Curricula and training products presentation

Curricula and Training products presentation

(First version for face-to-face learning)

 

  1. Curriculum and training content “ENTREPRISE BUSINESS AND INTELECTUAL PROPERTY IN LIFE SCIENCES”
    • Curriculum presents all the needed information to train the content: a general description of the 8 modules comprising the training content, needed knowledge and abilities level, the total time normally required training the content, teaching and learning methods, and assessment methods. The first 7 modules are to be learned on the e-learning platform (linked to the project site), but the last one is to be learned face to face.
    • Training content short description

MODULE 1 ENTREPRENEURSHIP AND STARTING BUSINESS

It is divided into 3 blocks of learning, with the following main issues:

  1. Entity formation

There are a limited number of types of entities to choose from.

Most important is Limited Liability Company (LLC).

  1. Ownership structure

The problem is that the value of the equity, which may be evaluated from almost nothing to 1 million or several million euro.

  1. Fundraising

Selling Equity versus Convertible Debt is the idea.

  1. Sources of bio product ideas
  2. Determine if a product concept is worth pursuing as a company

 

Three Initial Criteria for Assessing Technology Product Opportunities are analyzing in this chapter:

  1. Evaluate the underlying science and the technology.
  2. Evaluate the product’s perceived market potential.
  3. Evaluate the people factor

 

MODULE 2 RISK MANAGEMENT AND BUSSINES LAW

This module is dedicated to presentation of modalities to recognizing the business models in the different life sciences fields: therapeutic, biologic, diagnostic, medical device, clinical laboratory, and research reagent industry, adapted and modified for a company’s competitive advantage. It is divided into 2 blocks of learning, as follows:

  1. Business model

All companies operate within an underlying business model. The entrepreneurs should select and adopt the optimal business model for their company.

  1. Life science (LS) company evaluation tool.

The LS Company Evaluation Tool is a worksheet developed for assessing a company business and technology for the evaluation of investment advice, or potential for success and risks to be managed.

 

MODULE 3 SME MARKETING

A marketing strategy is a carefully thought out plan for how your product will bring value to, and reach its best customers. It is divided into 2 blocks of learning, as follows:

  1. Market – definition

This is dedicated to understanding the market for particular products respectively for existing and potential customers who need them and have the ability and willingness to pay for them. Markets include mechanisms or means for: (1) determining price of the traded item; (2) communicating the price information; (3) facilitating deals and transactions, (4) effecting of distributions.

  1. Develop a marketing strategy for the future product

A good market strategy identifies the target market customers, creates a value proposition for each of the three customer groups, and identifies the optimal market channels to successfully provide the product or service to the target market.

 

MODULE 4 BUSINESS FINANCE AN ECONOMICS

Capital for Life Sciences bio product development comes from a variety of sources and each source has their own preference for the stage at which they invest. Each of these investor groups has different investment risk tolerances along with differing motivations and limitations for investing. It very important that, the management team to understand these motivations and limitations, prior to a fundraising campaign. It is divided into 4 blocks of learning, as follows:

  1. Understand what comes with invested money: motivations and interests
  2. The capital sources available to LS companies
  3. Determining the value of development-stage LS companies
  4. Financing stages for a LS company

 

MODULE 5 FIRM MANAGEMENT AND ENTREPRENEURIAL PROCESS FUNDAMENTALS

In this module the topic of building and growing collaborative, interdisciplinary teams that identify and commercialize promising LS innovations and grow successful companies is covered. It is divided into 2 blocks of learning, as follows:

  1. Entrepreneurial team
  2. Strategic management

 

MODULE 6 THE BUSINESS PLAN

Business plans is a valuable tool for helping the entrepreneurs to carve out a strategic plan and to better think through how all the different pieces of their business fit together, in order that the venture to going forward. It is divided into 2 blocks of learning, as follows:

  1. Feasibility analysis versus business plans

The feasibility analyses determine if a business concept has the potential to become a viable business opportunity.

  1. The business planning process

This is presenting how to write a business plan, the contents of the business plan, respectively:

  1. What is the customer request and is the motivation likely to be strong enough for prospective customers to buy the offered solution?
  2. What sets this venture apart from existing competitors and will it be able to build and protect its competitive advantage?
  3. How big is the market and is there significant growth in this space?
  4. Has a quality team been assembled to lead this venture and why are they the right people to lead this concept forward?
  5. How will the business make money?
  6. Are the potential revenues and profits large enough to adequately reward the type of investors that you will be pitching too? The expenses and potential revenues will need to be shown to be realistic and lead to long-term profitability.

 

MODULE 7 INTELLECTUAL PROPERTY (IP) IN LIFE SCIENCES

This module is divided into 4 blocks of learning, as follows:

  1. Patents and IP rights: general issues
  2. Patenting in life sciences: historical overview and actual EU vision

Here is presenting the living organisms – historical retrospective; The ethical dimension of inventions in Life sciences; The European Patent Convention (EPC) and other important conventions, Patent law and animals; . Patent law and special subjects like Microorganism cells in reference deposits; Patent law and the human genome project; Patent law and human embryos; Blue sky research: patent law and frontier technologies.

  1. The strategy of patenting in life sciences. Innovative SME’s IP management

 

MODULE 8. NETWORKING AND PARTNERSHIP

This module aims to analyze and understand the challenges, opportunities and the conditions relating to the practices of partnership and networks, and refer to the proposed business; and while working the plan to create, acquire the skills to manage dynamic collaborative work in this approach.

  1. Partnership culture and networking

The objectives:

  • Knowing how to identify the characteristics, objectives and types of possible partnerships and be able to distinguish between the types of partners and types of resources that may be provided
  • Know the business models to build and activate a local / regional network
  • Identify and analyze existing partnership practices, identify its strengths and weaknesses.
  • Learn about the possibilities of formalizing an operational partnership agreement.
    1. Methods and tools for network management

The objectives:

  • Being able to identify the strategies and the most appropriate methods to achieve the objectives, while using the network.
  • Understanding the dynamics of measurement and evaluation of projects and communicate results inside and outside the network.
  • Analyze the possibilities and modalities for building self-assessment tools.
  • Understand the methods of group discussion, the terms to arrive at a decision of a real partnership (technical and strategic).
  • Being able to negotiate and meet the demands and the potential needs of the different actors involved in the partnership.
  • Being able to apply the techniques of problem solving in a group situation.
  • Being able to identify and manage conflicts.

 

 

  1. Curriculum and training content “SUSTAINABLE LIFE SCIENCES APPLICATIONS
    • Curriculum presents all the needed information to train the content: a general description of the modules, needed knowledge and abilities level, the total time normally required training the content, teaching and learning methods, and assessment methods. The first module and the last module (Synthesis conclusions) are to be studied on the e-learning platform, and the modules 2, 3, 4, and 5 are to be studied according to the face-to-face methodology.
    • The training content is organized in 5 modules and Final developed conclusions, each of them equally important for describing both the new technological achievements and the economic trends.

Module 1 SUSTAINABLE INNOVATIVE SMALL BUSINESS OR SUSTAINABLE LIFE SCIENCES APPLICATIONS

It is aimed to sustain the bio entrepreneur to be able to fulfill at the same time a double task – (a) to study, to develop and to transfer to the market a sustainable Life Sciences application; (b) to run a sustainable business.

It is divided into 3 blocks of learning, as follows:

  • Characterization of Life Sciences applications and companies
  • Sustainable business

Sustainability has become an important goal for society. For industry, sustainability means continuous innovation to make fundamental changes in resource consumption and product life-cycle management.

  • Sustainable Life Sciences applications

The eco-efficiency of industrial bio products and bioprocesses can provide a basis for moving a broad range of industries toward more sustainable production.

 

Module 2 A TYPICAL BIOMANUFACTURING PROCESS Case study: preparation of bio pharmaceutics

This module is dedicated to the presentation of a bio manufacturing technology. The most complex industrial installation to produce bio products is that for the preparation of bio pharmaceuticals, and that is why the case study is dedicated to this type.

It is divided into 3 blocks of learning, as follows:

2.1. Types of bio pharmaceutics

2.2. Key Phases of Biologics Development

The biologic product to be developed and manufactured starts with the discovery and proof-of-concept studies characterizing the product as well as defining the actual molecule and its mode of action. The study and knowledge of the molecule’s characteristics will be important in designing cell culture and bioreactor parameters in order to scale-up and produce a sufficient yield of product to satisfy early experiments and analytical development. This crude product will also be used for early clarification, downstream process development, and formulation studies.

2.3. Bio manufacture short characterization

The initial biopharmaceutical manufacturing facilities were constructed primarily as single product facilities. In an effort to support multi-product like operation, the second generation facilities were designed with multiple suites of each type and in some cases the suites were of different sizes. As Single Use (SU) technology was available, the facility design began to switch to the next generation, with the central concept that the SU technology provides closed or functionally closed system that would permit multiple Unit Operations to be run in the same area without cross contamination.

 

Module 3 BIOAGRICULTURE AND FOOD LIFE SCIENCES APPLICATIONS

It is aimed to present the most recent achievement in bio agriculture and food applications.

It is divided into 4 blocks of learning, as follows:

3.1. Bio Agriculture

Bio agricultural products can be divided into three major sectors: seeds, agro bio products instead of agro chemicals, and bio fertilizers.

3.2. Animal cells and plant cells cultivation technologies

3.3. Modern food biotechnology based on genetically modified organisms (GMOs, GE plants, GMM, GM Animal)

3.4. Food and Dietary Supplements.

 

Module 4 INDUSTRIAL BIOTECHNOLOGY

BIOFUELS & BIOREFINERIES

Industrial biotechnology products are applications of LS used for industrial purposes such as manufacturing and production of biomaterials. Industrial biotechnology uses natural biological processes, such as fermentation and the harnessing of enzymes, yeasts, and microbes as microscopic manufacturing plants, to produce mainly chemicals, materials and energy.

It is divided into 3 blocks of learning, as follows:

  • Industrial Biotechnology

Industrial biotechnology is grounded in bio catalysis and fermentation / bio processing technology. Industrial biotech involves working with nature to maximize and optimize existing biochemical pathways that can be used in manufacturing.

  • Bio-fuels production

Bio-fuels are important for a variety of reasons. The energy used for transportation is dependent on a limited amount of fossil fuels such as oil and petroleum. Bio-fuels can offer an energy fuel resource that is both renewable and sustainable. Bio-fuels are fuels produced from living organisms such as plants or plant-derived materials and microalgae or from metabolic byproducts such as organic or food waste, often referred to as “biomass.”

  • Bio refineries

Bio-refinery represents an assembly of industries specialized in the manufacture of sustainable vegetal resources in order to prepare food, chemical products, fuels, and materials.

 

Module 5 PARTICULAR LS TECHNOLOGIES:

Nano-biotechnologies

Environmental biotechnology

Tissue engineering

There is a group of LS technologies very important for the future scientific, technical and economic development of the domain with limited number of economic applications (municipal wastewaters bio treatments, soil bio remediation, some industrial effluent treatments and few others), but where the interest in research is huge in this moment, due to the probable valorization in many sectors.

It is divided into 3 blocks of learning, as follows:

  • Nanobiotechnologies

It refers to the ability to create and manipulate biological and biochemical materials, devices, and systems at atomic and molecular levels.

  • Environmental biotechnology

Environmental Biotechnology is the multidisciplinary integration of sciences and engineering in order to utilize the huge biochemical potential of microorganisms, plants and parts thereof for the restoration and preservation of the environment and for the sustainable use of resources.

  • Tissue engineering

Tissue engineering has emerged as an interdisciplinary field that applies the principles of engineering and life sciences toward the development of biological substitutes that restore, maintain, or improve tissue function or a whole organ.

CONCLUSIONS: VISION FOR A BETTER FUTURE

It presents the EU vision regarding the economic development of sustainable LS applications, useful indeed for the bio entrepreneurs. The topics are:

  1. European Industrial Biotechnology: a Vision for 2025
  2. The European Bio refinery Challenge for 2030
  3. The European Bio-based Economy in 2030