SHRINIWAS K.

KATTI Name and address: Shriniwas K Katti 221 High Point LN Raymore MO 64083-9096 Contact Information Current Home Telephone: 816 348 9046 Cell Phone 816 506 8889 Email (Permanent): sk1075ad6@westpost.net Citizenship: USA a" Naturalized in 1970. COMPUTER HARDWARE AND SOFTWARE EXPERTISE Hardware: APL Computers: PC, VAX, UNIX, Main frame on IBM. Data Management Experience: I was located next to the data management group which was given the job of putti ng the data that came from many forms onto the computer. They also would find er rors in the data sets and they would send queries to the nursing staff and the M edial Doctors to get the data set straightened out. I would take it from there a nd check the data for errors that they Data Mangers would miss. This took about half of my time. After that came the job of SAS programming to get the tables, listings graphs an d statistical analyses. Programming Languages: Visual Basic, Pascal, SAS Interaction with database: SQL Software Packages: SAS, MINITAB, IMSL, Scientific Word, WordPerfect, Excel EDUCATION Ph.D. Statistics, Iowa State University, Ames, Iowa M. A. Statistics, Iowa State University, Ames Iowa B.Sc. Mathematics, University of Delhi, Delhi, India PROFESSIONAL EXPERIENCE Post 2008 Experience As a retiree with many contacts at all levels, I continued to work with the MDs and my associates. a When we make many tests of hypotheses, there is a multiple test with the exact pre-set Type I error under the condition that the estimates being used are inde pendent and the variances have enough large degrees of freedom so that their use in the multiple test does not increase the Type I error. So, one does not have to use the conservative test used in SAS. There is an exact test for multiple co mparisons. a An MD, Dr. Nenad Markovic of NIH, and I are working on a screening test for yo ung girls which has high power and specificity. We convinced the FDA that we do not need sample sizes of the order of 300. aSpecificitya is the hard part. But w e can detect excessive growth with our method quite easily. Associating our test specifically to cancer of the cervix must use other considerations. a An MD from NSF and I are trying to set up a method to market the protocols and devices that have been developed in their laboratories in India. My family in I

ndia is quite ready. July 2008 _ August 22, 2008: a SDC Clinical *Statistics and Data Corporation, Developing TLGs for many rather simple trials. Jan. 3 2008 a" April 30, 2008: Statistician, Premier Research Group, Atlanta bra nch a" but working from home in Raymore, MO. The appointment is for six months w ith scope for permenancy. a Reading up on sedation of youngsters (<16 years of age). a Finished writing an extensive Training Manual to introduce the local staff to biostatistics and lead them in developing protocols, SAP and final reports. a Obtain sample sizes for two different studies. a Write Statistical Analysis Plans for two projects. Sept. 24, 2007 a" October 18, 2007 a" Sr, Biostatistician, Sanofi Aventis Compan y, 300 Somerset Corporate BLVD, Bridge Water, NJ Read up on Diabetes. Analyzed data collected by the Managed Care Group from Ins urance Companies with focus on the Sanofi Aventis drugs. It was a data mining jo b. March 29, 2007 a" June 15, 2007 - SR Biostatistician, Bristol Myers and Squibb, N Billerica, MA, a Reviewed two protocols, set up to test two drugs that contained their main pat ented drug, Definity. As written, they were cut and paste. By writing them from scratch, one can make them more explicit and permit easy collection of data and analysis. a Reviewed TLGs for two studies that had been stopped very early. The data was v ery scrappy. So, while catching many errors, not much more could be done than to develop elementary Tables and Adverse Events; and put out listings. It was all done in SAS. a Attended a Dinner Meeting called by an MD to discuss the over all role of stat istics in Drug Trials. May 2006 - February 2007 (private contractor) Sr. Biostatistician, from home a Work with Doctor Nenad Marcovic of Oncology who is in the process of developin g an NDA for testing ovarian cancer. Seeing scattered raw data, it is quite an e fficient method. a Work with Dr. John Rothman to write a paper on a new algorithm aimed at physic ians to permit them to select the drug mot suited for that patient. We note that when Drug A is proven better than Drug B, we show that the average effect of Dr ug A is higher than the average effect of Drug B. A given patient could be react ing better to Drug B than to Drug A. We have a recommendation on how a physician can do mini-trials on his patients and keep doing it to choose the best drug at any given time. November 2004 - April 2006, PAREXEL (CRO) a All of the work was done in SAS a Wrote SAP for a Phase I study. a Helped determine the Maximum Tolerable Dose (Dose Limiting Toxicity) and the d ose to be use in the next Phase II study. I fitted a logistic distribution to es timate the dose that has a probability of 1/3 of generating Dose Limiting Toxici ty. All intermediate calculations were done in SAS a" SAS is set up for such wor k.

a Act as a resource for other biostatisticians: I showed them what the likelihoo d for the mixed model is and where the various parameters are located. Mentored some workers; gave general lectures. a An interesting project was to find a formula that tells you when 30% of the ca ncer patients will be deceased based on current data to estimate the date when t he interim analysis is due. This was done in SAS and this program was made a pa rt of their data base so that when they add patients to the database and run it, they would automatically get an updated value for the Interim Analysis. a Review and validate SAS programs and statistical reports before they go out of our Department. I would program in SAS to validate their work. October 2003 a" September 2004 SR Biostatistician (contract position), Eli Lilly Pharmaceuticals, Greenfield, IN, Statistician, Animal Sciences Division a FDA/DVM submissions and ICH Guidelines: o Project statistician to finish a submission to CVM. CVM approved our submissio n without any revision. The work had been initiated in SAS; so I continued with it in SAS. o Established that the Lilly Chlorine Pills have high stability a" 132 months. P revious statisticians were getting insignificance for the period of stability be cause the method used to estimate the amount of chlorine in the pill had high va riability. There were cases where estimated amount was larger than the amount pu t into the pill. So, the model needed adjustment. This figure was accepted by th e FDA to which this was submitted. All of the work was in SAS since FDA is equip ped with SAS to validate our work quickly. April 2003a"Aug. 2003, Quintiles (CRO), Kansas City, MO, Senior Statistical Scie ntist a Provided statistical expertise to the other groups a" mentoring and giving bri ef lectures on some topics that they had missed. An interesting aspect was to sh ow them how to write a MACRO in a systematic way. Thus, write a program first an d check it out. If you are going to use it again, convert it into a MACRO a" thi s is better than cutting and pasting a" as they were doing. a Promoted better statistics through seminars, lecturing etc. a Senior Statistical review of reports, protocols and Statistical Analysis Plans . While SAS was the central software, I used other matrix based software to comp ute difficult formulae. a Worked with programmers and junior statisticians in Phase I a" IV studies. I would show them where the error, why it is wrong and how the correction is disco vered. All the programmers whom I mentored are still in the programming business . a Areas of interest: Asthma, apnea, use of insulin in growth retardant populatio n. May 2002a"Aug. 2002, Hoffman La Roche, Nutley, NJ, Consulting Biostatistician II a Acted as a resource person and Lecturer of Research Statistics for the local s tatisticians a Reviewed the literature on multiple comparisons and showed that there is an ex act test. Dec. 2001a"May 2002, Tyco/Mallinckrodt, St. Louis, MO, Consulting Bio-statistici an a Finished a Phase IV submission on imaging for cancer detection. My aDue Dilige

ncea part consisted of drawing high density graphs that depicted the data in the various areas. Problems would become apparent a" which otherwise would be maske d by the averaging that occurs in statistics. SAS/GRAPH is well suited for this work. a On rechecking, I found some unusually high numbers to be data transmission err ors. a Finished Meta Analysis of 28 papers on the use of two different agents for hig h lighting images. I had a well-defined recommendation. The imaging solution wit h a low half-life had immense superiority over those with long half-life. a All work was done in SAS. March 2000a"Dec. 2001, Progenics Pharmaceuticals Inc., Tarrytown, NY, Consulting Bio-statistician a This was a small company headed by four medical doctors. They would make up dr ugs based on their knowledge of the theses and dissertations in the major univer sities. Experiments in sets of four animals and three patients would be made at the graduate school level. If any drugs showed effectiveness, it would be set up for the phase II trial with FDA, NDA and all. Three of the drugs that I selecte d are now going through Phase II. Cancer and interferon: I noticed that the var iability was immensely higher than their expectations. My suggestion was that at every stage, three independent assays be made of the blood sample and any tissu e samples. My main conclusion was: that Interferon should be phased out over a three day period. After that you must phase in immunity building drugs to high l evels. a Stroke: Phase I study was made on baboons with the surgery being done at the C olumbia University. It served the purpose of clarifying the issue of the level o f drug to be used. It pointed us to the many errors that are possible when there is arterial occlusion. This also served to pin down an effective dose. a The type of work we did, with four to ten patients, did not permit the use of SAS. I would derive formulae and compute them using Excel. a HIV study: We had data on people in sets of five and ten with fairly strong H IV infection. They had many observations before dosing; then they had taken bloo d samples one hour post dosing, two hours post dosing, four hours post-dosing, e ight hours post dosing, 16 hours post-dosing, 48 hours post-dosing and 96 hours post-dosing. The variability is so high that when you draw HIV load against time for each patient, the graph is berserk up and down that some of the better doct ors were concluding that we have not yet obtained a drug which has any effect o f reducing HIV load. I developed a new method. I took al pre-dosing observations and computed the mean and standardized it by multiplying it by the square root of the number used in computing the mean so that the variability of the standard ized mean stays constant. I took the data at the four time periods and computed a similar standardized mean. Same with the next four observations. Then put toge ther the data on all patients and all doses. The dose response-response relation was obvious. Based on this graph, I estimated the dose needed to reduce the HIV load by 90%. Between the biochemist and the Medical Doctor, they made additiona l trials on a few more patients and the data ell right on my dose-response curve . After we convinced ourselves of the existence of a dug to cure HIV, our Bioche mist and MD went to work with other personnel in better resourced industries to develop better drugs that are easier to develop; made trials and established a f airly inexpensive method to reduce HIV by 50%. Soon, international trials were m ade and HIV was no more an unknown disease. It was just like any virology diseas e with high variability in detection. Read more about it in an article entitled, aWhat I bring to the Table.a October 1999Mar 2000, Janssen, Titusville, NJ, Consulting Bio-Statistician a Wrote the statistical part of the protocols and gave mock-tables. a I gave tests for equivalence and organized sequential tests. It was set up in SAS format.

June 1999-Oct. 1999, Janssen, Titusville, NJ, Consulting Bio-Statistician a Wrote the statistical part of the protocols and gave mock-tables. a I gave tests for equivalence and organized sequential tests. June 1999-Oct. 1999, ICON Inc. (CRO), Philadelphia, Consulting Bio-Statistician a Created Tables and Graphs for the clients. List of clients included Novartis a nd other major drug companies. All work was done in SAS. The original companies and FDA are all set up with SAS. So, gong along with SAS lead to speedy approval . a Validated programs written by others. This is 100% SAS work. a On time submissions and accuracy were the major issues. We always got the thin gs done faster than the demand. So, we were given additional work with additiona l funding. a I wrote flow chats and mini-SAS-programs for each piece. When a new job would come, we would see which piece apply. So, we did not hve to start from scratch o f each ne set of TLGs. April 1999-June 1999, New Drugs Services, Kennett Square, PA, Statistician a Review and revise Protocols, SAPs, Tables, Listings and Graphs. This was all b asic SAS-work. Sept. 1998-March 1999, Eli Lilly Pharmaceuticals, Indianapolis, IN, Statistician a Review and revise Protocols, SAPs, Tables, Listings and Graphs. This was all b asic SAS-work. a Dec. 1997-March 1998, Abbot Pharmaceuticals, Dallas, TX, Statistician a Review and revise Protocols, SAPs, Tables, Listings and Graphs. This was all b asic SAS-work. a Sept. 1997-Dec. 1997, Florida International University, Miami, FL, Professor of Statistics Taught two course, gave seminars May 1996a"Dec. 1996, Ryder Trucking Company, Miami, FL, Statistician a Use the APL-programming. They were trying out APL in comparison with SAS. The final decision was to use SAS. SAS is better set up for missing values. SPECIAL ACCOMPLISHMENTS: 85+ publications in statistical journals on methodologies on topics including 1. 2. 3. 4. 5. 6. 7. 8. 9. Design of Experiments Linear Models Non-Linear Models Multivariate Analysis Bayesian Methods Tests for Normality Independence/divisibility Medical/Biological Applications Computer Work

a Fellow, American Statistical Association.

a a a a a

Director of Graduate Studies in Statistics. Guided dissertations. Former Associate Editor of Biometrics. Founding Father of the Mid-Missouri Chapter of the ASA. Founding father of the Katti Family Endowment at UMC, value $100K.

UNIVERSITY EXPERIENCE: a Professor of Florida International Univ., 9/97-12/97 a Professor of University of Missouri-Columbia, 1970-1995 a Assistant and Associate Professor, Florida State University, Tallahassee, FL, 1960-1970. 1. It was I who started the Graduate program at Florida State University, starti ng with getting it approved, hiring faculty and students and developing program and administering it. 2. I was the Director of Graduate Studies for the entire period of ten years tha t I was there. 3. At the University of Missouri, they already had the Graduate Program approved but they had no faculty to develop it and get the students with enough knowledg e to be given MA and Ph.D. in Statistics. I was hired and assigned the position of Full Professor and Director of Graduate Studies. I developed a program and di d every thing that a Director of Graduate Studies does to start giving students their MA and Ph.D./ in statistics. None of our students had ever any difficulty in getting employment. I was the Director of Graduate Studies for 20 of the 25 y ears that I was there. FOREIGN LANGUAGES: Many languages of India, including Hindi, Marathi and more; r eading language of Sanskrit LIST OF PUBLICATIONS is given below. Please forgive the order of pasting. This i s the fierst timwe Iam combining apdfa with aworda with limited success.