Dr. Jane Fang has 25 years of unique multidisciplinary experience in medical practice, life science research and global biopharmaceutical R&D. Her pharma experience includes clinical trial design, study protocol development, strategic planning, trial operations, outsourcing, vendor selection, study management, patient recruitment, data analytics and monitoring, regulatory standards and submissions. Dr. Fang is also a pioneer in digital innovations for clinical trials from medical devices to virtual trials.
Dr. Fang possesses broad international experience in both US and China with extensive global study experience in oncology, autoimmune and respiratory diseases, metabolic and cardiovascular diseases, infectious diseases, and vaccines. Dr. Fang contributed to AstraZeneca/MedImmune’s Durvalumb (Imfinzi), Benralizumab (Fasenra) and FluMist development programs.
Dr. Fang received extensive medical education and fellowship training at one of the most prestigious medical universities in China. She also earned an M.S degree in healthcare management and informatics from University of Pittsburg. Prior to founding Polaris Strategic Partners, she had 20+ years of progressive career at leading global biopharmaceutical companies such as AstraZeneca/MedImmune and Schering-Plough/Merck.
• 华西医科大学临床医学系,临床内科专业硕士,匹兹堡大学医疗政策和医学系统管理专业硕士,阿肯色医科大学分子免疫博士培训学习一年。
• 25年资深生物医药从业经验,横跨临床,基础医学研究,医学信息技术,国际新药临床研发及外包管理,大数据创新。拥有20年直接在美国一流生物医药研究机构和全球领先制药公司工作和管理经验,丰富的国际视野及中美国多个地区的工作背景,对药物临床研发在全球及亚洲地区的发展趋势有敏感的洞察力,并与美国生物医药企业、研究机构、产业链提供商和投资商有广泛的人际关系。
• 熟悉全球精准医学临床开发,积累了200+多项跨全球(北美、欧洲、澳大利亚和亚太地区30多个国家)多中心临床研究项目(1-4期临床)的经验,涉及肿瘤、自身免疫、心血管疾病及疫苗领域,阿斯利康PD-L1抑制剂Imfinzi(英飞凡), Fasenra, FluMist临床开发团队经验, 谙熟新药临床开发战略,差异化制定临床执行计划,病人筛选和试验选点,临床试验服务提供商的选择和管理,临床数据总结,质量控制和申报。
Rebecca has 25 years of experience both in clinical development and clinical operations in leading biopharmaceutical companies ranging from smaller start-ups to large global organizations. She has broad experience with most types of clinical trials from small and large molecules, gene therapy to diagnostic and device. Rebecca has extensive clinical operations and innovation experience across several therapeutic indications including but not limited to immunology, transplant, rheumatology, cardiovascular and metabolic, ophthalmology and most recently rare diseases in adult and pediatric populations.
In the last 10 years of Rebecca's leadership roles in clinical operations, she has successfully built many high performing clinical operations functions and study management teams, by creating clinical organization infrastructures and developing key clinical project management talents to enable highest quality trial execution. Rebecca’s diverse experience across multiple indications, small and large companies and clinical leadership roles is what she leverages to create both high level operational strategies and detailed execution logistics to reach biotech companies' business goals.
Rebecca received her B.S. in chemistry from University of Pittsburgh. Her career started as a bench chemist in academic transplant research at the University of Pittsburgh Medical Center. She progressed her career at Merck/Schering Plough, Shire Pharmaceuticals, Pfizer/Wyeth, Fujirebio Diagnostics, MedImmune/AstraZeneca and REGENXBIO. Rebecca is currently advising a NewCo to establish a biotech organization as Head of Operations.
Beth is the President of Clinical Performance Partners, Inc. a clinical research consulting firm specializing in enrollment and site performance optimization (http://clinicalperformancepartners.com/). Beth also serves as the Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP). She has passionately pursued solutions for optimizing clinical trials and educating clinical research professionals for over three decades. Beth is also an Adjunct Assistant Professor at the George Washington University who has published and presented extensively in the areas of protocol optimization, study feasibility, site selection, patient recruitment and sponsor-site relationship management and clinical research professional competency.
Beth has 30 years of site, SMO, CRO, Pharma, Consulting, Training and Service Provider experiences, both domestically and internationally. Prior to found Clinical Performance Partners, Beth served several senior leadership roles in biopharma industry, including Chief Clinical Officer of Centerphase Solutions, Senior Vice President of D. Anderson & Company (a patient recruitment service provider) and Associate Director of Clinical Research Operations at Merck and CRA Director at MedTrials (a CRO).
Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.)
Dr. Farling has over 21 years of experience in clinical research and clinical operations. She has extensive clinical trial management and study site monitoring expertise from early Phase I & PK studies to late stage Phase III trials. Her therapeutic expertise is very broad and includes: Oncology, Cardiovascular Disease, Rheumatology Disease, Neurologic Diseases, Inflammation diseases, Dermatology, Psychotic Disorders, Immunology/Infectious Disease, Genetic Disorder Disease, Rare Diseases, Viral-Challenge study, Renal impairment and in healthy normal populations studies (FIM, SAD, MAD, ADME, PK, Food Effect, Drug-Drug Interactions and TQT studies).
Dr. Farling has unique expertise working with smaller emerging biotech and pharmaceutical companies, including China-based international drug development companies. She has a full range of clinical operations expertise covering:
· Clinical Leadership and serving as the main point of contact between Sponsors, outsourced CROs/clinical vendors, and clinical study sites.
· Assessment of study operational feasibility and preparation of study execution plan, study timeline and metrics.
· Preparation and management of project kick-off and investigator meetings, weekly project meetings with sites
· CROs and sites selection, budget negotiation, trainings
· Oversight of CRO monitoring activities, data collection activities and review monitoring reports.
· Creation of protocol/amendments, ICF templates and study training documents.
· Preparation or review of study-related documents (Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Data Management Plan, eCRFs and eCRF Completion Guidelines).
· Routine monitoring, co-monitoring visits and virtual monitoring visits at study sites for clinical studies.
· Development of SOPs for Clinical Operations and maintained all TMFs for ongoing and completed clinical studies.
· Preparation and submission of the INDs and routine regulatory submissions to the FDA.
Dr. Farling has a long career path and consultant experience serving as Clinical Operations Head, Sr. Clinical Trial Manager, Clinical Research Scientist with various pharmaceutical companies such as Immune Design, Vaxart, Inc., Portola Pharmaceuticals, Inc., Horizon Pharma, KangLaiTe-USA, Inc., Zogenix, Inc., CV Therapeutics, Inc., Guidant Corporation, Galileo Laboratories, Inc., and Centaur Pharmaceuticals, Inc. She received her B.S degree of Pharmacy from Shanghai Medical College of Fudan University, Ph.D. in Biochemistry from the State University of New York and had her Postdoctoral Fellow at Albert Einstein College of Medicine.
Dr. Qin is the leading consulting firm ZS Associates’ Global RWE lead and principle. He leads the development of RWE data science and technology capabilities and drives the mission to help life science clients realize the full value of RWE investment. He oversees RWE development for drug development across clinical, HEOR, medical, and commercial functions. His RWE expertise brings innovations to today and future’s clinical trials, specifically in clinical program strategy and patient population feasibility and identifications.
As a trained physician and data scientist, Dr. Qin has over 15 years of health informatics and data analytics experiences with in-depth knowledge of medical terminologies, data standards, clinical registries and various EHR products, pragmatics trials designs, observational study methods and health economics. He has a distinctive combination of health informatics, life science data analytics and leadership experiences across the healthcare industry. These include Director, Health Informatics at AstraZeneca where he led the development of global and cross-functional RWE technology and analytics capabilities; Chief Medical Informatics Officer at Acupera; Senior VP at Medversant Technologies; Associate Medical Director at Pfizer; and Principle Architect at GE Centricity.
Dr. Qin received his medical education and trainings from the prestigious School of Medicine, Beijing University and a Master’s degree in Health Informatics & Outcomes Research from Oregon Health & Science University.
Dr. Yan’s J Y Medical Writing ( https://www.jymedicalwriting.com/ ) has over 15 years of extensive experience in the medical and regulatory documents writing for pharmaceutical and biotech companies. She has written and published more than 300 news articles and served as a manuscript editor at American Journal of Health-System Pharmacy for 5 years.
J Y Medical Writing services have a wide range of therapeutic area expertise:
Therapeutic Areas:
Product Types:
Clinical Trial Regulatory Documents:
Dr. Yan and her medical writing capabilities have contributed to many study reports and clinical summaries in new drug applications and biologic licensing applications that were eventually approved by FDA regulatory agencies. J Y Medical Writing has served many small biotech companies and global pharmaceutical organizations, including:
Johnson and Johnson
MedImmune (now AstraZeneca)
Food and Drug Administration (CDER)
MannKind Corp
Analysis Group Consulting
Provention Bio, Inc.
Covance
Parexel
Amgen
Precision Biosciences
Prometic BioTherapeutics
Celimmune, Inc.
Grifols
American Psychiatric Association
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