• President, CEO, and Co-founder Timothy J. Miller, Ph.D., announces departure 

• John Maslowski, Chief Commercial Officer, to succeed Dr. Miller as President and CEO 

COLUMBUS, Ohio September 10, 2024 – Forge Biologics, a leading manufacturer of genetic medicines and member of the Ajinomoto Biopharma Services group, today announced that Chief Executive Officer Timothy J. Miller, Ph.D., will step down following almost five years of leadership at the Company he co-founded in 2020. John Maslowski, Forge’s Chief Commercial Officer, has been appointed as President, Chief Executive Officer, and a member of the Board of Directors, effective October 1, 2024.  

Mr. Maslowski is a seasoned biopharmaceuticals leader with over 25 years of industry experience. As the Chief Commercial Officer at Forge since June 2021, he has been directly responsible for building the Company’s commercial strategy and operations, which now supports nearly 50 clients. Mr. Maslowski came to Forge after serving as the President and Chief Executive Officer of Castle Creek Biosciences, Inc.  He served in the same role at Fibrocell Science, Inc., a NASDAQ listed cell and gene therapy company, from 2016 until it was acquired in 2019. At Fibrocell, he previously served as the Senior Vice President of Scientific Affairs and Vice President of Operations. 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. 

“I am honored to lead Forge’s talented team as we continue our important work—enabling access to gene therapies for our clients and the patient communities we serve. It’s an exciting time at Forge. Our team is not only growing, but we’re expanding our technologies and enhancing operational efficiencies to ensure we continue delivering on the remarkable innovations emerging from our industry,” said Mr. Maslowski. “I wish Tim all the best in this new chapter of his life. His legacy of innovation and focus on improving patient lives is ingrained in our foundation and will guide us well into the future.”   

Over the course of nearly five years, Dr. Miller led Forge’s transition from an early-stage venture-backed start-up through late-stage financings, and, most recently, a $620 million acquisition by Ajinomoto Group—a global food and biotechnology company. Under his tenure, Dr. Miller successfully grew the company to more than 350 employees, completed the expansion of Forge’s 200,000 square foot manufacturing facility, raised $330 million in funding, and advanced the Company’s lead program for patients with Krabbe disease into clinical trials.   

“I am immensely proud of what we’ve accomplished at Forge. From our first raise in 2020, when the company was just beginning, to looking into 2025 as a leading genetic medicine manufacturing engine, it’s been a remarkable journey,” said Dr. Miller. “I’ve had the privilege of working alongside an extraordinary team, pioneering cutting-edge technologies, and building a facility with the potential to transform lives. Under John’s capable leadership, I am confident that Forge will continue to fulfill the bold mission that we set out to achieve.” 

“It has been a pleasure working with Dr. Miller. As Forge’s CEO, he has led the Company to its success today: a leader in AAV manufacturing, bringing meaningful, innovative solutions for communities and society,” said Yasuyuki Otake, Board Chair of Forge. “The Board and I are incredibly pleased to see Mr. Maslowski succeed Dr. Miller as Forge’s next CEO. Mr. Maslowski has been an integral member of Forge’s executive leadership, built an impressive commercial team, and brings decades of operational, development, and strategy experience from his accomplished tenure as a biopharma executive. I’m looking forward to Forge’s continued success under John’s leadership.”  

About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 200,000L of manufacturing capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.

Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com

COLUMBUS, OHIO April 30, 2024 – Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced that it will deliver nine presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27^thAnnual Meeting, taking place May 7-11, 2024, in Baltimore, Maryland. The presentations include a late-breaking oral presentation, three technical session presentations, and five scientific posters spanning Forge’s process development, molecular development, integrated regulatory services, and clinical program advancements.

“As we continue to advance how genetic medicines are manufactured, we are thrilled to present data showcasing our novel molecular findings, platform process improvements, and regulatory knowledge all centered around efficient, safe, and scalable manufacturing of AAV gene therapies,” said Timothy J. Miller, Ph.D., President and CEO of Forge. “We are also especially encouraged by a late-breaking oral presentation that our Chief Medical Officer, Dr. Maria Escolar, will be delivering that provides a clinical update on FBX-101 where all five patients with Krabbe disease receiving Forge’s gene therapy are walking—a remarkable result. Retention of gross-motor function is one of the most visible and debilitating symptoms seen in patients with Krabbe disease, so this finding is a meaningful clinical outcome.”

ORAL PRESENTATION

Title: REKLAIM, A Phase 1b Clinical Trial Using a Novel Immune Modulation Strategy for Systemic Administration of FBX-101 (AAVrh10.GALC) After Umbilical Cord Blood Transplantation for the Treatment of Infantile Krabbe Disease
Presenter: Maria Escolar, M.D., Chief Medical Officer
Date and Time: Friday, May 10, 2024, 8:00-8:15 a.m. ET
Room: Ballroom 4

SESSION PRESENTATIONS

ASGCT Workshop
Title: Preparing for CMC Success: How Early CMC Decision Drives Your Pace and Success to the Clinic
Presenter: David Dismuke, Ph.D., Chief Technical Officer
Date and Time: Tuesday, May 7, 8:25 a.m. ET
Location: Ballroom 3

Tools & Technology Forum
Title: Improving Analytical Tools for AAV Characterization
Presenter: David Dismuke, Ph.D., Chief Technical Officer
Date and Time: Wednesday, May 8, 2:15-2:30 p.m. ET
Location: Exhibit Hall Theater

Sponsored Symposium
Title: Forge’s Discovery and Modification of Genetic Elements for Enhanced Productivity and Efficacy of AAV-based Gene Therapies
Presenters:
          Angela Adsero, Ph.D., Molecular Development Scientist II
          Frank Agbogbo, Ph.D., VP of Process Development
          David Dismuke, Ph.D., Chief Technical Officer
Date and Time: Thursday, May 9, 1:30-2:00 p.m. ET
Location: Room 337-338

POSTER PRESENTATIONS

Title: Development of a Scalable Upstream Process for Suspension HEK 293 rAAV Production in Single-Use Bioreactors for Efficient Manufacturing of Gene Therapy Products
Presenter: Danielle Sexton, Senior Scientist II, Process Development
Date and Time: May 8, 12:00 p.m. ET
Poster number: 528

Title: From Benchtop to Cleanroom; Designing an Optimized Platform Purification Process for rAAV Production to Meet the Growing Demand
Presenter: Blake Gursky, Scientist II, Process Development
Date and Time: May 8, 12:00 p.m. ET
Poster number: 527

Title: The Potential of Global Regulatory Harmonization in Gene and Cell Therapy
Presenter: Claire Marasco, Associate Director, Regulatory Affairs
Date and Time: May 8, 12:00 p.m. ET
Poster number: 526

Title: Regulatory Agility: Value of CDMOs Utilizing Platform Technology
Presenter: Angela Coy, Ph.D., Senior Manager, Regulatory Affairs
Date and Time: May 8, 12:00 p.m. ET
Poster number: 905

Title: The Sixth Element: Identification and Evaluation of the Adenovirus L4 22/33K Region as a Requirement for Adeno-Associated Virus Production
Presenter: Angela Adsero, Ph.D., Molecular Development Scientist II, Forge Biologics
Date and Time: May 9, 12:00 p.m. ET
Poster number: 954

Full abstracts are available on the ASGCT Annual Meeting website, and conference participants can also access posters through the ASGCT website.

Forge Biologics will be at booth #827 in the Exhibitor Hall.

About Forge Biologics
Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 200,000L of manufacturing capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.

Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com

Families and Clinician Inquiries
Maria Escolar, M.D.
Chief Medical Officer
advocacy@forgebiologics.com

Business Development  
Magdalena Tyrpien
Chief Business Officer
BD@forgebiologics.com   

• Research findings indicate a path to the development of potentially safer adeno-associated virus (AAV) gene therapies and provide additional avenues for improving AAV manufacturability for increasing yields
• The discovery was published as a peer-reviewed scientific article in a leading research journal Human Gene Therapy

COLUMBUS, Ohio December 12, 2023 –Forge Biologics (Forge), a leading manufacturer of genetic medicines, announced today the peer-reviewed publication of, “A novel role for the adenovirus L4 region 22K and 33K proteins in adeno-associated virus production,” in the research journal Human Gene Therapy. The article was authored by a team of scientists at Forge led by David Dismuke, Ph.D., Chief Technical Officer, Linas Padegimas, Ph.D., Molecular Development Senior Director, and Angela Adsero, Ph.D., Molecular Development Scientist II.

Specific adenoviral genes are required for AAV production. However, a novel, undiscovered gene in particular has been overlooked because of its shared DNA sequence with a gene regulatory region that determines when or how much protein is made from a gene. By using molecular techniques to decouple the dual-purpose nature of this sequence, the Forge scientific team demonstrated that the L4 region 22K protein is an additional requirement for AAV vector production that had previously gone unnoticed. The study also suggests that the L4 region 33K protein is important for increasing AAV production.

“Forge is committed to improving gene therapy manufacturing through scientific innovation. The discovery of these vital AAV production requirements provide the potential for a more targeted and efficient production strategy, while also strengthening our IP portfolio,” said David Dismuke, Ph.D., Chief Technical Officer at Forge. “I am exceptionally proud of the Forge team for their hard work in contributing to our understanding of the essential elements of AAV production so that we can keep advancing the field of gene therapy.”

The article’s lead author was Angela Adsero, Ph.D. Contributing authors include the following Forge scientists: Brendan Chestnut, M.Sc., Sara Shahnejat-Bushehri, Ph.D., Lalita Sasnoor, Ph.D., Travis McMurphy, Ph.D., Michael Swenor, Ryan Pasquino, Arun Pradhan, Ph.D., Victor Hernandez, Ph.D., Linas Padegimas, Ph.D., and David Dismuke, Ph.D. The full research article can be accessed through open access here: https://www.liebertpub.com/doi/epdf/10.1089/hum.2023.146

“This interesting finding may significantly impact gene therapy manufacturing and that translates to improved and potentially life-transforming genetic medicines for millions of patients suffering from genetic diseases worldwide,” said Robert Kotin, Ph.D., a leading voice in AAV and gene therapy manufacturing and a member of Forge’s Scientific and Manufacturing Advisory Board. “The Forge team has deep roots in developing genetic medicines and in vector manufacturing, as evidenced by these findings.”

About Forge Biologics 
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company focused on enabling access to life-changing gene therapies. Forge was founded in 2020 and is headquartered in the cell and gene therapy hub of Columbus, Ohio. Its 200,000 square foot facility, the Hearth, is dedicated to AAV manufacturing with 20 custom-designed cGMP suites. Offerings include scalable, end-to-end manufacturing services including process and analytical development, cGMP viral vector manufacturing, final fill, plasmid DNA manufacturing, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. Forge aims to accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.  

Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@forgebiologics.com

Client Development
Taleen Barsoumian
Vice President, Client Development
CD@forgebiologics.com

• Juan Ruiz, M.D., Ph.D., M.B.A. joins as Senior Vice President, Medical Affairs
• Frank Agbogbo, Ph.D., M.B.A. joins as Vice President, Process Development
• CEO Timothy J. Miller, Ph.D. participating in fireside chat and panel discussion at World Orphan Drug Congress August 25-27, 2021

COLUMBUS, Ohio – August 25, 2021 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), announced today the expansion of its leadership team with two key hires in process development and medical affairs. Juan Ruiz, M.D., Ph.D., M.B.A., will lead the clinical development team as Senior Vice President, Medical Affairs; Frank Agbogbo, Ph.D., M.B.A., will head process development in CDMO operations.

“I’m thrilled that we are able to bring these leaders with tremendous industry experience to our company,” said CEO, President and Co-Founder Timothy J. Miller, Ph.D. “With the strong leadership and technical expertise from Dr. Ruiz and Dr. Agbogbo, Forge’s CDMO operations growth and expanding pipeline will be poised to support our clients’ and patients’ needs.”

Dr. Juan Ruiz joins the company with more than 20 years’ experience in drug development in biotechnology and academic environments in the field of gene therapy. He has held leadership positions at Abeona Therapeutics, Lykera Biomed and Digna Biotech, where he spent more than a decade 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. 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 M.D. at the University of Navarra School of Medicine, his Ph.D. in molecular biology from the University of Navarra, earned his MBA from the IESE Business School at the University of Navarra, and was a post-doctoral fellow at the University of Connecticut.

Dr. Frank Agbogbo will serve as Vice President of Process Development, bringing to Forge over 15 years of experience in industry which includes process development in small and large scale bioreactors, process optimization, process characterization and scale-up from R&D to manufacturing (cGMP and non-cGMP). Previously, Dr. Agbogbo was the Senior Director of Process Development at Cytovance Biologics overseeing cell line development, cell culture, strain development and fermentation, with oversight responsibilities over the Upstream and Downstream teams. Prior to Cytovance, he was the Application Technology Manager at Mascoma Corporation where he contributed to the launch of two commercial products. Prior to Mascoma, Dr. Agbogbo was a Principal Scientist at ICM, Inc. and a Scientist at Novozymes. He has co-authored over 15 peer-reviewed publications and contributed to 5 patents. Dr. Agbogbo holds a Bachelor of Science in Chemical Engineering from Kwame Nkrumah University of Science and Technology, a Ph.D. in Chemical Engineering from Texas A&M University, and an MBA with a certificate in Entrepreneurship from the Price College of Business at Oklahoma University.

World Orphan Drug Congress Presentations August 25-27, 2021
Timothy J. Miller, Ph.D., Forge’s CEO, President and Co-Founder will be participating in two presentations at the upcoming World Orphan Drug Congress, including a keynote fireside chat on “Creating a multi-disciplinary, integrated ecosystem for patient access and affordability,” followed by a panel discussion on “Next generation manufacturing strategies for AAV,” where Dr. Miller will be joined by other gene therapy experts.

The conference is taking place August 25-27, 2021, at Gaylord National Resort & Convention Center in Oxon Hill, Maryland. To learn more about the event and registration, please visit: https://www.terrapinn.com/conference/world-orphan-drug-congress-usa/index.stm

About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 175,000 ft² facility in Columbus, Ohio, “The Hearth,” to serve as its headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. For more information, please visit www.forgebiologics.com.

Media Inquiries
Dan Salvo – Forge Biologics
Director of Communications and Community Development
media@forgebiologics.com

Business Development
Magdalena Tyrpien – Forge Biologics
Vice President and Head of Business Development
BD@forgebiologics.com

Investor Relations
Christina Perry – Forge Biologics
Vice President, Finance and Operations
Investors@forgebiologics.com

Families and Clinician Inquiries
Dr. Maria Escolar – Forge Biologics
Chief Medical Officer
medicalaffairs@forgebiologics.com

COLUMBUS and CLEVELAND, Ohio – July 6, 2021 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), has launched the Forge Forward gene therapy workforce development program in partnership with the National Center for Regenerative Medicine (NCRM) at Case Western Reserve University (CWRU). The goal: to train and attract top talent with specialized Good Manufacturing Practice (GMP) training to the company.

“The gene therapy manufacturing boom has created an unmet workforce demand whose training will be foundational for the success of the gene therapy industry. We are especially excited to be partnering with the NCRM to help expand the talent pool of trained gene therapy manufacturers in the Midwest,” said Timothy J. Miller, Ph.D., Chief Executive Officer, President, and Co-Founder of Forge.

Case Western Reserve is a nationally ranked private research university in Cleveland.

The inaugural Forge Forward program will help build and extend Ohio’s leadership in gene and cell therapy manufacturing by enrolling promising students wishing to learn the basics of gene therapy manufacturing. Selected candidates will learn how to work in both research and GMP environments and will gain hands-on experience in cell culture and sterile techniques through both lecture and laboratory teaching.

“The NCRM training environment offers a unique opportunity to respond adeptly to the needs of the regenerative medicine biotechnology industry of the state. We welcome the opportunity to work together to train an outstanding work force,” said Stan Gerson, M.D., Interim Dean of Case Western Reserve’s School of Medicine and NCRM director.

The Forge Forward internship initiative will integrate the experience of NCRM and the Master’s of Regenerative Medicine and Entrepreneurship (RGME), enhancing the educational and experiential exposure to gene therapy technology, manufacturing and clinical development. The goal of the hands-on education program will be to streamline the industry’s workforce development, providing dozens of opportunities for both internship participants and Forge Biologics.    

“This program has the potential to provide the experiential learning our students want and the specific skills they need for employment in this rapidly growing field,” added Cheryl Thompson, Ph.D., Associate Professor and Assistant Dean of Educational Initiatives for the School of Medicine.

About Case Western Reserve University and the NCRM
Case Western Reserve University is one of the country’s leading private research institutions. Located in Cleveland, we offer a unique combination of forward-thinking educational opportunities in an inspiring cultural setting. Our leading-edge faculty engage in teaching and research in a collaborative, hands-on environment. Our nationally recognized programs include arts and sciences, dental medicine, engineering, law, management, medicine, nursing and social work. About 5,100 undergraduate and 6,700 graduate students comprise our student body. Visit case.edu to see how Case Western Reserve thinks beyond the possible. https://case.edu/

The National Center for Regenerative Medicine (NCRM) is a platform to facilitate translational research, clinical application and commercialization of regenerative medicine, tissue engineering, and stem cell therapeutics across a consortium of institutions. NCRM is driven by three nationally ranked, medical research powerhouses, Case Western Reserve University, Cleveland Clinic and University Hospitals. Through this network of researchers and clinicians, research discoveries are actively being translated into cell-based therapies for patient care. https://case.edu/medicine/ncrm

About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 175,000 ft² facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge is building on the theme of “Hope in Ohio” to accelerate the timelines of these transformative medicines for those who need them the most. www.forgebiologics.com

Media Inquiries
Bill Lubinger – Case Western Reserve University
Associate Vice President of Media Relations and Communications
william.lubinger@case.edu

Dan Salvo – Forge Biologics
Director of Communications and Community Development
Forge Biologics Inc.
media@forgebiologics.com

Business Development
Magdalena Tyrpien – Forge Biologics
Vice President and Head of Business Development
BD@forgebiologics.com

Investor Relations
Christina Perry – Forge Biologics
Vice President, Finance and Operations
Investors@forgebiologics.com

Careers Inquiries
Mandy Medve – Forge Biologics
Director of Talent Recruitment
Careers@forgebiologics.com

• cGMP AAV Manufacturing, Process and Analytical Development Expanded in 2H 2021, Accelerates Commercial Capabilities

COLUMBUS, Ohio – June 3, 2021 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization (CDMO), announced today the appointment of John Maslowski to the newly created role of Chief Commercial Officer. Mr. Maslowski brings significant gene therapy manufacturing and development experience to Forge as the Company has expanded its cGMP AAV manufacturing capabilities, including process and analytical development. As CCO, Mr. Maslowski will lead the Marketing, Sales, and Client Development departments to support our partners and clients on their path towards commercializing gene therapies.

“We are excited to have John join the leadership team at such an important inflection point in the growth of Forge,” said Timothy J. Miller, Ph.D., CEO, President and Co-Founder of Forge Biologics.  “John is a seasoned biotech executive, bringing over 20 years of expertise and a proven track record in gene and cell therapy manufacturing, therapeutics development and commercialization, with a focus on rare disease.”

Mr. Maslowski comes to Forge after serving as the President and Chief Executive Officer of Castle Creek Biosciences, Inc.  He served in the same role at Fibrocell Science, Inc., a NASDAQ listed cell and gene therapy company, from 2016 until it was acquired in 2019. At Fibrocell, he previously served as the Senior Vice President of Scientific Affairs and Vice President of Operations. 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, an advocacy organization dedicated to advanced therapies, the scientific advisory board of Castle Creek Biosciences, and the advisory board of Life Science Cares Philadelphia, a charitable organization. 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, and on the board of directors of Castle Creek Biosciences and Fibrocell.

Prior to Fibrocell, Mr. Maslowski held positions at major pharmaceutical companies including Wyeth Pharmaceuticals, Merck & Co., Inc., and Teva Pharmaceuticals.  Mr. Maslowski received his B.S. in biology from Ursinus College and his M.S. in microbiology from Villanova University.

“The gene and cell therapy industry has seen tremendous growth over the past decade, but GMP manufacturing at larger scales remains a challenge,” said Mr. Maslowski, Forge Chief Commercial Officer. “Forge has developed multiple solutions to support end-to-end GMP AAV manufacturing, and I’m excited to help Forge supply clients with these transformative products.”

This news follows the accelerated growth path of Forge, which has raised over $160M in the past 12 months and completed buildout of the initial suites of the cGMP AAV manufacturing facility.

Reminder
Dr. Miller will be presenting a company overview tomorrow, June 4^th at 11:30 a.m. EST, at the Jefferies Virtual Healthcare Conference. Details on how to view the webcast here: https://wsw.com/webcast/jeff174/forge/1996245.

About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 175,000 ft² facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. For more information, please visit www.forgebiologics.com.

Media Inquiries
Dan Salvo – Forge Biologics
Director of Communications and Community Development
media@forgebiologics.com

Business Development
Magdalena Tyrpien – Forge Biologics
Vice President and Head of Business Development
BD@forgebiologics.com

Investor Relations
Christina Perry – Forge Biologics
Vice President, Finance and Operations
Investors@forgebiologics.com

Patient, Pediatrician, Genetic Counselors & Family Inquiries
Dr. Maria Escolar – Forge Biologics
Chief Medical Officer
medicalaffairs@forgebiologics.com

• Forge Biologics Strengthens Gene Therapy Leadership with Key Hires in AAV Manufacturing, Regulatory Affairs and Finance to Support Strategic Growth
• Forge Leadership team has over 100 years direct gene therapy development experience
• Key hires expand AAV manufacturing and regulatory expertise
• Company is on track for GMP AAV production in 1H 2021 at 50L and 500L scales

COLUMBUS, Ohio – September 16, 2020 – Forge Biologics, a viral vector gene therapy manufacturing and development company with the dual platform of CDMO capabilities and the development of proprietary gene therapy products, today announced the expansion of its leadership team to strengthen expertise in AAV manufacturing, regulatory affairs and financial operations. The key hires come on the heels of Forge’s emergence from stealth mode in early July after a successful $40M Series A financing. 

David Dismuke, Ph.D., joins as Chief Technical Officer, Christopher Shilling, M.S., as Vice President of Regulatory Affairs and Quality Assurance, and Christina Perry, MSA, CPA, as Vice President of Finance and Operations. All three leaders will be in place in September and join Forge’s executive leadership team.

“The addition of David, Chris, and Christina to the Forge leadership team brings immeasurable value to Forge and expands our team of gene therapy experts,” said Timothy J. Miller, Ph.D., Forge’s Co-Founder, President and CEO. “We believe that an accomplished and passionate team, with demonstrated experience in manufacturing and developing gene therapy products, is the foundation of fulfilling our mission to accelerate transformative medicines to reach those who need them most.” 

David Dismuke, Ph.D. joins Forge 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 large-scale manufacturing of pre-clinical and clinical-grade AAV vectors for more than 10 years. Prior to joining Forge, David 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 was also previously the 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, David was the 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 then performed his postdoctoral research at UNC Chapel Hill. 

Christopher Shilling, M.S. joins Forge as Vice President of Regulatory Affairs and Quality.  Mr. Shilling has over 15 years’ experience in development of novel gene therapies for rare and severe disorders.  He 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.  He received his Bachelor of Science degree in biology and a Masters of Science degree in Pathology both from the Ohio State University.

Christina Perry, MSA, CPA joins Forge Biologics as the Vice President of Finance and Operations. 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. Christina managed complex entity legal structures and has had extensive exposure to equity and debt financings. 

Over the last 15+ years Christina has worked with public and private companies and startups across varying industries, developing operational processes to scale with high growth. She spent the onset of her career at Deloitte, is a licensed CPA in the state of Ohio, earned her Bachelor of Business Administration at the University of Notre Dame and a Master of Accountancy from Miami University.  

These additions to the Forge Biologics leadership team continue Forge’s momentum within the biotechnology industry in Columbus Ohio, bringing positive impact to both Columbus and the global rare disease community. 

For more information, please visit https://live.forgeabps.com.

About Forge Biologics
Forge Biologics is a gene therapy development engine, focused on enabling access to life changing gene therapies. Forge aims to bring a patients-first approach to accelerate transformative medicines for those who need them most and is building capacity to address the growing demand for gene therapy manufacturing.  Through its state-of-the-art, 175,000 ft² cGMP facility, dedicated to AAV viral vector production, Forge offers end-to-end capabilities to accelerate gene therapy programs from preclinical stage through clinical, and on to commercial-scale production. With this facility as its foundation, Forge is developing a proprietary pipeline of disease-modifying AAV-based therapies to potentially help patients with rare genetic diseases.

Media Inquiries
Dan Salvo – Forge Biologics
Director of Communications and Community Development
media@forgebiologics.com

Business Inquiries
Erandi De Silva, Ph.D. – Forge Biologics
Co-Founder and Vice President of Product Development
bd@forgebiologics.com