|Event Name||Cell Therapy Manufacturing & Gene Therapy Congress 2016
Tuesday, November 29, 2016
Wednesday, November 30, 2016
|Cost||£700 - £2,999
|Description||Learn And Benchmark With Attendees From The Main Cell, Gene & Immunotherapy Communities
Optimise your process, manufacturing capabilities and analytical strategies
• How do you deal with the challenge of CMO selection, process transfer, and demonstration of comparability?
• What are the requirements for the commercial manufacturing process?
• What other steps must be taken in order to launch large scale manufacturing?
• What is best practise for defining the efficacy of your product?
• How do you correlate raw material attributes to your cells?
• What is best practise for assessing critical raw materials?
Ensure stringent cold chain and process automation strategies
• How do you develop a stringent, commercially viable manufacturing strategy?
• How do you bring bioprocessing technologies to these therapies to allow them to be made for the masses?
• What is best practise for keeping costs down in scale-out systems?
• How do you design facilities to make them financially feasible?
• What is best practise when working with automated systems for bioreactors?
• What are the major questions and issues surrounding cryopreservation
Learn how to accelerate preclinical studies and push products into the clinic
• Which new applications are showing the biggest promise for the clinic?
• What is needed from preclinical studies so a product can move smoothly into the clinic?
• How do you apply risk based approaches to reduce the amount of data required?
• How can the results from preclinical animal models be used to convince investors that your product is worthwhile?
• What is the best way to set CQA's early on in your process?
• How have companies secured funding for preclinical studies?
Successful clinical strategies and regulatory intelligence for efficient development
• What are the expectations surrounding the generation of clinical evidence?
• What are the most successful clinical strategies and development case studies?
• What are the current incentives for orphan drugs?
• How will the new European guidelines for clinical trials impact the evaluation of them?
• How can you ensure your business model supports your end goal?
• Can you get your product to market and re-imbursed?
Optimise your time out of the office and benefit from 3 days of additional content with our workshops
Pre-Conference Workshops: 28th November 2016
Next Generation Therapies and Technology Platforms
Post Conference Workshop: 1st December 2016
Characterising ATMP's: Developing Potency Assays