Thank you to all of our esteemed speakers who broughta wealth of knowledge and expertise to our event. Their insights and experiences undoubtedly made this an enriching and memorable occasion. We hope you enjoyed this year's Orange County/Long Beach ASA Symposium!
If you are a speaker for this event, please use the below link to upload your presentation slides.
Keynote Speakers - Day 1
Siddique Abbasi MD PhD, Executive Medical Director, Amgen
Siddique Abbasi is a physician-scientist who is an Executive Medical Director in the Cardiometabolic therapeutic area at Amgen. Siddique received his BA and MD from St. Louis University, graduating summa cum laude with a degree in Philosophy. He completed his internal medicine training at the University of Washington in Seattle followed by cardiovascular disease fellowship at the University of Illinois. He continued his cardiovascular training at the Brigham and Women's Hospital and Harvard Medical School, where he completed a postdoctoral research fellowship and also received a Master of Science in Epidemiology from Harvard TH Chan School of Public Health. Siddique was then appointed assistant professor at Brown University where he ran a research lab that studied the impact of obesity and diabetes on cardiovascular risk. Since joining Amgen in 2017, he has been the global development lead for programs in heart failure (omecamtiv mecarbil), lipids (Repatha), and now obesity (AMG133 and AMG786).
Zhenming Shun PhD, VP Daiichi-Sankyo
Dr Zhenming Shun is the Global Head of biostatistics and data management at Daiichi-Sankyo, Inc. responsible for leading statistics, programming and data management functions to support global R&D portfolio and post-marketing activities. Dr Shun has over 25 years of experience in various biopharmaceutical companies with increasing responsibilities. He has led development activities in various therapeutic areas including oncology and cardiovascular diseases. Dr Shun’s primary interest is in adaptive designs in clinical trials and random effect model-based methodology. Dr Shun received PhD from University of Chicago.
Harpreet Singh, MD, FDA
Dr Harpreet Singh is a medical oncologist and the Director of the Division of Oncology 2 at the US Food and Drug Administration (FDA) and expert in both geriatric and thoracic oncology. The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for thoracic head & neck, neuro-oncology rare cancers, pediatric solid tumors. Dr Singh continues to see patients in a prostate cancer multidisciplinary clinic at the National Cancer Institute. She is native of Los Angeles and graduated from the University of California, San Diego before completing her medical degree at the University of Southern California Keck School of Medicine. She completed her internal medicine residency and geriatrics fellowship at the Los Angeles County + University of Southern California Medical Center. She then went on to the National Cancer Institute at the National Institutes of Health for a fellowship in medical oncology. She focused on tumor immunology and biology, including cancer vaccines and immunotherapy clinical trials. Dr. Singh joined the FDA as a medical officer in 2015, where she quickly established herself as a leader in geriatric oncology. She has presented research at major conferences, including the American Society for Clinical Oncology and the American Society for Hematology. Dr. Singh is an active member of the Cancer and Aging Research Group, a dynamic group of geriatric oncology researchers across the nation who work in a collaborative effort to design and implement clinical trials to improve the care of older adults with cancer. She has been working actively with ASCO and other key stakeholders to increase the evidence base for treating older adults with cancer.
Keynote Speakers - Day 2
Aditya Rajagopal PhD, Founder, CTO, Chromacode
Dr Aditya Rajagopal is the Co-founder and the Chief Technology Officer at Chromacode, a multiplexed molecular diagnostics company with a bioinformatics focus and pedigree from Google[x], Illumina, Luminex, and Caltech. Chromacode is transforming the multi-billion dollar molecular diagnostics industry by democratizing personalized medicine.
Aditya is the inventor of HDPCR, ChromaCode’s core technology. Previously, he was a researcher at Google[x], where he worked on novel medical imaging methods. He has expertise in thermal engineering, digital signal processing, nano-scale electronics, low-power circuit design for implantable sensors, DNA sequencing structures and techniques, and PCR devices and applications.
Aditya is also the Executive Chairman & Co-Founder of Esperto Medical Company, a Caltech spin-out utilizing compressed sensing methods with ultrasound to continuously and non-invasively measure blood pressure. Backed by Maverick Ventures and others. Aditya received BS, MS and PhD from CalTech.
Jaime Wheeler MBA, CPhT, Edwards Lifesciences
Jaime Wheeler, MBA, CPhT is the Senior Vice President of Clinical Affairs for Transcatheter Heart Valves at Edwards Lifesciences. She has worked in both medical device and pharmaceutical research for over 25 years focusing on the strategy, design, and conduct of clinical research across various therapeutic areas including: Cardiology, Rheumatology, Pain Management, Peripheral Vascular/Embolic Protection and Structural Heart. She has managed multiple divisions and regions including an expatriate assignment in Tokyo, Japan. She was the Clinical lead on three successful Merger and Acquisition deals, the largest worth $1.5B. Ms. Wheeler holds two Bachelor of Science degrees, a Master of Business Administration degree, she was a prior Virginia State Emergency Medical Technician (EMT-B) and is a Certified Pharmacy Technician (CPhT). She currently sits on the AdvaMed Working Group for Women in Cardiovascular Device Trials, is a founding member of the MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research, and is a Board Member for OneOC in Santa Ana, California.
Session Invited Speakers
Arsela Prelaj, MD, Istituto Nazionale Tumori (National Cancer Institute), Milano, Italy
Dr Prelaj is a Medical Oncologist specializing in thoracic malignancies at the Thoracic Unit of Istituto Nazionale Tumori di Milano in Italy since 2018. She completed her residency in Medical Oncology at Sapienza University, Policlinico Umberto I Hospital in Rome, Italy. During her training, Dr Prelaj was awarded the ESMO Clinical Unit Visit in 2017 and spent time at The Christie Hospital in Manchester, collaborating with Dr. Raffaele Califano in the Lung Cancer Division from October to December 2017. Over the past seven years, her research has primarily focused on thoracic malignancies, particularly non-small cell lung cancer (NSCLC) and translational immunotherapy. Since May 2019, she has also directed her research towards the fields of bioengineering and artificial intelligence (AI) and is currently pursuing a Ph.D. at Politecnico di Milano’s Department of Electronics, Informatics, and Bioengineering. She serves as the principal investigator for multiple international clinical trials and is actively involved in coordinating various national and international grant applications in the field of thoracic malignancies and immunotherapy. As the head of the AI-ON-Lab (Artificial Intelligence for Oncology Lab) at Istituto Nazionale Tumori of Milano, she is responsible for leading research and development in the application of AI in oncology. Dr Prelaj is an ESMO, ASCO, AACR, IASLC and AIOM member and faculty at many congresses on AI.
Sunil Gupta, CDISC SME, PointCross
Sunil Gupta is an CDISC SME and works at PointCross. Sunil is also an international speaker, best-selling author of five SAS books and a global SAS developer and CDISC SME and corporate trainer. He is an advocate of CDISC automation and standardisation, with over 25 years of experience in the pharmaceutical industry. Sunil is currently teaching Practical R for SAS Programmers, a CDISC online class at the University of California at San Diego and classes on data science using SAS at UCLA and UCSD Extension. In 2019, Sunil published his fifth book, Clinical Data Quality Checks for CDISC Compliance Using SAS and, in 2011, launched his unique SAS mentoring blog, SASSavvy.com, for smarter SAS searches and R-Guru.com for R Programming. Sunil has an MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston.
Bhavin Busa, Principal and Co-founder, Clymb Clinical
Bhavin Busa is recognized as a thought leader in the areas of data standards, programming and regulatory submission. He is very passionate about leveraging standards and technology to expedite data review, analysis and submission processes. In line with his passion, Bhavin recently co-founded Clymb Clinical, a startup that is driving innovation and revolutionizing the clinical data industry through implementation of technology and open-source solutions. He devotes much of his time outside of his day job to volunteer with PHUSE and CDISC. He holds a position on the PHUSE Working Group Leadership Committee and serves on the CDISC Open-Source Alliance (COSA) Board. Additionally, Bhavin serves as a CDISC ARS Product Owner/Co-lead and is slated to be the Chair of upcoming PHUSE US Connect 2024.
Tomas Hovorka, Biostatistics Director, Edwards
After obtaining master degree from mathematical statistics at Charles University in Prague (Czech rep., Europe), Tomas worked on various projects involving all aspects of data science (data collection, analysis, presentation/visualisation) and many aspects of SW development (programming, analysis, management). Currently, Tomas leads a EU biostatistics group of Clinical Affairs, Transcatheter Heart Valve unit at Edwards Lifesciences. He is based in Prague.
Simon Heap, Senior Consultant, Phastar
Simon Heap works as Senior Consultant at Phastar, Copenhagen. Simon has 20+ years of experience with data handling and programming and 15+ years of experience with business intelligence tools from Qlik. Simon’s experience stems from clients in several industries, and he joined Phastar in 2022 to focus on clients and solutions within the pharmaceutical industry. Simon has a BA in musicology, aesthetics and cultural studies from Aarhus University, Denmark, and further studies within strategy and business from the IT University of Copenhagen. Phastar is a Qlik Sense Elite Partner and Simon holds the Qlik Sense Data Architect and Qlik Sense Business Analyst certifications.
Brian Ramos, Director Statistical Programming, Edwards Lifesciences
Brian Ramos is a Director of Statistical Programming at Edwards Lifesciences leading the programming efforts in support of Edwards’ PASCAL Transcatheter Valve Repair System. He has over 20 years of industry experience leading and supporting all aspects of statistical programming with several successful PMA submissions under his belt. As a big proponent of automation, he constantly seeks solutions to increase programming efficiencies to make programmer’s lives easier. He has previously presented at PharmaSUG and is happy to be presenting for the first time at OCBS. He is a native of Southern California, received his degrees from the University of California, Los Angeles, and doesn’t see himself leaving the area for any place else.
Li Huang, Biostatistician, PHASTAR
Jeff Cao, President, Viitai
Anthony Chow, Executive Director, Data Science, CDISC
Bruce Ho, Ph. D, Data Scientist, Bayezene AI
Jonathan Kowalski, PharmD, MS, Executive Vice President, Head of US HEOR at Lumanity
Dr. Damla Senturk, Professor & Chair of Biostatistics
Wei (Vivian) Zhuang, PH.D, Staff Fellow, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research/FDA
Panel Discussions - Opportunities for graduates, change in industry dynamics
A clinical research and development executive with over 20 years of experience in drug, device, and imaging diagnostic agent development and a proven track record of successful execution of clinical development and post-marketing activities in early-stage and pivotal clinical trials leading to NDA submissions, approvals, and market launch. A result-oriented team leader who provides directions to the team and strategy for the clinical development plan and execution to meet corporate objectives.
My experience and accomplishments highlight my expertise in biostatistics, particularly in the design and analysis of clinical trials, my leadership abilities, and my commitment to advancing medical research.
I currently serve as a lead biostatistician at JnJ MedTech CSS group, where I play a crucial role in providing statistical support for the design and execution of clinical trials within both Mentor and Coherex franchises. In my position, I not only offer statistical guidance to junior statisticians but also spearheaded the development of the first summer internship program for CSS. Additionally, I have successfully enhanced the processes for study routine reports and SOPs, ensuring greater efficiency and accuracy. Moreover, I have been a key statistician for a PMA submission of the Mentor team, contributing to the successful completion of an important regulatory milestone.
Prior to joining JnJ, I dedicated five years to working as a statistician at COG, specializing in pediatric oncology clinical trial designs. During this time, I gained expertise in various areas such as sample size calculation and conditional power analysis through simulation. Furthermore, I simultaneously handled statistical analyses and prepared publications for five projects that were part of the Malignant Germ Cell Tumors International Collaborative Consortium.
Before transitioning to industry, I had a rewarding six-year tenure as a faculty member in the Biostatistics Department at the Keck School of Medicine at USC. During this time, my primary research focus was on phase 3 pediatric oncology RCTs with COG. In this role, I collaborated closely with esteemed research clinicians to independently design 13 superiority and non-inferiority group sequential design trials. Additionally, I successfully managed a team of three statisticians, mentored seven MS students, and taught statistics to MD students, imparting my knowledge and expertise to the next generation of researchers. My contributions to the field of biostatistics are reflected in my extensive publication record, which includes over 27 collaborative papers.
I am a hybrid between an Environmental Scientist and a Biostatistician. I received my Master's in Biology from California State University Long Beach in 2012 with an emphasis in Marine Ecology. Though I love Marine Science I have developed an interest in Biostatistics along the way and subsequently completed a Master's in Applied Statistics. I currently work for Hoag Memorial Hospital Presbyterian as a Data Scientist/Statistician in the Strategic Analytics Department, supporting our partners hospital-wide with their data analytics needs.
I have been working here for about 2 years and it has been a great learning experience. My educational background stems from UC Riverside receiving both BS and MS degrees in Statistics. I grew up in San Diego, went to college in Riverside, and currently work in Irvine, CA. Along with my aspiration to be competent as a Statistical Programmer, I also strive to be impactful beyond my role at work. Aside from jogging, you can find me enjoying a cup of coffee or milk tea in my spare time.
Larry Z. Shen
Dr. Shen is a senior statistical advisor to numerous biopharmaceutical companies to support their drug development programs. He is Vice President and head of Biometrics Services at WuXi Clinical.
Dr. Shen is a fellow of the American Statistical Association. He has authored many articles on statistical methodology and their applications to drug development.
Dr. Shen was Vice President at Amylin Pharmaceuticals leading their entire clinical development organization in the development and approval of several first-in-class medicines. Following the acquisition of Amylin by Bristol Myers Squibb in 2013, he co-founded Pharmapace, Inc., a biometrics consulting and CRO company serving the biopharma industry, and served as its President and CEO. Pharmapace was later acquired by WuXi AppTec in 2019.
Dr. Shen obtained his Ph.D. in Statistics from the University of California at Berkeley and both BS and MS degrees in mathematics/probability theory from Beijing University in China.