Inside Ensoma

Jim Burns joined Ensoma from Locanabio, where he was CEO and director of the board from 2019-2023. Prior to Locanabio, Dr. Burns was CEO of Casebia Therapeutics and led the team in discovering new CRISPR/Cas9-based breakthrough therapeutics to treat blood disorders, blindness, and heart disease. Prior to Casebia, he spent the bulk of his career at Genzyme and Sanofi, where he held several leadership roles with increasing responsibility, including North America site head for R&D, where he coordinated R&D operations across key therapeutic areas. Dr. Burns is a former board member of MassBio and a member of the National Academy of Engineering. He also served as the industry representative for the U.S. Food and Drug Administration General Plastic Surgery Panel. Dr. Burns earned a Bachelor of Science degree in biology from Purdue University and Master of Science and doctorate degrees in bioengineering from the University of Illinois-Chicago, where his thesis work focused on drug delivery. Following his graduate studies, he was a postdoctoral researcher at the University of Florida.

Jon Garen has over 20 years of experience in Business Development, M&A, Corporate Strategy, Alliance Management, and Commercial Planning in organizations ranging from large pharmaceutical to startup biotechnology companies. He has completed over 25 licensing and acquisition deals, leading to multiple approved products and billions in revenue.

Jon served as Chief Business Officer for Dunad Therapeutics, Nocion Therapeutics, and the AAV gene therapy company uniQure. At uniQure, his accomplishments included leading the commercial planning for the first approved hemophilia gene therapy, the acquisition of Corlieve Therapeutics, and the partnership of uniQure’s hemophilia b program with CSL Bering. Jon was also a member of the Board of the Alliance for Regenerative Medicine. Earlier in his career, Jon was the Assistant Vice President of Business Development at Forest Laboratories, Director of Global Licensing with Pharmacia Corporation and a Founder and Vice President at Technology Exchange, Inc.

Jon holds a Master of Environmental Studies degree from Yale University and a Bachelor of Science degree in physics from the Massachusetts Institute of Technology.

Daniel Leblanc brings to Ensoma extensive experience in pharmaceutical development and operations with an emphasis on novel drug delivery systems. Prior to Ensoma, Daniel spent more than seven years at Flexion Therapeutics, where he was responsible for the technical operations and product development organizations leading the commercialization of Flexion’s first product, Zilretta®, and was instrumental in the identification, in-licensing and technical development of FX201, a novel gene therapy for the treatment of osteoarthritis.

Previously, Daniel spent more than four years as the director of pharmaceutical development at Merck Serono in Geneva, Switzerland, where he was globally responsible for drug product and process development of all large molecule programs throughout the development life cycle. He also spent 11 years at Alkermes, Inc. in various positions, specializing in the characterization and development of manufacturing processes for PLGA-based drug delivery programs, as well as the startup and operation of Alkermes’ internal manufacturing processes for Nutropin Depot®, Vivitrol® and Risperdal Consta®.

Daniel holds a B.S. from Syracuse University in chemical engineering and a joint M.S. from University of Pennsylvania School of Engineering and the Wharton School in technology management.

Rob Peters brings to Ensoma more than 20 years of research and development experience, including working on recombinant clotting Factor VIII and Factor IX Fc fusion proteins from their inception in research through manufacturing, clinical development and supporting market launch as Eloctate/Elocta and Alprolix, the first extended half-life clotting factors for the treatment of hemophilia A and B, respectively.

Prior to Ensoma, Rob was rare blood disorders head, research at Sanofi, where he helped establish the therapeutic area following the acquisition of Bioverativ, Ablynx and full control of fitusiran from Alnylam. There, he helped advance BIVV001, a further engineered FVIII fusion protein that began within his research group at Biogen, into Phase 3 clinical trials. Previously, Rob led the establishment of the research area in the Biogen spinoff Bioverativ as senior vice president, research, where he advanced a number of programs from research into clinical development and integrated a number of complement R&D programs brought in by the company’s acquisition of True North Therapeutics.

Rob began his career as the 11^th employee at the VC-backed startup Syntonix, where the promising preclinical data on the rFVIIIFc and rFIXFc fusion proteins led to the company’s acquisition by Biogen. There, he ultimately became vice president, hematology research, and oversaw the expansion of the portfolio beyond biologics to include small molecules, in vivo liver-directed lentiviral gene replacement, and ex vivo HSC gene editing programs in conjunction with academic and industry partners in hemophilia and sickle cell disease.

Rob holds a B.S. in biological engineering from Cornell University and a Ph.D. in biochemistry from the laboratory of Tom Maniatis, Ph.D., at Harvard University.

Stephanie Fedak brings over 20 years of experience in human resources, including building strong corporate cultures and employee experiences; developing leaders at all levels; coaching individuals and teams; and overall creating positive work environments.

Prior to Ensoma, Stephanie was the head of people partnering (HR BPs) at bluebird bio, where she created an exceptional high care People Partner team and co-led the rebuild of bluebird’s culture post-company split. Stephanie also coached individuals and teams to improve overall effectiveness. Prior to bluebird, Stephanie led the HR team of a mid-sized home healthcare company.

Stephanie holds a bachelor’s degree in psychology from the University of Oregon and a Master’s in Business Administration from Simmons School of Management. She is a certified coach through CTI (Co-active Training Institute) and ICF (International Coaching Federation), with training in Co-Active Leadership and neuroscience coaching.

Joe Salas brings to Ensoma an extensive track record discovering and advancing drug candidates into clinical development. Most recently, he served as the head of hemophilia and musculoskeletal disorders in Sanofi’s Rare Disease Unit, where he managed a diverse portfolio of novel therapeutics to address bleeding disorders and muscular dystrophies.

Prior to Sanofi, Joe was executive director of protein therapeutics at Bioverativ, a Biogen spinoff, where he led efforts to advance the hematology research pipeline while supporting development and life cycle management activities. Prior to Bioverativ, he started his career in biotech at Biogen, where he worked for almost a decade with increasing levels of responsibility discovering therapeutics in hemophilia and non-malignant hematology spanning a broad range of modalities, with a focus protein engineering approaches.

Joe holds a Ph.D. in microbiology from the University of Alabama at Birmingham and completed his postdoctoral training at Harvard Medical School.

Elinor brings over 25 years of extensive experience in intellectual property and legal counsel to Ensoma, having advised small and large biotech companies on legal issues, including IP strategy and procurement, lifecycle product planning, and complex transactional arrangements for early- and late-stage therapeutic programs, diagnostics, and technology platforms.

Before joining Team Ensoma, Elinor was Senior Vice President of Legal and Corporate Secretary at Chroma Medicine during its merger with Epsilen Bio. Previously, as Vice President of Intellectual Property at MyoKardia, Inc. (now Bristol Myers-Squibb), she built and led its Intellectual Property department and IP portfolio. Earlier, at Genentech, Inc., Elinor led the IP group responsible for all intellectual property matters of Genentech’s non-oncology medicines and pipeline. Before Genentech, Elinor was an attorney and patent agent in the law office of Fish & Neave in New York City.

Elinor holds a B.A. from Wellesley College, a Ph.D. in Biochemistry from Tufts University and a J.D. from Fordham University.

Chapman Wright is a technical leader who has amassed expertise in developing and transferring GMP-compliant bioprocesses across a variety of modalities. Chapman’s responsibilities at Ensoma span internal process and analytical development functions (CMC), CDMO management and program leadership roles. Prior to Ensoma, Chapman oversaw the process development team at Generation Bio, where he directed a cross-functional team to develop a production process for the company’s novel drug substance. There, his responsibilities included material generation for in vitro/in vivo preclinical studies, upstream and downstream process development, and management of CDMO operations. Previously, Chapman led teams in CHO cell culture development and gene therapy development (AAV) at Biogen, where his responsibilities covered cell line development through CMC program leadership.

Chapman holds a Ph.D. in biochemistry from the University of Delaware and completed postdoctoral training at Johns Hopkins University.

Patrick Au brings to Ensoma more than a decade of cell and gene therapy experience in both regulatory and industry functions. Prior to Ensoma, he was a senior director of regulatory, pharmacology and toxicology at Casebia Therapeutics, a gene editing company, where he was responsible for nonclinical strategy and nonclinical and clinical bioanalysis across therapeutic areas. Prior to Casebia, Patrick was a pharmacology and toxicology lead at gene therapy company Spark Therapeutics. He also served as director of regulatory affairs at Adverum Biotechnologies (formerly Avalanche Biotech). Patrick began his career at the U.S. Food and Drug Administration as a pharmacology and toxicology reviewer in CBER’s Office of Tissues and Advanced Therapies (formerly known as the Office of Cellular, Tissue and Gene Therapies).

Patrick holds a Ph.D. in medical engineering from Harvard-MIT Division of Health Sciences and Technology, and a B.S. in chemical engineering from Johns Hopkins University. He is also a certified diplomate of the American Board of Toxicology.

Betsy Bogard is dedicated to developing transformative therapies. Her younger brother Jud was born with a rare genetic disease, inspiring her to make a difference for patients and families facing debilitating conditions.

Betsy has worked in biotechnology for more than 25 years in areas that include portfolio and alliance management, program leadership, real-world evidence, registries, health economics and patient community engagement. Prior to Ensoma, she worked in gene therapy development at AVROBIO, where she was an early-stage program leader, and bluebird bio, where she was head of real-world evidence.

In addition to her role at Ensoma, Betsy is a board member for Global Genes, a non-profit organization dedicated to eliminating the burdens and challenges of rare diseases for patients and families globally, and a member of the ASGCT patient outreach committee.

Betsy holds a master’s degree in health economics and outcomes research from the Harvard School of Public Health.

Drew Dietz brings to Ensoma extensive expertise in clinical development, regulatory affairs, and research, with a particular focus on gene and cell therapy and RNA editing technologies. Prior to joining Ensoma, he led these functions for Shape Therapeutics, where he was instrumental in advancing the company’s preclinical pipeline, which includes innovations in RNA editing, next-generation AAVs, and gene therapy manufacturing.

Drew earned his medical degree from the University of Minnesota, followed by a pediatric residency at Seattle Children’s Hospital and a fellowship in hematology, oncology, and stem cell transplantation at the University of Minnesota. He spent six years in clinical and academic research, where he oversaw pediatric stem cell transplants, designed clinical trial protocols, and served as an investigator in early CAR T-cell trials for pediatric leukemia.

Transitioning to the biotech industry, Drew joined bluebird bio, where he played a critical role in the late-stage clinical trials that led to the regulatory approval of ex vivo lentiviral vector gene therapies in both the U.S. and EU. Drew has also contributed to the development of regulatory strategies and serves as a member of the ARM Gene Therapy Advisory Group and the ASGCT Diversity, Equity, and Inclusion Committee.

John DeSimone has deep financial and operational experience across multiple industries in both private and public companies. Most recently, he served as the interim head of finance at VOR Bio. John joined VOR in April 2019 to lead financial activities, build the financial infrastructure and manage the transition from incubator lab space to 70,000 square feet of lab, office and cGMP space.

Previously, John held CFO and planning roles in various companies and industries, including The Walt Disney Studios. Over his career, John has been involved in over 25 M&A transactions and related operational integrations. He began his career with PricewaterhouseCoopers.

John received a B.S. in finance and accounting from Boston College.

Prior to Ensoma, Dawn Houlihan served as senior director of QA operations at Flexion Therapeutics, where she led the QA operations team to achieve NDA approval and commercialization of ZILRETTA^®. Dawn also led quality operations for the FX201 gene therapy program, ensuring CDMO readiness, process and product control strategy, and phase-appropriate quality systems, leading to an on-time filing of the IND and first-in-human studies.

Previously, Dawn spent much of her career in a range of quality roles within Janssen Biologics, where she provided QA guidance and leadership to several monoclonal antibody programs.

Dawn holds a BSc. degree from University College Cork (Ireland), and post-graduate certifications in Upstream Biopharmaceutical Processing from Cork Institute of Technology and FDA Quality System Requirements and Industry Practice from the AAMI University.

Stefano Stella brings significant expertise in gene editing, structural biology, protein engineering and nucleic acid/protein interactions, ranging from ribosomes to TALENs and meganucleases to CRISPR systems. Prior to joining Ensoma, Stefano was the co-founder, chief technology officer, and director at Twelve Bio ApS and Associate Professor at the University of Copenhagen, Novo Nordisk Foundation Center for Protein Research, where he focused on understanding the atomic details of CRISPR-Cas12a cleavage activities.  Prior to the University of Copenhagen, Stefano held research positions at the Spanish National Cancer Research Centre and The Institute of Genetics and Molecular and Cellular Biology following completion of his postdoctoral training at University of California, Los Angeles.

Stefano holds a Master’s Degree in Biology and Biochemistry from Università della Calabria and a Ph.D. in Molecular Biology and Genetics from University of Camerino.

Yinghua Wang brings deep immuno-oncology experience to Ensoma, most recently from ReNAgade Therapeutics, where he served as Senior Director of Immunology. Before that, he headed the Boston Innovation Center at Simcere, where his team focused on developing innovative cell therapies for cancer. Previously, he directed teams and programs at Sanofi and Regeneron Pharmaceuticals, aiming to discover groundbreaking immunotherapies for cancer and inflammatory diseases. Throughout his career, his teams have successfully advanced multiple programs through key milestones, including investigator-initiated trials and IND submissions. Yinghua has also played a vital role in business development as a key opinion leader, contributing to several significant partnerships with both industry and academic institutions.

Yinghua received his Ph.D. in Immunology from Columbia University and subsequently completed a postdoctoral fellowship and served as an instructor at Harvard Medical School/Massachusetts General Hospital, where he researched metabolism in hematopoietic stem cells and leukemia.