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  • Berkeley Global

The Drug Development Process: An Intensive Seminar

PB HLTH 1023

41804
Delivery Options Online

Get a detailed picture of all aspects of the complex and highly interrelated activities involved in bringing a pharmaceutical discovery to approval and market. Although the focus is on pharmaceuticals, seminar discussions also integrate biologics, diagnostics and devices. This course is designed for executives, disciplinary experts who wish to broaden and advance their careers, nontechnical professionals, investors, and others interested in fully understanding the biopharmaceutical industry.

Class discussions are guided by experts with years of hands-on experience with large and small pharmaceutical, biotechnology and related companies. Seminar topics include industry environment, discovery and pharmacology, chemistry manufacturing and controls (CMC), toxicology, pharmacokinetics, program management, Food and Drug Administration (FDA) inspections, biologics, assays and devices, clinical trial design and conduct, clinical trial statistics, pharmacogenomics, FDA compliance regulations, patents and intellectual property, and commercial development.

How You Can Benefit From This Course

Understand the processes that are vital to successfully bringing a biotechnology product to market. Recognize the critical roles of each company unit, and gain insight into the integrated and multifunctional nature of drug development. Interact with experts and colleagues from a wide range of disciplines in the biopharmaceutical industry. Leave with knowledge of the entire process, enabling you to understand industry terminology and work more effectively in multidisciplinary teams.

Schedule (tentative)

Day 1: 8:30 am–5:30 pm

  • Welcome and introductions
  • Industry environment
  • IND/NDA documents
  • Introduction to case studies

Day 2: 8:30 am–5:30 pm

  • Drug discovery
  • CMC/pharmaceutical development
  • Toxicology
  • Regulatory affairs and approval process
  • Case study presentation and discussion

Day 3: 8:30 am–5 pm

  • Pharmacokinetics and metabolism
  • Project management concepts
  • Pharmacogenomics
  • Assays, devices and diagnostics
  • Case study presentation and discussion

Day 4: 8:30 am–5:30 pm

  • QA/QC and compliance
  • Clinical development
  • Clinical trial design and statistics
  • The FDA perspective on bioresearch monitoring (BIMO)
  • Case study presentation and discussion

Day 5: 8:30 am–1:00 pm

  • Biologics and biopharmaceuticals
  • Commercial development
  • Patents and intellectual property
  • Business planning and commercial development
  • Case study presentation and discussion
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Sections

Section 020

Apr 18, 2022 to Apr 22, 2022 Live Online

Course Fee(s)

Course Fee non-credit

$2,700.00

Section Schedule

Apr 18, 2022 to Apr 22, 2022

Type Live Online

Live Online courses provide an interactive learning experience with scheduled synchronous online sessions held via Zoom video conferencing (Pacific Time). As with courses held in person, the teaching methods for Live Online courses emphasize lectures, demonstrations, group discussions and collaborative activities. You should be prepared to attend every session and engage in class via webcam. Live Online format allows you to take classes from anywhere with an internet connection.

Learn more about the Live Online format.

You must have a Zoom account to participate.

Many schools are now accepting transfer credit for online coursework, including health and sciences programs. Check with your institution before enrolling.

Days

M, T, W, Th

Time

8:30AM to 5:30PM Pacific Time

Dates

Apr 18, 2022 to Apr 21, 2022

Type Live Online

Days

F

Time

8:30AM to 1:00PM Pacific Time

Dates

Apr 22, 2022

Schedule and Location

View Details

Instructional Hours

36.00

Location

Live Online

Delivery Options

Online

CEUs

3.6 CEUs

Instructors

  • Aditya Das
  • Dragana Antic
  • Dan Klassen
  • Natalie McClure
  • Melanie Morrison
  • Thomas Renau

Section Notes

Monday - Thursday:  Class hour 8:30 am to 5:30 pm

Friday (Last class meeting): Class hour 8:30 am - 1:00 pm.

This course applies to the following programs:

Certificate Program in Clinical Research Conduct and Management

Expand or collapse section

Required Courses

  • Introduction to Clinical Research: Clinical Trial Phases and Design
  • Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities
  • Clinical Trial Implementation: Site Initiation, Subject Recruitment, Monitoring and Safety Reporting
  • Clinical Trial: Data Analysis, Regulatory Audits, Vendor Selection and Project Management

Courses of Related Interest

  • Pharmacology
  • Genomic Medicine
  • Principles of Toxicology
  • Introduction to Biostatistics
  • The Drug Development Process: An Intensive Seminar
  • Principles of Product and Process Development
  • Principles of Quality and Compliance

Learn More About this Program

Notes

Departmental contact for academic questions: biotech_online@berkeley.edu | (510) 642-1062

English Language Proficiency Requirements

All of our courses are taught in English. If English is not your first language, please use the following test scores as guides in order to be successful:

  • TOEFL: 90
  • IELTS Academic Format: 7
  • DAAD: C1
  • TEM-4 or TEM-8: Level 70

Note: You do not need to submit test scores.

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PB HLTH 1023 - 020 - The Drug Development Process: An Intensive Seminar

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CEUs

The continuing education unit (CEU) is a nationally recognized means to document participation in organized non-credit continuing education. One CEU is defined as 10 contact hours of participation in organized continuing education under qualified instruction. The CEU provides a vehicle for employers, professional groups, and licensing agencies to account for participation in non-credit seminars, workshops, and courses.

Aditya Das

Aditya Das, M.B.A., Ph.D., is a founder and principal at Pharmaceutical Consulting LLC. He has 30 years experience in the U.S. biopharmaceutical industry focused on combination product therapeutic strategies for the treatment of infectious, genetic, allergic, metabolic, oncologic and cardiovascular disease. He assisted in the successful submission and marketing of Dry Powder Inhaled Insulin (Exubera, approved by EMA and FDA in 2006), Thermal Aerosol Vapor Staccato Loxapine (Adasuve, approved by FDA and EMA in 2012 and 2013, respectively) and Dry Powder Inhaled Tobramycin Sulfate (Tobi PodHaler, approved by FDA in 2013). His background in drug product development and commercialization and CMC strategies and submissions involves multiple global regulatory agencies.

Dragana Antic

Dragana Antic has a bachelor's degree in molecular biology and physiology and a Ph.D. in molecular virology and immunology from the University of Ottawa. She pursued postdoctoral studies at Duke Medical Center, investigating roles of mRNA binding proteins in mRNA metabolism and regulation of cell growth and differentiation. As a research scientist at Stanford University, she investigated genetic regulation of development and morphogenesis, focusing on a signaling pathway that controls polarity of epithelial cells within the plane of the epithelium using the fruitfly and mouse model systems. In 2010, Antic joined OncoMed Pharmaceuticals, where she led target discovery and validation projects in cancer stem cells and in immune-oncology. She brings extensive multidisciplinary research experience to the classroom and is passionate about teaching and mentoring students, and encouraging them to develop interdisciplinary and critical-thinking skills.

Dan Klassen

Dan Klassen is an expert in the field of sterile injectable pharmaceutical and biotechnological drug products with more than 30 years of industry experience in Regulatory Affairs, Regulatory Compliance and Quality Assurance. He assists with and advises companies on Regulatory Submissions; Regulatory Compliance; Inspections; Regulatory Authority Meetings; Crisis Management; and Remediation situations. Dan specializes in current Good Manufacturing Practice (cGMP); Chemistry, Manufacturing, and Controls (CMC), Regulatory Compliance, Inspection Management, and cGMP Training. He has been involved in the submission of hundreds of IND, BLA, NDA, and DMF applications; has extensive experience in FDA and foreign regulatory authority inspections; and has conducted manufacturing, laboratory, and supplier cGMP audits in the U.S. as well as internationally.  He has participated as guest lecturer for University of Southern California, School of Pharmacy, Master of Regulatory Science program.

Natalie McClure

Dr. Natalie McClure is a regulatory affairs consultant with extensive experience in drug development, regulatory affairs and quality assurance.  She has filed more than 50 INDs, and CTAs and supervised regulatory affairs and clinical research for clinical trials in the US, Canada, Western Europe, Eastern Europe, Russia, India, and China. Natalie has directed drug development programs for new chemical entities and controlled release dosage forms. 

Dr. McClure obtained her PhD in Organic Chemistry from Stanford University and BS in Chemistry from the University of Michigan and then spent 10 years working for Syntex Research working in the process development laboratories on new synthetic approaches to prostaglandins and large scale peptide synthesis. Over the past 30 years, Natalie has worked with multiple small companies to establish their internal regulatory affairs and quality assurance systems.

Melanie Morrison

Melanie Morrison is Chief of Staff to the CMO and Vice President, Process Optimization at Aduro Biotech.  She served previously as VP, Oncology Platform Lead at Immune Design leading the project leadership, management, and clinical operations functions.  As Medivation’s VP, Clinical Operations, she oversaw the development and execution of clinical development plans, and functional resourcing across early and late stage projects. She holds a Master's in Health Sciences from George Washington University School of Medicine & Health Sciences.  She is a Certified Clinical Research Associate (CCRA) and holds a Regulatory Affairs Certification (RAC-US).  She also holds certifications in project management, clinical research management, and public health from UC Berkeley, UC Santa Cruz, and UNC Chapel Hill, respectively.  She is an Executive Scholar in Leadership from the Kellogg School of Management.

Thomas Renau

Tom Renau, Ph.D. received his BS in Biology from UC Irvine and PhD in Medicinal Chemistry from University of Michigan. He has worked in the Pharmaceutical industry for over 20 years in areas spanning from lead discovery to marketed products both regionally and globally. He has held positions at both small and large companies in the Bay Area including Roche, Genentech, Onyx and Pharmacyclics with assignments on brands including Avastin, Rituxan and Kyprolis. He currently is Vice President of Medical Strategy at Vaniam Group LLC. He has been an Instructor with UC Berkeley Extension since 1997.

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