Premier Association Sponsor: PDA
October 19 – 21, 2021
Javits Center, NYC

Keynote Series

2021 Keynote Schedule Coming Soon

Location: Innovation Stage
INTERPHEX launched the Keynote Series with Pharmaceutical Technology and BioPharm International to feature industry experts delivering insight on key industry themes and challenges.

Commercialization Challenges for Cell and Gene Therapies

The early promise offered by cell therapies and gene therapies is tempered by the challenges associated with developing, manufacturing, and delivering the drug product to patients. The complexities of producing these therapies are testing established practices, from starting materials—to process development—to cGMP compliance—to supply chain security and reliability.

This session will highlight technical and regulatory hurdles associated with development and manufacturing steps, and strategies and solutions to facilitate development through commercialization steps. The discussion will include a focus on data management and scheduling strategies to guarantee transparency and chains of authenticity and custody for personalized therapies.

GMPs and Creating a Quality Culture

Recent FDA warning letters—often received years after inspectors first noticed the problems in 483s— have identified deficiencies in many pharma company quality systems, as well as failures to understand the root causes of recurring problems. In this session, experts will examine typical gaps in performance and how to prevent them from resulting in costly quality and compliance problems.

Technology Advances in Process Operations: Panel Discussion on How to Use Real-time Monitoring and AI to Optimize Manufacturing Operations

Today’s technology gives manufacturers the ability to collect and analyze large amounts of process data in real-time. How can artificial intelligence and machine learning can be employed to optimize bio/pharma manufacturing? What is a digital twin and how are early adopters using it? How is predictive maintenance being used in pharmaceutical manufacturing? What lessons can pharma learn from other industries? An expert panel will consider these questions and discuss best practices and the next steps forward for bio/pharma manufacturing.

Jennifer Markarian, Manufacturing Editor; Pharmaceutical Technology and BioPharm International

Amos Dor, General Manager of the Pharma Team; Automation Products Group, Applied Materials
Bikash Chatterjee, Chief Operations and Science Officer; Pharmatech Associates
Pamela Docherty, Life Sciences Industry Manager; Siemens
Bob Lenich, Global Life Sciences Director; Emerson

Genotoxic Impurities and Drug Quality: Lessons from the Nitrosamine Contamination Crisis

The discovery of genotoxic contaminants in commonly used prescription and OTC medicines over the past two years triggered expensive recalls and raised important questions about the safety of drug ingredients, testing procedures, and the supply chain for tracking materials and finished drug products.  Public health questions remain unanswered.  Speakers share best practices for identifying impurities and experiences with testing, and discuss the roles and responsibilities of ingredients suppliers, drug manufacturers, and regulatory authorities.