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DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

11th Pharmacovigilance 2016, 1st Dec 2016, Kohinoor Continental Hotel, Mumbai, India

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Oct 052016
 

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11th Pharmacovigilance 2016

“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management”

1st December 2016, Kohinoor Continental Hotel, Mumbai, India

After the successful journey of a series of 10 Pharmacovigilance conferences, Virtue Insight is proud to announce its 11th Pharmacovigilance 2016 in India. It is our great pleasure to invite you to the 11th Pharmacovigilance 2016, in Mumbai – India on 1st of December 2016. We have a wide range of scientific topics with something for everyone.

The past is reflected in a session about Indian traditional medicine and the future is discussed under Big Data analytics and in the research of our young scientists. However, we must live and act in the present and debate pressing challenges that face us today in pharmacovigilance (PV). The rates for medication errors are too high. We still struggle to communicate risk well. With the welcome drive towards transparency and respecting human rights, legal and ethical issues in PV have come to the fore. Society’s research enterprise as a whole needs to become far more aware of the commercial reality that PV underpins safety, with its intimate links to innovation, so that safety and must be intrinsically built into successful development and marketing. With governments round the world struggling to curb healthcare costs, the importance of integrating PV into National Health Programmes has never been more important.

It gives me great pleasure in welcoming all of you to the virtue insight’s 11th Pharmacovigilance 2016. I wish and pray that all our efforts will be beneficial to our industries and to our country at large.

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pic KANCHI SHAH, VIRTUEINSIGHT

 

KEY SPEAKERS INCLUDE

JEAN CHRISTOPHE DELUMEAU, Head of Pharmacovigilance Asia-Pacific, Bayer HealthCare (Singapore)

Jean-Christophe Delumeau

 

JESSICA THONGCHAREN, Associate Director Pharmacovigilance, Takeda Pharmaceuticals (Singapore)

 Jessica Thongcharen

ARUN BHATT, Consultant – Clinical Research & Development
V. KALAISELVAN, Principal Scientific Officer, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt. of India
SUDHIR PAWAR, Coordinator – ADR monitoring Center at LTMMC & GH, Under Pharmacovigilance Programme Of India (PvPI),Indian Pharmacopoeia Commission
ARUN BHATT, Consultant – Clinical Research & Development
BHASWAT CHAKRABORTY, Senior VP & Chair, Research and Development Core Committee, Cadila
SUTAPA B NEOGI, Additional Professor, Indian Institute of Public Health
DEEPTI SANGHAVI, Assistant Manager – Medical Writing, Tata Consultancy Services
JAMAL BAIG, Country Head – Pharmacovigilance, Merck
SIDDHARTH DESHPANDE, Assistant Professor Department of Clinical Pharmacology, KEM Hospital
ABHAY CHIMANKAR, Head, Global Drug Safety, Cipla
SANDESH SAWANT, Head, Clinical Operations (India and EM), Wockhardt
ABHAY PHANSALKAR, Head Clinical Trials, Cipla
GURPREET SINGH, Head Vendor Management, Drug Safety & Epidemiology, Novartis
MILIND ANTANI, Partner In-Charge – Pharma LifeSciences, Nishith Desai Associates
VARSHA NARAYANAN, Head Medical Affairs, Wockhardt
POOJA JADHAV, Manager, Sun Pharmaceuticals
GODHULI CHATTERJEE, Senior Medical Advisor and Clinical Safety Officer, Sanofi-aventis

Plus Many More..

PEOPLE YOU GET TO MEET

Vice Presidents, Directors, CRO’s, Heads and Managers of:
Pharmacovigilance Strategy, Drug Safety/Risk Management, Information and Clinical Data Management, Clinical Research, Research & Development, Product Safety/Assurance Assessment, Patient Safety & Outcomes Research & Data Analysis, Epidemiology project management, Regulatory Affairs and Compliance, Sales & Marketing, Biotech manufacturers

FROM VARIOUS

Pharmaceutical organizations, Generic pharmaceutical companies, Contract research organizations, Patient recruitment companies, Government- Department of health, Non-profit organizations/ Association, Consultants
This event also serves as a platform for networking opportunities in the relevant field , wherein you get to meet and  broaden  your  contacts to develop your business. We also have sponsorship opportunities available for the event which gives you an opportunity to speak/exhibit and create brand awareness. Or you could even attend the event as a delegate and get a better insight of the updates and  the increasing challenges in the industry . So hurry now and be a part of this massive event.

 

 

GLIMPSES OF MY( DR ANTHONY) INTERACTION

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with Fen Castro of VirtueInsight, Director , and his team , , —thanks for inviting me to 9th Biosimilars Congregation 2016., Lalit hotel, Mumbai, India, 22nd Sept 2016 — with Fen Castro, Kanchi Shahand Virtue Insight at The Lalit Hotel.

 

 

CONFERENCE BOOKING DETAILS

Online Registration http://www.bookmytrainings.com/all-courses/professional-events/event/44991-11th-pharmacovigilance-2016
Early Bird Discount Price – 1 Delegate Pass (INR 6,000 + Tax (15%) – Book and Pay before 17th October 2016 to avail this price
Standard Price (From 18th October 2016) – 1  Delegate Pass – (INR 7,000 + Tax (15%)
Group Discounts (Applicable for 3 or 4) – 1 Delegate Pass  – (INR 6,500 + Tax (15%)
Group Discounts (Applicable for 5 or more) – 1 Delegate Pass  – (INR 6,000 + Tax (15%)
Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, Exhibition Stall (Booth) or a paid Speaker Slot, you can simply call or email your interest and queries to TEL: +91 44 64614333, or sponsor@virtueinsight.com

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REGISTRATION PROCESS

In order to register simply email the below mentioned details to delegate@virtueinsight.com

  • Company Name & Address
  • Attendee Name/Names
  • Job Title
  • Contact Number

We also have some sponsorship opportunities available for the event, which gives you an opportunity to speak/exhibit, and create brand awareness. In addition, the networking opportunities in focused and relevant industry gathering provide the personal contact necessary for business development efforts.

In case you or any of your colleagues might be interested in participating in the same, please let us know and we will be happy to call you and help you with the registration.

 

SEE BROCHURE

Image result for waitALLOW BROCHURE TO LOAD

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Thank you for your time and consideration.

Fen Castro

Head – Productions

Virtue Insight

Image result for FEN CASTRO

Tel (India) –       + 91 44 64614333

Mobile (India) –  + 91 9003 26 0693

Tel (UK) –          + 44 2036120886

 

 

 

////////////11th Pharmacovigilance,  2016, 1st Dec,  2016, Kohinoor Continental Hotel, Mumbai, India, Conference, fen castro

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CHIRAL INDIA 2016, 5th International Conference & Exhibition Nov 8-9 2016, Holiday Inn, Mumbai, India

 CONFERENCE  Comments Off on CHIRAL INDIA 2016, 5th International Conference & Exhibition Nov 8-9 2016, Holiday Inn, Mumbai, India
Sep 072016
 

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India's only conference focusing on new chiral technologies for pharmaceutical fine chemicals. The event is a unique platform to learn about recent advances in chiral chemistry, technology and application.

Chiral India series which began in 2012 has now grown into a major must-attend event for the Pharmaceutical industry. This platform is the most popular chiral technology platform bringing together the top experts from China, Canada, USA, Japan, India and other countries to present the latest developments in chiral drug developments and brainstorm with leading R&D personnel from Indian pharmaceutical industry.

The fifth edition of Chiral India to be held on 8-9 November 2016, at Holiday Inn (Mumbai), follows the success of previous four annual editions (2012, 2013, 2014 and 2015) and is now an event awaited by R&D professionals across the industry.

International panel of Chiral experts will address on key Themes
  • Asymmetric hydrogenations: New directions
  • Chiral switches: Development of single enantiomer drugs
  • Chiral tool kit in new drug development
  • Organo molecular catalysts
  • Enzymatic processes for new chiral drug synthesis
  • Chiral chemistry in natural product synthesis
  • Chiral catalysis: An overview of recent advances
  • Chiral drugs: New regulatory directions
  • Chiral separation technologies
  • Flow reactions for chiral drug development

R  Rajagopal

+9198211 28341

rraj@chemicalweekly.com

kiran@chemicalweekly.com

Dr. R. Rajagopal B-602, Godrej Coliseum Tel: +91 22 24044477
Editorial Advisor K.J. Somaiya Hospital Road Fax: +91 22 24044450
Chemical Weekly Sion (East) Mumbai 400 022 www.chemicalweekly.com

DOWNLOAD BROCHURE…..

Please use http://www.chiralindia.com/Brochure.pdf link to download the Brochure.

Our website URL is www.chiralindia.com

 

Oganised By

 

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////////CHIRAL INDIA 2016, 5th International Conference, Exhibition,  Nov 8-9,  2016, Holiday Inn, Mumbai, India

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Virtue Insight invites you to the 9th Biosimilars Congregation 2016, 22nd Sept 2016, The Lalit Hotel, Mumbai, India

 CONFERENCE  Comments Off on Virtue Insight invites you to the 9th Biosimilars Congregation 2016, 22nd Sept 2016, The Lalit Hotel, Mumbai, India
Jul 132016
 

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9th Biosimilars Congregation 2016 during 22nd September 2016 Mumbai,  INDIA

22nd September 2016, The Lalit Hotel, Mumbai, India

Link http://www.virtueinsight.com/pharma/9th-Biosimilars-Congregation-2016/

ANINDITA DAS

ANINDITA DAS

Dr. Reddy’s Laboratories

MANISH VERMA

MANISH VERMA

Sanofi

DEBOLINA PARTAP

DEBOLINA PARTAP

Wockhardt

PARIKSHIT CHAUDHARI

PARIKSHIT CHAUDHARI

Nestle

HANMANT BARKATE

HANMANT BARKATE

Intas Pharmaceuticals

CONFERENCE INTRODUCTION:-

Virtue Insight invites you to the 9th Biosimilars Congregation 2016 during 22nd September 2016 Mumbai – India. This 9th Biosimilars Congregation 2016 brings together scientists, researchers and CROs from around the world. Biologics are a highly effective class of medicines that are based on naturally occurring proteins and produced using living cells. Current concepts of drugs and biologics, Unique considerations for biologics, Early clinical development essentials, Cancer therapeutics, Comparability for Biologics, Biosimilar approvals are the points of discussion in this session.

9th Biosimilars Congregation 2016 conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this global event will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscapes, biosimilar guidelines to the legal and economic aspects and current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place. By attending this biologics conference you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for biosimilars stakeholders to discuss and share best practices in expediting development in Biosimilars 2016 and onwards.

 

KEY THEMES DISCUSSED IN THIS CONFERENCE:-

  • Global biopharma policy & market trends
  • The future of biosimilars in India
  • The evolving biosimilar sector: Trends and Implications
  • Complex biological models in biosimilar development
  • Viable extrapolation strategies for biosimilars with special emphasis on TNF antagonists
  • Effectively communicate the value of biosimilar products to raise confidence in the class
  • Improving characterization of biosimilars with technology
  • Create a robust patient services and reimbursement support program for biosimilar products
  • The future of the biosimilar industry – mapping the evolution and development of the biosimilar sector
  • Forecasting the financial growth of biosimilars in the global healthcare marketplace
  • Planning of a biosimilar development project – what to consider from the very beginning
  • Clinical development strategies for biosimilars
  • Gaining Better Market Access: Is Commercial CMO Acceptable for the Biosimilars Market?
  • Regulatory Updates and Development
  • Be part of a major networking opportunity

 

WHO WILL YOU MEET:-

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

  • Biopharmaceuticals/ Biotherapeutics
  • Follow on Biologics/Follow on Proteins
  • Biologics/Biotechnology/ Biogenerics
  • Legal Affairs
  • Intellectual Property
  • Health Economics
  • Pricing and Reimbursement
  • Clinical Immunology
  • Principal Scientist
  • Chief Scientific Officer
  • Process Control and Analytical Technologies
  • Analytical Characterisation
  • Regulatory Compliance
  • Pharmacovigilance
  • Drug Safety & Risk Management
  • Quality Affairs/ Quality Control
  • New Product Development
  • Process Science
  • Portfolio Management
  • Research & Development
  • Business Development
  • Business Operations
  • Scientific Affairs
  • Commercial Affairs

 

WHY SHOULD YOU ATTEND?

Get more from the event, with a broader scope bringing the whole communications value chain together? Enjoy and make the best out of ourdedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition.Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margin

Fen Castro

Fen Castro

Head – Productions

Virtue Insight

Tel (India) –       + 91 44 64614333

Mobile (India) –  + 91 9003 26 0693

Tel (UK) –          + 44 2036120886

Fen Castro fen@virtuefirms.com
Cc: Siddhaarth siddhaarth@virtueinsight.co.in

Link http://www.virtueinsight.com/pharma/9th-Biosimilars-Congregation-2016/

 

//////

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Billion-Dollar Products Coming Off Patent in 2016

 PATENTS  Comments Off on Billion-Dollar Products Coming Off Patent in 2016
Jun 262016
 

2016 Patent Expirations.

READ AT

http://lab.express-scripts.com/lab/insights/drug-options/2016-drug-pipeline-full-of-blockbuster-potential

CUBICIN OFF PATENT IN 2016 IN US

JAPAN 2016

Blopress

BARACLUDE IN JAPAN IN 2016

ENTECAVIR, BARACLUDE

Vfend (Voriconazole) IN UK





According to a report by DCAT, based on IMS analysis, the following are some of the key patent expiries between 2014 and 2018.

  1. Nexium (esomeprazole): This patent expired in May 2014. Innovator AstraZeneca granted a license to Teva (TEVA) to produce the generic form in the United States.
  2. Celebrex (celecoxib): This patent expired in 2014. Pfizer conceded the drug to generic drug makers Actavis (ACT) and Teva after a prolonged lawsuit.
  3. Symbicort (budesonide/formoterol fumarate dihydrate): Some of AstraZeneca’s 13 patents have expired, but all won’t expire until 2023. No generic version of the drug exists.
  4. Crestor (rosuvastatin): AstraZeneca will lose its patent protection for Crestor in 2016.
  5. Cialis (tadalafi): Eli Lilly (LLY) is set to lose patent protection in the United States and Europe in 2017.

THE VIEWS EXPRESSED ARE MY PERSONAL AND IN NO-WAY SUGGEST THE VIEWS OF THE PROFESSIONAL BODY OR THE COMPANY THAT I REPRESENT, amcrasto@gmail.com, +91 9323115463 India

Ranking (by highest sales forecasts for 2020)

Drug

Disease

Pharmaceutical Company

2020 Forecast Sales (US $ billions)

1

Obeticholic acid

Chronic liver diseases, primarily primary biliary cirrhosis

Intercept Pharmaceuticals and Sumitomo Dainippon Pharma

2.621

2

Emtricitabine + tenofovir alafenamide (F/TAF)

HIV-1 infection

Gilead Sciences and Japan Tobacco

2.006

3

Tenofovir alafenamide + emtricitabine + rilpivirine (R/F/TAF)

HIV-1 infection

Gilead Sciences and Janssen R&D

1.572

4

MK-5172A (grazoprevir + elbasvir)

HCV infection

Merck & Co

1.537

5

Venetoclax

Chronic lymphocytic leukemia

Abbvie

1.477

6

Nuplazid (pimavanserin)

Parkinson’s disease psychosis

ACADIA Pharmaceuticals

1.409

7

Uptravi (selexipag)

Pulmonary arterial hypertension

Nippon Shinyaku Co and Actelion

1.268

2016 DRUGS-TO-WATCH FORECAST SALES RANKINGS

Analysis based on data accessed on January 08, 2016.

(SOURCE: Thomson Reuters Cortellis)

 SOME SELECTED STRUCTURES

Obeticholic acid

Obeticholic acid.svg

2Grazoprevir

Grazoprevir.svg

 3 Venetoclax

Venetoclax.svg

 4

Pimavanserin

New Blockbuster Drugs to Watch in 2016

Each of these new drugs could rake in $2 billion in sales.

Blockbuster drugs, those medicines that bring in more than $1 billion in sales every year, are the holy grail of drug development. They can make a pharmaceutical company and send them to rock-star status among investors, as evidenced by the rise of Gilead Sciences after the launch of its hepatitis C treatments. This year’s slate of new drug launches features at least seven drugs expected to hit blockbuster status within the next five years, according to a study by Thomson Reuters.

The line-up also reveals key trends within the pharmaceutical industry for this year and beyond, including an increasing focus on rare diseases, the development of more convenient single-dose regimens, and more affordable treatments.

Here are the seven drugs set to launch this year and reach blockbuster status by 2020.

1. Intercept Pharmaceuticals and Sumitomo Dainippon Pharma

Drug: Obeticholic acid

Indication: Chronic liver diseases, primarily primary biliary cirrhosis

2020 Forecast Sales: $2.62 billion

Intercept Pharmaceuticals’ ICPT -7.35% obeticholic acid has proved very effective in treating non-alcoholic steatohepatitis, a type of liver inflammation caused by fat build-up in the organ. This condition has no approved treatment and a potentially large market, which is expected to push the drug to blockbuster status, if approved. About 2% to 3% of the global population has non-alcholoic steatohepatitis and the share will likely increase due to rising rates of pre-disposing factors like obesity and insulin resistance.

2. Gilead Sciences and Japan Tobacco

Drug: Emtricitabine and tenofovir alafenamide (F/TAF)

Indication: HIV-1 infection

2020 Forecast Sales: $2 billion

Gilead’s GILD -3.48% two HIV-1 infection drugs in development are both expected to be big money-makers, and the company is hoping the new daily single-dosage options will be able to replace sales of its existing HIV treatments that are set to lose patent protections in 2017. The new TAF-based therapies show evidence that they are potentially a safer replacement for some current therapies, including Gilead’s own Truvada.

3. Gilead Sciences and Janssen R&D

Drug: Tenofovir alafenamide and emtricitabine and rilpivirine (R/F/TAF)

Indication: HIV-1 infection

2020 Forecast Sales: $1.57 billion

Like the No. 2 drug on this list, Gilead’s secondary TAF-based combination therapy in partnership with Johnson & Johnson’s JNJ -1.49% Janssen unit is expected to improve renal and bone mineral density measurements compared with some existing drugs. Those results combined with the improved longevity of HIV patients and increasing numbers of those eligible for antiretroviral drugs means a large and lucrative market for the two new TAF-based drugs.

Tenofovir alafenamide structure.svg

Tenofovir alafenamide

4. Merck & Co.

Drug: MK-5172A

Indication: Hepatitis C virus

2020 Forecast Sales: $1.54 billion

Merck MRK -3.12% is getting ready to enter the heated market for hepatitis C treatments, going up against Gilead’s Harvoni and Abbvie’s Viekira Pak. Following a significant setback when theFood and Drug Administration withdrew its “breakthrough drug” status, Merck’s treatment could finally launch this year to give another safe and high-quality treatment for the disease. A recent warning by the FDA concerning Viekira Pak has dampened sales of Abbvie’s drug, which could give Merck a leg up when it eventually brings its hepatitis C drug to market. It could also pursue an aggressive pricing strategy to gain market share, given the currently high price tags on current treatments.

5. Abbvie

Drug: Venetoclax

Indication: Chronic lymphocytic leukemia

2020 Forecast Sales: $1.48 billion

Abbvie’s ABBV -2.37% Venetoclax is a potential oral treatment for cancer, primarily focused on a type of chronic lymphocytic leukemia that is resistant to chemotherapy. The drug was a leading therapy at last year’s annual meeting of the American Society of Hematology after a clinical trial showed an overall response rate of 79.4% in patients with relapsed chronic lymphocytic leukemia. The drug is also being tested as a potential treatment for other hematological cancers like non-Hodgkin’s lymphoma, as well as in combination with tamoxifen in patients with metastatic breast cancer.

6. ACADIA Pharmaceuticals

Drug: Nuplazid

Indication: Parkinson’s disease psychosis

2020 Forecast Sales: $1.41 billion

ACADIA’s ACAD -6.18% nuplazid could be the first and only drug on the market to help treat Parkinson’s disease psychosis, which affects up to 40% of Parkinson’s patients. Clinical trials have shown that the drug does not worsen motor symptoms, a vital factor for these patients, while improving night-time sleep, daytime wakefulness, and caregiver burden. Nuplazid may also work in other psychosis settings, such as schizophrenia and Alzheimer’s disease psychosis. The combination of those three diseases means ACADIA’s drug has a potentially massive and therefore lucrative market.

7. Nippon Shinyaku and Actelion

Drug: Uptravi

Selexipag

Indication: Pulmonary arterial hypertension

2020 Forecast Sales: $1.27 billion

Nippon Shinyaky’s Uptravi is able to both delay the progression of pulmonary arterial hypertension, a type of high blood pressure that affects arteries in the lungs and heart, as well as reduce the risk of hospitalization. The drug is the only one on this list that’s already available. It entered the market in the first week of January 2016 and is expected to bring in $189 million in its first year, with sales increasing to $1.27 billion by 2020. Uptravi is being promoted as an additional therapy once baseline treatment has been started. A massive clinical trial showed that Uptravi reduced the risk of death from pulmonary arterial hypertension by 39% versus placebo.

2015

  1. Opdivo, Bristol-Myers Squibb, $5.684 billion
  2. Praluent, Regeneron Pharmaceuticals and Sanofi, $4.414 billion
  3. LCZ-696, Novartis, $3.731 billion
  4. Ibrance, Pfizer, $2.756 billion
  5. Iumacaftor plus ivacaftor, Vertex Pharmaceuticals, $2.737 billion
  6. Viekira Pak, AbbieVie, $2.500 billion
  7. Evolocumab, Amgen and Astellas Pharma, $1.862 billion
  8. Gardasil 9, Merck & Co., $1.637 billion
  9. Brexpiprazole, Ostuka Pharmaceutical and Lundbeck, $1.353 billion
  10. Toujeo, Sanofi, $1.265 billion
  11. Cosentyx, Novartis, $1.082 billion

SOME MORE STRUCTURES

Rilpivirine.svgRilpivirine

Elbasvir.svgElbasvir

Opdivo

Quetiapine

The pharmaceuticals losing patent protection in 2016

 

A review of the drugs to watch in 2016 identifies several key areas of continued focus in the pharmaceutical industry: rare diseases, FDC regimens and pricing. The year ahead is anticipated to be a very interesting, and challenging, one for the pharmaceutical industry.

THE VIEWS EXPRESSED ARE MY PERSONAL AND IN NO-WAY SUGGEST THE VIEWS OF THE PROFESSIONAL BODY OR THE COMPANY THAT I REPRESENT, amcrasto@gmail.com, +91 9323115463 India

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Indian Generics 2016

 PROCESS, regulatory  Comments Off on Indian Generics 2016
Aug 032015
 

 

The generic APIs market is expected to continue to rise faster than the branded/innovative APIs, by 7.7%/year to reach $30.3 billion in 2016. Asia-Pacific is expected to show the fastest growth rates (10.8%/year). The 24 fastest growing markets will include 11 in Asia-Pacific, seven in Eastern Europe and CIS, four in Africa-Middle East and two in Latin America (Figure ).

Figure  – Top growth markets for generic APIs to 2016

By 2016, China will account for 27.7% of the global generic API merchant market, while the US will have fallen to 23.8%; the mature markets as a whole will see their share fall from 41.8% in 2012 to 36.9%. India will be the third largest, with a 7.2% share.

 

 

 

 

 

101st Anniversary of the First Electric Traffic Signal System

 

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