Previous Centennial Scholarship Award Reception
The 5 recipients of full or partial FDAAA scholarships in 2013:
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.
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.
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.
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 of improving access to medicines in developing countries, while also becoming involved in 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.
A Senior Specialist at Accenture (formerly Octagon Research Solutions) in the Regulatory Operations department, Jillian holds a degree in Chemistry with a minor in Mathematics from Lafayette College. For the past five years, Jillian's career work has focused on building eCTD submissions including NDAs, INDs, MAAs, and CTAs. She serves as Project Manager on multiple client projects including eCTD submissions, document formatting, SPL, and submission readiness. Having seen first-hand how adverse events affect patients, she believes patient safety should always be the driving goal during drug development. She says her Temple University classes have given her an overview of the drug development process and enabled her to perceive issues beyond her specific niche. As her company expands globally, she is already putting into practice the principles she has learned in Temple classes. She will finish her Masters in QA/RA in December 2013.
In the fall of 2012, five outstanding FDA employees were selected to receive this prestigious award. Those individuals are:
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).
Boriana Tserovski - After graduating with a B.S. in Genetics and Psychology from Iowa State University, Ms. 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, 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
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.
Anshoo Chowdhary is currently a student at Temple University, pursuing her MS in Quality Assurance and Regulatory Affairs. She did her BS in Pharmacy from India and was awarded with the Global Public Foundation Award and scholarships for an Outstanding Academic achievement at the University. As a pharmacy undergraduate, she always wanted to take her education to next level and increase her abilities through an advance degree and more practical exposures.
Prior to coming to United States, she worked for a Pharmaceutical company in India. There, she performed a key role in the Total Quality Management team and learnt about the strict quality standards, GMPs involved at every step of the drug development. Since then, she had a deep desire to explore more into this field and broaden her knowledge and scope. Hence, after coming to USA she decided to opt for Temple's renowned QA/RA program, to gain the best knowledge of the Quality and Regulatory world.
Vishalkumar Patel - From India, Mr. 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 the 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 of improving access to medicines in developing countries, while also becoming involved in providing health care to underserved areas both in the U.S. and overseas.
In the fall of 2011, the 10th and 11th Scholarship awards were made to the following deserving candidates, Shannon Shrier and Anshoo Chowdhary.
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.
Anshoo Chowdhary earned her BS in Pharmacy from a major university in India, where she earned the Global Public Foundation Award as well as scholarships for outstanding academic achievement. Prior to coming to the US, she worked for a pharmaceutical company in India, where she performed a key role in the Total Quality Management team investigating strict quality standards and GMPs during every step of the drug development process. She is grateful to FDAAA for honoring her with this Scholarship which will help her explore the pharmaceutical field more deeply and 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.
In the fall semester of 2010, Temple University awarded two scholarships. 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. Paul Mouris, being awarded the FDAAA Scholarship for the second time, will be completing the four-course Drug Development certificate at the end of the fall 2010 semester.
The year 2009 resulted in the announcement of three scholarship award recipients. They are; Troy Timbrook, Megan Daly and Paul Mouris. Troy took his BS in Biology to work at AmeriFlora'92 and on to Boehringer Ingelheim Roxane Inc. Upon completion of his MS at Temple, Troy hopes to move out of QA and into DNA submissions. Megan's education path started with a 1998 Associate degree in Biological Science, was followed by an Associate in Applied Science in 01 and culminated with a BS in 05. During this time she worked as a lab tech, a clinical analyst, a private lab analyst, a hospital lab chemist and finally in the Microbiology Dept. of a drug company. Upon completion of Temple's QA/RA graduate program Megan wished to focus on pharmaceutical microbiology. Paul served 6 years in the US Navy before attending the University of Connecticut. In 2003, he graduated summa cum laude with a Doctor of Pharmacy degree. The past 6 years Paul has been an FDA Investigator focusing on the drug industry. Completion of Temple's QA/RA master's program will help him toward his goal "to become an even better FDA Investigator".
In 2008, Khyati Dave, student and research assistant at Temple's School of Pharmacy, was awarded the scholarship. An avid scientist, she left India where she worked as a QA analyst to pursue a master's degree in the pharmaceutical sciences. Learning of Temple's renowned QA/RA program, she committed to paying for courses out-of-pocket in order to become well-versed in US and global regulations.
The following year, the 2007 Centennial Scholarship was awarded to Katherine McKinney, PhD, MS, technical writer and biochemical engineer consulting with Hemispherx Biopharma in preparing CMC and process validation documents. Though she already earned two graduate degrees, she is pursuing Temple's MS in QA/RA to deepen her regulatory knowledge.
The 2006 recipient of the FDAAA Centennial Scholarship was Yevgeny (Gene) Tkachuk, who was a research technician at the Oncology Research Group of the Hackensack University Medical Center. Within a year, he obtained a position as Project Manager for CA Inc., (an IT Management Company). With just three more courses to complete, Gene has nearly reached his goal of a master's degree in QA/RA.