Cell & Gene Therapy Gala

Please join the PDA West Coast Chapter for our final event of 2024, the Cell & Gene Therapy Gala at the California Academy of Sciences, a renowned research institute and natural history museum located in San Francisco's Golden Gate Park. Celebrate the PDA West Coast Chapter's 35th Anniversary by attending our second annual Gala at the Academy of Sciences, and tuning into our 5th Annual Cell & Gene Therapy Panel.

Cell & Gene Therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines!

Whether you are producing biologic drug substance, conducting sterile fill-finish operations, or entering into cell and gene therapy, this meeting will provide the latest information to help your organization have the knowledge and agility needed to meet the needs of the patients we serve.

Our esteemed speakers will share their experiences and recent advancements on Cell & Gene Therapies, with insights from clinical trials to manufacturing and commercialization aspects of the medicines of the future.

Join this interactive panel discussion to connect with key players, learning their latest strategies, challenges, and vision for the future of Cell & Gene Therapies.

Due to security measures, all attendees must be pre-registered on Eventbrite prior to attending. Walk-in registration will not be available.

Please Note: Everyone attending must have a ticket registered under their own name.

Valerie Brown – Former Senior Vice President, Quality Assurance in Pharmaceutical Development and Manufacturing | Gilead Sciences, Inc.

Moderator:

• Valerie Brown – Former Senior Vice President, Quality Assurance in Pharmaceutical Development and Manufacturing | Gilead Sciences, Inc.

Panelists:

• Machelle Eppler – Group Vice President of Quality, Regulatory and EH&S, Pharma Service Group (PSG) | Thermo Fisher Scientific
• Priti Hegde – SVP and Global Head of Research | Kite Pharma, a Gilead Company
• Chris Horan – Chief Technical Operations Officer | Artiva Biotherapeutics
• Naymisha (Isha) Patel – Senior Vice President, Quality | Tenaya Therapeutics

Valerie Brown was most recently Senior Vice President, Quality Assurance in Pharmaceutical Development and Manufacturing at Gilead Sciences, Inc. She led a global team responsible for quality and compliance oversight of contract manufacturers producing active pharmaceutical ingredients, drug product intermediates, oral solid dosage forms, parenterals, biologics and medical devices for worldwide development and commercial markets.
She joined Gilead in 2010 and took on roles of increasing responsibility and was elevated to her current role as Senior Vice President, Global Quality Assurance in 2020. Prior to joining Gilead, Valerie was Global Director of Quality and Regulatory for ZaCh Systems and PPG Industries. She is a member of the Parenteral Drug Association and the International Society of Pharmaceutical Engineering.
Valerie holds an undergraduate degree in biology and chemistry and a graduate degree in Healthcare Management.

Machelle is currently the Group Vice President of Quality, Regulatory and EH&S, in the Pharma Service Group (PSG), at Thermo Fisher Scientific. She joined Thermo Fisher in 2017 as VP of Global Quality, Regulatory & Compliance. Throughout her career, Machelle has accumulated over 38 years of industry experience in Biotechnology and Pharmaceutical, including site and global quality leadership roles within Genentech and Roche.

She has extensive experience in developing and deploying Quality Systems, scaling Quality operations, strategic planning, and positioning quality as a business advantage. She is a strong passionate advocate for diversity & inclusion within Thermo Fisher and serves as the executive sponsor for this initiative within the PSG organization.

Machelle earned her B.S in Food Science and Nutrition from The Ohio State University.

Priti Hegde is SVP and Global Head of Research at Kite Pharma, a Gilead company, with a focus on developing novel engineered cellular therapies for diseases including cancer and inflammatory diseases. From 2019 to 2023, Priti was Chief Scientific Officer at Foundation Medicine, a Roche company, where she led research and development of molecular diagnostic tools for Cancer. Prior to that, Priti spent over a decade at Genentech where she led the Cancer Immunotherapy translational program. Prior to Genentech, she led the transcriptomics organization at GSK. Priti received her post doctoral training in Human Genomics at The Institute for Genomics Research and her PhD in Biochemical Pharmacology from SUNY at Buffalo. Priti serves as a member of Board of Directors at Adaptimmune and has been on the scientific advisory board of Bolt Therapeutics.

Chris spent 14 years at Genentech, a member of the Roche Group, where he held several leadership positions across technical operations, including as Senior Vice President, Global Product and Supply Chain Management for Roche in Basel, Switzerland. In that role, he led a 480-person team supplying all of Roche biopharma products worldwide. He joined Artiva from SanBio, where, as Chief Technical Officer (CTO), he led the process development, manufacturing, supply, and quality systems for their mesenchymal stem cell regenerative medicine approach to brain injury in support of a near-term registration in Japan. Before SanBio, he was Chief Technical Operations Officer at Dermira, where he led all aspects of pharmaceutical sciences, manufacturing, quality, supply chain, and procurement to launch the company’s first commercial product. He led the effort to prepare Dermira’s IL-13 monoclonal antibody program for Phase 3 trials and commercial filing and had a key role in supporting the company’s successful acquisition by Eli Lilly and Company. Chris started his career with over 16 years of increasing responsibility in technical operations and corporate roles at Merck & Co. He earned a B.E. in engineering from the Stevens Institute of Technology in New Jersey.

Ms. Patel is Senior Vice President of Quality at Tenaya Therapeutics, leading quality strategy and quality programs for the company’s GXP operations. Ms. Patel has over 25 years of industry experience in quality and compliance, with a focus on building quality functions from the ground up for diverse therapeutics, including some cell and gene therapies. Most recently, Ms. Patel served as Vice President, Quality, for Evolus Inc., where she strengthened quality systems in support of global commercialization of medical aesthetic products. Previously, she has held positions of increasing leadership at Ocular Therapeutics, Prothena, StemCells, Geron and Nektar Therapeutics.

Ms. Patel earned her B.S. from Maharaja Sayajirao (MS) University, India, her B.A. from California State University, and her MBA from Northcentral University.

more information at www.basciences.com/

more info at www.bayer.com

more info at www.biomerieux-usa.com

more info at www.boehringer-ingelheim.com

more info at https://www.criticalmass-consulting.com

more info at www.element.com

more info at www.EurofinsUS.com/BPT

more info at https://www.gene.com

more info at www.gilead.com

more info at www.globalcompliancepartners.com

more info at www.halolabs.com

more info at www.kitepharma.com

more info at www.thermofisher.com

more info at https://sterile.com/

more info at https://www.prudentialuniforms.com/services/cleanroom/

How can I contact the organizer with any questions?

You can contact the event organizer by sending an email to [email protected]. 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 01NOV24 to whomever would like to attend on your behalf.

What is the dress code?

Formal / Cocktail Attire (Black Tie Optional)

My company would like to become a PDA WCC Sponsor, do you have a sponsorship 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 [email protected] 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 10 business days before the event (01NOV24). 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 PDA WCC recording and/or photographing me and using those recording(s) and/or photograph(s) in the future PDA WCC promotional and marketing material, and to send me promotional information via email.

Host or Publisher Parenteral Drug Association West Coast Chapter