Temple University School of Pharmacy Brochure

TEMPLE UNIVERSITY

S C H O O L

O F

P H A R M A C Y

Temple University’s School of Pharmacy (TUSP) has emerged as a vibrant center for pharmaceutical education and research in the greater Philadelphia region.

Located in a major, urban, health sciences center, Temple University School of Pharmacy (TUSP) enables its students to draw upon the extensive resources of Temple University Hospital, the Medical and Dental Schools, the College of Health Professions, and the School of Podiatric Medicine. TUSP students are immersed in all aspects of healthcare, experiencing firsthand the critical role that pharmacists and pharmaceutical scientists play in patient care.

For 110 years, TUSP has actively sought and attracted a diverse student population. Each year, over 1,000 students attend TUSP programs to learn from an outstanding faculty of active clinical practitioners and pharmaceutical scientists and professionals. The students’ extensive cultural backgrounds add to the vigorous classroom experience.

Modern technology has now expanded the School’s reach to students in Singapore, Egypt, and India.

With more than 8,000 alumni, TUSP offers the following degree programs: • The Doctor of Pharmacy (PharmD) • The Master of Science (MS) in Quality Assurance/Regulatory Affairs (QA/RA) • The Master of Science (MS) and Doctor of Philosophy (PhD) in Pharmaceutical Sciences with concentrations in Pharmaceutics, Medicinal Chemistry and Pharmacodynamics.

Exciting new research facilities in drug discovery and pharmacogenomics enhance the rich, academic environment available to students at Temple University’s School of Pharmacy.

Academic Programs

Doctor of Pharmacy Program The Doctor of Pharmacy (PharmD) requires a minimum of six years of study: two years of pre-professional education followed by four years of full-time professional education at the School of Pharmacy. The School’s outstanding curriculum unfolds as a continuum of topics ranging from the fundamentals of drug action and dosage form design to the safe and efficacious use of therapeutic agents in patient care. Didactic lectures, small group recitations, compounding labs and patient simulations are integrated with introductory and advanced pharmacy practice experiences. Students may attend seminars, mentorship programs, roundtable discussions, and career days to enhance their knowl-

edge of the many career opportunities of the profession. They may also individualize their education through the use of student portfolios.

The PharmD program enables students to differentiate their degree by taking specialized electives in several tracks, such as Advanced Clinical Practice, Business, Clinical Research, Drug Safety, Nuclear Pharmacy, as well as research elective opportunities in both basic and clinical sciences. These elective tracks help expand career opportunities after graduation.

Master of Science in Quality Assurance/Regulatory Affairs (QA/RA) TUSP’s graduate program in Quality Assurance/Regulatory Affairs is widely recognized as the most comprehensive academic curriculum of its kind, which now includes over 70 course offerings provided by more than 100 industry and FDA instructors, offered in traditional classroom and remote learning formats. The curriculum deepens students’ appreciation of the quality practices of pharmaceutical and related industries, while sharpening their understanding of federal and global regulations. Courses promote interactive discussions and hands-on workshops to enhance

knowledge of the entire drug development process, from discovery to post-marketing approval and safety surveillance.

TUSP has introduced various cutting-edge certificate programs, including Drug Development, Pharmacovigilance, Medical Devices, Clinical Trials, Biosimilars and Generic Drugs, Basic Pharmaceutical Development, and GMPs for the 21st Century. The innovative program in QA/RA is delivered globally to more than 450 students and may be pursued entirely online. All courses are part of a comprehensive approach to instilling QA and RA principles.

MS and PhD in Pharmaceutical Sciences The School offers the following research-based concentrations: • MS and PhD in Pharmaceutical Sciences with concentrations in Medicinal Chemistry, Pharmacodynamics and Pharmaceutics* While taking their course work in the pharmaceutical sciences, students can engage in specialized research at the School’s Moulder Center, the Jayne Haines Center for Pharmacogenomics and Drug Safety, and the TUSP cGMP Facility.

Students are involved in research and discovery in every aspect of the pharmaceutical sciences, including cancer and AIDS research, potential cures for diabetes and Alzheimer’s, and the human genome project. *A non-thesis MS in Pharmaceutics is also available.

The Moulder Center for Drug Discovery Research The Moulder Center for Drug Discovery Research explores every stage of drug discovery for multiple diseases. It includes state-of-the-art medicinal chemistry and screening labs, a 40,000+ compound library for drug screening and optimization, and a computer-aided drug design system for virtual drug screening.

Research is performed by interdisciplinary teams of Temple experts drawn from the School of Pharmacy, the School of Medicine, the College of Science and Technology, and the College of Engineering, making this the first academic

center focused solely on drug discovery in the Greater Philadelphia region. The Center’s extensive facilities and superb research staff have the tools and chemical probes needed for modulating biological targets. The Moulder Center welcomes partnerships with pharmaceutical companies, biotechnology companies, and academic institutions to discover and develop new molecular entities into prospective therapeutic agents. For more information, contact Dr. Magid Abou-Gharbia at aboumag@temple.edu or at 215.707.4949.

cGMP Facility Temple’s cGMP Services produces and packages high quality supplies used in human and veterinary clinical trials. In addition to manufacturing oral capsules, tablets, and powders, the facility creates placebos for clinical trials as well as clinical packaging and labeling. Temple’s cGMP lab enables PharmD students to learn industrial pharmacy in a hands-on production setting; it also allows MS and PhD students to study

process and formulation development, while gaining regulatory expertise. The cGMP lab can assist with study randomization and formulation development for oral solids, oral liquids, topical creams and ointments, and transdermal products. It also provides consultant services for technology transfer and technical operations.

For more information, contact Dr. David Lebo at dlebo@temple.edu or at 215.707.5895.

The Jayne Haines Center for Pharmacogenomics and Drug Safety The goal of the Jayne Haines Center for Pharmacogenomics and Drug Safety is to make the general healthcare community more cognizant of genetic variability as a key risk factor in the treatment of disease. The staff strives to improve medication safety by disseminating knowledge about variations in the human genome, which can dramatically impact individuals’ physiological responses to therapeutic treatment. Research maximizes the efficacy of drug therapy while simultaneously

decreasing potential toxicity. The Center provides students, faculty, and researchers invaluable training and insights into understanding the vital role played by pharmacogenetics and pharmacogenomics. The Center pursues collaborative research with Temple University Hospital and other academic and industry institutions involved in Translational Research. For more information, contact Dr. Evgeny Krynetskiy at ekrynets@ temple.edu or at 215.707.4257.

The Laboratory for Bioanalysis and Pharmacokinetics The Laboratory for Bioanalysis and Pharmacokinetics is a fully functional drug metabolism/ pharmacokinetics (DMPK) facility for internal and external collaborations. Internal research projects include studies on drug metabolism, disposition and transport. Assays available for compound characterization and lead optimiza-

tion include microsomal stability, hepatocyte stability, unbound fraction assays, CYP inhibition, and permeability. In addition, preclinical pharmacokinetic studies in the mouse and rat are available. For more information, contact Dr. Ken Korzekwa at korzekwa@temple.edu or at 215.707.7892.

Temple University’s School of Pharmacy actively seeks international partnerships and collaborative opportunities.

TUSP actively seeks global partnerships with other institutions of higher learning, governments, and corporations: • Opportunities for international students to study at TUSP • 3 + 2 year BS/MS in Pharmaceutics or QA/RA (three years of study at the student’s home institution, followed by two years of study at TUSP leading to a BS and MS degree) • Master’s level work in thesis or non-thesis pharmaceutics programs • PhD work in medicinal chemistry, pharmacodynamics and pharmaceutics • Dedicated Laboratory Training for Students and/or Visiting Scientists: • Drug Discovery Methods (including Drug Design, Parallel Synthesis, Hit to Lead Optimization, and High Throughput Screening) • Solid Dosage Form Development and Manufacturing • Pharmacogenomics, Pharmacogenetics and Pharmacokinetics • Certificate Programs and the MS in Quality Assurance/Regulatory Affairs For over a decade, the QA/RA graduate program has provided high quality remote learning programs to numerous corporate sites throughout the U.S. and across the globe. The program offers short, non-credit seminars for workforce development and also delivers its courses, certificate programs, and the entire MS in QA/RA through videoconferencing or online.

Specialized certificates can be created to suit the unique needs of companies and educational institutions. For more information, contact Wendy Lebing at wlebing@temple.edu or at 267.468.8560.

Thank you for your interest in Temple University’s School of Pharmacy.

Temple University School of Pharmacy 3307 N. Broad Street • Philadelphia, PA 19140 www.temple.edu/pharmacy • 215.707.4990

Temple’s cGMP

cGMP Services

Services produces and packages high quality supplies used in human and veterinary clinical trials.

Designed, implemented, and led by Dr. David Lebo, Temple’s cGMP Services produces and packages high quality clinical supplies used in human and veterinary clinical trials.

The Facility manufactures oral capsules, tablets, and powders. In addition, cGMP Services specializes in creating placebos for clinical trials and also produces packaging and labeling for clinical supplies. The facility is committed to FDA compliance.

The cGMP Lab assists clients with study randomization and formulation development for oral solids, oral liquids, topical creams and ointments, and transdermal products. It provides consultant services for technology transfer and technical operations.

Clients have included Bloomsburg University, the U.S. National Institute of Health, FMC Corporation, NuPathe Technologies, Sheppard Pratt, and the University of Texas Southwestern Medical Center.

Temple’s cGMP Facility enables PharmD students to learn industrial pharmacy in a hands-on production setting; it also allows MS and PhD students to study process and formulation development, while gaining regulatory expertise. All collected fees help fund graduate student education at Temple’s School of Pharmacy.

Services Offered Production of Tablets and Capsules Packaging of Clinical Supplies Formulation Development for: Oral Solids Oral Liquids Topical Creams and Ointments Transdermal Products

Labeling of Clinical Supplies Study Randomization Consultant Services for: Technology Transfer Formulation Development Technical Operations

About The Director David B. Lebo, RPh, PhD Director of cGMP Services School of Pharmacy Temple University Dr. Lebo has more than eight years of industrial pharmacy experience in positions covering preformulation, formulation development, technical operations, and drug delivery. He received his degrees from the University of the Sciences (Philadelphia) and currently serves as Director of cGMP Services at Temple University’s School of Pharmacy, responsible for the design, implementation, and operation of a compliant cGMP facility. With research interests in the physical chemical aspects of solubility enhancement, he is a frequent lecturer in the School’s graduate pharmaceutics program.

GMP Equipment Equipment/Use

Manufacturer

Dissolution bath Friability tester UV/Vis Spectrophotometer Balances Capsule filler V-blender Analytical balance Tablet press Tray dryer HPLC Side-bi-side Diffusion Cells for iontophoresis Hardness tester

Vankel Dr. Schleuniger Pharmatron Hewlett-Packard Sartorius, Mettler Toledo Dott. Bonapace & Co. Globe Pharma, Inc. Denver Instrument Globe Pharma, Inc. Vanguard Pharmaceutical Machinery, Inc. Hewlett-Packard PermeGear

For more information: Dr. David Lebo, Director, cGMP Services Temple University School of Pharmacy 3307 N Broad Street, Philadelphia, PA 19140 http://www.temple.edu/pharmacy/about/cgmp.html david.lebo@temple.edu • 215.707.5895

Dr. Schleuniger Pharmatron

Temple’s Drug Discovery program provides faculty, recent graduate students and new industrial scientists with critical information that will contribute to the success of their research in the modern age of drug discovery.

The Moulder Center for Drug Discovery Research Dedicated on May 14, 2009, the Moulder Center for Drug Discovery Research of Temple University School of Pharmacy is equipped with cutting-edge facilities and staffed by a dedicated team of talented scientists. Their goal is to promote collaborative research that facilitates the discovery and development of novel therapeutic agents to improve the health and life of patients.

Within Temple, the Moulder Center serves as a multidisciplinary research hub for the further development of scientific discoveries identified by University faculty and scientists, enabling their research to move beyond the lab and into the broader research community. Yet the Center also promotes numerous partnerships in collaborative research opportunities with other academic institutions and pharmaceutical and biotechnology companies in the U.S. and abroad.

The Center explores every stage of drug discovery for multiple diseases by utilizing interdisciplinary teams of Temple experts drawn from the School of Pharmacy, the School of Medicine, the College of Science and Technology, and the College of Engineering. Facilities include vibrant medicinal chemistry and screening labs, a 40,000+ compound library for drug screening and optimization, and a computer-aided drug design system for virtual drug screening.

For more information, contact Dr. Magid Abou-Gharbia at aboumag@temple.edu or at 215-707-4949.

Magid Abou-Gharbia, Ph.D., FRSC

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Associate Dean For Research Prior to joining Temple University in 2008, Dr. Abou-Gharbia spent 26 years working in drug discovery research. During his tenure at Wyeth, he advanced to levels of higher responsibility, becoming Senior Vice President.

Under his leadership, his research group made numerous contributions in drug discovery which resulted in six marketed drugs and many drug candidates which advanced to clinical evaluation. Dr. AbouGharbia’s work at Wyeth resulted in 100 U.S. and over 350 worldwide patents. He has written over 225 publications and is a highly sought lecturer and presenter. For more information about the Moulder Center visit: http://moulder.temple.edu/.

For More Information: Dr. Magid Abou-Gharbia, Associate Dean for Research Temple University School of Pharmacy 3307 North Broad Street Philadelphia, PA 19140 USA Email: aboumag@temple.edu Phone: 215-707-4949

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TUSP has emerged as one of the most vibrant centers of education and research in the pharmaceutical sciences in the Philadelphia region.

Graduate Programs in the Pharmaceutical Sciences Temple University’s School of Pharmacy (TUSP) offers a dynamic curriculum taught by academic and industry experts who teach the most progressive advances in the field.

Our graduate programs foster a deep understanding and practical application of key disciplinary principles, including • drug action (pharmacodynamics), • drug synthesis (medicinal chemistry), • drug metabolism and disposition (pharmacokinetics, metabolism, and genetic predisposition), • drug delivery (pharmaceutics), • drug regulation, quality, and safety (quality assurance/regulatory affairs).

At TUSP students experience a multidisciplinary approach to learning, which blends classroom teaching, laboratory research, and experiential learning in the epicenter of the East Coast’s pharmaceutical industry. Our courses expose students to every aspect of the discovery, action, utilization, and evaluation of therapeutic agents, helping them to develop into promising research scientists or professionals in industry or academia.

Career Opportunities A graduate degree in pharmaceutical sciences opens the doors for a variety of career opportunities. Many TUSP graduates have pursued research and regulatory careers in the pharmaceutical industry (including Pfizer, Merck, Bristol-Myers Squibb, AstraZeneca, Novartis, Boehringer-Ingelheim, and numerous other companies). Other graduates have accepted faculty or postdoctoral positions at top academic institutions (including Harvard University, Washington University, Fox Chase Cancer Center, Florida A&M University, and Tufts University). Others have sought careers in the government, including the U.S. Food and Drug Administration.

For more information: Dr. Caniel Canney, Director of Graduate Studies Temple University School of Pharmacy Pharmaceutical Sciences Department 3307 North Broad Street, Suite 520B Philadelphia, PA 19140 USA Email: phscgrad@temple.edu Phone: 215.707.4948 • Fax: 215.707.5620 www.temple.edu/pharmacy/programs/Graduate.html

Programs

Choose from thesis-based or non-thesis based degree programs:

THESIS-BASED PROGRAMS (MS or PhD) These full-time programs lead to an MS (30 didactic and 6 research credits) or PhD (40 didactic and 12 research credits) in: • Medicinal Chemistry/Drug Discovery • Pharmaceutics • Pharmacodynamics THESIS-BASED PROGRAMS (MS and PhD) Thesis-based MS and PhD students pursue courses and research full-time at the Pharmacy School, using resources of the University’s Health Science Campus, including Temple University’s Hospital, Medical and Dental Schools, College of Health Professions, and School of Podiatric Medicine. In-depth research may be pursued at the Pharmacy School’s unique facilities, including: • the Moulder Center for Drug Discovery Research • the Jayne Haines Center for Pharmacogenomics and Drug Safety • the Laboratory for Bioanalysis and Pharmacokinetics • the cGMP Facility.

Breakthroughs are explored in many areas, including cancer, AIDS, diabetes, Alzheimer’s, and the human genome. The curriculum integrates three main areas of pharmaceutical science: medicinal chemistry, pharmaceutics, and pharmacodynamics.

Financial support in the form of teaching assistantships, research assistantships, and University Fellowships is available on a competitive basis to incoming PhD students.

NON-THESIS BASED PROGRAMS (PART-TIME MS) Designed for working professionals, these part-time programs lead to an MS degree (36 credits). Certificates (12 – 15 credits) are also available.

• Non-thesis MS in Pharmaceutics • MS in Quality Assurance/Regulatory Affairs (QA/RA) Pharmaceutics courses are taught by TUSP graduate faculty and industry experts in drug discovery and development, regulatory affairs, manufacturing and validation. Courses are conveniently scheduled on weeknights and weekends and can be videoconferenced to corporate sites nationally and internationally. Some courses are also available online.

Non-Thesis MS in Pharmaceutics: Addressing the needs of highly-skilled, technically-trained professionals with undergraduate or graduate science backgrounds, the Non-Thesis MS helps pharmacists, bench scientists, and laboratory technicians to expand career opportunities. Courses in Quality Assurance/Regulatory Affairs (QA/RA) blend the pharmaceutical sciences with the industry’s regulatory milieu. Learning advanced pharmaceutical sciences enables students to make valuable contributions to company projects while being cognizant of regulatory requirements.

A four-course certificate is available.

Non-thesis MS in QA/RA: Temple University’s School of Pharmacy pioneered the first graduate curriculum in QA/RA in the world in 1968. Over the last four decades, the School has fostered a strong relationship with the U.S. FDA and pharmaceutical industry. The QA/RA curriculum features over 60 courses on the latest quality practices and regulatory principles for beginning, midlevel, and veteran industry and FDA officials. The program is delivered locally, nationally, and internationally.

Eight certificates are available.

For additional information, please refer to the separate brochure on the QA/RA program or visit www.temple.edu/pharmacy_QARA.

Faculty Research Interests Drug design, discovery, and lead optimization, including: Synthesis of small molecule therapies in multiple diseases as lead drug candidates and as chemical probes to test biological hypotheses; structure Activity Relationships (SAR) studies involving ligands for pharmacologically relevant targets; selective enzyme inhibitors/ activators; Investigation of disease areas (such as neurodegenerative diseases, epilepsy, Alzheimer’s); and bio-organic/medicinal chemistry at membrane interfaces.

Screening methodologies and assay development for drug discovery, including: Cellular/molecular markers; allosteric modulators and biased ligands of G-protein coupled receptors; and molecular pharmacology.

Human pharmacokinetic predictions, including: Drug and xenobiotic metabolism; New technology platforms for multifunctional therapeutics

Role of pharmacogenetics in inter-individual variability of drug response, disease risk and incidence, including: Genetic polymorphism of drug-metabolizing enzymes; genotypephenotype associations; and drug targets that determine variations in drug response.

Formulation and development aspects of drug delivery systems based on drugs’ physical-chemical properties, including: Design of modified and novel drug delivery systems; nonomedicine to improve therapeutic efficiency of anticancer compounds; biopharmaceutics; and novel drug/gene delivery systems.

Theoretical pharmacology, including: Thermodynamics of drug-receptor interactions; synergistic drug interactions; opioid analgesitcs: evaluation, tolerance and dependence; pharmacological basis underlying preclinical effects of opioids, hallucinogens, antidepressants, antiobesity agents and antipsychotics; and behavioral pharmacology of opioids, serotonergics, chemotherapeutics, and cannabinoids.

Temple University’s innovative QA/RA

Graduate Program in Quality Assurance/Regulatory Affairs (QA/RA)

graduate program is a hands-on, industry-focused curriculum that prepares students for the global pharmaceutical market.

Master of Science (MS) in Quality Assurance/Regulatory Affairs (QA/RA) Established in 1968, the graduate program in QA/RA of Temple University's School of Pharmacy (TUSP) is widely recognized as the oldest and most comprehensive academic curriculum of its kind in the world. Advances in technology during the past decade now enable Temple to deliver the QA/RA program locally, nationally, and internationally.

• Offers more than 70 courses taught by over 100 U.S. industry and FDA instructors • Teaches current practices in numerous industry disciplines • Focuses on the critical need to adhere to U.S. and global quality practices and regulatory requirements • Provides a broad understanding of the global pharmaceutical industry • Promotes interactive/hands-on workshops in classes • Covers the entire drug development process • Accepts beginning, mid-career and veteran industry professionals • Offers evening, weekend, and morning classes

Course Delivery Temple’s QA/RA courses are offered in various formats: • Traditional classroom instruction at Fort Washington (PA), Frazer (PA), and Tarrytown (NY) • Intensive classroom instruction at pharmaceutical companies • Videoconferencing from Temple U to corporate sites and educational institutions • Quality online learning through an interactive format in real-time Short, non-credit seminars for workforce development are also available.

Master of Science • Twelve courses (4 required/8 electives) • Required courses: Drug Development; Food and Drug Law I; a Good Practices Course; Choice of Quality Audit or Investigational New Drug/New Drug Application (IND/NDA Submissions) • Eight elective courses from a variety of career tracks: Drug Discovery • Manufacturing • Compliance Clinical Trials • Global Regulatory Affairs Validation • Quality Assurance • Medical Devices Pharmacovigilance • Generic Drugs

Certificates Eight certificate programs are offered in the QA/RA graduate program: • Drug Development • Global Pharmacovigilance • Medical Devices • Clinical Trials • Biosimilars and Generic Drugs • Basic Pharmaceutical Development • GMPs for the 21st Century • Post Master’s Certificates in Advanced QA and RA

Students can complete a 4 or 5 course certificate and then apply all credits earned towards completion of the MS degree, if they are accepted for matriculation. Students focus on a specific aspect of the industry in a condensed period of time, mastering the skills needed to excel in a particular field. Specialized certificates can be created to suit the unique needs of an organization. The program also creates and delivers short, non-credit seminars for workforce development.

Quality Online Learning QA/RA offers over 30 online courses: • You can complete most certificates • You can complete the entire MS degree • You can pursue Post-Master's Certificates in Advanced QA or RA Online classes offer the same academic standards and hands-on learning that make Temple's graduate program in QA/RA the best of its kind.

Offering online classes since Fall 2006, the faculty are comfortable with the technology; the University provides 24-hour technical support; and the QA/RA staff is supportive of students' concerns.

International Partnerships For over a decade, the QA/RA graduate program has provided high quality remote learning programs to numerous U.S. corporate sites.

Since January 2009, TUSP has delivered courses and certificates though videoconferencing and online learning to the National University of Singapore, one of the world's top institutions of higher learning.

The QA/RA program actively seeks global partnerships with institutions of higher learning, governments, and corporations. Through videoconferencing or online technology, TUSP can: • provide non-credit courses for workforce development • deliver QA/RA graduate courses or certificate programs • create new certificates to meet workforce needs • deliver the entire QA/RA MS degree

For additional information: Temple University School of Pharmacy QA/RA Graduate Program Wendy Lebing, Assistant Dean 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 www.temple.edu/pharmacy_qara qara@temple.edu 267.468.8560

Temple University School of Pharmacy 3307 N. Broad Street Philadelphia, PA 19140 www.temple.edu/pharmacy 215.707.4990