BIH Clinical Incubator: Team
Dr. Garima Bhardwaj
Head of the BIH Clinical Incubator
Dr. Garima Bhardwaj is the Head of the BIH Clinical Incubator at the Berlin Institute of Health (BIH), where she leads efforts to bridge the gap between cutting-edge biomedical research and real-world clinical applications. Garima oversees the day-to-day operations of the incubator, collaborating with local stakeholders, managing a multidisciplinary team, and fostering an innovative ecosystem to accelerate the commercialization of novel therapies. Her work is centered on supporting life science entrepreneurs and driving advancements in personalized and regenerative medicine.
With a Ph.D. in Chemical Engineering from Northeastern University, Boston, USA, Garima has extensive experience across sectors including academia, biotech, and pharmaceuticals. She has held leadership roles in organizations such as LabCentral and Bayer Pharmaceuticals, where she spearheaded strategic partnerships, business development initiatives, and community engagement efforts. Her cross-functional expertise in scientific research, commercialization, and project management positions her uniquely to lead BIH's incubator toward meaningful medical innovations.
Dr. Franka Klatte-Schulz
Science Operations Manager
Dr. Franka Klatte-Schulz is the Science Operations Manager at the BIH Clinical Incubator (CLIC). In this role, she oversees and monitors the co-working lab environment, ensuring that regulations are followed and state-of-the-art equipment is sourced, installed, and maintained. Acting as a vital link between the scientific teams, the on-site lab manager, and the head of CLIC, Franka also provides scientific support and advice, helping teams connect with other researchers and core units within the Charité and BIH ecosystem. Her ultimate goal is to create a secure, collaborative space that empowers the scientific teams at CLIC to transform their innovative ideas into successful products.
As a seasoned researcher in regenerative medicine, Franka has successfully implemented her own translational research projects, secured public research funding, and led various interdisciplinary initiatives. She also headed the histology board, a service unit at the Julius Wolff Institute (JWI) and the BIH Center for Regenerative Therapies (BCRT). Driven by a passion for science management and a desire to enhance the scientific landscape for innovation, she embraced the opportunity to lead as the Science Operations Manager at CLIC, where she continues to foster cutting-edge research and collaboration.
Nicole Bormann
Lab Manager
Nicole Bormann serves as the Lab Manager of the Clinical Incubator at the Berlin Institute of Health (BIH). In her role, she provides comprehensive support and coordination for laboratory operations, ensuring smooth processes and the well-being of all laboratory personnel. Her responsibilities include overseeing laboratory safety in compliance with BioStoffV, GenTV, and GefStoffV regulations, as well as managing essential tasks such as developing operating instructions, maintaining the hazardous substances register, conducting risk assessments, and ensuring proper equipment maintenance. Nicole also handles inventory management, including materials and reagents, and oversees purchasing of new supplies.
Nicole holds a Diploma degree in Biotechnology from the University of Applied Sciences in Berlin, Germany. She began her career as a technical employee at the Julius Wolff Institute, focusing on bone and tendon regeneration. During this time, she independently planned, documented, and executed various research projects, applied extensive analytical techniques, and contributed to numerous scientific publications. Her expertise includes in vitro experiments with cell cultures, molecular biology, microbiological techniques, and supporting in vivo studies.
With her strong organizational skills, effective communication, and teamwork abilities, Nicole plays a pivotal role in ensuring the efficient and safe operation of the Clinical Incubator's laboratories.
Dr. Hisham Elazaly
Clinical Development and Regulatory Affairs Specialist
Dr. Hisham Elazaly is a regulatory affairs expert and clinical trial designer with a strong medical background. He coordinates projects throughout the translation process, offering regulatory support and assisting in the preparation and submission of essential documentation. Hisham also manages interactions and negotiations with regulatory authorities. His expertise in regulatory affairs, clinical trial design, and medicine ensures quality and compliance at every stage of clinical trial development.
Maja Pizevska
Clinical Development and Regulatory Affairs Specialist
As part of the BIH Clinical Incubator, Maja leverages her extensive expertise to bridge the gap between pioneering biomedical research and real-world clinical applications, with a special focus on cell and gene therapies. With five years of experience in regulatory affairs and clinical development, she plays a crucial role in assisting research teams and principal investigators in setting up early-phase clinical studies. Her guidance on regulatory pathways and interactions with authorities ensures that groundbreaking therapies transition smoothly from concept to clinical trials.
Maja’s scientific background in Biomedical Sciences, combined with pre-clinical lab experience in oncology at CECAD, Cologne University, and project management roles in clinical research organizations, brings a rigorous, evidence-based approach to her work within the incubator. She collaborates closely with multidisciplinary, international teams, offering valuable insights into the complexities of clinical research and development. Through workshops and hands-on consulting, Maja prepares teams for the challenges and opportunities inherent in this innovative field.
A key area of her focus is patient engagement, where she works with stakeholders to incorporate patient perspectives into clinical development, ensuring therapies are tailored to those who need them most. Maja is deeply connected to a dynamic network of patient advocates and pioneers, leveraging this community to ensure patient voices are integrated throughout the therapy development process. Her commitment to this area is further emphasized by her fellowship with EUPATI.
By working closely with life science entrepreneurs, regulatory bodies, and the broader Clinical Incubator community, Maja helps drive the advancement of personalized and regenerative medicine, ensuring the successful translation of novel therapies into clinical practice and beyond.
Constanze Gerhards
Project Controlling and Financial Management
Constanze Gerhards oversees Project Controlling and Financial Management at the BIH Clinical Incubator. In this role, she supports the incubator's development by managing a wide range of administrative tasks, with a particular focus on financial matters and personnel management.
Constanze holds a degree in Business Administration and previously worked at the Georg-August University of Göttingen, where she played a key role in establishing the university’s start-up support department. Her expertise in finance and operations ensures that the incubator runs smoothly, providing vital support to both the teams and projects within BIH.