PDA New England Chapter: 2023 Dinner Meeting Communications & Azzur Cleanroom Tour

The PDA New England Chapter would like to warmly invite you to join us for our 2023 Dinner Meeting Communications & Azzur Cleanroom Tour on 27 April in Devens, MA.

Tour Location:
Azzur Cleanrooms on Demand Devens
45 Jackson Road Devens, MA 01434

When: 4:30PM - 5:30PM
Azzur Cleanrooms

Host:

PDA NE Event Meeting Phase #1, Meeting Topic #1

Topic Title: Accelerating Early Phase Development Through Hybrid Manufacturing

Traditionally, biomanufacturing innovators have two choices for early clinical trial manufacturing: build or broker. With more and more virtual companies on the scene, the capital expense and time needed for building is a non-starter. Today, hybrid options exist that allow a risk-based approach to early phase clinical manufacturing. This presentation will:

• Explore the different options for biologics development and manufacturing
• Share results of a 2022 research study outlining the insights and challenges of today’s bio manufacturers
• Present blended solutions to traditional development and manufacturing options

Speaker:

David Frank, VP of Client Development, Azzur Group

David Frank leads customer-facing initiatives for Azzur Group nationwide including: Azzur Cleanrooms on DemandTM, Consulting and Advisory Services, Labs & Training.  For the past decade, David has consulted some of the world’s largest companies in pharmaceuticals, medical devices, technology, and financial services, aligning people, processes, and technology to drive sustainable business results. He has been recognized over the past 20 years for leading award-winning teams and is passionate about developing individuals into leaders. David received his Bachelor of Arts in Economics from The Pennsylvania State University and is a Lean Six Sigma Master Black Belt and PMP.  David resides outside of Philadelphia with his wife Kristen and twin boys, DJ and Chase.

PDA NE Event Meeting Phase #2, Meeting Topic #2

Topic Title: Quality Management Maturity – A Framework for Improving Quality and Patient Safety and Reducing Costs

Quality management maturity is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement – CDER. A Quality Management Maturity (QMM) Assessment holistically assesses the overall health of a quality management system and provides insight into the prevailing quality culture. Included in this presentation:

• Recent efforts by the FDA to secure drug supply chains with the piloting of CDERs QMM program.
• QMM framework: an essential element in charting a course for sustained quality improvement.
• Case studies
• How companies can use the QMM framework to improve quality, maximize patient safety, and reduce costs

Speaker:

Andy Papas, Vice President, NSF Health Science Regulatory Affairs

As Vice President, Andy leads the NSF Health Science Regulatory Affairs practice in Washington, DC with extensive experience providing strategic leadership and guidance on global regulatory affairs, quality, and drug development programs. He has over 40 years of combined industry and FDA scientist expertise that encompasses FDA-regulated pharmaceutical, biotechnology, cell and gene therapy, and combination products. Dr. Papas’ primary areas of regulatory expertise include US Regulatory Affairs; regulatory strategy from early-stage clinical development to marketing applications and on through to post approval changes; leading, reviewing, and/or authoring FDA submissions (IND, NDA, BLA, ANDA, 505(b)(2), combination product RFD, etc.) and leading agency meetings (ex. PIND, EOP2, PNDA, type C, etc.) for pharma/biotech drug clients. Additional experience includes serving as US Agent for foreign clients, regulatory expectations for developing biosimilars, orphan and breakthrough designations, global CMC requirements, US combination products and international requirements for biologics.

Speaker:

Varun Venkatachalam, MS, Principal Consultant, Pharma/Biotech Consulting, NSF

Varun is passionate about Quality Management Maturity and Human Performance in the Lifesciences Manufacturing sector. With over 13 years of experience across Industry (Hospira & Pfizer) and Management Consulting (PwC & EY), Varun is a multifaceted professional with Operational (Strategy and Operational excellence) and Technical (Regulatory, Quality and Manufacturing Systems) expertise. He is currently a Principal consultant in the Pharma/Biotech Consulting team at NSF international, based out of Toronto. Varun is a Biotech Engineer by training and has a MS in Biotechnology from the University of Warwick. He is currently pursuing his Global Executive MBA in Healthcare/Life Sciences at the Rotman School of Management, UofT.