Welcome to BioInsights

Christiane Niederlaender. has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. In that capacity she chaired and oversaw all formal scientific advice meetings and had in-depth involvement of Brexit preparedness. At the same time Christiane was a Senior Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). She was UK CAT Rapporteur responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline and quality lead for gene therapy section of new draft guideline for investigational ATMPs. She was a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector. Christiane has experience in CMC and regulatory strategy for all types of biological products, with a particular focus on gene and cell therapies, novel biotherapeutics, biosimilars and vectored vaccines. While at MHRA, she was the principal quality/CMC assessor for 10 centralized MAAs, including two full dossier applications for ATMPs as sole UK quality assessor (including CAR-T, see publications). She has in depth knowledge of all European procedure types, both centralized and MR/DCP, and can give advice on ATMP classification, ODD and the PRIME program. As an ex-member of the EMA CAT committee, Christiane is familiar with the thinking of all European regulators in the ATMP space and is used to dialogue and negotiation with many regulatory agencies, as well as presenting her thinking during committee discussions. Christiane undertook her undergraduate studies in biochemistry, neurobiology and molecular biology at Heidelberg University in Germany before obtaining her PhD in molecular developmental neurobiology at Kings College London in the UK. Christiane has published her academic research in many high impact journals, including Nature.

Zara holds a PhD in Pharmacology and Toxicology and has 15 years of industry experience in bringing innovative cell culture products and technologies to market. Prior to joining Corning, Zara was a post-doctoral fellow at Cornell University where she studied the mechanism of action of a novel tumor suppressor gene in human breast cancer cells.

Chris Heger, Senior Manager of Applications Science for the Analytical Solutions Division of Bio-Techne, leads a team chartered with creating scientific collateral, fostering collaborations, training, and coming up with new applications. Chris has expertise in immunoassays, capillary electrophoresis, antibody design and production, and chromatography. In recent years, his team has focused on developing analytical solutions for cell and gene therapy researchers.Chris received his doctoral degree in Pharmacology from Cornell University and completed his post-doctoral training at the National Cancer Institute. Working in the Antibody and Protein Purification Unit, Chris oversaw antibody development projects, from immunogen design to final product. A unique aspect of his postdoctoral training was his role in the evaluation of new technologies, serving as the gateway for cutting edge instrumentation to get into use at the NCI/NIH. Through this role, Chris became well-acquainted with ProteinSimple and after completing his postdoctoral training, began working for ProteinSimple (now part of Bio-Techne).

Joseph O’Connor, PhD, is currently a senior scientist in process development for Lonza’s Personalized Medicine Business Unit. His focus is on translating and optimizing manual autologous cell therapies into the Cocoon® Platform, a closed and automated cell therapy manufacturing solution. Joseph earned a doctorate in chemical engineering from the Pennsylvania State University while researching the mechanical regulation of gene expression. He has been with Lonza since 2017.

Bruce A Bunnell is a professor and Chair of the Department of Microbiology, Immunology and Genetics at the University of North Texas Health Science Center in Fort Worth, TX. Previously, he served as Director of the Tulane Center for Stem Cell Research and Regenerative Medicine and Professor in the Department of Pharmacology in the Tulane University School of Medicine. Dr. Bunnell obtained his PhD in Microbiology from the University of Alabama at Birmingham School of Medicine. He then pursued Postdoctoral Fellowship research at the Howard Hughes Medical Institute in the School of Medicine at the University of Michigan and the National Human Genome Research Institute at the National Institutes of Health in Bethesda, MD. Dr. Bunnell was an Assistant Professor at the Nationwide Children’s Hospital Research Institute, part of the Ohio State University School of Medicine prior to joining the faculty at Tulane University in 2002. Dr. Bunnell’s research program is focused on both the basic science and translational applications of adult stem cells isolated from the bone marrow and adipose tissue. Dr. Bunnell investigates use of mesenchymal stem cells (MSCs) isolated from the bone marrow or adipose tissue as a therapeutic intervention for both multiple sclerosis (MS) wound repair, lung injury and bone repair. He is particularly interested the interactions of MSC with the immune system and how the cells elicit robust anti-inflammatory effects in vivo. He is currently working towards a human clinical trials for the treatment of osteoarthritis, traumatic brain injury and MS with these cells. He has served as a reviewer of stem cell, regenerative medicine and tissue engineering grants for the National Institutes of Health, Department of Defense and several state funded programs including Maryland, New York, Virginia and Pennsylvania. He has also served on grant review panels for several foreign countries including Denmark, Ireland, Poland, Germany and Spain. Dr. Bunnell serves as an Editorial Board Member for several journals, including Stem Cells, BMC Genomics, and Regenerative Medicine.