Agenda
Drug Development & Delivery
Academic Keynote
Speaker: AAPS
Speaker: Amanda Micklus, Principal Analyst, Informa Pharma Intelligence
A look at the innovative products coming to market and the development challenges these pose:
• Keeping pace with innovation, what are the challenges for products currently in development?
• Requirements for emerging therapies - cell and gene technologies, immunotherapy, next-generation biologics, oligos, RNA Tech
• Digital disruptors – AI, Pharma 4.0
• Revisiting and repurposing existing molecules
• Regulatory perspectives
Moderator: Ly Nguyen-Jatkoe, Commercial Strategy Director, Informa Pharma Intelligence
Panellists:
• Eugene Choi, Ph.D, Executive Director, Medicines4All
• Bikash Chatterjee, President & CSO, Pharmatech Associates
• Siân Estdale, PhD, Head of Science and Innovation, CTTS, Covance Laboratories
Speaker: AAPS
• What are the process development benefits to outsourcing your molecule earlier on? How can this de-risk development?
• M&A activity
• Will this allow CDMOs to provide an end to end service to their clients?
Moderator: Peter Bigelow, President, xCell Consulting
Panellists:
• JoyL Silva, General Manager, PfizerCentreOne
• Bikash Chatterjee, President & CSO, Pharmatech Associates
• Sean Diver, Director – Commercial Development, Lonza
• Jim Miller, Former President & Founder, Pharmsource
• Anil Kane, Ph.D., Executive Director, Global Head of Technical & Scientific Affairs Pharma Services Patheon, part of Thermo Fisher Scientific
Drug Manufacturing
Speaker: Peter Shapiro PhD., Editor-in-Chief and Director of the Drugs Business Fundamentals Databases, PharmSource and Pharma Intelligence Center
In recent years, the world’s top pharmaceutical companies have started major research programs to switch from classical batch to continuous manufacturing of their active drug substances. There is a significant gap in technology for the continuous isolation of API. Alconbury Weston Ltd (AWL), a leading supplier of continuous crystallization and filtration equipment, has designed an innovative continuous carousel filter dryer (CCFD) which filters, washes and dries API in small aliquots simultaneously in a continuous manner.
The CCFD is a complete plant which replaces a traditional batch production facility and fits into a walk-in fume cupboard. The core technology is based on well-established Nutsche filtration, processing thin cakes in a fully automated system. A state-of-the-art vision system can be used to track the cake and liquid heights during filtration and washing, improving product purity, yields and quality attributes.
The presentation will describe the challenges and issues observed in batch filtration systems and demonstrate how these challenges can be addressed using continuous filtration. The talk will demonstrate the collaborative efforts required for the development of a novel continuous processing technology through to a commercial product. AWL has worked with Strathclyde University and CMAC (Glasgow, UK) and Purdue University (Indiana, US) to investigate the advantages of continuous filtration. The presentation will include case studies carried out at both academic centres of excellence.
The main points from the talk are as follows:
• Challenges of filtration and drying in batch systems
• Demonstrate how these challenges have been addressed using continuous filtration
• Present experimental work and case studies carried out at University of Strathclyde and Purdue University investigating this novel technology
Speakers:
• Alastair Barton, CEO, AWL
• Dr. Simon Coleman, Product Manager, Isolation and Drying, AWL
This session will take a look at how new pharmaceutical continuous manufacturing platforms and technologies promise great benefits to pharma drug product manufacturers, but implementation can pose many challenges as well. To address these challenges and to take maximum advantage of the opportunities, it is important to understand the integral relationship between process, equipment and facility. Considering just one element, without consideration of the other two, limits the success of implementation. Via real life project examples, the panel will share their experiences, strategies and pointers for successful integration of continuous manufacturing process, equipment and facilities.
Speaker: Dave DiProspero, Director of Pharmaceutical Process Technology, CBR
Matching the ever-evolving signals in demand to supply can be a significant challenge. Our presentation will focus on how building trust drives supply reliability between companies and their CDMO partners. Leveraging our extensive experience of working with customers’ forecasts, we will discuss our learnings on how to optimize information exchange and deploy innovative technology solutions to motivate open collaboration. The main audience for this talk are external supply and procurement leaders, outsourcing consultants, CDMO program managers, quality and regulatory leads.
Speakers:
• Nicole Strauss, Pipeline Development and Innovation, Pfizer CentreOne
• Tom Wilson, Contract Manufacturing, Pfizer CentreOne
Bioprocessing & Manufacturing
Training Workshop: An Introduction to Biopharmaceutical Processing, Current Strategies and Future Landscape
• Understanding the fundamental differences between pharmaceuticals and biopharmaceuticals with a focus on emerging product classes
• Outline the major process steps involved in production of a biopharmaceutical product using antibodies as a case study
• Understand the importance of modified mammalian cells in protein/antibody production
• Appreciate the current trends and future drivers within the biopharmaceutical manufacturing landscape
11:00-11:30: CDMO Selection and Relationship Management
11:30-12:30: Panel Discussion: Exploring Trends in Biopharmaceutical Contract Manufacturing
12:30-13:30: Lunch
13:30-14:15: Partner Presentation
14:15-15:00: Partner Presentation
15:00-15:30: Best Practices for Technology Transfers
15:30-16:30: Panel Discussion - Supply Chain Management, Security and Raw Material Quality Control