On March 13, 2019 Triumvira Immunologics, Inc., (Triumvira) a privately held biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, reported the appointment of Cynthia Molina as Vice President of Regulatory Affairs (Press release, Triumvira Immunologics, MAR 13, 2019, View Source [SID1234534313]). In this position, Cynthia will be responsible for global regulatory strategic development, oversight of regulatory submissions, and interactions with US and international governmental health authorities.
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Before joining Triumvira, Ms. Molina was most recently VP of Global Regulatory Affairs at Cell Medica, Inc in Houston, TX, for 6 years and accumulated 30 years of experience in multiple facets of product development for pharmaceutical, biotechnology, biologic, and in vitro diagnostic products, with a primary focus on regulatory affairs. In addition to regulatory affairs, her experience includes clinical and preclinical strategic planning, quality assurance, process development and manufacturing for oncology and infectious disease products. Ms. Molina has experience leading preparation of a variety of global regulatory submissions, including INDs, NDAs, BLAs, MAAs, global CTAs, 510Ks, PMAs, orphan and Fast Track submissions, and clinical study reports. She has held management positions at both large and small corporations, including Abbott Laboratories.
Paul Lammers, MD, MSc., President and CEO of Triumvira commented, "We are very pleased to welcome Cynthia to our management team. Her background and experience in regulatory affairs will enhance our interactions with regulatory agencies supporting our plan to bring multiple TAC product candidates into clinical development alone, as well as in collaboration with our business partners."
Additionally, several Triumvira executives are presenting at upcoming conferences. Triumvira Chief Technology Officer Donna Rill and Senior Vice President of R&D Dr. Andreas Bader will present at CellCAN’s Second Annual, Pan-Canadian Strategic Forum on Regenerative Medicine and Cell Therapy, to be held March 13-15, 2019, in Toronto, ON. Director of R&D and Head of Platform Development Dr. Christopher Helsen will present at the 26th International Molecular Med Tri-Conference on March 14, 2019, in San Francisco, CA. Topics of their presentations will be:
Characterizing products for GMP manufacturing: What, how and when? (Ms. D. Rill)
Optimizing cell and gene therapy manufacturing, Planning for Success – the path to commercialization (Ms. D. Rill)
TAC technology, its unique and novel MoA, preclinical data and considerations for biomarker analysis in our Phase I/II trial (Dr. A. Bader)
Development of a CD19-TAC therapy for a first in human phase I study (Dr. C. Helsen)
Triumvira also announces Joshua Carle, Vice President of Business Development, will attend the Bio-Europe Spring Partnering conference in Vienna, Austria from March 25–27, 2019. Mr. Carle and Triumvira are seeking to find out-licensing partners to accelerate our TAC pipeline development, collaborators with novel cancer cell surface antigens looking to expand into engineered T-cells, and to identify immuno-oncology assets that are complementary to our TAC T-cell platform.