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Biopharma Masterclass – Bridging Discovery to Clinical: A Roadmap for European Market Success

June 19

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

Please submit your expression of interest below. 

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.

Be informed about:

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

What to expect:

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

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.

Session themes:

Session 1: Innovations for the pharmaceutical market – Making your product unique
Session 2: Navigating regulatory pathways in pharmaceutical development – Understanding the regulatory landscape
Session 3: Navigating regulatory pathways in pharmaceutical development – Implementation and compliance
Session 4: Market entry strategies.

Program details

This Masterclass program has three parts:

  • Part A | BioForum: Tuesday 18 June 2024 | afternoon event, 1.5 hours, plus 1 hour networking
  • Part B | Masterclass Workshop: Wednesday 19 June 2024 | 9:00 am – 5:00 pm
  • 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 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
  • No refunds can be issued within 14 days of the program commencing.

International industry experts: Serum Life Science Europe GmbH

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.

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

 

 

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 Leander Grode, Managing Director, Serum Life Science Europe GmbH

Leander is 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 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 Hansen 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 Merve Kilinc, Associate Director Business Development, Serum Life Science Europe GmbH

Merve is Associate Director Business Development at SLS Europe. 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.

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 Fabio Pisano, Chief Development Officer, Serum Life SCience Europe GmbH

Dr. Fabio Pisano is Chief Development Officer (CDO) at SLS Europe 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 specialized in product development and regulatory consulting.

Key Knowledge Areas:

Regulatory consulting
Good Manufacturing Practice (GMP)
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 special focus on the 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).

Tickets

Member - In Person$800.00
Non Member - In Person$950.00
Biopharma Entrepreneur - In Person$685.00

Details

Date:
June 19
Cost:
$685 - $950
Event Category:

Contact

BioMelbourne Network
Phone:
+61 3 9667 8181
Email:
info@biomelbourne.org

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