- 1. Pharma ThinkTank Consulting Business Presentation Buenos
Aires, Argentina
2. THE TEAM 3.
- Pharma ThinkTank is conformed by a team of professionals
specialized in the different aspects of the Pharmaceutical Industry
and the Health Market, in general.
- Our human group is formed by men and women of diverse academic
and professional background, with a proven track of success in the
public and private sectors. Thiscrossed-expertiseallows us to
analyze the problems from different angles, ensuring a final
product tested under every light. This is not just a differential
treat of our company but a double-insurance for our clients,
guaranteeing savings in time and money.
- At Pharma ThinkTank we have a commitment to beingleaders in
serviceoffering original and personalized solutions to fit the
necessities of each one of our clients.
4.
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- He currently works as Pharma ThinkTank General Director (2008
onwards)
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- He held the position of Immunology Sales and Marketing Manager
with Abbott Laboratories in charged of products for Rheumatology,
Dermatology, Gastro. and Multiple Sclerosis (2006-2007)
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- He was appointed Sales Manager for Johnson & Johnson
Medical Devices & Diagnostic's Diabetes division after
occupying the position of Regional Marketing Manager for the
Southern Cone for the same division, where he successfully launched
the first TV campaign in the specialty (2002-2005)
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- He worked helping to establish a Biotech business incubator in
San Francisco, California (2001)
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- He was Founder and Manager of Viacom Consumer Products Cono Sur
(1998-2000)
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- He also occupied the position of Associate with HSBC Investment
Banking (1997-1998)
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- Federico holds a Master in Business Administration specialized
in Finance & Accounting from the University of Rochester, NY
(2002) and a Postgraduate Degree in Marketing from Universidad de
San Andrs (1998). He also holds a BA in Business Administration
from Univ. Torcuato Di Tella (1997)
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- Among other extracurricular activities, he has taught several
classes of Pharmaceutical Marketing and Loyalty Programs at the
UCES MBA Program and different after-graduate programs from
University of Bs. As. He has been guest-speaker in different events
related to the Health Industry
5.
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- She currently works as Mundo Sano Foundation General Director
(2008 onwards)
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- She was Argentina's National Director of Health Economics
(2007-2008)
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- She worked as Advisor in Drug Policies, Pharmacoeconomy and
Pharmaceutical Industry with the National Ministry of Health, and
Coordinator of the Strategic Research Unit of the National Ministry
of Health (2002-2007)
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- She was appointed as National Coordinator of Drug Policies for
the MERCOSUR Region (2002-2008)
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- She is a member of the Board of the Argentinean Health
Economics Association
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- Sonia is Dean of the Masters Degree in Pharmaco-Politics from
ISALUD University and active Faculty teaching several courses in
undergraduates and postgraduates careers at the UNLP Economics and
Medical Schools. She is also teaches Financing and Expenditure,
Health Economics and Drug Policies at ISALUD University
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- Is author of three books and several articles specialized in
the pharmaceutical industry, drug policies, financing,
pharmacoeconomics and intellectual property
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- Sonia holds a BA in Economics and a Masters Degree in Public,
Provincial and Municipal Finance from the UNLP. She is a Health
Economics, Pharmaceutical Industry and Public Service Regulations
Specialist from UADE University.
-
- She has served as guest-speaker in numerous national and
international congresses and has represented Argentina in several
Governmental Forums in relation to R&D, Innovation, IP and
Public Health
6.
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- He currently works as General Director DOC/HR Solutions and as
a free-lance Consultant for Korn Ferry International (2007
onwards)
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- He worked as Regional Director of Human Resources with Johnson
& Johnson Medical Devices & Diagnostics for the Southern
Cone and as HR Business Partner for LifeScan J&J division for
Latin America (1996-2006)
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- He worked as independent Psychologist and Organizational
Development Consultant (1981-1995)
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- He held a number of Sales positions over the years. He headed
regional sales teams for companies such as Noblex and Hitachi
(1978-1981), and a local team for Renault Group (1977-1978)
-
- Gerardo currently is an active Faculty teaching Managerial
Skills and Administration and Change Management at the Masters in
Business Administration Program from UCEMA. He is also a frequent
guest-speaker at IAE's Business School in topics related Leadership
and Organizational Development
-
- He holds a BA in Psychology from Universidad de Belgrano. He
has a Masters Degree in Diagnostic Techniques and Organization
Change from the same University and another Masters Degree in
Businesses Administration from CEMA. Additionally, he has completed
a Program in Executive Education at IAE University and a Program in
Executive HR Development at Michigan University
-
- Gerardo is an independent author of dozens of articles related
to Coaching, Leadership and Organizational Development
7.
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- He was Regional Manager for Asia, Africa and Europe for
Laboratorios Bag S.A. (2006-2008)
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- He held the positions of Quality Control Manager for
Laboratorios Bag S.A. (1998-2006) and Quality Engineering Manager
for Abbott Laboratories Argentina (1995-1998)
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- He was Head of the Analytical Laboratory of Ciba Geigy (today
Novartis) from 1992 until 1995
-
- Eduardo has specialized in quality and regulatory affairs
throughout the majority of his professional career. In the past few
years, however, he was appointed to occupy regional positions in
the commercial area. This multinational exposure left him with vast
knowledge of the pharmaceutical business in different regions of
the world. Among other things, he became an expert in the
development of business models for the registry, distribution and
commercialization of pharmaceutical products in different countries
of Asia, Africa and Europe
-
- In early stages of his career, Eduardo was a an active faculty
teaching Analytical Chemistry at the Department of Inorganic,
Analytic and Physic Chemistry from the University of Buenos
Aires
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- Eduardo holds a BA in Chemistry also from Universidad de Buenos
Aires and has a Masters Degree in Industrial Enterprise Management
from UCA-EOI (Madrid) and a Diploma in Project Management (PMI)
from the Instituto Tecnolgico de Buenos Aires (ITBA)
-
- Additionally, he has completed several courses at Instituto
Argentino de la Empresa (IAE) in Management and Human Resources, on
top of several others in Quality Affairs and Pharmaceutical
documentation in Chicago, USA. He has also taken courses in
Marketing and Neuro-Linguistic Programming
8.
9.
- Our objective is to be the consulting firmleader in servicein
each one of the markets in which we decide to operate.
Ourexpertiseis mainly concentrated on the areas of Pharmacoeconomy,
Legal, Regulatory, Commercial and Human Resources. Our success
rests upon the fundamental premise of being able tosatisfy with
excellencethe needs of our clients, Pharmaceutical Companies, CROs,
Research Centers, Medical Associations and Government Agencies,
based on four fundamental pillars of service: Agility, Reliability,
Flexibility and Seriousness.
10.
- We see Pharma ThinkTank as a legitimate way of adding value to
the society in which we live in and operate on. We view it as a
source of ideas and strategic/operative solutions at the benefit of
Pharmaceutical Companies and the Healthcare industry, in
general.
- As a group of professionals we share a common passion for
consulting services and for personalized attention to our clients.
We are keen to the use of technology and the most modern research
and marketing tools. We seek to reduce bureaucracy to the minimum
and to maximize growth opportunities. We strive permanently to
administer resources efficiently and for excellence in everything
we do.
- We want to be picked for and distinguished by the excellence of
our service. We want our workers and providers to be proud and
satisfied of working with us, recognizing us as fair and honest
counterparts with whom to create long-term alliances with.
- We desire to be recognized for our social engagement, for
taking part and collaborating with different projects involving the
communities in which we operate on .
- Finally, we establishethicsas our companyscorner stone . It
will be this and no other, who will prevail together withcommon
sense , in every single decision-making process.
11.
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- Ethicsandcommon sense,above all, as ultimate guiders of our
personal and professional conduct. Present in every decision-making
process.
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- Maximumconfidentiality , in dealing with our clients
information.
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- Equity ,responsibilityandtransparency , in each transaction,
activity, or potential or actual relation.
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- Empathy,to understand the problem from the clients perspective
and to look for the optimum solution in an objective manner.
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- Energyandpositivism,as a general attitude to achieve every
desired objective and milestone, no matter how hard or unreachable
it may seema priori .
12.
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- Current and potential clients
Pharma TT Medical Associations Publicand PrivateHMOs Clinical
Research Centers CROs PharmaceuticalCompanies Government Agencies
13.
Pharma TT
- Advisory and Auditing Services
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- Good Practices Certifications
- and Product Positioning Strategies
- The Argentinean Health System
- Workshops in Intellectual Property
- Legal support in commercial operations
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- To Law Firms / legal divisions
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- To Labor Union and Private HMOs
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- To Pharmacies and other institutions
- Vis--visstudies drugs vs. other treatments
- Pharmaceutical-cost indicators
- Economic valuation-tools of drug usage
- Training and Workshops on Pharmaco-
- Recruiting & Head-hunting
14.
PHARMACOECONOMY 15.
- Pharmaceutical cost indicators
- Identification, classification, analysis and determination of
economic costs
- Estimation of new products costs
- Temporary adjustment of costs and sensibility analysis
- Monetary valuation of resources utilized in the application of
a new product
- Supporting techniques for economic valuation
16.
- Vis--visstudies of drugs, treatments and medical
technology
- Evaluation of a new product vs. reference product/treatment
(Golden Standard)
- Evaluation of a new product vs. existing product
- Evaluation of a new product vs. placebo
- Evaluation of costs of a new product
17.
- Planning of studies and economic valuations
- Development ofCost Minimization Studies
(CMS)andCost-Effectiveness Studies (CES) . Analysis and application
of results in the decision-making process, economic valuation and
policy of drugs
- Development ofCost-Utility Studies (CUS),estimation of benefits
of diverse treatment alternatives. Usage and calculation of quality
adjusted life-years(QALY) .
- Development ofCost-Benefit Studies (CBS) . Monetary valuation
of results, development of a measure of monetary value and
valuation of results through willingness to pay
18.
- Executive education and training in pharmacoeconomics
- Courses and seminars in pharmacoeconomics, economic valuation
and analysis of results
- Elaboration of articles and statistical analysis
19.
LEGAL 20.
- Advisory to Law Firms / legal departments or divisions
- Our deep understanding of the Health Industry allows us to
successfully advice Law Firms and a broad array of legal
departments/divisions of players related to the industry
- Among other topics, general legal framework and specific norms
about the National System of Health Insurance, PMO (Mandatory
Medical Plan), national and international legislation on
Disability, Decentralized Operations Regime for Public
Hospitals
- Specific legislation on the different aspects and actors of
National and Provincial sanitary policy
21.
- Advisory to commercial divisions
- We offer legal support to commercial divisions of
pharmaceutical companies, drug-wholesalers, and other drugs and
medical devices distributors
- Drafting and/or review of existing provision and distribution
contracts, among others
- Advisory on current ANMAT (Argentinean Food and Drug
Administration Agency) legislation , Special Programs
Administration (or APE, in Spanish), Superintendence of Health
Services and the Federal Health Program
22.
- Advisory to commercial divisions (cont.)
- Legal support in topics related to Business Loyalty according
to Law 22,802
- Preventive legal analysis of advertisements, games and
promotions
- Advisory on Customer Defense issues related to administrative
and judicial claims
- Evaluation of alternatives before administrative fines in
relation to the application of Commercial Loyalty laws, Customer
Defense, legal and supply metrology, with vast knowledge of the
criteria followed by the corresponding National, Provincial and of
the Government of the City of Buenos Aires authorities
- Analysis and recommendation related to the convenience of
appealing to the Arbitration Court of Consumption
23.
- Advisory to Labor Union and Private HMOs
- General judicial framework and specific norms and regulations
on the National System of Health Insurance, PMO (Mandatory Medical
Plan), national and international legislation on Disability
- Special Programs Administration (APE): Current legislation.
Coverage: Medical assistance services. Drugs and treatments. Basic
mandatory services for disabled people. Procedure for presentation
of financial support forms. Exception ways. Reference values
- Superintendence of Health Services: Judicial ordering. National
Registry of Care Providers. Decentralized Operations Regime for
Public Hospitals: Fees and approved practices per category.
Formulary. Automatic debit system
24.
- Advisory to Pharmacies and other institutions
- Our company specializes also in topics related to obtaining
permits for pharmacies, drug-wholesalers, medical establishments,
among others
- Advisory on drug coverage by the National System of Health
Insurance, whether be it ambulatory or for special
treatments/pathologies. Alternative therapeutic drugs. Drugs with
100% coverage for beneficiaries
- Drafting or revision of provision contracts, distribution,
management and/or administration of pharmacies
- National Registry of Care Providers: professionals,
establishments and network of pharmaceutical services
25.
COMMERCIAL 26.
- Our organization counts with the support from experts in the
market research field with broad experience in projects related to
launching, positioning or repositioning pharmaceutical products and
medical devices at a local and regional level (Latin America)
- The different methods include background research or secondary
data, qualitative and quantitative research, motivational and
experimental research. Within the latter we can distinguish the
exploratory, conclusive and performance monitoring
- Among the techniques applied to research we can distinguish
personal, phone or on-line interviews to physicians, end-consumers
and/or purchase decision-makers, focus groups, multi-target groups
and mystery shopper technique
27.
- Launching and product-positioning strategies
- We specialize in generating ideas for launching new products,
uses, pharmaceutical forms and indications before the most diverse
audiences including prescribing physicians, KOLs, medical-auditors,
pharmacy personnel, Government agencies personnel, and patient
associations and their families (only for OTC products)
- Our services range from external logistics and/or
organizational assistance to Commercial Divisions to delivering
turnkey projects that include, among other things, audio services,
lighting, simultaneous translation (to virtually every language),
photography, video, catering, and transportation and hotel
accommodations for events inside and outside national
territory
28.
- Development of Overseas Markets
- We offer consulting and advisory services for the development,
registry and commercialization of pharmaceutical products in
Southeast Asia, MENA (Middle East and North Africa), Africa and
Europe.
- We have proven expertise in markets such as:
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- ASIA: Pakistan, Sri Lanka, Myanmar, Vietnam, Singapore,
Malaysia, Indonesia, China, Thailand, Korea and Philippines
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- MENA: Lebanon, Morocco, Jordan, GCC, Egypt, Iran and Yemen
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- Africa: Kenya, Sudan, Ivory Coast, Benin, Congo, Senegal, Togo,
Cameroon and South Africa
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- Easter Europe: Russia, Ukraine, Kazajstan, Georgia, Azerbaijan,
Armenia, Croatia
29.
COMMERCIAL Development of Overseas Markets (cont.) Each country
presents its own business model, regulatory barriers, standard
procedures for registering products and brand and fixating prices.
They also have their own traditional commercial channels,
reimbursement programs and tendering processes Each country
represents a different business opportunity according to the
therapeutic class and products chosen
30.
- Courses and workshops on aspects of The Argentinean
Health-System
- Design and general organization (turnkey projects) ofinternal
training coursesaimed at upper/middle management, as well at
general personnel
- Design, recruiting and general organization (turnkey projects)
ofexternal training courses , aimed at physicians, auditors,
pharmacy and HMO personnel, and/or at Government authorities.
- Topics include differences between thepublic and private
sectors , including general procedures and legal ordering, the
National System of Health Insurance, structure and functioning of
the Special Programs Office (APE), Mandatory Medical Program (PMO),
National Administration of Pharmaceutical Companies and Health
Institutes (ANLIS), Federal Programs, and every aspect related to
special treatments and drug-pharmacoeconomics, among others.
31.
- Workshops in Intellectual Property
- Introduction to the concept of Intellectual Property
(Patents)
- Advantages and disadvantages of its application from a
commercial standpoint
- International treaties and their implication in the
pharmaceutical business
- Current situation in Argentina
32.
- Advisory to commercial divisions
- We offer legal support to commercial divisions of
pharmaceutical companies, drug-wholesalers, and other drugs and
medical devices distributors
- Drafting and/or review of existing provision and distribution
contracts, among others
- Advisory on current ANMAT (Argentinean Food and Drug
Administration Agency) legislation , Special Programs
Administration (or APE, in Spanish), Superintendence of Health
Services and the Federal Health Program
33.
HUMAN RESOURCES 34.
- Design and organization of workshops on leadership, motivation
and managerial coaching specially tailored for executives whose
main responsibility is conducting technical and/or commercial
teams. Led by publicly-recognized figures in the field, these
workshops emphasize on solving problems and conflicts with a
lateral approach (out of the box thinking), in which all parts
included win while none lose (win-win agreements)
35.
- Recruiting & Head-hunting
- We count with a division specifically oriented to satisfying
the demand of our clients for executives oriented to the
health-industry. Ourexpertiselays mainly on searches aimed at upper
and middle managers/executives
- We specialize in reengineering and general consulting services
on Human Resources, including the analysis and development of
career plans based on core-competencies, succession planning,
compensation schemes, and searching, retaining and developing
internal talent within the organization
36.
REGULATORY 37.
- Agency services: Registrations
- We register medical specialties, medical products/devices,
pharmaceutical products registered and elaborated in a member-state
of MERCOSUR.
- We also register sworn declarations after Label changes (Disp.
3855/98), identification characteristic data and new pharmaceutical
form and concentration
38.
- Agency services: Registrations (cont.)
- We advice on and take care of inspection requests to
manufacturing plants from abroad, registration of medical products,
registration of diagnostic products of in vivo usage,bioequivalence
formularies (5040/06), formularies for importing medical products,
declarations of change of Medical Director (Disp. N 2319/02),
requests for alimentary-products analysis, registration of
alimentary products and dietary supplements (RNPA), authorization
for bottles and other materials in contact with food, forms for
free-circulation with alimentary-products, forms for
free-circulation with bottles and other materials in contact with
food
39.
- Advisory Services: Production of Dossiers
- We provide assistance in the production of Dossiers in spanish
for the registry of products in countries of Latin America, as well
as Dossiers in english for the registry of products in countries of
Asia, MENA (Middle East & North Africa), Africa and Europe in
accordance to the current norms and regulations of the country. We
also assist our clients during the registry process itself advising
them and dealing directly with the regulatory authorities of each
country.
40.
- Advisory and auditing services: Certification in Good
Practices
- Our crew of experts offer advisory in everything related to
obtaining certification for GMP / GCP / GLP, GMP for plants, GMP
for products exclusively made for export, GMP for product-registry
abroad, certification of lots clearance for pharmaceutical products
made for export, certification of OTC sale, certification of
pharmaceutical products according to WHO model and GMP
certification for export of raw materials
41.
- Advisory and auditing services: Certification in Good Practices
(cont.)
- We provide assistance in the prior stages of being audited or
inspected by foreign authorities of Latin-American countries or of
regions such as Asia, Middle East, Africa and Europe. We issue
improvement recommendations and layout action plans to prepare the
plant for the inspections. At the same time we stand by our clients
and advice them throughout the entire auditing process with the
final goal of getting approval in accordance to the actual norms
and regulations of the country conducting the inspection.
42.
- Advisory and auditing services: Clinical Research
- We offer a comprehensive list of services targeted to the
sponsors of Clinical Research studies. These include, among others,
the co-design an drafting of protocols for the different phases of
the study, advisory in the preparation and presentation of
documents before regulatory authorities, internal auditing, systems
and processes, selection and independent auditing to Research
Centers, contingency-plan development and monitors training
- We also offer complete methodological support and advisory to
Ethic Committees
43.
- We assist our clients in obtaining permits and completing
paperwork related to the opening and/or regularization of
pharmaceutical companies, laboratories specialized in clinical
analysis, drug-stores, pharmacies, physician offices, medical
centers, clinics, sanatoriums, institutes and maternity clinics,
orthopedic shops, optics shops, herbal shops, vaccination offices
and distributors of biomedical, sterile and disposable products in
accordance to Resolution N 255/94
44.
- Other agency services (cont.)
- We also help our clients obtain permits to import, export,
elaborate medical-specialties, handle active principles, establish
manufacturing and bottling facilities, resellers and importers of
fitotherapeutic drugs, permits to drug-distributing companies,
permits for bottling, reselling and warehousing companies of
Ethylic Alcohol destined for humane use, registry of establishments
that do interjurisdictional transit,permits of manufacturing and
importing establishments of medical products, and registry of
establishments and dietary and supplementary products
45.
OTHER SERVICES 46.
- Our company offers a unique 360 advisory service aimed at
satisfying the needs of those looking to establish temporary or
permanently in Argentina
- Our multidisciplinary team ensures the most comprehensive
coverage available in the market in issues related to Legal,
Regulatory, Commercial, Pharmacoeconomy and Human Resources
- Thanks to exclusive strategic alliances we also offer our
clients Real State (plants, warehouses, commercial offices) and
Financial advisory
47.
- Strategic partnering search in the local and international
market for the marketing of medical devices and/or pharmaceutical
products according to the company profile, line of products and
desired level of financial exposure
48. Sales Contact Federico Fascetto [email_address] Cell. (from
within Argentina): 155 182-5232 Cell. (from Abroad): +(54911)
5182-5232 Other Inquiries Attn: Consulting Team[email_address]
Phone/Fax (from within Argentina): 011 4778-0301 Phone/Fax (from
Abroad): +5411 4778-0301 Pharma ThinkTank Consulting Av. Pueyrredn
1194, 7 piso 25 Ciudad Autnoma de Buenos Aires (C1118AAB),
Argentina