The Chain: Protein Engineering Podcast Cambridge Healthtech Institute

Dr. Nimish Gera, Head of Biologics at Mythic Therapeutics, sits down with Christina Lingham, Executive Director of Conferences and Fellow at Cambridge Healthtech Institute, in this Episode of the Chain to talk about how the developability of bispecific antibodies topic came about, how the field is changing, new bispecific molecules coming through the pipeline, and his expectations for the future.

Rene Hoet is working for over 20 years in Biotech and Pharma Industry focusing on Antibody Research and development.
Since April 1 2021 Rene works as Chief Scientific Officer at Montis Biosciences, Leuven, Belgium to develop the next generation Immuno-Oncology drugs using a novel approach interfering in the Tumor Endothelial Cell and Perivascular Macrophage Interactions to restore a immunocompetent tumor microenvironment.
From Oct. 2018 till 26 March 2021 Rene worked as Chief Scientific Officer at Imcheck Therapeutics (Marseille, France) reporting to the CEO where he built up a successful mAb research & development group on first in class mAbs (and bispecifics) in immune-oncology targeting butyrophilins and immune modulating gammadelta T cell and macrophage subsets. In Nov. 2019, Rene together with the CEO raised 48 M euro series B investment and moved ICT01 an antibody to BTN3A1, the first activating gammadelta T cell mAb, from preclinical stage into the clinic (start clinical trial March 2020).
From 2010-2018 Rene worked for Bayer AG as Vice President Biologics Research (Cologne, Germany), part of the Biologics Research & Development leadership team at Bayer reporting to the Sr. VP. Biologics Research & Development. His group was responsible for Antibody Discovery and Optimization for all therapeutic areas in Bayer (incl. Cardiovascular Diseases, Oncology, Gynecology,Hematology and Autoimmunity) and during this period a number of antibodies from Bayer´s  internal pipeline entered into the clinic. Anetumab (Mesothelin-ADC), FXIa  (phase II), C4.4.a-ADC, FGFR2-ADC, PRLR, TIFPa, CD22-TTC, CEACAM6 (all phase I). 
In addition Rene was appointed in 2012 to extraordinary Prof. Biopharmaceutics at the University of Maastricht, The Netherlands to guide researchers to use antibodies to Bridge the Gap between academic research and pharma applications.
Between 2008-2010 Rene worked at Genmab as Sr. Director Research and was heading up Product Related Research, Scientific Communication & Translational Research. His team was driving new Antibody Discovery Programs and was also actively supporting Clinical Antibody Programs of Ofatumumab (CD20) (FDA approved 2009) and Daratumumab (CD38) (FDA approved 2015). 
From 1997-2008 Rene had various positions at Dyax and became V.P. Research and Operational Manager of Dyax sa. Rene and his team were driving internal Antibody Lead Discovery (in Dyax Liege Belgium and Cambridge US) as well as external collaborations and supporting out-licensing of Dyax antibody phage libraries. From the antibody phage libraries he developed at Dyax now 4 antibodies have been approved Ramucirumab (KDR), Lilly, 2014, Necitumumab (EGFR), Lilly, 2015, Avelumab (PDL-1) EMD Serono/Pfizer, 2017, and lanadelumab (kallikrein), Shire, 2018). In addition over 10 antibodies from this mAb library from various companies are still in clinical trial. Rene obtained his PhD at the Un. Nijmegen, the Netherlands and performed a post-doctoral study at the Un. Cambridge U.K.with Prof. G. Winter (nobel prize winner 2018). He contributed to over 40 scientific papers and is inventor on 20 patent /patent applications.

A University of Alabama Birmingham researcher was frustrated with inconsistent solutions and processes for purifying unique proteins and set out to develop a new approach for high throughput protein purification. Thus was the seed idea for TriAltus Bioscience, which aims to bring protein purification technology from the research bench to the production environment. The Chain spoke with Bob Shufflebarger, CEO of TriAltus to give the background story and insights into future developments. TriAltus lab manager Naomi Logsdon joined the conversation to share her scientific background and passion for discovery, plus explain the novel technology used in TriAltus purification.

Naomi Logsdon, Lab Manager, TriAltus Bioscience
Naomi Logsdon is a molecular biologist and laboratory manager with over 30 years of experience and an outstanding record of scientific research in both academic and industrial settings.  She is a co-author on more than 40 peer-reviewed publications and holds two gene patents. Logsdon graduated from Rice University cum laude with a B.A. in Biology.  She began her research as an undergraduate assistant and was co-author on four research publications studying oxygen radical toxicity.  Cell biology and cancer were the focus at subsequent positions at Baylor College of Medicine, DuPont Merck Pharmaceuticals, and the University of Delaware.  Protein expression and purification became an area of interest at AstraZeneca Pharmaceuticals, where she evaluated several expression systems for use in high-throughput screening.  She also cloned two novel potassium channels as potential drug targets.  She later joined the University of Alabama at Birmingham (UAB) at the Center for Biological Sciences and Engineering, where her protein expression and purification skills were applied to crystallographic studies of interleukins.  She held managerial and technical positions in several other labs at UAB prior to joining TriAltus in 2019. 
Bob Shufflebarger, CEO, TriAltus Bioscience
Bob Shufflebarger is a life sciences industry veteran. He has more than 25 years’ experience in various facets of life science and technology businesses, from his earliest years working at the scientific bench to experience directing operations, finance, and marketing; developing turnaround strategies, and initiating and completing licensing deals. Shufflebarger founded TriAltus Bioscience in 2017 to commercialize novel protein purification technology from the University of Alabama at Birmingham.
Prior to TriAltus, Shufflebarger worked at Atherotech Diagnostics for 16 years, where he held positions within the company including Finance Director, Vice President of Operations, and Chief Operating Officer. As COO he initiated a business pivot that led to revenue turnaround and substantial growth, culminating in sale to a Private Equity firm and eventual growth to more than $100M in annual revenue.
Shufflebarger earned a B.S. in Chemistry from Birmingham-Southern College and an MBA from Duke University. He was a member of the Board of Directors of the Birmingham Venture Club for 10 years, and served Board President in 2015 and 2016. He chaired the American Heart Association’s Heart Walk in 2015 and is a 2019 graduate of Leadership Birmingham. 

The Chain looks back to earlier this year when researchers virtually convened on the one-year anniversary of the first documented case of COVID-19 in the United States. This episode brings you a panel discussion from PepTalk Protein Science and Production Week, moderated by Karla Satchell, PhD, Professor of Microbiology and Co-Director of the Center for Structural Genomics of Infectious Diseases at Northwestern University. The panel discusses the role of data integration for the rapid R&D of therapeutics and vaccines, the immediate challenges in the new year – as the Delta variant spreads this summer in the United States -- and how we can transform nearsighted lessons learned into a farsighted vision of pandemic preparedness. 

Moderator: 
Karla Satchell, PhD, Professor, Microbiology; Principal Investigator and Co-Director, Center for Structural Genomics of Infectious Diseases, Northwestern University


Panelists:
William Gillette, PhD, Principal Scientist, Protein Expression Laboratory, Leidos Biomedical Research
Arvind Ramanathan, PhD, Computational Biologist, Argonne National Laboratory
Erica Ollmann Saphire, PhD, Professor, La Jolla Institute for Immunology
Anupam Singhal, PhD, Senior Product Manager, Antibody Discovery, Marketing, Berkeley Lights, Inc.

Nancy Sajjadi joins The Chain to share her quality control knowledge and experience of adopting a quality-by-design approach for assays. We discuss how the focus of her QC work has changed through the years, and what kind of challenges she foresees as the cell and gene therapy fields move forward. Ms. Sajjadi talks about consulting with clients who are developing cutting edge therapies and explains her approach of creating a “culture of quality” within scientific organizations to lead to more successful outcomes.   
Nancy Sajjadi, Independent Quality Consultant
Nancy Sajjadi, M.Sc. is an independent quality consultant with over 30 years of experience in biopharmaceutical product development. She began her career as a bench scientist doing malaria vaccine research before turning to development of cell and gene using therapy retroviral vectors for infectious disease, cancer, and cell therapy applications. Her responsibilities there included research, development, and quality control. She left her position as Director of QC at Chiron Technologies Center for Gene Therapy, in 2000 and to start a consulting business.   
She has provided services to biopharmaceutical companies, contract laboratories, non-profit organizations, universities, and US government agencies. She has assisted clients in the development, implementation, and improvement of quality programs for a range of biopharmaceutical products in early phase development.  She also has provided technical expertise in assay development, qualification, and validation. Ms. Sajjadi has authored several articles pertaining to bioassays and viral gene therapy, has served on 5 advisory panels for the United States Pharmacopeia (USP) and teaches introductory courses in bioassay design, development, and validation for non-statisticians.
 

In this episode, Dr. Willem Overwijk returns for a conversation with Dr. Éric Vivier. Dr. Vivier is a professor of immunology at Aix-Marseille and a hospital practitioner at Marseille Public University Hospital. Éric Vivier is also the Chief Scientific Officer at Innate Pharma, a clinical-stage biotech company that creates novel antibodies that activate the immune system to treat patients with cancer. They discuss Dr. Vivier’s scientific background, the importance and the potential of Natural Killer cells, and the next wave of immunotherapy.