Talk im Cube: „Building the Bridge from Pre-Clinical to Clinical Studies“
In the current global economic environment, companies need to become even more efficient to get their drugs through the development process. The transition from preclinical studies to human clinical trials is challenging in many ways - scientifically, regulatory and organizationally. Therefore, understanding the complexity of this step and the issues that arise can help streamline the process and minimize the risks and pitfalls.
Our speakers are proven experts in the field of preclinical and clinical development and have been working in a managerial and/or advisory capacity nationally and internationally for many years:
- Jens Hoffmann, Managing Director of Experimental Pharmacology & Oncology (EPO), Berlin-Buch GmbH,
- Michael Firgens, Managing Director at MF Biotech, Berlin,
- Virgilio Garcia Lerma, Executive Director, Regulatory Strategy at Worldwide Clinical Trials, Madrid, Spain,
- Uwe Lohmeier, Head of Gläsernes Labor Akademie (GLA), Campus Berlin-Buch GmbH (Moderation).
In the talk, they will introduce and discuss challenges
- to reflect clinical problems in preclinical models such as pharmacodynamic activity, safety and biomarker translational research,
- to weight ethical aspects in planning in vitro versus animal versus human experimentation,
- to continuously comply with all applicable regulatory requirements (at least such as ICH, EMA or FDA Guidelines and regulations),
- and nonetheless …. to consider the costs for preclinical and clinical development in order to be and to remain also financially successful.
Don't miss the opportunity to join in the discussion and exchange ideas with each other and our experts over snacks and drinks at the subsequent get-together and networking event.
Other topics planned for this year:
- The journey of company... "Founder stories"
- Team 4.0 - Networked working in biotechnology
- Life Science Marketing: A potential way of scientist to promote their products
- CROs in diagnostics and therapeutics development
About "Talk in the Cube"
With the new event series "Talk im Cube", we want to bring business and science together on the Berlin-Buch campus and connect founders of start-ups or life science companies with scientists, e.g. from the Max Delbrück Center, FMP, Charité and BIH. We invite experts on business topics or trends in the life sciences and highlight every month aspects such as
- What innovations are there in the start-ups and who is driving them forward?
- How does the life science business world work and where can synergies with science be created?
- How does the "networked laboratory" work and how do you live "sustainability in the laboratory"?
In addition, at the beginning of each event, a biotech company from our campus will briefly introduce itself.
Target audience:
Founders & scientists from start-ups, small and medium-sized life science companies and scientific institutions
Costs:
Participation is free of charge. Registration is requested.
Further information: Uwe Lohmeier per E-Mail: u.lohmeier@campusberlinbuch.de
