The Path to Market: Navigating the Biotech Roadmap

Adatok

A Tantárgybejelentőben megadott hivatalos adatok az alábbi tanévre: 2026-2027

Tematika

Developing a new medicine is a 10-year journey. This course is your "GPS" for that journey. We strip away the complex legal jargon and focus on the Product Lifecycle. You will learn the logic of Phase I, II, and III trials, how the FDA (USA) and EMA (Europe) make life-changing decisions, and why some multi-billion-dollar drugs fail at the very last step. This is essential "insider knowledge" for anyone wanting to work in Project Management, Clinical Research, or high-level drug development.

Előadások

• 1. The $2 Billion Gamble: An overview of the drug development timeline—why does it take so long? - Zand Afshin
• 2. The Pre-Clinical Gate: What data do you need from the lab before you are allowed to touch a human? - Zand Afshin
• 3. Phase I (Safety First): Testing on healthy volunteers—learning how to protect the pioneers. - Zand Afshin
• 4. Phase II (Does it Work?): Moving to small patient groups and finding the "Goldilocks" dose. - Zand Afshin
• 5. Phase III (The Final Hurdle): Massive global trials—proving your drug is better than what is already available. - Zand Afshin
• 6. The Dossier: How to bundle 10 years of data into an application for the FDA and EMA. - Zand Afshin
• 7. The Fast Track (Orphan Drugs): The special "VIP" lane for treating rare diseases. - Nancy Zeineddine
• 8. The Biosimilar Challenge: The specific rules for companies (like Richter Gedeon) to make complex biological versions. - Nancy Zeineddine
• 9. What Can We Say?: The rules of labeling and marketing—what is legally "true" about a drug? - Nancy Zeineddine
• 10. Phase IV (Safety Never Sleeps): Monitoring a drug’s performance once it’s in the hands of millions - Nancy Zeineddine
• 11. The Patent Cliff: What happens to a biotech company when their "Top Secret" formula becomes public property? - Nancy Zeineddine
• 12. Career Strategy: Interactive Summary on why "Regulatory Affairs" is one of the highest-paid and most stable jobs in biotech. - Nancy Zeineddine

Gyakorlatok

Szemináriumok

A tananyag elsajátításához szükséges segédanyagok

Kötelező irodalom

Saját oktatási anyag

Course materials consist of weekly presentation slides covering the lecture topics. These are supplemented by curated "Fact Sheets".Additionally, a "Curriculum Question Bank" consisting of 25 comprehensive questions will be distributed at the start of the semester to guide self-study and provide the basis for both the "Group-Pulse" interactive activity and the final written assessment.

Jegyzet

Ajánlott irodalom

A félév elfogadásának feltételei

One assignment at the end of the course

Félévközi ellenőrzések

It's not required

Távolmaradás pótlásának lehetőségei

Not possible

Vizsgakérdések

Logic: The "Why" of the Process

1.            Why is it logical to test a drug on healthy volunteers (Phase I) before testing it on sick patients?

2.            What is the logic behind having a "Double-Blind" study in Phase III clinical trials?

3.            Why does the EMA require different data for a "Biosimilar" than for a simple generic pill?

4.            How does the "Benefit-Risk Balance" determine if a drug is approved for a terminal illness?

5.            Why is a "Pilot Study" necessary before launching a trial involving thousands of people?

II. Application: Real-World Regulation

1.            If a drug shows high toxicity in animal models (Pre-clinical), can it still proceed to Phase I? Why?

2.            Describe a scenario where a drug might receive "Accelerated Approval" (the fast-track lane).

3.            How does "Pharmacovigilance" (Phase IV) protect the public after a drug is already in pharmacies?

4.            Why is it important for a scientist to understand the "Target Product Profile" at the start of research?

5.            How can a "Patent Extension" help a company recover the billions spent on research?

III. Mechanism: Navigating the System

1.            Explain the role of an "Institutional Review Board" (IRB) in protecting clinical trial participants.

2.            What is the basic purpose of a "Clinical Trial Protocol," and why can't it be changed mid-study?

3.            How does the "Informed Consent" process work from a legal and ethical perspective?

4.            Describe the difference between a "Centralized" and "Decentralized" approval process in Europe.

5.            How does a "Placebo" work as a mechanism to prove a new drug is actually effective?

IV. Diagnostics: Identifying Success & Failure

1.            What are the common "Red Flags" that cause a drug to fail in Phase II?

2.            How do we measure the "Safety Endpoints" versus the "Efficacy Endpoints" in a trial?

3.            Why is "Data Integrity" the most important part of a Market Authorization Application?

4.            How can a "Significant Adverse Event" (SAE) change the course of an ongoing clinical trial?

5.            Why is a "Bioequivalence" test the most important diagnostic for a Biosimilar drug?

V. Ethics & Professionalism: The Career Path

1.            Is it ethical to give a placebo to a very sick patient if a working drug might exist?

2.            Why is "Transparency" in clinical trial results an ethical requirement for big pharma?

3.            How do "Orphan Drug" laws help patients who have diseases that are too rare to be profitable?

4.            What is the ethical responsibility of a Regulatory Affairs Manager when they find a data error?

5.            Why is "Global Harmonization" (making rules the same everywhere) good for patient safety?

Vizsgáztatók

Gyakorlatok, szemináriumok oktatói