Senior Consultant, Biologics Consulting Group, Inc.
Gaithersburg, MD

Pharmacology/ Toxicology Reviewer, Division of Vaccines and Related Products Applications, CBER, FDA

• Evaluated and provided written review of preIND, IND and BLA submissions for viral and bacterial vaccines and adjuvants
• Conducted preIND consultation for nonclinical development and study design with sponsors
• Interpreted and applied  regulatory policy related to drug development using knowledge of FDA and CBER policies, practices and procedures regarding pharmacological/ toxicological issues
• Provided nonclinical data for support of clinical vaccine studies
• Consulted for CDER for immunotoxicology issues
• Presented (written and oral) regulatory policy to scientific organizations outside of government

Pharmacology/ Toxicology Reviewer, Division of Special Pathogen and Transplant Products, CDER, FDA

• Provided evaluation and written review of preIND, IND and NDA submissions for organ transplantation and anti-parasitic drug and biologic products
• Interpreted  and applied regulatory policy related to drug development using knowledge of FDA and CDER policies, practices and procedures regarding pharmacological/toxicological issues
• Provided nonclinical data for support of clinical drug studies
• Presented (written and oral) of regulatory policy to scientific organizations outside of government
• Prepared regulatory guidance on the analysis and interpretation of data
• Consulted for CDER on immunotoxicology issues

Pharmacology/Toxicology Reviewer, Division of Antiviral Drug Products, CDER, FDA

• evaluation and written review of preIND, IND and NDA submissions for antiviral drugs
• interpretation  and application of regulatory policy related to drug development using knowledge of FDA, CDER and division policies, practices and procedures regarding pharmacological/toxicological issues
• integration of nonclinical data for support of clinical studies

Postdoctoral fellowship, Division of Antiviral Drug Products, FDA Antiviral Research Laboratory

Research assistant, Smith Kline & French Corporation, Division of Reproductive Toxicology

PROFESSIONAL MEMBERSHIPS

• American College of Toxicology
• Society of Toxicology, Immunotoxicology Specialty Section

FDA COMMITTEE MEMBERSHIPS

• CBER Adjuvants Working Group
• CDER Pharmacology/Toxicology Immunotoxicology Subcommittee, past chair
• CDER Pharmacology/Toxicology Starting Dose Subcommittee
• CDER/CDRH Drug Coated Devices Working Group

FDA/CDER GUIDANCES FOR INDUSTRY, CO-AUTHOR

• Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers, 2005        
• Immunotoxicology Evaluation of Investigational New Drugs, 2006

FDA/CDER AWARDS

• FDA Award of Merit - Artesunate Review Team
• FDA Award of Merit - Nitazoxanide Review Team
• FDA Commendable Service Award - Sirolimus Review Team
• FDA/CDER Group Award - Start Dose Working Group
• CDER Regulatory Science Excellence Award - Immunotoxicology Committee
• CDER Group Recognition Award - Quinine Sulfate Review Team
• CDER Team Excellence Award - Inhaled Cyclosporine Review Team
• CDER Team Excellence Award - Malarone Review Team

RECENT PRESENTATIONS

“Regulatory Aspects of the Nonclinical Safety Assessment of Adjuvanted Preventative Vaccines”, Regulatory Affairs professional Society Annual Meeting, Boston, MA. September 24, 2007

“Immunotoxicological Evaluations of Investigational New Drugs: Regulatory Aspects” in Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics Course, Pharmaceutical Education and Research Institute (PERI), Arlington VA. September 12, 2006

“Transplantation Models for Drug Safety Studies”, American College of Toxicology Annual Meeting, Williamsburg, VA. November 7, 2005

“Immunotoxicological Evaluations of Investigational New Drugs: Regulatory Aspects” in Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics Course, Pharmaceutical Education and Research Institute (PERI), Arlington VA. September 13, 2005

“Overview on Immunotoxicology Testing- What it Predicts and What it Doesn’t”, American College of Veterinary Pathologists Annual Meeting, Orlando, FL. November 14, 2004

“Developmental Immunotoxicology: Regulatory Perspective for Drug Development”, Toxicology Forum Annual Summer Meeting. Aspen, CO. July 19, 2004

“Immunotoxicological Evaluations of Investigational New Drugs: Regulatory Aspects”, Drug Information Association Annual Meeting, Washington, DC. June 14, 2004

PUBLICATIONS

• Cherrington JM, Fuller MD, Mulato AS, Allen SJ, Kunder SC, Ussery MA, Lesnikowski Z, Schinazi RF, Sommadossi JP, Chen MS.  Comparative kinetic analyses of interaction of inhibitors with Rauscher murine leukemia virus and human immunodeficiency virus reverse transcriptases. Antimicrobial Agents and Chemotherapy 40: 1270-3 (1996)
• Kunder SC, Wu L, Morahan PS.  Protection against murine cytomegalovirus infection in aged mice and mice with severe combined immunodeficiency disease with the biological response modifiers polyribosinic-polycytidylic acid stabilized with L-lysine and carboxymethylcellulose, maleic anhydride divinyl ether and colony stimulating factor 1. Antiviral Research 21: 233-45 (1993)
• Kunder SC, Morahan PS.  NK cells and interferon as mediators of biological response modifier-mediated protection against MCMV and HSV-2 infection in normal and immunocompromised mice. Annals of the N Y Academy Science. 685: 618-9 (1993)
• Kunder SC, Kelly KM, Morahan PS.  Biological response modifier-mediated resistance to herpesvirus infections requires induction of alpha/beta interferon. Antiviral Res. 21: 129-39 (1993)
• Kunder SC, Wu L, Morahan PS.  Role of NK cells in immunomodulator-mediated resistance to herpesvirus infection. Antiviral Research 21:103-18 (1993)