PDA West Coast Chapter: Technical Outsourcing Conference

Featured Presenters

• 

  Nikoo Arasteh

  Senior Director of Quality Assurance, Jaguar Health

  Read Bio

  

  Nikoo Arasteh

  Jaguar Health

  Nikoo Arasteh is a Senior Director of Quality Assurance for Jaguar Health. Her two-decade long career in the bio-pharmaceuticals started with Bayer Pharmaceuticals, where she served in several roles within the Quality Department, including Deviation and CAPA management, raw materials QA, analytical methods life cycle, and project management. After some time at Genentech, she directed her journey from biotech to the world of small molecules by working for Jaguar Health, where she grew the quality department from infancy to a full-scope GXP quality operation. With major activities being outsourced in her current company, a large portion of Nikoo’s time and attention is dedicated to the quality management of a broad range of vendors, such as CDMOs, contract analytical laboratories, distribution centers, and CROs. Nikoo received her PhD from University of British Columbia with a focus on Passive Immunization using antibodies from another species . She also holds an MBA focused on Industrial Management.
• 

  John Farris

  Vice President, Head of GxP Quality, Kyverna Therapeutics

  Read Bio

  

  John Farris

  Kyverna Therapeutics

  A highly accomplished Quality Leader with a demonstrated track record of success in building compliant, and efficient processes and teams for start-up, pre-commercial, and commercial phase biotech companies. Proven ability to execute corporate policy and strategy and drive continuous improvement using Lean Six Sigma methodologies as well as conducting root cause analysis. Expertise with vendor oversight, technology transfer, and manufacturing quality systems. Developed teams supporting manufacturing and distribution, clinical, pharmacovigilance, laboratory, and computerized systems. Experience in the complete GxP body of knowledge including Quality System development and execution in compliance with ISO standards, ICH guidelines, FDA, and EMA regulations. Experience in Supplier management in aerospace and automotive industries.
• 

  Bruce Frazier

  Global Head of Biotech Business & Contracts, Bayer Pharmaceuticals

  Read Bio

  

  Bruce Frazier

  Bayer Pharmaceuticals

  Bruce joined Bayer’s Product Supply division in 2022 to lead the implementation of a new contract service offering within Biotech@Bayer. Based out of the Berkeley CA facility, he is responsible for oversight of a global team supporting the establishment of the business and service components as well as acquisition of external projects. The program was officially launched as BioPartnering SolutionsTM in early 2023, with the goal of providing innovators access to Bayer’s global network of CMC development and manufacturing capabilities, enabling them to deliver new therapies to patients and also exemplifying Bayer’s commitment to its vision of “Health For All”. Prior to this role, Bruce was VP of Business Development and Sales for Bionova Scientific, where he helped lead the expansion of the company from a contract development/analytical testing provider into a full-service CDMO, ultimately resulting in its acquisition by Asahi-Kasei.

  Bruce started his 20+ year career in the Biotech industry with a mAb/ADC developer that evolved into a CMO. This provided in-depth experience on both sides of the contract testing and manufacturing business, and it enabled him to contribute in a variety of roles of increasing responsibility with industry leading CROs and CDMOs that included sales, business development, account management, site leadership and business strategy. Bruce has experience in leadership and strategy with both small and large organizations, providing services spanning the full product life cycle from preclinical development to clinical and commercial supply, across multiple modalities, with an increased focus on cell and gene therapies in his current role with Bayer.

• 

  Loan Hoang

  Director of Quality Assurance, Nkarta, Inc.

  Read Bio

  

  Loan Hoang

  Nkarta, Inc.

  Loan Hoang is currently the Director of Quality Assurance at Nkarta, Inc. and is a seasoned professional with over 15 years of experience in the field of Quality. Loan has worked at early clinical-stage and commercial stage pharmaceutical companies. Her expertise encompasses a wide range of areas including auditing, vendor management, quality systems, quality operations, and validation. Throughout her career, she has consistently demonstrated a commitment to excellence and regulatory compliance in the industry. Loan studied Biology at University of California, Davis.
• 

  JR Humbert

  Vice President, Quality, INCOG BioPharma Services

  Read Bio

  

  JR Humbert

  INCOG BioPharma Services

  JR Humbert is currently the VP, Quality at INCOG BioPharma Services. JR has over 20 years of pharmaceutical and biotechnology industry experience in quality, validation , technology transfer, process engineering, and program management. Most recently, JR built and led the Quality department at INCOG BioPharma Services from inception of a new greenfield aseptic filling facility to a successful FDA inspection in 3 years. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica. JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.
• 

  Sian Jones-MacPhail

  Director of Contract Development & Manufacturing, Amgen

  Read Bio

  

  Sian Jones-MacPhail

  Amgen

  Siân Jones-MacPhail has spent close to two decades in the Pharmaceutical and Biotechnology Industry and is currently a Director, leading the Amgen Contract, Development & Manufacturing Small Molecule Business Unit within Manufacturing at Amgen. Sian has dedicated her career to advancing Synthetic assets at both Amgen, and previously at Merck & Co Inc., working across Research, Process Development Commercialization, Global Supply Chain and Manufacturing organizations in both Drug Substance and Drug Product. She has a passion for Manufacturing and understands the importance of the selection and management of CDMO’s to ensure a good technical, quality, and cultural fit, she believes that the supplier relationship is the foundation of success. Sian earned her Masters in Chemical Engineering from Heriot Watt University, Edinburgh.
• 

  Ramon Mendoza

  Scientific Director, Analytical Development, Johnson & Johnson

  Read Bio

  

  Ramon Mendoza

  Johnson & Johnson

  Ramon is the Scientific Director within the Cell and Gene Therapy Analytical Development group at Johnson and Johnson Innovative Medicine where he supporting the cell & gene therapy portfolio, leveraging his ATMP expertise. Prior to joining Janssen, Ramon worked for Bristol Myers Squibb (Celgene), Orchard Therapeutics, Rocket Pharma, Bayer Pharma and Analytical Lab Group now part of Element Materials Technology. During this time, Ramon had the responsibilities of leading analytical and commercial GMP quality teams, developing process and analytical control strategies for AAV, LV, RNP’s and CAR-T drug products. He has experience supporting Cell & Gene Therapy programs from early /late-stage development, well into the commercial lifecycle. He has authored many submissions and participated in agency inspection and meetings, leading to successful commercial approvals of new CAR-T drug products. Ramon has a PhD in Cell & Molecular Biology from the University of Washington, MS and BS in Biochemistry from San Francisco State University. He also held postdoctoral positions at the Fred Hutchinson Cancer Research Center in Seattle WA.
• 

  Kate Nelson

  Former Vice President of CMC, Sumitomo Pharma America

  Read Bio

  

  Kate Nelson

  Sumitomo Pharma America

  Kate Nelson is a pharmaceutical manufacturing and quality executive with 20 years of experience in the biopharma and medical device industries. She has worked in both small clinical stage biopharmas and large multinationals with multiple commercial products including Sumitomo Pharma America, Allakos, Dermira/Eli Lilly, Genentech, AstraZeneca, and Medtronic. Kate has led organizations in Quality and in Manufacturing for small molecules, monoclonal antibodies and for gene therapies. She holds a B.A. in Chemistry from Mount Holyoke College and a M.S. in Polymer Science and Engineering from the University of Massachusetts - Amherst.
• 

  Hanh-Uyen Nguyen

  Site Head of Quality, Minaris Regenerative Medicine

  Read Bio

  

  Hanh-Uyen Nguyen

  Minaris Regenerative Medicine

  Hanh-Uyen Nguyen is the Site Head of Quality for Minaris Regenerative Medicine, a cell and gene therapy CDMO located in Mountain View, California. She has spent nearly two decades of her career dedicated to bringing novel therapies to patients around the world. Her experience in Quality & Compliance spans across biologics, pharmaceuticals, and ATMPs. She has in-depth experience in establishing and maintaining strong relationships with external partners, having worked at both CDMOs and sponsor companies that have outsourced manufacturing, analytical testing, packaging, and supply chain services. She is extremely passionate about the future of cell and gene therapies and the benefits it will bring to the health communities and patients with unmet needs! Hanh holds a Bachelor’s of Science degree in Biomedical Engineering from the University of California, Davis.
• 

  Marsha L. Steed

  Founder & President Steed, Steed MicroBio LLC

  Read Bio

  

  Marsha L. Steed

  Steed MicroBio LLC

  Marsha Steed has over 30 years of experience as a microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is the Founder and President of Steed MicroBio, LLC which is an independent microbiology consulting firm and a Senior Microbiology Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc. consulting firm. Marsha is a globally recognized consultant specializing in sterility assurance and contamination control matters in pharmaceutical, biotech and medical device companies. Marsha is a USP Microbiology Expert Committee member and the chair of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha studied Biology at Western New England University in Springfield, MA. Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) ATMP Advisory Board and has previously served on the PDA Education Advisory Board (EAB); Scientific Advisory Board (SAB) and has served on numerous PDA Task Forces and meeting planning committees and has been the chair of the PDA Annual Meeting and PDA Microbiology.

• 

  Seema Zaidi

  Senior Manager, Global Business Development, Bachem

  Read Bio

  

  Seema Zaidi

  Bachem

  25 years of Life Sciences experienced focused on Pharmaceutical Drug Development & Commercialization. I have been in varying roles within the Global Business Development side of the equation (External Partner) for most of my career. My main passion has been joining forces together all around the table to work lockstep in order to collectively achieve our ultimate goal within the pharmaceutical industry. To advance global human health in order to together run a better world.