Ateneo - UPO

PHARMACOLOGY: Preclinical and clinical development of drugs. Principles of pharmacokinetics and pharmacodynamics. Main classes of drugs. Originator drug concept, generic drug, biosimilar medication. Main classes of drugs.
MANAGEMENT: The topics included in this course are:
From an idea to an innovation: managing innovative projects, the teams, and the project management
Managing and exploiting an invention: intangible assets, patents, and intellectual property
From the lab to the market – the commercial exploitation of research: the tech transfer process and its different contracts, launching a startup,
Funding a startup: angels, venture capitalists, corporate ventures, and collaborations
The valuation of an intangible asset
Business plan and business model canvas
The due diligence process
The elevator pitch
The Lea Startup concept
Some info on clinical trials
ECONOMY:From the scientific result to the company: the forms of technological transfer.
Introduction to management.
Management of biotech inventions.
Biotech market and industry.
Economic evaluation of (red) biotechnologies, with a focus on biotech medicines.

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

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.

Students are required to have a good preparation in biochemistry, physiology, anatomy and pathology

Lectures

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 4 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

At the end of the course students will have the basis to be able to face a new course of study in the field of pharmacological development