Welcome to the Statistics in Pharmaceuticals (SIP2022) conference. This unique conference aims to introduce a career in pharmaceutical industry to students studying in quantitative fields, especially statistics and data sciences. This two-day conference will connect you to the world of clinical statistics, and show you how statistics contributes to different phases and aspects of drug development and to improve patients’ lives.
View the conference on Whova web portal. You can also watch the sessions on Whova mobile app.
The University of Connecticut Storrs Campus is located in the northeast corner of Connecticut, off of Interstate 84. The conference will be held at the Lawrence D. McHugh Hall (MCHU).
Hotel: Hotel reservation can be made through the hotel reservation link. Alternatively, please call the Graduate Hotel at 860-427-7888 and ask for reservations.
Parking on Campus: Most visitors to UConn’s Storrs campus park in the South Garage, which are open 24 hours per day throughout the calendar year. The maximum duration of a single parking session in the South Garage is 3-days (72-hours) unless a parking session of longer duration is authorized in writing by Parking Services. More details and the garage parking rates. Please note the North Garage is closed this summer. PayByPhone parking is available in multiple locations. All the conference participants should pay close attention to all speed limit signs on and around campus. The usual speed limit around UCONN is about 25 or 30 mph. SAFE DRIVING!
Internet Access: Please refer to the UCONN-GUEST page for internet access at UConn campus.
Speaker: Dr. John Scott (attend in-person), FDA
John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, vaccine and drug safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2020 Guidance on Interacting with the FDA on Complex Innovative Trial Design, the ICH E9(R1) expert working group on estimands and sensitivity analyses, and the ICH E20 expert working group on adaptive designs. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an A.M. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is a past Editor of the journal, Pharmaceutical Statistics.
Clinical trials provide gold standard evidence of drug safety and effectiveness and have been the backbone of pre-market regulatory decision-making for decades. Increasing costs and complexity of scientific questions have put a strain on the traditional clinical trial enterprise, sparking innovation in design, statistical methodologies, and logistics. In this talk, I will survey efforts taken by the U.S. Food and Drug Administration to help address these strains via innovation in clinical trial design and analysis. I will touch on the wider acceptance of adaptive trial designs, increasing application of Bayesian methods, and FDA’s Complex Innovative Clinical Trial Design (CID) pilot review program. Case studies from each area will be presented. Finally, I will discuss emerging topics in each of these areas, including next steps for FDA’s CID program.
Speaker: Dr. Claude Petit (attend in-person), Astellas
In 2022 in the US, 1700 people will lose their battle against cancer every day.
25 years ago my dad was one of them.
This is why after earning my PhD in Biostatistics, I joined the Pharmaceutical Industry to bring my stone to clinical trials design and analysis. Lecturer at Yale School of Public Health for a decade and VP Biostatistics & Statistical Programming at Astellas, I am leading a global team of equally relentless Statisticians and Programmers in US, Japan and China. Eternal learner, I have a passion for leadership, growth and teaching. In 2021, I became a certified Executive Coach and funded Creating & Coaching Essential Leaders, LLC to empower one woman at a time.
Although the Biostatisticians do not communicate with the patients, they can have a direct and significant impact on their involvement and burden in clinical trials.
From a design point of view, a trial is successful if go/no go decisions can be confidently made as soon as possible and with the minimum number of patients included. Therefore, minimizing the sample size though innovative designs, simulations or the use of Real World/external data comes immediately to mind. Beyond that, Biostatisticians can ensure the safety of the patients and avoid useless exposure to ineffective drugs by leveraging adaptive designs and planning interim analyses. When collaborating with clinicians to select the endpoints, they can influence the trial duration and the invasiveness of the exams, as well as ensure that what matters to the patients is actually measured. Regarding patients selection, Biostatistician should support the inclusion of a diverse and representative population, while targeting those who have a better chance to respond and/or the least safety risks.
Last but not least, running state of the art analyses, choosing relevant estimands and correctly compensating for missing data will ensure that patients' contribution is valued and honored.
Abdul is a third year PhD mathematical sciences student at Clemson university. Abdul’s professional goal is to become a statistics research scholar with a stellar record of publications where he will be able to apply his knowledge to solve real world problems in both academic and nonacademic settings.
Caroline is a PhD candidate in Statistics at UC Santa Barbara. Her research is focused on semi-parametric mixed effects models with functional data to find connections between UV and blood pressure for a large patient dataset.
Sandra is from Ghana. She is a Ph.D. student in statistics at Western Michigan University. Her research interests include the development of Bayesian Methods in the pharmaceutical industry. Sandra's long-term career goal is to become a statistician in a pharmaceutical or biotechnology company.
Shreya is a second year master's student in the Statistics department at University of Michigan-Ann Arbor. Prior to starting her graduate degree, she worked at Exact Sciences as an Associate Data Scientist, which sparked a keen interest in healthcare analytics and Biostatistics. Today, she aspires to extend that interest by advancing healthcare through clinical trials, drug development and molecular diagnostics research.
Yan is a second year student in MS of biostatistics from Oregon Health & Science University. She has a BS of physics and Master of management. Yan hopes to work as a pharmaceutical biostatistician.
Jushawn is a master's student studying mathematics at Clemson University. His goal is to become a researcher in the precision medicine field and to teach and mentor the next generation of scientists.
Taylor is a Ph.D. student in the Biostatistics and Data Science program at the University of Mississippi Medical Center. So far in her studies, she has served as the Data Science student chair, President of the School of Population Health student body, and a Health Policy Fellow. She has strong interests in both professional and community service and aims to work in the pharmaceutical industry as a biostatistician after graduation.
Training the next generation of statisticians and data scientists is not limited to training them in statistical methodologies and technical skills alone. At SIP 2022, we are proud to announce that Dr. Steven Gilbert from Pfizer will present a training session on presentation skills. The focus will be on how to effectively communicate scientific ideas and messages in a clear and concise manner in either a poster or an oral presentation. Any successful presentation must start with an understanding of the audience. The presentation is then developed by using a style that the audience can comprehend, including the proper level of technical details to exhibit your depth of knowledge without making your audiences lose attention, and tailoring the scope of the presentation to fit in the allocated timeframe. Tips on how to prepare the presentation material and practice the delivery of the presentation will be provided.
If you want to learn more about application of statistics in pharmaceutical industry, you may consider to take the 1 credit course from University of Connecticut.
University of Connecticut: Ming-Hui Chen
Vertex: Glen Laird
Servier: Jian Zhu
Moderna: Qiqi Deng
Boehringer Ingelheim: Dooti Roy
Beigene: Jingjing Ye
Statistics & Data Corporation: Helen Li
Pfizer: Steven Gilbert
Biogen: Susie Sinks
Takeda: Veronica Bunn
Amgen: Tony Jiang
Merck: Yulia Sidi
FDA CBER: Zhenzhen Xu
Bristol Myers Squibb: Revathi Ananthakrishnan
Roche/Genentech: Godwin Yung
Promotional Partner: DhaShu
Operation Support: Courtney Trzasko and Tracy Burke, University of Connecticut
Whova Administer: Simiao Gao, University of Connecticut
Webmaster: Yelie Yuan, University of Connecticut
Xiaolin Chang (Chair), University of Connecticut
Zhiduo Chen, University of Connecticut
Zijian Huang, University of Connecticut
Aolan Li, University of Connecticut
Min Lin, University of Connecticut
Jiarui Liu, University of Connecticut
Hao Wu, University of Connecticut
Meiruo Xiang, University of Connecticut