growth and success through partnering & outsourcing
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Growth and Success through Partnering & Outsourcing
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Teva Salt Lake City- Contract Manufacturing Capability:Teva Salt Lake City- Contract Manufacturing Capability:
Purpose:
The Teva Salt Lake City (SLC) facility is considered a specialty manufacturing facility that partners with a variety of pharmaceutical companies who utilize the organization as a contract manufacturing organization (CMO).
Background:SLC manufactures products as Prescription(Rx), Generic(GRx), and Over the Counter(OTC).
Many of the top 10 pharmaceutical companies utilize Teva Salt Lake City to manufacture their products.
Contract / partner manufacturing can build relationships between competing pharma companies in order to:Decrease COGsIncreasing FTM opportunitiesReduce risk
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Overview
Benefits
Manufacturing for the Competition
Risks
Regulations
AgendaAgenda
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OverviewOverview
Why do companies use contract manufacturing organizations Big Pharma companies are consolidating
End of blockbuster drugs Personalized medicine Plant closings Elimination of R&D
The FDA seems to be overwhelmed and is now becoming more risk averse PDUFA V 2012:
Communication availability between applicants and the FDA review team Additional review time for the agency to meet with applicants Assessments will evaluate parameters that have an have not achieved the
product goals GDUFA I 2014:
Complete response letters to be provided to the applicant Division level deficiency review Prompt communication of easily correctable deficiencies First cycle post complete response meetings Expedited PIV (day 1 submissions)
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OverviewOverview
The more risk averse the big pharma companies become the more they need good partners. Reduces the risk of a failing product with their name on it Technical resources (such as: quality, regulatory, etc) are
more available and specialized Pharma companies can do more with less
The Blockbuster Drug Pipeline is coming to an end Companies are looking for ways to extend patents, brand
recognition, and new indications for existing products Small / Specialty pharma companies do not want to invest in
production capability High risk / high reward models Focus to create a unique drug / drug delivery IP
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Overview
Benefits
Manufacturing for the Competition
Risks
Regulations
AgendaAgenda
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BenefitsBenefits
Advantages of Contract Manufacturing Partners have no capital expenditure for plant or equipment Flexibility. Products are based on current business trends. Diversification. Big pharma companies tend to work with multiple CMOs which
provides flexibility The CMOs perform the “mundane” operations whereas the management team
from the partner can focus on alternate activities. Specialization of the CMO and resources / equipment
CMOs help minimize risks and uncertainty with partners who they trust that can bring something novel to market.
CMOs have expertise in the technical arena which can assist in product / manufacturing navigation CMOs have ~60% less reduced risk of RTRs from worldwide agencies
The collective understanding / learning of CMOs involve how to coordinate diverse production skills and integration of multiple technologies. Teva SLC takes these new technologies to a new level for our partners. The products manufactured in SLC are new markets / delivery systems for 90%+
of our partners
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Overview
Benefits
Manufacturing for the Competition
Risks
Regulations
AgendaAgenda
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Manufacturing for the CompetitionManufacturing for the Competition
Manufacturing Capabilities
Improving ValueReduction of
COGs
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Provides a stable revenue
No need to control critical market fluctuations
Unpredictable volumes / markets are not considered during manufacturing forecast Activities are contractually agreed upon prior to execution
Innovation and CMO capabilities are enhanced in key areas and not focused on a broader scope / market
The solid dosage market is expected to expand over the next five years at an annual rate of 12.5% and as much as $55 billion will be spent by 2017 on CMO-based solid dosage manufacturing.1
Manufacturing for the CompetitionManufacturing for the Competition
1 The Benefits of Contract Manufacturing. Pharmaceutical Online 25 Oct 2012.
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Overview
Benefits
Manufacturing for the Competition
Risks
Regulations
AgendaAgenda
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RisksRisks
Lack of control CMOs are dependent on the customers and their marketing campaigns in order to impact volume Project successes are difficult to predict
CMOs can meet all project demands and a pharma company can cancel the product
Being reactive rather than proactive You must react to customer requests
Timing Delivery schedules International markets Audits
CMOs must manage multiple organizational demands from the partners. Sometimes the quality group doesn’t communicate with their own technical team, etc…
Protection of our technology Our facility has highly technical equipment to manufacture our specialty products.
Cost efficient processes to ensure profitability to the company Potential competition for Teva brand product Utilization of skilled resources for the competitor market Sustaining skilled employees and keeping them
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Overview
Benefits
Manufacturing for the Competition
Risks
Regulations
AgendaAgenda
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RegulationsRegulations
The FDA created a draft guidance: Guidance for Industry: Contract Manufacturing
Arrangements for Drugs: Quality Agreements The guidance applies to the commercial
manufacturing of APIs, intermediates, finished drug products, combination products, and biological drug products.
It defines the who and what of contract manufacturing Establishes quality agreement requirements
A comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units for each party involved.
Identifies roles and responsibilities
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RegulationsRegulations
The CMO is responsible for maintaining compliance at all necessary markets & regulatory authorities. Example: if the product is to be marketed in Korea, the
KFDA will audit the CMO not the partner
The CMO will be audited by the partners in order to ensure compliance as well. Most pharma companies have internal quality audit
teams that visit CMOs to identify critical / major / minor issues prior to the regulatory agency arriving on site.
CMOs standards and criteria with regulatory agencies are heightened due to the varying products and potential impact if there is a compliance issue.
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FutureFuture
The future for the Teva SLC site is bright! The SLC facility has on-going development
activities with partners as addressed throughout the presentation as well as Teva brand products.
The SLC facility is also engaged with the Teva Specialty products
The SLC facility is also getting ready with the manufacturing of First to file PIV GRx products
The SLC facility is also engaged in bringing new unique technologies to the site for Teva future products
The site is currently engaged with the long term master plan
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Contact InformationContact Information
Habib Nasirullah- Site General Manager SLC: