dr Chris Nave

Managing Director, Brandon Capital Partners & CEO, Medical Research Commercialisation Fund

Anita Van Der Meer

Clinical Research Manager, Medtronic

Ben Wright

Chief Innovation Officer & Head of Investment Strategy, Cicada Innovations

Dr Paul Kelly

Partner, OneVentures

Dr Campbell Spence

R&D Tax Incentive Consultant

Anne O’Neill

Director, Office for Health and Medical Research, NSW Ministry of Health

Professor Nikolai Petrovsky

Founder & Research Director, Vaxine and Professor, Flinders University

Professor Andrew Davidson

Medical Director, Melbourne Children's Trials Centre (MCTC) Murdoch Childrens Research Institute, Senior Staff Anaesthetist and Director of Clinical Research for the Royal Children's Hospital

Dimitar Sajkov

Associate Professor, Flinders University of South Australia, Senior Staff Specialist, Southern Adelaide Local Health Network, Research Director, Australian Respiratory and Sleep Medicine Institute

Gordon McGurk Ph.D.

GAICD, Chair, Royal Brisbane and Women's Hospital HREC

Dr Megan Robertson

Director of Research - Research Directorate, St Vincent's Hospital Melbourne & Chair of the Clinical Trials Ready Development Committee

David Fuller

SVP Clinical Development Oncology, Syneos Health

Karen West

Executive Director Clinical Development Early Phase, Syneos Health

Sara Prickett

Chief Scientific Officer, Aravax

when & where

13 - 14 Nov 2018

Pullman Melbourne on the Park
192 Wellington Parade
Melbourne, VIC 3002

Book Accommodation with Lido Group
For your convenience Lido Group will manage your accommodation needs. Click here or call on 02 8585 0808.

contact

Still have a question?

Frankie Brewer
Conference Manager
+61 2 9080 4015
Francesca.Brewer@informa.com

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