Plenary Keynote Sessions

Monday, August 10th | 5:00-6:00 PM

Manufacturing Complex Modalities

Moderator:
Ran Zheng, Former CEO, Landmark Bio

Panelists:
Melissa J. Moore, PhD, Chair, Board of Directors, Waterfall Scientific; Board Member, Tessera Therapeutics

Jennitte L Stevens, PhD, Chief Technical Operations Officer, insitro

Weichang Zhou, PhD, CTO, MediLink Therapeutics

Wednesday, August 12th | 4:20-5:15 PM

The Correct Way to Bring Digital and AI into Biopharmaceutical Quality

Anthony Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences

Fireside Chat with Audience Q and A:

Moderator:
Susan Hynes, Global Head, Quality, GSK

Panelists:
Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer

Anthony Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences

Plenary Keynote Biographies:

Lynn Bottone, Senior Vice President, Quality Operations, Environment Health & Safety, Pfizer
Lynn Bottone is Senior Vice President of Quality, Safety & Environmental Operations (QSEO) at Pfizer, leading a global team that ensures quality, safety, and environmental stewardship across more than thirty internal and four hundred external manufacturing sites. With decades of experience in manufacturing, quality assurance, and compliance, Lynn has held leadership roles at Pfizer and Merck, driving operational excellence and innovation. She holds a B.S. in Chemistry from SUNY Purchase and lives in North Carolina.

Susan Hynes, Global Head, Quality, GSK
Susan Hynes is Chief Quality Officer at GSK, where she leads quality across the enterprise, an organization of over 6,000 employees. She joined GSK in late 2020, to lead the medicines quality organization and now drives the company’s transformation of quality as a competitive advantage.

With more than 25 years’ experience at Merck, BMS, Shire/Takeda, Susan has led major enterprise business transformations, overseen a large-scale biologics greenfield construction, and supported accelerated development and launch of a significant number of innovative medicines and vaccines across all platforms. She is recognized for shaping high-performing organizations and advancing enterprise-wide quality excellence. She currently leads one of three priority AI programs for GSK.

Anthony Mire-Sluis, PhD, Senior Vice President, Global Quality, Gilead Sciences
Dr Mire-Sluis is currently Head of Quality for Gilead Sciences. He was Head of Global Quality for AstraZeneca and Vice President, North America, Singapore, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry. Dr Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is the Chairman of the IABS Biotherapeutics Committee, Vice Chairman of the USP Biologicals Characterization Expert Committee, an expert for the International Committee for Harmonization and on the board of the Journal of Immunological Methods.

Melissa J. Moore, PhD Chair, Board of Directors, Waterfall Scientific; Board Member, Tessera Therapeutics
In her role as Chief Scientific Officer, Platform Research, Dr. Melissa Moore was responsible for leading mRNA biology, delivery and computation science research at Moderna. She joined Moderna in 2016 from the University of Massachusetts Medical School (UMMS), where she served as Professor of Biochemistry & Molecular Pharmacology, Eleanor Eustis Farrington Chair in Cancer Research and a long-time Investigator at the Howard Hughes Medical Institute (HHMI). Dr. Moore was also a founding Co-Director of the RNA Therapeutics Institute (RTI) at UMMS, and was instrumental in creating the Massachusetts Therapeutic and Entrepreneurship Realization initiative (MassTERi), a faculty-led program intended to facilitate the translation of UMMS discoveries into drugs, products, technologies and companies. Dr. Moore is a elected member of the National Academy of Sciences (2017) and a Fellow of the American Academy of Arts and Sciences (2019).

Dr. Moore holds a B.S. in Chemistry and Biology from the College of William and Mary, and a Ph.D. in Biological Chemistry from MIT, where she specialized in enzymology under Prof. Christopher T. Walsh. She began working on RNA metabolism during her postdoctoral training with Phillip A. Sharp at MIT. During her 23 years as faculty member, first at Brandeis and then at UMMS, her research encompassed a broad array of topics related to the roles of RNA and RNA-protein (RNP) complexes in gene expression, and touched on many human diseases including cancer, neurodegeneration and preeclampsia.

Jennitte L Stevens, PhD, Chief Technical Operations Officer, insitro
Jennitte brings an impressive track record in therapeutic discovery, design and development at Amgen. Jennitte will spearhead how insitro continues to build a unique research and preclinical engine that incorporates both experimental and computational technologies to generate a pipeline of differentiated therapeutics. For close to two decades, Jennitte was closely involved in advancing a range of Amgen’s novel technologies and modalities, including biologics, synthetics, cell therapies and oligonucleotides. In total, she supported 100+ therapeutic programs, including 30+ IND submissions and 10 BLAs. She has more than 40+ publications and multiple patents to her name and was recognized for the development and use of cutting-edge technologies to improve efficiency and shorten timelines. Jennitte was previously an Executive Director in Process Development at Amgen, having first joined Amgen in 2005 in the Protein Sciences Department in Discovery Research, with a focus on advancing protein expression technologies, protein engineering and molecule assessment. She was instrumental in advancing Amgen’s CHO expression platforms and implementation of cutting-edge technologies to improve efficiency and shorten timelines, winning 2 gold medals and 1 silver medal Amgen Innovation awards, and author on over 40 publications and an inventor on multiple patents. She also led a Pre-Pivotal Process Development organization, managing teams that have advanced therapeutics modalities such as biologics, synthetics, cell therapies and oligonucleoties to the clinic.

Ran Zheng, Former CEO, Landmark Bio
Ms. Zheng is a biotechnology industry veteran who brings more than 25 years of experience in biotechnology operations across multiple geographies to Landmark Bio. Ms. Zheng most recently served as Chief Technical Officer at Orchard Therapeutics, a commercial-stage global gene therapy company specializing in HSC based gene therapies. In this role, Ms. Zheng established the technical operations function and manufacturing network, and advanced the company’s product pipeline, including the approval of Libmeldy™ – the first gene therapy product for metachromatic leukodystrophy. Ms. Zheng has also held leadership positions at several major biotechnology companies including Genzyme (now Sanofi) and Amgen. At Amgen, Ms. Zheng played a key role in building differentiating capabilities in manufacturing for clinical supply and commercial product launch to enable speed to clinic and speed to market strategies for Amgen’s innovative products.

Weichang Zhou, PhD, CTO, MediLink Therapeutics
Dr. Weichang Zhou, Chief Technology Officer (CTO), MediLink Therapeutics, is a globally recognized leader in cell culture engineering and biomanufacturing. He previously held key leadership roles at Merck, Genzyme (Sanofi), PDL BioPharma, and WuXi Biologics. His pioneering research, industrial innovation, and leadership have driven a number of publications, patents, and groundbreaking bioprocessing technologies. He earned his Ph.D. from the University of Hannover and conducted postdoctoral research at DECHEMA, ETH Zurich, and the University of Minnesota. He is a recipient of Asia-Pacific Biopharma Excellence Awards CTO of the Year 2023 award (2024), ECI Cell Culture Engineering Award (2025), and ECI Integrated Continuous Biomanufacturing (ICB) Award (2025).