Loading Events

« All Events

  • This event has passed.

Biopharma Masterclass – Unlocking Europe: Operational Priorities for EU Market Entry

November 15, 2023 @ 8:30 am - 5:00 pm AEDT


The BioForum – A Clinical Approach to Europe is a stand-alone event as well as Part A of the Masterclass Program. Masterclass participants are not required to register separately to attend.

A fit-for-purpose, scalable operational structure is the cornerstone of any biopharma company as it progresses from R&D to commercial enterprise.The European market is second only to the US in terms of providing access to patients and generating value for biopharma ventures. The ecosystem is complex, but with the right strategy and clear understanding of key operational considerations, an EU plan is achievable alone or in partnership with established companies.

About the Masterclass program

Are you:

  • An early stage biopharma company advancing products for global markets?
  • A late pre-clinical or clinical stage venture, or business who has launched into other markets?
  • A scientist or executive working in pharmaceuticals, biotechnology, regenerative medicine, biologics or cell and gene therapy?

Join our customised Biopharma Masterclass program which will give you the knowledge, skills and tools to enter EU markets effectively and efficiently for long-term success. Participants will learn how to: prioritise operations, plan and budget for expansion, optimise product supply strategy, negotiate with investors and potential partners, or go it alone. Don’t miss this opportunity to learn firsthand from leaders in the field who have successfully helped emerging biopharma companies launch in the EU.

Be informed about:

  • The EU – Where to set up? Intellectual property, legal and financial considerations, and entity structures
  • Best practice – EU compliance, licensing, qualified persons, responsible persons and quality management systems
  • Supply chains – Vendor networks, FMD compliance, sales and operations planning and inventory management
  • Financial – Structures, customs and VAT
  • Hot topics – Early Access Programs, supply chain integrity and launch pathway implications.

What to expect:

  • A deep-dive into EU market fundamentals
  • Structured guidance to inform market entry
  • Intensive sessions on operational strategy
  • Practical information and applied knowledge
  • Rich educational discussions
  • Networking opportunities with peers and experts.

Who should attend?

  • Early stage biopharma companies advancing products for global markets
  • Late pre-clinical and clinical stage venture, or businesses who have launched into other markets
  • Scientists and executives working in pharmaceuticals, biotechnology, regenerative medicine, biologics, cell and gene therapy
  • Professionals working in operations, commercialisation, business development and those seeking to improve knowledge and skills, and foster connections.

Places are strictly limited. Participation in the program is subject to written approval and confirmation by BioMelbourne Network.

Program details

This Masterclass program has three parts:

  • Part A | BioForum: Tuesday 14 November | 4:00pm – 6:30pm | Allens, 37/101 Collins St, Melbourne VIC 3000 (includes 1hr networking)
  • Part B | Masterclass Workshop: Wednesday 15 November | 8:30am – 5:00pm | Monash Conference Centre, Level 7, 30 Collins St, Melbourne VIC 3000
  • Part C | 30-minute Advisory Session: Thursday 16 and Friday 17 November (individual meeting times to be advised).

Registration for the program includes:

  • Two additional complimentary registrations for colleagues to attend the BioForum
  • Attendance at the full-day Masterclass workshop for one company representative
  • One 30-minute advisory session (two company representatives may attend).

International industry experts: Orphan Drug Consulting

Orphan Drug Consulting is a team of industry-leading subject matter experts and professionals who provide consulting services to innovative pharmaceutical and biotech companies, and launch products to global markets.Combining industry-proven expertise and a clear cross-functional approach, our team lead companies through product launch strategy development, implementation and maintenance post-launch across all global markets, driving excellence end-to-end.Orphan Drug Consulting also provides tailored services in these areas:

  • Finance and entity structuring – Determining appropriate business model and entity structuring for clinical and commercial distribution.
  • Supply chain – Designing and managing complex global supply chains.
  • Quality assurance – Driving excellence in quality assurance leadership and management.
  • Vendor management – Managing extensive vendor networks from identification through to day-to-day operations.
  • Product launch and Expanded Access Programs – Launch expertise across multiple pathways in over 100 countries.
  • Customs and VAT – Determining optimal and compliant product flow and distribution models.
  • Regulatory affairs and pharmacovigilance – Advising on regulatory requirements to support progression to market.
  • Human Resources and organisational design – Designing phase-appropriate organisational structures to match corporate requirements.

Registration (in-person only):

BioMelbourne Network Member: $800
BioMelbourne Network Non Member: $950
*Biopharma Entrepreneur: $685*Biopharma Entrepreneur applies to startup companies developing biopharma products in the pre-seed stage and seed stage, prior to Series A capital raising and strictly pre-revenue.Unsure if your organisation is a member? Check our member directory.

Cancellation policy:

  • A full refund can be issued up to 14 days prior to 14 November 2023
  • No refunds can be issued within 14 days of the program commencing.

This high-value, heavily subsidised program is made possible with support from the State Government of Victoria.


Jason Cameron, Chief Operating Officer, Orphan Drug Consulting

Jason Cameron is Chief Operating Officer for Orphan Drug Consulting with over 25 years’ experience in the pharmaceutical industry working across supply chain, distribution, manufacturing, and broader technical operations, with a particular focus on rare disease companies. Jason is leading operational areas for multiple commercial product launches and global market expansions.

A core member of the Orphan Drug Consulting management team, Jason drives cross-functional excellence to support clients in an increasingly complex industry. Jason has held various senior leadership positions in companies such as Genzyme, Synageva, and Amicus Therapeutics, where he most recently was Senior Vice President of Global Technical Operations with responsibility for overseeing product supply (CMC RA, Process Development, Manufacturing, Quality and Supply Chain functions) for Amicus’ first commercially launched product while also progressing process development and clinical product supply of the company’s clinical pipeline.

Jason gained his degree in Supply Chain via the Chartered Institute of Procurement & Supply.

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.


November 15, 2023
8:30 am - 5:00 pm
$685 - $950
Event Category:


BioMelbourne Network
+61 3 9667 8181


News & opinion

Member Directory