From Preclinical Studies to
Marketing Authorization

A conference day intended for biotech start-up companies

June 01, 2021 - Novotel, Bern - Expo

About the conference

The “Biotech Start-up Conference” is intended to be a platform for connecting people from (bio-)pharmaceutical start-ups with the aim of promoting the exchange of knowledge and experience to speed-up the time-to-market process.

Why a conference day about “Pre­cli­nical ­Stud­ies to Marketing Authorization”

The key capacities of start-ups are the potential to innovate products with high added value as well as the advanced scientific knowledge.

Experience shows that the interface between the pre-clinical research and the clinical trials of new products represents a huge challenge for these companies.

Indeed, it is particularly difficult to combine the innovative academic spirit with the formal and demanding requirements on quality and regulatory affairs needed to obtain authorization for clinical trials or market authorization.

Several experts are invited to share their experience and knowledge with you by interactive presentation and Q&A session.

The Biotech Start-Up Conference aims to address these challenges, to share experiences and to create synergies between start-ups and specialists.

We believe that strong networks are fundamental for successful projects resulting in beneficial treatments for patients. See you there!

Why a conference day in “pre­sen­tial” modus now?

The primary objective is hosting a safe event that brings the community together.

The COVID-19 pandemic has led to a reduction of the professional and social contacts It is now time to reactivate and to recreate the professional network. The cooperation and the collaboration between the start-up community constitute the key elements to overcome the challenges ahead. This conference day will offer the chance to come together at a time when networking, learning and collaborating is as important as ever.

And what about the virus?

Ensuring the health and safety of all speakers, attendees, service partners and employees is top priority.

The hygiene concept and the safety measures that will be implemented during the conference will satisfy the recommendation from the BAG.

Cancellation policy

All cancellations must be electronically mailed to info@biotech-startup-conference.org

In case of cancelation, we must charge the following processing fees:

– until 2 weeks prior to the conference 10 % of the registration fee.
– within 2 weeks prior to the conference 50 % of the registration fee.

If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid.

We reserve the right to change the materials, instructors, or speakers without notice or to cancel an event.

Programm

from 8:30

Registration and coffee

09:00
09:15

Introduction

Dr. Philippe Paroz

Senior Consultant, PMS Process Manage­ment System GmbH

09:15
09:45

Quality Management System for start-ups

  • What is QMS in the pharmaceutical-biotech industry?
  • How to build a QMS and when to start it?
  • What are the main points to focus on?
  • What are the main points to avoid?

Dr. Claude Ammann

Director, Claude Ammann Consulting

09:45
10:15

Being agile and flexible in the biopharmaceutical space

  • How to lower the clinical entry barrier

Dr. Massimo Nobile

CEO, Swiss Biotech Center AG

10:15
10:45

Product development for ATMPs

  • All inclusive from bench to bedside

Dr. Vincent Ronfard

Chief Innovation Officer, Cutiss AG

10:45
11:10

Koffee break

11:10
11:40

Translating an autologous cell therapy from the bench through GMP-conform validation to patients

  • How to plan your pre-clinical experiments towards approval by the authorities
  • Bottlenecks of translating a straight-forward process into GMP settings.
  • Timing and meeting requirements for MA

Dr. Jenny Anne Prange

GMP Production Team Leader, University Hospital Zurich

11:40
12:20

How to get from your basement to your nanotech company

Dr. Stefan Halbherr

CEO, Innomedica AG

12:20
13.30

Lunch

13:30
14:00

sitem-insel: Bringing innovation to the patient

  • Translational Medicine (The importance of clinical data and technology transfer).
  • Meaning of MDR/VDR: Case study

Dr. Simon A. Rothen

CEO, sitem-insel AG

14:00
14:30

How to overcome the regulatory and quality hurdles to run your first in man clinical trial

  • QA, RA an Pharmacovigilance aspcects will be discussed with a focus on QA an RA in the swiss environment

Dr. Peter Durrer

Head QA, RA and PV at Swiss Group for Clinical Cancer Research AG

14:30
14:50

Koffee break

14:50
15:20

Appropriate stability study programs for drug and drug products

  • Factor that can influence the stability of the (formulated) drug substance and regulatory requirements during clinical phases
  • Longterm and accelerated stability studies
  • In-use stability studies

Dr. Andreas Kunze

Key Account Manager, UFAG Laborato­rien AG

15:20
15:50

Quality v. Compliance in manufacturing of Investigational Medicinal Products – Where is the acceptable limit?

  • Differences between Compliance and Quality
  • Presentation of several case studies coming from the practice describing not fully GMP compliant situations in IMP manufacturing and the related impact on the decisions from the authority, reps. The interpretation by the authority.

Stéphane Gumy

General Manager PMS Process Manage­ment System GmbH

15:50
16:00

Conclusion

Dr. Philippe Paroz

Senior Consultant, PMS Process Manage­ment System GmbH

Speakers

Dr. Claude Ammann

Claude is a Quality professional with over 25 years’ experience in the pharmaceutical and biotechnology industry. In 2009, Claude started his own business to assist pharmaceutical and biotech firms that wish to enhance their quality capabilities.

Dr. Massimo Nobile

Massimo joined CimArk SA in 2010 as case manager with a mission to support innovation in Life Sciences. Among his activities, Massimo is the CEO of Swiss Biotech Center SA (daughter company of CimArk) and managing the technological incubator BioArk, located in Monthey.

Dr. Vincent Ronfard

Vincent has more than 30 years of experience of applied research and product development in the fields of regenerative medicine, wound healing and cosmetics. He has worked in nine different companies located in Europe, United States and Asia. Currently, he is Visiting Technology Advisor at A*STAR (Singapore), CSO at Hairclone Inc. (UK), CIO at Cutiss AG (Switzerland).

Dr. Jenny Ann Prange

After working at Hoffann La Roche, Novartis, Frauenhofer Institute in Leipzig and the University of Prince Edward Island in Canada, Jenny Ann is now a researcher and a GMP manufacturing leader at the University Hospital Zürich.

Dr. Stefan Halbherr

Stefan studied Biochemistry at the University of Bern and continued his research at the University Institute for Immunology in the Insel hospital in Bern. Stefan Halbherr is now CEO and President of the Board of InnoMedica Switzerland AG, while also leading the R&D team. He restructured the company into a cutting-edge nanodrug company bringing the research concepts to a marketable product, introducing many innovations in the processes of industry-scale liposome assembly, drug loading, and especially in the design of biologically functional liposome surfaces.

Dr. Simon A. Rothen

Simon is CEO of sitem-insel AG. He studied biotechnology and bioprocess engineering at ETH Zurich. During his professional career he remained loyal to the life science industry by holding positions at Novartis, Berna Biotech and Medisupport.

Dr. Peter Durrer

Peter is deputy CEO and Head Quality Assurance, Regulatory Affairs and Pharmacovilgilance of Swiss Group for Clinical Cancer Research. Previously he has, among other things, held positions as head of Clinical Quality Assurance of the SAKK being a specialist of GCP compliance. Peter was also Director of Quality Affairs at Berna Biotech, Director of Quality Control and led the team for virological process control.

Dr. Andreas Kunze

After leading for 20 years Quality Control organization in international companies Andreas is today in charge of Key Account Management & Business Development at UFAG Laboratories

Stéphane Gumy

With over 18 years’ experience for pharma, biopharmaceutical & medical device industry in small and medium-sized enterprises as well as in international companies, leading QA, QC manufacturing and process development groups. Stéphane has a degree in chemistry and is since 2007 Independent consultant and general manager of PMS. Since 2013 he is also acting as a Qualified Person

Location

Novotel Bern Expo, Guisan Platz 2, Bern

Access

From Train Station:  Tram Nr. 9 to Bern Expo

By Car:  A1 – Exit Bern – Wankdorf

Hotel Parking free of charge

Sponsors

If you are interested in sponsoring this event, please contact Mr. Philippe Paroz: philippe.paroz@pmsystem.ch