Knowledge Partners

Organizing Partner

Two Days Workshop on

Drug Development Mouse to Man

Dates: November 25-26, 2011 First time in India
First time in India

Venue: Conference Hall, St. John's Auditorium Complex, John's National Academy of Health Sciences John Nagar, Koramangala, Bangalore.

First Time in India

Dr. K S Rao

Dr. Shiva Murthy N

First time in India Life time Experience Shared High Ended Practical Applications Discussed

Who Should Attend the Workshop Professionals working in - Drug discovery companies - Clinical research organizations - Pharma companies - Independent research workers - Clinical Pharmacologists - Preclinical pharmacologists Faculty of - Government and Non Government regulatory bodies and accrediting agencies - Medical, Dental, Pharmacy, Veterinary, Biotechnology and other life sciences academic institutions - Clinical research and preclinical research academies Students of above mentioned areas.

Two Industry Giants Coming Together With Diverse Experience

Knowledge Partners

Organizing Partner

Two Days Workshop on Drug Development Mouse to Man (November 25-26, 2011)
Introduction: Every drug paper or seminar starts with the age old statement that a typical drug development costs around a Billion US dollars. It is now the time we put such statements to rest and think fresh and find out why all of us have accepted such statements as facts for tomorrow without even questioning it. In the past, most scientists have worked in Silos. In addition, many scientists have not learnt to understand other related allied sciences which are involved in drug development. This lack of understanding or any effort to learn allied sciences on the part of the individual scientists, have made the drug development, a magic than a scientific discipline. Our objective in this current workshop (and hopefully in future such workshops) is to open the iron curtain and train new generation of scientists to learn cross disciplines, so that everyone has a sound understanding of all aspects of drug development. This level of understanding helps to question and even understand our colleagues language in other related sciences involved in drug development. The planned two day workshop covers an unprecedented breadth and more importantly the depth of science involved in drug development. This will liberate each one of you to think out of the box and will enable you to march on to a new path to drug development to reduce the cost, since you will not be in the dark on other allied disciplines involved in drug development.

Topics for Day 1 Dr. KS Rao 9.00 am to 6.00 pm, with two coffees and one lunch breaks
Sources of Drugs Lead Identification Herbal Chemical Metal Pharmacogenomics Bioinformatics Structure Activity Relationship Principles of Toxicology Pharmacokinetics and Drug Metabolism Good Laboratory Practices (GLP) Preclinical Toxicology Acute Toxicity Subacute Toxicity Chronic Toxicity Genotoxicity Reproductive Toxicity Carcinogenicity Risk Assessment Regulatory Affairs IND, NDA, ANDA Approval Process

Topics for Day 2 Dr. Shiva Murthy N 9.00 am to 6.00 pm, with two coffees and one lunch breaks

Study Designing Basics of Statistics Clinical Research Phases Micro-dosing, Phase 1, 2, 3, 4, Pharmacovigilance, Post Marketing Trials Ethics in Clinical Research Documentation in Clinical Research Pharmacy Management in Clinical Research Volunteers and Vulnerable Volunteers Clinical Practice Vs Clinical Research Can they be combined, how? Quality Assurance Fraud and Misconduct Clinical Operations Challenges Latest Tragedy in New Drug Development - TG1412 Lessons learnt form this event

Contact for Participation and Sponsoring the event: Ms. Sowmya Nataraj BE, PGDSE. Managing Director InvenStar Pharma Services Pvt Ltd sowmya.invenstar@gmail.com and Info@ipharmaservices.com Phone No. +91 8884328277 Preferred method of Communications Email or Phone or By post/courier

Method of Payment - DD/Cheque: Drawn in the name of InvenStar Pharma Services Pvt Ltd Payable at Bangalore, India - Bank Transfer Account Name Invenstar Pharma Services Pvt Ltd Account Number - 911020024934218 Bank Address Axis Bank, JP Nagar, Blore

Office Address InvenStar* Pharma Services Pvt Ltd No. 57, Keshava Nilaya, 4 Main, th Kothanur Dinne, JP Nagar 8 Phase, Near Water Tank, Bangalore-560076, Karnataka, India
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Knowledge Partners

Organizing Partner

Two Days Workshop on Drug Development Mouse to Man (November 25-26, 2011) REGISTRATION FORM Please check the applicable category: Industry Non-Industry Student

PLEASE PRINT ALL INFORMATION CLEARLY Degrees: _______________________________________________ Dr. Mr. Ms.

Last Name (Family Name):_______________________________________________________ First Name: ___________________________________________________________________ Job Title:_________________Affiliation (Company):___________________________________ Address (Please write your address in the format required for delivery to your country.) _________________________________ Business Address Home Address

_____________________________________________________________________________ ___________________________Postal Code___________ City Country___________________ Telephone Number_____________ Fax Number______________ Mobile Number____________ Email (Required for confirmation)___________________________________________________Sign/Date________ IF MAILING THIS FORM, PLEASE PROVIDE A COPY OF REGISTRANTS BUSINESS CARD.
Registration Fee (fee includes refreshment breaks, luncheons and Participation, Certificates, study material if any). This fee does not include travel or hotel accommodation.
Type Industry Accommodation: We have tied up with Bluemoon Shelters, Bangalore (www.bluemoongroup.in). They have agreed to provide subsidized accommodation exclusively for our participants. Options are as below: - Twin sharing basis, Non A/C Room - Rs.850 per person inclusive tax - Single occupancy, Non A/C Room - Rs.1100 per person inclusive tax Cost of both types includes Complimentary Breakfast and Wifi connection Interested participants can get in touch directly for their reservations: +91 80 25716999/ 09739711999, bookings@bmg.net.in Non Industry Student Fee for One day Rs. 5,500/- including tax Rs. 4,000/- including tax Rs. 2000/- including tax Fee for Two days Rs. 10,000/- including tax Rs. 7,500/- including tax Rs. 4,000/- including tax

Venue: Conference Hall, St. John's Auditorium Complex, John's National Academy of Health Sciences John Nagar, Koramangala, Bangalore

Early bird reduction: 10 % reduction on above fee. Applicable for single and two day participation Group Reduction: 3 or more registration from same company/Institute will get 20% reduction. Max 60 participants will be allowed.

Cancellation Policy: On or Before November 10, 2011 Cancellations must be in writing and received by November 10, 2011. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. If the event is cancelled, organizers are not responsible for any airfare, hotel or other costs incurred by registrants. Upon cancellation, the administrative fee that will be withheld from refund amount is: Full meeting cancellation: Industry/Non-industry Registration = Rs 3,000 Student Registration = Rs 500 Transfer policy: If you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email or post. Name changes and substitutions must be from the same company or organization and are not transferable between countries. Unforeseen situations: Organizers reserve the right to make alterations to the workshop/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of the organizers. If such a situation arises, we will refund your registration fee and we will try to reschedule the event.

Organizers reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Contact for Participation and Sponsoring the event: Ms. Sowmya Nataraj BE, PGDSE. Managing Director InvenStar Pharma Services Pvt Ltd sowmya.invenstar@gmail.com and Info@ipharmaservices.com Phone No. +91 8884328277 Preferred method of Communications Email or Phone or By post/courier

Method of Payment - DD/Cheque: Drawn in the name of InvenStar Pharma Services Pvt Ltd Payable at Bangalore, India - Bank Transfer Account Name Invenstar Pharma Services Pvt Ltd Account Number - 911020024934218 Bank Address Axis Bank, JP Nagar, Blore

Office Address InvenStar* Pharma Services Pvt Ltd No. 57, Keshava Nilaya, 4 Main, th Kothanur Dinne, JP Nagar 8 Phase, Near Water Tank, Bangalore-560076, Karnataka, India
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Two Days Workshop on Drug Development Mouse to Man (November 25-26, 2011)

Sponsorship Packages
Platinum Sponsor Rs. 1,50,000 5 Free delegates Brand opportunity Name and logo will be put on event brochures/advertisements/all internet marketing/promotional material and on the venue as Platinum sponsor Promotional literature will be inserted in all delegates kits Gold Sponsor Rs. 1,00,000 3 Free delegates Brand opportunity Name and logo will be put on event brochures/advertisements/all internet marketing/promotional material and on the venue as Gold sponsor Promotional literature will be inserted in all delegates kits

Silver Sponsor Rs. 80,000 2 Free delegates Brand opportunity Name and logo will be put on event brochures/advertisements/all internet marketing/promotional material and on the venue as Silver sponsor Promotional literature will be inserted in all delegates kits

Delegate Lunch Sponsor Rs. 60,000 1 Free Delegate Sponsor company logo on banners will be displayed at lunch stations as lunch partner of the event. Promotional Literature will be kept on lunch venue and inserted to in all delegate kit. Brand opportunity Name and logo will be put on event brochures/advertisements/all internet marketing/promotional material and on the venue

Delegate Bag Sponsor Rs. 40,000 1 Free Delegate Sponsor company logo printed on each delegate kit. We will place the logo based on your suggestion. Final decision will be taken by organizers. Brand opportunity Name and logo will be put on event brochures/advertisements/all internet marketing/promotional material and on the venue Promotional literature will be inserted in all delegates kits

Delegate Pens/Pads Sponsor Rs. 40,000 1 Free Delegate Sponsor company logo printed on attractive pens and are kept on every table and inserted in every delegate bag (provided by the bag sponsor) Brand opportunity Name and logo will be put on event brochures/advertisements/all internet marketing/promotional material and on the venue

Organizations Organizations and People involved in this Workshop

InvenStar Pharma Services Pvt Ltd Organizing Partner The organization was founded in 2008 and officially registered as per company act 1956 with ROC, Bangalore, Karnataka, India in January, 2011. The main services of the company are - Training and development in clinical research, pharmacology, biostatistics and other related life sciences - Scientific research manuscript writing and other related medical writing - Consultancy in clinical research and pharmacology (development of CROs, SOPs, development of protocols, study designs, auditing, quality assurance, clinical study site selection and monitoring - Pharma marketing Business development for pharma products both allopathic and ayurvedic products promotion More details available in www.ipharmaservices.com Sowmya Nataraj, Managing Director. Sowmya (BE, PGDSE) is a professional with training and experience in corporate environment. She was trained in Ranbaxy, Fortis Clinical Research and Lotus Labs (Part of Actavis) on Clinical Data Management, Clinical Study Report writing and Quality control. She worked for 30 bio-analytical method validation reports, 20 bio-analytical reports, 10 clinical study reports in ICH and ANVISA formats. She was part of the team that faced ANVISA and DCGI regulatory inspections at FCRL. Also she was part of various sponsor audits like Ranbaxy etc. She monitored clinical part of 5 BA/BE studies for compliance with SOPs, guidelines in Lotus Labs, Chennai. She has good understanding of Clinical research and regulatory requirements of reporting. Rao Toxicology Foundation Knowledge Partner Rao Toxicology Foundation (RTF) is headed by Dr. K.S. Rao, a Global veteran in toxicology. Objectives of the RTF are as follows: 1. Academic - Toxicology research guidance, continuing education programme, DABT Programme, Toxicology Consultancy 2. Regulatory - Regulatory Strategy, GLP Consultancy Offers one stop solutions and strategies for development of: Drugs, Biotech products, Vaccines, Biosimilars, Generic APIs for Impurity Qualifications, Pesticides, Food additives, Regulatory strategies and services, Full Dossier preparation Dr. K S Rao, Chief Scientific Officer Dr. K. S. Rao (M.V.Sc., Ph.D., DABT) is a board certified toxicologist with over 40 years of global experience in safety evaluation development the United States. Dr. Rao has worked at Searle labs, Dow Chemical and Quintiles in US. Currently, Dr. Rao offers expert advice to clients for product development strategies, reviews protocols and reports, prepares toxicology summaries and Dossiers for regulatory submission. He will also monitor studies, and provides continuing solutions to testing programs in drugs/biotech, Biosimilars, API impurity qualifications, and pesticides. During the last five years he has been mentoring hundreds of Indian scientists in toxicology and he was instrumental in bringing the Diplomate of American Board of Toxicology to India which resulted in over two dozen certified toxicologists in India. Dr. Rao has published papers and presented over 100 papers in international seminars. Quartesian CR Pvt Ltd Knowledge Partner Quartesian is a Data Service specialist with global presence. They have presence in USA, UK, Ukraine and India. The CRO was launched in 2003 andsuccessfully completed 8 years of operation. Quartesian is considered as a reliable and dependable service provider in Clinical Data Management (CDM), SAS programming, Bio-Statistical consultancy services, Medical Writing (CSR) areas. Quartesian also offers high ended industry training in CDM and SAS programming through exclusive partners like Cliniminds and Avigna learning academy. More details available in www.quartesian.com Dr. Shiva Murthy N, Director, Clinical research and Business Development: Dr. Murthy (MBBS, MD, PGDBA) is the clinical development leader in India, has more than 10 years experience in drug development and has worked on more than 120 clinical projects. This experience includes conducting Pre-clinical trials, Phase 1, 2, 3 and 4 trials, BA/BE trials and Pharmaco-epidemiology projects. Dr. Murthy has also developed clinical research and training departments in India for Quartesian, ICON, Fortis and Lotus. He is trained and experienced in GCP, BLS, ACLS, Clinical operations, Pharmacogenomics, Pharmacovigilance, Medical Affairs related activities. He is the member of Indian Pharmacologists Society (IPS), Indian Society for Clinical Research (ISCR) and official reviewers for Indian Journal of Pharmacology. He is also an advisory board member for Clinical Trial Magnifier, an online journal published by Clinical Trials Center, The University of Hong Kong.

Directions to Reach Workshop Venue Dear Delegates, We welcome you to Bengaluru the Garden City and IT Capital of India. Please find below details of Workshop Venue: Conference Hall St. John's Auditorium St. John's National Academy of Health Sciences, John Nagar, Koramangala, Bangalore. How to Reach the Venue: From Bangalore City Railway Station: About 10 Km; the route is via Hudson Circle- Shanthi Nagar- Hosur Road- St. John's Medical College Koramangala. Participants arriving by train are advised to use the pre-paid autorickshaw service available at the city railway station. The destination is Koramangala BDA Complex. The expected fare is about Rs.100/-. Beyond 10 PM or before 6 AM, the fare could be double this amount. From Bangalore Bus Stand: The Bangalore Metropolitan Transport Corporation (BMTC) operates bus services from Subhash Nagar bus stand (opposite the City Railway Station) to Koramangala. The route numbers are 171, 171H (Blue Colour Buses), J171, 171 (Pushpak Service). BMTC also operates buses from Shivajinagar to Koramangala and the numbers are 166, 164. You will have to alight at the Koramangala BDA Complex' bus stop, walk across the road in order to reach auditorium opposite to complex. From the Bangalore International airport: Here are the options: Vayu Vajra bus services. These are Red colored A/c VOLVO buses. Board the bus BIAL 7 (bound for Koramangala). The tickets can be purchased from the conductor after you board the bus. You have to alight at Koramangala BDA Complex stop. The fare is Rs.150/- and you have to pay in Indian rupees ONLY. Easy Cab taxi services. You can make use of this service to reach directly to the hotel you booked. These are white / green colored cabs and the fare is about Rs.750/- to Koramangala. From your hotel you can ask the cab drivers to reach Koramangala BDA complex. Walk across the road in order to reach auditorium opposite to complex. Important points to note: We strongly urge the international participants to carry out the exercise of Indian currency exchange at their point of embarkation itself. Helpline Contact: Ms. Sowmya Nataraj Dr. Shiva Murthy N Dr. K S Rao - 08884328277 - 08884328275 - 09620851915