Ateneo - UPO

The course aims to provide students with a basic understanding of pharmacology, particularly focusing on biotechnological approaches to drug development and pharmacodynamics. Along with the management and economics course, it also provides guidance on managerial procedures for drug development, providing insights into pharmacoeconomics.

PHARMACOLOGY
1. HP Rang and MM Dale – Farmacologia, Casa Ed Ambrosiana
2. Goodman & Gilman – Le basi farmacologiche della terapia di J.G.Hardman, L.E. Limbird, A.Goodman Gilman, Curatore edizione italiana: C.Sirtori, G.Folco, G.Franceschini, S.Govoni.
3. Farmacologia generale e molecolare, a cura di F.Clementi, G.Fumagalli, Ed UTET
John Wiley & Sons Inc
MANAGEMENT
Bad Blood: Secrets and Lies in a Silicon Valley Startup-John Carreyrou, Knoft publishing, Winner of the 2018 Financial Times and McKinsey Business Book of the Year Award; The Lean Startup, Eric Ries Crown Publishing; 100 Great Businesses (and the minds behind them), Emily Ross & Angus Holland Source, Books Publishing; Angel (how to invest in technology startups), Jason Calacanis Harper Business Publishing; Managing Innovation: Integrating Technological, Market and Organizational Change, Joe Tidd, John Bessant John Wiley & Sons Inc; Innovation and Entrepreneurship John Bessant Joe Tidd John Wiley & Sons Inc; La Gestione Del Trasferimento Tecnologico - Strategie, Modelli E Strumenti Andrea Piccaluga, Massimiliano Granieri, Giuseppe Conti 1 edizione (25 agosto 2011); Project Management: dall'idea all'attuazione. Una guida pratica per il successo Marion E. Haynes Editore: Franco Angeli; Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices Shreefal S. Mehta Cambridge University Press; Building Biotechnology: Biotechnology Business, Regulations, Patents, Law, Policy and Science Yali Friedman Editore: Logos Press; 4. Auflage.
ECONOMY
AA.VV., Lezioni di economia aziendale, seconda edizione, Giappichelli, Torino, 2013.
For the second part there is not a specific textbook. Different readings will be suggested in class. The following two textbooks cover some of the topics discussed in class:
- F Simon, G Giovannetti, Managing Biotechnology: From Science to Market in the Digital Age, Wiley, 2017
- C Shimasaki (editor), Biotechnology Entrepreneurship: Leading, Managing and Commercializing Innovative Technologies, Academic Press, 2020

PHARMACOLOGY. In the context of this Integrated Course, the module of Pharmacology will give to students the basis of pharmacokinetic and pharmacodynamic principles, the general concepts of “conventional small molecules” and biological/biotechnological drugs along with the most important pharmacological differences and their pre-clinical and clinical development. Moreover, the course will provide detailed information about selected drug classes.
The innovation and technology transfer management course aims to present, with a focus on life sciences, the major issues related to the management of research projects and the innovations resulting from these, as well as the pathways to exploit the results, both through technology transfer routes that start up innovative companies. Particular attention will be given to the analysis of the industrial aspects of these paths and to the patent problems and commercial exploitation of the results of scientific research, including the problems of business start-up, as well as the problems of project management and innovation management, together to the economy course that aims to provide students with the fundamental terminology and methodologies related to the business administration, useful for representing and understanding the functioning of companies. Managerial competences and tools are afterwards applied to biotechnologies, with a focus on the management of innovation and market access

Students are required to have a good preparation in biochemistry, physiology, anatomy and pathology and a good knowledge of the English language.

Frontal lectures, exercises and business cases.

Students are required to have a good knowledge of English, especially in reading.
Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

Writing test multiple choice for Pharmacology and Management.
Writing test for Economy.
The exam is considered passed if all modules are sufficient, with a final vote that derives from the weighted average of the 3 individual vote.

PHARMACOLOGY
Introduction to pharmacology
- Discovery and development of a new drug: pre-clinical and clinical phases
- The main principles of drugs, conventional small molecules, biological/biotechnological drugs, equivalent and biosimilar drugs
-Pharmacodynamic: receptors and signal transduction; meaning of agonist and antagonist; the dose-response curve;
-Pharmacokineti: absorbtion, distribution, metabolism and excretion of drugs; definition of half life, bioavailability, clearance and distribution volume
-Antiinflammatory drugs: FANS and glucocorticoids
-Immunosuppressive drugs
-Chemotherapeutci agents
-Drugs in cardiovascular system: Anti-coagulant and anti-thrombotic drugs, Anti-hypertensive drugs
-Drug for dyslipidemia
-Ttreatment for diabetes type I and II
- Drugs of nervous system: anti-depressives, anti-parkinson, anti-psycotic drugs, sedative-hypnotic, drug for neuromuscular disorders
Drug of abuse: opioids, psicostimulants, cannabinoids.
Integration of the gender dimension: where of interest, attention will be paid to gender pharmacology.

MANAGEMENT
Technology Innovation Management
Definition of research, invention, and innovation; analysis of the innovation process and its different phases; the market pull and the technology push for product innovation; from academia to a company and the valley of death; the definition of entrepreneurship

Project Management
Definition of a project and a team; criteria selection of a project, the phases of a project, 12 steps in project management, challenges in managing projects and teams; the project life cycle; basic elements of project management (PM); analysis of factors involved in PM; SMART goals; conflict resolution Importance of the role of the Project Manager in dealing with conflicts and conflict resolution; the concept of stakeholders; project planning and tools; the GANTT chart; the Work Breakdown Structure; examples of PM.

Technology (e)Valuation
The concept of technology valuation and evaluation.
Financing the startup: angels, Corporate Ventures, and Venture Capiitalists The concept of ownership dilution
The exit strategy: when and how it is done
Valuation models of an invention: The cost based approach, the market method, and the discounted cash flow method.

Intellectual Property and its Exploitation
Overview on patents and the process to patent an invention, analysis, and discussion on requirements for patentability.
Definition of the technology transfer process, analysis of best practice for a successful transfer of a technology, overview of contracts and agreements in the transfer of a technology, review of the patenting process in general and in different geographical areas (PCT, Italy, Europe, USA)

The business plan
Overview of Business Plan and its different sections; the elevator pitch and the presentation Intro to the concept of Business Plan (BP)
Different purposes of a BP Different models of BPs
Description and in-depth analysis of the different sections of a business plan, specifically: Executive Summary, Company description Management team Product(s) Market Competition, and Marketing activities

The Business Model Canvas and the Lean Startup model
Overview of the Business Model Canvas (BMC); analysis of the 9 components of the BMC; examples of BMC; definition of the Lean Start-up and the minimum viable product, the concept of the Lean Startup
Overview of the clinical trial process
Clinical development and clinical trials, valorization of a molecule via the clinical process

ECONOMY
1st part - Business and management:
- The enterprise as a system;
- The environmental influences;
- Main functional areas and processes;
- Marketing department;
- Organizational department;
- Administrative and Finance Department.

2nd part - Inventions in general
- Inventions in the biotechnology sector EP/IT
- Inventions in the US biotechnology sector
- Industrial applicability
- The state of the art
- What's new
- The novelty of chemical, selection and medical inventions
- Ep/IT inventive height
- The inventive height of chemical, selection and medical inventions
- Inventive height - practical cases
- Sufficiency of description
- Claims and scope of protection
- Claims and scope of protection - practical cases
- Supplementary protection certificates
- The patent, the rights conferred by it, the limits of the patent
- Patent litigation
. The patentability of stem cells

The Dublin descriptors will be used for assessment: D1 - KNOWLEDGE AND UNDERSTANDING: Students will know and understand the basic concepts of pharmacology that can be applied in the future development of new drugs, to identify new pharmacological targets. These concepts will be combined with management concepts to identify the major issues related to managing research projects and the resulting innovations. D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING: Students will acquire the ability to use the theoretical knowledge taught in class to reason critically, demonstrating the ability to make connections between different topics and to apply the knowledge acquired in the context of different drugs or toxic substances. They will also learn to evaluate ways to valorize the results, both through technology transfer and the launch of innovative businesses. Particular attention will be given to analyzing the industrial aspects of these approaches and to patent issues and the commercial exploitation of scientific research results, including business start-up issues, as well as project management and innovation management. This is in conjunction with the economics course, which aims to provide the fundamental terminology and methodologies of business economics useful for representing and understanding the functioning of companies. These tools are then applied to the context of red biotechnology, with a focus on innovation management and market access.
D3 - JUDGMENT ABILITY: Students will acquire the ability to critically examine the theoretical concepts acquired and to independently discuss issues arising from their practical application. D4 - COMMUNICATION SKILLS: Students will acquire the ability to disseminate the knowledge they have acquired using specific and appropriate vocabulary in order to engage in professional and competent discussions in both academic and professional settings. D5-LEARNING SKILLS: The student will acquire tools that they can apply to the context of red biotechnology with a focus on innovation management and market access