The Chain: Protein Engineering Podcast

In this episode of The Chain, host Tariq Ghayur, PhD, Tariq Ghayur Consulting, LLC, talks with Pamela Barney, former associate director of HR, AbbVie, about her career within biotech/pharma organizations and some key lessons learned, such as taking advantage of your contacts and network, managing diverse workforces, and HR's role in creating an engaged team. Barney also discusses why she entered the HR field and the challenges of culture changes when transitioning from a small organization to a large company. AbbVie: https://www.abbvie.com/   

In this episode of The Chain, host Brandon DeKosky, associate professor, speaks with MIT colleague Jessica Stark, Underwood-Prescott career development professor, about glycans and why they are important in cancer research. Stark discusses how she became interested in immunology, what her PhD and post-doctoral training was like, her thoughts on singlets operating as part of a network of checkpoint molecules, and what's currently going on in glycobiology. She also talks about her keynote presentation at PEGS 2025 and what her new lab is working on. LINKS: MIT Department of Chemical Engineering MIT Department of Biological Engineering MIT 

March 11, 2025 | In this episode of The Chain, host Andrew Buchanan, principal scientist at AstraZeneca, and Andreas Plückthun, professor and head of biochemistry at the University of Zurich, discuss AI/ML technologies in the antibody and protein engineering space. Plückthun shares his perspectives on what technologies show promise and success, why the definition of epitope is important when developing a drug, and what aspects he expects to improve in the ML field in the future.  

February 21, 2025 | This episode marks the 50th anniversary of one of the most influential papers in biomedical science—the 1975 Milstein and Köhler paper on hybridoma technology, which paved the way for monoclonal antibodies. Ralph Minter, Biotech CSO/CTO, discusses this important milestone with a true pioneer in the field, Sir Greg Winter, Nobel Laureate and one of the key figures in the development of therapeutic antibodies. 

In this episode of The Chain, host Andrew Bradbury, CSO of Specifica, an IQVIA business, speaks with Randolph Lopez, CTO and co-founder of A-Alpha Bio, about how A-Alpha Bio is changing the game of protein-protein interactions with their platform AlphaSeq. Lopez delves into the origins, the process, the successes, and the possibilities of the company's platform and how it can help with epitope mapping, affinity predictions, and off-target binding. With the data the platform generates, Lopez also discusses how this affects the potential of AI and ML. LINKS:    Bionavigen A-Alpha Bio Specifica 

November 12, 2024 | In this episode of The Chain, host Rakesh Dixit, PhD, DABT, president and founder of Bionavigen Oncology and Regio Biosciences, speaks with Anthony Tolcher, M.D., FRCPC, cofounder of NEXT Oncology, about antibody drug conjugates (ADCs) including the role of the bystander effect, approaching targets in oncology, dual-payload technologies, the potency of new payloads, and bispecific targeting. Tolcher also shares what inspired him to pursue oncology, how he came across ADCs, and where he sees ADCs heading in the future.        LINKS:    Bionavigen NEXT Oncology 

October 15, 2024 | In this month's episode of The Chain, host Rakesh Dixit, PhD, DABT, president and founder of Bionavigen Oncology and Regio Biosciences, and John Lambert, PhD, consultant, about antibody drug conjugates (ADCs) then, now, and beyond. Lambert shares his experiences from his decades-long career at ImmunoGen, why ADCs are more successful now compared to in the past, and where he sees ADCs going forward. He also discusses his thoughts on the half-life of diffusible payloads, the toxicity of the bystander effect, and more.  LINKS:BionavigenImmunoGen 

September 10, 2024 | In this episode of The Chain, host Nimish Gera speaks with Tariq Ghayur, founder of FairJourney Biologics (and a fellow host of the podcast), about the current renaissance of bispecifics and ADCs, the impact of AI in pharmaceuticals, and what to watch out for in the biopharma space in the next few years. Ghayur also shares his journey from BASF Pharma to AbbVie, what it was like when the industry shifted its focus from small molecules to biologics, and the major differences between doing a postdoc in academia versus in the industry. 

In this episode of The Chain, host Nimish Gera, Ph.D., vice president of biologics at Mythic Therapeutics, speaks with Peyton Greenside, CSO and co-founder of BigHat Biosciences, about the role of AI and machine learning in antibody engineering and targeting complex modalities, including bispecifics and ADCs. Greenside also discusses the work her organization does, what BigHat is doing to ensure the quality of data to train their AI models with, the methods of approaching harder targets such as GPCRs, and certain properties that AI can optimize better. 

In this episode of The Chain, host Brandon DeKosky, associate professor at MIT, speaks with Andrew Kruse, PhD, professor of biological chemistry and molecular pharmacology at Harvard University, about protein signaling and structural biology. Kruse explains what exactly bias signaling is and discusses the problems he and his team are working to resolve, as well as the tools they use to work out the dynamics of structures. He also shares the findings in signaling receptors and biology that he's most excited about, recent advancements that have caught his attention, and the new directions for him and his lab.  

his special episode of The Chain features a panel of industry experts who discussed AI and ML in antibody discovery and engineering at this year's PEGS Boston event. Peter Tessier, professor at the University of Michigan; Andrew Bradbury, CSO at Specifica; Andrew Waight, Senior Director of Machine Learning, Discovery Biologics & Protein Sciences at Merck Research Labs; Peyton Greenside, Co-Founder & CSO of BigHat Biosciences; and Paolo Marcatili, Director of Antibody Design at Novo Nordisk take on where AI/ML has the biggest impact, what the hype is in the use of AI/ML in antibody discovery, how new AI/ML methods are being benchmarked against traditional discovery methods, and what controls should be used in an AI/ML discovery or optimization campaign. 

In this episode of The Chain, host Tariq Ghayur, PhD, consultant and entrepreneur in residence, FairJourney Biologics, speaks with Tomoyuki Igawa, PhD, chief executive officer, Chugai Pharmabody Research in Singapore, about his 20+ years of experience in drug discovery and development. Igawa possesses a unique perspective that has allowed him and his team to develop innovative concepts, such as recycling sweeping antibodies and bispecific platforms. He discusses how the discovery and development organizations work together to provide a steady supply of products, how he builds the right team when starting a new project, and how to keep team members engaged and motivated. He also offers advice for young scientists on the importance of enjoying their work and how to maintain work-life balance. 

This month The Chain shares a recent episode of the Lab Rats to Unicorns podcast. Lab Rats to Unicorns, hosted by John Flavin, aims to demystify the process of creating a great company in the life sciences, biotech, medtech, clean energy, and beyond. In this episode, Flavin speaks with Lesley Millar-Nicholson, executive director of MIT's Technology Licensing Office (TLO). Millar-Nicholson discusses the role of the TLO, what happens after a patent is filed and licensed to a company or start-up, how she got her start in the field, and her journey from Scotland to the U.S. She also delves into finding the right people for the best team, the importance of a diverse workforce and awareness, and being around science as a non-scientist. 

In this month's episode of The Chain, host Ben Hackel, professor of Chemical Engineering & Materials Science at the University of Minnesota, speaks with Gabriel Rocklin, assistant professor of Pharmacology at Northwestern University, about two recently published papers from Rocklin's lab: one on advancing the ability to design challenging typologies and one on developing and leveraging a new technique on high-throughput protein biophysics. Rocklin shares the journey from ideation to realization of the research process, the inspiration that motivated the work, and interesting results and technological advancements discovered along the way. He also talks about the opportunities emerging from his team's research and the challenges that still need overcoming, as well as offers advice for future scientists interested in protein biophysics.  

How does one maintain innovation in the antibody industry? In this episode of The Chain, host Tariq Ghayur, PhD, consultant and entrepreneur in residence, FairJourney Biologics, talks with Janine Schuurman, PhD, president of The Antibody Society, independent biotech consultant and founder of Lust for Life Sciences, about her inspiration to get into antibody engineering, her impressive career at Genmab, advice for a productive work environment, and her current work. Dr. Schuurman also shares insights on staying innovative, how to deal with the challenges of the industry, why young scientists should not be afraid to fail, as well as her plans as the new president of The Antibody Society. Links:   Lust for Life Sciences: https://www.lustforlifescience.com/  The Antibody Society: https://www.antibodysociety.org/  FairJourney Biologics: https://fjbio.com/  

Bispecific antibody drug conjugates (ADCs) have been undergoing a renaissance in recent years. As big pharma continues to express more interest, what can the field expect for the future of ADCs? In this episode of The Chain, Nimish Gera, Ph. D., Vice President of Biologics of Mythic Therapeutics, speaks with Rakesh Dixit, Ph. D., President & CEO of Bionavigen, about his thoughts on the future of bispecific ADCs, what to keep in mind when selecting targets, and how to choose the right payload. Dr. Dixit also shares his 35 years of experience with top biotech and pharmaceutical companies, including Merck, J&J, and AstraZeneca, and how he is using his expertise to advise companies with their drug development programs. 

What can we expect from GPCRs in antibodies and biologics? In this episode of The Chain, host Rajesh Sundaresan, PhD, Scientific Leader and GSK Fellow of Protein Cell and Structural Sciences at GlaxoSmithKline, speaks with Thomas P. Sakmar, MD, Professor of Chemical Biology at Rockefeller University, about the history of GPCRs and various subunits, his early work with rhodopsin, and the impact of crystallography and structural work. He also shares how he got started with molecular biology training, as well as his thoughts on the state-of-the art for both biologics and small molecules in drug discovery.  LINKS:    Rockefeller University: https://www.rockefeller.edu  GlaxoSmithKline: https://www.gsk.com/en-gb/   

In this episode of The Chain, Richard Bonneau, PhD, and Marcel Hop, PhD, of Genentech interview Tala Fakhouri, PhD, of the FDA on her thoughts on the discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biologic Products” and the evolving role of AI/ML to create models and inform decisions in biopharmaceutical development and regulatory submissions. Dr. Fakhouri also discusses the impact AI/ML models could have on clinical trial conduct, patient enrollment, patient selection, and data interpretation. She also talks about the next steps to get the right processes in place and why transparency is important to establish trust with patients about AI/ML tools. 

With the whirlwind development of AI, it can be difficult to keep track of its uses in both research and the market. In this episode of The Chain podcast, host Ben Hackel, Professor of Chemical Engineering & Materials Science at the University of Minnesota, speaks with Enkelejda “Ledi” Miho, Professor of Digital Life Sciences at the University of Applied Sciences Northwestern Switzerland FHNW, who breaks down the current state of AI and its role in drug development. She talks about the opportunities of AI and drug discovery and how digital biomarkers and molecular data are helping with personalized medicine. Miho also discusses the challenges of advancing AI, why having an “adisciplinary” approach is the key to assembling the right team, and how to design studies to be as broadly robust as possible, as well as the advancements of her and her team's own research. 

What is the first step of getting into biotech? How do you make real progress in research? In honor of Ovarian Cancer Awareness Month, host Nimish Gera discusses these topics and more with Jonathan Sockolosky, PhD, Director of CSO Partner Team at Curie.Bio, in this special episode of The Chain. Jonathan details how he got started in biotech, what inspires him to keep going, his personal interests in ovarian cancer treatments, and what he does to raise funds to further ovarian cancer research. Jonathan also offers advice on how others can get involved in causes they are passionate about and how to give back to the community, as well as the progress that has been made in ovarian cancer therapy. Links from this episode:  Curie.Bio Mythic Therapeutics  

In this episode of The Chain, Brandon Dekosky, Associate Professor at MIT, speaks with Adrian Bot, Founding Chief Scientific Officer and Executive Vice President of R&D at Capstan Therapeutics, about his experiences in leadership roles, his scientific journey, and how he started work on immunotherapy for cancer. Bot also shares what it's like to be a “serial scientific entrepreneur” and the importance of networking to assemble a team that shares mutual interests, as well as how to motivate young scientists and researchers coming into the biotech industry. Finally, he discusses why he finds flat organizational structures with smaller teams more effective and what he does to maintain innovation. 

In this special episode of The Chain, G. Jonah Rainey, Senior Director of Protein Engineering at Eli Lilly and Company, hosts a panel at PEGS 2023 to discuss strategies to engineer parameters for solid tumor-targeting T-cell-engagers. Guests Stephen J. Demarest from Tentarix Biotherapeutics, Michelle Morrow from F-Star Therapeutics, Inc., and Dario Neri from Philogen provide their insights and experiences on navigating challenges, researching treatments, and the positives and negatives of certain targeting strategies. They also answer questions from the audience and share their perspectives on the future of tumor-targeting and what technology can do to help with developing effective cures. Links from this episode:  PEGS Boston Conference & Expo Engineering Bispecific Antibodies Eli Lilly and CompanyTentatrix Biotherapeutics   F-Star Therapeutics, Inc. Philogen 

In this month's episode of The Chain, Greg M. Thurber, associate professor of chemical engineering and biomedical engineering at the University of Michigan, sits with moderator Nimish Gera, vice president of biologics at Mythic Therapeutics, to talk about the development of antibody drug conjugates (ADCs). Thurber details the history of ADCs and the skepticism facing the field during the mid-2010s, despite showing great promise in anticancer treatment. He also discusses how recent FDA approvals and breakthroughs have reignited interest and pivoted research toward designing more successful ADCs. Finally, he shares his thoughts on the exciting developments in the field in the next few years, including how ADCs could play a key role in polytherapy.  

Kyron.Bio is revolutionizing drug production with its Next Generation Bioproduction Platform that will make the production of therapeutics easier, cheaper and faster. Voldborg and McLaughlin talk about their shared vision for using synthetic biology to improve the production of therapeutic proteins.   Kyron.Bio: https://kyron.bio/  

In this month's episode of the Chain, guest Peter Tessier, Albert M. Mattocks pharmaceutical sciences and chemical engineering professor at the University of Michigan, speaks with moderator Tariq Ghayur, scientific advisor and entrepreneur in residence at FairJourney Biologics, about expediting the developability of antibodies. He discusses the characteristics that best predict a molecule's drug-like properties, the different assays used for various intended outcomes, and why every scientist must assess the “greatest potential impact” before embarking on a new experiment. Tessier also talks about the core traditions that help him lead students in the lab while fostering a learning environment of ownership, integrity, and self-motivation. Last, he shares his predictions on how computational data will advance antibody discovery and developability in the future.  

Dr. Andrew Anzalone, head of the Prime Editing Platform and scientific co-founder at Prime Medicine, is the winner of the PEGS Boston 2023 Young Scientist Keynote. He was invited to sit down with Brandon DeKosky, assistant professor of chemical engineering at MIT, to discuss prime editing and its precision in treating inherited genetic mutations. Anzalone outlines the next generation tool's advantages over traditional CRISPR methods and the mechanism creating fewer gene editing errors. He also discusses his clinical training and background, the ongoing projects at Prime Medicine in engineering proteins for cell-based therapeutics, and his thoughts on the current challenges and future developments in gene editing and precision medicine. Links from this episode:  Prime Medicine PEGS Boston Conference & Expo   

Jan Terje Andersen, professor of biomedical innovation in the Department of Pharmacology at the University of Oslo and research group leader in the Department of Immunology at the Oslo University Hospital, has spent nearly two decades studying neonatal Fc receptors (FcRns) and their interactions with prominent blood proteins albumin and IgG. He sits down with moderator Nimish Gera, vice president of biologics at Mythic Therapeutics, to discuss the unique properties of FcRn and how it can be leveraged for novel therapeutic development. Additionally, Andersen details the mechanics of FcRn binding, why it prolongs albumin and IgG half-lives, and notable FcRn technological advancements and research findings in animal and human models. He also talks about engineering blood proteins for optimal function and launching his new venture, Authera, the preclinical stage biotech company using an FcRn-centered platform to study the receptor's versatility across multiple cell types. Links from this episode:  University of Oslo Mythic Therapeutics Authera 

In this month's episode of the Chain, Jim Wells, professor of pharmaceutical chemistry and cellular and molecular pharmacology at the University of California, San Francisco, sits down with moderator Ben Hackel, associate professor of chemical engineering and materials science at the University of Minnesota, to discuss Wells' work in advancing targeted protein degradation. Wells outlines the key design elements of targeted protein degraders and their general mechanism of action, how his lab developed antibody-based PROTACs—also known as AbTACs—to target extracellular proteins, and the innovative work from industry leaders that inspired his lab's discoveries. He also speaks about the lingering questions driving ongoing and future projects, the challenges facing the protein degradation space, and why he considers himself a “pirate of biology” rather than an inventor. Links from this episode:  University of California, San Francisco University of Minnesota Development of Antibody-Based PROTACs for the Degradation of the Cell-Surface Immune Checkpoint Protein PD-L1 PEGSBoston Conference and Expo 

Over the last two decades, cryogenic electron microscopy (cryo-EM) has transformed from what Dr. Andrew Ward calls the “outcast of structural biology” to one of the most promising technologies in the field. Ward, professor of integrative structural and computational biology at Scripps Research Institute, speaks with moderator Brandon DeKosky, assistant professor of chemical engineering at the Massachusetts Institute of Technology, about the evolution of cryo-EM and how its direct detector transformative technology enables scientists to craft favorable antibody responses. Ward also talks about cryo-EM's technological advantages when working with proteins, sterilizing immunity, and designing accurate structural biology pipelines that lead to next-generation vaccines. Finally, Ward offers his predictions about the immunological breakthroughs he thinks structural biologists will accomplish in the very near future.  Links from this episode:  Scripps Research Institute PepTalk Conference Discovery on Target Conference 

Dame Jane Osbourn, chief scientific officer at Alchemab Therapeutics, speaks with Ahuva Nissim, antibody and therapeutic engineering professor at Queen Mary University of London William Harvey Research Institute, about the career path that took her from studying molecular biology and building human phage libraries to developing therapeutics with convergent protective antibodies. Osbourn talks about the most inspiring mentors of her career, her interest in immunological resiliency, the importance of studying neurodegenerative diseases, and her drug discovery work at Alchemab Therapeutics. Finally, she talks about the technological advancements she hopes will move precision medicine forward in the near and distant future.  

Charlotte Deane, professor of structural bioinformatics at the University of Oxford and upcoming speaker at the 14th Annual PEGS Europe Conference in Barcelona, joins moderator Brandon DeKosky, assistant professor of chemical engineering at the Massachusetts Institute of Technology, to discuss the use of machine learning in antibody structure prediction. In this episode, Deane talks about her lab's AI tools for high-throughput prediction pipelines and why collecting general antibody property data will produce better models. She also speaks about the importance of using and building publicly available data sets and her thoughts on what it will take to finally generate a complete antibody design from a computer. Links from this episode:  University of Oxford Department of Statistics SAbDAb: The Structural Antibody Database PEGS Europe The Critical Assessment of protein Structure Prediction (CASP) 

After over 25 years as an intellectual property (IP) attorney, Jane Remillard, Nelson Mullins patents and biotechnology IP senior partner, is well-versed in navigating drug development and antibody patent law. In this episode, Remillard speaks with moderator Nimish Gera, Mythic Therapeutics vice president of biologics, about the intersection between science and law, the primary steps recommended to patent a scientific discovery, and how the antibody IP landscape has evolved in recent years. She also talks about the importance of implementing a strategy regarding the number and types of antibody patents filed, her advice to anyone considering a career in IP law, and what to expect from the industry moving forward. Links from this episode:  Nelson Mullins Mythic Therapeutics 

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 BioscienceNaomi 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 BioscienceBob 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 UniversityPanelists:William Gillette, PhD, Principal Scientist, Protein Expression Laboratory, Leidos Biomedical ResearchArvind Ramanathan, PhD, Computational Biologist, Argonne National LaboratoryErica Ollmann Saphire, PhD, Professor, La Jolla Institute for ImmunologyAnupam 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 ConsultantNancy 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.

This episode of The Chain features a live panel discussion moderated by Erica Ollmann Saphire, PhD of La Jolla Institute for Immunology. Expert panelists from academia and government assess the COVID-19 antibody and vaccine development thus far, including what did and did not go well during the pandemic. They also look towards the future and the role mRNA vaccines may play for diseases like influenza, what we learned about the United States’ ability to manufacture during surge production, and what infrastructure is still needed to fight both the current crisis and future outbreaks. Erica Ollmann Saphire, PhD, Professor, La Jolla Institute for ImmunologyPeter Hotez, MD, PhD, FASTMH, FAAP, Dean, National School of Tropical Medicine; Professor, Departments of Pediatrics, Molecular Virology & Microbiology; Co-Head, Section of Pediatric Tropical Medicine; Health Policy Scholar, Baylor College of MedicineLakshmi Krishnan, PhD, Vice-President, Life Sciences, National Research Council Canada, Government of CanadaPeter W. Marks, MD, PhD, Director, FDA CBER

The Center for Structural Genomics of Infectious Diseases at Northwestern University was prepared for COVID-19 long before the United States economy shut down. Now over a year since COVID-19 was first recorded in the U.S., co-director Dr. Karla Satchell speaks with The Chain about the role of structural genomics in preparing for disease outbreak and response.Karla Satchell, PhD, Professor, Microbiology; Principal Investigator and Co-Director, Center for Structural Genomics of Infectious Diseases, Northwestern UniversityDr. Karla Satchell is a Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine since 2000. She is also the Principal Investigator for the NIAID-funded Center for Structural Genomics of Infectious Diseases, a multi-site center in high-throughput structure determination for microbial pathogens. In 2020, the Center dedicated significant resources to structural biology of SARS-CoV-2, including efforts to provide structural biology data to support development of novel drugs, vaccines, and therapeutics. Across all areas of research, she has published more than 100 research articles. She has also been elected as a Fellow for the American Academy of Microbiology and the American Association for the Advancement of Science. 

Linoleic acid is an essential free fatty acid in the human body and its metabolic pathway is central to immune regulation and inflammation – which are also key symptoms in COVID-19. Using cryo-electron microscopy, Christine Toelzer’s research identified linoleic acid bound to a hydrophobic pocket of the SARS-CoV-2 glycoprotein. Christine shares her thoughts on how these findings will contribute to the fight against COVID-19 and how her lab work has been altered by the pandemic. Christine also discusses the future of other young scientists coming up in the protein science space. Christine Toelzer is currently a Research Associate at the University of Bristol. After a M.Sc. in biology and an additional M.Sc. in physics she continued with PhD work in biochemistry at the University of Cologne. Her research has always focused on structure function relationships, starting with structure determination of biotechnologically important proteins by x-ray crystallography, magnetic structure determination of inorganic compounds by neutron diffraction and recently using electron cryo-microscopy to obtain the structure of large protein complexes involved in transcription and diseases. In the last year (2020) she started coronavirus related work to contribute to the global effort aimed at better understanding the virus and uncover its potential weaknesses.About the Young Scientist Keynote Award:This recognition honors a young scientist from the international protein science community who has contributed to scientific advancement and innovation in this field. Nominations were solicited from across academic and industry research groups in the fall of 2020, and the finalists were determined through the votes and input of our 15-person advisory panel.

In this episode we talk with Dennis Karthaus of IBA Lifesciences about his early science interests and pursing his PhD. His passion for marine biology eventually led him on a path to study biotechnology, where he now focuses on protein expression and purification. Specifically, tag-based purification that can help researchers increase lab productivity. But, as our guest explains, scientists should consider their specific bottlenecks and applications for the protein of interest, to determine if a tag is right for them. 

In a roundtable discussion, three experts bring perspectives on different methods for generating antibodies, including generating antibodies from naive libraries, patients, and immunizations. They discuss how the COVID-19 pandemic has highlighted the advantages of refocusing on infectious disease research. As well as the importance of having ready immune libraries and immunized mice, plus other approaches, ahead of any future infectious disease outbreak.  

The purification requirements in the biopharmaceutical industry will be even more demanding in the coming years due to increased awareness of product-related impurities like oligomers, variants, positional isomers, and glycoforms. These impurities need to be separated from the final product. Dr. Raja Ghosh’s work focuses on the design and development of efficient chromatography devices that combine high-speed with high-resolution in separation. He speaks with Dr. David Wood of the Ohio State University about how the chromatography devices he is developing address these challenges.  

On this episode of The Chain, Dr. Willem Overwijk shares his personal experience of his recent transition from academia to industry, and the differences between the two. Dr. Overwijk moved to industry, in part, to follow his research interest in a specific molecule that he had been working on since graduate studies: interleukin-2. Thanks to advances in protein engineering, this once ultra-potent molecule now can be administered with lower toxicity while still being an effective cancer therapy. We discuss IL-2, plus the exciting future of protein engineering in immuno-oncology. 

Dr. Dimiter Dimitrov, Director of the Center for Antibody Therapeutics at the University of Pittsburgh, sits down with The Chain to discuss his research and its relevance to the current pandemic. His work focuses on human VH domains, which in contrast to the animal antibody domains, like llama and shark, may have lower probability of immunogenicity. Dr. Dimitrov helps develop several such domains, most recently against SARS2, and one of which that is in production for evaluation in human clinical trials. Beyond COVID-19, Dr. Dimitrov explains that clinical trials for various cancer-related proteins and HIV are also underway, showing the vast potential for domains both for industry growth and life-saving therapies.

Dan Chen returns for the Science Commune segment and speaks with Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER). Dr. Marks reflects on his fortuitous path from academia to industry to government, plus the differences between each area. Dr. Marks explains the research and regulatory role of CBER, especially as it pertains to the latest cell therapies. And finally, the two discuss the impressive speed of COVID-19 vaccine science breakthroughs and regulatory approval.

Christian Klein is a longtime and key member of the protein and antibody community. In this episode, he speaks with Executive Conference Producer, Christina Lingham, on how the field has changed since their first collaboration. Dr. Klein offers an overview of the latest applications of bispecific antibodies, including the latest progress of clinical trials by Roche and others. He also explains how the PD1-X molecule is unique and can increase specificity of therapeutics even more.

There are no bad ideas in developing bioanalytical testing, says Jim McNally, CSO of BioAgilytix. Not all ideas will work, of course. But he has found that it is the outside-the-box ideas that often turn out to be the solution in challenging assay work. Dr. McNally speaks with The Chain about his background in bioanalytical testing and supporting clinical trials, the exciting future of cell and gene therapies, and the importance of setting precedent in bioanalysis of these new, life-saving therapies. It is an exciting time for gene therapy especially, and Dr. McNally shares how new immunogenicity data is getting us closer to bringing this therapy to more people.

There are some proteins that still evade scientists in the race for better therapeutics. Some of the most elusive drug targets in cancer research are RAS oncoproteins. In a paper published this July, researchers demonstrated the delivery of an extremely potent pan-RAS-cleaving enzyme, opening the door for the first targeted pan-RAS inhibitor for cancer therapy. In this episode we speak with two of the researchers from this project, a cancer biologist and a protein engineer, to learn what sparked their collaboration and what their system means for the future of cancer biologics.

Carolyn Bertozzi grew up in a science family with a physicist father. But it was organic chemistry that “clicked” for Carolyn and started her down the path of understanding biology at a molecular level. Daniel Chen and Carolyn Bertozzi discuss her work in glycobiology. Bertozzi’s research finds that glycosylation has consequences in immune modulation, and that glycobiology plays an important role in human disease that has historically been underexploited in drug development. Finally, Chen and Bertozzi talk about gender representation in science and the importance of female role models for both women and men.