The Jie Du Center for Innovation and Excellence for Drug Development promotes innovation in drug development through education, training and mentorship, while fostering collaboration between Pacific students and industrial scientists. Students gain skills in pharmaceutical regulation, entrepreneurship and business to prepare them for navigating the challenges associated with new ventures in drug development.
Each year, hundreds of innovative ideas are assessed by investors for their scientific, clinical, regulatory and business merits, as well as commercial opportunities and limits. To prepare students for successful careers, they need a deep understanding of all aspects of the pharmaceutical and health care technology industries. The Center offers opportunities to take one’s scientific and clinical expertise and complement them with the specialized knowledge and skills that are valued in today’s competitive job market.
In addition to Pacific students, programs offered at the Center are open on a non-credit basis to alumni and scientists currently working in the industry.
We help you develop innovative products for unmet medical needs.
Mission
The Center will help the development of innovative enterprise by providing the tools necessary for the integration of science, technology and entrepreneurship.
Vision
The Center will enable entrepreneurs to achieve dreams that shape the future health care needs of our communities.
with Miki S. Park, PhD and Krishna Devarakonda, PhD, MPharm, FCP
Spring Semester | January 12 - March 29
What role does clinical pharmacology play in drug development? Deepen your understanding of the drug development stages and develop a strategic approach to gathering and decoding real-world data.
$950
12 Week Course, 2-3 Hours Per Week
Lectures on Fridays from 4 – 6 p.m. PST
Impact
This course presents a 360-degree view of the role of clinical pharmacology in the drug development process.
Who should attend?
Entrepreneurs, scientists, pharmacists, and other health care professionals interested in pharmaceutical development.
Introduction to drug development
Regulatory landscape and the role of clinical pharmacology.
Role of pharmacovigilance and drug safety in drug development
Monitoring safety during clinical trials and communication with FDA.
Assessment of risks/benefits
IND/NDA/ANDA submissions and regulatory decision making.
Early and late-stage clinical development
Design of trials (scaling, first-in-human (FIH) and the role of clinical pharmacology in early and late phase drug development.
Clinical studies and clinical pharmacology considerations in special populations
Pediatric, elderly, hepatic and renal patient populations.
Employment/professional opportunities for clinical pharmacologists
Right steps towards a brilliant career.
Role of biomarkers in drug development
Particular references to oncology and rare diseases.
Pharmacogenomics/pharmacogenetics
General principles with a special focus on drug safety.
with S. Prasad Peri, PhD
Spring Semester | January 9 - April 2
How does a new drug get approved? Learn the steps in the path to approval of a new drug product. Decode the science behind each stage of the drug development process.
$950
13 Week Course, 2-3 Hours Per Week
Lectures on Thursdays from 4 PM to 6PM
Impact
Understand the various aspects of drug development and regulatory guidance. Harness the underlying science crucial to each stage of development.
Who should attend
Entrepreneurs, scientists, pharmacists, and other health care professionals interested in pharmaceutical development or are seeking to launch products.
Differentiate IND, NDA and BLA
Understand the nuances of an Investigational New Drug Application, New Drug Application and Biologic License Application.
Understand FDA vs. EMA
Uncover the differences between the U.S. Food and Drug Administration and the European Medicines Agency regulations.
Grasp the different stages of drug development
Deepen your understanding of regulatory guidance at each stage of the drug development process.
Understand in vitro vs. in vivo
Learn the methodologies used for drug release and absorption and how to correlate them.
Contrast drug substance vs. drug product
Understand the stability of a drug substance and of a drug product. Compare the regulations for a drug substance and a drug product. Learn how to establish expiration dates.
Consider immediate release vs. modified release
Describe and differentiate the regulatory guidance on setting specifications immediate release and modified release.
Navigate production
Understand the guidance for formulation, process, scale-up and post approval changes.
Decode the life cycle management of a drug product
Navigate compliance and regulatory challenges.
Additional courses
Summer Semester | Week of April 24 - week of July 17
Learn the marketing components and tools necessary when developing a drug, from early development through the formation of a company. Hear real world examples of applying the principles of product, promotion, price, and place. Learn from case studies the differences between in-licensing and out-licensing. Practice working with a team to develop a pitch deck.
Fall Semester | Week of August 21
This course demystifies business thinking and translates scientific knowledge to entrepreneurial understanding. Understand the elements of starting a company, developing a business plan, deciphering funding cycles. Introduction to legal, accounting and finance partnerships, and other key components for your entrepreneurial goals.
Programs
- Certificate Program (4-12 months)
- Fellowships (6 months)
- Workshops
- Pathway Programs
Facilities
- University of the Pacific
- Incubation Center
- Additional contract laboratories that provide preferred services
Mentorship
- Advisory Board
- Organizations: Pharmaceutical & BioScience Society and Healthcare Businesswomen Association
- Business plan development and assessment
Pharmaceutical entrepreneur and Pacific Regent Jie Du ’90, ’93, PhD donated $5 million to establish the Center. The gift was Powell-matched, doubling the impact of Dr. Du’s gift and resulting in a $10 million endowment.
She earned her master of science and her doctor of philosophy in pharmaceutical sciences from Pacific. After a successful corporate career in the pharmaceutical industry, she founded JDP Therapeutics Inc. and served as its president and CEO until it was acquired in 2019. Under Dr. Du’s leadership, JDP Therapeutics created and developed Quzyttir, and eventually obtained approval from the Food and Drug Administration. Quzyttir is a new therapeutic product for acute allergic reactions, the first innovation in that space since 1955.
Bhaskara R. Jasti ’95, MPharm, PhD, FAAPS, executive director, directs the establishment of the long-term vision and objectives of the Center to achieve its mission.
Dr. Jasti’s two decades of academic and research experience in innovative drug product development includes serving as director of research and development at Corium Technologies as well as dean of graduate studies and associate provost for research at Pacific.
The Center seeks the guidance and expertise of individuals across the spectrum of pharmaceutical development. The advisory board members also serve as mentors for the Center’s students and guest scientists.
Christopher M. Cashman | Chairman, MBF Therapeutics, Inc.
Sharon Clarke | Chief Commercial Officer, Zensights
Jeffrey Cleland, PhD | CEO & Chairman, Ashvattha Therapeutics
Bhaskar Chaudhuri, PhD | Operating Partner, Frazier Life Sciences
Bhaskara R. Jasti ’95, MPharm, PhD | Executive Director, Chair | Professor, Associate Dean of Graduate Education and Research, University of the Pacific
Xiaoling Li, PhD | Ex-Officio Member | Professor, University of the Pacific
Shichang Miao, PhD | Vice President, ChemoCentrix, Inc
Sara Kenkare-Mitra, PhD | President, Head of Research & Development, Alector
Miki Susanto Park, PhD | Professor, University of the Pacific
Linda L. Norton ’91, PharmD | Professor, Department Chair, University of the Pacific
Atefeh Rabiee, PhD | Assistant Professor, University of the Pacific
Sanjeev Redkar, PhD, MBA | President, Apollomics, Inc.
Strategic Partners
The Center is working closely with Pharmaceutical & BioScience Society (PBSS) to provide certification programs in drug discovery and product development. PBSS brings together scientists and other professionals in the life science sector. PBSS has over 5,000 members, with organizations located throughout the U.S. as well as in Canada and Korea.
The Center also partners with Morrison & Foerster LLP for intellectual property protection and Meath & Pereira Attorneys & Counselors for business incorporation support.
Bhaskara R. Jasti ’95, MPharm, PhD, FAAPS
Executive Director, Jie Du Center for Innovation and Excellence for Drug Development
Professor, Pharmaceutics and Medicinal Chemistry
Associate Dean of Graduate Education and Research
jieducenter@pacific.edu | 209.932.3216
