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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