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[Free Online Symposium] Gene Therapy: Discovery, Development and Regulatory Perspectives

Speakers: Mark Milton (ex Novartis), Dhaval Shah (SUNY Buffalo), Brian Long (Biomarin), Abigail Johnson (FDA), Emmanuel Gyamfi (FDA)
Organizers: Shradda Sadekar (Genentech), Nagendra Chemuturi (Moderna), Dale Miles (Genentech), Snow Ge (BridgeBio)
Date: 2022-12-07- 12/7/2022
Time: 8:30-12:30 Pacific Time
Registration fee: 0
Location: Online via Zoom
Major Sponsor:
Vendor show vendors registered to date:
Registration deadline:2022-12-06  (it will close sooner if the seating cap is reached)

About the Topic

Objectives of the Symposium: 

- Gain an understanding of the different MOAs and durable pharmacology enabled by gene therapy, state of the field, and future outlook

- Appreciate unique challenges to gene delivery, PKPD translation, immunogenicity management, safety, and manufacturing of gene therapies

- Gain regulatory and preclinical and clinical development perspectives for effective bench-bedside development of gene therapies


Time (PST)

Time (EST)




8:30 - 8:35 am

11:30 - 11:35 am

PBSS Introduction/Welcome Remarks

Snow Ge, BridgeBio

Enas Mahmoud (PBSS)

8:35 - 8:40 am

11:35 - 11:40 am

Symposium Introduction

Shradda Sadekar, Genentech

Snow Ge (BridgeBio)

8:40 - 9:20 am

11:40 - 12:20 pm

In vivo AAV-based gene therapy- a brief primer

Mark Milton, PhD, Principal, Lake Boon Pharmaceutical Consulting, LLC

Shradda Sadekar (Genentech)

9:20 - 10:00 am

12:20 - 1:00 pm

Towards Development of a Platform PBPK Model for AAV Mediated Delivery of MAb Genes

Dhaval Shah, Associate Professor, PhD, MS, B.Pharm., SUNY Buffalo

Shradda Sadekar (Genentech)

10:00 - 10:40 am

1:00 - 1:40 pm

Immunogenicity Monitoring for AAV-Based Gene Therapies

Brian Long, PhD, Principal Scientist, Clinical Immunology at BioMarin Pharmaceutical Inc.

Shradda Sadekar (Genentech)

10:40 - 10:50 am

1:40 - 1:50 pm

QA Round 1 (Mark Milton, Dhaval Shah, Brian Long)

Shradda Sadekar (Genentech)

10:50 - 11:00 am

1:50 - 2:00 pm


Dale Miles (Genentech)

11:00 - 11:40 am

2:00 - 2:40 pm

Gene Therapy Products in Oncology: Clinical and Regulatory Perspective

Abigail Johnson, RN, BSN, Clinical Reviewer/Analyst, FDA

Dale Miles (Genentech)

11:40 -12:20 pm

2:40 - 3:20 pm

Gene Therapy Product Chemistry, Manufacturing and Controls: Regulatory Perspective

Emmanuel Adu-Gyamfi, PhD, CMC Reviewer (Gene and Cell Therapy), FDA

Dale Miles (Genentech)

12:20 -12:30 pm

3:20 - 3:30 pm

QA Round 2 (Abigail Johnson, Emmanuel Adu-Gyamfi)

Dale Miles (Genentech)

Note: This is an online meeting, The Zoom link will be sent to the registrants 1+ days before the event.

2022-12-15, [Free Online Symposium] Success Stories and Lessons Learned from Recent FDA Approvals: INQOVI (decitabine+cedazuridine) by Astex - Otsuka for the treatment of myelodysplastic syndromes (MDS)
2023-02-06, [Free Online Symposium] Promising Biotech Startups
2023-02-08, [Free Online Workshop] New Product Launch: What Does it Take to Bring a New Product to Market?
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