This presentation is a school work and represents student ideas and analysis ( safe harbor).
Perrine Dieusaert, Malam Aboubakar and I, presented it in January 2009.
HIPAA Compliance and its Relationship to PharmacovigilancePerficient, Inc.
Most of us have heard of the United States Health Insurance Portability and Accountability Act (HIPAA) and how it protects the privacy of our health information and gives us access to it. While discussions around HIPAA arise more frequently among healthcare institutions such as hospitals, HIPAA also plays an integral role in the life sciences industry.
Perficient's Christi Cordeiro, safety and pharmacovigilance project manager, provided an overview of U.S. HIPAA rules and discuss their application to pharmacovigilance programs.
Clinical Trials in Russia from a central lab perspectivemichaldysko
Russia has a huge potential for clinical trials to achieve fast patient recruitment and a low drop-out rate. However, a rapidly changing regulatory environment and continuous issues with supply chain and logistics are holding up clinical study sponsors to utilize all benefits of the region.
New clinical trial regulations and restrictions are introduced almost every quarter and together with lengthy custom clearance process and poor road infrastructure, this adds to unpredicted and significant delays.
A local expert partner who has a deep knowledge of actual clinical trials regulations and legislation. Understanding the realities and requirements of the import/export process is a critical factor in the success of trials conducted in Russia.
The perfect provider would also support you in other European countries and integrate your clinical data from Russia into single harmonized database with results collected from the whole trial.
HIPAA Compliance and its Relationship to PharmacovigilancePerficient, Inc.
Most of us have heard of the United States Health Insurance Portability and Accountability Act (HIPAA) and how it protects the privacy of our health information and gives us access to it. While discussions around HIPAA arise more frequently among healthcare institutions such as hospitals, HIPAA also plays an integral role in the life sciences industry.
Perficient's Christi Cordeiro, safety and pharmacovigilance project manager, provided an overview of U.S. HIPAA rules and discuss their application to pharmacovigilance programs.
Clinical Trials in Russia from a central lab perspectivemichaldysko
Russia has a huge potential for clinical trials to achieve fast patient recruitment and a low drop-out rate. However, a rapidly changing regulatory environment and continuous issues with supply chain and logistics are holding up clinical study sponsors to utilize all benefits of the region.
New clinical trial regulations and restrictions are introduced almost every quarter and together with lengthy custom clearance process and poor road infrastructure, this adds to unpredicted and significant delays.
A local expert partner who has a deep knowledge of actual clinical trials regulations and legislation. Understanding the realities and requirements of the import/export process is a critical factor in the success of trials conducted in Russia.
The perfect provider would also support you in other European countries and integrate your clinical data from Russia into single harmonized database with results collected from the whole trial.
Biosimilar Development Regulatory, Analytical, and Clinical Considerations SGS
The development pathway of a biosimilar is unlike that of a novel biotherapeutic. While there is an increased requirement for analytics throughout a biosimilars development project, and a Phase II clinical trial is generally omitted, careful consideration must be given to the planning of the other phases of development. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity. This presentation will provide a look at the multi-stage development for a biosimilar, including a review of the regulatory landscape, structural characterization techniques for biosimilarity assessment, and early phase clinical research challenges
Reducing technical and regulatory uncertinty in biosimilar developmentAjaz Hussain
Reducing risk of Biosimilar product development requires early attention to evidence development and effective communication to multiple stakeholders. Skill set for effective leadership and management, in the US market context, includes ability to: (1) Overcome the ‘blind spots’, (2) Analysis of knowledge, and (3) Evidence logic & communication. This presentation makes these points while comparing the EU and the USA regulatory context and the challenges of integration across multiple scientific and clinical disciplines.
Georgina Gal, Regulatory Affairs Manager, AbbVie, Hungary
Presentation at EIPG – BIPA Symposium “Clinical Trials Research” at the Faculty of Pharmacy, Medical University of Sofia, Sofia 2014.
What Your CRO Doesn't Know Could Hurt YouRoberto Lara
In this presentation, you'll get answers to these important questions that are having a big impact on improving oncology clinical trial performance in Canada. You will also see some real life stories about how the Reverse Feasibility Program is impacting patient outcomes:
1. How knowledge & relationships at Health Canada can remove bottlenecks and speed up the regulatory process;
2. How you can navigate ethics review boards more efficiently;
3. How a Master CTA template is speeding up site contract negotiations
09 CeoMeeting- Session 4- Medicines for MalariaMLSCF
Session 4: Health & Wellness
Title: The Changing Face Of Healthcare:
Where Are The Opportunities?
Special Speaker: Dr Chris Hentschel, Medicines for Malaria Venture
Gino Martini, EIPG President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
Biosimilar Development Regulatory, Analytical, and Clinical Considerations SGS
The development pathway of a biosimilar is unlike that of a novel biotherapeutic. While there is an increased requirement for analytics throughout a biosimilars development project, and a Phase II clinical trial is generally omitted, careful consideration must be given to the planning of the other phases of development. Many regulatory authorities reference a “step-by-step” approach to establishing biosimilarity. This presentation will provide a look at the multi-stage development for a biosimilar, including a review of the regulatory landscape, structural characterization techniques for biosimilarity assessment, and early phase clinical research challenges
Reducing technical and regulatory uncertinty in biosimilar developmentAjaz Hussain
Reducing risk of Biosimilar product development requires early attention to evidence development and effective communication to multiple stakeholders. Skill set for effective leadership and management, in the US market context, includes ability to: (1) Overcome the ‘blind spots’, (2) Analysis of knowledge, and (3) Evidence logic & communication. This presentation makes these points while comparing the EU and the USA regulatory context and the challenges of integration across multiple scientific and clinical disciplines.
Georgina Gal, Regulatory Affairs Manager, AbbVie, Hungary
Presentation at EIPG – BIPA Symposium “Clinical Trials Research” at the Faculty of Pharmacy, Medical University of Sofia, Sofia 2014.
What Your CRO Doesn't Know Could Hurt YouRoberto Lara
In this presentation, you'll get answers to these important questions that are having a big impact on improving oncology clinical trial performance in Canada. You will also see some real life stories about how the Reverse Feasibility Program is impacting patient outcomes:
1. How knowledge & relationships at Health Canada can remove bottlenecks and speed up the regulatory process;
2. How you can navigate ethics review boards more efficiently;
3. How a Master CTA template is speeding up site contract negotiations
09 CeoMeeting- Session 4- Medicines for MalariaMLSCF
Session 4: Health & Wellness
Title: The Changing Face Of Healthcare:
Where Are The Opportunities?
Special Speaker: Dr Chris Hentschel, Medicines for Malaria Venture
Gino Martini, EIPG President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
This report analyzes the worldwide markets for Contraceptives in US$ Million by the following product segments: Oral Contraceptives, Condoms, Implants/ Injections, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2007 through 2015. A seven-year historic analysis is also provided for these markets. The report profiles 164 companies including many key and niche players such as Ansell Limited, Bayer Schering Pharma AG, Church & Dwight Co. Inc., Conceptus, Inc., Condomi Health International GmbH, Female Health Company, Fuji Latex Co Ltd., Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceutical Inc., Merck & Co., Inc., Okamoto Industries, Inc., SSL International PLC, Teva Pharmaceutical Industries Limited, Warner Chilcott, Pfizer Inc., and Wyeth Corporation. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
8. - Treatment in developed countries :
DOT-HAART (Directly Observed Therapy of Highly-Active
AntiRetroviral Treatment)
- Example in South Africa :
first line regimen :
d4T, 3TC and Efavirenz
second line regimen :
AZT, ddI and Kaletra
Old medicines
Irrational use of treatment
Opportunistic infections treatment 8
9. CD4 below 350 or viral loads greater than 30,000 copies/ml of plasma.
Clinical signs and symptoms : Opportunistic infections, chronic diarrhea, weight loss,
neurologic complications, lowering of red/white blood cells counts…
9
10. - According to the WHO (World Health Organization),
in developed countries, a course of 1 year’s treatment
costs the equivalence of 4 or 6 months’ salary.
- In developing countries, it would consume 30 years
income.
10
11. The WHO’s 3*5 Program :
3M people access in 2005
6 M people infected with HIV in the developing world,
of which only 400,000 had access.
RESULT: « Missing the target »
(1,3M in 2005, december) 11
12. - International Institutions
The World Health Organization (WHO)
- Published treatment guidelines
- Prequalification process
- Essential medicines list
- National Institutions
A drug had to be registered in each country
A drug could be brought through an import waiver
12
13. - Funding
The main sources of funding in 2003 were :
The Global Fund
The President’s Emergency Plan for AIDS Relief (PEPFAR)
- Intellectual Property
The standards of patent protection varied widely around the
world.
The 1986-1994 of multilateral trade negociations resulted in
the Agreement on Trade-Related Aspects of Intellectual
Property Rights ( TRIPS)
13
14. The TRIPS agreement
Harmonizes the patent rights
•Patent protection for pharmaceutical products
•20 years protection
TRIPS provided for exceptions
•Compulsory Licence
•Parallel Importation
14
15. - Distribution
No physical presence
No local contact
No in-house expertise.
- Public Perception
Aids activist groups, health care providers
and some governments are strong critics
of pharmaceutical companies.
15
16. Let’s try to take
the Industries’ state of mind…
What are the positive and risky points?
Positive publicity for the company
BUT…
Reputational risk
Loss of profit
Parallel import, market risk
16
18. Let’s try to take
the Industries’ state of mind…
What are the positive and risky points?
Positive publicity for the company
BUT…
Reputational risk
Loss of profit
Parallel import, market risk
Emergence of resistance worldwide
Intellectual property problem
Lots of difficulties … 18
19. K Y P Y R IN TH G O A H M R E
E LA E S E L B L IV A K T
Bb
u ble S = R
ize elative Sales
60%
50% Gilead
40%
Growth (12 months to 3Q2006)
30%
20% Abbott
B. Ingleheim BMS
10% GSK
Roche
0%
0% 5% 10% 15% 20% 25% 30% 35%
Merck
-10%
-20%
Pfizer
-30%
Source: IM H lth (M T 3Q2006)
S ea A Share of Global H Market
IV
Source course of Pr. Jean-Pierre Osselaere 19
20. GILEAD SCIENCES
Research-based biopharmaceutical compagny.
Area of focus :
- Antiretrovirals
11 marketed products such as :
- Atripla (Emtricitabine+Efavirenz+Tenofovir) : 2006
- Truvada (Emtricitabine+Tenofovir) : 2004
- Viread (Tenofovir) : 2001
20
21. VIREAD(tenofovir disoproxil fumarate). U.S approval 2001
Immediate success.
- Once-a-day dosage
- Greater effectiveness
- A much improved side-effect profile.
Gilead planned the drug to be global in early 2003.
A high priority was to make it rapidly available to
millions of people in the least developed nations.
21
22. Gilead Access Program (April 2003)
OBJECTIVE :
make available the company's new drug VIREAD
at no profit to developing world.
22
23. QUALITY TIERED PRICING
GILEAD ACCESS PROGRAM
PRINCIPLES
PROTECTION
OF
INTELLECTUAL PARTNERSHIPS
PROPERTY
24. IMPLEMENTING THE GILEAD ACCESS PROGRAM
FOR HIV DRUGS
IN DEVELOPING COUNTRIES
2 KEY CONSIDERATIONS
PRICING DISTRIBUTION
26. Price issue
Affordable price for every patient.
USA / EU / JAPAN
68 least developed countries
High income
Widespread poverty
VIREAD priced taking into account:
VIREAD priced:
•Therapeutic value
at NO PROFIT
•Innovation
Price: $ 39 /month ( $1.30/day)
Price : $360 / month
Gilead strategy: generate sufficient volume to bring the price down
Over time GILEAD lowered price to $ 17 / month. 26
27. Distribution issue
LOCAL
AUTHORITIES
GILEAD
SCIENCES
Import
waivers
Import
waivers
Import
•LOCAL CLINICS waivers
•TREATMENT
PROGRAMS 27
28. After one year...
Gilead discovered that simply offering VIREAD at
low prices did not result in orders.
- AXIOS never received any large order
3 main problems :
- Clinics and government regulators awareness
- No working experience with the drugs
-The WHO medicine lists
28
31. GILEAD's tiers
Economic Number Price
of of Price of Viread
Tier
status countries Truvada
98
(Uganda,
Low income <$ 826 Bangladesh, $ 26.25/mo $ 17/mo
Haïti)
23
Lower-middle $826-$2.999 (India, Thaïland) About $ 45/mo About $ 30/mo
Up to a 70% Up to a 70%
13
discount relative discount relative
Upper-middle $ 3.000-$ 10.065 (Brazil, to high income to high income
Malaysia, countries countries
Russia)
>40 $ 934.50/mo in $ 578.87/ mo in
High income > $ 10.065 (US, EU, Japan) the U.S the U.S
•: Price calculations used 2007 average wholsale prices and the recommended dosing in the drug labels;
Source:BioCentury, The Bernstein Report on BioBusiness; September 3, 2007:15-26 31
32. Managing infrastructure development
IDENTIFY AND PARTNER WITH A LOCAL DISTRIBUTOR IN EVERY
COUNTRY
GILEAD SCIENCES
ASPEN PHARMACARE ( SOUTH AFRICA)
Licence to manufacture VIREAD
And Sell VIREAD to clinics in Access program countries
At no profit price + 5% markup for Aspen
BUILD AWARENESS IN AFRICAN AND ASIAN MARKETS
32
33. Managing Registration of VIREAD
After AXIOS management transition:
VIREAD’s country by country registration
- Gilead first focused on 15 countries (PEPFAR targets)
Anecdotes
- Gambia: immediate approval
- Botswana and Zambia: rejected application
- Nigeria requested more data.
- South Africa returned application : too much data.
- Uganda: $ 2 million shipment refused by customs!
33
34. • Managing corruption
Gilead as a corporate policy, refused to pay bribes!
As result :
- Delays in registration
- Generic manufacturers influence
• Managing Non Government Organization
Major role influencing international policy.
2 main problems :
- Gilead was late to recognize WHO as a regulatory authority.
- NGOs natural suspicion on the motives of pharmaceutical
companies.
34
35. Gilead’s third approach :
Non exclusive licence
- Indian generic manufacters
- Free pricing
- 5% royalties for Gilead.
Gilead’s objective :
- Generate competition
Bring the price down over time.
35