Inside Ensoma

Emile Nuwaysir serves as chief executive officer and member of the board of directors of Ensoma. He is the ex officio chairman of the Alliance for Regenerative Medicine, an international advocacy organization comprised of 400+ member companies dedicated to advancing cell and gene medicines. He joins Ensoma from BlueRock Therapeutics, an independently operated subsidiary of Bayer Pharmaceuticals, where he was CEO and continues to serve as chairman of the company’s board of directors. As the CEO of BlueRock from inception, Emile helped build a platform company at the intersection of cellular and genetic medicine, develop a pipeline of first-in-class therapeutic programs and manage the company’s acquisition and operation with Bayer. Prior to BlueRock, he served as president and chief operating officer of Cellular Dynamics International (CDI), A Fujifilm Company. He played a leading role in growing CDI and its stem cell therapy efforts from its inception, including its early efforts as a pre-revenue startup, to its successful IPO on Nasdaq and ultimate acquisition by Fujifilm. He was also president of Opsis Therapeutics Inc., CDI’s retinal cell therapy subsidiary. Before CDI, Emile was the first employee of NimbleGen Systems, serving as a member of the senior management team that built a successful company and orchestrated a dual-track IPO process leading to the company’s acquisition by Roche Diagnostics. After the acquisition of NimbleGen, Emile served as chief technical officer of the Roche NimbleGen subsidiary. Emile is also currently vice chairman of Invenra Inc., a multi-specifics antibody platform company he co-founded in 2011.

Emile has held postdoctoral fellowships at the National Institutes of Health and the University of North Carolina at Chapel Hill. He holds a B.A. from the University of Delaware and a Ph.D. in molecular toxicology with a focus on oncology from the University of Wisconsin-Madison.

Naina Bhasin brings to Ensoma nearly 15 years of life sciences experience in corporate and business development, strategic planning and operations. Most recently, she was the chief of staff to the CEO at Intellia Therapeutics, a genome editing company utilizing CRISPR/Cas9 technology, where she led planning and execution of a wide variety of strategic initiatives across the business. Prior to that role, Naina was director of business development at Shire, where she was responsible for the identification, evaluation and execution of transactions that supported the company’s rare disease strategy. Previously, she developed and managed the business development and communications functions at SciFluor Life Sciences as vice president of business development.

Naina began her career at CellzDirect, where she established its Hepatic Research Registry at 15 liver transplant and oncology centers throughout the U.S. Subsequently, she joined The Hamner Institutes, a nonprofit research organization, most recently serving as vice president of business development and operations.

Naina is a member of the Healthcare Businesswomen’s Association and has previously served as a Boston Chapter Board Member. She has also been involved with MassBio’s MassCONNECT program.

Naina holds a B.S. in cell and structural biology from the University of Illinois at Urbana-Champaign and a Ph.D. in cell and developmental biology from The University of North Carolina at Chapel Hill.

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.

Min Wang brings more than 20 years of senior leadership and operating experience in the biotechnology industry. Min served as chief operating officer at Monte Rosa Therapeutics, with responsibilities for legal, HR, communications, IT and other corporate functions. Prior to Monte Rosa, she served as chief operating officer of BlueRock Therapeutics and played a key role in shaping its strategy and operations in the U.S. and Canada through its acquisition by Bayer. Before BlueRock, Min held the position of senior vice president, general counsel and corporate secretary at Agios Pharmaceuticals and built its legal and compliance functions as the founding member from inception through its IPO to a fully integrated biopharmaceutical company. She began her career as a patent attorney at the intellectual property law firm of Fish & Neave and served as senior patent counsel at Genentech and Merck.

Min received her Ph.D. in organic chemistry from Brown University and her J.D. from the Fordham University School of Law.

Emilio Flano brings to Ensoma 25 years of experience as an immunologist, researcher and drug developer working in life sciences industry, spanning pharmaceutical, biotechnology, health care and academic institutions.

Emilio joins Ensoma from Boehringer Ingelheim, where he was vice president, head of global immune modulation and head of U.S. cancer immunology. In this role, Emilio led the development of immunotherapies across several therapeutic areas, including oncology, cardiometabolic, respiratory and immunology. Previously, Emilio was an executive director at Merck in the discovery immunology and oncology department, where he led a group of immunologists focused on developing targeted immunomodulatory therapies. Prior to Merck, Emilio held roles at leading biotechnology companies. At Seres Therapeutics, a microbiome company, Emilio was a senior director and led the immunology and inflammatory disease group. At Genocea Biosciences, a T-cell antigen and vaccine company, Emilio supervised preclinical vaccine development and translational immunology. Emilio began his career in academia as a principal investigator and associate professor at the Center for Vaccines and Immunity at Nationwide Children’s Hospital and The Ohio State University.

Emilio received his B.S and Ph.D. from the Universidad de León with a focus on cellular biology and completed post-doctoral trainings at The Trudeau Institute and St. Jude Children’s Research Hospital.

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.

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.

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.

Tony Forget brings to Ensoma more than 20 years of DNA repair and genome engineering experience focused on the mechanistic understanding of how cells react to DNA insult, as well how exogenous DNA can be utilized for transgene expression through integrated and non-integrating technologies. He has fostered platform technology innovation in a broad range of areas, including diagnostics and therapeutic approaches, as well as has a track record of building, enabling and leading successful high-functioning teams.

Prior to Ensoma, Tony was senior director at Intellia Therapeutics, where he co-led innovation and development of the company’s genome editing platform technology, including DNA repair, vector engineering and functional genomic screening functions. During his four-year tenure, he advanced complex genome editing capabilities and target gene integration for in vivo and ex vivo applications, enabling T cell engineering and expansion of Intellia’s emerging in vivo pipeline to include insertion targets, notably maturing hemophilia A and B programs leading to a co-development partnership with Regeneron Pharmaceuticals. Prior to joining Intellia, Tony was an associate director at the MIT-Broad Institute Synthetic Biology Foundry, where he built the infrastructure to enable the implementation of novel, high-throughput methods for synthetic biology at unprecedented scale. Previously, Tony held roles of increasing responsibility at electronic genome mapping company Nabsys, Inc. Earlier in his career, he served as a project scientist at UC Davis and MIT following completion of his postdoctoral training at the University of California, Davis.

Tony earned his bachelor’s degree in biology from Norwich University, doctorate in biochemistry and molecular pharmacology from the University of Massachusetts Medical School and completed postdoctoral studies at the University of California, Davis.

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.

Soumitra Roy brings to Ensoma more than 25 years of experience in vector development for gene therapy, both in academia and in industry. Prior to Ensoma, he worked on adenoviral and adeno-associated virus (AAV) vector development at the gene therapy program at the University of Pennsylvania and at Johnson & Johnson (Janssen Vaccines), greatly expanding the repertoire of available adenoviral vector serotypes, as well as designing capsid mutants.

Earlier in his career, Soumitra worked at Genetic Therapy Inc., one of the earliest startup companies in the field of gene therapy, and then at the Gencell division of Aventis Pharma (now Sanofi).

Soumitra holds an M.D. from Calcutta Medical College in India, a Ph.D. from the University of Amsterdam, and is a fellow of the Royal College of Pathologists (London). He completed his postdoctoral training at the University of California, San Francisco and Genentech.

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.

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.

Chapman Wright is a technical leader with deep experience building and managing GMP-compliant bioprocessing systems across a variety of modalities. Prior to Ensoma, Chapman Wright served as director of process development at Generation Bio, where he guided the development of the company’s novel drug substance production platform. There, his responsibilities included material generation for in vitro/in vivo preclinical studies, upstream and downstream process development, and management of CMO operations.

Previously, Chapman led teams in cell culture development and gene therapy development at Biogen, where his responsibilities spanned 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.