For a more in-depth look at this topic, take a deep-dive into our Biopharma Masterclass Program – Unlocking Europe: Operational Priorities for EU Market Entry. The program includes this BioForum along with a full-day workshop and one-on-one advisory session.
About the BioForum
Join local and international experts for an exploration of Europe’s clinical, regulatory and commercial ecosystem.Gain valuable insights as our speakers unravel complexities of the evolving clinical trials landscape, delve into recent changes in clinical trials legislation, and analyse the commercial, operational and compliance considerations stemming from these changes.Don’t miss this opportunity to finetune your knowledge and harness the value of the world’s second-largest biopharmaceutical market.
Be informed about:
- Biopharma opportunities in Europe and the positive impacts for emerging Australian companies
- The new Clinical Trials Regulation and changes to EU clinical trials application, approval and conduct
- Early stage regulatory milestones, orphan drug designations, scientific advice, and laying the foundation for an EU marketing authorisation
- Building a scalable expansion strategy clinical testing to commercial launch:
- Protecting your IP: tax, corporate structure and financial considerations
- Selecting a go-to-market business model and key considerations
- Commercial, operational and compliance considerations on your go-to-market business model
- Success factors and pitfalls to avoid.
What to expect:
- The latest updates from industry experts
- Engaging information for diverse audiences
- Dynamic panel Q&A sessions
- In-person networking opportunities with peers.
Who should attend?
- Biopharma companies advancing products for global markets
- Scientists and executives working in pharmaceuticals, biotechnology, regenerative medicine, biologics, cell and gene therapy
- Professionals working in operations, commercialisation, regulatory affairs, business development, consultancy, government, funding bodies and venture capital
- Biopharma professionals seeking to improve knowledge and foster connections.
Date: Tuesday 14 November 2023
3:45pm: Guest arrival and registration
5:00pm: Panel and Q&A
Venue: Allens, 37/101 Collins St, Melbourne VIC 3000
Sponsored by: State Government of Victoria
In collaboration with: Orphan Drug Consulting
The BioForum is a stand-alone event as well as Part A of the Masterclass Program. Masterclass participants are not required to register separately to attend.
Registration (BioForum only):In-person: Members $95; Non Members $195
Online: Members $25; Non Members $45Unsure if your organisation is a member? Check our member directory.Cancellation policy (BioForum only):In person registration
- Full refund given up to 7 days prior to the event
- No refunds within 7 days of the event
Kindly sponsored by the State Government of Victoria
In collaboration with Orphan Drug Consulting
Kindly hosted by Allens
Brian Gilmartin, Business Development & Consulting Lead (APAC), Orphan Drug Consulting
Brian Gilmartin has more than 20 years of international experience in the pharmaceutical industry, having worked across Europe, Asia Pacific, Japan and ANZ. He holds a Master of Science in Bioinformatics and a Bachelor of Science (Honours) in Biological Sciences with a Biotechnology speciality.
Earlier in his career, Brian began as a Bioinformatics computer associate working in drug discovery startups before joining a genome project at the University of Cambridge, Institute of Medical Research. Brian crossed over to the pharmaceutical industry in 2004, focusing on regulatory affairs and gaining substantial experience in new product development, manufacturing and clinical with leading commercialisation consulting companies.
During the past decade, Brian has channelled his broad exposure across the pharmaceutical industry into building out a pharmaceutical products and services company across the JAPAC region supporting clinical trial supply, early access programs, unlicensed supply and the commercialisation of lifesaving medicines to address the unmet medical needs of patients.
Brian joined Orphan Drug Consulting in April 2023 to support the development of a business case and service offering for the APAC region.
Evelyn Kelly, Founder and Chief Executive Officer, Orphan Drug Consulting
Evelyn has over 20 years’ experience in the pharmaceutical industry in both distribution and orphan drug companies, working across Supply Chain and Quality Assurance. Evelyn brings years of experience in manufacturing and distributing orphan and speciality drugs to over 50 countries globally.
Evelyn specializes in the management of supply via virtual, outsourced models and has been named as both a QP and RP on multiple licenses. She has also held various supply chain leadership positions in Shire, NPS Pharma and PTC Therapeutics.
Evelyn is experienced in facilitating cross functional strategic entity decisions, organizational redesign, selection of vendors and corporate activities. Evelyn founded Orphan Drug Consulting in 2017, with the vision of supporting companies across keys areas such as Supply Chain, Quality Assurance, Launch and Finance/Tax.
Evelyn holds a Master of Pharmacy from Robert Gordon University and a Master of Business from the Irish Management Institute, as well as being an Adjunct Professor for the Trinity College Dublin School of Pharmacy.
Nicoletta Muner, Managing Director, Canary Regulatory Affairs
Nicoletta is the Managing Director of Canary Regulatory Affairs which provides scientific and strategic advice to pharmaceutical and biotechnology companies.
Nicoletta brings broad international experience across product, pre-clinical and clinical development from a career with organisations including Kendle and Mayne Pharma. Having led market authorisations in the EU and US to bring a first-in-class drug to international markets for Clinuvel Pharmaceuticals, an ASX 200 company, Nicoletta is adept at negotiating outcomes with international health authorities and influencing policy changes.
Since funding Canary Nicoletta has assisted clients navigate regulatory pathways in international markets and with their development program across therapeutic areas ranging from analgesia and anaesthesiology to dermatology, neurology and oncology.
As a Non-Executive Director in the health sector, Nicoletta is committed to public health.
Nicoletta also supports innovation both as an investor and adviser to entrepreneurs in the life sciences through Springboard Enterprises.