Date: Mon, 21 May 2001 15:46:09 EDT From: Consultsas@aol.com Subject: BASUG Quarterly Meeting Announcement, June 21, 2001 -------------------------------------------------------------------------- The Boston Area SAS Users Group Meeting Announcement -------------------------------------------------------------------------- WHAT: Quarterly BASUG Meeting WHEN: Thursday, June 21 , 2001, 1:30 to 4:30 PM WHERE: PAREXEL International Corporation . Conference Center, Floor 1, Tower 3 Crosspoint Building, 900 Chelmsford Street, Lowell, MA 01851 (Directions are included below) Upon your arrival in Crosspoint building (tower 3), take the elevator and go to Floor 1, look for sign conference center. RSVP: REQUIRED! by e-mail ONLY to: Dave Russo, ConsultSAS@aol.com NOTES: So that we may accommodate as many attendees as possible without exceeding the capacity of the meeting room, you MUST RSVP for this meeting. Please include your full name and the company for which you work in the RSVP e-mail. Please Note the following : This meeting will be mainly on Clinical programming, data analysis and drug approval process. The target audience is SAS users (programmers, statisticians, etc.) from pharmaceutical, biotech, CRO, healthcare, and related companies. AGENDA: 1:30-2.30 - 'SAS Output for Clinical Trial Reports', Shylendra Kumar, Datafarm, Inc., Marlboro, MA 2:30-3:30 - 'Experiences in FDA Submission of New Drug Application', Melissa Nichols and Elizabeth Singer, Genzyme Corp., Cambridge, MA 3:30-4.30 - 'Statistical considerations in FDA Submissions', Peter Lam, PAREXEL International, Waltham, MA CONTACT: If you have questions about the following, contact for RSVP, David Russo 781-648-1429 for Meeting details, and others, Gajanan Bhat 781- 434-4617 --------------------------------------------------------------------- ABSTRACTS AND BIOS: --------------------------------------------------------------------- 1:30-2:30: 'SAS Output for Clinical Trial Reports', Shylendra Kumar, Datafarm, Inc., Marlboro, MA In January 1999 the FDA issued two guidance documents: Guidance for Industry- Providing Regulatory Submissions in Electronic Format- General Considerations and NDAs. These guidance documents are part of the series of guidance documents intended to assist applicants making regulatory submissions in electronic format to CDER and the CBER. Since major portions of the clinical sections of regulatory submissions include SAS generated output as clinical trial report in-text and end-text tables, figures and listings, compliance with the guidance and recommendations is critical. SAS V8 and especially the ODS technology provide us with the programming capabilities we need. In this presentation we will discuss output generation using SAS Software from the perspective of today (V6.12 or earlier) and tomorrow (V8). We will also discuss about SAS based applications and other essential tools which will help us create submission ready PDF documents. Shy Kumar is President of Datafarm, Inc. Datafarm provides integrated computing solutions with hands-on experience for biotech, pharmaceutical and other healthcare related companies on clinical data analysis and regulatory submissions. The company has consistently grown over the last few years and have several clients across the nation. With their services and specialized custom software applications that facilitate the preparation of electronic regulatory submissions, Datafarm worked with several clients in approval of many new drugs over the past few years. ------------------------------------------------------------------------- 2:30 - 3:30: 'Statistical Considerations in FDA Submissions', Peter Lam, PAREXEL International, Waltham, MA In this presentation, the basic elements of intent-to-treat principle in clinical trial reporting and randomization strategy to treatments will be illustrated; The experience of working with a large team of statisticians and programmers on an NDA submission will be shared. The most important aspect of completing the statistical programming is the way to handle the complicated programming in the core analysis datasets such that the tables/listings/figures programming can be a 'simple' task. This facilitates the review process of consistent outputs and shorten the reviewing time. Peter Lam received his B.S. degree in Mathematics and Computer Science from Gonzaga University, an M.S. degree in Mathematical Statistics from Purdue University and a Ph.D. in Management Science/Operation Research from Purdue University. In 1992, he joined PAREXEL International Corporation as a biostatistician and he currently holds the position of Principal Biostatistician in the Waltham headquarters, Massachusetts. He has been responsible to provide a broad statistical support, including clinical trial design, protocol and case report form development, Data Safety Monitoring Board support, data analyses and reporting for clinical trials. ----------------------------------------------------------- 2:30 - 3:30: 'Experiences in FDA Submission of New Drug Application', Melissa Nichols and Elizabeth Singer, Genzyme Corp., Cambridge, MA Communication between Statistician and SAS programmer is essential to completing accurate data tables. A key element to effective communication is the Programming Specification Document ("Spec"). This document lays out the specifics of each table's numbering scheme (based on ICH Guidelines), title, layout, content, and the associated SAS program that generates the table. Once devised, this document serves, at first, as a roadmap for table production, and then as a resource for answering the inevitable questions that come from FDA post-submission. Melissa Nichols is a Senior Biostatistician at Genzyme Corporation, where she has worked for 2 years. Prior to Genzyme, Melissa worked at Howmedica (now Stryker Howmedica Osteonics) as a biostatistician. She has a Master of Sciences Degree in Biostatistics from the University of Albany. Elizabeth Singer is a Principal SAS Programmer at Genzyme Corporation, where she has worked for 3 years. She has 8 years of programming experience in the biotech and pharmaceutical industries. Elizabeth received her Bachelor of Arts degree from the Johns Hopkins University. ----------------------------------------------------------- DIRECTIONS: There is plenty of parking around the building and near Showcase Cinema right next to the Crosspoint building. Parking is free. Please note that there is no train connection to this site. By Car: >From Route 128 North · take exit 32A (route 3 north) from 128 · take exit 31A (110 east) from route 3 · (this exit comes quickly, right after the I495 on ramps) · take a right at the end of the ramp · make a right into the driveway after the Mobil Gas Station You will be entering the parking lot at tower 3. >From 495 South · take the Lowell Connector · take exit 3 (Industrial Avenue) · bear to the right off the ramp · at the rotary go half way around the rotary · CrossPoint will be on your left >From 495 North · Take exit 34 (Rt. 110 Lowell) · Bear Right off ramp toward Lowell · CrossPoint will be 1 mile on right >From Boston Logan Airport · Follow the signs to the Sumner Tunnel · Go South to the Mass Pike West · Follow from 128 North Directions above --------------------------------------------------------------------- BASUG Contacts Mail: BASUG PO Box 253 Boston, MA 02117 Check out our Web Site: < http://www.basug.org> To email our Webmaster: webmaster@basug.org Subscribe to our email list: Subscribers receive automatic e-mail notification of upcoming meetings, courses, and conferences of interest to local SAS users. --------------------------------------------------------------------- To subscribe to this message list, send a message to: < Mailto:subscribe@basug.org> Subject: subscribe To unsubscribe from this message list, send a message to: < Mailto:basugwm@basug.org> Subject: unsubscribe ---------------------------------------------------------------------