Programs & Education Event: ATMPs in Focus: Innovation and Challenges in Accelerating Advanced Therapies
Tue Feb 4, 2025 6:00 PM - 8:00 PM EST
SK Pharmteco; Main Auditorium, 411 Swedeland Rd, King of Prussia, PA 19406
Description
ATMPs represent the cutting edge of medical innovation, holding the potential to transform the treatment landscape for patients worldwide. But bringing these therapies from the lab to life is no easy feat. This dynamic panel discussion brings together a powerhouse of experts shaping the future of ATMPs—exploring the clinical development journey, the patient’s voice, and the challenges of scaling production to meet commercial demand.
Together, they will tackle questions such as: How do we ensure ATMPs are both innovative and accessible? What strategies are critical to navigate the leap from small-scale clinical trials to global commercialization? And most importantly, how do we put the patient’s needs at the heart of it all?
Join us for an engaging hour of thought-provoking conversation and fresh perspectives, followed by a vibrant networking session with refreshments and light bites. Attendees will receive 1 PDH Credit for this event.
Moderator:
Laura-Ann Chin, P.E
Laura-Ann Chin is Director, Life Sciences at Barry-WehmillerDesign Group and also the current President of ISPE-Delaware Valley Chapter. Laura-Ann offers over 13 years of international and domestic contract and hands on process engineering experience in the design and construction of cGMP facilities in the US, Europe and Asia. She specializes in Single-Use Solutions and Modular Technologies for Scale-Up, Scale-Out and Technology Transfer in maximizing the performance of ATMP, biotech, and bulk pharmaceutical facilities.
Laura-Ann’s dynamic proficiency in process engineering combines best business practices and technical expertise in executing projects with exceptional value, speed and compliance. She prides herself in engaging clients upfront and developing strong relationships in the design process.
In most recent years, Laura-Ann has taken a strong affinity in the development of Advanced Therapy Medicinal Products (ATMP) Clinical and Manufacturing facilities where she continues to extend value and creative solutions to cutting edge engineering clients. In addition, Laura-Ann has continued to provide leadership to the engineering design process through the development of highly customized PFDs & P&IDs, mass & energy balance, critical utility calculations, sensitivity analysis and process modeling, bioprocess and cGMP equipment design, hydraulic & pump calculations, vessel relief scenarios, HAZOP and Risk Assessment workshops and value engineering efforts.
Laura-Ann serves an active role on the executive board of ISPE Delaware Valley Chapter (DVC), ISPE Biotechnology Communities of Practice (COP) Co-Chair, ISPE Biotechnology Conference Programming Chair and is a sounding director on the AIChE DVS Board.
Panelists:
Daniel Baker
Daniel Baker is an immunologist and PhD student at the University of Pennsylvania, training with Dr. Carl June and Dr. Zoltan Arany. He focuses on expanding the horizon of cellular therapies beyond cancer to treat chronic diseases. Recognized as an emerging leader in this field, he has published in leading academic journals and prominent media outlets.
Pinar Cicalese, PhD
Pinar Cicalese has over 20 years of experience in strategy and supply of Biopharmaceuticals and Cell Therapies at various companies delivering many late stage clinical and commercial biopharmaceutical assets to the patients.
Pinar holds a PhD in Chemical Engineering from Drexel University and was a Fulbright scholar during her PhD studies. She worked at academia and industry in companies such as EMD Pharmaceuticals and GSK.
As a Sr. Director at Immatics, she leads the commercial CMC strategy for cell therapy programs for various solid cancers and is the head of the Global Patient Supply focusing on optimizing the patient journey.
Stephanie Heathman
Stephanie (Steph) Heathman is the leader of business development at the Opie Jones Foundation, a UK-based charity focused on supporting families through and beyond childhood cancer by funding emotional and mental health support for patients and family members, creating access to cell therapy resources for the patient community, raising awareness of childhood cancers as well as their advanced therapy product treatments, and advocating for advanced therapies to be more accessible to those who need them. Stephanie met Lucy, mum of Opie, who inspired the foundation by championing infant leukemia at the age of 1 after receiving a lifesaving CAR-T therapy, which inspired her to volunteer for the foundation. Since then, Stephanie has dedicated herself to building the Opie Jones Foundation alongside the Ellerker-Jones family and advocates for cancer patients world-wide. In addition to serving the foundation, Stephanie has experience in sales and business development roles in the cell and gene therapy industry.
Justin Jay
With a 25-year career devoted to life science, Justin has first-hand experience in almost every aspect of the business – from research and development to clinical project management to commercial GMP manufacturing operations within industry and government contracting to commercial oversight and business development. His diversified background, entrepreneurial spirit, and agile adaptivity allow Justin to deliver operations leadership, strategy, and innovation that optimize projects of all sizes, complexity, and duration for success.
His past work in the life science industry includes serving as a project and portfolio management leader for global biologics manufacturing sites, directing late-stage drug development projects for major global pharmaceutical companies, and designing project management infrastructures that seamlessly incorporate into larger global development planning efforts.
Justin has supported cell therapy manufacturing initiatives at a wide range of organizations throughout his career, including Lonza CGT, BioReliance, Nantkwest, ABL Inc., Neumedicines, and AstraZeneca. An expert in building robust manufacturing and analytical processes for cell-based products including CAR-T, NK and MSC, he is also an adept cross-team facilitator with a successful track record in developing, optimizing, and scaling projects and technologies.
Raymond Luke
Raymond Luke is a Senior Director of Manufacturing Science and Technology at Verismo Therapeutics and brings more than 10 years of experience in CMC. Prior to joining Verismo Therapeutics, Mr. Luke spent six years at Adaptimmune developing TCR-T and next generation cell therapies targeting NY-ESO-1, MAGE-A4, MAGE-A10 and AFP against solid tumor indications He held leadership roles within CMC and was responsible for GMP manufacturing and technical oversight at CDMOs, technology transfer (sending and receiving) into cGMP manufacturing and technical oversight of manufacturing operations. He also led teams responsible for developing automated processing solutions, analytical development of commercial-ready assays and late-stage process characterization for afamitresgene autoleucel.
Raymond worked in a variety of roles at WuXi AppTec, University of Pennsylvania, Cancer Institute of New Jersey, LifeCell and Chromocell. Mr. Luke holds a Bachelor of Arts Degree in Genetics from Rutgers University.
Pierre-Axel Vinot
Pierre-Axel Vinot brings over 10 years of experience in preclinical research, clinical trials, and CMC management, particularly in the field of cell and gene therapies. He holds a Pharm.D. from the University of Paris and a Ph.D. from Sorbonne University and completed a specialized residency in biotech product development within AP-HP, Europe’s largest hospital group. His career spans academic research, public hospitals, and biotech companies, where he has worked on advancing innovative therapies.Currently, Dr. Vinot leads the CMC portfolio at SparingVision, focusing on the development and manufacturing of gene therapy solutions for retinal degeneration.
Registration will open at 6:00 pm; the panel discussion will begin at 6:45 pm and conclude by 8:00 pm.
"WALK-INs" will be accepted the night of the event, with a $20 surcharge per ticket type (PayPal, cash and credit card will be accepted).
Schedule of Events:
- 6:00 pm – 6:45 pm: Check-in; Pre-event Networking & Dinner (Meet at bottom of Auditorium Stairs)
- 6:45 pm – 8.00 pm: Panel Discussion + Q&A
Boxed Dinner Included with Registration - Shanghainese cuisine (2 course meal and desserts); Please be sure to list any dietary restrictions when you register.
Location:
SK Pharmteco 411 Swedeland Rd, King of Prussia, PA 19406 |
Parking Information:
Please proceed to the GUEST PARKING LOT first and then overflow to the Overflow Parking Lot if necessary.
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Thank you to our sponsors for this event:
Location
SK Pharmteco; Main Auditorium, 411 Swedeland Rd, King of Prussia, PA 19406