Page 9 - RxBound Winter 2015 Extended
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to the pharmaceutical industry by and gained insight on proposed
enrolling in a two-year, clinical strategies from various sponsors seeking
pharmacology fellowship provided by indications for their antiviral drugs.
Rutgers University and Hoffmann-La Dr. Ayala recently joined the
Roche in New Jersey. He worked with a compliance/enforcement branch in the
team of clinical pharmacologists in Office of Scientific Investigations where
Why WesternU?
“The best thing about WesternU is the duality of its programs when
it comes to learning and practicing. Right from the start, you roll up
your sleeves and begin community and hospital rotations. So you
don’t just sit in class and memorize terms, but you actually go out
there and practice what you learn, as you learn it. This is a great
advantage over other pharmacy programs because you can use your
knowledge by applying it to actual community cases.”
developing oncology drugs. Specifically, he hopes to continue promoting the
he designed four clinical studies in FDA’s mission — to safeguard the
patients with metastatic melanoma, and public — by auditing domestic and
analyzed pharmacokinetic and international facilities who conduct
pharmacodynamic data obtained from bioequivalence studies. His pharmacy
those studies. The most rewarding education from Western University of
aspect of the fellowship was the Health Sciences facilitates his evaluation
opportunity to utilize his pharmacist of bioanalytical practices, reliability and
skills. He determined the adequate dose validity of study data, and compliance
based on the safety and efficacy profile with applicable code of federal
of the drug, the blood sampling scheme regulations. He also spearheads the
to characterize the drug’s creation of compliance program
pharmacokinetics, and patient guidance manuals for the
inclusion/exclusion criteria among other pharmaceutical industry.
elements of study design. The four It has been almost seven years since
studies eventually supported the Dr. Ayala first became interested in
marketing approval of a new oncology research at the Jeffrey Goodman Center.
drug in the United States.
His passion for research led him from
In 2010, Dr. Ayala joined the Office of patient care to his current role in a
Clinical Pharmacology at the US Food regulatory setting. He encountered
and Drug Administration (FDA) and many challenges and opportunities
gained experience in guiding drug along the way, but certain aspects of his
development from a regulatory life remain constant: his pharmacy
perspective. He reviewed investigational training and perseverance to pursue his
new drug (IND) submissions, new drug interests. Dr. Ayala believes that
of the cost originating from medications applications (NDAs), and pediatric pharmacists play a crucial role in drug
alone. Despite the expensive treatment, studies submitted by sponsors in development, and encourages all
1
some patients achieved sustained support of antiviral drugs. Some of his pharmacists to explore career
virologic response after completing their most notable reviews include boceprevir opportunities outside of conventional
48-week regimen. As the clinical rotation for the treatment of HCV and pharmacy.
concluded, Dr. Ayala was determined to tenofovir/emtricitabine for prevention
learn the intricacies of drug development. 1
of HIV infection. As a clinical Evaluation of a Multidisciplinary Treatment Protocol
Shortly after graduation, Dr. Ayala pharmacology reviewer, Dr. Ayala had for Hepatitis C in Patients with HIV Infection,
Ruben Ayala, PharmD, candidate and preceptor
transitioned from a patient care setting oversight of many drug applications James D. Scott, PharmD.
WesternU, College of Pharmacy 7
enrolling in a two-year, clinical strategies from various sponsors seeking
pharmacology fellowship provided by indications for their antiviral drugs.
Rutgers University and Hoffmann-La Dr. Ayala recently joined the
Roche in New Jersey. He worked with a compliance/enforcement branch in the
team of clinical pharmacologists in Office of Scientific Investigations where
Why WesternU?
“The best thing about WesternU is the duality of its programs when
it comes to learning and practicing. Right from the start, you roll up
your sleeves and begin community and hospital rotations. So you
don’t just sit in class and memorize terms, but you actually go out
there and practice what you learn, as you learn it. This is a great
advantage over other pharmacy programs because you can use your
knowledge by applying it to actual community cases.”
developing oncology drugs. Specifically, he hopes to continue promoting the
he designed four clinical studies in FDA’s mission — to safeguard the
patients with metastatic melanoma, and public — by auditing domestic and
analyzed pharmacokinetic and international facilities who conduct
pharmacodynamic data obtained from bioequivalence studies. His pharmacy
those studies. The most rewarding education from Western University of
aspect of the fellowship was the Health Sciences facilitates his evaluation
opportunity to utilize his pharmacist of bioanalytical practices, reliability and
skills. He determined the adequate dose validity of study data, and compliance
based on the safety and efficacy profile with applicable code of federal
of the drug, the blood sampling scheme regulations. He also spearheads the
to characterize the drug’s creation of compliance program
pharmacokinetics, and patient guidance manuals for the
inclusion/exclusion criteria among other pharmaceutical industry.
elements of study design. The four It has been almost seven years since
studies eventually supported the Dr. Ayala first became interested in
marketing approval of a new oncology research at the Jeffrey Goodman Center.
drug in the United States.
His passion for research led him from
In 2010, Dr. Ayala joined the Office of patient care to his current role in a
Clinical Pharmacology at the US Food regulatory setting. He encountered
and Drug Administration (FDA) and many challenges and opportunities
gained experience in guiding drug along the way, but certain aspects of his
development from a regulatory life remain constant: his pharmacy
perspective. He reviewed investigational training and perseverance to pursue his
new drug (IND) submissions, new drug interests. Dr. Ayala believes that
of the cost originating from medications applications (NDAs), and pediatric pharmacists play a crucial role in drug
alone. Despite the expensive treatment, studies submitted by sponsors in development, and encourages all
1
some patients achieved sustained support of antiviral drugs. Some of his pharmacists to explore career
virologic response after completing their most notable reviews include boceprevir opportunities outside of conventional
48-week regimen. As the clinical rotation for the treatment of HCV and pharmacy.
concluded, Dr. Ayala was determined to tenofovir/emtricitabine for prevention
learn the intricacies of drug development. 1
of HIV infection. As a clinical Evaluation of a Multidisciplinary Treatment Protocol
Shortly after graduation, Dr. Ayala pharmacology reviewer, Dr. Ayala had for Hepatitis C in Patients with HIV Infection,
Ruben Ayala, PharmD, candidate and preceptor
transitioned from a patient care setting oversight of many drug applications James D. Scott, PharmD.
WesternU, College of Pharmacy 7
