TTC-Philadelphia 1-11-11 Final by qingyunliuliu

VIEWS: 15 PAGES: 22

									Clinical Trial Costs in Emerging
      Geographies: China

      R. Stephen Porter, Pharm.D
   President, CEO and Chairman VDDI Pharmaceuticals
                 Director & Co-founder
                Dragon Bio-Consultants, Ltd.
                     Hong Kong, SAR
          VDDI Pharmaceuticals
• As its name suggests, VDDI Pharmaceuticals
  utilizes a virtual business model.
• Virtual drug development entails: (i) a small core
  group of employees responsible for strategic
  management, regulatory strategy, and financial
  control, (ii) outsourcing all non-core business
  functions, including preclinical and clinical drug
  development, and (iii) electronic data capture
  and data submission to regulatory authorities.
        Xemilofiban Summary

• Product has already been studied in both Phase
  II and Phase III clinical trials 12K patient
  experiences
• Proven safety and efficacy
• Advantages over existing products
• Growing total market flattening sales with
  expanded indications
• Advantage of IV to oral conversion
                   PROPRIETARY                     3
      Strategy for Development
• Secure Local Operating Company agreement
• Meet with sFDA for Guidance
  – Translation key documents
• CMC tech transfer
  – PO and IV Formulation
• Phase II III Multi-Center Trials China and Then
  US


                      PROPRIETARY                   4
             Dragon Bio-consulting:
         Services Currently Being Provided
• Clinical Trial Management Services - MASH™
• Preclinical translational and toxicology services
• Bioprocessing & Engineering Consulting
• Inspection and diligence services for cGCP, cGLP, and cGMP
• Business and commercial development services in the Asia-
  Pacific pharmaceutical and biotechnology sectors
• Regulatory and resource mobilization services in the Asia-
  Pacific markets
• Partnering and M&A
• Import Export services for Branded and Generic
  Pharmaceuticals ( Green Channel Logistics)
                         Why China
Market:
  China is expected to become the world's 3rd-largest prescription drug
  market in 2011, and the market in China may be doubled by 2013
  (IMS data)
Special SFDA Regulations:
   • Clinical trials are required for all imported drugs before marketing.
      So, trials for marketing registration will be greatly increase
   • Data generated from Chinese sites in a global trial can be used for
      an import drug registration, so that the clinical trial can be exempted
      if the data comply with SFDA’s requirements. This may save 2-4
      years for a new drug to be marketed in China. More global trials
      are anticipated as more and more pharmaceutical companies
      become aware of this regulatory strategy.
                        Why China
Trends of Drug Development :
   There have been increasing number of R&D centers set up by major
   global pharmaceutical companies in China in the last three years. As a
   consequence, more and more global trials for new drugs are predicted
   to be led from China
            CRO’s – clinical development
                         ASIA
• Mainland China
    – Local; Kendle, TigerMed ,
    – MNC or JV; Accelovance, Covance, Excel (PPD), ICON (Fountain Medical), Quintiles
• Taiwan
    – DCB
• India
    – Local; Biocon (Clinigene),
    – MNC
• Singapore (Malaysia, Thailand, Vietnam)
    – Local; Gleneagle (pan-Asian and Australia)
    – MNC; Covance, Parexcel, etc
• South Korea
    – MNC and local
       Business environment - China
• Perceived market – true market
  –   Pharma market expected to grow 17% in 2010, becoming 3rd largest in 2015.
  –   Resources needed to penetrate the many diverse markets
  –   Pricing; Biologics 50 – 90% below west, so far sub-standard drugs
  –   Ability/Inability to pay for a treatment
  –   Public health insurance, pricing practices and change!
• Hidden / “Unaccounted” costs
  – HR; turn-over, training, efficiency, foreign staff as local employees (rent, schools,
    corporate credit cards, foreign currency exchange …)
  – Unpredictable and changing regulations
  – Corruption
  – State sponsored industrial espionage
   Business environment - China
 Tax incentive for new and high tech R&D
    o Exempt of import duty and VAT for equipment and reagents.
    o 1000 Talents program
    o 5.85 B USD investment by PRC in Biotech and HC and Pharmaceuticals
 Price pressure on pharmaceuticals.
    o New “Measures for the Administration of Drug prices” announced June 2010, off-
      patented originator pricing will go down
 Legal and Regulatory hurdles:
    o Product registration 6-9 months minimum for approvals to begin trials often 1 year of
      more
    o Clinical trial data acceptance, 1601 trials have been conducted in China by MNCs since
      2008. Mostly Phase III-IV
    o Levies and import duties
    o Competition watchdog ; M&A (In 2010 Pfizer forced to sell animal vaccine to local
      company)
     Force foreign business to set-up manufacturing
      and operations in China.
          Regulatory environment
• Formal regulatory frame work
    –   SFDA moving towards PIC/S
    –   KFDA moving towards USFDA
    –   ASEAN’s mutual recognition scheme 2012
    –   Central Drugs Standard Control Organization (CDSCO), India,
        Directorate General of Health Services, Ministry of Health and Family
        Welfare, Government of India (WHO CGMP)
•   200 Reviewers at SFDA, 2000 at USFDA
•   Enforcement/Graft
•   Generic- & TCM-traditions Vs. NCE & NBE
•   CRO/CMO; Mindset and level of understanding
     Market Attractiveness Matrix for
                  Asia
             Country                Patient             Cost            Market                 Regulatory Approval
                                    Access                            Opportunity                   timelines
            Australia                  ++                 +                +++                       2 - 3 months
                  India              +++++             ++++                 ++                       3 -4 months
              China                  +++++              +++              +++++                     10 - 12 months
              Korea                    +++               ++               ++++                       3 - 4 months
             Taiwan                    ++                ++                 ++                      3 – 4 months
           Singapore                    +                ++                  +                       1- 2 months
           Indonesia                   +++             ++++                  +                      3 – 4 months
            Malaysia                   ++               +++                 ++                      3 – 4 months
            Thailand                   +++              +++                  +                      3 – 4 months
          Philippines                  +++             ++++                  +                      3 - 4 months
            Vietnam                    +++            +++++                  +                      4 – 5 months

12    N o r t h    A m e r i c a • E u r o p e • A s i a / P a c i f i c • L a t i n   A m e r i c a • A f r i c a
                           Business environment
   The herd mentality in Pharma industry:
            May06              Nov06                Jan07
                                                   Dec06                  Feb07               Mar07                   Apr07            Jun07




        AstraZeneca $100   Novartis $100 M     Roche plans to         GSK plans to        AstraZeneca          GSK sets up a R&D     Lilly $100M
        M investment,      investment, R&D     expand R&D             establish a fully   China R&D center     center (CEDD) in      investment in
        R&D Center         Center in           center in              integrated R&D      will be located in   neurodegenerative     5 years
                                                                                                               disease in Shanghai
                           shanghai, 400       Shanghai               center              Shanghai
China                      FTEs




        Amgen sets up      Merck / Advinus     Eli Lilly / Nicholas   AstraZeneca sets    GSK / Ranbaxy        BMS/ Biocon /         GSK / Tata
        clinical           risk sharing deal   Piramal                up process R&D      $100 M risk          Accenture $300M       Consultancy
        development        on metabolic         $100M risk            lab in Bangalore    sharing              partnership           Service
        center in Mumbai   disease target      sharing                                    partnership                                partnership
                                               partnership
India
Recommended Second Tier Cities




                                 2nd Tier Cities
                                 •Changchun
                                 •Chengdu
                                 •Hangzhou
                                 •Hefei
                                 •Kunming
                                 •Taizhou
                                 •Tianjin
                                 •Xian
                                 •Zhenghou
                            Blood Draw
Procedure     Country       Flag       Low (USD)   Medium (USD) High (USD)
Blood Draw    USA                      22          26           33
              China                    5           6            7
              Hong Kong                7           7            10
              Korea                    5           6            7
              Thailand                 2           3            4
              Taiwan                   10          11           12
Source: GrantPlan® (www.ttc-llc.com)
                                       ECG
Procedure     Country       Flag        Low (USD)   Medium (USD) High (USD)
EC G          USA                       99          103          128
              China                     38          42           56
              Hong Kong                 32          47           49
              Korea                     14          21           34
              Thailand                  17          23           30
              Taiwan                    32          47           49
Source: GrantPlan® (www.ttc-llc.com)
     Initial Physical Exam (~60 min.)
Procedure     Country       Flag       Low (USD)   Medium (USD) High (USD)
Initial       USA                      202         239          260
Physical      China                    61          97           151
Exam
              Hong Kong                111         162          204
              Korea                    87          91           108
              Thailand                 53          67           80
              Taiwan                   55          98           101
Source: GrantPlan® (www.ttc-llc.com)
            Physical Exam (~15 min.)
Procedure     Country       Flag       Low (USD)   Medium (USD) High (USD)
Physical      USA                      130         151          152
Exam          China                    36          50           60
              Hong Kong                63          88           105
              Korea                    40          48           55
              Thailand                 39          56           89
              Taiwan                   51          73           94
Source: GrantPlan® (www.ttc-llc.com)
     Keys to Success Factors : China
•   Talent – “Hai Gui”
     – Leadership – recruitment and retention
     – Technical expertise – Clinical, industrial R&D, and regulatory experience
     – Communication with international sponsors
•   Regulatory and compliance
     – GLP and cGMP training and practice enforcement
     – IND, NDA, ANDA experience
•   Communication and client interface
     – Working language – English and Chinese, notebook, verbal and written communication
     – Recognizing culture differences on both sides (“fee for service” and “guaranteed
       results”)
•   Supporting mechanism – infrastructure and funding
     – Need greater support – Ease of procuring patients, sample shipping and etc.
•   Training – start with a clean slate
     – cGCP, cGLP, cGMP
     – Technical training ( Cato, Beckloff Associates etc….)
     – Compliance training needs time
                            Risks: China
• Dynamic / fluid Environment
    – Economics, work force training & retention
         • (high cost of living & poaching in 1st Tier Cities)
    – SFDA regulatory uncertainties
         • leading to reluctant clients
         • Delayed programs
    – Governmental oversight / monitoring (Internet)
         • Repatriating monies out of country
         • Internet privacy data corruption

• Conflicts between different cultures, traditions, as well as value systems.
    – Goal mis-alignment between partners
    – Moral Hazard Situations
• Ethical concerns & corruption is endemic
    – There are “no secrets” in China
    – Contract law
    – “Red Envelop mentality”
香港中環
Central, Hong Kong SAR
雪廠街10 號 Company No.: 1429099
HK Registered
SKYPE: virtualdoc77室
新顯利大廈5 樓 55
香港公司註冊號碼:1429099
+86.15021242314 (Cell China)
+1(615)445-5761 (Cell USA)
                            Contact Information
http://dragonbio-consultants.com
             R. Stephen Porter, Pharm.D., FCP MRCP



Dragon Bio-Consultants, Ltd.                         VDDI Pharmaceuticals
Suite 55, 5/F New Henry House, 10 Ice House Street   Chairman, President and CEO
Central, Hong Kong SAR                               115 Penn Warren Drive
HK Registered Company No.: 1429099                   Suite 300-389
SKYPE: virtualdoc77                                  Brentwood, TN 37027
                                                     (615)445-5761 (cell)
+86.15021242314 (Cell China)
                                                     +86.15021242314 (Cell China)
+1(615)445-5761 (Cell USA)                           virtualdoc@gmail.com
Steve.P@dragonbio-consultants.com                     http://www.virtualdrugdevelopment.com
http://dragonbio-consultants.com

香港中環
雪廠街10 號
新顯利大廈5 樓 55 室
香港公司註冊號碼:1429099

								
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