SeerPharma is excited to be sponsoring BioMelbourne Network’s BioSymposium focusing on Devices + Diagnostics – Navigating our New World. The event to be held Thursday the 29th of April.
For over 30 years, SeerPharma has assisted a number of medical device and diagnostic companies in the Asia-Pacific region on matters of Quality Assurance and compliance. Assisting such firms with achieving, maintaining and automating ISO 13485 compliant Quality Management Systems. Medical Device companies approach SeerPharma routinely to help navigate the regulatory challenges placed on operations/manufacturing, one of the many challenges that firms face to bring and keep product in market.
After a tumultuous year of change, how has the COVID-19 pandemic impacted the global medical technology landscape?
Device and diagnostic development pathways have had to shift to adapt to our new world. Although international travel bans continue to challenge the way we do business, we’re embracing new methods of working effectively with business partners, regulators and investors world-wide.
The shift to virtual meetings has meant deals that once took months to land can be closed in weeks. Regulatory bodies have altered their approach to collaboration and product approval in response to pandemic demands. And leading accelerators around the world have pivoted to increase accessibility and optimise cohort exposure.
But some uncertainty and questions remain. What fundamental processes have changed when developing your business strategy, courting investors, or navigating regulatory pathways? Which processes haven’t? And what will be the new normal of ‘best practice’ once the world stabilises?
BioMelbourne Network’s BioSymposium Devices + Diagnostics: Navigating our New World, will address these questions and more.
To achieve a truly global perspective, this event will be delivered virtually with speakers presenting around the world.
PROGRAM OUTLINE
Session 1: PIVOTING FOR SUCCESS
What impact has the pandemic had on the global medical technology landscape and how have businesses pivoted to adapt?
In this session attendees will gain insights into the UK and US markets, while exploring emerging business opportunities, strategic challenges, and inherent market shifts for these leading medtech hubs. Learn top tips for success from the world’s largest life science accelerator and hear first-hand from a local startup on how they adapted their US market entry strategy in response to the pandemic.
Speakers:
Session chaired by Michelle Peake, Senior Consultant, SeerPharma Pty Ltd (Australia)- Christine Winoto, Deputy Director, QB3. Director, UCSF Rosenman Institute. Founding Partner, MedTech Venture Partners (USA)
- Dr Anabela Correia, Chief Executive Officer, Livac Pty Ltd (Australia)
- Paul Grand, Chief Executive Officer, MedTech Innovator (USA)
- Michael Branagan-Harris, Chief Executive Officer, Device Access (UK)
Session 2: NAVIGATING THE REGULATORY ROADMAP
Navigating the regulatory roadmap is complicated, even more so during a pandemic. What fundamental processes have been impacted as a result, and which haven’t?
In this session, leading experts will provide global regulatory insights and forecasts for 2021, 2022 and beyond. We’ll examine the FDA landscape and discuss US market access for medical devices, real world evidence and primary market research. TGA experts will also explore trends and interactions between global bodies, medical device assessment and approval for supply in Australia, and regulatory support for SMEs and researchers.
Speakers:
Session chaired by Dr Jill Freyne, Deputy Research Director AEHRC, CSIRO (Australia)- Alexander de Leeuw, Director, MedTech Strategy, Global Strategy Head, IQVIA (Belgium)
- Avi Rebera, Assistant Secretary, Regulatory Engagement, Education and Planning Branch, TGA (Australia)
- Meryl Clarke, Assistant Secretary, Medical Devices Authorisation Branch, TGA (Australia)
- Sarah Haverin, Vice President, Business Development, Oriel STAT A MATRIX (USA)
Session 3: CLOSING THE DEAL ON INVESTMENT
Working virtually has changed the way we do business. What shifts in investment have emerged as a result of the pandemic and how can we harness our new reality to succeed in closing the deal?
In this session, attendees will gain valuable insights into emerging trends in the global investment landscape and how best to engage with investors in our new world. We’ll also examine gaps in healthtech investment, emerging investment pathways and opportunities to bolster access to early-stage capital for Victorian startups.
Speakers:
Session chaired by Matt Murphy, Managing Director, Prime Accounting & Business Advisory. Executive Director, Prime Financial Group (Australia)- Andrew Maxwell, Founder, Chatsworth Associates (Australia)
- Dr Amol Jadhav, Global Life Sciences Practice Industry Analyst, Frost & Sullivan (India)
- Dr Kate Cornick, Chief Executive Officer, LaunchVic (Australia)
- Rainer Grote, Co-Founder and Director, Global Innovation Consulting (Australia)
Session 4: NETWORKING
Details and tickets for the post-event networking function will be released soon
For more details and to join us at this special event , visit: https://biomelbourne.org/event/biosymposium-devices-diagnostics-navigating-our-new-world/
