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PROGRAM South Asian Chapter of American College of Clinical Pharmacology 8 th International Annual Conference Translational Clinical Pharmacology Research in Drug Development Pre Conference Workshop Date: 23 rd April 2015 Conference Dates: 24 th -25 th April 2015 Venue: Nehru Centre, Dr Annie Besant Rd, Worli, Mumbai, India.

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Page 1: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

PROGRAM

South Asian Chapter of American College of Clinical Pharmacology

8th International Annual Conference

Translational Clinical Pharmacology Research in

Drug Development

Pre Conference Workshop Date: 23rd April 2015

Conference Dates: 24th-25th April 2015

Venue: Nehru Centre, Dr Annie Besant Rd, Worli, Mumbai, India.

Page 2: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

8th Annual Conference Highlights:

The Theme of 8th Annual Conference of SAC-ACCP is - Translational Clinical Pharmacology for Drug Development. Needless to state, drug development for local-regional health needs is a very important topic for India and the South East Asia region. There are two parallel track pre-conference workshops – one in Clinical Pharmacology /translation of PK/PD of Anti-infective drugs and the other in Medical writing taking into consideration needs of young researchers and the Industry. A conscious decision was taken by the organizing committee in this edition of the annual conference to concentrate on translational Clinical Pharmacology of both Infectious diseases (Tuberculosis, Malaria) and Non Communicable diseases (Diabetes Mellitus, Oncology) from the perspective of Public health Importance in the South East Asia region. Every researcher would agree that ultimately, medical research must translate into improved treatments or treatment regimens for patients. The Organizing committee has been fortunate to have eminent faculty from Academia, Government and the Industry who have agreed to speak on their work in the chosen field and also provide information on how collaborations between different stakeholders are enabling development of better health care, improved quality of life, and enhanced treatment for patients. The faculty will enlighten the audience on how findings in the laboratory are getting translated into drug development and how it all goes into producing changes in clinical practice, from bench to bedside. International Faculty: Dr Meibohm Berndt Prof. Mark Atkinson Dr. Gangadhar Sunkara Dr Michael Conlon Dr Stephan Chalon Dr Peter K Hoffmann Dr Barbara Werner Dr Dakshina Chilukuri National Faculty: Dr M.K. Bhan Prof.DK Kochar Dr Kavita Singh Dr. Soumya Swaminathan Dr Umesh Gupta Dr Manoj Nesari Dr Subramanian Ganesan Dr Ayyappa Chaturvedula Dr. Rama Sivasubramanian Dr Praveen Myneni Dr Suhasini Sharma Dr Nithya Gogtay Dr AjithKumar Vasudevan Ms Dilmaher Guzder Dr. Rajesh Naik Dr Suhas Pingle Dr Jay Prakash Jain Dr Madhav Marathe Dr Bobby George Dr M Joseph

We have also recieved approval for four MMC credit points for the conference

Page 3: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Preconference workshop - I

Application of Translational Pharmacokinetics (PK)/Pharmacodynamics (PD) Principles in the Development of Anti-infective drugs

Day 1: Thursday, 23rd April 2015

Venue: Hall of Harmony

08.00am-09.00 am Registration/ Breakfast

09.00am-09.15am Opening Remarks

Dr. Nilima Kshirsagar, National Chair of Clinical Pharmacology, ICMR, India and President, SAC-ACCP

09.15am-10.00am

Drug exposure- Drug response relationship Concepts: Anti-bacterial drugs (Bacterial replication kinetics, Drugs review, PK-PD modeling)

Dr. Gangadhar Sunkara, Novartis Institute for Biomedical Research, USA

10.00am- 10.45am In vitro models, Animal models and early stage clinical development translation of anti-bacterial drugs: 2 case examples

Dr Subramanian Ganesan, Novartis Healthcare Ltd, India

10.45am-11.00am Tea

11.00am-11.45am

Application of NLME Approaches in Pre-

Exposure Prophylaxis (PrEP) of HIV infection Dr Ayyappa Chaturvedula, GVK Life sciences, India

11.45am- 12.30pm “Dengue Nucleoside Antivirals: Biopharmaceutical and PK/PD Challenges”

Dr. Rama Sivasubramanian, Novartis Healthcare Ltd., India

12.30pm-01.45pm Lunch

1.45pm -3.15pm

2- Case Studies for participants to work on (One nucleoside and on anti-TB drug case study) 15 min – review of cases 75 min – Breakouts

All faculty to be involved

3.15pm-3.30pm Tea

3.30pm -5.00pm 30 min – team presentations (each team) All faculty to be involved

Page 4: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Preconference workshop - II

Enhancing Skills in Medical Writing

Day 1: Thursday, 23rd April 2015 Venue: Hall of Culture

08.00 am-09.00 am Registration/Breakfast

09.00 am-09.15 am Opening remarks

Orientation to workshop

Dr Nilima Kshirsagar, ICMR, Mumbai

India

Workshop Director: Dr Padmaja Marathe ,Seth G S Medical College and KEM Hospital, Mumbai, India

09.15am-09.45 am Medical Writing: Scope and Skills Dr Suhasini Sharma, Director, Medical Affairs, Sciformix, Pune, India

9.45am-10.45am Critical Appraisal:1

All faculty

10.45am-11.00am Tea

11.00am-12.30pm Critical Appraisal:2

All faculty

12.30pm-1.45pm Lunch

1.45pm-2.15pm From the desk of an editor Dr Nithya Gogtay, Journal of Postgraduate Medicine, Mumbai, India

2.15pm-2.35pm Publication ethics Dr AjithKumar Vasudevan Novartis Limited., Hyderabad, India

2.35pm-3.15pm Safety writing in the pharmaceutical industry

Dr. Supriya Desai, Sciformix Corporation, Mumbai, India.

3.15pm-3.30pm Registration/Breakfast

3.30pm-4.15pm The Art and Science of Writing an SAE narratives (15 min) Team presentations (30 min)

Ms Dilmaher Guzder Lead Medical Writer and Writing Coach, India

4.15pm- 4.35pm 4.35pm- 5.00pm

Ethical Advertising 1. Pharmaceutical advertising

2. Advertising by Medical Practitioners

Dr. Rajesh Naik,Head, Medical Affairs Boehringer Ingelheim, Mumbai Dr Suhas Pingle, Mumbai

5.00pm-5.15pm Open House and participant feed back Concluding remarks

Dr Padmaja Marathe,Mumbai, India Prof. YK Gupta, AIIMS, Delhi

Page 5: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Main Conference

Day 2: Friday, 24

thApril, 2015

Venue: Hall of Culture

07.30am-8.00am Registration and Breakfast

08.00am-9.30am

Session 1: ORAL/POSTER PRESENTATIONS

Session 1a: Clinical-Oral

Hall of Culture

Presentation No: CL/OR/01 to

CL/OR/06

Session 1b: Pre-Clinical-Oral

Hall of Harmony

Presentation No: PR/OR/01 to PR/OR

/06

POSTERS

Session 1c: Clinical Poster Evaluation (CL/P)

Session 1d: Pre-Clinical Poster Evaluation (PR/P)

9.30am-10.30am

Session 2: INAUGURATION

by

Padma Vibushan Prof BK Goyal, Padma Vibushan Dr Anil Kakodkar and

Padma Bushan Prof GB Parulkar

Felicitation of Dr V. M. Katoch, Dr M. K. Bhan, Dr Ram Vishwakarma (TBC), Mr

Pankaj Patel, Mr Glenn Saldhana (TBC) and Mr Dilip Shanghvi (TBC)

10.30am-11.30am Session 3 : KEY NOTE ADDRESS

10.30am-11.00am Role of clinical pharmacology discipline in drug discovery and development to improve the healthcare of patients

Dr M.K. Bhan, IIT, New Delhi, India

11.00am-11.30am State-of-the-art Science in clinical pharmacology to support drug discovery and development: vision 2020

Dr Meibohm Bernd, President, ACCP,USA

11.30am- 11.50am Tea

11.50am-1.30pm Session 4: TRANSLATIONAL EFFICACY

11.50am-12.10pm

“Keynote presentation” Are we getting the dose right in late stage clinical trials? – Lost in Translation? (Differences in clinical biomarkers from Diabetes perspective)

Prof. Mark Atkinson, Univ. of Florida, FL, USA

12.10pm-12.30pm Challenges in translating efficacy between animal models and humans:(Oncology Case Study)

Dr Praveen Myneni, NATCO, Hyderabad, India

12.30pm-12.50pm FDA Critical Path Initiative – Translational Research!

Dr Michael Conlon, Univ. of Florida, FL, USA

12.50pm-1.10pm Translational research with Anti hyperglycemic agents Indian perspective

TBC

1.10pm-1.30 pm Q&A

1.30 pm-2.30pm Lunch

2.30pm-4.10pm Session 5: TRANSLATIONAL CLINICAL PHARMACOLOGY

RESEARCH IN THE DEVELOPMENT OF ANTI-MALARIA DRUGS

2.30pm-2.50pm Why is malaria still a dangerous disease? Epidemiological and microbiological perspective

Prof.DK Kochar, Consultant Physician, India

2.50pm-3.10pm Translational aspects in Malaria Vaccine development

Dr Kavita Singh, Program Director, MVDP, New Delhi, India

3.10pm-3.30pm Combination drug development strategy to treat Malaria: PK-PD considerations

Dr Jay Prakash Jain, Novartis, Hyderabad, India

Page 6: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

3.30pm-3.50pm

“Keynote presentation” An effective game plan to combat Malaria

through innovative drug discovery and

development: focus on translational clinical

pharmacology

Dr Stephan Chalon, MMV, Switzerland

3.50pm-4.10pm Q&A

4.10pm-4.30pm Tea

4.30pm-5.30pm

Session 6: PANEL DISCUSSION-TRANSLATIONAL RESEARCH IN

SOUTH ASIA AND USA

Moderators : Prof Nilima Kshirsagar and Dr Gangadhar Sunkara

Panelists: Dr T.S. Rao, DBT, Govt. of India; Dr Vipin Kumar, National Innovation

Foundation ; Dr O.P Agarwal, Ex- CSIR; Bejon Misra, Quality Council of India, Dr Rajendra Jani, SVP, Zydus Cadila and Dr Mahmed Salahuddin, Bangladesh

5.30pm-6.30pm

Session 7: ORAL/POSTER PRESENTATIONS

Session 7a:Clinical-Oral

Presentation No: CL/OR/07 to CL/OR/16

Hall of Culture

Page 7: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Day 3: Saturday, 25th April 2015 Venue: Hall of Culture

7.30am-8.00am Registration and Breakfast

8.00am-9.30am Session 8: ORAL/POSTER PRESENTATIONS

Session 8a:

Clinical-Oral

Hall of Culture Presentation No:

CL/OR/17 to CL/OR/23

Session 8b:

Pre-Clinical-Oral

Hall of Harmony Presentation No:

PR/OR/07 to PR/OR/14

POSTERS EVALUATION

Session 8c: Clinical Poster Evaluation (CL/P)

Session 8d: Pre-Clinical Poster Evaluation (PR/P)

9.30am-11.10am Session 9 : TRANSLATIONAL SAFETY

9.30am-9.50am Investigative Toxicology: Challenges in translating general toxicity data to early stage clinical safety studies

Dr Peter K Hoffmann, Novartis, USA

9.50am-10.10am Translating Liver Function across species: Future directions

Dr Madhav Marathe, Toxicologist, SPARC, Baroda, India

10.10am-10.30am

Translating Benefit/Risk Assessment between early and late stage clinical trials: Role of comedications, co-morbid disease conditions, Regions?

Dr Barbara Werner, Novartis, USA

10.30am-10.50am

Predictive value of preclinical safety studies: Challenges in translating cardiovascular safety pharmacology data to early stage clinical safety studies

Dr Peter K Hoffmann, Novartis, USA

10.50am-11.00am Q &A

11.00am-11.10am Tea

11.10 am-12.30 pm Session 10 : TRANSLATIONAL CLINICAL RESEARCH IN THE

DEVELOPMENT OF ANTI-TUBERCULOSIS DRUGS

11.10 am-11.30 pm

Key note Presentation: Is fighting MDR/XDR-Tuberculosis a difficult battle?: Epidemiological and microbiological perspective

Dr. Soumya Swaminathan, Director, National Institute for Research in Tuberculosis, India.

11.30 am-11.50pm In vitro and animal models to assess the efficacy of anti-tuberculosis drugs: Current advances in the field and future directions

Dr Umesh Gupta, JALMA, Agra

11.50 am-12.10pm Translational PK/PD strategy : Historical experience (preclinical to clinical translation) – Finding a right dose for Phase 2 studies

Dr Subramanian Ganesan, Novartis, India

12.10 pm-12.30pm Q & A

12.30 pm-1.30 pm Lunch

1.30 pm-1.50 pm

Key Clinical Pharmacology Aspects of TB Drug

Development Dr Dakshina Chilukuri, USA

1.50 pm-2.10 pm “Keynote presentation”

Ongoing fight against Tuberculosis - do we have enough army?

Dr Gangadhar Sunkara Novartis Institute for Biomedical Research, USA

2.10 pm-2.30 pm Q & A -

2.30 pm-3.30pm Session 11: REGULATORY ASPECTS – TRANSLATION TO PUBLIC

HEALTH

2.30 pm-2.50 pm Traditional Medicine: challenges and opportunities in translational research

Dr Manoj Nesari, AYUSH, India

Page 8: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

2.50pm-3.10pm Regulatory requirements for Bench to Bedside translation for drug discovery & development in India

Dr Bobby George, Reliance Clinical Research, Mumbai, India

3.10pm-3.30pm Translation of anti TB drugs from bench to Bedside - Lupin story

Dr M Joseph Lupin Pharma., Pune, India

3.30pm-3.50pm Tea

3.50pm-5.00pm Valedictory function

Page 9: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Dr Peter Hoffmann

Dr Praveen Mayneni

Dr Soumya Swaminathan

Dr Barbara Werner

Dr Hoffmann currently works at Novartis in

Preclinical Safety. He supports safety

evaluations for projects in cardiovascular and

metabolic indications and serves as Global

Preclinical Expert for Cardiovascular Safety

and co-chair of the Translational

Cardiovascular Advisory Team. He is an MD

and PhD from the Medical School at the Martin

Luther University in Halle, Germany

Dr Mayneni is currently Medical Officer &

Coordinator - Drug Development at

NATCO Pharma Ltd.

Dr Swaminathan is a Paediatrician by training,

having completed her medical education at the

Armed Forces Medical College and the All

India Institute of Medical Sciences (India)

followed by a fellowship in pediatric

pulmonology at the Children’s Hospital of Los

Angeles (USA). She is currently Director of the

centre and heads the NIH International Centre

for Excellence in Research.

Dr Werner is an American Board certified

Psychiatrist who has been in both Academia and

Industry in the domain of drug development. She

currently works as VP- Global Safety in Novartis

Pharmaceutical, USA.

Page 10: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Prof Umesh Gupta

Dr Bobby George

Dilmaher Guzder

Dr Madhav Marathe

Dr Gupta is currently Deputy Director/Scientist F

at the National JALMA Institute for Leprosy &

Other Mycobacterial Diseases based out of Agra,

India. He has been associated as PI and Co-PI in

number of projects funded by DBT and ICMR on

Leprosy and Tuberculosis

Dr. George is currently Vice President & Head

Regulatory Affairs, Reliance Life Sciences Pvt

Ltd. where he is responsible for providing

regulatory guidance and strategic inputs for their

Pharmaceutical, biopharmaceutical, and novel drug

development programs including stem cells to

assure appropriate and timely regulatory filing and

approvals, across different regions globally. He

holds a M. Pharm and Ph.D. in Pharmacology from

Panjab University, Chandigarh

Dilmaher Guzder is a Clinical Pharmacist with 16

years of work experience, including 8 years in the

international healthcare sector and about 8 years in

pharmacovigilance and medical writing. She has

completed M. Sc in Clinical Pharmacy (Hospital),

University of Bradford, UK. She is a Lead Medical Writer with expertise in

quality and editorial review of various types of

scientific, safety and regulatory documents and

training.

Dr Marathe is currently Vice President, Pre-

clinical Toxicology at Sun Pharma Advanced

Research Company Ltd, (SPARC), Vadodara. He

is a Masters in Veterinary Pathology (M.V.

Sc.)with distinction from Bombay University,

Toxicology & QA Certification form US-FDA and

also the Senior most Pre-clinical Toxicologist and

Pathologist in India, in New Drug Discovery

Research and NDDS with over 42 years of

experience

Page 11: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Dr Ajith Kumar Vasudevan

Dr Suhasini Sharma

Dr Nithya Gogtay

Dr Supriya Desai

Dr Vasudevan is currently Group Lead -

Medical Communications, Respiratory

Novartis Healthcare Private Limited Global

Medical and Clinical Services . He is a PhD

and a Project management professional

(CMPP).

Dr. Sharma is an MD who is currently the

Director, Medical Affairs at Sciformix

Technologies, a functional service provider

to global biopharmaceutical companies. She

provides medical expertise and guidance for

Company’s services in the areas of Scientific

Writing, Safety & Risk Management, and

Medical Affairs & Clinical Research

Dr Nithya Gogtay is currently working as

Additional Professor in the Department of

Clinical Pharmacology Seth GS Medical

College & KEM Hospital, Mumbai

(Bombay, India. She has over 100 peer

reviewed publications to her credit. She has

received special training in

Pharmacovigilance at the Uppsala

Monitoring Centre, Sweden. She is also

theEditor of the Journal of Postgraduate

Medicine and member of the Journal of

Association of Physicians of India.

Dr. Desai is a Clinical Research and

Pharmacovigilance (PV) Executive with

over 16 years of experience in clinical

practice and in various leadership roles in

clinical research, drug safety and PV. In her

current role as Practice Head and Medical

Director at Sciformix, she provides scientific

and operational leadership to a global team

of physicians and RNs involved in medical

review activities across pharmacovigilance,

safety writing, signal management and allied

safety surveillance activities, spanning

diverse therapeutic areas.

Page 12: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Dr Bernd Meibohm

Dr Dakshina Murthy Chilukuri

Dr Ayyappa Chaturvedula,

Dr Jay Prakash Jain

Bernd Meibohm, Ph.D. is serves as President

for the American College of Clinical

Pharmacology (ACCP) and is a Professor of

Pharmaceutical Sciences at the College of

Pharmacy, The University of Tennessee

Health Science Center, Memphis. His

scientific interests include pulmonary

infectious and inflammatory diseases,

pediatric pharmacotherapy and the

application of quantitative modeling and

simulation techniques in preclinical and

clinical drug development, with specific

focus on therapeutic proteins.

Dr Chilukuri is a Ph.D. in Pharmaceutical

Sciences from the Medical University of

South Carolina, Charleston, SC and

currently serves as Senior Clinical

Pharmacology Reviewer, Office of Clinical

Pharmacology, FDA, USA

Dr Chaturvedula, PhD. is currently General

Manager, Informatics and Analytics, GVK

Biosciences. He is a Pharmacometrics

scientist with pharmaceutical industry and

academic experience. Current research

interests are in mechanistic modeling,

population pharmacokinetic analysis

methods and quantitative pharmacology

Dr Jain is a PhD. from NIPER, Chandigarh,

India and currently works with Novartis

Institutes for biomedical research in the

Global Pharmacokinetics /

Pharmacodynamics division of the Drug

Metabolism and Pharmacokinetics (DMPK)

department. The current area of his work is

Clinical Pharmacology in Drug

Development with special focus on malaria

as dieses area.

Page 13: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Dr Kavita Singh

Dr. Mark Atkinson

Dr Michael Conlon

Dr Stephan Chalon

Dr Singh is currently Program Director,

Malaria Vaccine Development Program. She

is an MD (Microbiology) from PGI,

Chandigarh and has worked in academia,

government and Industry. She is a member of

Safety Monitoring Committees, Small

Business Innovation Research Initiative

(SBIRI) of department of biotechnology,

Project Monitoring Committee of various

projects of BIRAC.

Dr.Atkinson is currently the American

Diabetes Association Eminent Scholar for

Diabetes Research at The University of

Florida. He also serves as the Director for

the Diabetes Institute. Dr. Atkinson is an

internationally recognized authority on

multiple aspects pertaining to type 1

diabetes, with particular interests in disease

prediction and prevention, the role for

environment in the initiation of the disease,

stem cells and pancreatic regeneration, and

the identification of markers of tolerance and

immunoregulation.

Dr. Conlon is a Ph.D. in Statistics from the

University of Florida and currently serves as

Co-director of the University of Florida

Clinical and Translational Science Institute.

His responsibilities include strategic

program development, expansion and

integration of research and clinical

information resources, and strategic planning

for academic health and university research.

Dr Chalon is currently Medical Director –

Early Development & Clinical

Pharmacology at the Medicines for Malaria

Venture (MMV) based out of Geneva. He is

a PhD. in Pharmacology and has been with

Clinical Pharmacology drug development

groups across the industry in senior level

positions.

Page 14: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Padma Vibushan Dr BK Goyal

Dr Nilima Kshirsagar

Padma Vibushan Dr Anil Kakodkar

Padma Bushan Dr G.B Parulkar

Dr Goyal is the honorary dean and chief

cardiologist at the Bombay Hospital Institute

of Medical Sciences and is a former

Director-Professor of cardiology of JJ Group

of Hospitals and Grant Medical

College, Bombay. Goyal is a visiting

professor of cardiology at the University of

Alabama, in USA and visiting cardiologist to

the Oschner Heart Institute, New Orleans.

He served as a member of the Executive

Council and Senate of the University of

Bombay for several years.

Dr Kshirsagar is currently- National Chair

Clinical Pharmacology Indian Council of

Medical Research Govt. of India and

President of SAC ACCP. She has been

honoured with several awards most notably

Dr BC Roy award and Vasvik award for

Industrial research and for societal

contribution. Her research interests include

Infectious diseases, clinical trials, drug

development, therapeutic drug monitoring,

pharmacovigilance, She has been the guiding

force for developing an indigenous version

of Liposomal Amphotericin.

Dr Kakodkar became the Director of BARC

in the year 1996 undeterred by the

restrictions imposed by the international

community, succeeded in developing various

systems for the pressurized heavy water

reactors, in building the Dhruva reactor

starting from the conceptual stage, in

rehabilitation of Madras Atomic Power

Station Units. He played a key role in

nuclear tests in 1974 &1998 at Pokhran.

Kakodkar’s sterling leadership led to a

significant boost to India’s nuclear power

programme

Dr Parulkar is consultant cardiovascular

surgeon, former Dean & Director Prof. &

head dept. Cardiovascular surgery, GSMC &

KEM hospital, Mumbai. Dr. Parulkar has

carried out pioneering clinical and scientific

research in many areas including

extracorporeal circulation, transmyocardial

revascularization, and several innovations in

the techniques of surgical management of

patients with complex congenital heart

disease, correction and replacement of

valvular heart diseases and coronary bypass

surgery.

Page 15: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Dr Gangadhar Sunkara

Dr Joesph Marialouis

Padma Bhushan Dr MK Bhan

Dr T.S. Rao

Dr Sunkara is currently Executive Director

at Novartis Institute of Biomedical Research,

New Jersey, USA. Dr. Sunkara earned his

BS and MS in Pharmaceutical Sciences from

Kakatiya University in India and his PhD in

Pharmaceutical Sciences from the University

of Nebraska Medical Center in Omaha,

Nebraska. He has been a Lead

Pharmacokineticist in the Exploratory

Clinical Development division at Novartis

Pharmaceuticals.

Dr Marialouis is currently Assistant

Director, Clinical Operations, at Lupin

Bioresearch Center, Lupin Pharma ltd.,

Pune, India. He is a Clinical Research

Professional with 10 years of Industry

Experience in the conduct of

Bioavailability/Bioequivalence, 505b2, POC

& Clinical End point studies. He has a post

graduate degree in Pharmacology from

Madras Medical College.

Dr MK Bhan obtained his MD (Pediatrics)

from Delhi University, Delhi. His areas of

specialization are pediatric gastroenterology,

pediatric infectious diseases and

nutrition. He identified G9 as an important

serotype in childhood diarrhea, which led to

its incorporation in the candidate rotavirus

vaccines. Bhan developed low osmolarity

oral rehydration solution, which has been

introduced in the Diarrheal Disease Control

Programme by WHO and by the

Government of India.

Dr. T.S. Rao is currently Adviser in the

Department of Biotechnology, Ministry of

Science & Technology, Govt. of India. He is

coordinating the programs related to Medical

Biotechnology, Human Genetics & Genome

Analysis, National Bioethics Committee,

Vaccines Research and Development since

1988-89.Dr. Rao has also worked at National

Institute of Communicable Diseases, M/o

Health & FW, Govt. of India, in the area of

development of Malaria vaccine by using

molecular biology methods and developed

monoclonal antibodies for blood stages

of P.falciparum.

Page 16: Translational Clinical Pharmacology Research in Drug ... filePROGRAM South Asian Chapter of American College of Clinical Pharmacology 8th International Annual Conference Translational

Dr Vipin Kumar

Bejon Misra

Dr Rajendra Jani

Dr Manoj Nesari

Dr Kumar is currently Director, National

Innovation Foundation-India, Department of

Science and Technology, Govt of India.

National Innovation Foundation-India is an

autonomous body of the Department of

Science and Technology, Government of

India, based on the Honey Bee Network

philosophy, which provides institutional

support to grassroots innovators and

outstanding traditional knowledge holders

from the unorganized sector of the society.

Bejon Misra has been in the consumer

movement in India for the last 25 years

starting from Jamshedpur in 1983 as the

founder of the Consumer Guidance Society

of Jamshedpur. He is a management

graduate with marketing as major from the

Banaras Hindu University. He has

professional experience for more than 35

years working as an entrepreneur. He is is at

present the Executive Director of a leading

consumer organisation, Voluntary

Organisation in Interest of Consumer

Education (VOICE) based in New Delhi.

Dr Jani is currently Senior VP , Clinical

R&D at Zydus Cadila Healthcare Ltd. He

has a doctorate in Pathology and

Bacteriology from faculty of medicine and

has more than 35 years’ experience. He has

conceptualized and conducted 35 “first in

man” (phase 1) studies with new chemical

entities and more than 180 phase ii – iv

clinical studies.He was responsible for

clinical research and development of two

new chemical entities; Miltefosine and

Saroglitazar.

Dr Nesari is currently Joint Adviser

(Ayurveda), Department of AYUSH

Ministry of Health & Family Welfare,

Government of India. He has 20 years

experience in the profession as Ayurveda

clinician during which, he has developed

expertise in Ayurvedic management of Pain

dominant conditions e.g. Spinal

Degenerative Diseases. His contribution

towards development of AYUSH Sector has

been varied in areas such as policy and

planning for matters pertaining to Ayurveda.