Agenda

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Drug Development & Delivery

Keynote: Preparing for the Therapies of the Future, what will Drug Development Look Like?
10:00 AM - 10:30 AM Drug Development & Delivery Theater
Drug Development & Delivery

Academic Keynote
Speaker: AAPS

Industry Outlook: Pipelines, Innovative Medicines, Clinical Trials, State of the Industry
11:00 AM - 11:30 AM Drug Development & Delivery Theater
Drug Development & Delivery

Speaker: Amanda Micklus, Principal Analyst, Informa Pharma Intelligence

Panel Discussion: The Future of Drug Development
11:30 AM - 12:30 PM Drug Development & Delivery Theater
Drug Development & Delivery

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

Lunch
12:30 PM - 01:30 PM Drug Development & Delivery Theater
Drug Development & Delivery
Continuous Flow Chemistry for Molecule Makers
03:00 PM - 03:30 PM Drug Development & Delivery Theater
Drug Development & Delivery

Speaker: AAPS

Panel Discussion: Drug Development – the next frontier for CDMOs?
03:30 PM - 04:30 PM Drug Development & Delivery Theater
Drug Development & Delivery

• 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

State of the Drug Manufacturing Industry
10:00 AM - 10:30 AM Drug Manufacturing Theater
Drug Manufacturing

Speaker: Peter Shapiro PhD., Editor-in-Chief and Director of the Drugs Business Fundamentals Databases, PharmSource and Pharma Intelligence Center

Filling the Gap” in Continuous Pharmaceutical Technologies: A Novel Continuous Filtration Drying System
10:30 AM - 11:00 AM Drug Manufacturing Theater
Drug Manufacturing

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

Break
11:00 AM - 11:30 AM Drug Manufacturing Theater
Drug Manufacturing
Systech Session
11:30 AM - 12:00 PM Drug Manufacturing Theater
Drug Manufacturing
Lunch
12:30 PM - 02:00 PM Drug Manufacturing Theater
Drug Manufacturing
Keynote: FDA Office of Manufacturing Quality
02:00 PM - 02:30 PM Drug Manufacturing Theater
Drug Manufacturing
Continuous oral solid dosage manufacturing - a transformational processing platform that is here today and is here to stay
02:30 PM - 03:00 PM Drug Manufacturing Theater
Drug Manufacturing

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

Dare to Trust: Enhancing Supply Reliability through Open Collaboration
03:00 PM - 03:30 PM Drug Manufacturing Theater
Drug Manufacturing

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

Happy Hour
03:30 PM - 04:30 PM Drug Manufacturing Theater
Drug Manufacturing

Bioprocessing & Manufacturing

Bioprocessing 101
10:00 AM - 11:00 AM Bioprocessing & Manufacturing Theater
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

Contract Manufacturing, Supply Chain Management and Technology Transfer
11:00 AM - 03:30 PM Bioprocessing & Manufacturing Theater
Bioprocessing & Manufacturing

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