Explore life sciences/healthcare innovation from the vantage point of the world’s most successful startup ecosystem – Silicon Valley.
Explore diagnostic development: regulatory roles, approval pathways, quality systems. Understand reimbursement.
What are considered good publication practices for communicating company-sponsored medical research and how do these practices impact publication development and planning? Learn more in this pub planning module.
A good regulatory strategy is essential to a good business strategy.
Gain a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
Can you use a competitor’s data in your promotion; or open-label data in your print ad? Learn the FDA regs and more.
AAV Gene Therapy Manufacturing describes the properties of the naturally occurring Adeno-associated virus, discusses the use of this virus as a viral vector, and explains the manufacturing and control process including manufacturing platforms, vector characterization, and regulatory considerations.
Learn from experienced dealmakers a review of example models, a dissection of actual deals, have live participant interaction and Q&A opportunities.
Dive into antibodies' versatile role in research & clinic. Explore monoclonals, diagnostics, & more. Enhance fluency in antibody science.
Learn the art of crafting compelling resumes & cover letters for life science jobs. Stand out from the crowd with step-by-step guidance.
Enhance your skills in negotiations, influencing, decision-making, and game theory. Game theory will be applied to real-life pharma/biotech negotiation cases.
Explore a broad range of issues faced by entrepreneurs from the managerial, scientific, and academic communities...
Learn about the science driving today’s hottest biopharma innovations including CRISPR, CAR-T, gene therapy, and much more...
Explore challenges in biologics manufacturing. Learn about production differences from small molecule drugs.
Explore biopharma business essentials: financing, IP law, lifecycle management, & drug pricing.
Discover biosimilar science, manufacturing, & regulations. Learn about protein structure & disease mitigation.
Learn from senior executives to expertly navigate transactional and intellectual property law; business development; finance...
Discover CAR therapy for cancer challenges. Assess cell line pros/cons. Explore future cell therapies' potential.
Explore cGMP benefits & challenges. Learn about pillar requirements: QMS, Premises, Personnel, Materials, Documents, Validation. Understand audits & remediations with case studies.
Gain foundational knowledge on clinical development: trial conduct, design principles, GCPs, & trial phases I-IV.
Explore Phase I objectives & regulatory roles. Learn about bioequivalence, PK/PD studies & dosing protocols."
Discover Phase II/III objectives & trial design nuances. Learn about endpoints, statistics, & expedited approvals
Explore Phase IV: post-approval assessments & risk management. Learn about adverse effects & real-world data.
Explore CMC's vital role in drug development. Emphasizing patient safety, it covers implementation, stages, & regulatory implications.