A forum is an interactive platform for discussion and information and will be filled by contributions out of the Special Interest Groups (SIG). Special Interest Groups provide an opportunity for direct interaction with your peers in specialized fields.

active groups

SIG "BioEntrepreneurship"

SIG "Tissue Remodelling"

SIG "Regulatory Aspects during Biopharmaceutical Development"

SIG "Regenerative Medicine"

SIG "BioEntrepreneurship"
The SIG aims to provide an European platform, to share experiences and to discuss different opinions on selected current critical topics life science entrepreneurs have to face, trends and business models, best business practices, ip issues, fundraising etc.
Events will be open to the biosciences community. Attendees will be for instance scientists who are just starting to think about founding a company, graduate students and professors, bioentrepreneurs, corporate professionals, or consultants who provide advice and services to the biotech community. The goal is to catalyze interactions among members and invited professionals. Members could understand how to build a startup, how to raise funds and how to organize a team.
Invited speakers will be experts from venture firms and successful entrepreneurs to give their perspectives about startups. But also all stakeholders around start up creation and growth: investors, technology transfer experts, incubators ... - They will share some case studies of lessons learned, strategies for success, and in-depth analysis of current business challenges.

first meeting: (exact date follows)
programme

 

SIG "Tissue Remodelling"
This SIG creates a forum for basic researchers, pharmacologists, and clinicians to discuss and expedite the understanding of physiology and pathophysiology and the development of novel therapeutic strategies.
The first workshop of this SIG will be focused on "Relaxin".
Alterations of the cellular and non-cellular components of tissues often constitute the basis for clinically and economically important pathologies. Vice versa, targeted modification of those processes - the so-called tissue remodelling - may prove a promising solution to a series of challenges of current clinical medicine: cancer spreading, malfunctions in early pregnancy, cardio-vascular and renal diseases, ageing.

first meeting: December 2, 2011, Berlin
programme

presentations: Thomas Dschietzig (Introduction / Organ fibrosis), Claudia Binder (Oncology), Almuth Einspanier (Early Pregnancy), Eugenia Makrantonaki (Skin Ageing)

SIG "Regulatory Aspects during Biopharmaceutical Development"
This Special Interest Group takes care of hot topics in regulatory developments in the biotech area and offers a platform for industrial CMC experts and regulatory professionals for discussion in presentations and discussion forums. Subjects like (e)CTD M3, Biosimilar guidances, Quality by Design, Subvisible Particles, new clinical trial regulation etc. will be presented in webinars, white papers and/or discussed in special meetings. Each and every interested member is invited to apply for SIG membership and propose subjects for discussion.

Important events of the SIG

2012
December 5: in a webinar on "Revision of the Clinical Trials Directive"  Axel Wenzel, PhD, MSc, BSc, FTOPRA, EAPB's 1st VP and head of the SIG, presented the ongoing process of the EU in revising the Directive 2001/20/EC (so called Clinical Trials Directive). The European Commission proposed a new "regulation on clinical trials on medicinal products for human use" to repeal the Clinical Trials Directive. In the webinar he explained why this new proposal is of fundamental importance for companies and academia.
The webinar received wide observance. The 30 participants dialed in from four continents to follow the given presentation.

2010
In combination with the biotech trade fair Biotechnica  EAPB held its workshop of regulatory aspects on October 4, 2010Programme  Presentations: Thomas Stangler, Maren von Fritschen, Karoline Bechtold-Peters, Brigitte BrakeThe aim of this workshop was to bring together experts on regulation and experts from academia and industry in order to share experiences and discuss different opinions on two selected current hot topics: "Quality by Design" and "Subvisible Particles".

next meeting: not yet scheduled

 

SIG "Regenerative Medicine"
The mission of this group is to promote the discussion and distribution of new information related to one or two topics in this field per year. Within the first year we will discuss current developments in stem cells technology for non- and therapeutic applications addressing in this regard also questions relating to manufacturing and regulatory processes. In the forthcoming years all members of the group will decide on the next topics which should be discussed.
Our goal is to create a bridge and network between scientists working in the fields of regenerative medicine, stem cell biology, and drug discovery.

In combination with the biotech trade fair Biotechnica EAPB held its last SIG of regenerative medicine on October 4, 2010
Programme
Presentations: Joachim Noeller, Jens Reinhardt, Gabriele Dallmann, Monika Chabicovsky
Advanced Therapy Medicinal Products (ATMPs) are tightly regulated by the European Medicines Agency (EMA) with the intention to ensure the safety, efficacy as well as the good quality of the products. A well defined risk evaluation in order to cover the whole development process and not only quality or safety risks should be set-up. For example, tumorigenicity, genome stability, biodistribution are now among the top issues during non-clinical and clinical development and need to be addressed for stem cell-based products early. A key point is hereby an efficient communication with the regulators as early as possible to avoid detours or even worst failures. So the scientific advice became a very powerful tool to find the right way through the jungle of guidelines, reflection papers, regulations and the expectation of the regulators.

The aim of this SIGis to bring together experts on regulation and developers from academia and industry in order to share experiences and handy tips for the process of scientific advice by regulatory agencies and for the development of cell-based products in Europe. Presentations are about the significance of scientific advice for small enterprises and the "dos and donts" during the process of scientific advice as well as quality standards of stem cell based therapies.

next meeting: Stuttgart, Haus der Wirtschaft, Willy Bleicher Straße 19,
March 29, 2012
programme

Registration form to become member of a SIG
Registration form to become EAPB member