# Event Details - **Event Name**: Networking & Fireside Chat with Former FDA Directors - **Event Start and End Date**: Tue, 21 Jul, 2026 at 05:00 pm – Tue, 21 Jul, 2026 at 08:30 pm - **Event Description**: Join the PDA West Coast Chapter and Deffai for an exclusive interactive discussion featuring former FDA leaders.About this EventJoin the PDA West Coast Chapter and Deffai for an exclusive interactive discussion featuring former FDA leaders Johnny Lam and Laura Rose as they provide an insider's perspective on how the Agency approaches CMC development for Cell and Gene Therapy products.Co-Host https://cdn-az.allevents.in/events5/banners/26b806b0-80b0-11f1-8a8c-3fe57d70e589-rimg-w1200-h600-dc000000-gmir.jpg Speakers https://cdn-az.allevents.in/events2/banners/26f7ced0-80b0-11f1-957f-f1f06462340d-rimg-w740-h740-dc2e2f44-gmir.jpg Laura Rose, PhDChief Regulatory Officer | DeffaiLaura is a former FDA Director with nearly 8 years of FDA experience at CDER (Center for Drug Evaluation and Research) and CDRH (Center for Devices and Radiological Health), where she directed a multi-disciplinary team of 14+ medical officers, epidemiologists, engineers, biologists, and chemists.As signing authority on marketing submissions, Dr. Rose oversaw 300+ submissions spanning tissue engineering, regenerative medicine, restorative and repair orthopedic devices and combination products with biologics, small molecules, recombinant proteins, and peptides. Her supervisory record includes 25+ original IDEs, 220+ 510(k)s, 300+ Q-Submissions, 8+ De Novo petitions (including the first-granted combination product), and multiple original PMAs. She has expertise in special programs including Breakthrough, RMAT, and Fast Track designations. https://cdn-az.allevents.in/events9/banners/2731ca90-80b0-11f1-957f-f1f06462340d-rimg-w740-h740-dc2e3230-gmir.jpg Johnny Lam, PhDHead of Regulatory Strategy | DeffaiJohnny is a former FDA CMC reviewer and Director for Policy with nearly 12 years of FDA experience at CBER (Center for Biologics Evaluation and Research) with a special focus in cell & gene therapy (CGT), tissue engineering, and complex biologics.Dr. Lam has reviewed 300+ submissions across INTERACT, pre-IND, IND, IDE, PMA, and Master Files including RMAT designations. He oversaw product jurisdiction activities for OTP-regulated products and served on the Tissue Reference Group adjudicating whether HCT/Ps qualify for 361 regulation or require premarket review as a drug, device, or biological product. He conducted over 100 product assessments and served as policy lead on FDA guidance documents including Potency Assurance for Cellular and Gene Therapy Products and Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products.Platinum Exhibitors: https://cdn-az.allevents.in/events5/banners/2767ceb0-80b0-11f1-957f-f1f06462340d-rimg-w740-h740-dc000000-gmir.png more info at https://www.bayer.com/ https://cdn-az.allevents.in/events5/banners/27a17c50-80b0-11f1-a0f0-b3fc05930e16-rimg-w739-h740-dc173e7d-gmir.png more info at https://www.biomerieux.com/ https://cdn-az.allevents.in/events1/banners/27d7f5a0-80b0-11f1-a0f0-b3fc05930e16-rimg-w1200-h379-dcfffffe-gmir.jpg more info at https://bionovascientific.com/ https://cdn-az.allevents.in/events8/banners/280e6ef0-80b0-11f1-957f-f1f06462340d-rimg-w1140-h740-dcffffff-gmir.jpg more info at https://www.element.com/ https://cdn-az.allevents.in/events9/banners/284adbb0-80b0-11f1-957f-f1f06462340d-rimg-w1200-h312-dc000000-gmir.png more info at https://www.gene.com/ https://cdn-az.allevents.in/events2/banners/2876cdb0-80b0-11f1-8a8c-3fe57d70e589-rimg-w1200-h338-dc000000-gmir.png more info at https://www.gilead.com/ https://cdn-az.allevents.in/events5/banners/28b6bce0-80b0-11f1-957f-f1f06462340d-rimg-w1200-h371-dcffffff-gmir.jpg more info at https://globalcompliancepartners.com/ https://cdn-az.allevents.in/events8/banners/28f26650-80b0-11f1-8a8c-3fe57d70e589-rimg-w1200-h559-dcffffff-gmir.jpg more info at https://www.sterile.com/Directions & ParkingAddress: IPS Office, 2000 Powell Street, Tenant Lounge Emeryville, CA 94608Parking: Available in parking garage at 2000 Powell St. Take a ticket upon arrival. Instructions: The tenant lounge can be accessed by taking the elevator from the lobby to the second floor of 2000 Powell St. The lounge can also accessed from the top floor of the parking garage.FAQsHow can I contact the organizer with any questions?You can contact the event organizer by sending an email to rsvp@wccpda.org. Please allow a few days for the response, emails will not be monitored on the day of the event.Is my registration fee or ticket transferable?Tickets are not reimbursable, however you can transfer your ticket by 13JUL26 to whomever would like to attend on your behalf.My company would like to become a WCC PDA Exhibitor, do you have an exhibitor program?Yes, our offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life Science Community. Please reach out to rsvp@wccpda.org if you are interested in sponsoring the PDA West Coast Chapter.Cancellation & Refund Policy:Tickets are non-refundable. Seating is confirmed and reserved in advance. All sales are final and no refunds will be provided, including but not limited to non-attendance at the event. If a registrant cannot attend, substitutions are welcome no later than 13JUL26. The Chapter reserves the right to cancel an event if the minimum number of attendees is not met by the Monday prior to the event. The Chapter reserves the right to not answer emails or phone calls on the day of the event.Privacy Policy:We manage your personal data responsibly and align with PDA Privacy Policy.REGISTRATION AGREEMENT: By registering to this event, I consent to the WCC PDA recording and/or photographing me and using those recording(s) and/or photograph(s) in the future WCC PDA promotional and marketing material, and to send me promotional information via email.Agenda?: 05:00 PMRegistration Opens?: 05:00 PM - 06:30 PMNetworking & Dinner?: 06:30 PM - 07:15 PMFireside Chat with Former FDA Directors?: 07:15 PM - 08:00 PMQ&A?: 08:00 PM - 08:30 PMNetworking Reception - **Event URL**: https://allevents.in/emeryville/networking-and-fireside-chat-with-former-fda-directors/100001992395848617 - **Event Categories**: fitness, health-wellness, science-fair - **Interested Audience**: - total_interested_count: 0 - **Event Highlights**: - Duration: 3 hours 30 minutes - Location: IPS-Integrated Project Services, LLC - Languages: English ## Ticket Details - **Ticket Price Range**: min: 55.2, max: 65.87, currency: USD ## Event venue details - **city**: Emeryville - **state**: CA - **country**: United States - **location**: IPS-Integrated Project Services, LLC - **lat**: 37.8384623 - **long**: -122.3011845 - **full address**: IPS-Integrated Project Services, LLC, 2000 Powell Street, Emeryville, United States ## Event gallery - **Alt text**: Networking & Fireside Chat with Former FDA Directors - **Image URL**: https://cdn-az.allevents.in/events5/banners/6a5d83b9401c83fd991be47616dd4195857c9d3f9afdec0bfe6cbd91d0e8fdea-rimg-w1200-h800-dceff4f8-gmir.jpg?v=1782537432 ## FAQs - **Q**: When and where is Networking & Fireside Chat with Former FDA Directors being held? - **A:** Networking & Fireside Chat with Former FDA Directors takes place on Tue, 21 Jul, 2026 at 05:00 pm to Tue, 21 Jul, 2026 at 08:30 pm at IPS-Integrated Project Services, LLC, 2000 Powell Street, Emeryville, United States. - **Q**: Who is organizing Networking & Fireside Chat with Former FDA Directors? - **A:** Networking & Fireside Chat with Former FDA Directors is organized by Parenteral Drug Association West Coast Chapter. ## Structured Data (JSON-LD) ```json [ { "@context": "https://schema.org", "@type": "Event", "name": "Networking & Fireside Chat with Former FDA Directors", "image": "https://cdn-az.allevents.in/events5/banners/6a5d83b9401c83fd991be47616dd4195857c9d3f9afdec0bfe6cbd91d0e8fdea-rimg-w1200-h800-dceff4f8-gmir.jpg?v=1782537432", "startDate": "2026-07-21", "endDate": "2026-07-21", "url": "https://allevents.in/emeryville/networking-and-fireside-chat-with-former-fda-directors/100001992395848617", "location": { "@type": "Place", "name": "IPS-Integrated Project Services, LLC", "address": { "@type": "PostalAddress", "streetAddress": "2000 Powell Street", "postalCode": "94608", "addressLocality": "Emeryville", "addressRegion": "CA", "addressCountry": "US" }, "geo": { "@type": "GeoCoordinates", "latitude": "37.8384623", "longitude": "-122.3011845" } }, "eventAttendanceMode": "https://schema.org/OfflineEventAttendanceMode", "description": "Join the PDA West Coast Chapter and Deffai for an exclusive interactive discussion featuring former FDA leaders.", "offers": [ { "@type": "AggregateOffer", "availability": "https://schema.org/InStock", "priceCurrency": "USD", "availabilityStarts": "2026-09-05", "availabilityEnds": "2026-07-21", "validFrom": "2026-09-05", "lowPrice": "55.20", "highPrice": "65.87", "price": "55.20", "url": "https://allevents.in/emeryville/networking-and-fireside-chat-with-former-fda-directors/100001992395848617" }, { "@type": "Offer", "availability": "https://schema.org/InStock", "priceCurrency": "USD", "availabilityStarts": "2026-09-05", "availabilityEnds": "", "validFrom": "2026-09-05", "url": "https://allevents.in/emeryville/networking-and-fireside-chat-with-former-fda-directors/100001992395848617", "price": "65.87", "name": "General Admission" }, { "@type": "Offer", "availability": "https://schema.org/SoldOut", "priceCurrency": "USD", "availabilityStarts": "2026-09-05", "availabilityEnds": "", "validFrom": "2026-09-05", "url": "https://allevents.in/emeryville/networking-and-fireside-chat-with-former-fda-directors/100001992395848617", "price": "55.20", "name": "Early Bird Admission" } ], "organizer": [ { "@type": "Organization", "name": "Parenteral Drug Association West Coast Chapter", "url": "https://allevents.in/org/parenteral-drug-association-west-coast-chapter/17645688", "description": "https://www.pda.org/chapters/north-america/west-coast\r\n " } ] } ] ```