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...
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.
A first-time CEO's playbook to empower you to navigate the commercialization journey effectively.