Quality Ball

https://www.pda.org/chapters/north-america/west-coast

Parenteral Drug Association West Coast Chapter

Join the PDA West Coast Chapter for our third-annual Gala.

California Academy of Sciences

Check our website for more meetings available at www.wccpda.org; feel free to reach out at rsvp@wccpda.org for any question.

Please join us for the PDA West Coast Chapter's 2025 Quality Ball located at the California Academy of Sciences, a renowned research institute and natural history museum located in San Francisco's Golden Gate Park. The event will be focusing on the critical intersection of quality, compliance, and innovation in today’s rapidly evolving industries. This thought-provoking gathering will explore how these three areas can work in harmony to overcome challenges, drive success, and improve outcomes in today's industry. As new technologies emerge, innovation plays a crucial role in advancing quality improvements and enabling more efficient, effective ways of working. But how do we balance the drive for cutting-edge solutions with the rigorous demands of quality and compliance? This event will dive deep into the synergies—and tensions—between these three forces, while also addressing the challenges that regulations can place on technological advancement. Our expert speakers will share valuable insights on: - How innovation can act as a catalyst for enhancing quality - How organizations can strike the right balance between pushing the envelope and staying compliant - The complexities of integrating all three areas into a cohesive strategy - Real-world challenges faced in the quest for innovation - How they've overcome hurdles to ensure compliance and maintain the highest standards of quality Join us for an interactive panel discussion with experts and peers, as we uncover the latest trends and approaches that are shaping the future of quality, compliance, and innovation. Don't miss this opportunity to connect, collaborate, and learn from the best in the industry! Whether you're navigating regulatory requirements in a new market or striving to bring breakthrough technologies to life, this event will provide you with the knowledge and strategies you need to thrive in today’s complex landscape. <h2>Visitor and Vendor Policy:</h2>Due to security measures, all attendees must be pre-registered on Eventbrite prior to attending.Please Note: Everyone attending must have a ticket registered under their own name.

<h2>Speakers:</h2><h3>*Subject to change based on availability</h3>

<h3>Matt Cushing</h3><h4>Vice President, Quality and Science Global, Nelson Laboratories | Moderator</h4> Matt Cushing is the Vice President of Quality and Science at Nelson Laboratories, where he oversees global initiatives and regulatory interactions for teams across multiple sites to uphold the company’s standards in quality, service, and science. With over 20 years of leadership experience in highly regulated environments—including GMP, GLP, ISO, FDA, and more—Matt brings a deep commitment to quality systems and people-centric leadership.His career at Nelson Labs spans roles from Quality Auditor to Senior Director and now Vice President, during which he has successfully managed global quality integration, high-risk scientific issues, and regulatory responses. Matt is known for building high-performing teams and mentoring future leaders, including facilitating leadership development programs, and participating in and driving mentorship initiatives across Sotera Health.A recipient of numerous academic and professional honors—including the President’s Award from the University of Utah and the 2025 Nelson Labs Inspired Mentorship Award—Matt continues to model values-driven leadership with a focus on service, collaboration, and continuous improvement.

<h3>Parsa Famili</h3><h4>President and CEO, Novatek International | Panelist</h4> Parsa Famili, is the President and CEO of Novatek International. He was honored as the business personality of Year 2019 for expanding Novatek worldwide. Novatek International has won several awards for Innovations, Export and Corporate Citizenship since its inception in 1996. Novatek’s products and solutions are in use in hundreds of corporations around the globe.Mr. Famili started his career as a professor of Chemistry at Vanier College and held senior management positions in the quality departments of several pharmaceutical companies in Montreal prior to joining Novatek. He is a worldwide speaker and author of several scientific papers and chapters.Mr. Famili has created and volunteers at Hope for Dementia Charity to give back to the society. Hope for Dementia is a registered Charity dedicated to supporting prevention, early diagnosis and treatment of dementia and other cognitive disorders. Mr. Famili received the King Charles III coronation medal for his charity work in 2025.

<h3>Gary Koe</h3><h4>Chief Technical Officer, Electra Therapeutics | Panelist</h4> Gary Koe serves as Chief Technical Officer at Electra Therapeutics, bringing more than 30 years of expertise in biopharmaceutical development, large-scale biologics manufacturing, and quality operations. Throughout his career, he has played a pivotal role in advancing complex biologics programs through the various phases of clinical development.Before joining Electra Therapeutics, Gary was Head of Technical Operations at Aravive, Inc., where he led the large-scale manufacturing of a novel affinity Fc-sAXL fusion protein. His prior experience includes leadership roles of increasing responsibility at prominent biopharmaceutical companies such as Genentech, Valentis, Revance, and Versartis. Gary has overseen the scale-up, technology transfer, manufacturing, and quality control testing for numerous clinical-stage biologics and has managed operations across more than ten manufacturing facilities, including both in-house and contract development and manufacturing organizations (CDMOs).Gary holds a PhD in Chemical Engineering from the University of California, Los Angeles, and a BS in Chemical Engineering from the University of California, Davis.

<h3>Vinita P. Kumar</h3><h4>Senior Vice President and Head of Global Quality, Mirum Pharmaceuticals | Panelist</h4> Vinita P. Kumar is currently at Mirum Pharmaceuticals as the Senior Vice President and Head of Global Quality. She is responsible for overseeing GxP quality operations across Mirum’s clinical, laboratory, document control, training, and IT systems. She led the development of quality strategy to enable Global launch of Mirum products. She was also instrumental in developing and executing global inspection readiness strategies, which includes the oversight of quality management system implementation and ongoing maintenance. Vinita has more than three decades of experience, distinguished by her ability to cultivate high-performing quality teams and seamlessly transition programs from early development through commercialization.Prior to her role at Mirum, she held significant quality leadership positions at Corcept Therapeutics (2018-2021), Versartis (2016-2018), and Relypsa (2007-2016). Her extensive background also includes work at various Bay Area biotech companies, notably NAME5/Roche, where she contributed to areas such as pre-formulation, analytical development, manufacturing, and quality control. Vinita earned a Master of Science in physical organic chemistry from Southern Illinois University, and holds both a Master of Science in organic chemistry and an undergraduate degree from Patna University.

<h3>Eric Fulmer</h3><h4>Senior Vice President Global Quality, Cellares | Panelist</h4> Eric is the Senior Vice President of Global Quality at Cellares. He oversees the teams that perform Quality Control, Quality Assurance, Validation, Design Assurance, and Regulatory Affairs activities for Cellares in-house technology development and operations, and of the Integrated Development and Manufacturing Organization (IDMO) services in the Cellares Smart Factories. Prior to Cellares, Eric established the phase-appropriate Quality Management System and the Quality, Regulatory, and EH&amp;S teams at Bionova Scientific, a start-up CDMO with expertise in cell line development and complex biologics process design. He led the Drug Substance Quality team for Clinical and Commercial Plants at Samsung BioLogics in South Korea, providing inspection management and operational decision making for 186,000L of multi-client and multi-product capacity. Before moving to South Korea, Eric held roles in Quality and Manufacturing at Amgen, as well as product development and manufacturing at Profile Diagnostics.

<h2>PDA WCC Distinguished Service Award Recipient</h2>

<h2>Diane Hagerty | PDA WCC Distinguished Service Award Recipient</h2> Diane Hagerty currently serves as the Chief Quality Officer at Kardigan. In thiscapacity Diane leads the Quality and Compliance function with global executionand oversight responsibilities across all GxP activities. Previously Diane hasserved in executive Quality roles at Allogene, MyoKardia, Dermira, Ultragenyx,Genentech/Roche and Johnson &amp; Johnson. In these roles Diane is known forbringing a pragmatic approach to ensure the successful development, licensingand ongoing commercialization of a wide variety of platform technologiesspanning biologics, pharmaceuticals, medical devices and combination products.Diane is also active across industry forums, exercising her passion for developingthe next generations of GxP Quality leaders. Diane started her working career atSmithKline Beecham Pharmaceuticals holding roles of increasing responsibility inResearch &amp;amp; Development and Regulatory Affairs.Diane holds a Bachelor of Science in biology from Bates College and a Masters ofScience in pharmaceutical quality assurance and regulatory affairs from TempleUniversity.

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<h3>FAQs</h3>How can I contact the organizer with any questions?You can contact the event organizer by sending an email to <a href="http://rsvp@wccpda.org" title="http://rsvp@wccpda.org" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">rsvp@wccpda.org</a>. 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 28OCT25 to whomever would like to attend on your behalf. My company would like to become a PDA WCC Sponsor, do you have a sponsorship program?Yes, our <a href="https://www.pda.org/images/default-source/default-album/chapters/west-coast/2025/pda-wcc-2025-marketing-brochure-sponsorships_page_2.jpg?sfvrsn=87292fff_5/" title="https://www.pda.org/images/default-source/default-album/chapters/west-coast/2025/pda-wcc-2025-marketing-brochure-sponsorships_page_2.jpg?sfvrsn=87292fff_5/" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">PDA WCC Sponsorship Program </a>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. Cancellation &amp; 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 days before the event (280CT25). 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 <a href="http://pda.org/privacy-policy" title="http://pda.org/privacy-policy" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">PDA Privacy Policy</a>.REGISTRATION AGREEMENT: By registering to this event, I consent to 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.

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