PDA Pacific Northwest Chapter: Process Validation and Regulatory Strategy for ATMPs

Seattle, WA
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Program Highlights


Lotte McNamara
Lotte McNamara
BDO Life Sciences, Managing Director, BioProcess Technology Group

Dr. McNamara is a pharmaceutical scientist with 30 years experience in the development and regulatory areas of the biopharmaceutical industry. During the past 20 years she has provided CMC technical and regulatory consulting services for numerous small and large companies with an emphasis on CMC issues for biological products including antibodies, biosimilars, antibody-drug conjugates, cell and gene therapy products, PEGylated proteins, and polypeptide-drug conjugates. She has provided CMC development and validation strategies to support regulatory submissions for clinical trials and pre- and post-approval marketing applications in Europe, US, Japan and ROW. She has supported strategy development for and attendance at FDA and EMA Agency meetings.

In addition, she has supported selection, management and auditing of contract manufacturing organizations including analytical method and process transfers, process scale-up, and analytical method and process validation for aseptically-processed liquid and lyophilized drug products. She has extensive technical expertise in biologics development using utilizing Quality-by-Design concepts, as appropriate, including QTTP, CQA, DoE and risk assessments, including manufacturing, formulation, analytical method development, method and process validation, characterization, lyophilization, and stability programs.

Darius Pillsbury
Darius Pillsbury
Senior Consultant ValSource

Darius Pillsbury is a Senior Consultant with ValSource who has extensive experience working with many organizations in developing and manufacturing cell and gene therapy (Advanced Therapy Medicinal Products), biopharmaceutical/ biotechnology, small molecule, and vaccine medicinal products. Darius focuses on developing, implementing, and managing phase-appropriate Quality Systems and Process Validation activities through all stages of the product lifecycle. He collaborates with many industry professional organizations and currently serves on the Parenteral Drug Association (PDA) Advanced Therapy Medicinal Products Advisory Board.

The first half of this event will present current challenges and provide solutions to the application of the process validation lifecycle for developing and manufacturing cell and gene therapy products, including a case study as an example.

The second half of the event will cover the benefits and challenges of speedy drug product development - what are the benefits and challenges. When a drug meets an unmet medical need and/or shows a substantial improvement over existing therapies, it may be eligible for priority review and/or accelerated approval. Regulatory considerations for early and late-stage development of drugs, including cell and gene therapies, meeting the requirements for fast-track development will be discussed.

Format: Hybrid; In-Person and Virtual attendance options (event is not recorded).

Zoom Meeting Information

An email with the virtual meeting room information will be sent to you by approximately noon on the day of the event. The meeting room will open at 6:15pm on the event day. Please plan to log in a few minutes early to ensure everything is working properly for you.

Event Flyer

Contact Information

Email: [email protected]


ValSource Lundbeck

More information coming soon.

Day 1

  • 5:30pm| Doors Open
  • 5:30pm - 6:00pm| Networking
  • 6:15pm - 8:00pm| Virtual Meeting Open
  • 6:30pm - 8:00pm| Presentations
  • 8:00pm - 8:30pm| Closing & Final Networking
Agenda is subject to change.

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