Pre-registration for this event is now closed. Email us at office@ispeboston.org if you have any questions.
PROGRAM SUMMARY:
Speed with Quality
is essential to advancing innovative therapeutics from the bench through
clinical and into commercial production. This webinar will highlight two
perspectives of how digital tools can increase efficiencies for technology
transfer in pharma, followed by discussion and Q&A.
Czarina Santos will present: In preparing for
Technology Transfer, it is critical that each step is assessed up front, with
goals and expectations set for all parties involved. Examples of tools used in
collaboration and the must haves for a successful tech transfer project will be
discussed.
Charlie Maher will
present:
We will also learn how Digital Twin technology can be applied to accelerate the
product lifecycle while achieving step improvements in product quality and
yield. Key objectives of a successful Digital Twin Technology initiative and
how it can be used to significantly accelerate technology transfer and product
realization will be presented.
SPEAKERS:
Charlie Maher, Project Director, Resilience
Charlie
serves as the Project Director for the design, construction, and qualification
of Resilience's gene therapy manufacturing facility in Marlborough, MA.
He is also the Resilience’s global business process owner for commissioning and
qualification across network of manufacturing facilities. Before joining
Resilience, Charlie served as the Global Director of Process and Manufacturing
Technology at CAI where he enabled life science firms achieve ambitious goals
for manufacturing pharmaceutical and biopharmaceutical products. Earlier
in his career, Charlie served in the submarine force of the United States Navy
where he commanded a nuclear-powered submarine and was the Chief of Staff of
the Naval Undersea Warfare Center, the Navy’s R&D facility for undersea
weapon systems
Czarina Santos, Head of Project Management,
Delta Project Management
Relevant
Accomplishments: Clinical Manufacturing Site Construction and Technology
Transfer, Product and Process Tech Transfer from Product Owner (Sending Unit)
to CDMO, CMO to CMO, Product Development/Scaleup to Clinical/Commercial MFG
Areas of
Expertise: Project Management, Technology Transfer of Facilities and Product,
Process Engineering, Equipment and Process
Commissioning/Qualification/Validation (CQV)
Professional
Philosophy: Make the process simple to be sustainable. Streamline information
sharing for transparency. Be inclusive.
MEETING
MANAGERS:
Christopher Ciampa, CAI
Kelly Doering, Aspen Technology
PROGRAM FEES:
Member: FREE
Student Member: FREE
Young Professional Member: FREE
Non-Member: $15
Registration Deadline is Wednesday, February 16 at 10:00 am EST.
LOG ON INFORMATION:
Prior to the webinar a confirmation e-mail will be sent with the Zoom information. The webinar can be accessed through phone, online, or through the Zoom webinar app.
Thank you to our Sponsors!