Join us for a panel discussion featuring local experts in regulatory pathways, guidance, and accommodations available through regulatory agencies for cell and gene therapy. We will focus on development, manufacturing, and scalability to consistently produce complex personalized therapies for broader patient access. We'll also cover the multi-pronged considerations for regulatory approval and commercialization post-approval. 

Program 

5:00 p.m. – 6:15 p.m.  Check-in and Networking
6:15 p.m. – 6:45 p.m.  Opening Remarks and Introductions
6:45 p.m. – 7:45 p.m.  Panel Discussion
7:45 p.m. – 8:00 p.m.  Q&A and Closing Remarks 

Speaker Bios

Susan Catalano, Chief Scientific Officer of Circle Biopharma 

Dr. Catalano is a biopharmaceutical industry executive with 25 years of experience in strategic and operational scientific leadership of neurobiology, oncology, and gene therapy drug discovery and development companies. She currently advises life science entrepreneurs and consults as a seasoned executive and subject matter expert. She served as the Chief Scientific Officer and Advisor at Capsida and CODA Biotherapeutics and co-founded Cognition Therapeutics, where she was the Chief Science Officer and a member of the Board of Directors. Under Dr. Catalano’s leadership, the company scaled from an idea through a full Phase 2 clinical program to an initial public offering in October 2021 (NASDAQ: CGTX). In her early career, she held scientific leadership positions at Acumen Pharmaceuticals, Rigel Pharmaceuticals, and Roche. She is a recipient of the Pittsburgh Venture Capital Association Outstanding Entrepreneur Award, the Carnegie Science Center Entrepreneur Award, and the Ernst & Young Entrepreneurial Winning Women Award. At the national level, Dr. Catalano actively participates on three NIH External Advisory Boards and two Editorial Boards for peer-reviewed scientific journals. Susan received her BA from Barnard College/Columbia University and a PhD in neurobiology from UC Irvine, with postdoctoral training at UC Berkeley and Caltech.  

Kim Jaffe, PhD, Chief Business Officer at BlueSphere Bio

Kim is the Chief Business Officer at BlueSphere Bio, where she oversees operations and business development. She has more than a decade of experience in varying positions in the biotech industry, including head of research and development, as well as overseeing business development and operations at two different clinical-stage, publicly traded oncology companies. Dr Jaffe received her bachelor’s in cell and structural biology with a minor in chemistry from the University of Illinois at Urbana-Champaign and her PhD in biochemistry, cell biology, and molecular biology from Northwestern University. She completed her post-doctoral training in cell and molecular biology at Princeton University. In 2011, she joined Oncobiologics, a biosimilars company, where she served as the head of cell line development, played a significant role in the regulatory filings, and was instrumental in the early development of the biosimilar product LYTENAVA™, which recently received European Commission Marketing Authorization for the treatment of wet AMD. In 2017, she moved to Advaxis, a public, late-stage clinical oncology company. Here, she was able to bridge the gap between the R&D and product development groups to bring two neoantigen therapies to the clinic before transitioning to the head of R&D. Prior to joining BlueSphere, Dr Jaffe was at OncoSec, a public, clinical-stage immuno-oncology company. As Associate Vice President of Business Development and Operations, she was instrumental in several licensing deals, as well as a large strategic transaction. In addition, Dr Jaffe oversaw all non-finance-related operations while at OncoSec.

Katie Jorgensen, VP and Site Head at ElevateBio BaseCamp Waltham

Katie is a strategic, dedicated, and mission-driven operations professional with experience across development, manufacturing, maintenance, capital planning, project management, continuous improvement, engineering, and business strategy. Katie has direct experience within the biologics/large molecule drug substance, antibody-drug conjugate, and cell & gene therapy spaces supporting a variety of clinical, commercial, and third-party programs. She is currently serving as Site Head at the ElevateBio BaseCamp Waltham facility, responsible for supply chain, facilities, technical operations, manufacturing, and program management, supporting strategic contracts and valued partnerships bringing innovative cell and gene therapies to patients. Katie enjoys spending time with her family & dogs, any activity that gets her outside, experiencing new places, and Mexican food (especially queso and spicy margaritas).

Anna Mamo, Director of Translational Sciences at UPMC Enterprises, Moderator

Anna's early career focused on both academic and biotech research, with time spent in genetics and immunology labs at the University of Pittsburgh and also as a research scientist at Pittsburgh-based start-up company Carmell Therapeutics, which developed regenerative bone and tendon therapies. After developing an interest in the business side of science, she went back to school for her MBA and subsequently worked on commercializing healthcare-related technologies that spun out of Pittsburgh universities, spending time with the Coulter Foundation, Idea Foundry, and Highmark Health in their innovation and strategic partnership departments. After helping to launch an enterprise-wide technology commercialization process (VITAL) at Highmark, she left for UPMC Health Plan, where she led a team developing business cases for novel consumer-facing digital technologies. She eventually transitioned to UPMC Enterprises when they launched their Translational Sciences fund and now oversees a portfolio of investments accelerating university technologies towards the clinic as well as new venture creation. Women's health is an area of investment that Anna is very passionate about, and she spends much of her time here, as well as participating as a board observer for Translational Science's first new venture created in 2019 and TCRT cell therapy company, BlueSphere Bio. Ms. Mamo graduated from Grove City College with a bachelor’s in biology and French, a master’s in microbiology and infectious disease from the Pitt Graduate School of Public Health, and an MBA from the Katz School of Business at the University of Pittsburgh.

Parul Nisha, PhD, Sr. Director, Clinical Development at Cook MyoSite

Dr. Nisha is with the executive leadership of Cook MyoSite, an industry leader in regenerative medicine pioneering autologous muscle-derived cell therapy, and is currently in an advanced clinical stage. She has 25 years of Life Sciences Research experience spanning both industry and academia, from Cancer Epigenetics and Immunology bench research to clinical and regulatory affairs of Pharma and MedTech product development- supporting her passion and enthusiasm for research, innovation, and entrepreneurship in healthcare. Prior to joining Cook MyoSite Inc., Parul led scientific, clinical, regulatory, and business development functions at a local boutique consulting firm, Clinical Research Strategies LLC, as well as worked for Philips Respironics Sleep and Respiratory Care Division within a few different clinical and regulatory functions. She continues to advise entrepreneurial ventures with her expertise in scientific & clinical affairs, as well as regulatory strategies. Dr. Nisha received her PhD from Carnegie Mellon University and did post-doctoral research at the National Institutes of Health (NIH) and Children's Hospital, University of Pittsburgh Medical College (UPMC). She is extensively involved with the growth and talent development within the Pittsburgh life sciences ecosystem, is the founding Chair of the Executive Women In Bio Committee for Women In Bio Pittsburgh (WIB-Pittsburgh), and is a former Chapter Chair (2024). Parul is an Indian classical music enthusiast and lives with her husband and two boys in Sewickley, Pittsburgh.
 

Pricing Information

• Members/Guests: $25
• Non-members*: $45

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Please read WIB's Code of Conduct, In-Person Event Waiver, and Refund Policy.

Note: A confirmation email will be sent after registration has been completed. 

Maximum Capacity

100

Parking Information

Free parking is available on-site.

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