Drug Development I Stanford Graduate Certificate

Drug Development:

From Discovery to Commercialization

Stanford Graduate Certificate

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Meet Your Instructors

This brand new graduate certificate, offered by the School of Medicine's Translational Research and Applied Medicine program, comprises 3 required courses in translational medicine and one elective.

The core of the certificate is the "A to Z of Medical Translation" sequence, comprising two of the required courses that delve into the complex landscape of medical translation, including preclinical development and advanced topics in biopharmaceutical development. These courses provide a strong foundation essential for understanding the industry's nuances. Alongside these core courses, you will take "Human Studies in Drug Development" to gain comprehensive insights into clinical pathways and regulatory requirements. As an elective, you can choose either "Biotechnology Law" or the third course in the "A to Z of Medical Translation" series, "Emerging Trends in Drug Development and Next-gen Innovations", each course allows you to explore specific issues in drug development in depth.

Gain a deep understanding of medical translation
Engage with industry professionals
Build a strong foundation for successful careers in the field of medical translation and biopharmaceutical development
Earn a Stanford University Graduate Certificate

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Why Stanford Online?

Take Courses Online

Stream lectures live or on-demand and complete coursework entirely online.

On Your Schedule

Flexible enrollment options to complete your program.

Learn From The Best

Learn from distinguished professors at Stanford's School of Medicine and leading industry experts.

Earn a Certificate

Earn a Stanford University Graduate Certificate when you complete 4 courses.

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Who Should Enroll

Researchers

Bring your power to understand human behavior and learn to use it to prioritize the most useful and desirable features in a product.

Engineers and developers

Bring your ability to build products the best way and combine it with the knowledge to capture opportunities and create economic value.

Designers and UX designers

Polish your ability to create products that are wonderful to use and combine it with the ability to plan go-to-market strategies.

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Marketing & Sales

Combine your powers to acquire customers with the ability to prioritize the features that will make them loyal.

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Founders and entrepreneurs

Develop the skills that will help you manage your products’ lifecycle once you bring your ideas to life.

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Graduate or Professional course - which is right for you?

Time Commitment

Achievement

Classmate Interactions

Cost

Graduate Certificate Courses

90–120 hours per course

Earn up to 18 units of academic credit that may contribute to a certificate or a degree

Frequent collaboration with other students taking courses at the same time

$$$$

Professional Program

8-10 hours per course

Take a professional course to build your skills and advance your career

Potential to connect with other participants through private social media groups

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Certificate Courses

A to Z of Medical Translation: Fundamentals and Technical Considerations of Drug Development

Required, Course 1

Dive into the fundamentals of medical translation, with a focus on drug development. Explore topics like drug development planning, preclinical requirements, drug development from a biopharmaceutical perspective, good manufacturing practices (GMP), quality assurance standards, and compliance. Industry experts offer valuable insights, providing students with a strong foundation for the field.

A to Z of Medical Translation: Strategic Challenges in Drug Development

Required, Course 2

Delve into the broader ecosystem of medical translation, examining critical aspects including leadership and management skills, developing and maintaining intellectual property, working with venture funds, portfolio evaluation, diagnostic development, market access and healthcare equity. Guest speakers offer insights into real-world challenges and opportunities in the industry.

Human Studies in Drug Development

Required, Course 3

A comprehensive exploration of the clinical development pathway, spanning from initial discovery to FDA approval. In this course, you will gain in-depth knowledge and practical skills, including understanding regulatory processes, developing study protocols for various clinical phases, ensuring safety management, managing data effectively, and preparing for NDA/MAA submissions. Expert-led sessions and workshops provide students with the expertise required to navigate the complexities of clinical trials and clinical studies in drug development.

Biotechnology Law

Elective Option 1

Focus on the impact of the legal and regulatory system on research, products, and intellectual property for companies and academia and will include an overview of legal, corporate, intellectual property, ethical and regulatory issues impacting the biotechnology and pharmaceutical industries. Basic topics covered include intellectual property, patent law, and licensing in the field of biotechnology. You will learn how to submit an idea, go through the disclosure and licensing process, and apply for a patent.

A to Z of Medical Translation: Emerging Trends in Drug Development and Next-gen Innovations

Elective Option 2

Explore topics such as novel therapeutic modalities; artificial intelligence and personalized medicine; new methodologies for drug discovery; the future of pharmaceutical development, marketing, and healthcare cost containment. This quarter offers a forward-looking perspective, preparing students for the ever-evolving landscape of medical translation and biopharmaceutical development.