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.
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.
This year we will offer ~15 scholarships to attend Biopharmaceutical Summer Academy course in University of Connecticut as well as free SIP2022 conference registration. To promote diversity among the field of statistics, applicants who come from underrepresented communities will be given priority during the selection process. Final decisions will be made at the sole discretion of the SIP award committee.
Scholarship applications for SIP 2022 have ended, the deadline for the applications was June 09, 2022.
"Hello, I am a biostatistics student from University of Bremen. When I first saw this organization I felt so excited but to be honest at the beginning I did not expect that I could really get the scholarship. However, my intention was I could participate more meetings and got more experiences and got to know more talented statisticians and learned knowledge from them. And I attended and I did learned something. This made me really happy. After the meetings they really gave me the scholarship as they promised. So it was like you learned and you also earned. About how did I use my scholarship? I bought some books with this money and the rest of them I paid for my university semester ticket. I am really grateful that such a good opportunity helped me a lot and kind of lessened my burden somehow. So I really hope more and more students could join. BTW, is this organization still allow the students already joined last year could also join this year?? hahahaha."
--- Alidan Duoerkongjiang, Universitaet Bremen, SIP2021 Scholarship Recipient
The submission of poster is open to everyone who wish to present ideas or information of statistical or data science application in drug and biologic product development and evaluation and who can be students from high schools to graduate schools. All students who currently study statistics and data science and participate in 2022 summer intern programs in Pharmaceutical/biotech industries, regulatory agencies and health organizations are encouraged to submit posters based on their summer intern projects. In addition, students who participate in the 2022 summer boot camp for biostatistics and data science offered by the University of Connecticut are encouraged to submit posters based on their course projects.
This is an excellent opportunity to practice presenting your scientific results to others in a logical and concise manner. This is also a great opportunity to meet scientific peers of your age as well as more senior colleagues and interact with and learn from all of them. The competition process will select posters for the poster award. In addition, the intern posters may be invited for paper submission to the New England Journal of Statistics in Data Science. The evaluation will separate interns, summer boot camp students, and high school students. The SIP 2022 poster committee will grade the posters based on merits in contents, such as creativity and clarity.
All posters submitted will be presented in Whova and participate oral presentation during the poster session of the conference. The presentation will be 5 min speed presentation. Please fill out the submission form and register for SIP 2022. Registration to SIP 2022 is required as only registered participants can sign in Whova to upload the poster and respond to comments and questions during the conference. The promotion code for waiving the SIP registration fee will be emailed to you after the submission form is completed. Please use the same email address when filling out the submission form and registering for the conference. The submission deadline is August 19th, 2022.
Poster should be a PDF file with a 16:9 aspect ratio. If you use PowerPoint to create your PDF, simply select the widescreen 16:9 slide size. If you will be presenting your poster in person, your poster must be smaller than 44” tall by 66” wide to fit the designated board. Here is a poster template.
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