Biopharmaceutical Section of the American Statistical Association

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Upcoming Webinar

The distance learning committee is excited to announce the upcoming event: 

 

Real-World Evidence HHSU01 FDA grantees series Part 1

 

Date and Time: March 8 2024 10.00am – 11.00 am Eastern Time

 

Speakers:                   

Marie Bradley, FDA

Tianxi Cai, Harvard

Ashita Batavia & Benjamin Ackerman, Janssen

 

Registration link:

https://asabiop.ticketleap.com/real-world-evidence-nihu01-fda-grantees-series-part-1/

 

Below are the titles and abstracts of the talks by Marie, Tianxi, and Ashita/Ben, respectively.

Title: Overview of CDER’s Real-World Evidence Demonstration Projects

Abstract: Aligned with the U.S. 21st Century Cures Act, FDA established a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision-making. The program is multifaceted and supports activities such as demonstration (research) projects, guidance development, internal Agency processes, external stakeholder engagement, and the Advancing Real-World Evidence initiative. This talk will present an overview of several RWE demonstration projects and will describe, for select projects, how learnings directly or indirectly serve to support FDA regulatory decision-making in evaluating the effectiveness and safety of medical products.


Title: Deriving reliable Real world evidence with electronic health records data

Abstract: Real-world clinical data hold tremendous potential to advance our understanding on the efficacy and safety of therapeutic interventions in broader populations, including disease modifying therapies for chronic diseases. However, these data remain underutilized due to methodological constraints and the inability to efficiently link and integrate data sources across study types and healthcare settings. This talk will discuss opportunities and challenges in leveraging electronic health records data to derive reliable real world evidence.


Title: Novel methods for aligning real-world progression-free survival (rwPFS) and clinical trial PFS endpoints in Multiple Myeloma

Abstract: Randomized clinical trials remain the gold standard for evaluating treatment efficacy because of their rigorous design and data collection parameters, which reduce bias and allow for valid inference of causal relationships. In Multiple Myeloma (MM), the brisk pace of drug development has seen twelve new therapies approved in the past decade - many of these were accelerated approvals based on single arm trials. Robust Real World Evidence (RWE) can enhance the interpretation of single arm studies, however comparisons between real world and clinical trial endpoints are limited by measurement bias.

J&J Innovative Medicine has established a consortium that includes leading academic RWE methodology experts, MM clinician scientists and Flatiron Health to develop novel treatment-agnostic methods for aligning rwPFS and clinical trial PFS. We will discuss our research approach, inclusion of under-represented minorities, and potential future applications of this work in this ASA Biopharma webinar.

Upcoming Webinar

Open-Source Software for Regulatory Submissions/Environments & Introducing openstatsware BIOP working group

 

Date and Time: February 23 2024 11.00am – 12.00 pm Eastern Time

 

Speakers:

Paul Scheutte, FDA

Ya Wang, Gilead

 

Registration link:

https://www.eventbrite.com/e/webinar-open-source-software-tickets-802097293597

 

Title: Open-Source Software for Regulatory Submissions and Regulatory Environments

Abstracts: Regulatory submissions and regulatory computing environments have traditionally been associated with the use of proprietary software packages.  While academic institutions have embraced open-source software, both industry and government have been slower to adopt open-source alternatives.  I will discuss some of the challenges and issues with using open-source software in a regulatory environment, followed by some of the lessons learned in the ongoing R Consortium R Submission Pilot, as well as emerging issues.

 

Title: Introducing openstatsware: Who we are and what we build together

Abstracts: In this talk, we would like to introduce openstatsware, an official working group of the American Statistical Association (ASA) Biopharmaceutical Section. The working group has a primary objective to engineer R packages that implement important statistical methods, and a secondary objective to develop and disseminate best practices for engineering high-quality open-source statistical software. We will talk about what R packages we have been developing and what we have done to disseminate the best practices, as well as our long-term perspective and next steps.

We would also like to give an overview of our three active workstreams. The MMRM R package development workstream aims to develop a comprehensive R package for mixed models for repeated measures (MMRM) that is robust, well documented, and thoroughly tested.  The Bayesian MMRM R package development workstream aims to develop an R package for Bayesian MMRM to support robust analysis of longitudinal clinical data. The HTA-R workstream aims to develop open-source R tools of good quality to support crucial analytic topics in Health Technology Assessment (HTA) dossier submission across various countries.

Previous Webinar

Don’t go it alone: Benefits of joining our community of statisticians in small biotechnology companies:
The distance learning committee is excited to announce the upcoming event:

Date and Time: December 1 2023 11.00am – 12.00 pm Eastern Time

Don’t go it alone: Benefits of joining our community of statisticians in small biotechnology companies

Panelists: 

Liang Fang, Nuvation Bio
Mohamed Hamdani, Larimar Therapeutics
Alan Hartford, Clene Nanomedicine
Sharon C. Murray, BioCryst

Moderator: Alan Y. Chiang, Lyell Immunopharma

Registration link: https://www.eventbrite.com/e/753502274587?aff=oddtdtcreator

Abstract

With the rapid growth of biotechnology in the last half century, new drug discovery and development have now reached an inflection point where hundreds of emerging small biotech are evolving into the clinical development stage. These companies employ a growing number of statisticians.  While the majority of statisticians in the pharmaceutical industry are employed by big pharma, we are seeing an increasing number taking the leap into the small biotech world.  The purpose of this panel-discussion is to connect statisticians who either work for or want to work for a small biotech company so that they can share strategies, experiences, and ideas.

There are several challenges and opportunities when working in a small biotech. For example, there may be only one or a few statisticians/programmers working at the company, which means that there is heavy reliance on CROs for statistics and programming work. Consultants may be required for advice or to review documents. On the other hand, the statistician will have many opportunities for growth while making an impact on advancing human health through innovation. They will need to wear many hats, perhaps working on multiple phases of clinical trials, preparing for audits, answering analyst questions related to statistics, developing departmental SOP’s, participating in regulatory discussions and/or advisory committee meetings, and overseeing outsourcing. Resources are limited and forming a strategy is key. Part of that strategy involves determining the level of CRO oversight, selecting preferred vendors, deciding what work to do in-house vs. outsourcing, acquiring statistical software, and liaising with other departments as the company grows. The strategy will need to be revisited on a regular basis as the company evolves.

The panel discussion will focus on four key questions:

- Considering the many ways in which the field of statistics contributes value in drug development, what are the unique career opportunities in a small biotech?

- What are the main challenges one needs to overcome in interdisciplinary collaboration?

- How has the application of statistics played a key role in innovation, decision making, and clinical advances in a small biotech company?

- How could members benefit from being part of the ASA community for statisticians working in small biotech companies?

LATEST BIOPHARMACEUTICAL REPORT

Biopharmaceutical Report Summer 2023

LATEST PODCAST

Episode 107: SPAIG Committee

Date: 2024-02-09

Description: Scott Clark, Satrajit Roychoudhury, and Michelle Shardell discuss the Statistical Partnerships Among Academe, Industry & Government (SPAIG) Committee. https://community.amstat.org/spaig/home

Previous Webinar

Putting Pharmacovigilance into Action:
The ASA Biopharmaceutical Section is pleased to announce the following webinar, presented by Dr. Frank W. Rockhold and Dr. Tjark Reblin on September 16, 2021. The Distance Learning Team is hosting a new webinar series on Partnerships between Statisticians and Clinical Professionals in the Biopharm Industry.  Each quarter we will have a clinical and statistical scientist pair to provide pragmatic and motivating examples of cross-disciplinary scientific engagement in biopharmaceutical research. If you have any question about this event, please contact Michelle Zhang (
michelle.zhang@affamed.com).

3rd Quarter (10:00 – 11:30 am Eastern Time, September 16, 2021)

Speakers: Dr. Frank W. Rockhold1 and Dr. Tjark Reblin2

1 Professor of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University Medical Center

2 Global Head of Drug Safety and Risk Management, ViforPharma, Gattbrugg, Switzerland

Moderator: Dr. Greg Ball

Registration Link: BIOP webinar series: Putting Pharmacovigilance into Action Tickets, Thu, Sep 16, 2021 at 10:00 AM | Eventbrite

Abstract

Every pharmaceutical company collects, analyzes, and reports safety data collected in trials and in the general use on their products to fulfill regulations and detect new signals to keep their product labels up to date.  While those actions have an indirect benefit for the patient, to truly help them and their healthcare practitioners it is necessary to go beyond the raw data and translate the information into the benefit to risk context, informing risk management plans and specific mitigation actions that are derived from data.   The goal of pharmacovigilance should be to minimize pain and suffering in patients who strive to benefit from the medicine prescribed by their physician.  By properly characterizing benefits and risks of medicines in appropriate populations and semi-quantitatively or quantitatively estimating whether and to which extent the benefits outweigh the risks one can create tangible context for regulators, prescribers, and patients. This informs specific action plans for the health care provider to optimize the use of the treatment ensuring the right medicine gets to right patient.  We will present our experience on some specific examples derived directly from our joint experience in safety and pharmacovigilance.



A message for 2021 ASA Fellow Candidates
This message is intended for BIOP members who plan to submit their ASA Fellows dossiers in 2021.  Effective October 1, 2020,  as approved by the Biopharmaceutical Section Executive Committee, an anonymous BIOP section working panel of dossier reviewers has been formed. The reviewers serving on the panel are experienced statisticians including former and present members of the ASA Committee on Fellows. Nominators from BIOP are encouraged to send completed dossiers for review to a current chair of the BIOP Fellows Committee (Ilya Lipkovich, 
ilya.lipkovich@lilly.com). All dossiers will be treated in strictest confidence.  Nominators may anonymize the dossier before sending.  The reviewing committee chair will send it to one of the available reviewers and provide feedback regarding potential gaps and improvements within approximately two weeks. Please submit for review well in advance of the ASA submission deadline, in order to receive feedback in time to make adjustments to the dossier.  The committee will not share any personalized information about the reviewed dossiers with the BIOP Section Executive Committee, or any other committee beyond the reviewers.

You can see more details at BIOP page

We encourage you to take advantage of this service offered to the members of BIOP, and give our members the best opportunity to achieve the honor of ASA Fellow.

Pharmaceutical Statisticians

The need for qualified statisticians is growing, especially in the biopharmaceutical industry. There are opportunities in academia, consulting firms, the government or in major pharmaceutical companies. Learn more about biopharmaceutical careers by checking out the career profiles!

 

You will hear from real professionals about their job responsibilities, education and training, and overall why they chose a career in biopharmaceutical statistics. Click on each of the names below to view their career profiles.

Cindy                         Dionne                     Steve

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