On Tuesday 21 October there are two workshops taking place that will provide the perfect way to start your week at AusBiotech International 2025. Please review both of them below and note that spaces are limited – if you wish to attend it is advised to register as soon as possible.
Navigating global pre-IND meeting and scientific advice meeting: Best practices and strategic insights.
- Date: Tuesday 21 October
- Time: 09.00am – 1.00pm
- Venue: Melbourne Convention & Exhibition Centre
- Pricing: Member $315 | Non member $365
The workshop aims to provide pharmaceutical professionals with an in-depth understanding of pre-investigational new drug (pre-IND) meetings for the FDA and Scientific Advice Meetings in the EU, focusing on regulatory frameworks and strategic approaches the respective regions. As the pharmaceutical landscape becomes increasingly globalised, the need for effective communication and collaboration with regulatory authorities is paramount.
Format:
The workshop will include presentations from industry experts, case studies, interactive discussions, and breakout sessions. Participants will have the opportunity to engage in practical exercises to hone their skills in preparing for and managing pre-IND meetings.
Outcomes:
Participants will leave the workshop with enhanced knowledge of the pre-IND meeting process, a toolkit of best practices, and a network of peers and experts to support their ongoing regulatory efforts.
Objectives:
- To explore the purpose and significance of pre-IND meetings in the drug development process.
- To compare the regulatory requirements and expectations for pre-IND meetings in the US and Europe.
- To discuss best practices for preparing for and conducting successful pre-IND meetings.
- To identify common challenges and strategies to overcome them in both regions.
- To facilitate networking and knowledge sharing among participants.
Target Audience:
This workshop is designed for regulatory affairs professionals, clinical development teams, heads of R&D.
Workshop Facilitator:
Dr. Ilona Baraniak-Lang, Associate Principal Consultant, PharmaLex
Ilona is a vaccinologist and virologist and specialises in global regulatory affairs strategies. Based in Germany, she serves as Deep Subject Matter Expert and International Service lead for vaccines and leads clinical development consulting group at PharmaLex, a part of Cencora.
She has successfully supported 200+ vaccine, ATMP and other biopharmaceutical development projects, with clients including big pharma, SMEs, start-ups, governmental institutions, non-profit organizations as well as academia. Based on expertise, she developed a precise vision on how the CMC, non-clinical and clinical development of the novel pharmaceutical technologies could be merged with smart regulatory solutions, world-wide.
Presented by:
Australia’s bioprecincts unlocked
- Date: Tuesday 21 October
- Time: 2.00pm – 5.00pm
- Venue: Melbourne Convention & Exhibition Centre
- Pricing: Member $165 | Non member $215
Step inside Australia’s most exciting biotech and life sciences precincts in this exclusive showcase celebrating innovation, collaboration, and the power of place. Bringing together leaders from across the ecosystem, this event will shine a light on the precincts driving Australia’s health and biotech future.
Whether you’re looking to collaborate, invest, or simply stay ahead of the curve, this is your gateway to the people and precincts powering biotech innovation across the country.
Agenda:
2.00pm – Welcome & Introduction
- Dr. Dean Moss, CEO, UniQuest and Board Member, AusBiotech
2.10pm – Keynote: Turning Science into Prosperity: Australia’s Bioprecinct Opportunity
- Neil Deacon, Founder, Health Advance Connect
2.30pm – Panel: Emerging Innovation Precincts in Australia: Defining Success and Seizing Opportunities
- Chair: Trent Munro, General Manager, Boggo Road Innovation Precinct
Panellists:
- John Ratcliffe, Chief Investment Officer, Altea Investments
- Chris Molloy, Chief Executive Officer, Catapult UK
- Nick Smith, Chief Executive Officer, Kurraba Group
- Dave Whelan, Chief Business Officer, Big4Bio
3.15pm – Fireside chat: Innovation precincts through an industry lens
- Moderator: Dr. Robyn Lindner, Director of State and Committee Engagement, AusBiotech
- Dr. Brenton Hamdorf, Precincts Manager, Thermo Fisher
3.35pm – Rapid fire presentations from some of Australia’s innovation precincts
- The University of Western Australia and WA Life Sciences Innovation Hub – Kevin Pfledger, Director, Biomedical and Health Innovation,
- Herston Health Precinct – Dr. Pat Silvey, Precinct Director
- Gold Coast Health & Knowledge Precinct – Kathy Kruger, Senior Manager Strategic Projects and Engagement
- Boggo Road Innovation Precinct – Trent Munro, General Manager
- Sydney Biomedical Accelerator – Holly Pobjie, Program Manager and Dr Joy Francisco, Chief Commercial Officer, Sydney Local Health District
- Macquarie Park Innovation District (MIPD) – Mel Ryan, Director of Entrepreneurship and Innovation, Macquarie University
- Jumar Bioincubator – Camille Shanahan, General Manager
- Cicada Innovations – Lilly Bojarski, General Manager, HealthTech Hub
- Melbourne Biomedical Precinct and the University of Melbourne – Vanessa Campbell, Director of Innovation Precincts, University of Melbourne
- Research and Applied Innovation District (RAPID) – Gerard Blood, Executive Director, Head of University City, La Trobe University
4.45pm – Closing Remarks
5.00pm – Networking