Fellows, Meet Your Greatest Supporters
Founded in 1905, the USC School of Pharmacy is the first and foremost pharmacy school in Southern California. Recognized as one of the most innovative schools of pharmacy in the nation, the USC School of Pharmacy has served as a model for other progressive pharmacy schools throughout the country. The Pharm.D. program offered by the USC School of Pharmacy paves the groundwork of a clinical therapeutic understanding for Pharm.D. graduates who desire a career in the biopharmaceutical industry.
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. In making this commitment, we work to develop an unparalleled level of insight into patients' wants and needs — and into the priorities and concerns of the medical specialists who treat them. For nearly 60 years, Allergan has been committed to the health, safety, and well-being of the people who put their trust in our products. Every day, we strive to better people's lives in a wide range of ways — from developing new treatments for complex and disabling medical conditions to offering science-based medical aesthetic solutions.
Allergan and the University of Southern California School of Pharmacy team up to give you a distinctive fellowship advantage – a unique environment that expands your potential and optimizes your career. This is the promise that Allergan and the USC School of Pharmacy make to our fellows.
The Allergan-USC Pharmaceutical Industry Fellowship Advantage
At the end of the fellowship, a fellow should be proficient or have had experience in the following areas, depending upon the department and projects chosen:
- Insider’s look and team member’s approach to what it takes to be successful in industry.
- Depth and breadth of industry experience.
- Hands-on opportunity in three thriving areas – biologics, pharmaceuticals and devices – rarely found under “one roof”.
- Forefront of thriving Southern California pharmaceutical and biotech industry – capital of the Pacific Rim.
- Networking in one of nation’s hottest markets – punctuated by California’s global leadership position in stem cell research.
Regulatory Affairs and Drug Development
Operating with health authorities around the world, the Regulatory Affairs & Drug Development Fellowship offers either a one or two-year program focusing on developing regulatory strategies, understanding global regulatory requirements and completing global regulatory documents.
Allergan’s Regulatory Affairs group constructs a strategic approach that ensures the acceptance of investigational and marketing applications by global regulatory health authorities. As a fellow, you gain cross-functional experience as the department provides guidance to the discovery, development, registration, and life cycle enhancement processes of a drug by analyzing worldwide health agency requirements, guidelines, regulations, and competitor’s programs. You’re part of the group that coordinates the submission of key global regulatory documents including investigational applications for a new drug or clinical use, marketing authorizations, post approval changes, and regulatory maintenance activities (e.g., annual reports) in electronic Common Technical Document (eCTD) format.
Activities and Responsibilities
The Regulatory Affairs fellowship emphasizes:
- Drug product optimization, including the clinical, chemistry, manufacturing, control, and toxicology studies needed to meet global regulations
- Product information including Allergan drug development, pertinent global regulatory policies, guidance, and International Conference on Harmonization documents
- Drug development team meetings for investigational and marketed products in various stages of development
- Teamwork within a multifaceted department, which includes regulatory strategy, chemistry and manufacturing and control, pharmacovigiliance, risk management and epidemiology, regulatory operations and intelligence, electronic submissions, and publishing
- Attendance at various pharmacy and industry conferences
Global Pharmaceutical Sciences
This one-year fellowship provides a hands-on experience with the Global Pharmaceutical Sciences group that develops and produces clinical supplies from the moment the product enters human trials to the point of commercialization. Fellows are involved in developing manufacturing procedures and analytical methods,constructing regulatory submission documentation, and fostering rapid assessment of drug candidates.
Through the group’s work, you gain exposure in various aspects of chemistry, manufacturing, and control (CMC), including quality assurance, quality control, validation, and facility/equipment/instrumentation services. You learn about a wide array of regulatory, quality, and operational aspects of drug development, manufacturing, and release.
Activities and Responsibilities
The Global Pharmaceutical Sciences fellowship emphasizes:
- Assembly and management of regulatory documents in eCTD format that meet FDA standards
- Interaction with Global Regulatory Affairs, Clinical Development, Project Management, Clinical Manufacturing, Method Development, Process Development, Analytical Testing, Research and Development, Drug Safety, Toxicology, Clinical Pharmacokinetics, Labeling, Quality Assurance, Publishing, and Marketing to discuss issues specific to Pharmaceutical Sciences, and enhance the practical application of the information acquired
- Review and discussion of analytical method development, validation, and implementation with CMC team leaders and analytical scientists
- Attendance at various pharmacy and industry conferences
Clinical Pharmacology and Quantitative Sciences
This one-year fellowship provides an understanding of the challenges that the modern pharmaceutical industry faces in developing new drug products and how clinical pharmacology principles are applied to support the expensive, long, complex, but rewarding journey of drug development. Fellows develop a thorough understanding of therapeutic areas and are able to devise appropriate strategies for each area, paying special attention to trial design, interaction with investigators, and ethical and legal issues. The ultimate goal of the program is to make the fellow a competent drug developer, a good clinical investigator, a capable overseer of clinical trials with a keen understanding of safety issues.
Clinical pharmacology fellows arrive with good skills and complete the program with stellar skills. After a two-month ramping up time, you’re ready to really contribute to the team – working with R&D project teams, assisting in the transition of the compound from non-clinical to clinical development by providing scientific and operational expertise. With the rest of the team, you generate phase, compound, and indication-appropriate data to support key decision-making in early development, considering dose response based on non-clinical/clinical pharmacokinetics, tolerability, biomarkers, safety profiles, pharmacodynamics, pharmacogenomics, the role of demographic factors and other variables affecting drug response and systemic drug exposure.
The Clinical Pharmacology Fellowship also offers a second track, focusing on the quantitative aspects of clinical modeling. Fellows pursue computer modeling, simulations and data analysis. Quantitative track candidates should have either a Pharm.D. or Ph.D. for consideration in this program.
Activities and Responsibilities
- Understanding the road map of new drug discovery and development.
- Strategic approach to clinical pharmacology, including a fellow-led project focusing on the compound of interest.
- Processes of conducting clinical pharmacology studies in humans with a specific application of accepted Good Clinical Practices and their application to the conduct of human studies.
- In-depth look at pharmacokinetic and pharmacodynamic principles including analysis of the type of clinical pharmacokinetic, drug metabolism,immunogenicity and pharmacodynamic data that are generated and the impact of these data on decision making.
- Determining genotype and biomarkers in humans requiring knowledge of necessary laboratory support and the attendant information provided to clinical pharmacology by the lab (ie, drug concentration measurements, genotype and biomarker determinants in humans).
- Recognition of the total team approach to the discovery and development of a new drug – including discovery, clinical research, regulatory, clinical pharmacology, pharmaceutical science and drug safety.
Pharmaceutical Development
This one-year fellowship provides an excellent opportunity for PhD holders to develop a research edge in the marketplace and a savvy knowledge of how the industry works. Fellows are exposed to groups that deal with physical chemistry, early drug formulations, product formulations, manufacturing processes, drug delivery, device and packaging, analytical sciences and applied microbiology.
The Pharmaceutical Development Fellowship offers two distinct tracks: one focusing on drug delivery research and development that requires a PhD in pharmacology, pharmaceutical sciences, polymer chemistry or equivalent from an accredited university, The other track is looking at the design of devices, packaging and process development using computational and laboratory techniques that requires a Ph.D. from an accredited engineering program (chemical, mechanical or polymer) or equivalent.
Activities and Responsibilities
- All steps required to transform an active substance into a dosage form accessible to patients.
- Understanding physical and chemical properties of the drug and drug delivery systems.
- Manufacturing process development, packaging issues to ensure product integrity, and shipping protocols.
- Bi-weekly meetings, sharing knowledge with other scientists as discussions focus on work underway to provide patients with products that are safe, of the highest quality and provide the most benefit.
- Quarterly seminar series participation
Admission
Applicant Requirements
- Doctor of Pharmacy degree from an accredited college of pharmacy or the equivalent. Completion of a Masters of Regulatory Science, pharmacy industry track courses, and industry internships are desirable.
- Applicants are expected to devote some time to instruction and other educational activities at the USC School of Pharmacy. These activities include participating in appropriate graduate coursework and teaching staff, pharmacy students, and graduate students in Regulatory Affairs related issues. Specific teaching activities may include providing presentation to staff, precepting fourth year pharmacy clerkship students, or acting as a teaching assistant for evening and weekend courses offered in the USC Masters of Regulatory Sciences program.
- Meeting attendance, timely completion of assigned projects, good oral and written communication skills, ethics, professionalism, and an interest in biopharmaceutical industry are required for the position.
Information and How to Apply
William C. Gong, Pharm.D., FASHP
Associate Professor of Clinical Pharmacy
Director, Residency & Fellowship Training
University of Southern California School of Pharmacy
1985 Zonal Avenue
Los Angeles, CA 90089-9121
(323) 442-2625
Res-Fellow@pharmacy.usc.edu