Empowering professionals for over 24 years

Empowering professionals for over 24 years

Live Drug Development Immersion

Live Drug Development Immersion
Bring InHouse

Gain a strategic understanding of the scientific, regulatory, and commercial decisions that drive a drug from discovery to launch. Drug Development Immersion explores the evaluation of drug candidates, the design of clinical trials, the acceleration of regulatory approvals, and the management of products for long-term success.

  1. Become proficient in the terminology and acronyms used in preclinical and clinical development
  2. Learn the essential activities and regulatory requirements involved in Phase I through Phase IV clinical trials to better evaluate pipelines
  3. Understand the roles of regulatory agencies worldwide and list the tools they use to ensure approved drugs are safe and efficacious

Rapid learning for results-driven professionals

  • Designed for non-scientists in the life science industry
  • Taught by experts with real-world industry experience
  • Focused on practical, applicable knowledge
  • Ideal for individual learners or company teams
  • Trusted by top biotech and pharmaceutical companies

What You'll Learn

  • Setting the Stage
    Compares the characteristics of small molecule drugs to biologics and provides insight into the success rates, timelines, and costs each incurs during drug development.
  • The Business of Drug Development
    Explains how pharmaceutical companies use the Target Product Profile (TPP) and stage gate criteria to guide go/no-go investment decisions.
  • The Regulatory Process
    Highlights FDA and EMA regulatory frameworks, expedited programs, and approval pathways for small molecule drugs, biologics, generics, biosimilars, and orphan drugs.
  • Preclinical Development
    Teaches the objectives of each sequential step in evaluating candidate drugs before submitting an IND or CTA for authorization to begin human studies.
  • The Players: Who Is Involved
    Highlights the roles of subjects, sponsors, investigators, CROs, advocacy groups, ethics committees, and data monitoring committees.
  • General Principles: Ethics and Risk
    Discusses risk management, data integrity, and minimizing bias through blinding, randomization, and ethical trial conduct.
  • Conduct of Clinical Trials
    Explains the purpose and elements of clinical trials, including study designs, endpoint selection, eligibility criteria, and safety reporting.
  • Clinical Development Phase I
    Examines the purpose and structure of Phase 0 and Phase I trials, covering dose selection methods and bioequivalence studies.
  • Clinical Development Phase II
    Explores the purpose and structure of Phase II trials, covering randomized control trials and statistical considerations such as null hypothesis, P values, and Type 1 and 2 errors.
  • Clinical Development Phase III
    Identifies the purpose and structure of Phase II trials, covering trial designs, database locks, and regulatory submissions.
  • Clinical Development Phase IV
    Discusses the purpose of Phase IV trials, covering post-marketing safety reporting, pharmacovigilance, and lifecycle management.

Logistics

Customized Training, Delivered Your Way

Biotech Primer designs and delivers customized courses tailored to your organization’s specific needs. Whether live onsite at your location or live online, our expert-led programs range from half-day sessions to three-day deep dives—ensuring the right fit for your team’s schedule and goals.

Deliverables

  • Expert-Led Course Content: Customized training developed and delivered by seasoned industry professionals.
  • Comprehensive Course Materials: Electronic PDF of all presentation slides provided for reference and continued learning.
  • Interactive Course Activities: All required lab materials, case studies, and supporting documents supplied to facilitate hands-on engagement.
  • Certificates of Completion: Formal recognition for participants who complete the course.

FAQ

What options are there for live training?
Who are the instructors?
Are training materials provided?
Do I receive a certificate?
Who attends your open enrollments?
Where can I find a list of all the upcoming open enrollments?
Do open enrollments sell out? Are they ever canceled?
What should I wear and bring to an open enrollment?
What is your refund policy?
What discounts are available for live, open enrollments?
What can Biotech Primer’s in-house training offer my team?
How many people typically attend your customized in-house training sessions? What is the minimum number of participants? What is the maximum number of participants?
What sort of training materials do you provide?
Can you hold the training at our company facility?
What kind of room setup is needed?
Do you provide in-house training internationally?
I’m looking for training on a topic not listed on your website. Can you help?
Do you offer half-day training sessions?
How far in advance do I need to book in-house training?
What is the cost of the on-site customized training?
How do I contact Biotech Primer for questions about customized training options for my team?
Do you offer services beyond training?

WHAT PEOPLE ARE SAYING

I’ve been involved with med tech companies, so I had picked up on the development path in general, but the Medical Device Development Immersion course was really helpful in providing a full context and clarifying the details. All your [Biotech Primer] courses are really solid...

Elayne Wandler

Director, Programs​, Canada’s Digital Supercluster

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