• 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

 

New leadership team appointments strengthen Forge’s manufacturing capabilities with a focus on gene therapy clinical and commercial cGMP manufacturing  

COLUMBUS, Ohio – January 25, 2023 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today the addition of three key leadership hires to further the Company’s growth as a leading manufacturer of genetic medicines.

“Our team has built one of the largest genetic medicines manufacturing facilities in the world, with the ability for end-to-end AAV production of 50L to 5,000L,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge. “Expanding our leadership team with these strategic hires, and the caliber of experience each member brings, supports our vision for growth and the value we provide to our more than 30 partners as we continue to expand our leadership in gene therapy development and manufacturing. I am delighted to welcome Mr. McPherson and Ms. Barsoumian, and congratulate Dr. Davis on his new role.”

Chris McPherson, Vice President of GMP Manufacturing
Chris McPherson will oversee clinical and commercial cGMP manufacturing operations of Forge’s 50L to 5,000L bioreactors in 20 cGMP suites. Mr. McPherson joins Forge with over 25 years of industry experience in commercial biologics manufacturing, technology transfer, validation and BLA/MAA preparation, bringing his expertise in continuous improvement for efficiency and compliance, problem solving, and scale up of client processes in a contract manufacturing environment. Prior to joining Forge, Mr. McPherson helped to scale processes and complete the technology transfer from 20L to 15,000L of biologics manufacturing. He’s held technical leadership positions in industry as Director of Manufacturing, Principal Scientist for Validation, Audits, and Inspections and Head of Clinical Manufacturing with Guilford Pharmaceutical, Cambrex Bioscience, WuXi Apptec, Biotest Pharmaceutical and Samsung Biologics. Mr. McPherson’s two B.S. degrees are in Chemistry and Biochemistry from Pennsylvania State University.

Taleen Barsoumian, Vice President of Client Development
Taleen Barsoumian will lead Forge’s client development strategy and new business operations across Forge’s suite of manufacturing solutions. Ms. Barsoumian was previously the U.S. Director of Sales and Business Development for Cell and Gene at Barkey Corporation, and brings 18 years of experience working with partners in academia, biotech, pharma, government and diagnostics. Prior to joining Barkey, she was the BioScience Western Regional Sales Manager for North America at Greiner Bio-One, following seven years with Novartis Pharmaceuticals, where she was Senior Cardiovascular Sales Consultant. Ms. Barsoumian earned her B.S. in Epidemiology from the Keck School of Medicine at the University of Southern California.

Adam Davis, Ph.D., Vice President of Analytical Development
Adam Davis leads the in-house analytical development and testing team supporting clients throughout product development and manufacturing. Dr. Davis joined Forge in 2020 after 15 years of experience in recombinant adeno-associated viral (AAV) vector product development, process development, and manufacturing. His teams lead the phase-appropriate development, qualification and validation of analytics to support the production of pre-clinical and clinical recombinant gene therapy vectors. Prior to joining Forge, Dr. Davis was the Director of Manufacturing at Abeona Therapeutics, he held the position of Manufacturing Scientist at BioMarin Pharmaceuticals, and completed his post-doctoral work in gene therapy development and manufacturing at Nationwide Children’s Hospital. He earned his Ph.D. from The Ohio State University, focusing on the rational design of recombinant AAV vector capsid for targeted delivery.

About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support 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. To learn more, visit www.forgebiologics.com.

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

 

  • Gene therapy leaders bring expertise in gene therapy development and manufacturing to help advance Forge’s proprietary technologies, client offerings, and pipeline development from preclinical stages through commercialization

COLUMBUS, Ohio – May 17, 2022 – Forge Biologics, a gene therapy-focused contract development and manufacturing organization, announced today the formation of an independent board of preeminent experts, a Scientific and Manufacturing Advisory Board (SMAB), to advise the Company on its gene therapy manufacturing offerings and therapeutics pipeline development. The board will serve the traditional functions of a scientific advisory board, with a distinct and strategic emphasis on manufacturing advancements.

“We are thrilled and privileged to have gathered such a renowned group of experts in gene therapy development and manufacturing to work with us to us deliver quality products to our clients, especially as we accelerate AAV production with our new 5,000L bioreactor,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics. “The board’s guidance will help focus our mission of manufacturing potentially life-saving therapies to patients suffering from genetic diseases.”

Members of Forge’s inaugural Scientific and Manufacturing Advisory Board include:

  • Steven J. Gray, Ph.D., Associate Professor, Department of Pediatrics, University of Texas Southwestern Medical Center. Dr. Gray serves as the director of the UTSW Viral Vector Facility. His core expertise is in adeno-associated viral (AAV) gene therapy vector engineering, followed by optimizing approaches to deliver a gene to the nervous system.  His research focus has also been heavily focused in developing AAV-based treatments for neurological diseases, several of which have translated into clinical trials.
  • Robert Kotin, Ph.D., Executive and scientific co-founder at Stealth Newco; Scientific co-founder of Generation Bio and Frontera Therapeutics; Vice President of Production, Voyager Therapeutics. Dr. Kotin is a preeminent expert in AAV gene therapy manufacturing and the co-inventor of the baculovirus-based AAV production system. He joined Voyager from the National Heart, Lung and Blood Institute of the National Institutes of Health, where he served for more than 20 years in roles of increasing responsibility, most recently as Senior Investigator and Laboratory Chief. Previously, Dr. Kotin served as head of the AAV gene therapy program at Genetic Therapy and as Senior Research Scientist of the Medical Research Division at Lederle Laboratories. 
  • Karen Kozarsky, Ph.D., Co-Founder and Chief Scientific Officer, SwanBio Therapeutics. Dr. Kozarsky has over 25 years of experience in gene therapy, with a primary focus on the development of gene therapy for inherited rare diseases utilizing AAV vectors. She has been involved in the development of multiple gene therapy products that are in clinical trials. Previously, Dr. Kozarsky was President of Vector BioPartners, Vice President of R&D at REGENXBIO Inc., and Head of Gene Therapy in the GlaxoSmithKline Biopharmaceutical Center of Excellence for Drug Discovery.
  • Haiyan Ma, Ph.D., Director of Science, Northern Biomolecular Services. Dr. Ma is a scientific leader with over 30 years of experience in academic laboratories, pharmaceutical industry, and contracted research. She has a broad background in molecular and cell biology, applications of cell and gene therapy, bioanalysis of DNA/RNA/proteins, and virology. She led the establishment of a GLP compliant molecular biology lab, and served as Study Director or Contributing Scientist in 150+ studies.
  • Simon N. Waddington, Ph.D., Professor of Gene Therapy at University College London. Dr. Waddington’s research has spanned viral and non-viral gene therapy. He has published in Cell, Nature Medicine, and Science Translational Medicine on Adenovirus, AAV and lentivirus biology. Some of the fruits of this work are in late-stage clinical trials.

The board will advise Forge leadership on strategic direction and goals, specifically in the areas of manufacturing and scientific or therapeutic program development.

“The landscape for clinical gene therapy is constantly evolving, and we are eager to work with our board members to ensure that we are observant, thoughtful and agile in our responses to the developments in the field,” said Erandi De Silva, Ph.D., Co-Founder and Senior Vice President of Product Development at Forge. “We are striving to effectively build strategies to overcome the barriers to efficient manufacturing and development in gene therapy, and this group’s guidance will be invaluable.”

About Forge Biologics
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge has a 200,000 square foot facility in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV 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. To learn more, visit www.forgebiologics.com.

Media Inquiries 
Marina Corleto – Forge Biologics
Senior Manager, Marketing and Communications
media@forgebiologics.com   

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

Client Development
John Maslowski – Forge Biologics
Chief Commercial Officer
CD@forgebiologics.com

Investor Relations  
Christina Perry – Forge Biologics
Senior Vice President, Finance and Investor Relations  
Investors@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 4th 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://forgebiologics.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