Pla d'estudis

Assignatura

ECTS

Resum

• Overview of the Biopharmaceutical and MedTech Sectors. Review of global key players and stakeholders. Key trends in the industry. Current challenges and opportunities for the sector. 
• The Business of Biomedicine. Turning scientific knowledge into social and economic value. Industry drivers. Historical perspective. Key differential characteristics of the biomedicine business.
• Biopharmaceutical value chain and medicines life' cycle: its unique differential points in terms of costs and development timelines.
• Professional career opportunities in the Biopharma sector: opportunities and demand.
• Developing your professional profile. What is relevant? Evolution of job requirements. Defining the competency profile of a professional for the biopharmaceutical sector: knowledge, skills and attitude. The sector dynamics: concentration, new technologies, cost-efficiency, VUCA context. Trending positions.

- Seminar: A CEO vision about professional development.
- Seminar: Managing the Recruitment Process: the headhunter perspective.

Assignatura

ECTS

Resum

• The Drug Discovery Process: Target selection, feasibility, hit to lead, lead optimisation and candidate selection. Comparison Pharma vs. Biotech. 
• Preclinical Development. Comprehensive review of Non-clinical studies: pharmacokinetics, pharmacodynamics, ADME. Toxicology and safety pharmacology studies in animals. Genotoxicity, Immunotoxicity, Carcinogenicity. NOAEL, MTD and extrapolations.
• Clinical Development & Statistical analysis. Clinical trials in humans; phases, clinical development plan, protocols, endpoints, inclusion and exclusion criteria, limitations, statistical analysis.
• Project Management: R&D projects coordination at biopharmaceutical companies. Historical perspective. Role of project management today.

DRUG PRODUCTION

• API (Active Principle Ingredient) production: process development, process flow, QA, ICH Guidelines.
• Pharmaceutical Development and Manufacturing: formulation considerations, excipients, process development for solid dosage forms. Other formulations (liquid, semi-solid, sterile, inhalers, patches, etc).
• Quality Assurance/Quality Control functions in biopharmaceutical production.

INTELLECTUAL PROPERTY PROTECTION

• IP Protection. Relevance of intellectual property for industry and research centres. Basic aspects of the patent system. Prosecution, patentability, applicable laws, content of a patent, priority, treaties and conventions, requirements. Patent strategy. What can be patented in biotechnology 
• Life Science patents in practice. 
• Intellectual property protection in the pharmaceutical industry: company’ patent portfolio and product’ patent family.
   

• Regulatory Affairs. European regulatory environment. Bodies and Agencies (EMA, CHMP, HMA, CMDh). Nomenclature. Scientific advice. Orphan drug designations. Paediatric investigation plans. PRIME: Priority Medicines scheme. Applications: IB and IMPD. Advanced therapy medicinal products. EU Registration procedures (Centralised, Mutual Recognition, Decentralised, Repeat Use). Evaluation of EU Applications. 
• Pharmacovigilance. Basics of Drug Safety and key stakeholders. Pharmacovigilance in the product life cycle. Safety monitoring as a continuous process. Adverse reactions reports.
• Price & Reimbursement and Market Access. Global PMA strategy for drugs. Structure of drug pricing by country. Value based pricing: Added-value vs. Commodity. Health Technology Assessment and cost containment measures. Payer perspective and current situation by European country.
• Market Access: Health Economics and Outcome Research (HEOR). Economic evaluation by payers. Efficiency and priority setting. Cost-effectiveness: Quality of Life and QUALYs. Entry based agreements: Outcome based, discounts, price-volume, continuation, capitation, budget caps, etc.
   

• The Medical Technologies world. Diagnostic tools and Medical Devices. Healthcare (R)evolution: the opportunity for MedTech. Types of Medical Devices. Development of Medical Devices. 
• R&D aspects of Medical Devices. Similarities and differences vs. drugs: timelines, costs and type of investors. How a new medical device is developed and brought to market.
• In vitro Diagnostic tools (IVD). The IVD value chain: Characteristics and differentiation vs. drug development. Types of IVD products.  Precision medicine and biomarkers. IVD market drivers and constraints. Development of an IVD product: designing a diagnostic platform, design process of a diagnostic assay and reaching the market with a valuable product.
• Regulatory and Market Access specifics. Review of the particularities of the registration process and the access to market procedures for Medical Technologies, and its main differential aspects vs. medicines. What is a medical device, what is not? Why do regulatory affairs matter? Stakeholders. Legal framework for medical devices. Transitional period and timelines: what is changing? CE marking and Conformity Evaluation. Overview of FDA Regulations for Medical Devices. Medical Devices reimbursement. 
   

Assignatura

ECTS

Resum

• General concepts of Marketing and Sales for non-economists.
• Sales in the Biopharma sector: regulation and ethics related to drug and health industry. Introduction to sales and marketing strategies within the Biopharma industry. Gradual change of marketing strategies in the last decades. Marketing Departments in Biopharma industries: their internal role. Introduction to clients: Physicians and Patients and consumers. Current patient centric approach. Marketing Departments in Biopharma industries and their interaction with sales networks. Traditional and New field networks for Biopharma companies: MSL, KAM, etc. SFE Parameters and keywords. New metrics and KPIs.
• Brand Plan. SWOT analysis. Marketing Objectives. SMART objectives. Examples and case studies. Buying process and product positioning. Market segments. Segmentation and targeting. 
• Communication in the Biopharma sector. Three pillars to structure communication objectives: ultimately enhance image and reputation. Sanofi communication as a case example (business objectives, commitments and position).  Communication skills: how to improve.
• Market Research and Competitive Intelligence. Market Intelligence – Role and sources. Secondary sources: how to use IQVIA data to monitor product performance; other secondary sources. Primary sources: Market Research; methodologies; types of MR in the lifecycle. Other primary sources. Forecasting: Epi-based forecast; Sales-based forecast.

• Basic financial concepts. What’s an enterprise? Registering a company in Spain. Balance sheets. Profit and Loss accounts: meaning and how to interpret them. Business Plans. Net present value (NPV) models for projects’ financial evaluation. 
• Entrepreneurship and finance for biopharmaceutical start-ups. How are new ventures financed? Views from a serial entrepreneur. 
• Sources of capital in biopharma. Capital risk investment/Venture capital.
• Entrepreneurship case studies explained by company’ founders.

- Seminar: Minoryx.
- Seminar: Iproteos/Exheus.

• BD&L. What is Corporate Development? Why is it important? Partnering process: evaluation steps and Due Diligence. Identifying partners of choice. Contacts with companies. "Selling" your project: information packages. Technology Transfer Offices. Types of contracts. General framework of agreements: review of main contractual clauses and economic terms. Alliance Management.

• Strategic planning at Biopharmaceutical companies and its importance. Definition of strategy and its consequences: therapy areas of interest, R&D capabilities, growth drivers, portfolio management. Recent examples and case studies.
   

• Leadership and Personal Branding course: Leadership Context. Trust. Rapport. MBTI test. Giving and Receiving Feedback. Collaboration. Listening. Asserting. Influence. Emotional Intelligence. Virtual Distance. Trusted Advisor Experience. Adding Value in Conversation. GAIN. Customer Insight. True Professionalism. Leadership Storytelling. Delegating and Empowering. Skill/Will. Coaching. Facilitation. Presenting with Impact. Difficult Conversations. Dealing with Conflict. Five Dysfunctions of a Team.