Pre Conference Workshop Day
9:30 am - 10:00 am Welcome Registration and Coffee
10:00 am - 12:30 pm Building your Manufacturing Process with Commercialization in Mind from Day OneKaty Spink - COO and Managing Partner Dark Horse Consulting
With Cell and Gene Therapies transforming treatment options for patients with a variety of rare and chronic conditions, there is no doubt that it is an exciting time for developers, physicians and patients alike. Unfortunately, issues of manufacturability still plague our industry, manifesting in challenges ranging from process robustness, scalability and high cost of goods. If issues of manufacturability are not addressed early in development, the end result of product commercial failure is predictable. Unfortunately, our industry has seen many failures that can be traced to manufacturability, despite apparent proximate causes ranging from failed clinical trials, long development timelines, poor margins, or lack of compelling value for money.
Whatever your current stage of development for your Cell or Gene Therapy product, now is the time to ensure that your development and commercialization strategy will pave the way for the transition to commercialization and market demand. Unfortunately, most development organizations have neither the time nor the money to build a commercial manufacturing process for use in Phase 1 clinical trials.
This workshop is designed to provide you with concrete and pragmatic steps you can take early in development to optimize your limited development resources towards development of a manufacturing process with commercialization in mind.
Attend this workshop to:
- Understand common pitfalls and challenges in development of cell and gene therapy manufacturing processes
- Discuss key steps you can take, regardless of stage of development or resource availability, to optimize future manufacturability of your product
- Learn about key tools that can assist you in developing your ‘manufacture to market’ roadmap
Workshop Leader: Katy Spink, Ph.D., COO & Managing Partner, Dark Horse Consulting
Katy has spent the past 15 years in leadership roles in cell and gene therapy product development, including roles as a corporate officer of two publicly traded, clinical stage cell therapy companies.
Prior to joining Dark Horse in March of 2018, Katy served as Executive Vice President and Chief Operating Officer at Asterias Biotherapeutics. She was a founding member of the company’s executive team and led the company’s manufacturing, quality, facilities, process development, research, program management, business development, strategy, intellectual property and investor relations functions during her 5 year tenure at Asterias. Katy started her career at strategic management consulting firm McKinsey & Company, where she consulted for an array of biotechnology, medical device and pharmaceutical companies on topics ranging from R&D strategy to marketing and business development. She then moved on to Geron Corporation, initially in a business development role, and quickly rising to Senior Vice President of Cell Therapy Program Operations and Alliance Management. While at Geron, Katy led the team to FDA clearance to initiate the first-ever clinical trial of a pluripotent stem cell-derived therapy, among many other accomplishments.
Katy has a B.A. in Biochemistry from Rice University, and a Ph.D. in Cancer Biology from Stanford University, where she was a Howard Hughes Predoctoral Fellow.
Katy SpinkCOO and Managing Partner
Dark Horse Consulting
12:30 pm - 1:30 pm Lunch
1:30 pm - 4:00 pm Considering the Payer’s Perspective on Cell and Gene Therapy DevelopmentsOmar Ali - Visiting Lecturer Value Based Pricing and Former Advisor University of Portsmouth and NICE
With the ever increasing market move towards commercialisation of innovative cell and gene based therapies for patient treatment, it is important to consider the realities of treatment reimbursement and how to position yourself for payer approval in such a high cost environment. When looking towards payer approval, Real World Data has become an integral part of payers evaluations and reimbursement structures. This workshop will look at the role of the payer in supporting CGT industry growth, and a variety of different ways to value innovation and real world efficacy in the pharmaceutical industry.
Attend this workshop to:
- Gain an in-depth overview of global healthcare payer landscape & medicines
- Develop a framework for valuing innovation in the pharmaceutical industry – how will we really pay for our health?
- Plan for a successful market roll-out the reality of Real World Evidence in the Cell and Gene space – how can you make the most of your data to support a payer application?
- Analyse a variety of reimbursement models and their applicability to the CGT industry before deep diving into the possible framework of outcomes based pricing
Omar AliVisiting Lecturer Value Based Pricing and Former Advisor
University of Portsmouth and NICE