focus group

RESEARCH
STRATEGIES FOR
PHARMACEUTICAL
ENTERPRISES
Industriy research requirements and future technology and
management trends - The activities of pharmaceutical focus group
Emilia-Romagna Region
This publication was realized by ASTER Science Technology Business in collaboration with TEFARCO INNOVA and with the support of the
Emilia-Romagna Regional Ministry for Productive Activities, Economic Development and Telematic Plan.
All information here reported was collected either directly or from previously published sources.
Special thank goes to the Enterprises, the Academic Research Groups and to the Laboratories of the Emilia-Romagna High-Tech Network,
for their partaking in the activities of the Pharmaceutical focus group:
ACME S.R.L.
ALFA WASSERMANN S.P.A.
AMBROSIALAB S.R.L.
CHIESI FARMACEUTICI
DOPPEL FARMACEUTICI
ERATECH
FATRO S.P.A.
IMA S.P.A
MEDEL S.P.A
NILFISK-CFM S.P.A.
OPOCRIN S.P.A
ASC LAB
ER-GEN TECH
GeBBA-Lab
UNIVERSITÀ DI BOLOGNA
Dipartimento di Scienze Farmaceutiche - Gruppo di Chimica Farmaceutica Computazionale
Dipartimento di Elettronica, Informatica e Sistemistica - Laboratorio di Ingegneria Cellulare e Molecolare per lo Studio dei
Bionanosistemi
UNIFE
Dipartimento di Scienze Farmaceutiche - Gruppo Farmaceutico Tecnologico Applicativo
UNIVERSITÀ DI MODENA E REGGIO EMILIA
Dipartimento di Scienze Biomediche - Gruppo di Farmacologia Molecolare e di Farmacogenomica
Dipartimento di Scienze Farmaceutiche - Laboratorio di drug discovery di inibitori enzimatici (LADDIE)
Dipartimento di Scienze Farmaceutiche - Centro di Ricerca sulle Tecnologie Farmaceutiche Tradizionali ed Innovative (Te.Far.T.I.)
UNIVERSITÀ DEGLI STUDI DI PARMA
Dipartimento di Ingegneria Meccanica - Area di Meccanica Applicata alle Macchine
Dipartimento Farmaceutico - Gruppo di Chimica Farmaceutica
Dipartimento Farmaceutico - Gruppo di Tecnologia Farmaceutica
Published in Bologna – December 2007 – 1st Edition
Realizzazioni grafiche I MUSICANTI NON DORMONO MAI [email protected]
INTRODUCTION
This document summarizes the main outcomes of a group
discussion focused on the Pharmaceutical sector.
Eleven regional enterprises, representative of the Emilia-Romagna
human and veterinary pharmaceutical industry, including both the
production and manufacturing sectors, have been invited to express
their position on the scientific and economic challenges they meet
on the way towards the development of new pharmaceutical
products. Researchers from regional academic institutes and
leading actors of the Life Sciences Laboratories of the EmiliaRomagna Hi-tech Network have been also invited to take part to
the discussion, in order to draw possible scientific solutions on the
basis of their competences.
The working group activity was organized by Aster in cooperation
with the Regional Centre for the Innovation of Health Products,
TEFARCO INNOVA. The activities were conducted by mean of the
focus group methodology, with the major goal to improve the
dialogue between enterprises and researchers and to speed-up
future interactions.
THE CONTEST AND THE
“FOCUS GROUP” METHODOLOGY
In the last years, Emilia-Romagna Government overall strategy has
been strongly intended to support Industrial Research and
Technology Transfer, with the main purpose to invest in the
knowledge and innovation-based development of the regional
production system. ASTER contributes to this policy issue by
promoting the co-operation between universities, research centres,
enterprises, financial markets and consulting services, so as to
establish a regional framework where human resources can be
reinforced and knowledge can be spread out and integrated.
Since 2004 Aster has been coordinating the creation of the EmiliaRomagna High-Tech Network, connecting scientific competences,
which share human resources and advanced instrumentation. From
2005, thanks to the Regional Programme for Industrial Research,
Innovation and Technology Transfer (PRRIITT), 5 “Networked
Regional Laboratories” focused on Life Science and related
technologies have been created.
Among these, there is one centre specifically focused on the
pharmaceutical sector and two laboratories whose research
activities are strictly connected to this sector:
-
-
-
TEFARCO INNOVA – Regional Centre for Innovation of
Pharmaceutical and Health Products, coordinated by the
University of Parma
ASC LAB – Stem Cells for Tissue Repair, coordinated by the
University of Bologna and soon to be transferred inside the new
laboratory of the IRET Foundation of 1600 square meters
R-GenTech – Emilia-Romagna Genomic and Biotechnology
Innovation Laboratory coordinated by the University of Ferrara,
with facilities in Bologna, Modena and Ferrara
The focus group initiative, recently launched by Aster consists in a
series of guided discussions conceived to explore, in a group setting,
what participants think and how they feel about previously decided
themes. Participant of the group discussions are regional
enterprises and academic research actors, faced in order to find a
common way to overcome the perceived bottlenecks in the
development pathway of a specific industrial sector. Three focus
groups on the Mechanic, Food and Life Sciences sectors have been
already carried out and others will be established in the near future.
THE RATIONALE FOR THE
PHARMACEUTICAL SECTOR
According to the latest report published by the industrial association
Farmindustria, the Italian pharmaceutical industry is quite strong,
ranking the third position in the European economy and the fifth at
world level. The sector, which faced a crisis in the late 1990s, today
accounts for 340 enterprises and more than 70 thousand
employees. Among the Italian enterprises, there are many big
companies with more than 250 employees and a larger number of
small and medium-sized businesses with promising development
potential, which account for almost 20 thousand jobs.
In this contest, Emilia-Romagna is one of the leading regions of the
Italian Pharmaceutical industry. Regional companies are few (11),
but they encompass 3500 employees, especially concentrated in
the area of Parma and Bologna.
These two cities rank in the first ten provinces in Italy in terms of
number of employees, with the presence of two industrial colossal:
the Chiesi group based in Parma and Alfawassermann in Bologna.
The continuous emergence of new diseases that require the fast
development of chemical substances with a therapeutic effect gives
to the pharmaceutical market a highly competitive nature and
indissolubly links it with the scientific research for the generation of
innovative products.
3. Medicine manufacturing and quality
4. Efficacy, safety and dedicate instruments for analysis
Accordingly, Italian industry is strongly directed towards R&D
activities, giving rise to a 77 pharmaceutical product pipeline.
Among these, we can count 35 drugs in the pre-clinic phase and 42
on clinic experimentation, of which 60% are biotech products. The
74% of the Italian clinical trials are conducted in Emilia-Romagna,
basically supported by local enterprises.
1. Drug discovery
Crucial bottlenecks in this sector are, first of all, the several
challenges arising from the molecular, gene or protein targets
discovery and from the identification of “drug-like molecules” active
on these targets. Secondly, the definition and interpretation of the
effects on biological complex systems and the validation of new
targets of therapeutic relevance. In this contest the lack of reliable
animal models becomes critical.
The long and risky pathway towards innovative medicines can be
facilitated by fostering of the research centres and industrial
companies to jointly tackle the challenges arising by emerging
diseases. The promotion of science - industry partnerships in the
pharmaceutical field is fundamental to achieve human and animal
wellbeing through prevention, diagnostic and manufacturing
technologies for an improved public health environment.
In order to overcome these difficulties enterprises must invest in
emerging technologies of combinatorial synthesis, high-throughput
screening, bio/nanotechnologies, cellular and tissue engineering.
The development of e-technologies and the progress in molecular
biology and pharmaco-informatics will help in modeling, simulating
and predicting a candidate substance with pharmacological,
pharmacokinetic and toxicological properties.
Keeping this in mind, the main objectives of the pharmaceutical
focus group are:
1. to analyse the actual pharmaceutical industry challenges
through the voice of a group of companies, representative of
the Emilia Romagna area;
2. to evaluate current barriers and constraints to pharmaceutical
industry development and innovation and to draw possible
solutions;
3. to raise awareness of the results achieved, producing a
document which can be used as a driver for future regional
policy.
2. Drug Delivery Systems
Drug delivery research focuses on the development of new drug
administration routes, leading to the product efficacy
implementation and to the patient compliance increase.
Major issues faced by pharmaceutical enterprises in this sector are
on one hand, the numerous problems related to the emerging
biotech substances administration and, on the other hand, the need
for the development of medicines for children, different from
medicines designed for adults or for the elderly. The improvement
of personalized medicines according to physical or genetic individual
differences are also wide sectors of emerging interest.
The starting point of the focus group activity came from a first
discussion group on the pharmaceutical sector, coordinated by
Aster in spring 2007 and established in the framework of the
Emilia-Romagna Health Technologies Platform. A relevant output of
this action was a document presented to the European Commission
in response to the public consultation on the future of
pharmaceuticals for human use in Europe, launched in July 2007.
Moreover, drug delivery technology is called to respond to the
necessity to have dosage forms for advanced therapy with biological
elements. Important diseases of this century, such as cancer,
Alzheimer, Parkinson, viral infections, tuberculosis, malaria, require
innovation for the goal to hit the affected parts of the body without
involving the healthy ones.
The Pharmaceutical focus group and its outputs reported in the
present document, has been intended to give a continuum to the
activities of the previous working group, enlarging the boundaries of
the discussion also to the veterinary sector and putting more
emphasis on the enterprises point of view.
THE DISCUSSION THEMES
Finally, vaccination without needle still remains a challenge. In this
field the new delivery technologies like microspheres, nanoparticles,
ionophoresis, electroporation, colloidal vectors, delivery devices for
alternative routes (inhalation, transdermal, buccal, vaginal, oral etc.)
play a key role as far as they can change the drug properties
without chemistry intervention.
Based on what emerged from the previous working group and on
what reported to the European Commission, four technical themes
have been identified and discussed:
1. Drug discovery
2. Drug Delivery Systems
IV
3. Medicine manufacturing and quality
research data collected in a GXP structure, suitable to directly
underway the regulatory procedures. The solution to this problem
could pass through the development of academy and interdepartment center consortia, where the academy bureaucratic
slowness can be overcome and the time-schedule imposed by a
competitive market can be matched.
Medicine quality anticipates efficacy and safety requirements and is
critical for the delivery to the market of new products. New
concepts are on the table of the manufacturing practices such as
the Quality by Design and Process Applied Technology, that are
intended to support manufacturers guaranteeing quality in real time
and with high confidence level. Emilia-Romagna region is particularly
known for its expertise in manufacturing machines. The
manufacturers are now considering a new approach to the
pharmaceuticals market consisting in the proposition of new
technologies of drug delivery coupled with new machines for
manufacturing new drug delivery systems.
Key steps to be undertaken by academy for the creation of these
structures are:
- to facilitate company access to research activities and speed
up the delivery process of reliable results;
- adoption by the research groups of transparent and well
defined procedures in terms of intellectual property, leading to
an easier establishment of commissioned research activities;
- to reinforce the academic linkage with hospitals, in order to
allow pre-clinical and clinical studies to be performed in the
same location.
4. Efficacy, safety and dedicate
instruments for analysis
The collaboration in pre-competitive research for drug development
is part of an EU iniziative known as IMI, Innovative Medicines
Initiative. IMI addresses the causes of delay or bottlenecks in the
R&D process in order to accelerate discovery and development of
more effective innovative medicines with fewer side-effects. The
targeted aspects include improved predictivity of non-clinical safety,
translational safety biomarkers, immunogenicity, non-genotoxic
carcinogenesis, expert systems for in silico toxicity prediction,
pharmacovigilance, islet cell research, surrogate markers for
vascular endpoints, genetics and genomics of type 2 diabetes, but
also training programs on safety sciences, pharmaceutical and
integrated medicines development and pharmacovigilance.
The availability of recognized research centers will provide industry
with the following added values:
- reduction of the number of contracts with foreign centers by
the national companies;
- improvement of the transfer of trained personnel from these
centers to the companies;
- attraction of new commitments, also from foreign companies;
- use of the center in a combined way between the medicine
manufacturer and the manufacturing machine producer.
Finally, veterinary industries pointed out the emerging vigor with
which animal health is influencing, during the last decade, human
health and food safety, in the light of the 90’s outbreaks of major
animal diseases. At present several factors threaten the veterinary
industry competitiveness, including the regional and more widely the
European regulatory framework and the increased development of
time and costs for new products faced by a sector mostly
characterized by small enterprises. The need for a close
collaboration between veterinary and human companies can be an
important step towards the innovation of this sector. Indeed, animal
research has the potential to produce important lessons for human
medicine development and thus to speed up the process for the
control of key human diseases.
INDUSTRY REQUIREMENTS
The delivery to the market of new pharmaceutical products is a
high-risky, time-costly business, that involves many different actors.
By the examination of this process, it clearly emerged that the
future of the pharmaceutical industry is strongly dependent on a
more intensive collaboration between all these actors, including
biologists, chemists, clinicians, engineers, pharmacists and official
functionaries. Pharmaceutical companies, especially small-medium
enterprises, cannot afford all the expenses and the competences
involved in the production process and academic support is critical
for them to remain competitive on the national and international
market. Moreover, a crucial requirement for introducing a new
product into the market is its efficacy, quality and safety certification
by health authorities. In this scenario, the enterprises expressed
the urgent need for the upgrading of current research laboratories,
not yet equipped for operating in an environment recognized by
health authorities, in light of the fundamental importance to obtain
THE EMILIA-ROMAGNA
RESEARCH EXCELLENCES
Pharmaceutical research in Emilia-Romagna is rich and
strengthened by a wide range of scientific expertise. Competences
V
According to the reported analysis, the Emilia-Romagna region is
well equipped to become what we could define a “Drug Discovery
and Drug Delivery Region”, with the mission to discover, develop and
manufacture innovative medicines.
in the sector range from chemistry, biology and biotechnology,
pharmacogenetics and genomics to drug delivery and machine
manufacturing.
THE FOCUS GROUP RESULTS
Taking into account the four themes discussed by the
Pharmaceutical focus group as reference, Emilia-Romagna scientific
base can support industry innovation and new medicine
development by offering advanced competences especially on the
following areas.
The focus group activity allowed to identify two concrete possible
answers to the current challenges met by pharma -industries within
the region.
New molecules and cells
- Computational techniques for the design and screening of new
molecules
- Synthesis of new molecules
- Computational systems biology
- Study and characterization of molecules having innovative
mechanisms of action
- Study of natural substances
- Methods of quick screening
- Pharmaco-genomics (database construction, genetic kits and
markers for resistance or response)
- Luminescent cellular biosensors
- Cellular drugs
First of all, universities called for a valorization campaign aimed at
increasing the industry awareness in the great resource
represented by the significant number of spin-offs recently
established in the region. Actually these spin-off at the moment may
be considered the more effective interface between academy and
industry. The creation of new spin-off or start-ups should promoted
and supported as well.
Secondly, all the participants, unanimously recognized the great
advantage that would stem from the presence in the region of an
advanced pharmaceutical laboratory working in GMP for the
manufacturing of bio-batches, lots of orphan drugs and structured
for research activities to be conducted in a GLP regime. This
laboratory could give to Emilia-Romagna a unique position in Europe,
coping for the Emilia-Romagna industry competitiveness. Such kind
of new facility is the target of a project proposed by TEFARCO Innova
for the generation of XL-PHARMA Lab, a new pharmaceutical
integrated infrastructure, fully dedicated to industrial research and
technology transfer, in the respect of the GXP certification.
Clinical and preclinical tests
- Development of bio-engineering methodologies
- Models and animal protocols optimization
- In vivo ed in vitro models and protocols
- In silico models and protocols
- Pharmacokinetics and metabolism (ADME)
- Clinical shared database
This aspect, joint to the impulse toward the creation of new spinoffs, will reduce the existing gap between research and industry,
leading to the creation of innovation processes more aligned to
business requirements.
Mew medicines, devices and materials
- Combined products
- Preformulation studies
- Inhalation products
- Drug delivery e targeting
- Veterinary medicines
- Personalized medicines
- Non-viral carriers for gene therapy
CONCLUSIONS
The focus group allowed the industrial actors to interact directly
with researchers, giving insights on the actual challenges faced by
regional pharmaceutical industry. In turn, the presence of university
researchers provided quick and tailored answers and clarifications
to the issues raised by enterprises.
Manufacturing and quality of medicines
- Process engineering
- Material/devices functionalizing
- Continuous processes
- Automatic machines and validation
- Sustainable automation
Moreover, the concurrent presence of human and veterinary
industries allowed to highlight possible advantages stemming from
interdisciplinary research carried out with enhanced collaboration
between groups skilled respectively on human and animal disease.
VI
In this context it is relevant the role of integrating structures like ASTER
and TEFARCO for the promotion of specific initiatives addressed to
facilitate the dialogue between academy and industry. The focus group
experience paves the way for futures synergies and co-operations for
the improvement of the competitiveness of the regional pharmaceutical
productive context.
The results here reported are not intended to be exhaustive. They
rather represent the initial stage of a more structured process to be
improved in the next future and hopefully supported by local, national
and European policy actions.
VII
THE FOCUS GROUP ACTORS
ACME DRUGS, also based in Reggio Emilia (Italy) produces the
drugs marketed by ACME and an innovative product to control
fertility in urban pigeons. ACME DRUGS has developed high-level
technological know-how in the production of paste and granules
dosage forms for the pharmaceutical industry.
THE COORDINATOR
TEFARCO INNOVA
ACME and ACME DRUGS collaborate in the development and
carrying our of pre-clinical and clinical researches on animals’
model and target species.
TEFARCO Innova is the Regional Centre for Innovation of Health
Products coordinated by the Interuniversity Italian Consortium of
Innovative Pharmaceutical Technologies. Its activity focuses on
innovative technologies for health products that can be transferred
to companies, in particular SMEs, active in pharmaceutical, food
and cosmetic fields.
For more information: www.acmedrugs.com
ALFA WASSERMANN S.P.A.
TEFARCO major goal is to develop scientific potentialities of all Italian
academic partners by a unitary action of transfer of their products
toward the industries, by mean of direct contacts, research
contracts, seminars and scientific communication, consultancy,
publications in cooperation.
Founded in 1948, Alfa Wassermann SpA is a consolidated
presence on the Italian pharmaceuticals market, researching,
producing and selling both prescription and self-medication
specialities. The headquarters and research laboratories are
located at the original premises in Bologna, while there is a modern
production unit at Alanno (Pescara). The International and
Diagnostic Divisions are based in Milan.
The intellectual and technical resources provided by the research
groups of the Consortium are represented by high technology
products, such as preparations for therapeutic or health use, having
high innovative content and added value. The centre also offers postgraduate courses on the themes of quality and manufacturing of
pharmaceutical, nutracuetical and cosmetic products.
Alfa Wassermann SpA promotes its products by means of a
network of medical representatives who visit general practitioners,
specialists and pharmacists as well as public and private
laboratories. With a workforce of over 700, the company also acts
as a holding company for the group (8 subsidiaries in Europe, USA,
China and North Africa with more than 1,100 employees).
The constant connection with innovative research and education
centres at national and international level, allow Tefarco Innova to
be constantly up-to-date for what concern scientific and training
requirements in the health products field.
One of the strong points of Alfa Wassermann SpA is that more than
60% of turnover is generated by its own products, developed by inhouse research. Alfa Wassermann also has a Division marketing
and selling non prescription specialities with an extensive network
of direct promoters to pharmacies.
For more information: http://www.tefarco.unipr.it/centro
PHARMACEUTICAL ENTERPRISES
ACME S.R.L.
Alfa Wassermann is also present in the human in vitro diagnostic
sector. In Italy the Diagnostics Division distributes products by
leading Japanese and American companies. This Division is the
technical partner of choice for numerous colorectal cancer
screening initiatives supplying faecal occluded blood test kits.
ACME s.r.l. is a veterinary pharmaceautical company set up in 1987
in Reggio Emilia (Italy) as a company specialized in the production of
food supplements and feeds for horses; soon ACME launches the
production of its products for dog and cat. In 1994 ACME obtains
its first authorization to market a drug containing an antiinflammatory for the therapy of the horses. To this day, ACME
markets drugs specifically for dogs, cats, horses, cattle and pigs in
addition to its production of complementary and high quality feeds,
cosmetics, feeds for cats and dogs and fluid therapy.
For more information: www.alfawassermann.it
AMBROSIALAB S.R.L.
Ambrosialab is an academic spin-off of the University of Ferrara. It
is an outsourcing source of applied research and services for
IX
- development projects in the respiratory area, cardiovascular,
central nervous system and rare diseases;
- development of delivery systems and formulations;
- advanced therapies.
companies, institutes and clinics in pharmaceutical, cosmetic,
nutritional fields.
Ambrosialab holds an authoritative know-how in the field of oxidative
process and posses a wide range of methods even exclusive
(dermanalyzer) for the determination of the oxidative stress and of
the antioxidant capacity of pure substances as well as complex
substrates such are body fluids, foods, pharmaceutical, cosmetic
and food supplements products.
For more information: www.chiesigroup.com
DOPPEL FARMACEUTICI
Doppel Farmaceutici was created in 1994 through a spin-off from
Hoechst Roussel Group. Since its foundation, Doppel chose to be a
"plain outsourcer": working only and exclusively on contract
manufacturing for other Italian and International Pharmaceutical
Companies.
Ambrosialab can evaluate by means of many different methods the
anti-oxidative potential of any substratum, using both instrumental
techniques (e.g. ORAC, PCL and DPPH test) and in vivo studies with
non-invasive bio-engineering methods (Dermanalyzer and SkinColor).
By the use of a solar simulator, which has the characteristics
required by European and international regulation institutions
(Colipa and FDA), we develop new strategies and original protocols
to test the efficiency of products aimed to protect the skin from
photo-oxidative damages deriving from solar radiations.
Starting out with about 40 employees, in 10 years Doppel has
become one of the biggest Italian companies with an estimated 400
people, two avant-garde production units in Italy (one in
Cortemaggiore, Piacenza and the other in Rozzano, Milan).and
partnership agreements with two very important Companies:
Farmaceutici Procemsa in Turin and the Swiss I.P.A.S.
Ambrosialab can offer complete scientific assistance in all steps of
the project, from its drafting to the creation of a prototype suitable
to be put onto the market, going from the identified molecule or
active principle to the training of the staff involved in the scientific
divulgation.
Doppel Farmaceutici is specialised in contract manufacturing of all
galenic forms especially: capsules, tablets, coated tablets,
pharmaceutical and alimentary granules, suppositories, ointments,
gels, creams, vaginal suppositories, drops, syrups, mouthwashes,
vaginal washes, oral solutions in single-dose container with active
ingredient reservoir cap, aerosol vials, sterile filling injection
ampoules or ampoules with final sterilization; medical foods and
nutritional supplements (Procemsa Farmaceutici). The company is
also allowed to manufacture small-scale batches for experimental
clinical use.
For more information: www.ambrosialab.com
CHIESI FARMACEUTICI
The Chiesi Group is a pharmaceutical company that researches,
develops, manufactures and sells innovative prescription drugs.
In 2007 Chiesi invested more than 80 million Euro in R&D activities,
with around 300 researchers, becoming one of the leading Italian
companies in the sector. Chiesi employs more than 3.000 people
and has a direct presence in more than 24 countries, in Europe,
Asia and the Americas.
Doppel Farmaceutici can also offer a wide range of services such
as analytical development, formulation development, stability
studies (ICH), process development and scale-up, process validation,
regulatory support, technology transfer and CTD compilation.
For more information: www.doppel.it
The Group’s main interests are the respiratory area, especially
asthma and COPD, where Chiesi has developed a number of delivery
technologies (sprays and dry powder inhalers), formulations (sprays,
powders and nebulising formulations) and innovative products,
neonatology, where Chiesi is world leader with Curosurf®,
cardiovascular and the central nervous system.
ERATECH S.R.L.
Eratech is a drug development company specialized in the field of
inhalation drug delivery via nasal and pulmonary administration, for
local and systemic therapies. The support offered by Eratech can be
provided at different levels moving from the simple consulting
service to the more sophisticated use of Eratech’s proprietary
formulation technologies.
Sectors of interest are:
- research projects in the respiratory area and rare diseases;
X
Eratech’s know-how and technological expertise are diversified in
the following areas:
- Liquid and dry powder formulation: design and lab development
of inhalatory formulations using powder production
technologies (dry powder blending, spray drying and
supercritical fluids
- Formulation characterization: definition of the critical properties
of the formulation in terms of solid state, particle size
distribution dry and wet, and stability
- Aerosol performance: evaluation of properties like dispersibility
and in vitro deposition in combination with the inhaler
- Scale-up: Eratech is capable of scaling-up the formulations
selected at lab scale for clinical and registration purposes
- Clinical studies and registration: Eratech, in collaboration with
a selected team of clinical experts, has the capabilities to
identify the ideal clinical strategy and conduct clinical trials
- Registration: Eratech’s team has several years of experience
in the registration of drug products for the Italian and European
market.
market innovative and high-quality products; its R&D laboratories
are GLP certified. In order ot satisfy EU requirements for the
development of veterinary medicinal products, fully respecting the
health and well-being of the animals, FATRO is also equipped with
GLP-certified animals facilities in a conventional environment and in
a confined one.
The key areas on which FATRO counts are: gynecology, anti-infection
therapy, metabolic therapy, liver therapy, anti-deficiency and
prevention (vaccines), by means of originally developed products.
In its facilities of Ozzano Emilia (Bologna, Italy), all the products and
vaccines for cattle, swine, sheep and goats, rabbits and fish are
manufactured, whereas avian vaccines are manufactured in the
facilities of Maclodio, (Brescia, Italy).
In addition to production facilities in Italy, there are production units
in Poland, Argentina and the Czech Republic. Moreover, some vetpharma companies have been totally or partially acquired in Spain,
Greece, India, Uruguay and Mexico.
Eratech is very active in the identification of new innovative
technological advancement in the area of inhalatory formulations.
The broad list of new opportunities offered allows for the
identification of original products that are characterized by improved
dispersibility, pulmonary deposition and sterility applicable to dry
powders or liquid formulations.
For more information: www.fatro.it
OPOCRIN S.P.A
Opocrin is a company active in research, production and marketing
of active pharmaceutical ingredients (APIs). Through its R&D
Laboratories, the company has also focused on researching
innovative APIs with high therapeutic value.
For more information: www.eratech.it
FATRO S.P.A.
The company is particularly interested in the following research
areas:
- pathologies that are connected with haemostasis and
thrombosis, typical of industrialized countries;
- ophthalmic and gynaecologic pathologies.
Active in the veterinary pharmaceutical sector exclusively for sixty
years, FATRO has been manufacturing vaccines and medicinal
products for farm and companion animals. The FATRO stock capital
is fully private and Italian: in Italy it has more than 280 employees,
and 80 technical scientific representatives who cover the whole of
the national territory. Through the years, FATRO has developed
constantly, acquiring a high pharmaceutical technological level and
achieving a leading position in Italy, thanks to investments in
research, a strong marketing action and a widespread selling
network in Italy and abroad.
In order to balance the high risks of the medium-long term projects
needed to develop innovative drugs, Opocrin’s strategy aims at
including in its product portfolio also medical devices, controlled
release pharmaceutical substances and new forms of
administration for drugs with high tolerability.
The main APIs currently produced and marketed by Opocrin are:
Parnaparin, Lung Surfactant, TSP (Tamarind Seed Polysaccharide),
Catalase, Sodium and Calcium, Heparin, Mesoglycan, Sulodexide,
Dermatan Sulfate, Iron Complexes (Sodium Ferric Gluconate; Iron
Sucrose; Ferric Protein), ANTEMA®.
Indeed, FATRO exports its products in 80 countries according to
an international expansion plan which adjust strategies to the
various local situations.
As regards the research and development sector, FATRO invests a
large share of its capital in order to obtain and introduce into the
Opocrin is mainly active in the production of active pharmaceutical
XI
Zanchetta S.r.l.
ingredients to be used in thrombohemolytic troubles, prevention of
postoperative thromboembolism, dialylsis (such as Parnaparin and
Sodium and Calcium Heparin) as well as in the treatment of deep
venous thrombosis (Dermatan Sulfate). Opocrin has recently
enlarged its APIs product range by introducing TSP (active principle
used as artificial tear) and some Iron Complexes such as Sodium
Ferric Gluconate, Iron Sucrose and Ferric Protein. Besides these
APIs, Opocrin has developed ANTEMA®, a medical device used as
a haemostatic adjuvant in the healing process of acute/chronic
vascular, traumatic and decubitus ulcers.
For more information: www.ima.it
MEDEL S.P.A
Medel designs and manufactures, since 1966, inhalation devices,
aerosoltherapy systems, disgnostic equipment and other products
for the home healthcare. Medel is driven by Research and
Development, which works in close relationship with the medical
community world and several pharmaceutical companies. Several
milestone in the nebulizer history were set by Medel: latest R&D
efforts materialized in the development of a unique and patented
technology that considerably reduced the size of nebulizer systems,
now the size of a cellular phone, battery operated. This technology
has made life of millions of asthma patients worldwide an easier
and a better one. Medel products are distributed in the best
pharmacies and medical shops worldwide: more than 60% of sales
are made abroad, in more than 70 countries, from U.S. to Middle
East, from Europe to Japan.
For more information:
MECHANIC MACHINES
MANUFACTURE ENTERPRISES
IMA S.P.A
Established in 1961, IMA is the world leader in the design and
manufacture of automatic machines for the packaging of
pharmaceutical products and of tea in filter bags.
The Group has more than 3,000 employees, more than 1,400 of
whom overseas, and a consolidated turnover of 425.2 million Euro
for the fiscal year 2006, with more than 92% earned on
international markets. The pharmaceutical sector, which is
characterised by a high and constant growth rate, accounts for
83% of the Group's sales (17% is in the tea sector).
Drug delivery via inhalation for pulmonary applications;
aerosoltherapy; nasal inhalation; inhalation; diabetes control and
therapy; diagnosis and prevention of hypertension; measurement of
body temperature.
For more information: www.medel.it
NILFISK-CFM S.P.A.
Nilfisk-CFM is world leader in the production of industrial vacuums,
pneumatic conveyors, centralized vacuum systems, high power
vacuums. Thanks to the high specialization, Nilfisk-CFM is partner of
the biggest production companies such as Roche, Alpha
Wasserman, CIBA, IMA, Volkswagen, Barilla, Ferrari, Fiat... NilfiskCFM core business are industrial vacuums, 40 basic models and
more than 500 versions able to satisfy the needs of many different
sectors.
IMA can count on 17 production plants in Italy, Germany, the United
Kingdom, the Netherlands, the United States, India and China. IMA
has an extensive sales network comprising 9 branches which
provide sales and service in France, the United Kingdom, Germany,
Austria, Spain, Portugal, the United States, China and Thailand,
representative offices in Central and East European countries and
over 50 agencies covering a total of more than 70 countries. IMA
is also participating in 2 joint-ventures in China for production and
service.
In its continuous endeavor to achieve total customer satisfaction,
Nilfisk-CFM has always given priority to the development of “special”
products, expressly made for specific applications. The most
demanding sector is the chemical-pharmaceutical one and it’s
precisely for these customers that Nilfisk-CFM developed a
complete range of dedicated products to meet their requirements:
the WHITE RANGE. Designed to comply with the strictest European
and worldwide norms and regulations, today the Nilfisk-CFM white
range can satisfy also the most exigent market’s
needs, even in hazardous environments in full compliance
IMA has recently acquired the freeze-drying machinery business of
the BOC Edwards Pharmaceutical Systems Group, undisputed
leader in this sector and with its main office in the Usa. IMA S.p.A.
has been listed on the Milan Stock Exchange since 1995 and in
2001 joined the STAR segment. The following companies are part
of the IMA Group: Co.ma.di.s. S.p.A., IMA Flavour S.r.l., IMA Kilian
GmbH & Co. KG, IMA Libra S.r.l., IMA Safe S.r.l., Nova Packaging
Systems Inc., Precision Gears Ltd., Swiftpack Automation Ltd.,
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with the ATEX directive.
The white range satisfies the safety and quality exigencies, that are
typical of this sector granting the maximum hygiene and preserving
the product quality and the operator’s health. Think only about the
features of this line: small size, wide filtration surface, high silence,
absolute filter and/or special filters for toxic dust (L-M-H). The white
machines can be realized in stainless steel or in ATEX flame-proof
version. Nilfisk-CFM offers high quality products to its customers, in
fact Nilfisk-CFM has obtained the most important and selective
International certifications such as ATEX, IECEx, TÜV, GS, Ce, CESI
and for the quality procedures Vision 2000.
For more information: www.nilfisk-cfm.com
EMILIA-ROMAGNA HI-TECH
NETWORK LABORATORIES
ASC LAB
Stem Cells for Tissue Repair: Development of Products and
Protocols for Research Laboratories
Research at ASCLAB is intended to bridge the gap existing in the
study of the alternative uses of stem cells in reparative medicine
through: (1) the creation of a bank collecting embryonic stem cells
(eSCs) and adult stem cells (aSCs) derived from different animal
species and grouped according to species-specific proliferation and
differentiation characteristics and (2) the development and transfer
of protocols for the use of stem cells to national as well as
international research centres.
The main scientific activities can be summarised as follows
- Analysis of the proliferative activities of eSCs and aSCs derived
from the tissues of various animal species (e.g. cattle, horses,
cats, dogs and mice)
- Analysis of the lineage of eSCs and aSCs from a neural
perspective (i.e. astrocytes, oligodendrocytes and neurons)
- Study of the role of micro-environmental signals in phenotypical
differentiation
- Development of a skin stem cell bank and skin organotypic
cultures
- Standardization of the use of eSCs and aSCs for
pharmacological and toxicology studies
When all objectives are achieved, a number of technologies can be
transferred to business and research partners such as protocols
for the production of clones derived from eSCs and aSCs;
cryopreserved primary cultures of astrocyte and oligodendrocytes
and, finally, protocols for the production of neural cells and for their
characterisation by means of RT-PCR, real time PCR,
immunocytochemistry and cytofluorimetry.
For more Information: http://www.aster.it/asclab.html
ER-GENTECH
Emilia-Romagna Genomic and Biotechnology Innovation
Laboratory
The laboratory specialises in genomics research and the
development of innovative biotechnologies with the objective of
becoming a centre of excellence for the transfer of new
technologies to the biotech and pharmaceutical industries as well
as to medical practice, thus narrowing the gap existing between
biotech/genomics research and industry applications and reducing
the delay with which research outputs are accessed by the industry.
ER-GenTech is currently conducting research in a number of key
areas:
- Genomic and post-genomic analysis of the ageing process,
tumour growth processes and chronic diseases
- Development and implementation of “decoy” molecules able to
alter the expression of genes that play a key role in human
disorders
- Development of last-generation viral carriers for the
introduction of recombinant proteins
- Creation of engineered proteins that play a key role as
“biosensors” of cell parameters to be used in the functional
analysis of normal and pathological cells and for drug screening
purposes
- Development of protocols for the use of engineered proteins to
create innovative therapies to cure widespread pathological
conditions such as hyper-cholesterolaemia
- Analysis of the self-regeneration and differentiation
mechanisms of stem cells aimed at developing treatments for
thalassaemia, osteoporosis and osteopenia
For more Information: http://www.ergentech.it
GEBBA-LAB
Virtual Laboratory for the Application of Bioinformatics to
Genomics and Medical Biotechnologies
Main aims of the lab are:
- integration of ICT, Bioinformatics and Biology researches;
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- application of bioinformatics to innovative technologies for
genomics and medical biotechnologies;
- synergy between the public research system and the
industries.
Current research is focused on the identification and
characterization of new molecular targets underlying drug action.
At present the main lines of research are:
1. The study of genes and mechanisms involved in the action of
antidepressant drugs
2. Genetic mechanisms underlying drug resistance
3. The development of new models (both at the cellular and
animal) that may provide a more efficient study of drugs and
their action
4. All key techniques used in molecular pharmacology and
pharmacogenetic studies: receptor binding, in vitro models for
the study of drug action, behavioral and genetic animal models,
proteomics, gene expression (real time PCR gene CHIP),
genotyping
The activities of the lab currently focuses on three bioinformatics
applications:
- Softwares for data management: GeBBA produced GePhCARD (Genotype-Phenotype Correlation, Analysis and Research
Database), an information repository that allows a complete
analysis of genetic and clinical data. This DBs create reports,
perform statistic analysis and collect epidemiological data
- Microarray data analysis: a service able to organize all the
information related to the microarray analysis and to integrate
them with analysis tools of quantified microarray hybridization
data. This service can be accessed at various level: from
storage and database organization, to data analysis and mining,
and on-line reporting
- Expression data analysis tools for the identification of Single
Nucleotide Polymorphisms (SNP). A new expression data
projection tool working at the genomic level is currently being
developed including specific protocols for the study of new RNA
such as microRNA
For more Information: www.dsb.unimo.it
Department of Pharmaceutical Science
Medicinal Chemistry group, Drug Discovery of Enzyme Inhibitors
Laboratory, (LADDIE)
LADDIE is located in the Department of Pharmaceutical Science
(SciFarm), that represents the main department of research in the
field of Drug Discovery at UNIMORE. The main research expertises
of the Department are molecular modelling, advanced synthetic
chemistry, analytical tool, enzymatic screening and drug delivery.
GeBBA-Lab is also interested in establishing connections with
similar laboratories in other European countries, in exchanging
knowledge and creating productive synergies.
The Medicinal Chemistry area is focused on anticancer,
antinfectives and antiadrenergic drugs. A research centre (Tefarti)
and a Spin-Off (Tydockpharma) have been developed among the
technological transfer activities. The SciFarm Department carries
on national and international research projects granted by WHO,
European Commission and industrial partners. The technological
platform is based on modern instrumentations including those for
design and synthetic chemistry (parallel chemistry, microwave
chemistry, rapid separation techniques); techniques for biological
screening and calorimetric studies (multiplate readers and ITC) and
it is integrated with the Centre of Large Instrumentations and
Centre for computational studies located in the scientific campus
area.
For more Information: http://www.gebbalab.it/
EMILIA-ROMAGNA
UNIVERSITY DEPARTMENTS
University of Modena e Reggio Emilia
Department of Biomedical Sciences:
Molecular Pharmacology and Pharmacogenomic research group
The
laboratories
of
Molecular
Pharmacology
and
Pharmacogenomics are situated at the Department of Biomedical
Sciences which counts more than 200 researchers covering the
various biological aspects related to health, disease and therapy.
The effects of that a drug may have on living systems are analyzed
at different levels that range from its effects on DNA to the function
of proteins up to the most complex integrative and behavioral
systems. This type of research is carried out both in extremely
simplified in vitro models using for example cell cultures, as well as
in vivo using various types of animal models.
The main research topics are: computational and experimental drug
design, combinatorial chemistry, microwave chemistry, library
design and chemical biology studies. Natural products studies. The
unit is focused on the discovery, synthesis and rapid screening
techniques of enzyme inhibitors and protein-protein interference in
the area of anticancer, antiparasitic drugs and beta-lactamase drug
resistant infections. In particular ovarian carcinoma is studied within
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spectroscopy, microscopic analysis (SEM/ESEM, TEM, AFM,
confocal microscopy), dimensional and surface analysis (PCS,
ESCA).
resistant bacterial infections. The Research products are
publications and 4 patents.
The Lab offers following services: design of new bioactive molecules
through experimental and computational techniques, library design,
combinatorial chemistry, protein purification and rapid screening
assay. Bioassays set up. In vitro predictive pharmacology
experimental models. Enzymological screening in GMP.
The centre has different instruments at customer’s service such
as drying machines for solution (i.e. Spray-drying) or instruments
suggested by Italian Pharmacopea for the determination and assays
on powders (density, absorbent capacity) and solid pharmaceutical
products (determination of dissolution, of disaggregation time),
along with the more common and used instrumentations for the
preparation of granulates, tablets and capsules.
For more information:
http://cdm.unimo.it/home/dipfarm/costi.mariapaola/
Department of Pharmaceutical Sciences
For more information: www.tefarti.unimo.it
University of Bologna
Department of Pharmaceutical Sciences
Research centre on Traditional and Innovative Pharmaceutical
Technologies (TEFARTI)
Te.Far.T.I. is a university research center which brings together
researchers from the university of Modena and Reggio Emilia.
Te.Far.T.I. develops multi-disciplinar fields of research (maintaining
a broad spectrum of applications) along with the primary focus on
pharmaceutical field (Traditional and Innovative Pharmaceutical
Technologies) with interventions and high quality works which adapt
themselves to the market’s requirements.
Group of Computational Medicinal Chemistry
The research Group employs several bioinformatic and
computational methods, which permit the construction and use of
models of molecules and molecular complexes of different sizes,
from small organic molecules to fully solvated protein complexes in
membrane. Besides basic modeling techniques (based on classical
mechanics or on quantum chemistry), procedures specifically aimed
at the design or identification of lead candidates, like
pharmacophore building, molecular docking, and virtual screening,
are used.
The researchers belonging to Te.Far.T.I. Modena are managing
researches on the preparation of polymeric and colloidal carriers
(microparticles, liposomes, polymeric nanoparticles and solid-lipid
nanoparticles) able to target and deliver pharmaceuticals and gene
materials to the brain and against tumors. The synthesis of modified
polymers and lipids (pegilation, linkage with antibodies or peptidic
fragments) used in the preparation of carriers able to selectively
deliver drugs to the target site and to cross the cellular membrane,
is fundamental for the modern drug delivery and for the production
of “smart” innovative delivery systems.
Current activities of the Group concern both the identification of
new molecules candidate to become pharmaceutical leads, and the
study of target protein systems. The research lines cover various
therapeutic fields, like cancer, neurodegenerative diseases
(Alzheimer) and neglected diseases (trypanosomiasis), as well as
the drug safety field (drug-induced long QT syndrome). With regard
to the identification of possible leads, we are presently considering
such molecular targets as BACE1 and Cdk5 (Alzheimer’s disease),
Cdk2/Cyclin E and cytochromes P450 19 and 17 (cancer), Fab
and trypanothione reductase (trypanosomiasis). The molecular
systems currently under investigation are the Cdk7/Cyclin H
complex involved in the control of cell cycle and gene transcription,
and the cardiac potassium channel hERG, whose blockade is one of
the most relevant causes of the long QT syndrome in both the
inherited and the drug-induced forms.
The knowledge developed by Te.Far.T.I. researchers consists of the
modification of FDA approved biodegradable polymers, such as polylactide-co-glycolide acid, and of the solid-phase synthesis of peptides.
The ability of the formulated vectors has been proved by in vivo and
in vitro tests with both qualitative and quantitative assays.
The centre offers both experiences on pharmaceutical preformulation and formulation and on the use of advanced
technologies for the chemico-physical characterization of drugs and
pharmaceutical products, along with thermal analysis (DSC), high
performance liquid chromatography (HPLC), gas-chromatography,
nuclear magnetic resonance (NMR), X-ray crystallography, IR
The Computational Medicinal Chemistry Group is fully available to
welcome people from Institutions or Companies, and to train them
to the comprehension and utilization of the methods used in the
computational laboratory. Furthermore, the Group welcomes the
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systems.
For more information:
http://www.ing2.unibo.it/Ingegneria+Cesena/Facolta/Strutture+d
i+servizio/Laboratori/Cesena/ICM/default.htm
participation in multidisciplinary projects aimed at the discovery of
lead candidates, or at the preclinical development of leads. In this
context, expertise and instrumentation can be provided, as well as,
through the collaboration of other groups in the Department, the
synthesis of designed single molecules or small libraries of analogs.
UNIVERSITÀ DEGLI STUDI DI PARMA
For more information: http://www.scfarm.unibo.it/
Department of Electronic, Informatics and
Systemic (DEIS)
Industrial Engineering Department
Applied mechanic group
The research group aims at research and implementations about
automated machines design, motion control and tribology, in
particular in the fields of pharmaceutical and food industry.
Laboratory of Cellular and Molecular Engineer for the study of
Bio-Nano-Systems
The laboratory research topics focus on the use of cell molecular
components in new systems for diagnosis and medical therapy. The
design of such system is carried out with a multidiscipline approach,
integrating competences from biochemists, biologists, engineers
and doctors. The Laboratory was created in 2005 within the
Cesena Campus thanks to the contribution of three departments of
the Bologna University (DEIS, ARCES, Biochemistry). The laboratory
is involved in many important research projects, both at national
and international level, focused on bio-nano technologies, synthetic
biology, pharmacogenetics, tissue engineering.
Experimental activities make use of some test-beds designed for
investigations on sustainability issues: contaminants sealing
systems and methods, friction reduction, reducing residual
vibration. Moreover, new software tools have been written for
mechanism synthesis with advanced laws of motion, for simulation
with multi-body analysis of mechanical systems including large scale
problems, like granular flows.
Ongoing agreements with industries are aimed at implementing
new technologies for sterilizing containers for low acid canned
foods, building an innovative automated factory for manufacturing
medical devices where new autonomous guided vehicles will be
used. Some researches are active members of the Italian GAMP
forum and strictly cooperate with the main world pharmaceutical
equipment manufacturers.
The Laboratory is equipped to perform experiments of cellular and
molecular biology and computer simulation of biological processes
at cellular and molecular scale. Current research activities deal with:
biophysics of cellular membranes and systems for the generation
of artificial lipidic membranes; bioreactors and engineered tissues;
bioinformatics and computational biology; ionic channels and ligandreceptors interactions; prediction of the ternary structure of
proteins and analysis of the molecular dynamics; bio-nanoelectronic
devices; electrophysiology and electrochemistry; epigenetics; gene
expression and signal network; nanopores for clinic applications;
molecular sensors based on bio-morph and mixed domain
technologies; software for cellular and molecular imaging; matrixes
of micro-transducers and micro-manipulation; molecular computing;
synthesis of genetic programmes for the control of protein
synthesis and of cellular functions.
The department houses a postgraduate course on design and
validation of automated machines for life sciences industries. The
research group is willing to start collaborations and agreements
aimed at transferring its
know-how on pharmaceutical
manufacturing technologies. Moreover, it is possible to agree
research programs for designing bespoke machine prototypes and
for redesign existing machines taking in account energy saving and
environmental sustainability issues as newer standards and energy
costs require.
The laboratory offers the following services: electrophysiology
measures on heart cells and neurons for drug screening;
experimental evaluation of the drug action on the activity of a single
ionic channel and identification of the site of action through
computer analysis; analysis of the epigenetic profile regulating the
gene expression for genes of physiopathology interest; production
of expression systems for protein generation; design of bioreactors
for cellular cultures; design and production of process control
For more information: http://ied.unipr.it/silve
Pharmaceutical Department
Pharmaceutical Chemistry Group
The group includes several full-time researchers and a varying
number of graduated and post-doc students, working in the field of
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medicinal chemistry to the discovery and development of new
compounds having potential therapeutic applications. The group is
divided into three units, fully coordinated, dedicated to synthetic, bioanalytical and computational chemistry, respectively.
The research in the drug design and discovery area allowed the
identification of new compounds with promising biological
properties. In particular, a new class of endocannabinoid tone
modulators, have been discovered with the contribution of the
group, and a new compound has been advanced to clinical study
for the treatment of anxiety and depression; the medicinal chemistry
investigations also resulted in the characterization of new histamine
H3 antagonists, melatonin receptor ligands and EGFR inhibitors,
potentially useful for the treatment of obesity, sleep disorders and
cancer, respectively. The group is also involved in projects at the
development stage, studying drug stability, pharmacokinetics and
metabolism; optimization of these features by structure-activity and
structure-property relationship analysis have been actively pursued.
In the last few years the group has registered several international
patents, all of them licensed to Regional and extra-Regional
Pharmaceutical industries.
The group offers the following services: design and development of
drug delivery systems prototypes; validation of drug manufacturing
procedures; laboratories dedicated to the development of inhaling
therapy and trans-dermal preparations.
For more information: www.unipr.it/arpa/dipfarm
Design and synthesis of new compounds devised as enzyme
inhibitors or receptor ligands. Purity samples for chemical
substances (NMR, HPLC, elemental analysis: C, H, N, S).
Chemoinformatics and computational chemistry: design and
analysis of compound libraries; estimation of physicochemical
properties; virtual screening.
Drug metabolism and pharmacokinetics: in vitro evaluation of
compound metabolism (plasma, liver extracts); quantification of
drug and metabolite levels in vivo after systemic administration (LCUV, LC-MS). Detection and measurement of drug-protein adducts
(MALDI-TOF).
For more information: www.unipr.it/arpa/dipfarm/medchem
Pharmaceutical Department
Pharmaceutical Technologies Group
The group is composed by a number of permanent personnel and
host several PhD, post-doc, fellows students, including Italian and
International students. The group is focused on the discovery and
development of new technique, products and drug delivery
platforms.
Group activities include drug delivery studies for administrations
alternative to the parenteral rout, especially the pulmonary, nasal,
trans-dermal and oral routes.
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