Biographies and Testimonials of the James S. Benson FDA Alumni Association Centennial Scholarship Awardees Fall 2006 – Fall 2018

2019 Recipients

Hilda Guerrero

James Mason

2018 Recipients

Christopher Ganter

Chris Ganter holds a B.S. in Chemistry from Drexel University in Philadelphia. He has ten years of combined QA experience in pharma R&D and marketed product stability. As a Senior Scientist in the GMP quality laboratories, he was responsible for analytical investigations of marketed drug products. He then served as Senior QA Specialist in Global R&D QA at Johnson & Johnson and currently as Senior Quality Lead, in Global Product Development Quality Assurance for Genentech conducting quality audits for GLP, GCP and GVP AND computerized systems audits. Chris entered the RA/QA graduate program last fall after temporarily pursuing a successful professional athletic career. He is excited to expand his knowledge base at time when new technology is driving innovation and posing fresh challenges in data integrity and GxP compliance. With sincere gratitude, he wishes thank the FDA Alumni Association for the opportunity to receive the James S. Benson FDA Alumni Association Centennial Scholarship.

James Mason

Jonathan Chapman

2017 Recipients

Ebern Dobbin

2016 Recipient of the FDAAA Scholarship for FDA Personnel

Ebern Dobbin is a Consumer Safety Officer for the Office of Processes and Facilities, Division of Inspection Assessment at FDA's Center for Drug Evaluation and Research. Ebern holds a B.A. Degree in Chemistry from the University of North Carolina at Charlotte. His career began in the pharmaceutical industry as a Quality Engineer in Abbott Laboratories Quality Professional Development Program. During the program he rotated through three divisions of Abbott (Ross Nutrition, Abbott's Hospital Products Division and Abbott's joint venture "TAP Pharmaceutical's") working in various areas such as the chemistry lab, validation, product complaints, product release, division quality assurance and packaging and finishing. Ebern also worked for Bristol Myers Squib and Merck & Co., Inc. supervising packaging operations and finally working as a Senior Quality Associate in Merck's External Manufacturing QA group. He then transitioned into the public sector to work for the FDA. Prior to leaving Merck, Ebern obtained a certification as an ASQ Certified Quality Auditor and began pursuing a Masters degree in QA/RA at Temple. In his spare time he enjoys spending time with his wife and son biking, fishing and camping.

James Mason

Jonathan Chapman

2016 Recipients

Artur Shchukin

Born in Russia, Artur Shchukin moved to the U.S. after finishing high school. As he entered college, he selected a pre-med major and spent months shadowing physicians, volunteering, and working in three hospitals. When he applied for an internship with Propper, a medical device company, he was immediately hired as a full time Research and Development Chemist due to his academic achievements and healthcare-related experience. He was subsequently transferred to Propper's QA and RA Department and studied CDRH Learn on the FDA website to learn more about Quality Systems. In that role, he enjoyed being part of a team that helped medical organizations provide quality service to patients and prevent adverse events through the creation of understandable and functional procedures. Artur changed his career plans when he realized that as part of a Quality Assurance Team, he could help countless people. Currently Artur is Director of Regulatory Compliance at Ampak Company, Inc, where he created the company's first Quality Management System and continues to monitor its compliance to the FDA, USDA and other state and federal regulations.

Ebern Dobbin

2016 Recipient of the FDAAA Scholarship for FDA Personnel

Ebern Dobbin is a Consumer Safety Officer for the Office of Processes and Facilities, Division of Inspection Assessment at FDA's Center for Drug Evaluation and Research. Ebern holds a B.A. Degree in Chemistry from the University of North Carolina at Charlotte. His career began in the pharmaceutical industry as a Quality Engineer in Abbott Laboratories Quality Professional Development Program. During the program he rotated through three divisions of Abbott (Ross Nutrition, Abbott's Hospital Products Division and Abbott's joint venture "TAP Pharmaceutical's") working in various areas such as the chemistry lab, validation, product complaints, product release, division quality assurance and packaging and finishing. Ebern also worked for Bristol Myers Squib and Merck & Co., Inc. supervising packaging operations and finally working as a Senior Quality Associate in Merck's External Manufacturing QA group. He then transitioned into the public sector to work for the FDA. Prior to leaving Merck, Ebern obtained a certification as an ASQ Certified Quality Auditor and began pursuing a Masters degree in QA/RA at Temple. In his spare time he enjoys spending time with his wife and son biking, fishing and camping.

Erin R. Smith

Erin Smith holds a B.A. in Biology from Denison University and has more than 10 years of experience working in FDA-regulated industry. After completing her degree, she worked for the American Red Cross, where she performed quality control testing on blood products. In 2009, Erin began working as a Quality Control Scientist for West-Ward Pharmaceuticals Corp (formerly Boehringer Ingelheim - Roxane, Inc.), where she performed chemical analysis of finished oral solid dosage forms. She then became a Regulatory Compliance Specialist, focusing on internal auditing, supplier auditing, inspection management and DEA compliance. Erin completed Temple’s Drug Development Certificate in Spring 2016 and matriculated into the RAQA Graduate Program that summer. One of the things she enjoys most about the RAQA program is that she can immediately apply concepts from her courses to her daily work.

James Mason

Jonathan Chapman

Kevin Lin

Originally from Fujian province in China, Kevin Lin came to the United States at the age of 12 and speaks Mandarin fluently. He received his B.S. in Molecular Biology from the University of Maryland in 2011. An ASCP licensed Cytogenetics Technologist at Integrated Oncology/Integrated Genetics since 2012, Kevin started his career as a technologist analyzing chromosome karyotypes in bone marrow, blood and tumor tissue samples. After successfully initiating and implementing a more efficient re-testing method for his department, Kevin received the Outstanding Performer in Quality Improvement Award in 2016. He plans to pursuit a career in the pharmaceutical industry with the hope of better integrating western and Chinese traditional medicine. Kevin is honored and grateful to receive the FDAAA Centennial Scholarship Award and expects to finish his MS in RAQA in December 2017.

Ksenia Sidorova

Ksenia Sidorova received her M.D. degree from Siberian State Medical University in Russia. Since coming to the United States she has worked in pharmaceutical marketing in a regulatory and clinical consulting capacity. Passionate about pharmaceuticals, she is beginning her MS degree in Quality Assurance and Regulatory Affairs at Temple University. She strives to deepen her regulatory knowledge and focus her career on Pharmacovigilance. She believes that patients’ safety is the backbone of a successful pharmaceutical industry. She is grateful to accept the FDAAA scholarship. It inspires her to achieve a beneficial role.

Megan Eastman (Licardi)

A Certified Professional IACUC Administrator and Laboratory Animal Technologist, Megan Eastman earned her B.S. degree from Quinnipiac University. She started her career as a Veterinary Technician, practicing in emergency animal hospitals, before transitioning to the role of Senior Associate Scientist at Pfizer in 2009. In 2011, she started as a Compliance and Training Coordinator at Columbia University. Currently she is the Assistant Director of the Office of Animal at SUNY Downstate Medical Center.

Michelle Natalie

Originally from Clinton, Indiana, Michelle Natalie received her BA in Human Biology from the University of Indianapolis. In 2014, she moved to Tampa, FL, and started as a Compliance Specialist at the Pinellas Park CSL Plasma. Two years later, she became the Quality Manger for the Tampa CSL. At the end of 2016, she will have earned the Drug Development Certificate from the RAQA graduate program and will also be promoted to the position of Technical Consultant for CSL. She plans to graduate with the MS in RAQA in 2018 and eventually become an auditor. She enjoys kayaking, going to the gym, and traveling.

2015 Recipients

Bobby Nguyen

A first generation Vietnamese American raised in Philadelphia, Bobby Nguyen was inspired by his parents' work ethic. He financed nearly all of his college education through grants and scholarships at LaSalle University, focusing on Biotechnology/Information and Knowledge Management, which blends science and technology into an interdisciplinary field in medical science. After graduation, Mr. Nguyen worked at DuPont Performance Coatings (now Axalta Coating Systems). In his position in the Product Stewardship & Regulatory Group, he was responsible for the regulation and support of raw materials in manufacturing and R&D sites. He plans to focus on Medical Devices courses as he pursues Temple's QA/RA graduate program, so he can contribute to medical technology, providing happier and healthier lives for all.

Ebern Dobbin

2016 Recipient of the FDAAA Scholarship for FDA Personnel

Ebern Dobbin is a Consumer Safety Officer for the Office of Processes and Facilities, Division of Inspection Assessment at FDA's Center for Drug Evaluation and Research. Ebern holds a B.A. Degree in Chemistry from the University of North Carolina at Charlotte. His career began in the pharmaceutical industry as a Quality Engineer in Abbott Laboratories Quality Professional Development Program. During the program he rotated through three divisions of Abbott (Ross Nutrition, Abbott's Hospital Products Division and Abbott's joint venture "TAP Pharmaceutical's") working in various areas such as the chemistry lab, validation, product complaints, product release, division quality assurance and packaging and finishing. Ebern also worked for Bristol Myers Squib and Merck & Co., Inc. supervising packaging operations and finally working as a Senior Quality Associate in Merck's External Manufacturing QA group. He then transitioned into the public sector to work for the FDA. Prior to leaving Merck, Ebern obtained a certification as an ASQ Certified Quality Auditor and began pursuing a Masters degree in QA/RA at Temple. In his spare time he enjoys spending time with his wife and son biking, fishing and camping.

Ezinne Okwuego

Ezinne pursued an undergraduate degree in Biochemistry. While completing an internship at GSK, she wanted to gain more knowledge on how drugs were made and marketed. After earning an MS in molecular biotechnology from the University of Pennsylvania, she worked as a research analyst in Pfizer. Her passion for healthcare and wanting to learn how healthcare professionals can contribute to drug development led her to complete the PharmD at Temple University School of Pharmacy. After becoming a licensed pharmacist, Novartis Consumer Health offered her a position as a medical information specialist, where she worked with the Regulatory Affairs team on projects, which spurred her interest in learning more about FDA regulations and post approval requirements. She is currently enrolled in Temple’s RAQA graduate program with a focus on regulatory affairs.

Kaylene Charles

Kaylene Charles is a Document Control Specialist within a clinical research lab. She is entering her second year of study at Temple's Regulatory Affairs and Quality Assurance graduate program to develop more skills and gain more knowledge in the area of quality. She hopes to focus on compliance and auditing. Her career goal is to assist in protecting the public's health by assuring the safety, effectiveness, quality and security of food, drugs and cosmetics. Kaylene believes the technical expertise of Temple's RAQA MS program and the generosity of the FDAAAA will help her attain her goals.

Ksenia Sidorova

Ksenia Sidorova received her M.D. degree from Siberian State Medical University in Russia. Since coming to the United States she has worked in pharmaceutical marketing in a regulatory and clinical consulting capacity. Passionate about pharmaceuticals, she is beginning her MS degree in Quality Assurance and Regulatory Affairs at Temple University. She strives to deepen her regulatory knowledge and focus her career on Pharmacovigilance. She believes that patients’ safety is the backbone of a successful pharmaceutical industry. She is grateful to accept the FDAAA scholarship. It inspires her to achieve a beneficial role.

Layne Chaya, VMD

Layne is a 2011 graduate of the University of Pennsylvania where she obtained a degree in Veterinary Medicine. Prior to veterinary school, she attended Smith College in Northampton, Massachusetts, where she completed a Bachelor of Arts in Biology in 2006. She currently works as a senior specialist in Global Pharmacovigilance for Merck Animal Health.

Mark Zappacosta

Mark is a 2010 Temple graduate from the College of Public Health and started the QARA master’s program in spring 2014. His foundation in this industry started at J&J as a Biotechnician where he supported commercial pharmaceutical manufacturing and learned about GMPs. He is now working for Merck in clinical QA and is starting to understand how complex the drug lifecycle really is. He hopes that completing the QA/RA graduate program will provide him the knowledge and abilities to better contribute to this complex and ever-changing industry.

Priscilla Herpai

Priscilla currently works as a Regulatory Specialist for a medical device company that makes dialysis catheters, ports for chemotherapy, and PICC lines. I have been in the pharmaceutical and medical device industry for over 9 years in both QA and RA. The FDAAA Scholarship will enable her to finish the last course in the program.

Tiffany Elle Connelly

During her undergraduate studies at Neumann University, Tiffany Connelly explored her passion for academics, research, and creating opportunity through peer mentoring. She acted as a supplemental instructor in chemistry and was an active member in the Sigma Zeta Honor Society for Science and Mathematics along with the American Chemical Society in her local branch. In her senior year, Tiffany completed a one-year internship with the University of Pennsylvania performing research in flow cytometry. When she was not in a lab or classroom, she could be found in the dormitories as a Resident Assistant and mentored over 100 freshmen women a semester. Tiffany is now working full time as a QA Compliance Specialist at IGI Laboratories, Inc., while pursuing her MS in RAQA. Tiffany continues to support young women pursing STEM degrees and assists Neumann University in creating internship programs with pharmaceutical companies in the Greater Philadelphia Area to provide educational experiences for aspiring chemists.

Vishalkumar Patel

From India, Mr. Vishalkumar Patel completed his Bachelor of Pharmacy degree from Rajiv Gandhi University BEA school of Pharmacy in 2006. He then earned his Bachelor of Pharmacy Honors degree from Nirma University School of Pharmacy in 2010. Currently he is working as a Pharmacy Graduate Intern, while pursuing his Pharmacy practice license in United States. His professional interests include academia, research, drug regulation and administration which made him pursue the Master of Science in QA/RA at Temple University in 2011. He plans to pursue a career in the pharmaceutical industry. In addition, he has a greater goal to improve access to medicines in developing countries, while also providing health care to underserved areas both in the U.S. and overseas. He wishes to thank the FDAAA for their scholarship and also wishes to thank his family, friends, and mentors for their continued support and encouragement.

2014 Recipients

Bobby Nguyen

A first generation Vietnamese American raised in Philadelphia, Bobby Nguyen was inspired by his parents' work ethic. He financed nearly all of his college education through grants and scholarships at LaSalle University, focusing on Biotechnology/Information and Knowledge Management, which blends science and technology into an interdisciplinary field in medical science. After graduation, Mr. Nguyen worked at DuPont Performance Coatings (now Axalta Coating Systems). In his position in the Product Stewardship & Regulatory Group, he was responsible for the regulation and support of raw materials in manufacturing and R&D sites. He plans to focus on Medical Devices courses as he pursues Temple's QA/RA graduate program, so he can contribute to medical technology, providing happier and healthier lives for all.

Jeffrey Baffoe-Bonnie

Spring 2015 Recipient

Jeffrey Baffoe-Bonnie is currently a student at Temple University, planning to pursue the MS in Quality Assurance and Regulatory Affairs. He earned a BS in Biology at Pennsylvania State University from the Eberly College of Science and also minored in history. While an undergraduate, he focused on the neurobiology and pharmacological aspects of health, performing scientific research at Fox Chase Cancer Center and Penn State. Prior to this he joined a health mission team to Guatemala and studied the health of young children in Ghana. With this background he has developed a strong desire to help protect the public health with regards to medicines that they’re engaged with. He is furthering his education at Temple’s prominent QA/RA program to gain a deeper understanding of drug development.

Lia Shields

Lia Shields graduated from Drexel University in 1999 with a BS and MS in Organic Chemistry and has worked in the pharmaceutical industry for 15 years, with one foot in the business and the other in IT. Though she has worked in pharmacovigilance, sterile manufacturing, research and development, devices, and nutrition, the main focus of her work has been systems validation and regulatory compliance. She was recently recognized as a “Quality Star” for her work supporting the validation of systems for a new manufacturing facility in Singapore. In her current position, she works from her home office in Hammonton, NJ for a multi-national pharmaceutical company’s nutrition division.

Fall 2013 Recipients

Ding Ding

Ding Ding received a bachelor’s degree in Chemistry from Peking University in China before coming to the United States to pursue a master's degree in Chemistry from the Catholic University of America in Washington, D.C. Her career in the pharmaceutical industry started as a scientist at DuPont Pharmaceuticals. Upon joining Pfizer, she initially worked as a Bioanalytical Analyst, developing and validating bioanalytical assays for GLP studies and clinical trials for regulatory submissions. She then became a Regulatory Document Specialist, working within the Submission, Toxicokinetic, and Reporting Group focusing on Pharmacokinetics, Dynamic and Metabolism. While working at Pfizer, she received the company's Individual Performance Award eight times, a distinction that recognizes exceptional performance and excellent leadership. Currently enrolled in the QA/RA graduate program, she has already applied her coursework knowledge to the writing of regulatory reports and documents for submission and to the increased awareness of how global clinical trials are conducted. Ding finds the flexibility of the QA/RA program supports her ability to juggle her time between a professional career, family and two small children.

Donald Ertel

Donald Ertel MT(ASCP) is a Regulatory Officer for the Division of Manufacturing and Product Quality at the FDA’s Center for Biologics Research and Evaluation and also a commissioned officer in the United States Public Health Service. LCDR Ertel holds a B.S. Degree in Medical Technology from the University of Maryland. For almost three years, Donald’s primary responsibility at the FDA has been performing scientific regulatory review (CMC) of BLAs, PMAs and supplements. He is a qualified lead inspector for CBER performing pre-license and pre-approval inspections for BLAs and supplements. LCDR Ertel has over 20 years of experience working in Quality Assurance and Compliance in and with regulated industries of Blood Banking & Cell Therapy (prior employment at Johns Hopkins Hospital), Biotechnology, and Pharmaceuticals (prior employment at Shire). When he is not performing duties to promote and protect the health and safety of our nation, Donald is pursuing nonstop activities with his wife and three daughters or his musical endeavors as a tenor in the USPHS Choral Ensemble and bass player. Having received the certificate in Drug Development, Donald is truly grateful and honored to receive this award, and is thrilled to continue his pursuit of the QA/RA Master’s degree at Temple.

Margery Dillenbeck

With an MS degree in both nursing and education, Margery is licensed as a registered professional nurse and as a nurse practitioner in family health. She is also certified as a public school teacher, having majored in Special and Elementary Education. In her professional nursing career, she has achieved Level III critical care nurse status (the highest level of achievement as a staff nurse), which has proved to be invaluable experience for her subsequent work as a member of global product surveillance teams at pharmaceutical companies. In particular, she learned first-hand about the critical importance of diligent investigation of side effects when she served as a contract worker for Bausch & Lomb and witnessed the recall of ReNu ML. Currently, she assesses adverse events for both pre- and post-market products as a Drug Associate for Lundbeck, Inc., which specializes in CNS disorders. Residing in Rochester, NY, with her husband and four children, Margery is pursuing Temple's QA/RA program to enhance her knowledge of pharmacovigilance.

Fall 2012 Recipients

Anshoo Chowdhary

Anshoo Chowdhary earned her BS in Pharmacy from Rofel College of Pharmacy, Veer Narmad South Gujarat University, India, and was awarded the Global Public Foundation Award as well as awards and scholarships for her outstanding academic achievement at the University. She worked on a project regarding COX-2 Inhibitor drugs which was presented at the Indian Pharmaceutical Congress. Prior to coming to the US, she worked in India in the Office of Production at IPCA Laboratories, Ltd, (an US FDA approved pharmaceutical company). There she performed a key role in the Total Quality Management team learning about strict quality standards and GMPs during every step of the drug development process. She has had training in pharmaceutical production in Quality Assurance, Quality Control, and Store Management. She has conducted a seminar on Oral Hypoglycemic Drug – Glimeperide and, while at Temple University, presented a seminar on SiRNA, an upcoming tool in the field of biotechnology. She has also presented a seminar on the implication of cGMPs in the pharmaceutical industry. She is grateful to FDAAA for honoring her with the Centennial Scholarship which will help her broaden her theoretical and practical knowledge. She says the scholarship inspires her to keep working hard to attain excellence in her field and to make a valuable contribution to society.

Boriana Tserovski

After graduating with a B.S. in Genetics and Psychology from Iowa State University, Boriana Tserovski worked as a microbiologist at the Microbial Food Safety Unit at the USDA on a Hatfield Quality Meats project devising processing strategies to detect and eliminate pathogenic bacteria in meats. While subsequently working as a senior microbiologist in biopharmaceutical testing services at CRL, she pursued graduate courses in advanced diagnostic microbiology. Most recently, while raising her family, she enrolled in courses leading to the Drug Development Certificate in Quality Assurance/Regulatory Affairs offered at Temple University School of Pharmacy to stay in touch with the developments in the field as well to gain understanding of the full picture of drug development. After excelling in the courses required for the certificate, she was accepted into the Master’s Program in Quality Assurance and Regulatory Affairs.

Boriana says, "I am deeply honored to receive the FDA Alumni Association Centennial Scholarship and I hope someday to make a contribution to public health worthy of this award. Having gained technical understanding of microbiological quality control in my education and experience, I believe that a quality/regulatory mindset will prepare me to be a part of the industry shift towards microbiological risk assessment and the adoption of new technologies. In light of the many challenges facing the industry in regards to product quality and patient safety, I hope to be part of the effort to enhance the quality of pharmaceutical products."

Donald Ertel

Donald Ertel MT(ASCP) is a Regulatory Officer for the Division of Manufacturing and Product Quality at the FDA’s Center for Biologics Research and Evaluation and also a commissioned officer in the United States Public Health Service. LCDR Ertel holds a B.S. Degree in Medical Technology from the University of Maryland. For almost three years, Donald’s primary responsibility at the FDA has been performing scientific regulatory review (CMC) of BLAs, PMAs and supplements. He is a qualified lead inspector for CBER performing pre-license and pre-approval inspections for BLAs and supplements. LCDR Ertel has over 20 years of experience working in Quality Assurance and Compliance in and with regulated industries of Blood Banking & Cell Therapy (prior employment at Johns Hopkins Hospital), Biotechnology, and Pharmaceuticals (prior employment at Shire). When he is not performing duties to promote and protect the health and safety of our nation, Donald is pursuing nonstop activities with his wife and three daughters or his musical endeavors as a tenor in the USPHS Choral Ensemble and bass player. Having received the certificate in Drug Development, Donald is truly grateful and honored to receive this award, and is thrilled to continue his pursuit of the QA/RA Master’s degree at Temple.

Laxmi Padmini Kasichayanula

Laxmi Padmini Kasichayanula is a trained pharmacist and an active participant in the RAPS NY/NJ Chapter. She holds a RAPS Certificate in Pharmaceutical Regulatory Affairs and is currently pursuing a MS degree in Regulatory Affairs from Temple University. Ms Kasichayanula worked as an Associate Professor in Pharmacology in a recognized pharmacy school in India, where she actively participated in several extramural activities related the role of pharmacy in patient education and disease awareness. She hopes to pursue a career in regulatory affairs and looks forward to gaining expertise in biologics and small molecule regulatory strategy.

Vishalkumar Patel

From India, Mr. Vishalkumar Patel completed his Bachelor of Pharmacy degree from Rajiv Gandhi University BEA school of Pharmacy in 2006. He then earned his Bachelor of Pharmacy Honors degree from Nirma University School of Pharmacy in 2010. Currently he is working as a Pharmacy Graduate Intern, while pursuing his Pharmacy practice license in United States. His professional interests include academia, research, drug regulation and administration which made him pursue the Master of Science in QA/RA at Temple University in 2011. He plans to pursue a career in the pharmaceutical industry. In addition, he has a greater goal to improve access to medicines in developing countries, while also providing health care to underserved areas both in the U.S. and overseas. He wishes to thank the FDAAA for their scholarship and also wishes to thank his family, friends, and mentors for their continued support and encouragement.

Fall 2011 Recipients

Anshoo Chowdhary

Anshoo Chowdhary earned her BS in Pharmacy from Rofel College of Pharmacy, Veer Narmad South Gujarat University, India, and was awarded the Global Public Foundation Award as well as awards and scholarships for her outstanding academic achievement at the University. She worked on a project regarding COX-2 Inhibitor drugs which was presented at the Indian Pharmaceutical Congress. Prior to coming to the US, she worked in India in the Office of Production at IPCA Laboratories, Ltd, (an US FDA approved pharmaceutical company). There she performed a key role in the Total Quality Management team learning about strict quality standards and GMPs during every step of the drug development process. She has had training in pharmaceutical production in Quality Assurance, Quality Control, and Store Management. She has conducted a seminar on Oral Hypoglycemic Drug – Glimeperide and, while at Temple University, presented a seminar on SiRNA, an upcoming tool in the field of biotechnology. She has also presented a seminar on the implication of cGMPs in the pharmaceutical industry. She is grateful to FDAAA for honoring her with the Centennial Scholarship which will help her broaden her theoretical and practical knowledge. She says the scholarship inspires her to keep working hard to attain excellence in her field and to make a valuable contribution to society.

Shannon Shrier

Shannon Shrier has most recently been involved as a Clinical Quality Assurance Auditor, specializing in the detailed review of various types of clinical and regulatory documents generated during the drug development process and FDA submission. She has also held positions in medical device research and development, and in monitoring and auditing all phases of clinical trials. She has always taken great pride in her professional work, but rarely had opportunities to progress in her education. At one of the 2008 Quality Assurance/Regulatory Affairs program’s Open Houses, she learned of the vast range of courses offered in this graduate program and was encouraged by considerations made for full time working students. Returning to the University was a great challenge and required discipline and sacrifice, but she says it has more than paid off. She is proud to have earned A’s in every course completed in the QA/RA Master’s Program. As a result of recent company restructuring, her position was eliminated, and she was forced to put her studies on hold until she learned of the FDAAA Scholarship. Deeply honored to have been awarded this honor, Shannon looks forward to completing her studies in the QA/RA program, leading to the Master of Science degree.

Fall 2010 Recipients

Paul Mouris

After graduating from high school, Paul Mouris enlisted in the United States Navy where he worked as a Nuclear Reactor Mechanic onboard a nuclear powered aircraft carrier. After six years of service, he attended the University of Connecticut from 1997-2003. Putting himself through college without outside help spurred a great appreciation for the value of education. Graduating summa cum laude, with a Doctor of Pharmacy Degree in the spring of 2003, Paul became a licensed pharmacist in Connecticut.

As an Investigator with the Food and Drug Administration in White Plains, NY, for the past six years, Paul inspects pharmaceutical manufacturers to ensure that they are manufacturing safe and effective products in accordance with Current Good Manufacturing Practices. He is committed to staying on the cutting edge of technology and pharmaceutical development.

Paul says that receiving the Centennial Scholarship Award will enable him to continue his studies "to become an even better FDA Investigator" with the goal of achieving a Level III Drug Investigator Certification. His current position familiarizes him with examining a drug for safety after it has been produced, but Temple’s QA/RA master’s program will enable him to learn more about regulatory issues during research and clinical trials. Already matriculated, Paul is starting the QA/RA program this fall.

Update: Paul continues to work as an FDA inspector in NY. He commented, "I am extremely grateful for having been selected for the FDAAA Scholarship for the 2009/2010 school year at Temple University. I continue to take classes toward a Master's in QA/RA. Having to pay for the cost of going back to school on my own, the FDAAA Scholarship helped me out a great deal and will allow me take an extra class during the summer semester to graduate sooner. The classes I take are directly relevant to my job as an FDA Investigator, and I think the knowledge gained from the courses make me a more well rounded Investigator. I recently earned Level 2 Drug Investigator Certification and am striving to become Level 3 Certified, joining FDA's elite Pharmaceutical Inspectorate. I would, once again, like to thank the FDAAA Board for affording me the privilege of being an FDAAA Scholarship recipient."

Poonam Rajput

Poonam Rajput has industry experience in pharmaceutical and clinical research. She has worked as a Clinical Research Associate in various therapeutic areas (Oncology, Diabetes, and Cardiovascular) with PPD and iGATE Clinical Research International. Prior to this, Poonam worked as a Marketing Executive for USV Ltd., GlaxoSmithKline. She handled their Mumbai territory in India, achieving the Best Performance award at USV. With a BS in Pharmacy and a post-graduate Diploma in Clinical Research from India, Poonam is currently pursuing her MS degree in Quality Assurance and Regulatory Affairs from Temple University.

Fall 2009 Recipients

Megan Daly

In 1998 Megan Daly received her Associate of Liberal Arts degree in Biological Science from Montgomery County Community College, PA. She qualified as a Medical Laboratory Technician and received an Associate’s degree in Applied Science in 2001. She then became an analyst performing clinical and forensic toxicological testing in a private laboratory. While employed, she returned to school, enrolling in Gwynedd-Mercy College’s Medical Technology program, completing her internship at a local hospital.

Megan received her B.S. degree in 2005. Continuing employment at a private laboratory, she also worked part time in a nearby hospital’s chemistry laboratory. In 2006 she began teaching in the Phlebotomy Technician Program at Montgomery County Community College. Two years later she worked in the Microbiology Department of a local generic pharmaceutical company. In spring 2009 she enrolled in Temple University’s QA/RA graduate program to attain additional knowledge on how the pharmaceutical industry works. When her employer went through reorganization, she decided to attend classes on a full-time basis.

When Megan reenters the pharmaceutical field she plans to focus on microbiology. The background she is receiving from Temple is providing her with a broader view of the field, introducing her to many aspects of the industry.

Update: The FDAAA Scholarship inspired Megan to apply for and matriculate into the MS in QA/RA program on a full-time basis as of the spring 2010 semester. She continues to enjoy her coursework.

Paul Mouris

After graduating from high school, Paul Mouris enlisted in the United States Navy where he worked as a Nuclear Reactor Mechanic onboard a nuclear powered aircraft carrier. After six years of service, he attended the University of Connecticut from 1997-2003. Putting himself through college without outside help spurred a great appreciation for the value of education. Graduating summa cum laude, with a Doctor of Pharmacy Degree in the spring of 2003, Paul became a licensed pharmacist in Connecticut.

As an Investigator with the Food and Drug Administration in White Plains, NY, for the past six years, Paul inspects pharmaceutical manufacturers to ensure that they are manufacturing safe and effective products in accordance with Current Good Manufacturing Practices. He is committed to staying on the cutting edge of technology and pharmaceutical development.

Paul says that receiving the Centennial Scholarship Award will enable him to continue his studies "to become an even better FDA Investigator" with the goal of achieving a Level III Drug Investigator Certification. His current position familiarizes him with examining a drug for safety after it has been produced, but Temple’s QA/RA master’s program will enable him to learn more about regulatory issues during research and clinical trials. Already matriculated, Paul is starting the QA/RA program this fall.

Update: Paul continues to work as an FDA inspector in NY. He commented, "I am extremely grateful for having been selected for the FDAAA Scholarship for the 2009/2010 school year at Temple University. I continue to take classes toward a Master's in QA/RA. Having to pay for the cost of going back to school on my own, the FDAAA Scholarship helped me out a great deal and will allow me take an extra class during the summer semester to graduate sooner. The classes I take are directly relevant to my job as an FDA Investigator, and I think the knowledge gained from the courses make me a more well rounded Investigator. I recently earned Level 2 Drug Investigator Certification and am striving to become Level 3 Certified, joining FDA's elite Pharmaceutical Inspectorate. I would, once again, like to thank the FDAAA Board for affording me the privilege of being an FDAAA Scholarship recipient."

Troy E. Timbrook

Troy E. Timbrook graduate from Grove City College, OH, in 1991, where he was inducted into Beta Beta Beta National Biology Honorary Society and earned a B.S. in Biology. An active member of the national service fraternity, Alpha Phi Omega (APO), Troy became an advisor of the APO chapter at The Ohio State University. He continued his volunteer APO work as Sectional Chair of Eastern Ohio and was subsequently elected to the national board of directors for two years as a Regional Director. His first professional position was with AmeriFlora’92 as a Volunteer Coordinator, assisting site development. Soon after, he began his sixteen year career with Boehringer Ingelheim Roxane Inc., where he is currently employed. Starting as a Technician in the Quality Assurance Department, Troy was later promoted to Scientist in the Quality Control Department. Troy is matriculated in Temple University’s MS program in QA/RA and nearing completion of his degree. Upon graduating, he hopes to move into the Drug Regulatory Affairs Department, working on submissions of NDAs.

Testimonial from Troy: Troy commented, "The FDAAA scholarship has helped me to finish my degree a year earlier then was originally planned. I was only able to budget one class a semester. The scholarship allowed me to finish my master’s degree in May 2010, since I was able to complete two courses during my final semester. I am very grateful to the FDAAA for their generous scholarship. My MS in QA/RA will enable me to transition my career from QA inspections and QC laboratory testing (which I’ve been doing for 14 years) to applying for new positions in regulatory within the company. Thank you Temple and FDAAA!"

Fall 2008 Recipient

Khyati Dave

Khyati Dave, M.Pharm, is a full time student at Temple University School of Pharmacy, pursuing her master’s degree in Quality Assurance/Regulatory Affairs. She completed the certificate in Pharmaceutical Sciences at Temple, following a master’s degree in Pharmaceutical Sciences and undergraduate studies at Pune University, in India.

Her master’s research in India focused on the effects of various surface-active carriers on the dissolution profile of Valdecoxib. She also researched topics such as formulation and evaluation of fast-dissolving tablets of famotidine, and performed similar studies on extended release matrices for venlafaxine hydrochloride, based on glyceryl behenate and glyceryl palmitostearate. Her publications include two articles covering research in these areas in the Indian journals, Indian Drugs and Eastern Pharmacist.

While in India, Mrs. Dave worked as a Quality Assurance Analyst at Ipca Laboratories, Ltd, drafting Annual Product Reviews (APRs) for various analytical tests. She also performed internal audits of various departments at Ipca Laboratories, Ltd. Currently, she is working as a Research Assistant in the group of Dr. Marc A. Ilies, Temple University, where she synthesizes novel carbonic anhydrase activators and gene delivery agents. Her work on carbonic anhydrase activators was presented as a poster at the 236th American Chemical Society National Meeting, Philadelphia, PA. She also worked with Dr. Robert Raffa on delivery of fluorescent markers in Planarians.

Her future plans include returning to the pharmaceutical industry after graduation to pursue additional research in drug discovery.

Update: Khyati is now working as a Senior Chemist at Merck. She says, "I was very honored and privileged to have received the FDAAA scholarship. It motivated me to work even harder towards earning my MS in QA/RA degree, which certainly helped me in developing my career. After I graduated, I moved into the industry, working in Drug Discovery."

Fall 2007 Recipient

Katherine McKinney

Katherine L. McKinney, PhD, MS, is a Technical Writer and Biochemical Engineer with 11 years of pharmaceutical industry experience. Her background includes preparation and filing of Chemistry, Manufacturing, and Controls (CMC) sections of international regulatory documents (BLAs and INDs) leading to licensure of vaccines or approval to conduct clinical trials as well as an NDA currently under review. Ms. McKinney is a consultant at Hemispherx Biopharma, Inc. (New Brunswick, NJ) preparing CMC and process validation documents. Prior to that she worked at Merck Research Laboratories (West Point, PA) in Bioprocess Research and Development as a Senior Research Biochemical Engineer and Technical Writer. Ms. McKinney earned both her PhD and MS in Chemical Engineering at Rensselaer Polytechnic Institute. She completed her undergraduate work at Columbia University earning a BS in Bioengineering.

Update on her biography: Katherine has worked as a part-time consultant on and off for the last several years, primarily writing CMC sections for New Drug Applications (NDAs) as well as process validation documentation. She is caring for three children between the ages of four and nine, so she plans to continue being a consultant for another two years until all of them are in school for the full day. She states, "The FDAAA scholarship was a great help in allowing me to continue my education in the QA/RA program at Temple. The QA/RA program has helped me to stay current in my field and be able to do the kind of consulting work that I enjoy. The faculty has been outstanding and extremely knowledgeable. I'm looking forward to learning more over the next few years as I complete my Master's degree and transition back to full-time work."

Fall 2006 Recipient

Yevgeny Tkachuk

Yevgeny (Gene) Tkachuk completed a highly selective Physician’s Assistant program overseas, before pursing a Bachelor of Science in Biology at Rutgers University where he participated in laboratory research devoted to the long-term reduction of malaria through genetic studies of disease-transmitting mosquitoes. His findings were presented at the New Jersey Academy of Science in 1994.

Subsequently he joined a management consulting firm where he oversaw an off-shore consulting division developing software applications for U.S. and European clients. Subsequently he was assigned to a division devoted to the development of international clinical research projects. The job entailed extensive coordination with foreign hospitals and regulatory agencies (such as the Russian Ministry of Health), adapting research methodologies, documenting regulatory conformance, and hiring and managing personnel. He quickly assimilated pharmaceutical and clinical trial development in an environment of regulatory adversity and organizational obstacles. In 1999, he earned a Master’s in Business Administration at Farleigh Dickinson University.

In 2004, he became a Research Associate at Hackensack University Medical Center, where he helped pursue the hospital’s goal of elucidating the immunopathological mechanism to prevent graft versus host disease, a major complication of clinical allogeneic hematopoietic cell transplantation. This research utilized animal-to-human translational studies with important oncology applications, taking Gene’s research skills to a higher level, while also providing him with an up-close, practical view of the many facets of drug development.

Gene was the first recipient of the FDAAA Centennial Scholarship in fall 2006. The scholarship enabled him to complete a certificate in Clinical Trial Management. He subsequently received the MS in QA/RA in January 2010 and is currently working as a Services Project Manager for CA, Inc. (an IT company).