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October 12, 2011

Increase Firm Value thru Commercialization
of Cardio Drug & Device in India


Speakers for this Event:
  • Ajoy Kumar, MD, Chief Executive Officer, Max Neeman International   Learn More
  • Donald Swankie, MBA, Vice President, USA, Max Neeman International   Learn More
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    Strategic ‘ex-US’ regions, and particularly the Asia-Pacific region, are becoming vital to Pharma, Biotech & Medical Device not only for cost effective, ICH GMP research services, but for post market commercialization in-country.

    This program will provide overview and key lessons in leveraging India as a strategic venue for research, as well as post market approval in a growing economy whose in-country population is 1.3 Billion.

    The time is ripe for major drug and device companies to start looking at India not just as a country of a billion people, but as a market that provides huge opportunities for top- and bottom-line growth.

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    Positioning for increased firm value, growth and revenue thru market approval in India

    • Commercialization
    • Regulatory Approval
    • Clinical research

    Healthcare Scenario in India

    • Growth over past years
    • Public & Private hospital settings

    Regulatory Environment in India

    • Regulatory bodies & framework
    • Current Regulatory Processes
    • Government Initiatives
    • Combating the Regulatory challenges

    It has been anticipated that India's pharmaceutical market could reach a size of USD 20 billion by 2015, becoming one of the top 10 drug markets in the world.

    The cardiology products market in particular is experiencing strong growth to $635.7 million in 2012, and estimated compound annual growth rate of 26.4%.  The surge is the result of a dramatic rise in cardio disease among increasingly affluent and urbanized Indians who are demanding high quality cardio care.

    Another key sector growing at CAGR of 12% is the medical device industry encompassing various therapeutic areas.

    Improved regulatory scenario, better healthcare facilities and the fact that India is home to a large and diverse group of patients, substantiates the country's potential as a hub to carry out clinical studies.

    Key Takeaway Points:

    • Understanding of India's market approval potential
    • Updated information of India’s regulatory environment
    • Opportunities and risks of clinical research in India
    • Process of integrating India into USA based clinical trials
    THIS PROGRAM IS INTENDED FOR:
    • Decision makers looking to increase firm value through market approval/commercialization
    • Device and Cardiology Executives and Physicians wanting cost-effective options outside the USA
    • Those involved and responsible for identifying strategic venues regarding clinical trial research needs
    • Pharmaceutical, Biotech, Nutraceutical, Device, Contract Research Organizations looking to understand better the market approval potential in India
    ABOUT OUR SPEAKERS:

    Ajoy Kumar, M.D., Chief Executive Officer, Max Neeman International

    Dr.Kumar brings with him over 19 years of experience with Apollo Hospitals, Cummins Diesel as CEO and Director and Tata Sons as GM (Group HR). Dr. Kumar was responsible for operations of the Apollo group of hospitals. His credits include initiating the Apollo Clinical Excellence model, Emergency Network and the development of common corporate database. Dr. Kumar also conceptualized and implemented the Disease Management program for Apollo group and lead of the nationwide Apollo Heart Plan.

    Dr. Kumar holds an MBBS from JIPMER, Pondichery with Master’s degree in Business Administration, Hospital Administration and Preventive and Promotional Healthcare and Medical Informatics.

    Donald Swankie, MBA, Vice President, USA, Max Neeman International

    Mr. Swankie is responsible for the territories of North America and Latin America at Max Neeman. He has twenty years business development and consulting services experience with many in Life Sciences and Clinical Research, in both Biotechnology and U.S. Public Health care forums. Past companies he worked for include Quintiles Transnational and Science Application International [SAIC].

    Mr. Swankie holds a Masters Degree from Wake Forest University Babcock Graduate School of Business, 1995. He also holds a BSBA in Business and Economics from St. Peter’s College. He has an Executive education in Life Sciences, Duke University Associated with Max Neeman International for 4 years.

    OUR XTALKS PARTNER FOR THIS EVENT:

    Max Neeman International is a leading India-based Contract Research Organization and the wholly-owned clinical research subsidiary of Max India Ltd., [Life Sciences business group in India with interests in Life Insurance, Healthcare and Clinical Research.] For over a decade, Max Neeman has offered customized services to the global pharmaceutical, biotech and device companies in the conduct of clinical and device trials as well as data management. Operational since 2001, Max Neeman is an ISO certified CRO for Site Management, Monitoring, Data Management and Information Security Management Systems with 6 regional offices, 175 sites across 31 cities, headquarters in New Delhi and USA office based in Cary, North Carolina.

    Max Neeman has been awarded 255 trials and 90% of 325 employees are physicians trained in ICH GCP guidelines.

    Services include:

    • Project Management
    • Regulatory Submission
    • Site Monitoring
    • Clinical Data Management
    • Biometrics and Report Writing
    • Site Management
    • Device Importation, Warehousing & Distribution

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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