Transitioning from the discovery phase to approved pharmaceutical product represents a pivotal and challenging journey for biotech and pharma companies. To support Australian companies in navigating this crucial transition with a focus on entering the European market, Serum Life Science Europe GmbH (SLS Europe) is offering a tailored Masterclass designed to address the unique challenges and opportunities that arise during this phase.

With a comprehensive understanding of the entire product development spectrum, SLS Europe serves a diverse range of organisations, from small start-ups to large enterprises, private funding bodies, and academic research groups. Leveraging its expertise as a German-based regulatory consultancy and robust global network, SLS Europe aims to provide participants with the knowledge and strategies necessary for successful clinical development and European regulatory approval.

About the Masterclass:


The Masterclass Program is specifically designed to assist companies at a critical phase in their development process. Moving beyond initial discovery, the focus is on the rigorous demands of clinical development, regulatory approvals and strategic market entry into Europe.

The Masterclass will build on foundational knowledge while introducing concepts and practical strategies tailored to the clinical stage.

Participants will receive a clear roadmap and actionable strategies to navigate the clinical journey towards successful European market integration.

Be informed about:


  • Regulatory guidance
  • Clinical development strategy 
  • Market entry planning. 

What to expect:


  • The latest updates from industry experts
  • Dynamic panel Q&A session
  • In-person networking opportunities with peers.

This BioForum is sponsored by the State Government of Victoria, delivered in collaboration with international industry experts Serum Life Science Europe GmbH and supported by Accelagen.

Program details:


This Masterclass program has three parts:

  • Part A | BioForum: Tuesday 18 June | 4:00 - 6:30 pm | ACMI, Swinburne Studio, Federation Square, Melbourne VIC 3000
  • Part B | Masterclass Workshop: Wednesday 19 June | 8:30 am - 5:00 pm | Stamford Plaza Melbourne, 111 Little Collins Street, Melbourne VIC 3000
  • Part C | 30-minute Advisory Session: Thursday 20 June – Friday 21 June 2024 (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).
AGENDA
Part A | BioForum: Tuesday 18 June
ACMI, Swinburne Studio, Federation Square, Melbourne  
3:45 pM
Guest arrival and registration
4:00 pM
BioForum: Journey to Global Pharmaceutical Markets - Leveraging European Engagement 
5:00 pM
Panel Discussion and Q&A
5:30 pM
Networking function
6:30 pM
Close
PART B | Masterclass Workshop: 
Wednesday 19 June 
Stamford Plaza Melbourne, 111 Little Collins Street, Melbourne
8:00 AM
Participant arrival, registration, tea and coffee, networking
8:30 AM
Welcome | Bridging discovery to clinical: A roadmap for European market success
9:00 AM
Session 1: Innovations for the pharmaceutical market - Making your product unique  
10:30 AM
Morning break
11:00 AM
Session 2: Navigating regulatory pathways in pharmaceutical development - Understanding the regulatory landscape
12:45 AM
Networking lunch
1:45 pM
Session 3: Navigating regulatory pathways in pharmaceutical development - Implementation and compliance
3:00 pM
Afternoon break
3:15 pM
Session 4: Market entry strategies
4:45 pM
Wrap-up and closing discussions 
5:00 pM
Close
PART C | 30-Minute Advisory Session Masterclass: 
Thursday 20 June - Friday 21 June 2024 (Individual meeting times to be advised)
9:00 AM
Company 1
9:40 AM
Company 2
10:20 AM
Company 3
10:50 am
Morning break
11:10 am
Company 4
11:50 aM
Company 5
12:20 pM
Lunch
1:20 pM
Company 6
2:00 pM
Company 7
2:40 pM
Company 8
3:10 pM
Afternoon break
3:30 pM
Company 9
4:10 pM
Company 10
Part A | BioForum: Journey to Global
Pharmaceutical Markets - Leveraging European Engagement
Please note: 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.


For a more in-depth look at this topic, take a deep-dive into our Masterclass Program – Bridging Discovery to Clinical: A Roadmap for European Market Success. The program includes this BioForum along with a full-day workshop and one-on-one advisory session.

About the BioForum:


Join international experts Serum Life Science Europe GmbH for an exploration of the intricacies of Europe’s dynamic clinical and regulatory ecosystem.

Gain valuable insights into business strategy and regulation, and see how they are applied for various products, conditions and clinical trials.

Be informed about:


  • European regulatory strategy: Unlock the advantages of Europe’s pharmaceutical development
  • Global development strategies: From initial research to market launch, learn the essential steps
  • Special focus areas: 1. Indication: Oncology, rare diseases, paediatric trials and advanced therapy medicinal products and 2. Expanding into Europe: Navigate multinational trials and bridging studies with confidence
  • Real-world applications: Explore impactful case studies.

What to expect?

  • The latest updates from industry experts
  • Dynamic panel Q&A session
  • In-person networking opportunities with peers.

Who should attend?


  • Biopharma professionals and industry service providers, ranging from academia and start-ups, through to SMEs and corporates
  • Biotech and pharma companies transitioning from discovery to clinical stages
  • Early-stage companies (late pre-clinical / clinical stage) with ambitions to develop products for the local or global market
  • Biopharma professionals seeking to improve knowledge and foster connections.
Speakers and facilitator
Dr Leander Grode (speaker)
Managing Director,
Serum Life Science Europe GmbH
Dr Merve Kilinc (facilitator)
Associate Director Business Development, Serum Life Science Europe GmbH
Dr Marcus May (speaker)
Medical Director and QPPV,
Serum Life Science Europe GmbH

BioForum details:


Date: Tuesday 18 June 2024
Time (AEST):
3:45 pm: Guest arrival and registration
4:00 pm: Presentations
5:00 pm: Panel and Q&A
5:30 pm: Networking
6:30 pm: Close
Format: Hybrid – In person and online
Venue: ACMI, Swinburne Studio, Federation Square, Melbourne VIC 3000
Facilitator:
Dr Merve Kilinc, Associate Director Business Development, Serum Life Science Europe GmbH
Speakers:
Dr Leander Grode, Managing Director, Serum Life Science Europe GmbH
Dr Marcus May, Medical Director and Qualified Person Responsible for Pharmacovigilance, Serum Life Science Europe GmbH
Panellist:
Greg Plunkett, CEO, Accelagen Pty Ltd

BioForum registration:


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 $45

Unsure 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

Online registration:

  • Full refund given up to 3 days prior to the event
  • No refunds within 3 days of the event


This BioForum is sponsored by the State Government of Victoria, delivered in collaboration with international industry experts Serum Life Science Europe GmbH and and supported by Accelagen.

Part B | Masterclass Workshop: Bridging Discovery to Clinical: A Roadmap for European Market Success
Registration for this Masterclass includes:

Part A: BioForum | Part B: Masterclass Workshop | Part C: 30-minute Advisory Session
Transitioning from the discovery phase to approved pharmaceutical product represents a pivotal and challenging journey for biotech and pharma companies. To support Australian companies navigating this crucial transition and wishing to enter the European market, Serum Life Science Europe GmbH (SLS Europe) is offering a tailored Masterclass designed to address the unique challenges and opportunities that arise during this phase.

With a comprehensive understanding of the entire product development spectrum, SLS Europe serves a diverse range of organisations, from small start-ups to large enterprises, private funding bodies, and academic research groups. Leveraging its expertise as a German-based regulatory consultancy and robust global network, SLS Europe aims to provide participants with the knowledge and strategies necessary for successful clinical development and European regulatory approval.

About the Masterclass:


The Masterclass Program is specifically designed to assist companies at a critical phase in their development process. Moving beyond initial discovery, the focus is on the rigorous demands of clinical development, regulatory approvals and strategic market entry into Europe.

The Masterclass will build on foundational knowledge while introducing concepts and practical strategies tailored to the clinical stage.

Participants will receive a clear roadmap and actionable strategies to navigate the clinical journey towards successful European market integration.

Session themes:


Session 1: Innovations for the pharmaceutical market - Making your product unique

  • Understanding regulatory and medical expectations for commercial success
  • Selection of a suitable indication and target population
  • Preparation of a target product profile.

Session 2: Navigating regulatory pathways in pharmaceutical development – Understanding the regulatory landscape

  • First regulatory interactions – scientific advice meetings in Europe and beyond
  • Early and late clinical trials 
  • Special considerations: 
  • Risk-based clinical trial management
    1. Indication: oncology, rare diseases, paediatric trials and advanced therapy medicinal products
    2. Medical device regulation and in-vitro diagnostic medical devices regulation 
    3. Advantages of Australia or Europe (timing and strategic considerations).

Session 3: Navigating regulatory pathways in pharmaceutical development – Implementation and compliance

  • Expanding development to Europe: Multinational trials and bridging studies
  • Clinical trial applications in Europe (Clinical Trial Information System) 
  • Data protection: Adhering to European standards
  • Investigational medicinal products management: Import and release in Europe.

Session 4: Market entry strategies

  • Marketing Authorisation Holder (Sponsor) in Europe
  • Marketing Authorisation application pathways 
  • Legal Representative
  • Import procedures and release requirements
  • Pharmacovigilance requirements for market entry.

Who should attend?


  • Biopharma professionals seeking to improve knowledge, skills and expertise.
  • Biotech and pharma companies transitioning from discovery to clinical stages
  • Early-stage companies (late pre-clinical / clinical stage) with ambitions to develop products for the local or global market
  • Founders, CEOs, CSOs, CTOs, commercial heads, BD managers, researchers, scientists.

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

Speakers
Dr Inci Aydin
Senior Clinical Project Manager and Senior Project Manager,
Serum Life Science Europe GmbH
Dr Leander Grode
Managing Director,
Serum Life Science Europe GmbH
Dr Steffi Hansen
Director Quality Assurance and Deputy QPPV, Serum Life Science Europe GmbH
Dr Merve Kilinc
Associate Director Business Development,
Serum Life Science Europe GmbH
Dr Marcus May
Medical Director and QPPV,
Serum Life Science Europe GmbH
Dr Fabio Pisano
Chief Development Officer, Serum Life SCience Europe GmbH

Program details: 


This Masterclass program has three parts:

  • Part A | BioForum: Tuesday 18 June 2024 | 4:00 – 6:30 pm | ACMI, Swinburne Studio, Federation Square, Melbourne VIC 3000
  • Part B | Masterclass Workshop: Wednesday 19 June  2024 | 9:00 am – 5:00 pm | Stamford Plaza Melbourne, 111 Little Collins Street, Melbourne VIC 3000
  • Part C | 30-minute Advisory Session: Thursday 20 June – Friday 21 June 2024 (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).

Registration (in-person only):
BioMelbourne Network Member: $800
BioMelbourne Network Non Member: $950
*Biopharma Entrepreneur: $685

*Biopharma Entrepreneur applies to start-up 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
  • No refunds can be issued within 14 days of the program commencing.


This Masterclass program is sponsored by the State Government of Victoria, led by international industry experts Serum Life Science Europe GmbH and supported by Accelagen. 

Speakers
Dr Leander Grode, Managing Director, Serum Life Science Europe GmbH

Leander is the Managing Director at Serum Life Science Europe GmbH since 2019. He has been at the company since 2013, where he was Chief Scientific Officer and Director Business Development (2008).
 
He is an expert in regulatory affairs, patent strategy and immunology.
 
Previously, Leander was the coordinator of the vaccine development group at the Max-Planck Institute in the Department of Immunology from 2001 to 2003.
 
Leander graduated in 1997 with a degree in biology at the Max-Planck Institute of Biophysics in Frankfurt/Main and later completed a PhD from the Max-Planck Institute of Infection Biology. Leander’s doctoral research focused on vaccine development against tuberculosis based on live carriers, including Salmonella or Mycobacterium bovis BCG.
Dr Fabio Pisano, Chief Development Officer, Serum Life Science Europe GmbH

Dr Fabio Pisano is Chief Development Officer at Serum Life Science Europe GmbH and is responsible for all aspects of project management and consulting services. He joined SLS Europe as Project Manager and Quality Assurance Manager, and later specialised in product development and regulatory consulting.

Key Knowledge Areas:

  • Regulatory consulting
  • Good Manufacturing Practice 
  • Portfolio development

Fabio Pisano studied pharmaceutical biotechnologies at the University of Bologna and performed his doctoral studies at the Helmholtz Centre for Infection Research in Braunschweig. Afterwards, he worked as a postdoctoral researcher in the field of immunology and infectious diseases, with a special focus on virulence strategies of the enteric pathogens Yersinia and Salmonella.

After training as a Project Management Associate, he worked as Scientific Officer in the German Centre for Infection Research (DZIF).
Dr Marcus May, Medical Director and QPPV, Serum Life Science Europe GmbH

Marcus is Medical Director and QPPV (Qualified Person Responsible for Pharmacovigilance) at Serum Life Science Europe GmbH. He is a Medical Doctor with almost 20 years of experience in clinical practice, academia and the pharmaceutical industry. He is a Board Accredited Clinical Pharmacologist and has a Master’s degree in Health Business Administration.

Marcus is an expert in medicine and GCP-regulations, methods in clinical research,
pharmacovigilance and healthcare economics.

He has extensive experience conducting over 70 clinical trials in various indications with small molecules, advanced therapy medicinal products or vaccines, and setting up clinical development strategies for investigational medicinal products.

Previously, Marcus was a senior investigator and head of clinical operations for an academic site management organisation and later as Medical Expert, Medical Director and QPPV at SLS Europe, where he gained extensive expertise in ICH regulations, quality management, regulatory affairs and post-marketing pharmacovigilance.
 
After Marcus received his license to practice medicine in 2007, he worked in two hospitals as a resident physician in internal medicine. In 2011, he completed his doctoral thesis.
Dr Steffi Hansen, Director Quality Assurance and Deputy QPPV, Serum Life Science Europe GmbH

Steffi is Director Quality Assurance and Deputy QPPV at Serum Life Science Europe GmbH.

Steffi is experienced in state-of-the-art quality management. She acts as our consultant and assists companies in bespoke design QMS and brings them up to speed with current and future regulatory requirements.

Steffi is an expert in QMS consulting, teaching, coaching and good pharmacovigilance practice.

She has a doctorate in pharmacy from Saarland University, Germany.

Steffi has held several academic positions, including as visiting scientist at Winkle College of Pharmacy, University of Cincinnati, in the US, and a team leader in the field of transdermal vaccination at the Helmholtz-Institute for Pharmaceutical Research Saarland, Germany.
Dr Inci Aydin, Senior Clinical Project Manager and Senior Project Manager, Serum Life Science Europe GmbH

Inci holds dual roles as Senior Clinical Project Manager and Senior Project Manager at Serum Life Science Europe GmbH.

Inci has over six years of experience in the development of medicinal products, specialising in clinical research and regulatory affairs. She oversees clinical trials and manages overall project operations from bench to market.

Her core competencies encompass the management of clinical trials, preparation of paediatric investigation plans and marketing authorisation applications.
Dr Merve Kilinc, Associate Director Business Development, Serum Life Science Europe GmbH

Merve is Associate Director Business Development at Serum Life Science Europe GmbH. With over five years of experience in project management and two years in business development, she focuses on fostering partnerships to support product development initiatives, and steering these projects.

Merve earned Bachelor's and Master's degrees in Molecular Biology and Genetics from Bogazici University, Turkey, and later completed her PhD in Genetics at the University of Cologne. Her doctoral research centered on understanding cellular signaling pathways and their effects on gene expression in health and disease states.

Her core competencies lie in translational and clinical development of pharmaceutical candidates, regulatory interactions, GxP compliance and proficient project management.
Sponsors
BioMelbourne Network

Web: biomelbourne.org
Email: [email protected]
LinkedIn: linkedin.com/company/biomelbourne-network/
Twitter: twitter.com/biomelb

BioMelbourne Network is the peak body in the Victorian healthtech industry, driving engagement and growth through local and international networks. Since 2001, we are actively fostering and growing an innovative, globally competitive sector and transforming our Network as well as the broader Victorian ecosystem.

Our members are diverse and experts in their respective fields, from early-career researchers to company executives and experienced directors, and start-ups through to large multinational corporations. We represent universities, researchers, manufacturers, government departments and the services sector, which includes commercialisation, product design and development, intellectual property, investment and legal sectors.

We are committed to maximising our value to the ecosystem through the delivery of our three-year strategic plan.
State Government of Victoria

Web: djsir.vic.gov.au
Email: [email protected]
LinkedIn: linkedin.com/company/department-of-jobs-skills-industry-and-regions/

Victoria is home to world-class health technology companies and is a preferred location for many international organisations including CSL, Moderna, Illumina, Gingko Bioworks and Johnson & Johnson. There are many reasons international organisations choose Victoria for commercial product development – its cost-competitive environment for basic discovery, clinical and commercial research, strong collaborative networks and a supportive government.

Victoria’s key research and development capabilities include:
· Infectious disease and diagnostics
· Digital health and patient monitoring
· Cancer
· Cell therapies and regenerative medicine
· Neuroscience

Victoria’s health technologies expertise is supported by its experienced talent pool, favourable regulatory and research and development environment, and world leading infrastructure all backed by the Victorian Government’s investment into the sector.

The Victorian Government has charted a bold course to continue building a globally competitive research and innovation ecosystem. Its global network of 23 international business offices is working with companies worldwide to develop novel health technologies and services.

We would welcome the opportunity to talk with you further to discuss how we can provide you with our insights and offer you the full range of capabilities and talent in Victoria.
Serum Life Science Europe GmbH

Web: https://sls-eu.com/
Email: [email protected]
LinkedIn: https://www.linkedin.com/company/70013481/ 

Serum Life Science Europe GmbH (SLS Europe) – formerly Vakzine Projekt Management GmbH (VPM) – offers tailor-made consultancy and services supporting biopharmaceutical development in Europe and beyond.

We offer exceptional knowledge in the development of biopharmaceutical candidates and a team that has vast experience in clinical and translational project management. This enables you to bring your development projects into clinical trials and market authorization faster, more cost-effectively and with a higher probability of success.

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