Accelerating QbD

Perspectives on Product Risk Assessments for Advanced Biologics

Accelerating QbD: Perspectives on Product Risk Assessments for Advanced Biologics


Perspectives on Product Risk Assessments for Advanced Biologics

A 60-minute cross-industry panel of experts will share their perspectives on conducting product risk assessments for biologics under a holistic, Quality-by-Design (QbD) framework.

Drug sponsors, practitioners, regulatory professionals, pharmaceutical executives, academics, and other interested parties will gain an understanding of how to apply these principles as described in the ICH guidelines. The discussion will be based on real-world experiences and best practices that produce more complete and comprehensive submissions



Attendees will learn:

The do’s and don’ts of product risk assessments for biologics

Practical tips to meet the requirements of ICH Q8, Q9, and Q10

How digitization and vertically-integrated knowledge management can help to organize and facilitate risk assessments


Meet the Moderator

Praveen Prasanna, PhD

Senior Director Technical Operations and Head of Biologics Development and Manufacturing, AVEO Oncology

Praveen Prasanna is currently Senior Director and Head of Biologics Development and Manufacturing at AVEO Oncology. He is responsible for the development of AVEO’s biologics pipeline, including Ficlatuzumab and AV-380.

Praveen previously worked at ImmunoGen as Director, External Manufacturing and Supply Chain, where he was responsible for antibody-drug-conjugate (ADC) drug substance and drug product production. At Shire, over nine years, Praveen had increasing responsibility leaving Shire as Associate Director/Principal Engineer, Commercial Technical Services – Drug Product. Praveen facilitated the process transfer, validation, and routine manufacturing initiation for four commercial drug products, including liquid vials, lyophilized vials, and pre-filled syringes.

Praveen is active in the Parenteral Drug Association and was a co-author of PDA Technical Report 60. His interests are phase-appropriate QbD implementation and external manufacturing best practices.


Meet the Speakers

Mark Mitchell

Principal Engineer, Pharmatech Associates

Mark primarily focuses on process engineering, facility design, statistical applications, quality remediation, and CMC preparation for NDA’s for clients with aseptic, solid oral dosage forms, biological, and combination products. He specializes in Quality by Design and implementation of the FDA Process Validation Guidance and ICH Q8/9/10 for new and legacy products.

Prior to joining Pharmatech Associates in 2009, Mark was the Associate Director of Process Engineering and Validation for Novo Nordisk Delivery Technology (NNDT). Mark began his career in the pharmaceutical and medical device industry in 1991.

Mark has authored several articles on statistical applications for process validation and technology transfer and holds a patent in aseptic mixing technology.

Rebecca Waterbury

Head of Quality, CherryCircle Software

Rebecca has 18 years of experience in the life science space working with pharmaceuticals, medical devices, biologics, and combination products regulated in the U.S. and Internationally. She has worked with companies such as Genentech, Eli Lilly, Abbott Laboratories, Savara, Xeris, Menarini Silicone Biosystems, Pfizer, J&J and others.

Rebecca was one of the key voices in the development of QbDVision after seeing many pharmaceutical companies struggle with similar problems during product development and commercialization. As a member of our advisory team, she brings her deep experience and enthusiasm to our software development efforts providing the “customer voice” from the perspective of quality, product development, quality operations, and regulatory compliance

Barrett Fallentine

Director of Product and Process Development, Pharmatech Associates

Mr. Fallentine has held director level and senior engineering positions in both start-up, Fortune 500, and biosimilar companies and has more than 20 years of experience in the management of biologics, process development, process engineering, CMC, and manufacturing operations. He has broad expertise in scale-up and reactor characterization and development of large-scale cell culture processes for clinical manufacture of monoclonal antibodies and fusion proteins.

Mr. Fallentine has managed multiple cell culture technology transfers conducted at external CMO’s and played a critical role in the development of two commercially approved drugs (Kogenate, Bexxar). He has also served as Engineering Lead for three clinical monoclonal antibody programs, BDS Lead for a pre-commercial biosimilar program, BDS Lead for a late-stage biosimilar program, and Process Engineering lead for a fusion protein program.

Mr. Fallentine received a B.S. in Microbiology and Molecular Genetics from the University of California, Los Angeles.


Accelerating QbD​: Perspectives on Product Risk Assessments for Advanced Biologics