DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........
DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contributio
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Thursday, 24 September 2015

Shailja Dixit




 Shailja Dixit
 Executive Director, Medical Affairs, Allergan

Earlier  Head Global Evidence & Value Development-Diabetes & Aging Division at sanofi-aventis
Shailja is an accomplished healthcare executive and has 15+ years of industry experience. She has served in variety of leadership role & has a 360 degree understanding of healthcare industry having worked in different industries within Healthcare. In her current role, she is responsible for leading Global Health economic & outcomes team at Actavis across entire portfolio. She has been instrumental in laying foundation for new HEOR & Value model, collaborative research with academia & stakeholder engagement strategies. Shailja has led successful Global launches and has led the teams responsible for “end to end “evidence development to support market access & reimbursement.

Summary

Accomplished healthcare & pharmaceutical physician executive with more than 15 years of healthcare industry experience with Big Pharma (Sanofi and Pfizer), Big-5 Consulting (Accenture), Payer(Aetna) and Provider Groups.

• Global perspective gained from roles in the US, Europe and Asia-Pacific in variety of areas:
• Big Pharma Experience in elderly population portfolio (Alzheimer’s, pain, osteoarthritis, hearing disorder), metabolic (diabetes), cardiovascular ( lipid lowering) and neutraceuticals.
• Experience in Device, Drug value and evidence development for a successful launch & optimum access in Global Markets
• Experience in Health Outcomes and Health Economics methodologies and models.

Shailja Dixit, @ShailjaDixit

 https://www.facebook.com/shailja.dixit.355
 https://www.linkedin.com/pub/shailja-dixit/6/b7/21a

 Shailja Dixit

Experience






Global Head HEOR and Field Managed care Science Liaison

Allergan
– Present (2 years 6 months)

Head Global Evidence & Value Development-Diabetes & Aging Division

sanofi-aventis
(2 years 1 month)Greater New York City Area
• Leading the Evidence and Value Development team in Therapeutic Strategic R&D Unit of Diabetes, PCSk9 and Aging.
• Responsible for end to end evidence creation starting with identification of elements of differentiation, incorporating them into R&D strategy working with cross function (R&D) teams and finally, developing a successful payer value proposition i.e. Core Value Dossier for optimal reimbursement & coverage.





Healthcare Executive- Healthcare IT and Management Consultancy

Accenture
(1 year 8 months)
• Advised and lead projects for large payer organization laying strategies for new payment and healthcare reforms like Accountable Care Organizations and Medical Home.
• Help build strategies for evidence and value development for late stage projects/products
• Build launch readiness health outcomes and evidence generation plan for products in phase III
• Conducted strategy workshops for higher leadership in various pharma companies to discuss impact of changing healthcare landscape.
• Worked across Phase II / III and IIIb / IV groups with input to clinical development plans, publications and regional marketing campaigns
• Clinical trial design, optimization of protocols, medical monitor and assistance with clinical trial operations
• Optimization of payer submissions / dossiers and regulatory responses
• Provided consultancy services to major payer on Value Based Reimbursement





Marketing Director, HIT, GE HealthCare

GE Healthcare
(4 years 1 month)
Reporting into GM & VP for Strategic Marketing, GE Healthcare, responsibilities include leading product and strategies for Quality Improvement, Clinical Decision Support and Business Intelligence.
• Led new product initiatives for Clinical Data Services focused on Pharma Sector. Groomed, developed and managed the GE-Roche strategic partnership for collaboration on type 2 diabetes “comprehensive solution”. The comprehensive solution leverages the EMR based interventions to increase adherence to standard of care, increase compliance and study outcomes.
• Led meaningful use initiative for GE products working closely with provider community.
• Laid out strategy for Clinical Content, Decision Support Tools and Business Intelligence (BI) offering for GE healthcare IT. The BI offering provides advanced reporting and analytics tools for pharmaceutical industry to support data needs for HEOR.





Clinical Director, Strategic Marketing

GE Healthcare
(2 years)
• Led Clinical Decision support innovation team to create product agnostics platform that will provide point of care decision support based evidence based medicine.
• Developed and evangelized GE’s Total Population Management tools for Chronic Disease Management product development in provider segments.

• Led customer collaboration efforts at Centricity-EMR (GE’s EMR) Health User Group (CHUG ’08, ’09 and ‘10) to define role of Health Information Technology to facilitate the changing role of physician in care delivery i.e. collaboration and information sharing with patients and family members.
• Filed 2 patents around Chronic Disease Management Decision support and Targeted Education (Evidence Based Medicine).
(Open)1 honor or award





Asst.Director : Clinical Development

Pfizer Health Solutions
(2 years)
In the Clinical Development/Analytics Team, responsibilities include being clinical and informatics subject matter expert on International projects. The international projects require a thorough knowledge of Healthcare structure of the country, knowledge about Pfizer’s business strategy in the target country. This also involved a thorough analysis of HealthCare Information Technical and Electronic Tools used in the country.





Head of Informatics, Clinical Consulting

Aetna
(2 years)As Head of Informatics (Clinical Consulting), leading a team of 4 analyst and clinical consultants. The Clinical Consulting Team supports the information needs of Aetna's Medical Directors, National Medical Services, Health Care Delivery, Medical Cost Management, and other areas of Aetna, to help improve member health, the efficiency of Aetna’s operations, and the customer appeal of Aetna’s products and services
Professional Experience
2011 - Present
2010 - 2012
2006 - 2010

Educational Background
2003 - 2005
2000 - 2002
1993 - 1999
 








 The Government Medical College Aurangabad was founded in 1956 and it is one of the premier medical institutions in the Maharashtra State.The hospital of the college started with 300 beds in a small Nizam Bungalow in 1960 is presently equipped with 1170 beds distributed across various departments and wards . The foundation stone for the main building of medical college was laid by then chief minister of Bombay State Yashwantrao Chavan on 27 October 1957. The building was inaugurated by Sushila Nayyar, then minister of Health, Government of India on 20 June 1964. Various other buildings were added to the campus over period of time.




 L-R Anando Sen Gupta, Rajendra Pratap Gupta , Dr. George Smoot (Nobel Laureate), Dr. Shailja Dixit
 


 

 

 
 
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MoUNTAIN VIEW CALIFORNIA VISITOR  E MAIL ME amcrasto@gmail.com

Tuesday, 22 September 2015

Shalini Sharma




Shalini Sharma

Assistant Principal Scientist (AGM) at USV LIMITED

3rd International Conference and Exhibition on
Biowaivers, Biologics and Biosimilars
October 27-29, 2014 Hyderabad International Convention Centre, Hyderabad, India

posters

Shalini Sharma

Intas Pharmaceuticals Ltd., India

Title: Analytical biosimilarity: Strategies and chImage result for intas
allenges
Biography:
Shalini Sharma is microbiology Postgraduate from Maharaja Sayajirao University (MSU), Baroda. She is a Principal Scientist in Analytical Development Lab (Global Development) with the Biotech division of Intas Pharmaceuticals Ltd., and has more than 10 years of experience in the field of analytical method development and validation for biological drug products, which includes liquid chromatography methods, electrophoresis, ELISA and LC-MS. She has played key role in developing analytical methodologies and strategies, for establishing biosimilarity for EU and US registrations. 
Abstract:
Unlike small molecules, biological medicinal products are complex in nature. Despite the guidance from regulatory agencies like EMA and US-FDA, establishing analytical biosimilarity of a biological product with the reference product remains a challenge for analytical scientists, owing to the complex nature of biological medicinal products. Analytical similarity has gained more importance in recent years, since the analytical characterization data-package directly impacts the extent of clinical studies required to establish biosimilarity. The recent US-FDA draft guidance on establishing biosimilarity states the impact of the outcome of analytical similarity studies on biosimilar product development programme, wherein, based on the analytical biosimilarity results, the biosimilar product under development can be categorized as non-similar, similar, highly-similar and highly-similar with fingerprint like similarity. It further states that “The outcome of the comparative analytical characterization should inform the next steps in the demonstration of biosimilarity”. Considering these facts, demonstration of analytical biosimilarity becomes one of the most important aspects of biosimilar product development. An accurate and reliable analytical biosimilarity evaluation requires not only state-of-the art methods, but also an in-depth assessment of capability of analytical methodologies to detect minor differences between the biosimilar product and reference product. Employing methods like LC-MS, peptide-mass fingerprinting, circular dichroism, differential scanning calorimetry is imperative for structural evaluation during biosimilarity demonstration. Comparison of product related impurities in biosimilar product with the reference product can be particularly challenging, and needs to be evaluated using routine methods like reverse phase chromatography, SDS-PAGE etc, along with orthogonal high-end techniques like Analytical ultracentrifugation, SEC-MALS, CE-SDS etc. Identifying these impurities through LC-MS analysis, and comparing stability behaviors of both the products is also equally important. Choosing a set of right and useful analytical techniques is the key to successful demonstration of analytical biosimilarity, which can sufficiently support an abridged clinical trial, thus decreasing the cost of biosimilar development.


Summary

Scientist
Analytical Development Lab,
INDUS Biotherapeutics Ltd, Ahmedabad, India

- Impurity Characterization: Sequence and structural characterization of product related impurity variants

- Biosimilarity and Comparability studies: Comparability of Biosimilar products with Reference products approved in European Union as per EMEA guidelines

Senior Research Associate (2006-2008)
Analytical Development Lab,
INDUS Biotherapeutics Ltd, Ahmedabad, India

- Analytical Method Development and Validation: Developing and validating analytical methods like high-pressure liquid chromatography, Size Exclusion Chromatography, Ion-Exchange Chromatography, Capillary Zone Electrophoresis, Electrophoresis, peptide mapping, ELISA, etc. for lot release, stability analysis and other in-process analysis.
- Development of methods for characterization of glycosylation and methods for quantification of sugars and amino acid metabolites/additives in process.

Research Associate (2004-2006)

Specialties:Glycosylation characterization, protein structure analysis, impurity analysis and identification/characterization.

Working on various aspects of product Biosimilarity.

Experience






Associate Principal Scientist (AGM)

USV LIMITED
 – Present (6 months)Mumbai Area, India





Principal Scientist

Intas Pharmaceuticals Ltd. (Biotech Div)
 –  (11 years 10 months)Ahmedabad Area, India
Map of USV Limited

 







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