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Fact sheet
Unlocking new markets
Maximize your product’s potential
Diversity in Asia influences product development
When developing a product for the Asian markets, pharmaceutical
companies require not only an intimate knowledge of the regulatory
landscape and the requirements for Asia, but also a clear
understanding of the medical landscape, treatment guidelines,
manufacturing considerations among others.
Quintiles helped
develop or commercialize
100%
of the Top 100 best-selling
products or compounds
of 2013
Asia
“
“Quintiles recently provided valuable
insight to the Asian development
strategy for three of our drugs.
We highly recommend their
knowledgeable staff and appreciate
the straightforward way those
projects were conducted.”
– Debiopharm Group
Additionally, companies would need to look at the need for conducting local trials,
with the corresponding recruitment timelines, rates and best possible countries to
recruit patients for various indications. These factors mean that developing a product
in Asia will be different compared to running a trial in the U.S., Europe or any other
market.
To successfully develop drugs in Asia, you shouldn’t adopt a
“one size fits all” approach
Development in Asia is complex and operating in this environment requires
expertise and a deep understanding of the multiple nuances across geographies.
The Strategic Drug Development (SDD) team from Quintiles integrates all
these factors and considerations when providing customers with different strategic
development options that align with the customer’s commercial imperatives for their
product.
SDD can help biopharma companies navigate complexities in Asia
Based in Singapore, Quintiles’ Strategic Drug Development is set up to help pharma
and biotech companies bring their product from early preclinical stages to late stage
phase III development, including support to obtain product approvals in different
markets. We provide effective drug development strategies to enhance our clients’
probability of success in introducing and commercializing new products in Asia.
Our solutions optimally balance development timelines and costs, benefits and
risks, leveraging Quintiles’ global and local footprint. We know the challenges of
commercializing a new product in Asia amidst the complex regulatory environment.
Customer Centricity:
Integrated strategy for optimizing success
Validated framework to strike
the right balance between risk
and opportunity
• Maximize asset
• Minimize development risk
Unlock new markets
• Speed to market
• Go or no-go decisions
• Return on investment
• Opportunity risk
Asia: Characterized by a diversity
of macro factors which influence
the development landscape
SDD clinical and regulatory
experts
Political diversity
• Healthcare policies
• Regulatory framework
• Generics’ policies
• Patent recognition
Economic diversity
• Costs of drugs
• Medical insurance scheme
• Pricing and reimbursement
• Payor vs. payee
Cultural & social diversity
• Religious beliefs
• Ethnic differences
• Migration of workforce
80+
Combined years of pharmaceutical
experience ranging from discovery to
development, manufacturing, compliance,
registration and approvals of product
to market
Medical environment diversity
• Standard of care
• Response to treatments/ outcomes
Regulatory environment complexity
• Constantly evolving
• Currently no harmonized approach as
found in U.S./EU
• Increasingly stringent requirements
Operational challenges
(GCP compliance)
• Increased competition
• Competition for investigators/patients
with more studies
• Higher costs
SDD’s bespoke solutions for
our clients
30+
Helped developed solutions for products
ranging from stem cells to vaccines,
modified generics, biologics, biosimilars,
small molecules and drug device
combination products in a variety
of indications
Key services offered at a glance
Product gap analysis
Regulatory landscaping
Technical due diligence
Medical landscaping
Strategic development options
Target product profile
Protocol synopsis
Health authority consultation
Technical portfolio assessment
Ad hoc regulatory/ clinical consulting
Clinical development plan
Scientific advisory board
“
“Our overall experience with Quintiles was very satisfying. The quality of
deliverables met the high standards expected as they are able to draw on their
vast pool of global expertise. More than a service provider, Quintiles worked
with us as partners with great dedication to efficient delivery. We look forward
to engaging Quintiles on future assignments as well.”
– Dr. Durgaprasad Annavajjula, Stelis Biopharma Pvt. Ltd.
While SDD can provide comprehensive end to end solutions, our services can also
be broken down into modular units to tailor to your specific needs. For us it is
important that the final results provide you with a viable and customized development
solution to meet and exceed your needs.
Case Study 1: Increasing the possibility of success of investing in a
cutting edge, innovative technology
Background
Asian pharma is interested in investing in a cell based therapy which is being
developed for multiple indications
The client has traditionally focused their development efforts in their domestic
market and is now interested in commercializing the cell based therapy in
overseas markets primarily Asia, and subsequently in developed markets
Quintiles was tasked with evaluating their development program and assessing
the commercial value of the technology
Approach
Assembled cross functional team to conduct intensive on-site due diligence
Covered all functional areas (regulatory, clinical, CMC, pre-clinical, commercial)
Conducted on-site interviews to access quality of personnel and processes
Benefits to Client
Identified developmental risks to more accurately assess the costs of
he investment
Helped the client understand the risks and benefits of the investment to
enable a go-no-go decision
Client was able to make an informed investment decision with increased
confidence to enhance their return on investment
Case Study 2: Biosimilar strategies for Asian and developed markets
Background
Asian pharma interested in developing a pipeline of biosimilar products for Asia
and global markets
Development of biosimilar is a new area of growth for the client
Client has manufactured several batches of the biosimilar products and intends
to demonstrate CMC comparability with the Innovator products
Quintiles was tasked to provide a biosimilar strategy for several of their
lead biosimilar products, including protocol synopses for demonstrating
comparability and a feasibility assessment for conducting the trials
Approach
Conducted review of client’s CMC data and its comparability plan, in-country
regulatory requirements and evaluated the need and type of recommendations
and clinical studies required
Evaluated feasibility of conducting trials in Asia and Europe and identified
optimum number of sites and investigators for conduct of study
Benefits to Client
Provided a biosimilar strategy that incorporated global regulatory requirements,
CMC strategy, clinical strategy with protocol synopses, and feasibility of
conducting trials across markets of interest
Contact us
U.S. toll-free: 1 866 267 4479
EU direct: +1 973 850 7571
Asia direct: +65 6602 1245
Website: www.quintiles.com
Email: [email protected]
Copyright © 2015 Quintiles. All rights reserved. 03.0032-1-04.15
Provided the client with several strategic development options with benefits and
risks and mitigation strategies for each strategic option, which would allow the
client to introduce their biosimilar products earlier (up to 2 years of savings in
development time) across various geographies