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India opportunities in 2016 and beyond

At The Westin Copley Place Boston
October 28th, 2015, 9:00 AM – 12:00 PM
Hosted By Excel Life Sciences • 919.889.6387

The conference has passed, but you can still connect with Excel Life Sciences. Click here to request a meeting to learn how we can help you with your next clinical trial.

I am pleased to personally invite you, along with other Boston-Cambridge area industry executives, to ‘India – Opportunities in 2016 and Beyond for Clinical Research and the Pharmaceutical Industry’.

As you continue 4Q global business development and clinical trials activity and begin 2016 planning, challenges in recruitment, cost containment, choice of global site locations, and even market registration are ever present. This will be an important session for Biotech, Pharmaceutical and Medical Devices executives who are evaluating a Southeast Asia clinical research strategy.

This no-cost, half-day event will provide first-hand understanding of FDA submission of clinical studies conducted in India. In addition we will illustrate the rapidly growing Indian healthcare market for pharmaceutical products and medical devices.

Join us for an interesting and informative session on India in 2016 and beyond, with a focus on:

  • India as a strategic destination to conduct trials as part of global studies
  • India as a hedge against slow enrollment in other markets
  • Expectations: Regulatory timelines, accelerated enrollment, cost savings and quality.
  • Specific focus on: oncology, metabolics, cardiovascular & ophthalmic centric studies.
  • Market potential for pharmaceutical products and medical devices

Location: The Westin Copley Place Boston, 10 Huntington Avenue, Boston, MA 02116

Leader: Dr. Vijai Kumar, M.D. Chief Medical Officer of Excel Life Sciences, Boston Massachusetts

Date & Time: Wednesday, October 28, 9:00 AM to 12:00 PM

Event Cost: None

About Excel Life Sciences
The Excel Life Sciences team has conducted numerous global trials with 40 studies targeted for FDA submission, and has undergone successful FDA and EMEA audits. ELS is India’s premier clinical trial and site management organization with extensive regulatory and clinical trial expertise. ELS leads a network of ICH-GCP compliant investigators across 30 cities. ELS focuses on conducting studies for FDA submissions for its North American and European based clients via its offices in Boston, Chicago, New Delhi, and Research Triangle Park, NC.Dr. Vijai Kumar, M.D. – ELS Chief Medical Officer

Dr. Kumar is Boston based and has played important roles as a member of committees constituted by the Drugs Controller General of India to frame the Indian guidelines for Good Clinical Practice and make changes to globalize India’s clinical research enterprise. Dr. Kumar and other members of the ELS team also play important roles as advisors, members and Board of Governors of the Institute of Clinical Research, India (ICRI), as well as the Central Drugs Standard Control Organization, World Health Organization, and other industry associations.

Click the button below to Reserve Your Attendance RSVP Link

Agenda8:30 AM to 9:15 AM: Coffee and refreshments

9:15 AM to 9:25 AM: Opening remarks, agenda overview

9:25 AM to 10:40 AM: General Session

  • Vijai Kumar, MD – Excel Life Sciences
    • The growth of the Indian pharmaceutical industry
    • Evolution of Regulatory Process
  • Flavio Leonin, MD – PSivida Inc.
    • India as location for pivotal ophthalmology trials for US FDA approval-lessons learned
  • Vijai Kumar, MD
    • Disease profile and standard of care of a few important life style diseases;
      - Cancers, Cardiovascular disorders, Metabolic and Ophthalmology
    • Pivotal studies done in India
    • US FDA and EMA inspections and their outcome

10:40 AM to 11:00 AM: Break – Coffee and refreshments

11:00 AM to 11:30 AM: India as part of Global Studies; Lessons Learned

  • Pankaj Bhargava, MD – Dicerna Pharmaceuticals considerations for conduct of oncology trials in India
  • David Maggs, MD – Bio Dome Partners, [formerly Amylin, Pfizer] experiences in conduct of clinical trials in India
  • Dan McDonald – D. Anderson and Company Patient Recruitment Services challenges in global clinical trials recruitment

11:30 AM to 11:55 AM: Speaker’s Panel – Audience/Participant’s Question & Answer Session

11:55 AM to 12:00 Noon: Program Wrap-up and Close

[*] No Risk Regulatory Approval for your Phase II – III (IV) global clinical study portion in India, for applications in the next six months.