Abbott Laboratories, Inc - IPEC
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International Pharmaceutical Excipients Council of the Americas Member Company Representatives and Staff Contacts DIRECTORY 2013 Last Updated January 4, 2013 International Pharmaceutical Excipients Council of the Americas 3138 10th Street N., Suite 500 Arlington, VA 22201 ipecamer@aol.com i Table of Contents Member Companies Abbott Laboratories..........................................................................................................................................1 AbbVie....................................................................................................................... .......................................2 ABITEC Corporation………………………………………………………………………………………....3 Alkermes Inc.....................................................................................................................................................4 Americhem Pharmaceutical Corporation..........................................................................................................5 Amgen, Inc........................................................................................................................................................6 APOTEX, Inc....................................................................................................................................................7 Aptalis Pharmatech, Inc. …………………………………………………………………………………......8 Archer Daniels Midland....................................................................................................................................9 Asahi Kasei America, Inc.................................................................................................................................10 Ashland Inc.................................................................................................................................................... 10 Avantor Performance Materials.......................................................................................................................1 2 BASF Corporation. ........................................................................................................................................ 13 Baxter Healthcare Corporation. ..................................................................................................................... 14 Brenntag Specialties, Inc. .............................................................................................................................. 15 Capsugel...........................................................................................................................................................16 Catalent Pharma Solutions ............................................................................................................................ 17 Celanese International Corporation…………………………………………………………………………..18 Charles Tennant & Company ........................................................................................................................ 19 Colorcon ....................................................................................................................................................... 20 Consumer Healthcare Products Association .................................................................................................. 21 Covidien ........................................................................................................................................................ 22 CP Kelco ....................................................................................................................................................... 23 Croda, Inc. ..................................................................................................................................................... 24 CyDex Pharmaceuticals, Inc. ........................................................................................................................ 25 DMV Fonterra Excipients USA LLC.............................................................................................. .................26 Doe & Ingalls of NC, LLC...............................................................................................................................27 Dow Chemical Company ....................................................................................................................... 28-29 Dow Corning Corporation, Healthcare Industries Materials Site .................................................................. 30 Eastman Chemical Company......................................................................................................................... 31 Eli Lilly & Company ..................................................................................................................................... 32 EMD Millipore Corporation ......................................................................................................................... 33 Evonik Industries ........................................................................................................................................... 34 FMC BioPolymer .......................................................................................................................................... 35 Gelita, North America. .................................................................................................................................. 36 Genentech A Member of the Roche Group .................................................................................................. 37 Generichem Corporation .............................................................................................................................. 38 Grace Davison ............................................................................................................................................... 39 Innophos ........................................................................................................................................................ 40 J.M. Huber, Engineered Materials ................................................................................................................. 41 Johnson & Johnson Pharmaceutical Research & Development .............................................................. 42-44 Jost Chemical Company ................................................................................................................................ 45 JRS Pharma LP .............................................................................................................................................. 46 Kerry Ingredients & Flavours ........................................................................................................................ 47 Lubrizol Advanced Materials Inc .................................................................................................................. 48 LyondellBasell Industries .............................................................................................................................. 49 Merck & Company, Inc. ................................................................................................................................ 50 Mingtai Chemical Co., Ltd. ........................................................................................................................... 51 Mutchler, Inc. Pharmaceutical Ingredients .................................................................................................... 52 NSF DBA...................................................................................................................... ...................................53 NSF International.................………………………………………………………………………………....54 Perrigo Company ........................................................................................................................................... 55 Pfizer Inc. ...................................................................................................................................................... 56 Pharmaceutical Technology ......................................................................................................................... 57 PlusPharma, Inc. ............................................................................................................................................ 58 Procter & Gamble Company ........................................................................................................................ 59 ii PSC Biotech Corporation……………………………………………………………….……………………60 Purdue............................................................................................................................................................ 61 Roquette America. ......................................................................................................................................... 62 Sanofi U.S . ................................................................................................................................................. ..63 Sensient Pharmaceutical Coating Systems.......................................................................................................64 SPI Pharma, Inc. ........................................................................................................................................... 65 Tablets & Capsules ........................................................................................................................................ 66 Univar ............................................................................................................................................................ 67 Vanderbilt Minerals, LLC................................................................................................................................68 VWR International LLC ................................................................................................................................ 69 Member Consultants……………………………………………………………………………………..70 e-SubmissionsSolutions.com FinnBrit Consulting IBS Consulting in Quality LLC Labtopia Inc. Lachman Consultant Services, Inc. PFAR Consulting Maria de Lourdes Rivera Academic and Graduate Student Members ....................................................................................... 71 IPEC Federation .............................................................................................................................. ...72-73 IPEC China IPEC Europe JPEC United States Pharmacopeia ............................................................................................................... ...74 Committees and Working Groups, Counsel ............................................................................... .75-78 Staff .............................................................................................................................................................. 79 iii Abbott Laboritories John Margetson* Direector of Supplier Quality 100 Abbott Park Road Department 03QA, Bldg. AP6C-1 Abbott Park, IL 60064-6088 Tel: (847) 938-5396 Fax: (847) 938-9385 Email: john.margetson@abbott.com Scott Messner Senior Regulatory Affairs Manager 100 Abbott Park Road Deptartment 03QSA, Bldg. AP6C-3 Abbott Park, IL 60064 Tel: (847) 938-0888 Email: scott.messner@abbott.com Demetra Macheras Director, Quality Data Surveilance 100 Abbott Park Road Department 03QY, Bldg. AP6C-4 Abbott Park, IL 60064-6088 Tel: (847) 938-5603 Email: demetra.macheras@abbott.com 1 AbbVie Vlasios Andronis Technical Manager 1 North Waukegan Road D-045M, Bldg. NC-A4 North Chicago, IL 60064 Tel: (847) 937-3944 Email: vlasios.andronis@abbvie.com Ronald M. Martin Section Manager Technical 1 North Waukegan Road D-045M, Bldg. NC-A4 North Chicago, IL 60064 Tel: (847) 937-8413 Email: ronald.martin@abbvie.com Richard P. Poska Director, Regulatory Affairs 1 North Waukegan Road D-PA71, Bldg. AP-504 North Chicago, IL 60064 Tel: (847) 938-5901 Email: richard.poska@abbvie.com Stephen M. Tyler* Director, Quality Engineering 1 North Waukegan Road D-050Z, Bldg. J23-3 North Chicago, IL 60064 Tel: (847) 937-1074 Email: stephen.tyler@abbvie.com Ronnie L. Yeager Senior Scientist II, Toxicology 1 North Waukegan Road D-R468, Bldg. AP-13A North Chicago, IL 60064 Tel: (847) 938-1656 Email: ronnie.yeager@abbvie.com Xiaohong (Michelle) Zheng Associate Director, Pharmaceutical Development 1 North Waukegan Road D-R417, Bldg. AP-31 North Chicago, IL 60064 Tel: (847) 938-9329 Email: michelle.zheng@abbvie.com 2 ABITEC Corporation Jeffrey J. Fulton Product Development Manager 1530 S. Jackson Street Janesville, WI 53546 Tel: (608) 290-3879 Fax: (608) 755-9842 Email: jfulton@abiteccorp.com Corinne Jones* Technical and Regulatory Associate 501 West First Avenue Columbus, OH 43215 Tel: (614) 429-6475 Fax: (614) 299-8279 Email: cjones@abiteccorp.com Donald Kelemen, Ph.D. Global Business Director, Pharmaceuticals 501 West First Avenue Columbus, OH 43215 Tel: (614) 429-6435 Fax: (614) 299-8279 Email: dkelemen@abiteccorp.com Rick Kettinger National Key Account Manager 501 West First Avenue Columbus, OH 43215 Tel: (610) 584-4052 Fax: (614) 299-8279 Email: rkettinger@abiteccorp.com Jim Williams, Ph.D. Principal Scientist 501 West First Avenue Columbus, OH 43215 Tel: (614) 429-6438 Fax: (614) 299-8279 Email: jwilliams@abiteccorp.com 3 Alkermes, Inc John Chippari Director, Regulatory Affairs 852 Winter Street Waltham, MA 02451 Tel: (781) Fax: (781) 609-5855 Email: john.chippari@alkermes.com Magali Hickey* Senior Staff Scientist, Formualtion Development 852 Winter Street Waltham, MA 02451 Tel: (781) 609-6435 Fax: (781) 609-5855 Email: magali.hickey@alkermes.com Hector Guzman Principal Engineer, Process Development 852 Winter Street Waltham, MA 02451 Tel: (781) 609-6930 Fax: (781) 609-5855 Email: hector.guzman@alkermez.com Stephen Zolla Director, Quality 852 Winter Street Waltham, MA 02451 Tel: (781) 609-6625 Fax: (781) 609-5855 Email: stephen.zolla@alkermes.com 4 Americhem Pharmaceutical Corporation Juan Carlos Otero* Director of Operations/Technical Manager 2862 N.W. 79th Avenue Miami, FL 33122 Tel: (305) 591-0100 Fax: (305) 591-9223 Email: jcotero@americhempharm.com 5 Amgen, Inc. Denise Young Senior Specialist, Supplier Quality One Amgen Center Drive MS 37-2-C Thousand Oaks, CA 91320 Tel: (805) 313-1054 Fax: (805) 480-0068 Email: dyoung@amgen.com Eric Berg Director, Supplier Quality One Amgen Center Drive MS 92-1-A Thousand Oaks, CA 91320 Tel: (805) 313-1478 Mobile: (805) 279-5378 Fax: (805) 376-8319 Email: eberg@amgen.com Marc Fages Specialist, Supplier Quality One Amgen Center Drive MS 92-2-C Thousand Oaks, CA 91320 Tel: (805) 313-1550 Fax: (805) 480-0068 Email: mfages@amgen.com Lisa Hart Director, Supplier Quality One Amgen Center Drive MS 92-1-A Thousand Oaks, CA 91320 Tel: (805) 313-1333 Fax: (805) 480-0068 Email: lhart@amgen.com Luis O. Rivera* Corporate Commercial SQM/Supplier Quality Specialist P.O. Box 9243 Humacao, PR 00792 Tel: (787) 916-3811 Email: lorivera@amgen.com Karen Seiberlich Senior Manager, Supplier Quality One Amgen Center Drive MS 92-1-A Thousand Oaks, CA 91320 Tel: (805) 313-1672 Fax: (805) 480-0068 Email: kseiberl@amgen.com Martin Van Trieste Vice President Quality One Amgen Center Drive MS 37-2-C Thousand Oaks, CA 91320 Tel: (805) 313-1524 Email: mvantrie@amgen.com 6 APOTEX, Inc. Linda Angaritis Site Director, Quality Assurance, Signet 150 Signet Drive Toronto, ON M9L1T9 Ed Carey Director, Corporate Compliance 150 Signet Drive Toronto, ON M9L 1T9 Tel: (416) 401-7321 Email: ecarey@apotex.com Jeff Derraugh Site Director, Quality Assurance, Richmond Hill 380 Elgin Mills Road East Richmond Hill, ON L4C 5H2 Tel: (905) 884-2050 ext. 2410 Email: jderraugh@apotex.com Jill Lau* Manager Supplier Quality 150 Signet Drive Toronto, ON M9L 1T9 Tel: (416) 749-9026 ext. 8657 Email: jlau@apotex.com Dr. Stephen Simmons Vice President, Corporate Quality 150 Signet Drive Toronto, ON M9L 1T9 Tel: (416) 401-7703 Fax: (416) 401-3865 Email: ssimmons@apotex.com Dr. Samba Sow Site Director, Quality Assurance Etobicoke 50 Steinway Boulevard Etobicoke, ON M9L 1T9 Tel: (416) 675-8427 Email: ssow@apotex.com 7 Aptalis Pharmatech, Inc. Tim Grinstead Plant Manager 845 Center Drive Vandalia, OH 45377 Tel: (937) 898-9669 Fax: (937) 264-2656 Email: tim.grinstead@aptalispharma.com Peter Maruszewski Supply Chain Director 845 Center Drive Vandalia, OH 45377 Tel: (937) 898-9669 Fax: (937) 264-2656 Email: peter.maruszewski@aptalispharma.com Erin O’Brien Director of Marketing, Pharmaceutical Technologies 100 Somerset Corporate Boulevard Suite 2000 Bridgewater, New Jersey 08807 Tel: (908) 927-9600 ext. 4084 Email: eobrien@aptalispharma.com Bill Webb* Director, Global Compliance 845 Center Drive Vandalia, OH 45377 Tel: (937) 415-0313 Fax: (937) 264-2656 Email: bill.webb@aptalispharma.com 8 Archer Daniels Midland Allan Buck Director, R&D Food Ingredients Technical Service 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-7655 Fax: (217) 451-3981 Email: buck@admworld.com Larry Ritchie Vice President Product Quality Office of Compliance and Ethics 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-3975 Fax: (217) 451-2248 Email: ritchie@admworld.com Mark W. Empie Vice President Regulatory Affairs Office of Compliance and Ethics 1001 N. Brush College Road Decatur, IL 62521-1656 Tel: (217) 451-2463 Fax: (217) 451-4561 Email: empie@admworld.com Dave Tull Industrial Sales Manager 36 Cordage Park Circle Suite 305B Plymouth, MA 02360 Tel: (508) 746-9396 Fax: (508) 746-9386 Email: dave_tull@admworld.com Mike Munar Divisional QA Manager, Protein, Cocoa, Health & Nutrition 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-2835 Email: munar@admworld.com David Watson* Divisional Quality Manager, Corn Processing/BioProducts 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-7439 Fax: (217) 451-7415 Email: david.watson@adm.com Ann Nation Technical Service Representative Citric Acid and Sorbitol 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-7655 Fax: (217) 451-4524 Email: a_nation@admworld.com Patty Pagel Divisional Quality Manager, Corn Processing and BioProducts 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-2314 Fax: (217) 451-4524 Email: patty.pagel@adm.com Mike Rambo Technical Service Representative Xantham Gum and Lactic Acid 1001 N. Brush College Road Decatur, IL 62521 Tel: (217) 451-7655 Fax: (217) 451-3910 Email: rambo@admworld.com 9 Asahi Kasei America, Inc. Linda Herzog* Marketing Director 535 Madison Avenue, 33rd Floor New York, NY 10022 Tel: (212) 371-9900 ext. 218 Mobile: (917) 224-1791 Fax: (212) 371-9050 Email: lherzog@ak-america.com Nobuya Kaneko Vice President 535 Madison Avenue, 33rd Floor New York, NY 10022 Tel: (212) 371-9900 Fax: (212) 371-9050 Email: nkaneko@ak-america.com 10 Ashland Inc. John E. Carney Sales Manager, Americas; Pharmaceuticals Ashland Research Center 500 Hercules Road Wilmington, DE 19808 Tel: (610) 358-4303 Fax: (302) 995-4668 Email: jecarney@ashland.com Denise Crotty Manager, Regulatory Affairs 1361 Alps Road Wayne, NJ 07470 Tel: (973) 628-3958 Email: dcrotty@ashland.com John Flanagan General Manager Fine Chemicals Pharmaceutical Business Director, NA 1361 Alps Road Wayne, NJ 07470 Tel: (973) 628-3379 Email: jflanagan@ashland.com William Foreman Senior Quality Systems Specialist P.O. Box 37 Calvert City, KY 42029 Tel: (270) 395-1537 Fax: (270) 395-4174 Email: wforeman@ashland.com George Mansveld Manager Regulatory Affairs EMEA Hercules International Ltd. LLC Veraartlann 8, 2288 GM Rijswijk, PO Box 5822, Netherlands Tel: 31-70-4134287 Fax: 31-70-3902715 Email: gmansveld@ashland.com Tim McArragher Regulatory Affairs Manager Ashland Europe Waterfield, Tadworth, Surrey KT20 5HQ Tel: +44 (0) 1737 377089 Email: tmcarragher@ashland.com Carl Perini Manager Quality Compliance Corporate Quality Assurance 1361 Alps Road Wayne, NJ 07470 Tel: (973) 628-3240 Fax: (973) 628-3160 Email: cperini@ashland.com Bob Sulouff ** Regulatory Coordinator Aqualon Hopewell Plant 1111 Hercules Road Hopewell, VA 23860 Tel: (804) 541-4484 Fax: (804) 541-4353 Email: resulouff@ashland.com Dereke Tsao Manager, Regulatory Affairs Asia-Pacific Hercules Chemicals (Taiwan) Co., Ltd. 7F1, No. 37, Min Chuan E. Rd. Sec. 3, Taipei, Taiwan, R.O.C. 10476 Tel: +886 (2) 25002247 Mobile: +886 (9) 32381765 Fax: 886 (2) 25044077 Email: dtsao@ashland.com Jeffrey Wolff Director, Phar. Personal Care & Food Aqualon Division 500 Hercules Road Bldg. 8162 Wilmington, DE 19808-1599 Tel: (302) 995-3100 Fax: (302) 995-4668 Email: jswolff@ashland.com Jane S. Vergnes, Ph.D., DABT Sr. Manager, Toxicology Acting Head of Department 1361 Alps Road Wayne, NJ 07470 Tel: (973) 628-4087 Email: jvergnes@ashland.com Priscilla Zawislak* Global Regulatory Affairs Manager 500 Hercules Road Wilmington, DE 19808-1599 Tel: (302) 995-3400 Mobile: (302) 824-2525 Fax: (302) 995-3445 Email: pszawislak@ashland.com 11 Avantor Performance Materials, Inc. Juanita Garofalo Director, Regulatory Affairs 3477 Corporate Parkway Suite 200 Center Valley, PA 18034 Tel: (610) 573-2763 Email: juanita.garofalo@avantormaterials.com Jennifer Goodman Manager , Quality Auditing 3477 Corporate Parkway Suite 200 Center Valley, PA 18034 Tel: (610) 573-2764 Email: jennifer.goodman@avantormaterials.com Mary Hanner Technical Service Specialist 3477 Corporate Parkway Suite 200 Center Valley, PA 18034 Tel: (610) 573-2600 ext: 32684 Email: mary.hanner@avantormaterials.com Gerald L. Moss Vice President Global Sales, Active Pharmaceutical Ingredients 675 McDonnell Boulevard Hazelwood, MO 63042 Tel: (314) 654-6816 Fax: (314) 654-6510 Email: jerry.moss@avantormaterials.com Anita Nemeth 3477 Corporate Parkway Suite 200 Center Valley, PA 18034 Email: anita.nemeth@avantormaterials.com Richard Siberski* Global Quality Director 3477 Corporate Parkway Suite 200 Center Valley, PA 18034 Tel: (610) 573Email: richard.siberski@avantormaterials.com Stephanie Sparrow 3477 Corporate Parkway Suite 200 Center Valley, PA 18034 Email: stephanie.sparrow@avantormaterials.com 12 BASF Corporation Javier Beeck Marketing Manager-North America Pharma Ingredients & Services and Dietary Supplements 100 Campus Drive Florham Park, NJ 07932 Tel: (973) 245-6381 Fax: (973) 245-6843 Mobile: (973) 262-7697 Email: javier.beeck@basf.com Karen Dhanraj Account Manager, Nutrition and Health Cognis Canada Corporation 2290 Argentia Road Mississauga, Ontario L5N 6H9 Tel: (905) 542-7551 ext. 225 Fax: (905) 542-7588 Cell: (416) 452-2264 Email: karen.dhanraj@basf.com Nigel Langley, Ph.D., MBA* Head Technical Sales, Pharma Ingredients and Services 500 White Plains Road Tarrytown, NY 10591-9005 Tel: (914) 785-3828 Mobile: (973) 262-0620 Email: nigel.langley@basf.com Nicholas Shackley Director, Pharma Ingredients & Dietary Supplements 100 Campus Drive Florham Park, NJ 07932 Tel: (973) 245-7174 Fax: (973) 245-6843 Email: nicholas.shackley@basf.com 13 Baxter Healthcare Corporation Lynn Best Associate Director Medical Products 25212 W. IL Route 120 Round Lake, IL 60073 Tel: (847) 270-5612 Email: lynn_best@baxter.com Andrew Erickson Manager, Supplier Quality 25212 W. IL Route 120 Round Lake, IL 60073 Tel: (847) 270-5283 Fax: (847) 270-4681 Email: andrew_erickson@baxter.com Linda Mikulan-Maxfield * Senior Manager, Global Compliance and Supplier Quality 25212 W. IL Route 120 Round Lake, IL 60073 Tel: (847) 270-6622 Fax: (847) 270-2345 Email: linda_mikulan_maxfield@baxter.com Portia Peng Manager II, Supplier Quality 25212 W. IL Route 120 Round Lake, IL 60073 Tel: (847) 270-5834 Fax: (847) 270-5834 Email: portia_peng@baxter.com 14 Brenntag Specialties, Inc. Frank McGonigle Director Regulatory Affairs 1000 Coolidge Street South Plainfield, NJ 07080 Tel: (908) 561-6100 ext. 4239 Fax: (908) 561-5823 Email: fmcgonigle@brenntag.com Robert Przybylowski * Vice President National Accounts 1000 Coolidge Street South Plainfield, NJ 07080 Tel: (908) 561-6100 ext. 4227 Email: rprzybylowski@brenntag.com 15 Capsugel Mark Hazard Director, Global Quality Systems 535 North Emerald Road Greenwood, SC 29646 Tel: (864) 942-6578 Fax: (864) 942-3058 Email: mark.hazard@capsugel.com Edward Holzi* Manager, Global Regulatory and Compliance 535 North Emerald Road Greenwood, SC 29646 Tel: (864) 942-6518 Fax: (864) 942-3058 Email: edward.holzli@capsugel.com Mia Hunnicutt Manager, Regulatory and Compliance 535 North Emerald Road Greenwood, SC 29646 Tel: (864) 942-3734 Email: mia.hunnicutt@capsugel.com Michael Marini Sr. Manager, Global Quality Systems 535 North Emerald Road Greenwood, SC 29646 Tel: (864) 942-6640 Fax: (864) 942-3058 Email: michael.marini@capsugel.com Jerry Rentz Director Quality Assurance 535 North Emerald Road Greenwood, SC 29646 Tel: (864) 942-3775 Email: jerry.rentz@capsugel.com Ronny Van De Neste Director, Global Quality Systems CAPSUGEL COLMAR 10, Rue Timken F-68027 Colmar, Cedex France Tel: (011) 33(0)3 89 20 57 41 Fax: (011) 33(0)3 89 41 48 11 Email: ronny.vandeneste@capsugel.com Kimberly Weeks Manager, Regulatory and Compliance 535 North Emerald Road Greenwood, SC 29646 Tel: (864) 942-3876 Fax: (864) 942-3058 Email: kim.weeks@capsugel.com 16 Catalent Pharma Solutions Robin Forte** Director of Supplier Quality Management 14 Schoolhouse Road Somerset, NJ 08873 Tel: (732) 560-5240 Fax: (215) 613-0311 Email: robin.forte@catalent.com Harry Jeffreys* Vice President, QMS and Compliance Catalent Pharma Solutions 14 Schoolhouse Road Somerset, NJ 08873 Tel: (732) 560-5251 Mobile (732) 595-6714 Email: harry.jeffreys@catalent.com Sharon Johnson SVP, Quality and Regulatory Affairs 14 Schoolhouse Road Somerset, NJ 08873 Tel: (732) 537-6223 Email: sharon.johnson@catalent.com James Webb VP, QMS and Compliance 2200 Lakeshore Drive Woodstock, IL 60098 Tel: (815) 245-5429 Fax: (215) 613-0311 Email: james.webb@catalent.com 17 Celanese International Corporation Ken Anderson Market Development Technical Leader 1601 West LBJ Freeway Dallas, TX 75235 Tel: (972) 443-4067 Fax: (972) 443-8595 Email: ken.anderson@celanese.com Jamie Beggs Market Development Manager 1601 West LBJ Freeway Dallas, TX 75235 Tel: (972) 443-8234 Fax: (972) 443-8595 Email: jamie.beggs@celanese.com Emad Choudhury Pharma Product Stewardship Leader 1601 West LBJ Freeway Dallas, TX 75235 Tel: (972) 443-3084 Fax: (972) 443-8595 Email: emad.choudhury@celanese.com Dr. Karl Enters* Global Product Stewardship and Toxicology Leader 1601 West LBJ Freeway Dallas, TX 75235 Tel: (972) 443-3848 Fax: (972) 443-8595 Email: karl.enters@celanese.com 18 Charles Tennant & Company Richard Viflanzoff * Corporate Compliance Officer 34 Clayson Road Toronto, M9M 2G8 Ontario Canada Tel: (416) 747-3114 Fax: (416) 741-6642 Email: rviflanz@ctc.ca 19 Colorcon Dennis Cummings President – North America 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 661-2651 Fax: (215) 661-2251 Email: dcummings@colorcon.com Alexa Smith Regulatory Services Manager 275 Ruth Road Harleysville, PA 19438 Tel: (215) 661-2706 Fax: (215) 661-2206 Email: asmith@colorcon.com Christopher DeMerlis Regulatory Affairs Manager 275 Ruth Road Harleysville, PA 19438 Tel: (215) 661-2766 Fax: (215) 661-2778 Email: cdemerlis@colorcon.com Amy E. Vaughn, Project Coordinator Global Regulatory Affairs 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 661-2777 Fax: (215) 661-2377 Email: avaughn@colorcon.com Tom Farrell Director, New Product Development 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 661-2773 Fax: (215) 661-2373 Email: tfarrell@colorcon.com Steve Zenuh Senior Vice President Commercial Operations 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 699-7733 Fax: (215) 661-2605 Email: szenuh@colorcon.com William Motzer Vice President, Global Operations 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 661-2668 Fax: (215) 661-2268 Email: wmotzer@colorcon.com Craig Palumbo VP, Global Operations 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 661-2559 Fax: (215) 661-2159 Email: cpalumbo@colorcon.com David R. Schoneker* Director, Global Regulatory Affairs 275 Ruth Road Harleysville, PA 19438 Tel: (215) 661-2513 Fax: (215) 661-2113 (computer) Email: dschoneker@colorcon.com 20 Consumer Healthcare Products Association Barb Kochanowski, Ph.D. Vice President, Regulatory & Scientific Affairs 900 19th Street NW, Suite 700 Washington, DC 20006 Tel: (202) 429-3530 Fax: (866) 290-2153 Email: bkochanowski@chpa-info.org John Punzi, Ph.D.* Director, Quality Assurance & Technical Affairs 900 19th Street NW, Suite 700 Washington, DC 20006 Tel: (202) 429-3536 Fax: (866) 397-5650 Email: jpunzi@chpa-info.org 21 Covidien Beth C. Ball Senior Research Chemist 3600 N. Second Street St. Louis, MO 63147 Tel: (314) 654-0398 Fax: (314) 654-1717 Email: beth.ball@covidien.com Eileen L. McClendon Senior Principal Analytical Chemist 3600 N. Second Street St. Louis, MO 63147 Tel: (314) 654-1608 Email: eileen.l.mcclendon@covidien.com Barry McKenzie* Senior Principle Analytical Chemist 3600 N. Second Street St. Louis, MO 63147 Tel: (314) 654-1764 Fax: (314) 654-1985 Email: barry.mckenzie@covidien.com Tim J. Nieters Director Product Management 675 McDonnell Boulevard Hazelwood, MO 63042 Tel: (314) 654-5805 Fax: (314) 654-1176 Email: tim.nieters@covidien.com Richard G. Pudlo Principal Chemical Engineer 385 Marshall Avenue Webster Groves, MO 63119 Tel: (314) 654-2820 Fax: (314) 654-2716 Email: rich.pudlo@covidien.com 22 CP Kelco Megan Bevill Sr. Product Regulatory Specialist 3100 Cumberland Blvd, Suite 600 Atlanta, GA 30339, USA Tel: (678) 247-2124 Email: megan.bevill@cpkelco.com Malcolm Laws Managing Director 3000 Corporate Center Drive Suite 260 Morrow, GA 30260 Tel: (770) 960-9967 Fax: (770) 960-1267 Email: malcolm.laws@noviantgroup.com Paul Newcomb Director, Product Regulations 2150 Lullwater Court Lawrencewille, GA 30043 Tel: (678) 247-7403 Fax: (678) 247-7703 Email: newcomb@charter.net Cheryl Van Dyne* Senior Manager, Regulatory Affairs 2025 E. Harbor Drive San Diego, CA 92113 Tel: (619) 595-5027 Fax: (619)595-5036 Email: cheryl.vandyne@cpkelco.com Steve Zapoticzny Senior Director, ESH 2025 E. Harbor Drive San Diego, CA 92113 Tel: (619) 595-5081 Fax: (619) 595-5036 Email: steve.zapoticzny@cpkelco.com 23 Croda, Inc. Patricia Jarmon* Manufacturing Standard Advisor 315 Cherry Lane New Castle, DE 19720 Tel: (302) 429-5445 Email: patricia.jarmon@croda.com Ann Kolynych Quality Coordinator 315 Cherry Lane New Castle, DE 19720 Tel: (302) 429-5329 Fax: (302) 429-5448 Email: ann.kolynych@croda.com Jim Lapoint Quality Manager 8 Croda Way Mill hall, PA 17751 Tel: (570) 748-7796 x 33163 Email: jim.lapoint@croda.com Dean Myers QA Manager 8 Croda Way Mill hall, PA 17751 Tel: (570) 748-7796 x 33122 Fax: (570) 748-8042 Email: dean.myers@croda.com David Niehaus Quality Manager 315 Cherry Lane New Castle, DE 19720 Tel: (302) 429-5301 Fax: (302) 429-5448 Email: david.niehaus@croda.com 24 CyDex Pharmaceuticals, Inc. Vincent Antle, Ph.D.* Sr. Director of Technical Operations and Quality Assurance 2029 Becker Drive Lawrence, KS 66047 Tel: (913) 402-3514 Fax: (913) 685-8856 Email: vantle@ligand.com Alan Watson Scientist III 2029 Becker Drive Lawrence, KS 66047 Tel: (913) 402-3503 Fax: (913) 685-8856 Email: awatson@ligand.com 25 DMV Fonterra Excipients USA LLC Dr. Jian-Xin Li* Technical Manager, North America 902 Carnegie Center, Suite 440 Princeton, NJ 0854 Tel: (609) 356-5113 Fax: (609) 858-2118 Email: jian-xin.li@dfepharma.com Eric Escobar General Manager, North America 902 Carnegie Center, Suite 440 Princeton, NJ 0854 Tel: (609) 356-5118 Fax: (609) 858-2118 Email: eric.escobar@dfepharma.com 26 Doe & Ingalls of NC, LLC James R. Fell* Quality System Manager 2520 Meridian Parkway Suite 500 Durham, NC 27713 Tel: (813) 503-5427 Fax: (919) 598-1707 Email: jfell@doeingalls.com Andrew Finn Director of Distribution Services 2520 Meridian Parkway Suite 500 Durham, NC 27713 Tel: (919) 598-1986 Fax: (919) 598-1707 Email: afinn@doeingalls.com Jerilin Kenney QuaIity System Manager 2520 Meridian Parkway Suite 500 Durham, NC 27713 Tel: (919) 598-1986 Fax: (919) 598-1707 Email: jpkenney@doeingalls.com Brooke McIntyre Quality System Manager 2520 Meridian Parkway Suite 500 Durham, NC 27713 Tel: (919) 598-1986 Fax: (919) 598-1707 Email: bmcintyre@doeingalls.com 27 The Dow Chemical Company Tim Cabelka Sr. Product Research Specialist Pharmaceutical Applications Tel: (989) 636-0714 Fax: (989) 636-9836 Email: tdcabelka@dow.com Bruce DeBolt 2301 Brazosport Boulevard, Bldg. 1605 Freeport, TX 77541 Tel: (409) 238-4200 Fax: (409) 238-0385 Email: bdebolt@dow.com Connie L. Deford Global Environmental Health & Safety Leader 1691 North Swede Midland, MI 48636 Tel: (989) 636-6978 Fax: (989) 638-9836 Email: cldeford@dow.com Kimberly A. Fisher WVO Site Quality Specialist/LRQA Corporate Contact Union Carbide Corporation, a subsidiary of the Dow Chemical Company 437 Maccorkly Avenue, SW Bldg. 82 Room 933 South Charleston, WV 25303 Tel: (304) 747-3633 Fax: (304) 747-1197 Email: fisherka@dow.com Cherie Holliman Pharmaceutical Industry Manager 311 Nicholas Drive Delran, Delran 08075 Tel: (856) 461-0983 Fax: (800) 819-4378 Email: holimcl@dow.com Marshall Kern Water Soluble Polymers EH&S Global Product Leader 1425 Vidal Street South Sarnia, Ontario, Canada N77 8C6 Tel: (519) 339-5026 Fax: (519) 339-3417 Email: mkern@dow.com Frank Murphy* Senior Product Regulatory Specialist Environment, Health & Safety 11700 Preston Road, PMB 103 Suite 660 Dallas, TX 75230 Tel: (972) 386-0671 Email: fhmurphy@dow.com Ann C. Perry Business Quality Lead Water Soluble Polymers 171 River Road Piscataway, NJ 08854 Tel: (732) 563-5734 Fax: (732) 563-5086 Email: perryac@dow.com Dennis R. Reiswig Senior Quality Specialist 61 Cypress Road Huntsville, TX 77340 Tel: (979) 235-1700 Email: dreiswig@dow.com Sandy J. Schlesinger Quality Systems Specialist 1319 Building Midland, Midland 48667 Tel: (989) 638-6994 Fax: (989) 636-4894 Email: sjschlesinger@dow.com Dr. Robert L. Schmitt Technology Manager 171 River Road Piscataway, NJ 08854 Tel: (732) 563-5075 Fax: (732) 563-6072 Email: schmitrl@dow.com Imogene E. Treble, Ph.D. Product Regulatory Leader 171 River Road Piscataway, NJ 08854 Tel: (732) 563-5706 Fax: (732) 563-6074 Email: trebleie@dow.com 28 Garry M. Wiltshire Issues Manager Environment, Health & Safety Product Regulatory Management 1803 Bldg. Midland, MI 48674 Tel: (989) 638-1557 Fax: (989) 638-9933 Email: wiltshiregm@dow.com DowWolff Cellulosics Tina P. Dasbach Global Market Development Manager – Pharma 1691 N. Swede Road Midland, MI 48674 Tel: (517) 636-4027 Email: tdasbach@dow.com M. Ann Van Meter Senior Quality Systems Specialist 437 Kanawha Turnpike South Charleston, WV 25303 Tel: (304) 747-4055 Mobile: (304) 419-4055 Fax: (304) 747-4889 Email: vanmetma@dow.com 29 Dow Corning Corporation, Healthcare Industries Materials Site Debora S. Ackerman Healthcare Industries Materials Site Quality Team Leader 1635 N. Gleaner Road Hemlock, MI 48626 Tel: (989) 642-5224 ext. 2497 Fax: (989) 642-7416 Email: deb.ackerman@dowcorning.com Julie Budnick Healthcare Industries Materials Site Quality Engineer 1635 N. Gleaner Road Hemlock, MI 48626 Tel: (989) 642-5224 ext. 2392 Fax: (989) 642-7416 Email: j.a.budnick@dowcorning.com Kelly Burgard Healthcare Industries Materials Site Quality Engineer 1635 N. Gleaner Road Hemlock, MI 48626 Tel: (989) 642-5224 ext. 2314 Fax: (989) 642-7416 Email: kelly.j.burgard@dowcorning.com Roger Gibas Healthcare Industries Materials Site Quality Technical Support 1635 N. Gleaner Road Hemlock, MI 48626 Tel: (989) 642-5224 ext. 2276 Fax: (989) 642-7416 Email: r.a.gibas@dowcorning.com Gary B. Kolesar, MPH, DABT Health & Environmental Sciences Product Toxicology 2200 W. Saltzbur Road Midland, MI 48686-0994 Tel: (989) 496-4190 Email: gary.kolesar@dowcorning.com David J. Neun, Ph.D. Global Regulatory Steward Dow Corning Corporation 1635 N. Gleaner Road Hemlock, MI 48626 Tel: (989) 642-7429 Fax: (989) 642-7416 John Price Healthcare Industries Materials Site Quality Assurance Lab Team Leader 1635 N. Gleaner Road Hemlock, MI 48626 Tel: (989) 642-5224 ext. 2342 Fax: (989) 642-7416 Email: j.m.price@dowcorning.com Patricia Rafidison, Ph.D/Pharmacist Healthcare Life Sciences Risk Management 11 Domaine du Piol F-06650 Opio, France Tel: +33 493 774 285 Fax: +33 493 884 287 Mobile: 33 607 746 237 Email: p.rafidison@dowcorning.com Lise Tan-Sien-Hee Regulatory Compliance Dow Corning, S.A. Pare Industriel 7180 Seneffe Belgium Tel: +32 0 64 88 8861 Fax: +32 0 64 88 8942 Email: lise.tan_sien_hee@dowcorning.com Katherine L. Ulman* Associate Scientist & Global Regulatory Compliance Manager 2200 W. Saltzburg Road Midland, MI 48686-0994 Tel: (989) 496-6780 Fax: (989) 496-5710 Email: katherine.l.ulman@dowcorning.com Regina Malezewski Senior Development Scientist P.O. Box 0994 Midland, MI 48686-0994 Tel: (987) 496-4158 Fax: (987)496-5710 Email: gina.malezewski@dowcorning.com 30 Eastman Chemical Company Shane L. Jones* cGMP Quality Assurance Manager P.O. Box 511, Bldg. 65F Kingsport, TN 37662 Tel: (423) 229-2693 Fax: (423) 224-0672 Email: sljones@eastman.com Tammy Nave Formulation Products Business Manager P.O. Box 431 Kingsport, TN 37662-5054 Tel: (423) 224-2423 Fax: (423) 224-0648 Email: tnave@eastman.com Donna Jackson Sade** Product Regulatory Representative P.O. Box 511 Kingsport, TN 37662-5054 Tel: (423) 224-0260 Fax: (423) 224-0208 Email: dsade@eastman.com 31 Eli Lilly & Co. Adrian Bone Senior Director, Quality: Manufacturing and Marketing Affiliates, Asia Pacific/Latin America, Lilly UK Erl Wood Manor Windlesham, Surrey UK GU20 6PH Tel: +44 1276 483586 Email: bone_adrian_l@lilly.com Robert E. Wiens GMH Coordinator /Sr. Quality Representative Lilly Corporate Center Drop Code 2638 Indianapolis, IN 46285 Tel: (317) 276-4861 Mobile: (317) 402-5617 Fax: (317) 433-0268 Email: wiens_robert_e@lilly.com Judy Grimes Quality Representative-Development Lilly Corporate Center Drop Code 3852 Indianapolis, IN 46285 Phone: (317) 276-5751 Fax: (317) 276-8116 Email: j.grimes@lilly.com Matthew H. Yates Synthetic Organic Chemist Lilly Chemical Process R&D Group Email: yates_matthew_h@lilly.com Gwyn Murdoch* Director, Quality Systems/Materials/Packaging Lilly Corporate Center Drop Code 2643 Indianapolis, IN 46285 Tel: (317) 276-0235 Email: murdoch_gwyn_l@lilly.com Neil Schwarzwalder Associate Quality Consultant Lilly Corporate Center Drop Code 2638 Indianapolis, IN 46285 Tel: (317) 276-9787 Fax: (317) 433-0268 Email: nas@lilly.com Maria Soler-Nuñez Manager Global Quality Materials Lilly Corporate Center DC 2643 Indianapolis, IN 46285 Tel: (317) 651-2095 Fax: (317) 651-6342 Email: solermaria@lilly.com Daniel A. Sweat Team Leader- Development Raw Materials Team Lilly Corporate Center Indianapolis, IN 46285 Tel: (317) 433-3806 Fax: (317) 651-4969 Email: d.sweat@lilly.com 32 EMD Millipore Corporation Bretta Erskine* Regulatory Services-Pharm Chemical Solutions-US 290 Concord Road Billerica, MA 01821 Tel: (781) 290-9434 Email: bretta.erskine@emdmillipore.com Joe Schoellkopff QA Manager, Quality Assurance 480 S. Democrat Road Gibbstown, NJ 08027 Tel: (856) 423-6300 Fax: (856) 423-6703 Email: joe.schoellkopff@ emdmillipore.com Donald R. Ewert Technical Manager, Cosmetics One International Plaza Suite 300 Philadelphia, PA 19113 Tel: (484) 652-5675 Fax: (800) 304-1985 Email: don.ewert@emdmillipore.com Anne Gochman Director of Regulatory Affairs 480 S. Democrat Road Gibbstown, NJ 08027 Tel: (856) 599-6723 Fax: (856) 423-6703 Email: Anne.Gochman@emdmillipore.com Diana R. Hickey Manager, Quality Assurance 110 EMD Boulevard Savannah, GA 31407 Tel: (912) 964-9050 ext. 343 Fax: (912) 966-1891 Email: diana.hickey@emdmillipore.com Brian McCarter Maintenance Manager, Engineering & Maintenance 110 EMD Boulevard Savannah, GA 31407 P.O. Box 1206 Tel: (912) 964-9050 ext. 53363 Fax: (912) 964-7402 Cell: (912) 313-8719 Email: kenneth.b.mccarter@emdmillipore.com Stephen O’Neill Senior Business Development Manager Life Science Materials & Microbiology 480 S. Democrat Road Gibbstown,NJ 08027 Tel: (973) 729-5662 Fax: (973) 729-0525 Email: stephen.o’neill@emdmillipore.com 33 Evonik Industries Chris Armstrong* Health & Nutrition Pharma Polymers 2 Turner Place PO Box 365 Piscataway, NJ 08854 Tel: (732) 981-5339 Fax: (732) 981-5484 Mobile: (732) 691-6569 Email: chris.armstrong@evonik.com Yann D’Herve North American Business Director 2 Turner Place Piscataway, NJ 08854 Tel: (732) 981-5365 Mobile: (484) 620-1570 Email: yann.dherve@evonik.com Dr. Johanna Eisele Director of Regulatory Affairs Roehm GmbH, Chemische Fabrik Kirschenallee 64293 Darmstadt, Germany Tel: 49-615-118-4763 Fax: 49-615-118-3249 Email: johanna.eisele@evonik.com Andrew Honeycheck Marketing Manager 2 Turner Place Piscataway, NJ 08854 Tel: (732) 981-5383 Fax: (732) 981-5484 Email: andrew.honeycheck@evonik.com Nasser Nyamweya Technical Services Manager 2 Turner Place Piscataway, NJ 08854 Tel: (732) 981-5175 Fax: (732) 981-5484 Email: nasser.nyamweya@evonik.com 34 FMC BioPolymer Susan C. Byer Regulatory Affairs Assistant 1735 Market Street Philadelphia, PA 19103 Tel: (215) 299-6447 Fax: (215) 299-6821 Email: sue_byer@fmc.com Brian AC Carlin, Ph.D. Director Open Innovation 801 Princeton South Corporate Center Ewing, NJ 08628 Tel: (609) 963-6287 Mobile: (609) 865-8354 Email: brian.carlin@fmc.com Dave Stone Global Quality Director FMC BioPolymer business unit of FMC Corporation 1735 Market Street Philadelphia, PA 19103 Phone: (215) 299-6219 Email: dave.stone@fmc.com Michael Yarbrough Director Pharmaceutical Excipient Business 1735 Market Street Philadelphia, PA 19103 Tel: (215) 299-6172 Fax: (215) 299-6669 Email: michael_yarbrough@fmc.com Eunice M. Cuirle* Manager, Global Regulatory Affairs 1735 Market Street Philadelphia, PA 19103 Tel: (215) 299-6999 Fax: (215) 299-6368 Email: eunice_cuirle@fmc.com Robert L. Neel System Development Specialist 1301 Ogletown Road Newark, DE 19711 Tel: (302) 451-0156 Fax: (302) 451-0117 Email: robert_neel@fmc.com Edward Selinger Analytical Research & Services Manager P.O. Box 8 Princeton, NJ 08543 Tel: (609) 951-3685 Fax: (609) 951-3680 Email: edward_selinger@fmc.com Dave Simcox General Manger, Pharmaceutical and Personal Care 1735 Market Street Philadelphia, PA 19103 Tel: (215) 299-6182 Fax: (215) 299-6409 Email: dave_simcox@fmc.com 35 Gelita North America J. Michael Dunn, Ph.D.* Vice President Scientific & Regulatory Affairs P.O. Box 927 Sioux City, IA 51102 Tel: (712) 943-1688 Fax: (712) 943-0327 Email: mike.dunn@gelita.com Carol Ostendorf Manager, Quality Assurance P.O. Box 927 Sioux City, IA 51102 Tel: (712) 943-0340 Fax: (712) 943-0327 Email: carol.ostendorf@gelita.com Mark Viksten Manager, Regulatory Affairs P.O. Box 927 Sioux City, IA 51102 Tel: (712) 943-1659 Fax: (712) 943-0327 Email: mark.viksten@gelita.com 36 Genentech a member of the Roche Group Joe Famulare Senior Director, Quality and Compliance, External Relations and Collaboration 1399 New York Avenue, #300 Washington, DC 20005-4769 Tel: (202) 572-3074 Email: famulare.joseph@gene.com Lisa Milano* Global Supplier Quality System 1 DNA Way Building 82/Room 13159 South San Francisco, CA 94080 Tel: (650) 467-0611 Fax: (650) 467-9681 Mobile: (650) 438-7393 Email: lmilano@gene.com Amelia Mutere** PTQXM Supplier Quality 1 DNA Way Building 82/Room 13159 South San Francisco, CA 94080 Tel: (650) 467-9828 Email: mutere.amelia@gene.com 37 Generichem Corporation Terrance W. Connolly* President 5 Taft Road P.O. Box 457 Totowa, NJ 07511-0457 Tel: (973) 256-9266 Fax: (973) 256-0069 Email: twconnolly@generichem.com Joseph M. Kaye 5 Taft Road P.O. Box 457 Totowa, NJ 07511-0457 Tel: (973) 256-9266 Fax: (973) 256-0069 Email: jmkaye@generichem.com Eric Oishi New Product Development Manager 5 Taft Road P.O. Box 457 Totowa, NJ 07511-0457 Tel: (973) 256-9266 Fax: (973) 256-0069 Email: eoishi@generichem.com 38 Grace Davison Bill Gallion Global Sales Manager – Consumer Products 7500 Grace Drive Columbia, MD 21044 Tel: (410) 531-4147 Fax: (410) 531-4301 Email: bill.gallion@grace.com Tina Jones* Quality Manager/Silicas Product 7500 Grace Drive Columbia, MD 21044 Tel: (410) 531-4306 Email: tina.jones@grace.com Bill McCarthy Product Manager – Consumer Products 7500 Grace Drive Columbia, MD 21044 Tel: (410) 531-4242 Fax: (410) 531-4301 Email: william.mccarthy@grace.com 39 Innophos Lewis Hendricks Technical Service Manager 259 Prospect Plains Road Cranbury, NJ 08512 Tel: (609) 366-1212 Email: lew.hendricks@innophos.com Roy Lyon, Ph.D.* Manager of Regulatory Affairs and Product Stewardship 259 Prospect Plains Road Cranbury, NJ 08512 Tel: (609) 366-1282 Email: roy.lyon@innophos.com Laurian Popovici HQSE Manager 1101 Arnold Street Chicago Heights, IL 60411 Tel: (708) 575-2513 Fax: (708) 575-2552 Email: laurian.popovici@innophos.com Steve Schneider Q.A. Manager 259 Prospect Plains Road Cranbury, NJ 08512 Tel: (609) 366-1238 Email: steve.schneider@innophos.com 40 J.M. Huber, Engineered Materials Samantha Brooks Marketing Associate 3100 Cumberland Boulevard Suite 600 Atlanta, GA 30339 Tel: (678) 247-7529 Mobile: (267) 574-1586 Email: samantha.brooks@huber.com William Dale Carter* Global Quality Director-Silica 3100 Cumberland Boulevard Suite 600 Atlanta, GA 30339 Tel: (678) 247-2735 Mobile: (443) 655-7645 Email: dale.carter@huber.com Rajeev Karpe Global Operations Director, Silica P.O. Box 310 907 Revolution Street Havre de Grace, MD 21078 Tel: (410) 939-7274 Fax: (410) 939-7313 Email: rkarpe@huber.com Kathleen Pike Laboratory and Analytical Support Manager P.O. Box 310 907 Revolution Street Havre de Grace, MD 21078 Tel: (410) 939-7377 Email: kathie.pike@huber.com 41 Johnson & Johnson Pharmaceutical Research & Development LLC Stanley Altan, Ph.D. Biostatistics Research Fellow Route 202 P. O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 704-4083 Fax: (908) 526-2567 Email: saltan@prdus.jnj.com Walter F. Joppy Sr. Director, Quality Assurance Consumer and Personal Products 199 Grandview Road Skillman, NJ 08558-9418 Tel: (908) 874 1474 Fax: (908) 874-1531 Email: wjoppy2@its.jnj.com Selima Begum, Ph.D. Principal Scientist Route 202 P.O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 704-4761 Fax: (908) 704-4996 Email: sbegum@prdus.jnj.com Susan A. Lerke, Ph.D. Assistant Director, Analytical Development P.O. Box 776 Welsh & McKean Roads Spring House, PA 19477 Tel: (215) 628-5997 Email: slerke@prdus.jnj.com Donald L. Doyle Research Manager Route 202 P. O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 704-5782 Fax: (908) 218-0621 Email: ddoyle@prdus.jnj.com Angela Falzone, Ph.D. Principal Scientist, Pharmaceutical Development, New Product Development Route 202 P. O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 704-4769 Fax: (908) 722-5406 Email: afalzone@prdus.jnj.com Stefan Geisshüesler, PhD Director, Analytical R&D RWJ PRI, a Division of CILAG AG Hochstrasse 201 CH-8205 Schaffhausen Switzerland Tel: 41 52 630 9457 Fax: 41 52 630 9338 Email: sgeisshu@cilch.jnj.com John Giannone Director, US Sales & Business Development Noramco Inc. 503 Carr Road, Suite 200 Wilmington, DE 19809 Tel: (302) 761-2906 Email: jgianno@its.jnj.com Signe Lund Senior Director 1125 Trenton-Harbourton Road Titusville, NJ 0856 Email: slund2@its.jnj.com Arpad J. Madarasz, DVM Department of Toxicology 1000 Route 202, P.O. Box 300 Raritan, NJ 08869-0202 Tel: (908) 704-4596 Fax: (908) 218-0668 Email: amadaras@prdus.jnj.com Stefan Merkle, Ph.D. Director Pharmaceutical Development RWJ PRI, a Division of CILAG AG Hochstrasse 201 CH-8205 Schaffhausen Switzerland Tel: 41 52 630 9453 Fax: 41 52 630 9338 Email: smerkle@cilch.jnj.com Donna Panasewicz Director Regulatory Affairs, Global CM&C Marketed Product Support Route 202 P. O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 218-6140 Fax: (908) 231-0056 Email: dpanasew@prdus.jnj.com 42 William J. Powers, PhD Senior Director, Preclinical Development Route 202 P. O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 704-4447 Email: wpowers@prdus.jnj.com Thomas M. Rossi, Ph.D. Vice President, Global Chemical, Pharmaceutical & Preclinical Development Welsh and McKean Roads Spring House, PA 19477 Tel: (215) 628-5493 Fax: (215) 628-7100 Email: trossi@prdus.jnj.com Thomas W. Schultz, Ph.D.* Senior Director, Regulatory Sciences Global CM&C Regulatory Affairs 1125 Trenton-Harbourton Road Titusville, NJ 08560 Tel: (609) 730-7746 Fax: (609) 730-2706 Email: tschultz@its.jnj.com Basant Sharma, Ph.D. Vice President, EPO Technical Development/CMC Leader Route 202 P. O. Box 300 Raritan, NJ 08869-0602 Tel: (908) 704-4906 Fax: (908) 218-0621 Email: bsharma@prdus.jnj.com Doris St. John-Randalls Pharmaceutical QA & RA Manager, Supplier Quality 200 Tournament Drive Horsham, PA 19044 Tel: (302) 256-1244 Email: dstjohn@its.jnj.com Raritan, NJ 08869-0602 Tel: (908) 704-4858 Fax: (908) 704-1612 Janssen-Cilag Ltd. Simon Hince Director, Regulatory Affairs P. O. Box 79 Saunderton High Wycombe Buckinghamshire HP14 4HJ England Tel: 44 1 494 567 501 Email: shince@jacgb.jnj.com Ortho Biotech Inc. Dennis Kraus Quality Control Supervisor Rt. 202 P.O. Box 670 Raritan, NJ 08869 Tel: (908) 218-6255 Fax: (908) 218-7101 Email: dkraus@obius.jnj.com Peter J. Lisi, Ph.D. Director, Quality Control Laboratories Rt. 202 P.O. Box 670 Raritan, NJ 08869 Tel: (908) 704-5441 Fax: (908) 218-0578 Email: plisi@obius.jnj.com Ron Sperling QC Laboratory Manager Rt. 202 P.O. Box 670 Raritan, NJ 08869 Tel: (908) 218-6293 Fax: (908) 218-7101 Email: rsperlin@obius.jnj.com Heather Sturtevant Senior Scientist McNeil Consumer Healthcare 7050 Camp Hill Road Fort Washington, PA Tel: (215) 273-7580 Email: hsturte9@its.jnj.com Alza Corp. Shay Behzadi Analytical Sciences Manager 1010 Joaquin Road Mountain View, CA 94039 Ph: (650) 564-5587 Fax: (650) 564-2091 Email: sbehzadi@alzus.jnj.com James V. Weber, Ph.D. Research Manager, Spectroscopy/Drug Chemistry Route 202 P. O. Box 300 Scott Dekker Alza Supplier Assessment Auditor Alza Corporation 1900 Charleston Road 43 Mountain View, CA 94043 Tel: (650) 564-2546 Fax: (650) 564-2007 Email: sdekker@alzus.jnj.com Joan-Huey Dow, Ph.D. Alza Corporation Associate Director 1058B Huff Avenue Mountain View, CA 94043 Tel: (650) 564-5342 Fax: (650) 564-2700 Email: jdow@alzus.jnj.com Mary Nielsen Sr. Materials Specifications Specialist 1010 Joaquin Road P.O. Box 7210 Mountain View, CA 94039-7210 Ph: (650) 564-4127 Fax: (650) 564-2091 Email: mnielse2@alzus.jnj.com J&J Consumer Companies, Inc. Irene Brennam Director, QA - North America Supplier Quality 5760 West 96th Street Los Angeles, CA 90045 Tel: (310) 410-5948 Mobile: (310) 291-5108 Email: ibrennan@its.jnj.com 44 Jost Chemical Company Jerry Jost President 8150 Lackland Road St. Louis, MO 63114 Tel: (314) 428-4300 Fax: (314) 428-4366 Email: jerry.jost@jostchemical.com Philip H. Merrell, Ph.D.* Technical Marketing Manager 8150 Lackland Road St. Louis, MO 63114 Tel: (314) 813-1912 Fax: (314) 428-4366 Email: phil.merrell@jostchemical.com 45 JRS Pharma LP Craig E. Scott* Director, Quality Systems 2981 Route 22, Suite 1 Patterson, NY 12563 Tel: (845) 878-8336 Fax: (845) 878-8373 Email: craig.scott@jrspharma.com 46 Kerry Ingredients & Flavours Frank Crawford Global QA and Regulatory Manager 158 State Highway 320 Norwich, NY 13815 Tel: (607) 334-1768 Fax: (607) 334-1792 Email: frank.crawford@kerry.com Michael Crowley Product Development Manager Excipients 158 State Highway 320 Norwich, NY 13815 Tel: (607) 334-1774 Fax: (607) 334-5317 Email: Michael.crowley@kerry.com Penny Marsh Director, Regulatory Affairs Kerry Ingredients & Flavors Inc. 3400 Millington Road Beloit, WI 53511 Tel: (608) 363-1463 Fax: (608) 363-3225 Mobile: (608) 215-3634 Email: penny.marsh@kerry.com Materesa Marshall Senior Quality Assurance Representative/Supplier Lead Auditor P.O. Box 301183 Chicago, IL 60630 Tel: (847) 645-7366 Fax: (847) 645-7392 Email: materesa.marshall@kerry.com Stephanie Speers* Regulatory Affairs Specialist 3400 Millington Road Beloit, WI 53511 Tel: (608) 363-3728 Fax: (608) 363-3225 Email: stephanie.speers@kerry.com 47 Lubrizol Advanced Materials, Inc. Dr. Edward Greenberg** Global Business Director, Pharma 9911 Brecksville Road Cleveland, OH 44141-3247 Tel: (216) 447-5833 Fax: (216) 447-5740 Email: ed.greenberg@lubrizol.com Brussels, Belgium Tel: +32-2-678-1930 Fax: +32-2-678-2002 Email: stijn.verschuuren@lubrizol-be.com Robert K. Hinderer, Ph.D. Director Occupational Health, Sustainability and Product Safety Programs 9911 Brecksville Road Cleveland, OH 44141-3247 Tel: (216) 447-5181 Fax: (216) 447-5760 Email: robert.hinderer@lubrizol.com Thomas Malfronte Senior Vice President and General Manager, Personal Care & Pharmaceuticals 9911 Brecksville Road Cleveland, OH Cleveland Tel: (216) 447-5455 Fax: (216) 447-5740 Email: thomas.malfronte@lubrizol.com Larry Sexton GMP Manager 9911 Brecksville Road Cleveland, OH 44141-3247 Tel: (216) 447-5000 Fax: (216) 447-5670 Email: larry.sexton@lubrizol.com Meera Raghuram* Manager, Regulatory Affairs – LifeScience Polymers 29400 Lakeland Boulevard Wickliffe, OH 44092 Tel: (440) 347-2242 Fax: (440) 347-4790 Email: meera.raghuram@lubrizol.com Cynthia Sullivan Global Product Stewardship Manager 9911 Brecksville Road Cleveland, OH 44141-3247 Tel: (440) 347-5527 Fax: (440) 347-4295 Email: cindy.sullivan@lubrizol.com StijnVerschuuren Vice President, Pharmaceuticals, Household & Food Chaussee De Wavre 1945, B-1160 48 LyondellBasell Industries Roger A. Heckman* Technical Services Manager, Americas One Houston Center 1221 McKinney Street, Suite 700 P.0. Box 3646 Houston, TX 77253-3646 Tel: (713-309-2512 Fax: (713-951-1602 Email: roger.heckman@lyondellbasell.com William Claude White Manager Product Safety One Houston Center 1221 McKinney Street, Suite 700 P.0. Box 3646 Houston, TX 77253-3646 Tel: (713) 309-7339 Fax: (713) 951-1602 Email: claude.white@lyondellbasell.com 49 Merck & Company, Inc. Kaushik Dani Technical Assessment Manager 556 Morris Avenue Mail stop S-7-C1340 Summit, NJ 07901 Tel: (908) 740-2694 Fax: (908) 740-2338 Email: kaushik.dani@merck.com David Monteith, Ph.D. Director of Drug Delivery 556 Morris Avenue Mail Stop S-7-C/D3 Summit, NJ 07901 Tel: (908) 473-5886 Email: david.monteith@merck.com Phyllis Walsh* Senior Compendial Manager 2000 Galloping Hill Road Mail Stop K-6-1 1620 Kenilworth, NJ 07033 Tel: (908) 740-2542 Fax: (908) 740-5100 Email: phyllis.walsh@merck.com Mark Wiggins Compendial Affairs Principal Scientist WP82-10 Sumneytown Pike West Point, PA 19486-0004 Tel: (215) 652-3964 Fax: (215) 652-0834 Email: mark_wiggins@merck.com 50 Mingtai Chemical Co., Ltd. Mark H. Chen* Chairman & President 1142, Shin Hsing Road Bah-Der City, Taoyuan Taiwan, R.O.C. 33452 Tel: +886-33682295 Fax: +886-33681438 Email: mark.h.chen@mingtai.com Peter Chen President, Mingtai Chemical LLC 608 Sherwood Parkway Mountainside, NJ 07902 Tel: (908) 928-9401 Fax: (908) 928-9407 Email: seiu@topaz.ocn.ne.jp Ping-Hong Chung Special Assistant to President 20-1F, Alley 5, Lane 24 Sectio 3 Ting-Cho Rad Taipei, Taiwan Tel: +866-2-2368-2146 Fax: +886-33681438 Email: phchung@pitdc.org.tw Victor C. Go Manager, Technical Services 18 Golf Road Bloomfield, NJ 07003 Tel: (973) 338-5336 Email: victor.go@mingtai.com Welkin Liao Manager, Sales and Marketing 1142, Shin Hsing Road Bah-Der City, Taoyuan Taiwan, R.O.C. 33452 Tel: +886-33682295 Fax: +886-33681438 Email: welkin.liao@mingtai.com Francis X. Quinn Executive Vice President 608 Sherwood Parkway Mountainside, NJ 07902 Tel: (908) 928-9402 Fax: (908) 928-9407 Email: fxquinn@mingtaiusa.com 51 Mutchler, Inc. Pharmaceutical Ingredients Dwight Mutchler** Vice President P.O. Box 373190 Cayey, Puerto Rico 00737-3190 Tel: (787) 714-3000 Cell: (787) 306-4884 Email: dwight.mutchler@mutchlerinc.com Glenn Mutchler* President 20 Elm Street Harrington Park, NJ 07640 Tel: (201) 768-1100 Fax: (201) 666-3652 Email: glenn.mutchler@mutchlerinc.com Griselle Vargas Quality Manager P.O. Box 373190 Cayey, Puerto Rico 00737-3190 Tel: (787) 714-7000 Email: griselle.vargas@mutchlerinc.com 52 NSF DBA Lori Bestervelt* 789 Dixboro Road Ann Arbor, MI 48105 Tel: (734) 769-5345 Fax: (734) 827-7733 Email: bestervelt@nsf.org Janeen Skutnik-Wilkinson 129 South Street, 6th Floor Boston MA 02111 Tel: (734) 545-6940 Email: jskutnik@nsf-dba.com 53 NSF International Edward P. Wyszumiala* General Manager, Dietary Supplement Programs 789 Dixboro Road Ann Arbor, MI 48105 Tel: (734) 913-5706 Fax: (734) 827-6138 Email: ewyszumiala@nsf.org 54 Perrigo Company Michael S. Bradley** Director Quality 4615 Dairy Drive Greenville, SC 29607 Tel: (864) 627-3704 Fax: (864) 288-5530 Email: mbradley@perrigo.com Michael Fairbanks* Global Head Supply Chain Quality 515 Eastern Avenue Allegan, MI 49010 Tel: (269) 686-3765 Email: michael.fairbanks@perrigo.com Lee Kang Director Asia-Pacific Quality Operations 500 Eastern Avenue Allegan, MI 49010 Tel: (269) 686-1528 Email: lee.kang@perrigo.com Steven Lum VP Global Compliance & Quality Systems 500 Eastern Avenue Allegan, MI 49010 Email: steven.lum@perrigo.com Paul Weninger VP Global Quality & Compliance 500 Eastern Avenue Allegan, MI 49010 Tel: (269) 686-1634 Fax: (269) 673-7643 Email: pweninger@perrigo.com Louis Yu Sr.VP Global Quality & Compliance 500 Eastern Avenue Allegan, MI 49010 Email: louis.yu@perrigo.com 55 Pfizer, Inc. Sheila Alexander Sr. Director GMC SOM-PPK6-02-621 100 Route 206 North Peapack, NJ 07977 Tel: (908) 901-8370 Email: sheila.m.alexander@pfizer.com Dennis Casey Vice President, Analytical R & D. Pharm MS8118A-2015 Eastern Point Road Groton, CT 06340 Email: dennis_l_casey@groton.pfizer.com Gerry Migliaccio Vice President, Global Quality Operations 235 E. 42nd Street, MS:27 New York, NY 10017 Email: gerry.migliaccio@pfizer.com Steve Teo, Ph.D. DABT Director, Toxicology and Safety 5 Giralda Farms Madison, NJ 07940 Tel: (973) 660-5416 Fax: (973) 660-7162 Email: steve.teo@pfizer.com Maria Guazzaroni Jacobs, Ph.D.* Director of Quality and Regulatory Policy 235 E. 42nd Street, 235/12/77 New York, NY 10017 Tel: (212) 733-2134 Fax: (646) 441-6255 Email: maria.guazzaroni.jacobs@pfizer.com Thomas Kline Vice President, Supply Chain Management, Procurement 235 E. 42nd Street MS:15A New York, NY 10017 Email: tom.kline@pfizer.com John Mandy Director Global Quality Audit Pfizer Global Manufacturing 100 Route 206 North Peapack, NJ 07977 Tel: (908) 901-6087 Fax: (908) 901-6800 Email: john.mandy@pfizer.com Gina Maria Marsee Regulatory Operations Lead, Quality and Regulatory Policy 4300 Oak Park, B116/62048 Sanford, NC 27330 Tel: (919) 566-5678 Email: gina.marsee@pfizer.com Jackie Massey Global Manager, Compliance & RA Capsugel, Division of Pfizer 535 N. Emerald Avenue Greenwood, SC 29646 Tel: (864) 942-6518 Fax: (864) 942-3058 Email: jackie.massey@pfizer.com 56 Pharmaceutical Technology Maribel Rios Advanstar Communications Senior Editor 485 Route One South, Building F, 1st floor Iselin, NJ 08830 Tel: (732) 346-3045 Fax: (732) 596-0005 Email: ptpress@advanstar.com Patricia Van Arnum* Advanstar Communications Senior Editor 485 Route One South Building F, 1st floor Iselin, NJ 08830 Tel: (732) 342-3072 Fax: (732) 596-0005 Email: pvanarnum@advanstar.com 57 Plus Pharma, Inc. Celine Lacote, Pharm.D. Scientific & Regulatory Affairs Director 2460 Coral Street Vista, CA 92081 Tel: (760) 597-0200 Fax: (760) 597-0734 Email: celinel@pluspharm.com William Roberts* President 2460 Coral Street Vista, CA 92081 Tel: (760) 597-0200 Fax: (760) 597-0734 Email: billr@pluspharm.com Vince Tunzi Regional Sales Manager 9475 Nicklaus Lane Lakewood, IL 60014 Tel: (815) 479-9953 Fax: (815) 444-8032 Email: vincet@pluspharm.com 58 Procter & Gamble Company Don Appleby 11530 Reed Hartman Highway Cincinnati, OH 45241 Tel: (513) 626-3950 Christopher Binski Principal Researcher 8700 Mason-Montgomery Road Mason, OH 045040-9462 Tel: (513) 622-2069 Fax: (513) 622-3573 Email: binski.cj@pg.com Dennis M. Walker* Principal Scientist, Product Safety & Regulatory Affairs Sharon Woods Technical Center 11530 Reed Hartman Highway Cincinnati, OH 45241 Tel: (513) 626-0777 Fax: (513) 626-1313 Email: walker.dm@pg.com Tina Engel Principal Scientist Mason Business Center 8700 Mason-Montgomery Road Mason, OH 45040-8006 Tel: (513) 622-3723 Email: engel.tm@pg.com Denny Lietz Senior Scientist Sharon Woods Innovation Center 11530 Reed Hartman Highway Cincinnati, OH 45241 Tel: (513) 626-3394 Fax: (513) 626-1313 David B. Mitchell, Ph.D. Section Head & Toxicologist 8700 Mason Montgomery Road Mason, OH 45040-9462 Tel: (513) 622-3786 Fax: (513) 622-0519 Email: mitchell.db@pg.com Gwen Rucker Principal Researcher 5289 Vine Street Cincinnati, OH 45217 Tel: (513) 627-4718 Fax: (513) 277-6214 Email: rucker.ge@pg.com Mr. Randall A. Stolt Associate Director, Oral Care Sharon Woods Innovation Center 11530 Reed Hartman Hwy Cincinnati, OH 45241 Tel: (513) 622-2012 Fax: (513) 622-3573 Email: stolt.ra@pg.com 59 PSC Biotech Corporation John Clapham* CEO 700 Corporate Center Drive, Suite 201 Pomona, CA 91768 Tel: (909) 784-3350 Fax: (909) 784-3354 Email: jclapham@biotech.com Scott Dyer Vice President 700 Corporate Center Drive, Suite 201 Pomona, CA 91768 Tel: (909) 784-3350 Fax: (909) 784-3354 Email: sdyer@biotech.com Bart Groninger 700 Corporate Center Drive, Suite 201 Pomona, CA 91768 Tel: (909) 784-3350 Cell: (909) 784-8529 Fax: (909) 784-3354 Email: bart@biotech.com Pat O’Hara Director 94 Church Street, Suite 301 New Brunswick, NJ 08901 Tel: (973) 932-6931 Fax: (732) 640-1177 Email: pohara@biotech.com Nancy Tomoney Director 94 Church Street, Suite 301 New Brunswick, NJ 08901 Tel: (973) 943-5305 Fax: (732) 640-1177 Email: ntomoney@biotech.com 60 Purdue Chuck Forsaith Director, Supply Chain Security 498 Washington Street Coventry, RI 02816 Tel: (401) 262-9226 Email: charles.forsaith@pharma.com Cindy Libonati* Director, Supply Management 700 Union Boulevard Totowa, NJ 07512 Tel: (973) 837-5060 Fax: (973) 247-9904 Email: cindy.libonati@pharma.com 61 Roquette America, Inc. Sherri Main* Analytical Services Team Leader 1417 Exchange Street P.O. Box 6647 Keokuk, IA 52632 Tel: (319) 526-3272 Fax: (319) 526-3589 Email: sherri.main@roquette.com 62 Sanofi U.S. Mark E. Blazka, PhD Principle Research Investigator 55 Corporate Drive, #55A-435A Bridgewater, NJ 08807-1265 Tel: (908) 231-3119 Email: mark.blazka@sanofi.com Linda Bowen, MS, RAC, FRAPS Regulatory Policy and Intelligence Global Regulatory Affairs 55 Corporate Drive, #55A-435A Bridgewater, NJ 08807-1265 Tel: (908) 981-4876 Email: linda.bowen@sanofi.com Mark Desieno Sr. Director, Industrial Development & Innovation, N. America 55 Corporate Drive, #55A-435A Bridgewater, NJ 08807-1265 Tel: (908) 231-3594 Email: mark.desieno@sanofi.com David B. Klug, MS* Senior Manager, Supplier Audit US Quality & Compliance 55 Corporate Drive, #55A-435A Bridgewater, NJ 08807-1265 Tel: (816) 523-0576 Email: david.klug@sanofi.com Leonard Valenzuela Senior Manager USP Labeling 55 Corporate Drive, #55A-435A Bridgewater, NJ 08807-1265 Tel:1 (908) 981-7536 Email: leonard.valenzuela@sanofi.com *Dues Invoice Address 63 Sensient Pharmaceutical Coating Systems Mark Goldschmidt Global Director of Product Quality 2515 North Jefferson Avenue St. Louis, MO 63106-1939 Tel: (314) 658-7404 Email: mark.goldschmidt@sensient.com Ron Groman* Senior Regulatory Scientist Sensient Colors 2515 North Jefferson Avenue St. Louis, MO 63106-1939 Tel: (314) 658-7342 Email: ron.groman@sensient.com Todd Jacobs Quality Manager 2526 Baldwin Street St. Louis, MO 63106 Tel: (314) 889-7323 Email: todd.jacobs@sensient.com Steve Strickland General Manager 2515 North Jefferson Avenue St. Louis, MO 63106-1939 Tel: (314) 658-7352 Email: steven.strickland@sensient.com Bill Thys Quality Manager 107 Wade Avenue South Plainfield, NJ 07080 Tel: (800) 853-7804 Email: bill.thys@sensient.com Eric Van Ness Director of Product Development 2515 North Jefferson Avenue St. Louis, MO 63106-1939 Tel: (314) 286-7135 Email: eric.vanness@sensient.com 64 SPI Pharma, Inc. Elisa Burger* Regulatory Manager 503 Carr Road Wilmington, DE 19809 Tel: (302) 576-8524 Fax: (302) 576-8567 Email: eburger@spipharma.com John E. Burrows President & CEO 503 Carr Road, Suite 200 Wilmington, DE 19809 Tel: (302) 576-8524 Fax: (302) 576-8567 Email: jburrows@spipharma.com Katrina Elia** Global Head of Quality & Regulatory 503 Carr Road Suite 210 Wilmington, DE 19809 Tel: (302) 576-8528 Fax: (302) 576-8567 Email: kelia@spipharma.com Lisa Fischer Regulatory Affairs Manager 1711 Tiles Court Grand Haven, MI 49417 Tel: (616) 935-6904 Fax: (616) 935-6939 Email: lfischer@spipharma.com 65 Tablets & Capsules Richard Cress Publisher 1155 Northland Drive St. Paul, MN 55120 Tel: (651) 287-5601 Fax: (651) 287-5650 Email: rcress@cscpub.com Matthew Knopp* Editor 1155 Northland Drive St. Paul, MN 55120 Tel: (651) 287-5618 Fax: (651) 287-5650 Email: mknopp@cscpub.com Carrie Loudon Assistant Editor 1155 Northland Drive St. Paul, MN 55120 Tel: (651) 287-5622 Fax: (651) 287-5650 Email: cloudon@cscpub.com John A. McCarty 1155 Northland Drive St. Paul, MN 55120 Tel: (651) 287-5618 Fax: (651) 287-5650 Email: john.mccarty@cscpub.com 66 Univar USA Charly Bonnie * Director of Quality Assurance 200 Dean Sievers Place Morrisville, PA 19067 Tel: (215) 337-5402 Mobile: (215) 669-8731 Email: charly.bonnie@univarusa.com Jeffrey Langa Business Development Mgr-Pharma 4 Steel Road, East Morrisville, PA 19067 Tel: (732) 766-5922 Fax: (732) 866-1889 Email: jeff.langa@univarusa.com Tom Nist Director, Pharmaceutical Industry 2001 Continental Boulevard Charlotte, NC 28273 Tel: (704) 295-0321 Fax: (704) 588-8050 Email: tom.nist@univarusa.com Jane Wells Vice President Marketing 17425 NE Union Hill Road Redmond, WA 98052 Tel: (425) 889-3441 Fax: (425) 889-4160 Email: jane.wells@univarusa.com 67 Vanderbilt Minerals, LLC Peter Ciullo Director, Specialties and Minerals R&D 30 Winfield Street Norwalk, CT 06855 Email: pciullo@vanderbilt.com George Collins VP, Vanderbilt Mineral Co. 396 Pella Way Murray, KY 42071 Tel: (270) 753-492 Email: gcollins@rtvanderbilt.com Frank Flynn* Manager, Specialties and Bio-Chemicals 30 Winfield Street Norwalk, CT 06855 Tel: (800) 562-2476 ext. 432 Fax: (203) 855-1220 Emal: fflynn@rtvanderbilt.com Randall Johnson V.P. and Global Business Manager – Minerals 30 Winfield Street Norwalk, CT 06855 68 VWR International, LLC Ken Crossley Quality Assurance Manager Radnor Corporate Center 100 Matsonford Road Building 1, Suite200 Radnor, PA 19087 Email: ken_crossley@vwr.com Charlotte Hicks Category Manager, Chemicals Radnor Corporate Center 100 Matsonford Road Building 1, Suite 200 Radnor, PA 19087 E-mail: charlotte_hicks @vwr.com Colin Lafferty* VP Supplier Quality Management Radnor Corporate Center 100 Matsonford Road Building 1, Suite 200 PO Box 6660 Radnor, PA 19087-8660 Tel: (610) 386-1574 Email: colin_lafferty@vwr.com Jim Luchsinger Category Manager, Production Chemicals Radnor Corporate Center 100 Matsonford Road Building 1, Suite 200 Radnor, PA 19087 Tel: (610) 386-1751 Email: james-luchsinger@vwr.com Joe Zerillo VP Distribution Radnor Corporate Center 100 Matsonford Road Building 1, Suite 200 Radnor, PA 19087 Email: joe_zerillo@vwr.com 69 MEMBER CONSULTANTS: Ashok Katdare Lachman Consultant Services, Inc. 11 Hill Road Berkley, CA 94708 Email: ashokatdare@yahoo.com Michael J. Plover* Senior Associate 762 Hazelwood Drive North Wales, PA 19454 Tel: (215) 699-2040 Fax: (215) 699-2955 Email: m.plover@lachmanconsultants.com e-SubmissionsSolutions.com Antoinette Azevedo President & CEO 3519 Eugene Place San Diego, CA 92116-1930 Tel: (619) 220-7081 Fax: (619) 243-7207 Email: aazevedo@e-submissionssolutions.com FinnBrit Consulting R. Christian Moreton, Ph.D.* Principal 29 Shawmut Road Waltham, MA 02452 Tel: (781) 894-2572 Fax: (781) 894-9992 Email: themoretons@usa.net IBS Consulting in Quality LLC Irwin B. Silverstein, Ph.D.* 27 Seward Avenue Piscataway, NJ 08854-4235 Tel: (732) 463-8710 Fax: (732) 463-3937 Mobile: (732) 319-6481 Email: irwin.s@verizon.net Maria de Lourdes Rivera* Quality Manager Calle 27 2T14 Mirador Bairoa Caguas, PR 00725 Tel: (787) 402-0751 Email: lourdes.2.rivera@gmail.com PFAR Consulting Sidney A. Goode, Pharm D* President and Owner P.O. Box 2446 Midland, MI 48641 Tel: (989) 859-5721 Mobile: (989) 835-2706 Email: sagpfar3@yahoo.com Labtopia Inc. Gretchen L. McAuliffe, M.S.* President 12929 Gulf Freeway, Suite 108 Houston, TX 77034 Tel: (281) 619-2600 Fax: (281) 619-2607 Email: gmcauliffe@labtopiainc.com Jeanné Mensingh Chief Executive Officer 12929 Gulf Freeway, Suite 108 Houston, TX 77034 Tel: (281) 619-2600 Fax: (281) 619-2605 Email: jmensingh@labtopiainc.com 70 ACADEMIC AND GRADUATE STUDENT MEMBERS: Academic Associate Members Graduate Student Associate Members Moji Christianah Adeyeye, Ph.D.* Professor of Pharmeceutics and Pharmeceutical Technology College of Pharmacy, Roosevelt University 1400 N. Roosevelt Boulevard Schaumburg, IL 60173 Tel: (847) 330-4547 Email: madeyeye@roosevelt.edu Jennifer Chi San Diego State University 1310 Brookside Court Upland, CA 91784 Tel: (626) 353-8237 Email: yilin311@yahoo.com Lawrence H. Block, Ph.D.* Professor of Pharmaceutics Duquesne University 437 Mellon Hall, Division of Pharmaceutical Sciences Pittsburgh, PA 15282 Tel: (412) 396-6362 Fax: (412) 396-5599 Email: lhblockphd@gmail.com Dennis Runser, Ph.D., DDS, RAC* President, Regulatory Compliance Consulting Technology Management Integration, Inc. University of Wisconsin School of Pharmacy 7111 West 151 Street, PMB 367 Overland Park, KS 66223 Tel: (913) 681-2083 Email: drunser@earthlink.net Xi Han New Jersey Institute of Technology 138 arren Street, York Bldg., Room 328 Newark, NJ 07102 Tel: (347) 366-2956 Email: xh7@njit.edu Grace A. Ilevbare Purdue University 575 Stadium Mall Drive West Lafayette, IN 47907 Tel: (209) 623-8288 Email: ilevbare@purdue.edu Sumit Kumar University of Connecticut 69 N. Eagleville Road, U3092 Storrs, CT 06269 Tel: (860) 486-5613 Email: sumit.kumar@uconn.edu Ting Wang University of Maryland, Baltimore PHS649, 20 N. Pine Street Baltimore, MD 21201 Tel: (443) 825-5801 Email: twang005@umaryland.edu Amit S. Wani Wayne State University 259 Mack Avenue, Room 3250 Detroit, MI 48201 Tel: (313) 283-3826 Email: amitwani@wayne.edu 71 IPEC FEDERATION: IPEC Federation Chair: Janeen Skutnik-Wilkinson Partner NSF-DBA 129 South Street, 6th Floor Boston, MA 02111 Tel: (734) 545-6940 Mobile: (860) 694-9986 Email: jskutnik@nsf-dba.com IPEC Europe Flavia Arce, Ph.D. Supplier Management Eli Lilly & Company Lilly Alcobendas, Avda. De la Industria, 30 Alcobendas Madrid Tel: +34 91 6635340 Mobile: +34 639 750658 Email: arce_flavia@lilly.com Alexandra Brand, Ph.D Director Global Marketing Pharma Ingredients & Services, Care Chemicals Division BASF-The Chemical Company BASF SE, G-EMP/M-LI554, D-67117 Limburgerhof Germany Tel: +49 621 60-28471 Mobile: +49 173 3797275 Email: alexandra.brand@basf.com Bernhard Fussnegger** BASF SE Global Technical Service Excipients Tel: +49 621 60-28559 Fax: +49 621 60-6628559 BASF SE, G-EMP/ME - LI554, D-67117 Limburgerhof, Germany Email: bernhard.fussnegger@basf.com Chairman of the European Pharmacopoeial Commission (until June 2010) 6, Place des Pleiades 92415 Courbevoie Cedex France Tel: +33-1-5572 6178 Fax: +33-1-5572 6225 Email: hdejongleiden@hetnet.nl Patricia Rafidison Global Quality & Regulatory Affairs Life Sciences Dow Corning (France) Tel: +33 0 493774285 Fax: +33 0 493774287 Email: p.rafidison@dowcorning.com Mike Thompson Vice Chair GSK Director Supplier Quality BEAME Tel: +44 1833 693124 Fax: +44 1833 693060 Cell: +44 777 1673865 Email: mike.p.thompson@gsk.com ECCO Carole Capitaine (administrative issues) Avenue des Gaulois 9 1040 Brussels Belgium Tel: +32 2 736 53 54 Fax: +32 2 732 34 27 Email: info@ipec-europe.org Evert Izeboud Consultant (in charge of the IPEC Europe recruitment activities) Kerkweide 27 2265 DM Leidschendam The Netherlands Tel: +31-70-320 9894 Fax: +31-70-320 3759 Email: amrs@planet.nl Henk de Jong, Ph.D. Servier (IRIS) Vice Chair IPEC Europe (Retired) 72 (IPEC Federation continued) IPEC China Meredith Ge Chair Ashland Email: MGe@ashland.com Martin Tao Vice Chair FMC Email: martin.tao@fmc.com Cloris Tian Chair Elect Dow Chemical Email: ctian7@dow.com Iris Chai Treasurer Evonik Degussa Paul Zeng Chair of Regulatory Committee Roquette Jessica Zhen (Alex Sun, BASF temp. Chair) Chair of Industry Communication Committee Dow Corning Takashi Morimoto Chairman of Testing & Specification Committee San-Ei Gen F.F.I., Inc. Email: tmorimoto@saneigenffi.co.jp Toyozo Kaneko Chairman of Safety Committee Email: kanetoyo@hotmail.com Hiroshi Mitsui Chairman of Federation/Guideline Committee Evonik Degussa Japan C., Ltd. Email: hiroshi.mitsui@evonik.com Yoshiaki Ogasawara Chairman of Regulatory Committee Colorcon, Japan Email: yogasawara@colorcon.com Dr. Keiji Kijima Secretary-General Kanda Chuo Building 701 507 Nishikanda Chiyoda-ku Tokyo 101 Japan Tel: 011 81 353 759529 Fax: 011 81 353 755951 Email: office@jpec.gr.jp JPEC (Japan Pharmaceutical Excipients Council) Kenji Hamai Chairman Asahi Kasei Chemicals Corporation Fumio Arai Vice-Chairman Shin-Etsu Chemical Co., Ltd. Takeo Inoue Vice-Chairman San-Ei Gen F.F. I., Inc. Yoshinobu Nakai Vice-Chairman Emeritus professor of Chiba University Ueda Masashi Chairman of GMP Committee Gotoku Chemical Co., Ltd. Email: m-ueda@gotoku.co.jp 73 United States Pharmacopeia Todd Cecil Director of Standards 12601 Twinbrook Parkway Rockville, MD 20852 Email: tlc@usp.org Angela G. Long VP, Volunteer and Organizational Affairs/Executive Secretariat 12601 Twinbrook Parkway Rockville, MD 20852 Tel: (301) 816-8382 Fax: (301) 816-8373 Email: agl@usp.org Jennifer R. Payette Manager, New Product Development Corporate Planning & Development 12601 Twinbrook Parkway Rockville, MD 20852 Tel: (301) 816-8198 Fax: (301) 816-8373 Email: jrp@usp.org Catherine M. Sheehan Director, Food and Excipient Standards Division of Standards Development 12601 Twinbrook Parkway Rockville, MD 20852 Tel: (301) 816-8262 Fax: (301) 816-8373 Email: cxs@usp.org Hong Wang, Ph.D. Senior Scientific Associate 12601 Twinbrook Parkway Rockville, MD 20852 Tel: (301) 816-8351 Fax: (301) 816-8373 Email: hw@usp.org Roger L. Williams, MD Executive VP & CEO 12601 Twinbrook Parkway Rockville, MD 20852 Tel: (301) 816-8255 Fax: (301) 816-8299 Email: rlw@usp.org 74 2013 Committees and Working Groups Executive Committee Chairman David B. Klug Senior Manager, Supplier Audit US Quality & Compliance Sanofi U.S. 55 Corporate Drive, 55A-435A Bridgewater, NJ 08807-1265 Tel: (816) 523-0576 Mobile: (816) 918-1700 Email: david.klug@sanofi.com Chair-Elect John Giannone Director, US Sales & Business Development Noramco Inc. 503 Carr Road, Suite 200 Wilmington, DE 19809 Tel: (302) 761-2906 Email: jgianno@its.jnj.com Vice-Chair for Administrative Affairs Janeen Skutnik-Wilkinson NSF DBA 129 South Street, 6th Floor Boston MA 02111 Tel: (734) 545-6940 Email: jskutnik@nsf-dba.com Vice Chair for Harmonization and Compendial Monographs Priscilla Zawislak Manager, Regulatory Affairs Ashland Inc. 500 Hercules Road, Bldg. 8139 Wilmington, DE 19808-1599 Tel: (302) 995-3400 Mobile: (302) 824-2525 Fax: (302) 995-3445 Email: pszawislak@ ashland.com Vice-Chair for Maker & Distributor Relations David R. Schoneker Director, Global Regulatory Affairs Colorcon 275 Ruth Road Harleysville, PA 19438 Tel: (215) 661-2513 Mobile: (267) 251-3123 Fax: (215) 661-2113 (computer) Email: dschoneker@colorcon.com Vice-Chair for Membership Nigel Langley, Ph.D., MBA Head, Technical Sales, Pharmaceutical Ingredients & Services BASF Corporation 500 White Plains Road Tarrytown, NY 10591-9005 Tel: (914) 785-3828 Mobile: (973) 262-0620 Email: nigel.langley@basf.com Vice-Chair for Science & Regulatory Affairs Katherine L. Ulman Associate Scientist & Global Regulatory Compliance Manager Dow Corning Corporation 2200 W. Salzburg Road Midland, MI 48686-0994 Tel: (989) 496-6780 Mobile: (989) 954-5787 Email: katherine.l.ulman@dowcorning.com Vice Chair for User Relations Thomas W. Schultz, Ph.D. Senior Director, Regulatory Sciences Global CM&C Regulatory Affairs Johnson and Johnson Pharmaceutical Research and Development, LLC 1125 Trenton-Harbourton Road Titusville, NJ 08560 Tel: (609) 730-7746 Mobile: (215) 803-1754 Fax: (609) 730-2706 Email: tschultz@its.jnj.com 75 Elected Executive Committee Members IPEA Liaison Bretta Erskine Regulatory Services-Pharm Chemical Solutions-US 290 Concord Road Billerica 01821 Tel: (781) 290-9434 Email: bretta.erskine@merckgroup.com Arthur J. Falk, Ph.D. Southport, NC 28461 Tel: (908) 735-4812 Maine Tel: (207) 693-5156 Mobile: (908) 403-9148 Email: art.falk@roadrunner.com Gina Maria Marsee Regulatory Operations Lead, Quality and Regulatory Policy 4300 Oak Park, B116/62048 Sanford, NC 27330 Tel: (919) 566-5678 Email: gina.marsee@pfizer.com Standing Committee & Working Group Chairs Linda Mikulan-Maxfield Senior Manager, Global Compliance and Supplier Quality Baxter Healthcare Corporation 25212 W. IL Route 120 Round Lake, IL 60073 Tel: (847) 270-6622 Mobile: (847) 207-8298 Email: linda_mikulan_maxfield@baxter.com M. Ann Van Meter Senior Quality Systems Specialist DowWolff Cellulosics 437 Kanawha Turnpike South Charlestown, WV 25303 Tel: (304) 747-4055 Mobile: (304) 419-4055 Email: vanmetma@dow.com Dates indicate year appointed as chair Compendial Review/Harmonization Priscilla Zawislak (2008) Manager, Regulatory Affairs Ashland Specialty Ingredients 500 Hercules Road Bldg. 8139 Wilmington, DE 19808-1599 Tel: (302) 995-3400 Mobile: (302) 824-2525 Fax: (302) 995-3445 Email: pszawislak@ ashland.com Excipient Composition Brian A.C. Carlin, Ph.D. (2007) Director Open Innovation FMC Biopolymer 801 Princeton South Corporate Center Ewing, NJ 08628 Tel: (609) 963-6287 Mobile: 609-865-8354 Email: brian.carlin@fmc.com Excipient Qualification Immediate Past Chair William Dale Carter Global Quality Director-Silica J.M. Huber, Engineered Materials 3100 Cumberland Boulevard Suite 600 Atlanta, GA 30339 Tel: (678) 247-2735 Mobile: (443) 655-7645 Email: dale.carter@huber.com IPEC Federation Chair: Janeen Skutnik-Wilkinson NSF DBA 129 South Street, 6th Floor Boston MA 02111 Tel: (734) 545-6940 Email: jskutnik@nsf-dba.com Bretta Erskine (2012) Regulatory Services-Pharm Chemical Solutions-US EMD Millipore Corporation 4545 Forest Park Avenue, #520 St. Louis, MO 63108 Tel: (781) 290-9434 Email: bretta.erskine@merckgroup.com Good Manufacturing Practices M. Ann Van Meter (2011) Senior Quality Systems Specialist Dow Wolff Cellulosics 437 Kanawha Turnpike South Charleston, WV 25303 Tel: (304) 747-4055 Mobile: (304) 419-4055 Fax: (304) 747-4889 Email: vanmetma@dow.com 76 Quality Agreement Validation Alexa Smith (2007) Regulatory Services Manager Colorcon 275 Ruth Road Harleysville, PA 19438 Tel: (215) 661-2706 Mobile: (267) 252-7792 Email: asmith@colorcon.com M. Ann Van Meter Senior Quality Systems Specialist DowWolff Cellulosics 437 Kanawha Turnpike South Charlestown, WV 25303 Tel: (304) 747-4055 Mobile: (304) 419-4055 Fax: (304) 747-4889 Email: vanmetma@dow.com Quality by Design Product Development Brian A.C. Carlin Ph.D. (2007) Director Open Innovation FMC Biopolymer 801 Princeton South Corporate Center Ewing, NJ 08628 Tel: (609) 963-6287 Mobile: (609) 865-8354 Email: brian.carlin@fmc.com Counsel Theodore M. (Ted) Sullivan, Esquire Buchanan Ingersoll & Rooney PC 1700 K Street, NW, Suite 300 Washington, DC 20006 Tel: (202) 452-7992 Mobile: (202) 549-9665 Fax: (202) 452-6057 Email: sullivantm@bipc.com Regulatory Affairs Meera Raghuram (2012) Manager, Regulatory Affairs LifeScience Polymers Lubrizol Advanced Materials, Inc. 29400 Lakeland Boulevard Wickliffe, OH 44092 Tel: (440) 347-2242 Email: meera.raghuram@lubrizol.com Jean Rodgers Tel: (202) 452-7315 Email: rodgersjw@bipc.com Safety Christopher DeMerlis (2009) Regulatory Affairs Manager Colorcon 415 Moyer Boulevard West Point, PA 19486 Tel: (215) 661-2766 Mobile: (267) 252-7664 Fax: (215) 661-2778 Email: cdemerlis@colorcon.com USP Liaison David R. Schoneker (2011) Director, Global Regulatory Affairs Colorcon 275 Ruth Road Harleysville, PA 19438 Tel: (215) 661-2513 Mobile: (267) 251-3123 Fax: (215) 661-2503 Computer Fax: 215-661-2113 Email: dschoneker@colorcon.com 77 Staff Kim Beals Executive Director/Secretary-Treasurer IPEC-Americas 1655 North Fort Myer Drive, Suite 700 Arlington, VA 22209 Tel: (703) 875-8712 Fax: (703) 525-5157 Mobile: (571) 239-4531 Email: ipecamer@aol.com or kim.beals@ipecamericas.org Tammy Kramer Office Manager IPEC-Americas 1655 North Fort Myer Drive, Suite 700 Arlington, VA 22209 Tel: (703) 351-5265 Mobile: (301) 807-1688 Fax: (703) 525-5157 Email: ipecamer@aol.com or tammy.kramer@ipecamericas.org Alan W. Mercill Staff Consultant IPEC-Americas 1655 North Fort Myer Drive, Suite 700 Arlington, VA 22209 Tel: (703) 875-2127 Fax: (703) 525-5157 Mobile: (703) 220-7421 Email: ipecamer@aol.com Valeria Stewart Office Manager IPEA, Inc. 1655 North Fort Myer Drive, Suite 700 Arlington, VA 22209 Tel: (703) 351-5266 Mobile: (703) 229-7053 Fax: (703) 525-5157 Email: ipeainc@aol.com or valeria.stewart@ipecamericas.org 78
