Transcript Habib Nasirullah TEVA - Growth and Success throught Outsourcing

Growth and Success through
Partnering & Outsourcing
11.2014
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 COGs
 Increasing FTM opportunities
 Reduce risk
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Agenda

Overview
 Benefits
 Manufacturing for the Competition
 Risks
 Regulations
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Overview
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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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Overview
 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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Agenda
 Overview
 Benefits
 Manufacturing for the Competition
 Risks
 Regulations
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Benefits

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
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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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Agenda

Overview
 Benefits
 Manufacturing for the Competition
 Risks
 Regulations
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Product
Knowledge Base
Manufacturing for the Competition
Improving Value
Reduction of COGs
Contract
Manufacturing
In House
Manufacturing
Manufacturing Capabilities
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Manufacturing for the Competition
 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
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The Benefits of Contract Manufacturing. Pharmaceutical Online 25 Oct 2012.
Agenda

Overview
 Benefits
 Manufacturing for the Competition
 Risks
 Regulations
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Risks

Lack of control
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Being reactive rather than proactive
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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
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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
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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Agenda

Overview
 Benefits
 Manufacturing for the Competition
 Risks
 Regulations
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Regulations
 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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Regulations
 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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Future
 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 Information
Habib Nasirullah- Site General Manager SLC:
[email protected]
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