Forge Biologics | Manufacturing Gene Therapies for Life (2022)

Forge Biologics | Manufacturing Gene Therapies for Life (1)

Leading the way to transformative genetic medicines

About

Mission

Forge Biologics | Manufacturing Gene Therapies for Life (2)

Manufacturing gene therapies for life.

Forge Biologics | Manufacturing Gene Therapies for Life (3)

Our mission is to enable access to life changing gene therapies and help bring them from idea intoreality.We partner with innovators in the gene therapy community: scientists, physicians, biotech andpharma companies and patient groups. We bring expertise in gene therapy manufacturing and therapeuticsdevelopment to the table, helping champion teams that are navigating the long road from the lab bench to thebedside. With a patients-first approach, we are forging new models for working together to better acceleratethese transformative medicines to reach those who need them the most.

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About

Approach

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Forge is building capacity to directly address the growing demand for gene therapy manufacturing.

Forge is currently building the "Hearth”, a 200,000+ ft2 custom-designed cGMP facility, dedicated toAAV viral vector manufacturing. We offer end-to-end manufacturing services to accelerate gene therapy programsfrom preclinical stage through clinical, and on to commercial manufacturing.

With the Hearth as our foundation, Forge is building a promising pipeline of disease-modifying AAV-basedtherapies to potentially help patients with rare genetic diseases. Forge is a true gene therapy developmentengine bringing together access to quality, in-house manufacturing, the experience of our team in gene therapyproduct development, and an exciting pipeline of new therapies for patients.

About

Leadership

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Forge Biologics | Manufacturing Gene Therapies for Life (7)

Timothy J. Miller, Ph.D.

CEO, President and Co-Founder

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Timothy J. Miller, Ph.D.

CEO, President and Co-Founder

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David Dismuke, Ph.D.

Chief Technical Officer

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Erandi De Silva, Ph.D.

Co-Founder & Senior Vice President of Product Development

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Jaysson Eicholtz

Co-Founder & Chief Operating Officer

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John Maslowski

Chief Commercial Officer

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Maria Escolar, M.D.

Chief Medical Officer

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Christopher Shilling

Senior Vice President of Regulatory Affairs and Quality

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(Video) Forge Biologics

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Magdalena Tyrpien

Senior Vice President and Head of Business Development

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Steven Goden

Senior Vice President of Finance & Operations

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Christina Perry

Senior Vice President of Finance & Investor Relations

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Frank Agbogbo, Ph.D.

Vice President of Process Development

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Meghan Leonard

Vice President of Quality Management

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Timothy J. Miller, Ph.D.

CEO, President and Co-Founder

Timothy Miller is CEO, President and Co-Founder of Forge Biologics, Inc., a VC-backedgene therapy development engine focused on accelerating access to potentially life-saving AAVgene therapies. Prior to founding Forge, Dr. Miller co-founded Abeona Therapeutics, a rare diseasegene and cell therapy company. He served as Abeona’s CEO and President from 2012-early 2018, takingthe company public in 2015. He is a proven biotech leader with experience in driving gene therapypipeline development, regulatory strategy, investor relations, M&A activities, licensing, GMPmanufacturing, clinical development, and leading stakeholder/shareholder engagement. Dr. Miller hasover 20+ years of business development, scientific research, product development and clinical operationsexpertise, with a focus on transitioning novel gene and cell therapies through pre-clinical and Phase 3human clinical trials. He is an avid patient-centric drug developer and entrepreneur. Dr. Miller earneddegrees in Pharmacology (Ph.D.) and Biology/Molecular Science (M.S. and B.S.) from John Carroll University.

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Jaysson Eicholtz

Co-Founder & Chief Operating Officer

Jaysson Eicholtz is Co-Founder and Chief Operating Officer at Forge Biologics. Mr. Eicholtz has 20+ years of operational experience in FDA regulated industry and specializes in design and operation of aseptic processing facilities. Prior to launching Forge, Mr. Eicholtz held operational management roles with increasing levels of responsibility at Tyson Foods, Wyeth, Sanofi Pasteur, Dendreon, Unither, Nationwide Children's Hospital and Scout Bio. He graduated with a B.S. in Animal Science from the University of Maryland where he also received his M.S. in Biotechnology.

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Erandi De Silva, Ph.D.

Co-Founder & Senior Vice President of Product Development

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Erandi De Silva is Co-Founder and Senior Vice President of Product Development at Forge Biologics. She is an experienced scientist and entrepreneur, with 10+ years of experience in discovery research, therapeutic development, and partnering across oncology, infectious disease, and gene therapy. Prior to founding Forge, Dr. De Silva held leadership roles in both academic and industry settings, including at Myonexus Therapeutics. She earned a Ph.D. in Molecular Biology from Princeton University, where she was awarded the Procter Fellowship in recognition of exceptional research, and her B.S., with honors, from Stanford University. Dr. De Silva was also a Postdoctoral Research Scientist at Genentech.

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Maria Escolar, M.D.

Chief Medical Officer

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Maria Escolar is the Chief Medical Officer at Forge Biologics and is a Tenured Professor of Pediatrics at the University of Pittsburgh and Founder of the Program for the Study of Neurodevelopment in Rare Disorders (NDRD) at UPMC Children's Hospital of Pittsburgh. Dr. Escolar has more than 20 years of experience as a practicing clinician and researcher and is internationally known for her work in children with rare genetic neurodegenerative conditions such as leukodystrophies and mucopolysaccharidosis. Dr. Escolar has authored more than 80 manuscripts, including two original research articles in the prestigious New England Journal of Medicine. Her translational research focuses on prospectively studying the natural progression of these diseases, developing treatments that translate into meaningful neurobehavioral outcomes and the relationship with neuroimaging and biomarker changes. She has contributed to the design of multiple trials and has been the lead investigator on many gene therapy and ERT trials. Dr. Escolar is a graduate of the Escuela Colombiana de Medicina, she has a M.S. in human nutrition from Columbia University and completed a residency in general pediatrics and fellowship in child development and behavioral pediatrics at the Cornell University Medical Center.

(Video) Forge Biologics

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Ashley Craddick

Director of Process Development

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Ashley Craddick is the Director of Process Development at Forge Biologics. Ashley has 10 years ofexperience in gene therapy and specializes in downstream purification focusing on optimizing FDAcompliant processes. Prior to joining Forge Biologics, Ashley held operational management anddevelopmental roles with Scout Bio and Nationwide Children's Hospital. She graduated with a BS inChemistry from Urbana University in 2009. Ashley and her husband, Adam, have two young children thatoccupy their free time taking them to sporting events and exploring outside.

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Jeremy Pupillo

Director, Supply Chain and Facilities

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Jeremy Pupillo is the Director, Supply Chain and Facilities at Forge Biologics. Jeremy brings 20+ yearsof supply chain operations knowledge, with 10 years in an FDA regulated environment. Prior to joiningForge Biologics, Jeremy held operational management roles with increasing levels of responsibility withBall Corporation, Dendreon, Unither, Bristol-Meyers Squibb and Lonza. He earned his MBA with ColumbiaCollege in 2016 and his CSCP certification from APICS in 2017. When not on a softball field with hisdaughter, you can find Jeremy spending time with his wife Kim, their three grandchildren and two sons ontheir boat in the Finger Lakes.

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Carolyn Odom

Director of Clinical Program Managementt

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Carolyn Odom is the Director, Clinical Program Management at Forge Biologics. Prior to enteringclinical research, she worked in the non-profit realm for a decade promoting independence and access tosport for people with disabilities. Carolyn has worked on the site, CRO and industry levels frompre-clinical through Phase III clinical trials, most recently as Director of Program Management atAbeona Therapeutics. She received an MA (Honours) in History from the University of St. Andrews. Carolynis a puppy raiser for Canine Companions for Independence and is rarely seen without a dog at her side.She is currently raising Zia III at Forge.

David Dismuke serves as Chief Technical Officer and came to Forge Biologics with more than 15 years of experience in large-scale manufacturing. He is an authority in the bioprocessing and design of gene therapy vectors and has led CMC operations in the manufacturing of pre-clinical and clinical-grade AAV vectors for more than 10 years. Prior to joining Forge, Dr. Dismuke was the Vice President of Manufacturing at StrideBio where he directed the development of manufacturing and analytical processes for AAV vectors that utilize novel capsids. In addition, he led the design of therapeutic and reporter transgenes and innovative molecular enhancements to improve AAV production and therapeutic function. He also served as Head of Vector Production at Voyager Therapeutics, where he led teams in the manufacturing and analytical testing of AAV using the baculovirus/Sf9 production system. Prior to Voyager, Dr. Dismuke was Director of the UNC Vector Core, where he oversaw GMP operations as well as the production of research-grade vectors. He earned his Ph.D. from Vanderbilt University, focusing on the molecular biology and lifecycle of HIV-1, and conducted postdoctoral research at UNC Chapel Hill.

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John Maslowski

Chief Commercial Officer

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Mr. Maslowski is Chief Commercial Officer at Forge Biologics. He served as the President and Chief Executive Officer of Castle Creek Biosciences, Inc. from January 2020 to March 2021 and served in the same role at Fibrocell Science, Inc. (a NASDAQ rare disease cell and gene therapy company) from 2016 until Fibrocell was acquired in 2019. Prior to the acquisition, Mr. Maslowski served as Senior Vice President of Scientific Affairs and Vice President of Operations of Fibrocell between 2012 to 2016. Mr. Maslowski has extensive experience in the field of cell and gene therapy, including advancing D-Fi, a genetically modified autologous fibroblast therapy, to pivotal clinical trials, and LAVIV ®, a non-modified autologous fibroblast therapy, through U.S. FDA approval and commercialization.Mr. Maslowski also serves on the board of Alliance for Regenerative Medicine, the scientific advisory board of Castle Creek Biosciences, and the advisory board of Life Science Cares Philadelphia. Mr. Maslowski previously served as the Chairman of the board of directors of Falcon Therapeutics, a privately held Durham, N.C. company focused on the development of cell therapy products for oncology, from 2019 to 2021, and on the board of directors of Castle Creek Biosciences and Fibrocell from 2016 to 2021. Mr. Maslowski has 20+ years of experience in pharmaceutical and biologics development at major pharmaceutical companies including Wyeth Pharmaceuticals, Merck & Co., Inc., and Teva Pharmaceuticals Industries Ltd. Mr. Maslowski received his B.S. in biology from Ursinus College and his M.S. in microbiology from Villanova University.

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Christina Perry

Senior Vice President of Finance & Investor Relations

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Christina Perry is Senior Vice President of Finance and Investor Relations at Forge Biologics. She spent the last several years as the CFO of Drive Capital where she built out all accounting and finance operations, back-office needs, and investor relations and reporting. Ms. Perry managed complex entity legal structures and has had extensive experience in equity and debt financings. Over the last 15+ years, she has worked with public and private companies and startups across varying industries, developing operational processes to scale with high growth. Ms. Perry spent the onset of her career at Deloitte, is a licensed CPA in the state of Ohio, earned her B.B.A. at the University of Notre Dame and a Master of Accountancy from Miami University.

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Juan Ruiz, M.D., Ph.D.

Senior Vice President of Clinical Affairs

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Juan Ruiz serves as Senior Vice President of Clinical Affairs at Forge Biologics. He has decades of experience in clinical drug development and has held C-level positions at Abeona Therapeutics, Lykera Biomed and Digna Biotech, where he spent more than ten years leading teams dedicated to developing gene therapy translational medicine programs. His proven track record demonstrates a start-to-finish scope, from early preclinical and proof of concept studies to manufacturing, regulatory IND and IMPD submissions, clinical trial design and execution, as well as manufacturing and quality control of the adenoviral vectors. Dr. Ruiz has been instrumental in achieving multiple Orphan Product Designations, has led teams for successful Scientific Advice and Protocol Assistance meetings with the FDA and EMA, and has helped design Patient Reported Outcomes (PRO) in the U.S. to assess skin outcome measures in patients with systemic sclerosis for use as primary endpoints in late-stage clinical trials.He is the author of more than 40 peer-reviewed journal articles and book chapters and is an inventor on multiple issued patents. Dr. Ruiz earned his Ph.D. in molecular biology from the University of Navarra. He was a post-doctoral fellow at the University of Connecticut and earned his M.B.A. from the IESE Business School at the University of Navarra.

(Video) Launching Your Gene Therapy Career With Forge Biologics

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Christopher Shilling

Senior Vice President of Regulatory Affairs and Quality

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Christopher Shilling is Senior Vice President of Regulatory Affairs and Quality at Forge Biologics. He has over 15 years of experience in the development of novel gene therapies for rare and significant disorders. Mr. Shilling is an experienced leader in gene therapy regulatory affairs, pharmacology, toxicology, and project management focused on developing strategies for early phase clinical trials in support of a variety of transformative therapeutics for pediatric and rare diseases. Prior to joining Forge, Mr. Shilling started the Drug and Device Development program at Nationwide Children’s Hospital which was instrumental in gaining acceptance from regulators for over twenty first-in-human gene therapy clinical trials of novel biologic products, a dozen orphan drug designations, and two fast track designations. This body of work contributed to over fifteen successful licenses with industry partners for technologies discovered while at Nationwide Children’s Hospital and The Ohio State University. He has provided regulatory guidance and strategy to patient-focused foundations and industry ranging from angel invested startups to late stage and commercial staged biopharma. Mr. Shilling received a B.S. in biology and his M.S. in Pathology from The Ohio State University.

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Dan Salvo

Director of Communications and Community Development

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After graduating college with a B.S. in Business Administration, Dan created DP Studios Productions, anaward winning photography, film production, and live streaming company. Over the past 15 years, he hascaptured millions of photographs, created hundreds of films, and consulted for dozens of businesses fromaround the world to develop their creative vision and content for media communications.

Coupled with strong attention to detail and a wealth of technical knowledge, Dan’s storytelling andcommunication skills stand paramount in each of his projects. Clients rely on his ability to absorblarge, amorphous concepts and goals, and convert those into actionable projects, effortlessly andcreatively bridging the gaps between businesses, technology, and the people that bring them together.

Dan brings an innate ability to navigate within delicate and nuanced spaces, an invaluable mandate whenworking in the rare disease space. This capacity for capturing and communicating arcs of emotion ispreeminent in his two documentary films, The Weight of aMountain and At the Edge of Hope. These films requiredthousands of hours of filming and editing as well as the indelible trust of those featured. In return,these powerful projects provided viewers with an intimate glimpse into the world of rare disease, genetherapy, and the resilience of the human spirit.

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Adam S. Davis, Ph.D.

Senior Director, Analytics

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Adam Davis joins Forge Biologics with more than 15 years of experience in recombinant adeno-associatedviral vector product development, process development, and manufacturing. He has led various teams inthe scalability of multiple platforms for the production, purification, and characterization of bothpre-clinical and clinical recombinant gene therapy vectors. Prior to joining Forge Biologics, Adam wasthe Director of Manufacturing and Contract Manufacturing at Abeona Therapeutics, where he establishedmanufacturing capabilities to supply early pre-clinical development in adherent cell culture. Adam alsodeveloped suspension culture capabilities, both in-house and through contract development andmanufacturing partners. Prior to his work at Abeona Therapeutics, Adam was a scientist at BioMarinPharmaceutical where he led a team optimizing yield in the Sf9/baculovirus system to produce ValoctogeneRoxaparvovec, the company’s first gene therapy product. Prior to BioMarin, Adam contributed to thedevelopment and manufacturing of clinical gene therapy vectors at Nationwide Children’s Hospital. Heearned his Ph.D. from Ohio State University, focusing on the rational design of recombinant AAV vectorcapsid for targeted delivery.

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Steven Goden

Senior Vice President of Finance & Operations

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Steve Goden serves as Senior Vice President of Finance and Operations at Forge Biologics, and has over 35 years of financial and administrative management expertise in a wide range of organizations in all stages of development, from start‐up through rapid growth and maturity. Prior to joining Forge, Mr. Goden was Senior Director of Finance and Operations at Abeona Therapeutics, a rare disease NASDAQ gene and cell therapy company. He previously served as Chief Financial Officer of Red5 Pharmaceuticals, a biotech start-up that developed novel diagnostic assays, and SironRx Therapeutics, another biotech start-up that developed dermal wound therapies to reduce scarring. Prior to his biotech experience, Mr. Goden served as Executive Vice President for Cohesant Inc., an investment holding company that acquired, grew and divested of a variety of companies, including GlasCraft Inc., CuraFlo, and Raven Lining Systems. Earlier in his career, Mr. Goden served in senior financial roles at Cole National Corporation (e.g. Pearle Vision, Target Optical, Things Remembered) and Progressive Insurance.

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Magdalena Tyrpien

Senior Vice President and Head of Business Development

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Magdalena Tyrpien is Senior Vice President and Head of Business Development at Forge Biologics. Previously, she was Director of Business Development at PTC Therapeutics, a global commercial stage small molecule and gene therapy biopharmaceutical company. Ms. Tyrpien was directly responsible for leading efforts around licensing and acquisition of assets and led a $268M company acquisition with a Phase III ready asset for patients with PKU. Her professional experience spans in corporate business development, strategic planning, and investor relations in the biotechnology and venture capital industries across a range of therapeutics areas and stages of development. Prior to joining PTC, she spent 4+ years as Director of Corporate Strategy and Business Development at Abeona Therapeutics, a gene and cell therapy company. In this role, she identified, acquired, licensed, and leveraged strategic assets, with a focus in cell and gene therapies for rare neurogenerative diseases. Ms. Tyrpien earned her B.A. from Montclair State University and an M.B.A. from the University of Liverpool (UK).

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Laura Carfagna

Director of Sales and Client Development

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Laura Carfagna is the Director of Sales and Client Development at Forge Biologics. Laura has 11 years ofsales and management experience in the Life Science Industry. Prior to joining Forge Biologics, Lauraheld sales and sales management roles with Corning Life Sciences, VWR, and Life Technologies. Shegraduated with a BS in microbiology from Bowling Green State University in 2009. Laura and her husband,Luciano, enjoy spending their free time hiking and cooking new recipes.

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(Video) Forge Biologics: Hearthside Chat - The Future of Gene Therapy

Hannah Munizza

Director of Marketing

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Before joining Forge Biologics, Hannah spent the last 7 years as the Senior Director of BusinessDevelopment and Marketing at the National Venture Capital Association (NVCA), the venture capitalindustry’s preeminent trade group, leading business development, programming, industry relations, andmarketing. In this role Hannah helped create and market benefits, resources, and programs for NVCA’s300+ members.Prior to joining NVCA, Hannah worked at CTIA – The Wireless Association. There, she served as themarketing, public relations, and partnerships coordinator for CTIA’s conventions department. She beganher career in CTIA’s Regulatory Affairs Department, where she was a member of the association’sregulatory policy advocacy team.Hannah received her BSBA cum laude in marketing and management from Robert Morris University, where sheplayed for the university’s Division I volleyball team.

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Frank Agbogbo, Ph.D.

Vice President of Process Development

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Frank Agbogbo is Vice President of Process Development at Forge Biologics. He has over 16 years of experience in industry. Previously, Dr. Agbogbo was Senior Director of Process Development at Cytovance Biologics where he oversaw cell line development, cell culture, strain development and fermentation. He was at Cytovance for over 7 years where he took increasing responsibilities from Director of Fermentation to Director of Process Development with supervision of the Upstream and Downstream teams. Prior to Cytovance, Dr. Agbogbo was the Application Technology Manager at Mascoma Corporation where he contributed to the launch of two commercial products.He was also a Principal Scientist at ICM, Inc. and a Scientist at Novozymes. Dr. Agbogbo’s experience includes process development, Design of Experiments (DoE), process optimization, process characterization and scale-up from R&D to manufacturing (cGMP and non-cGMP). He was co-chair at scientific conferences such as the Society for Industrial Microbiology and Biotechnology Annual Meeting (SIMB) and Recent Advances in Fermentation Technology (RAFT) on many topics including process optimization, scale-up, DoE, process characterization, downstream development, and process analytical technologies. He has co-authored over 15 peer-reviewed publications and contributed to 5 patents. Dr. Agbogbo earned a B.S. in Chemical Engineering from Kwame Nkrumah University of Science and Technology, a Ph.D. in Chemical Engineering from Texas A&M University, and an M.B.A. with a certificate in Entrepreneurship from the Price College of Business, Oklahoma University.

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Meghan Leonard

Vice President of Quality Management

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Ms. Leonard is Vice President of Quality Management at Forge Biologics. She started her career in industry in 2004 at Ben Venue Laboratories (a Boehringer Ingelheim Company). Ms. Leonard has over 17 years of experience in FDA-regulated industries as a quality leader, operations leader, and project manager, with experience in compliance, operations, quality systems, and regulatory initiatives within the sterile, injectable pharmaceutical industry. She has experience in the cell and gene therapy, medical device, and chemical industries. Prior to joining Forge Biologics, Ms. Leonard held a quality management role at Abeona Therapeutics for 3 years where she gained experience in cell and gene therapy. Over the course of her career, she has interacted with numerous regulatory health authorities and clients as both a subject matter expert in quality systems and an audit/inspection lead. Ms. Leonard is passionate about building a compliant, efficient, and sustainable QMS that the Forge team is committed to providing to patients and partners. She earned a Bachelor’s degree in Biology from Case Western Reserve University.

About

Board

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Timothy J. Miller

Forge Biologics

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Chris Garabedian

Xontogeny

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Matthew Hammond

RA Capital

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Fred Callori

Xontogeny

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Molly Bonakdarpour

Drive Capital

About

Scientific & Manufacturing Advisory Board

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Steven J. Gray, Ph.D.

UT Southwestern

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Robert Kotin, Ph.D.

Stealth Newco

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Karen Kozarsky, Ph.D.

SwanBio Therapeutics

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Haiyan Ma, Ph.D.

Northern Biomolecular Services

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Simon Waddington, Ph.D.

University College London

(Video) Forge Biologics: Vision

FAQs

What does forge biologics do? ›

Forge Biologics is a gene therapy development engine, focused on enabling access to life-changing gene therapies and helping bring them from an idea into reality. The company partners with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups.

What is the meaning of gene therapy? ›

Gene therapy is a technique that modifies a person's genes to treat or cure disease. Gene therapies can work by several mechanisms: Replacing a disease-causing gene with a healthy copy of the gene. Inactivating a disease-causing gene that is not functioning properly.

What are the 3 types of gene therapy? ›

There are basically three types of gene therapy: ex vivo, in vivo, and in situ. In ex vivo gene therapy, the target cells are removed from the patient's body, engineered either by the addition of the therapeutic gene or by other genetic manipulations that allow correction of the phenotype of the disease.

Is gene therapy a permanent cure? ›

Gene therapy offers the possibility of a permanent cure for any of the more than 10,000 human diseases caused by a defect in a single gene. Among these diseases, the hemophilias represent an ideal target, and studies in both animals and humans have provided evidence that a permanent cure for hemophilia is within reach.

What diseases can gene therapy cure? ›

Gene therapy replaces a faulty gene or adds a new gene in an attempt to cure disease or improve your body's ability to fight disease. Gene therapy holds promise for treating a wide range of diseases, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS.

Which type of gene therapy is the most controversial? ›

5.2 Germ Line Gene Therapy

Germ line gene therapy is much more controversial (Nelson 2000). It would introduce 'normal' human genes into the eggs or sperm of parents, or into the fertilized egg or early embryo of the offspring. The goal would be to change the eventual child's genetic inheritance.

How long does gene therapy last? ›

How long can I expect the effects of gene therapy to last? At this time, no one really knows the answer to this question. There ae several clinical trials underway with data that suggests the possibility of some factor expression in excess of 7 years.

What is the most common form of gene therapy? ›

Gene therapy is an experimental technique that uses genes to treat or prevent disease. The most common form of gene therapy involves inserting a normal gene to replace an abnormal gene. Other approaches include: Swapping an abnormal gene for a normal one.

Who is a good candidate for gene therapy? ›

Choosing Candidates For Gene Therapy

For you to even consider gene therapy, the answer must be "yes." For instance, genetic disorders caused by mutations in single genes tend to be good candidates for gene therapy, while diseases involving many genes and environmental factors tend to be poor candidates.

What are the disadvantages of gene therapy? ›

Genetic therapies hold promise to treat many diseases, but they are still new approaches to treatment and may have risks. Potential risks could include certain types of cancer, allergic reactions, or damage to organs or tissues if an injection is involved. Recent advances have made genetic therapies much safer.

How much does gene therapy cost? ›

The moral impetus makes it clear that gene therapy for global health is the way to go. However, gene therapies are often unaffordable to those that need them most. At $2 million a dose, only the very wealthiest can be cured with a single treatment.

What is the most current gene therapy trials target? ›

Q3: Most current gene therapy trials target...
  • Alzheimer's Disease. ...
  • HIV. ...
  • Cystic fibrosis. ...
  • Cancer.
29 Oct 2021

What happens if your DNA is altered? ›

By altering one of these regions, a variant (also known as a mutation) in noncoding DNA can turn on a gene and cause a protein to be produced in the wrong place or at the wrong time. Alternatively, a variant can reduce or eliminate the production of an important protein when it is needed.

What does a biologic do? ›

Biologics are large molecules produced in living cells. Both help protect against the effects of inflammation, but in different ways. Conventional DMARDs suppress the overall immune system, whereas biologics block specific parts of the immune system, such as proteins that promote inflammation.

Why are biologics different from drugs? ›

In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination.

What is a biologic in simple terms? ›

Biologics are powerful medications that can be made of tiny parts like sugars, proteins, or DNA. Or they can be whole cells or tissues. These medications also come from all sorts of living sources, such as humans, animals, and even bacteria. Biological medications tend to be at the forefront of drug research today.

What drugs are considered biologics? ›

Biologics are drugs made from complex molecules manufactured using living microorganisms, plants, or animal cells. Many are produced using recombinant DNA technology. They're sometimes referred to as biopharmaceuticals or biological drugs.

What can you not eat on biologics? ›

Unpasteurised milk and dairy products, e.g. cheese made from unpasteurised milk. Mould ripened soft cheeses (e.g. Brie and Camembert) and blue cheeses (whether pasteurised or not), feta and goats cheeses. Raw eggs, or foods with this in, e.g. home-made mayonnaise. Raw or undercooked meat and fish.

What is the best biologic? ›

Other highlights for biologics included:
RankBiologicCompany
1Humira (adalimumab)AbbVie
2Remicade (infliximab)Johnson & Johnson and Merck & Co.
3Rituxan (rituximab, MabThera) includes sales of next generation version of Rituxan -GazyvaRoche and Biogen Idec
4Enbrel (etanercept)Amgen and Pfizer
7 more rows
19 Mar 2015

Do you have to take biologics forever? ›

4. Once you start biologics, you will likely continue to take them, even in remission. If you stop taking biologics, they may not work as well when you start taking them again. This is because your body can build up antibodies that make the drug less effective.

Is gene therapy the same as biologics? ›

Unlike traditional small molecule drugs or biologics, gene therapies are designed to be one-time fixes for inherited genetic defects, raising critical questions about how companies should measure the durability of a treatment's benefit.

Is hydroxychloroquine a biologic? ›

Consider these non-biologics.

Non-biologics include: Methotrexate (Rheumatrex, Trexall, and generic) Leflunomide (Arava and generic) Hydroxychloroquine (Plaquenil and generic)

What are side effects of biologics? ›

Side effects of biologics like these are rarer:
  • Central nervous system issues. These include sudden vision problems, numbness, or tingling.
  • Heart problems. Things like shortness of breath or sudden heart failure are possible.
  • Lupus-like syndrome. ...
  • Cancer. ...
  • Liver problems. ...
  • New joint pain.
23 Jun 2021

Are biologics safe? ›

Because biologics change the way your immune system works, they do pose some serious risks. Some people taking biologics may have a higher risk for infections such as tuberculosis and hepatitis. Others may have a higher risk for certain types of cancer.

Are probiotics a biologic? ›

If a probiotic is intended to diagnose, cure, mitigate, treat or prevent a human disease, it is regulated as a drug and a biological product by the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research and an Investigational New Drug application is required to pursue clinical studies in human ...

Are biologics better than drugs? ›

Chemical drugs are often more pure and better characterized by current analytical technology than biologics. A biologic agent's activity may be affected by the cell system in which it is produced, the fermentation media, or operating conditions. The use of living organisms to produce therapeutic extracts is not new.

Do biologics affect the liver? ›

Biologics are among the most commonly prescribed medications for several chronic inflammatory diseases. Tumor necrosis factor alpha inhibitors, more so than other agents, have been observed to cause drug-induced liver injury.

How do you tell if a drug is a biologic? ›

Biologics Stem From Live Cells

The strictest definition says biologic drugs only come from living systems or contain organic molecules, whereas small-molecule pharmaceuticals largely come from chemicals. Often, biologics are injected. If it's swallowed, it's probably not a biologic drug.

What was the first biologic drug? ›

The first biologic drug, insulin, was produced using E. coli cells. Researchers soon realized, however, that they couldn't produce every therapeutic in bacterial cells. Highly complex proteins, such as monoclonal antibodies and certain enzymes, present two main obstacles.

Videos

1. AGC Biologics
(Alliance for Regenerative Medicine)
2. Forge Biologics: You In?
(Forge Biologics)
3. No Disease is Safe with Dr. Tim Miller, Forge Biologics
(614startups)
4. Forge Biologics: Where It All Begins
(Forge Biologics)
5. Forge Biologics: You In?
(Forge Biologics)
6. AGC Biologics
(Alliance for Regenerative Medicine)

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