Teach Me in 10: Accelerating Cell and Gene Therapy Development

Jon Pileggi has over 13 years of experience in biotech with a focus on adoptive cell therapy development using automated equipment and closed systems. Over the last 7 years, Jon has helped to develop over 10 cell therapy programs for entry into clinical manufacturing with a variety of modalities, including CAR-T, TIL, and Natural Killer cells. Jon received his Bachelor of Science degree in Biology from Augusta State University.

I am co-head of Fieldfisher's International Life Sciences and healthcare group. I have over 20 years' experience in advising some of the leading organisations in the life sciences industry on both corporate and IP transactions. On the corporate side these include venture investment, joint ventures, pharma asset divestment and in particular cross-border structured M&A deals. In the transactional intellectual property field deals include structured licensing, strategic partnering, co-operative research and development and drug supply. I'm passionate about the life sciences sector and have a D.Phil. in Biochemistry from the University of Oxford. I am also a fellow of the Royal Society of Medicine and a fellow of the Royal Society of Biology and sit on a number of advisory committees of the UK's Bio Industry Association (BIA).

I am a Project Manager, with 7 years of experience specializing in clinical trial operations in healthcare. My role primarily involves ensuring that clinical trials are conducted in accordance with the designated protocol and FDA regulations. This encompasses the entire spectrum of trial management, from start-up and recruitment to closure with the oversight of regulatory, safety and data management activities.

Rebecca Warfield is the East Coast Field Application Scientist at ACROBiosystems. Rebecca earned her Ph.D. from Temple University, where her hands-on experience with state-of-the-art bioassay techniques solidified her dedication to providing top-tier biotechnology solutions. In alignment with ACROBiosystems' mission, Rebecca is dedicated to advancing the development of high quality and innovative biotechnology products that empower scientists worldwide. At ACROBiosystems, Rebecca works directly with researchers to bridge the gap between research goals and experimental execution driving scientific excellence within partnered industries and institutions.

Jorge Escobar is the Product Manager, Bioprocess Solutions of Eppendorf, Inc., Enfield, Connecticut, USA. He joined the company in 2019 and has worked on applied research focused on efficient expansion of adherent and non-adherent cells (e.g. stem cells, adult primary cells) in cell culture bioreactors. After his Ph.D. in Biomedical Engineering at the Polytechnic University of Valencia (UPV), he gained experience in the fields of cell therapy and regenerative medicine working as a researcher at the Center for Biomaterials and Tissue Engineering (UPV, Valencia, Spain), Institute of Biomaterial Sciences - Helmholtz-Zentrum Geesthacht (Berlin, Germany) and Institute for Regenerative Engineering (University of Connecticut Health, Connecticut, USA). Additionally, in 2017, he was promoted to Assistant Research Professor, Department of Chemical and Biomolecular Engineering, University of Connecticut.

Alex Hastie is a PhD trained scientist who has focused on scientific advances in optical genome mapping for the past 12 years. Alex received training during his PhD in cancer genetics, biochemistry, and biophysics at the Roswell Park Cancer Institute. He focused his research on novel technology and received a patent as coinventor for a method for detection of protein-protein interactions. After a post-doctoral fellowship at the Max Planck Institute in Munich, Germany, he joined Bionano Genomics as a scientist, where he has been an inventor on multiple patents and coauthored over 90 peer reviewed publications. Currently, Alex serves as vice president of clinical and scientific affairs where he leads clinical trials and the company’s scientific publication portfolio.

After completing a PhD at the University of Glasgow, Catriona started work as a lab analyst with BioOutsource, a CRO based in Glasgow, Scotland that was acquired by Sartorius in 2015. Catriona has since held positions in Operations management, technical sales and product development teams. Key areas of interest include development, qualification and validation of analytical methods and bioassays in a GXP environment, generation of data to support claims of biosimilarity for submission to regulatory authorities and more recently, development of a suite of assays for characterisation of AAV therapeutics. In her current role, Catriona looks forward to bringing this client-focused experience to the Applications Development team and contributing to their success in producing engaging content to share with a wide audience in the biopharmaceutical industry.

As a solutions consultant at Benchling, Brian supports digital transformations at top-tier R&D organizations to help scientists get more done in the lab and work together better by leveraging a modern SaaS platform. Before Benchling he worked with genomics teams to utilize a novel sequencing modality to improve genome assembly contiguity and link phages to their microbial hosts. He received a M.S. in Materials Science and Engineering from the University of Washington and a B.S. in Biochemistry from the University of California San Diego.

Dr. Jérémie Parot is a passionate researcher with expertise in physico-chemical characterization of nanodrug delivery systems, formulation design, and production of lipid-based nanoparticles. Jérémie specializes in developing and combining analytical methods to accelerate the discovery, characterization, formulation, process development, and quality control of RNA-LNPs and is currently working on microfluidic devices to produce high-quality RNA-LNPs. He is also responsible for developing standardized methods for characterizing nanomaterials (e.g., within ASTM E56) and regulatory science. In addition, Jérémie works on multiple European project consortia and industrial projects aiming at developing, characterizing, and scaling up nano-pharmaceuticals. Since 2020, he has been working as a Research Scientist at SINTEF in Norway and previously worked at NIST (National Institute of Standards and Technology) in the USA.

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. He also is the working group co-coordinator for the NIH Common Fund program on Somatic Cell Genome Editing, one of the leaders of the Platform Vector Gene Therapy (PaVe-GT) pilot project and the co-chair of the Bespoke Gene Therapy Consortium(link is external). He also represents NCATS in the International Rare Diseases Research Consortium (IRDiRC). In May 2022, Brooks was selected as the recipient of the 2022 Sonia Skarlatos Public Service Award(link is external) by the American Society of Gene & Cell Therapy for consistently fostering and enhancing the field of gene and cell therapy. Brooks received his doctorate in neurobiology from The University of North Carolina at Chapel Hill. After completing a postdoctoral fellowship at The Rockefeller University, he became an investigator in the NIH intramural program, where he developed an internationally recognized research program focused on two distinct areas: the molecular basis of alcohol-related cancer, and rare neurologic diseases resulting from defective DNA repair, including xeroderma pigmentosum, Cockayne syndrome and Fanconi anemia.

Amicia Elliott is a scientist and product leader working at the intersection of life sciences, technology development, and entrepreneurship. At Form Bio, Dr. Elliott leads product strategy for biological computing, workflow development, user experience for scientific platform features, and laboratory validation of machine learning models. Prior to this role, she was a Research Fellow at the NIH in behavioral neuroscience and high- resolution optical imaging. Dr. Elliott’s scientific expertise is in genetics, light microscopy and optical engineering, and computer vision machine learning. She has experience in academia and government leading science policy efforts in biomedical research and ethical AI, and is a 2x Founder and Scientific Advisor. Dr. Elliott completed a postdoctoral fellowship at the NIH/NIGMS, received her Ph.D. from Vanderbilt University in the Department of Molecular Physiology and Biophysics, and earned her B.S. in Genetics at Purdue University.

Mikael has been interested in life sciences for as long as he can remember. He studied chemistry at University of Göteborg, Sweden, and obtained his B.Sc. in chemistry in 1984. He then worked at Astra Hässle (today part of AstraZeneca), studying the K+/H+-ATPase inhibitor omeprazole, which became the bestselling pharmaceutical drug of its time for treating ulcers. In 1988, he received his Ph.D. in physical chemistry for studies of nucleic acid interactions with polarized light spectroscopy. After post-doctoral studies on transcriptional foot-printing (Melbourne, Australia), and chromatin and epigenetic modulation of nucleosomes (Yale, USA), he started his own research group in Göteborg on DNA-ligand interactions. His group discovered a novel mechanism of transcriptional activation of oncogenes, which led to the development of a new class of anticancer drugs targeting specific quadruplex DNA structures. Mikael’s team also developed methods for multidimensional data analysis (based on which MultiD Analyses AB was founded), and invented the light-up probes for nucleic acid detection in homogeneous solution, which led to the foundation of LightUp Technologies AB as Europe’s first company focused on quantitative real-time PCR (qPCR)-based diagnostics. In 2001, Mikael founded TATAA Biocenter as a center of excellence in qPCR and gene expression analysis, initially as a training institution and later as a custom service and high-quality reagent provider. During his career, Mikael has registered 21 patents and has founded five biotechnology start-up companies focused. He has also authored over 170 original research papers and 19 reviews in international peer-review journals that have been cited more than 15,000 times. Mikael also co-authored the MIQE guidelines for RT-qPCR analysis, which receives an average of 25 citations per week, and is a member of the CEN/ISO group drafting guidelines for the pre-analytical process in molecular diagnostics.

Martin Michaelis received his Pharmacy Degree (Approbation, 1998) and his PhD (2001) from the Goethe-University, Frankfurt am Main, Germany. He then worked as a postdoc and later a deputy group leader in the research group of Professor Jindrich Cinatl at the Institute of Medical Virology (Goethe-University, Frankfurt am Main, Germany) and the Dr Petra Joh-Haus, a private research institute run by the Frankfurter Stiftung für krebskranke Kinder in Frankfurt am Main. In 2011, Martin joined the School of Biosciences at the University of Kent (Canterbury, UK) as Professor of Molecular Medicine). He runs a joint wet/ dry laboratory research group together with Mark Wass (Professor of Computational Biology at Kent).