*Online registration for this event is closed, but walk-ins will be accepted on-site*

WHEN:     Thursday, April 13 | 4:30 pm – 7:00 pm

WHERE:   STC Biologics, 330 Nevada Street, Newton, MA 02460

PROGRAM DETAILS:
Operational Readiness is critical to CDMO manufacturing lifecycles and the process can be arduous for startup teams to undertake themselves. Learn about how industry leaders are adopting their process and the benefits they are able to achieve by leveraging lessons learned to reduce risks.

AGENDA:
4:30 pm - Arrival and Networking
5:30 pm - Opening Remarks and Intro to STC Biologics
5:45 pm - Panel Discussion and Q+A

SPEAKERS: 

Magdalena Leszczyniecka, President/CEO, STC Biologics
Magdalena is the President and CEO of STC Biologics. STC Biologics, Inc. is a boutique CDMO located in Newton, MA that provides full CMC services and consulting to enable its partners to advance their biologic products from discovery to commercial approval. Magdalena started STC Biologics in 2009 with the goal to bring biosimilars to the market. Since 2012, STC changed its strategy and focused on CDMO services. STC Biologics strives to realize “Speed to Clinic” through integrated product development, technical rigor, and flexibility. Before STC she gained start-up experience working for two venture capital firms: Flagship Ventures and Atlas Ventures. Before that She led the development of MM-121, anti-HER3 antibody program, at Merrimack Pharmaceuticals. In 2002, she started her scientific career at Novartis Pharmaceuticals as a project leader for two oncology development products.  She received her Ph.D. from a joint program between Columbia University and NYU, an MBA from Babson College, and a B.S. in Biochemistry from Rutgers University.

Kelly O’Hare, SVP Operations, Lykan Bioscience
As Senior Vice President of Operations at Lykan Biosciences, Kelly oversees management of the day-to-day site operations, including Manufacturing, Supply Chain, Project Management, and IT. Kelly has more than 30 years of experience in various stage biopharmaceutical companies including biologics, small molecules, cell and gene therapies and diagnostic imaging agents, at both product-based companies and CDMOs. Kelly is inspired by leading teams and initiatives to success through the establishment of compliant, robust, and efficient processes. She is a champion of continuous improvement and risk-based decision-making, and of strong partnering within the Lykan organization and with our Partners and suppliers. Before joining Lykan Bioscience, she held various senior leadership roles in various Quality and Technical Operations disciplines with Solid Biosciences, OvaScience, Lantheus Medical Imaging, Vertex, Shire, and Lonza. Kelly is a proud contributor to the commercialization of three novel products, is a supporter of future women leaders in STEM, and a member of the Industry Advisory Board for the Northeastern University College of Science Biotechnology program.

Shawn Fitzpatrick, Head of Manufacturing-Marlborough, Resilience
Shawn Fitzpatrick is the Head of Manufacturing for Resilience, Marlborough site, which is in currently in construction and nearing completion. The facility, upon completion, will be focused on gene therapy and vaccines. Shawn has over 25 years of experience in Biotechnology primarily in Manufacturing related roles of increasing responsibility across small and large pharma companies including TKT, Shire, Takeda and Wuxi Biologics. In addition, Shawn is Board Member for the Just-a-Start Corporations, a non-profit which is focused on promoting equity by creating access to stable housing and building pathways to economic opportunity. One educational program includes biotechnology education.

David DiPietro, Senior Project Manager, CAI
Dave DiPietro is a Senior Project Manager with CAI, an expert in Program and Project Management who has led cross functional teams to deliver complex, high value projects on time and on budget. As a recognized leader in human performance and project management in the built environment, he has leveraged his varied experience in life sciences, shipbuilding, and military operations to achieve operational and organizational excellence. Most recently served as the Startup and Test Director for a 120,000 sf cGMP manufacturing and QC lab facility. At home he serves in a support ministry and as a project manager for various missions in the US and overseas.

MEETING MANAGER:
Ryan Dessert, LeftField PM

REGISTRATION FEES:

Registration by Thursday, April 6, 2023
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members (Early Bird): FREE

Registration after Thursday, April 6, 2023
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: FREE

THANK YOU TO OUR WONDERFUL SPONSORS: