PDA West Coast Chapter (PDA WCC)

Speaker Spotlight! 🎤✨ We are thrilled to announce that Anthony Mire-Sluis, Senior Vice President, Quality at Gilead, will be speaking at the PDA West Coast Chapter: Full-Day Quality Conference! Gain valuable insights from a leader in quality management. 🔬📈 Conference Details: 🗓️When: February 10, 2026, 8am-5:30pm PST 📍Where: Gilead Sciences, Inc. Spaces are filling up—register today! Don't miss out! ➡️ tinyurl.com/fulldayquality #PDAWestCoast #QualityAssurance #Biotechnology

🎉 Join Us for the PDA WCC Winter Networking Mixer! ❄️ As 2025 comes to a close, PDA West Coast Chapter is excited to bring our Life Sciences community together for an evening of connection, conversation, and celebration. Whether you’re looking to expand your network, reconnect with industry colleagues, or simply enjoy a relaxed night out — this is the perfect way to wrap up the year. Sign up here! - https://luma.com/0qpvsaxu 📍 Venue: Drake’s Brewery 🗓️ Date: December 4, 2025 ⏰ Time: 5:30 PM – 8:30 PM 📫 Address: 1933 Davis St, San Leandro, CA 94577 Expect great people, great conversations, and a strong sense of community. We look forward to seeing you there! #PDAWCC #LifeSciences #NetworkingEvent #BiotechCommunity #PharmaIndustry #YearEndMixer

✨ Join Us for a Full-Day Quality Conference with the PDA West Coast Chapter! ✨ Quality leaders, professionals, and innovators — this one’s for you. On Tuesday, February 10th, 2026, from 8:00 AM–5:00 PM PST, the PDA West Coast Chapter is hosting a full-day Quality Conference at Gilead Sciences in Foster City. This event brings together industry experts for a day of learning, discussion, and collaboration around the latest trends, challenges, and best practices in Quality across the life sciences industry. Whether you’re looking to strengthen your network, gain new insights, or stay ahead of evolving regulatory expectations, this is the place to be. 🔗 Register here: https://lnkd.in/gTSg9cBK We hope to see you there! 🚀

🌟 Celebrating Excellence in Leadership! 🌟 We’re proud to recognize Diane Hagerty as the recipient of the PDA West Coast Chapter (PDA WCC) Distinguished Service Award! Diane has been an impactful leader whose dedication, expertise, and commitment have greatly strengthened both our chapter and the broader life sciences community. Her contributions continue to inspire collaboration, innovation, and excellence across the industry. Please join us in congratulating Diane on this well-deserved honor! 👏🎉 #PDAWCC #Leadership #LifeSciences #Excellence #Recognition

This past Friday, November 7th, 2025, the PDA West Coast Chapter (PDA WCC) held its 3rd annual gala, the Quality Ball at the California Academy of Sciences in San Francisco, California. 🐊 Claude the albino alligator can attest to this night being a grand gathering where industry professionals came together to discuss quality, compliance, and innovation, along with the challenges and demands of a rapidly evolving industry. Diane Hagerty was presented with the PDA WCC Distinguished Service Award as an impactful leader to our chapter and industry. Following the award presentation was an insightful discussion between our discussion moderator, Matt Cushing and our wonderful panel speakers: Parsa (Al) Famili, Gary Koe, Eric Fulmer, and Vinita Kumar. A very special thanks goes out to Stephanie Lee, Deirdre Killebrew (PhD, PMP), and Hanh-Uyen Nguyen for organizing and planning this night, and to all of our event volunteers. PDA WCC Officers: Yashu Sarna, Autumn Lee, Alaina Touchton, Deirdre Killebrew (PhD, PMP) PDA WCC Board Members At-Large: Nikoo Arasteh, Shuhui Chen, Fabio De Martino, Sumin Dong, Whitney French, Nick Kapp, Stephanie Lee, Ming Lei, Raymond Ma, Kate Nelson, Hanh-Uyen Nguyen, Jonathan Scott, Namrata Sher, Rick Tao, Kaushik Thakkar, Bob To, Michelle Tu, Catalina Villouta, Noah Vo, Melat Zewdie The next PDA West Coast Chapter (PDA WCC) event will be our Quality Conference hosted at Gilead Sciences on February 10th, 2026 in Foster City. We hope to see you at our upcoming 2026 events! #PDAWCC #PDAWCCqualityball #quality #compliance #biotech #biopharma #pharma #networking #bayarea

Thank you everyone who joined us at the PDA West Coast Chapter (PDA WCC) and Emery Pharma’s joint Sip and Learn Session last Thursday at Emery Pharma’s site in Alameda. It was great to hear from industry leaders as they discussed CMC challenges and best practices for streamlining drug development from early development through commercialization. A big thank you to our moderator and panelists for forming such an engaging panel. Moderator: Aryo Nikopour Panelists: Milan Tomic, Ramin (Ron) Najafi, Ph.D., Fariba Chalajour, Nicole Kovacs #biotech #biopharma #pharma #pdawcc #networking

🌟 Meet Vinita Kumar, one of our fantastic panelists for our upcoming Quality Ball in San Francisco on Friday, November 7th from 6-10:30 pm! 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. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END THIS WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

🌟 Meet Gary Koe, one of our fantastic panelists for our upcoming Quality Ball in San Francisco on Friday, November 7th from 6-10:30 pm! 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. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END THIS WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences

🌟 The PDA West Coast Chapter is proud to present our Q3 2025 Volunteer of the Quarter Award recipient: Ming Lei! 🎉 Ming Lei currently serves as director, product quality lead at Kardigan, an upcoming leader in cardiovascular disease drug development. She has a wide range of in-depth experience in biopharmaceutical industry, including quality, regulatory and analytical development. She spent her first 12+ years in the industry in Genentech, grown from research associate to team lead in analytical development and quality control through all phases of development. After that, she made a career move to regulatory affairs, CMC at Gilead Sciences where she supported multiple key regulatory filings including NDA, sNDA and BLA. Ming holds a PhD in pharmaceutical chemistry from Kansas University and has 10+ peer-reviewed publications with a focus on protein higher order structure. She is also an amateur behavioral economist with a special interest in antifragility theory and practices. She has been volunteering as a Member-At-Large for PDA WCC since 2023 where she founded the annual full-day interactive seminar series and co-lead the inaugural "Meet-the-FDA Gala" in 2023. She strives to make positive impacts through collaboration, insights and kindness. Thank you for your dedication and contributions to PDA WCC, Ming!

🌟 Meet 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. 📍 California Academy of Sciences 🎟️ Early bird discounted tickets are ON SALE NOW AND END THIS WEEK! Secure your seat → https://lnkd.in/gZdQxbQt #pdawcc #cellgenetherapy #gala #networking #biotech #pharma #lifesciences