Sonica Sachdeva Batra Dr. Reddy's Laboratories
Chintesh Dwivedi Zydus Cadila
Himanshu Gadgil Enzene Biosciences (Subsidiary of Alkem Laboratories)
Chandra Sekhar Reliance Life Sciences
Udaykumar Rakibe Wockhardt
Chirag Trivedi Sanofi
Randhirsinh Solanki Lambda
Piyush Gupta GNH India
Sambit Patnaik Clintech India
Kalpesh Shah Reliance Life Sciences
Pravin Ghadge Reliance Life Sciences
Milind Antani Nishith Desai Associates
Debolina Partap Wockhardt
Vikas Dandekar The Economic Times
Hanmant Barkate Intas Pharmaceuticals
Sridhar Yeshamaina Wockhardt
Vandana Jolad VIaTAL Pharma
27th November 2015, Kohinoor Continental Hotel, Mumbai, India
“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”
- Conference Info
- Day One
- Sponsorship Opportunity
Studies after research predicts the world market for biosimilars and related follow-on biologics will reach $9.2bn in 2018, and multiply in size to 2024. By 2020, some $55 Billion worth of biologic patents are due to expire. Key factors driving market growth include patent expiries of key biological drugs, cost containment measures from governments, aging population, and supporting legislations. The recent establishment of regulatory guidelines for biosimilars in the US is expected to add further momentum to the growth of the global biosimilars market. Increasing pressure from governments and insurers for greater biologic competition, there exists an incredible opportunity for biosimilar producers to capitalize on what is set to become the fastest growing sector of the pharmaceutical industry. Advice from experts was clear; biosimilar companies need to focus on products that see IP [intellectual property] begin to expire beyond 2020, the so-called third wave of biosimilar opportunity.
It is also predicted that the world biosimilar monoclonal antibody (mAbs) market will generate $3,229m in 2018. That drug industry earned $61.88m in 2012.
This conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this 7th Biosimilars Congregation 2015 will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects. This Biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place. By attending this 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 Biosimilars development.
It gives me great pleasure in welcoming all of you to the Virtue Insight’s 7th Biosimilars Congregation 2015. I wish and pray that all our efforts will be beneficial to our industries folks at large.
KEY THEMES DISCUSSED IN THIS CONFERENCE:-
- Cutting edge insights into India’s growing biotech markets
- Gain access to the latest developments and expert views on future trends across a range of topics, from competitive strategy, clinical development, IP, policy and pricing
- How to approach the rapidly emerging and developing biosimilar market?
- Next generation monoclonal antibody development and clinical challenges with biosimilars drug development
- Understand the key issues, such as country-level policy changes in relation to biosimilars naming, interchangeability and automatic substitution
- Biosimilars Infliximab – Experiences and Expectations
- Capitalizing partnership opportunities and overcoming challenges to develop biosimilars
- Strategies for expediting the biosimilars development with aid of strong bio comparability programme and regulatory process
- Exploring analytical methods in biopharmaceutical process evaluations
- Biosimilars development and impact on clinical practice
- Safeness – Patients and their data
- Biosimilarity concept: a paradigm shift for many key stakeholders
- Practical advice for designing and implementing successful bioequivalence studies for biosimilars and non-biologic complex drugs (NBCDs)
- 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
- 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 our dedicated 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
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues
09:30 – Chairperson opening remarks
VANDANA JOLAD, Director, VIaTAL Pharma
MARKET OVERVIEW & ANALYSIS
09:40 – Optimising Innovator sourcing for Biosimilars Development
- Significance of Source Markets
- Effects on Regulatory, Cost and Time to Market of Source markets
- Key points in sourcing of Comparators
- Minimising Excess inventory, Short expiry and Returns
- Role of Comparator Sourcing Organisation
PIYUSH GUPTA, Associate Director, GNH India
10:10 – Biotech Manufacturing and Regulatory expectations
- Scale-ups and technology transfer
- Commercial Manufacturing and controls
- Quality assurance and regulatory perspectives
UDAYKUMAR RAKIBE, Senior Vice President – Quality, Wockhardt
10:40 – Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
11:00 – Panel Discussion: Challenges and Opportunities for biosimilars in emerging markets
- Market size of biosimilars in the emerging market
- Selling of biosimilars in the emerging markets having government protectionism
- Macro-analysis of the current biopharma environment and market drivers
- What are the constraints, opportunities and challenges?
- Innovation in the industry- who is taking the lead? Who are the silent players?
- How are Big Pharma and Biologics Majors reacting to the Biosimilars opportunity?
- Where are the Next Generation MaBs Biosimilars likely to come from?
- Emerging markets that are highly attractive for biosimilars in India
- Pros and cons of serving multiple growing markets
- Myths and realities about biosimilars
- Nomenclature: biosimilars, biobetters, and intended copies
- Approaches in rapidly emerging and developing biosimilars markets
- Clinical application of biosimilars: extrapolation, interchangeability, switching, and safety
VIKAS DANDEKAR, Editor - Pharma / healthcare, The Economic Times
HIMANSHU GADGIL, CSO, Enzene Biosciences (Subsidiary of Alkem Laboratories)
SRIDHAR YESHAMAINA, General Manager Global Clinical Development and Pharmacovigilance, Wockhardt
RANDHIRSINH SOLANKI, General Manager (Medical Affairs) Clinical Trial Management department, Lambda
11:40 – Biosimilar Drugs: Opportunities and Issues
- Biologicals versus traditional small-molecule drugs
- Regulatory landscape of biosimilars in USA and Europe
- Interchangeability of biosimilars and indications for use
- Safety concerns and Pharmacovigilance
- Financial implications with the advent of biosimilar drugs
RANDHIRSINH SOLANKI, General Manager (Medical Affairs) Clinical Trial Management department, Lambda
12:10 - Biosimilar Development & Marketing - Opportunities & Challenges for India
- Global scenario of Biosimilars Development
- Contribution of India in global biosimilar Industry
- Opportunity & Challenges for Indian Biosimilar Industry
- Competitiveness of Indian Research in Biosimilars development
- Affordable Quality solution to global problems
CHINTESH DWIVEDI, DGM – Strategic Marketing Cell & Business Development, Zydus Cadila
12:40 – Networking luncheon
Afternoon Chair Person
SAMBIT PATNAIK, CEO & Medical Director, Clintech India
14:00 – Panel Discussion - Symbiotic partnerships to accelerate biosimilars market launches & strategies
- The current situation (latest regulation guideline, clinical trial status of major players)
- How to make a suitable and feasible globalization strategy in developed regions, emerging markets and/or both?
- What are the main concerns during establishment of symbiotic partnership
o Tough and uncertain regulation
o Regional protection
o Political issues
o Money and time
o Patent risk
o Price and profit
- Overview of recent trends in clinical research
- Cultural considerations for a successful partnering
- Effective biosimilars clinical study designs for India
- Identifying the role of each stakeholder
CHIRAG TRIVEDI, Director & Head of Clinical Study Unit, Sanofi
KALPESH SHAH, General Manager - Medical Writing, Reliance Life Sciences
SONICA SACHDEVA BATRA, Director - Medical Sciences Clinical Development, Dr. Reddy's Laboratories
SAMBIT PATNAIK, CEO & Medical Director, Clintech India
14:50 – Regulatory approval process of biologics in India
- Definition of Biosimilars
- Current Indian regulatory & guidelines vis-à-vis Europe & USA
- Data requirements for marketing authorization in India
o Pre-clinical studies
o Clinical studies
- Post marketing data requirements
HANMANT BARKATE, VP & Head- Medical Services, Intas Pharmaceuticals
15:20 – Afternoon Tea/Coffee
15:40 – Biosimilar _ Safety Prospective
- Biosimilar vs. innovator safety determinant
- Analysis of safety data biosimilar
- Summary of product characteristic _ Biosimilar
- Post marketing, Safety update & Signal detection
- Biosimilar safety conclusion
PRAVIN GHADGE, Head - Medical Writing & Pharmacovigilance, Reliance Life Sciences
16:10 – Regulatory updates and development
- Clinical approvals for biosimilars
- Regulatory differences between the DCGI, FDA, EMA and local agencies in India and other emerging markets such as china & SEA
- How to demonstrate the process consistency and its requirements
- Updates on Biosimilars guidelines in Indian market
- Regulatory demand for demonstrating biosimilarity
- The Legal/IP for Biosimilars
- Data integrity and how to face audits successfully
- Insights on the development of the biosimilars market by 2020
MILIND ANTANI, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associates
DEBOLINA PARTAP, Vice President Legal and General Counsel, Wockhardt
HANMANT BARKATE, VP & Head - Medical Services, Intas Pharmaceuticals
CHANDRA SEKHAR, Vice President Quality, Reliance Life Sciences
16:50 – Chairperson’s closing remarks and end of conference
SAMBIT PATNAIK, CEO & Medical Director, Clintech India
17:00 – 18:00 – Networking Drinks Session
Sonica Sachdeva Batra
Director - Medical Sciences Clinical Development
Dr. Reddy's Laboratories
“Sonica is a medical doctor, and obtained her MD from one of the top 10 medical schools in India (King Georges Medical University). She has been a gold medalist during her graduation and also holds National Board Certification (DNB) in Pharmacology. She has over 12 years of experience across Academics and CRO/ Pharmaceutical Industry. She has clinical development/operations, medical monitoring and medical writing expertise across various therapeutic areas (such as, oncology, gastroenterology, cardiovascular, metabolic diseases, respiratory, ophthalmology, dermatology) for phase I to phase IV clinical studies. She has also played key roles in partnering and due diligence efforts across organizations. Clinical development and strategic planning, specifically for differentiated products and biosimilars remain her key areas of interest and expertise.
Presently she is Director - Medical Sciences, Clinical Development, at DRL Biologics, Hyderabad, India.”
DGM - Strategic Marketing Cell & Business Development
Chintesh K Dwivedi, B. Pharm, MBA (Marketing)
Leading Bio-similar portfolio development & launch strategy Projects in the field of Oncology, Rheumatology, Hepatology, Nephrology & Vaccines.
Project Lead for Strategic Roadmap & Go-to-market strategy development of Saroglitazar-Lipaglyn (first NCE of India developed & marketed by Zydus).
Actively involved in business development initiatives for identifying & building future portfolio across therapeutic segments.
Facilitating Strategic Marketing projects related to SFE, Digital Marketing & other projects related to commercial/ operational excellence.
Enzene Biosciences (Subsidiary of Alkem Laboratories)
Vice President Quality
Reliance Life Sciences
Chandra Sekhar is currently Vice President-Quality-Pharma Division of Reliance Life Sciences based in Navi Mumbai. Prior to that, he was looking after the Data Integrity function at Ranbaxy. He is a certified Quality Auditor from American Society for Quality (ASQ). He has Pharma QC, QA, Compliance experience of more than 20 years including United States Pharmacopeia (USP) and Dr.Reddy’s. He has done his Master’s from BITS, Pilani. Post Graduate Diploma in Quality Management from Central University. Post Graduate Diploma in IPR and patents from NALSAR University.
Senior Vice President - Quality
M. Pharmacy & MBA from Pune University – was recruited in 2013 by Wockhardt Ltd., as Senior Vice President – Quality to turnaround the Quality Management, lead and manage the remediation of Quality initiatives.
Udaykumar is a quality professional with a dynamic career steering organizations through complex Quality & Regulatory challenges, transitions, building an empowered and talented workforce in cross cultural environment within highly competitive products and regulatory environment.
He began his career in Quality function in the Executive in-process QA with Glenmark Pharma Ltd., and then moved to different levels and organization spanning 23 years of hands-on and hardcore experience in pharmaceutical regulatory environment. He has gained the domain experience in Quality by working 16 years’ in Quality operations and 7 years in Corporate Quality functions. He has worked as a senior member of the Quality Team with Ranbaxy Labs Ltd., Dahur India Ltd., Gland Pharma Ltd., Intas Pharma Ltd., and currently with Wockhardt Ltd.
Director & Head of Clinical Study Unit
Chirag Trivedi is currently working in Sanofi as Director and Head of Clinical Study Unit (CSU) in India. The CSU manages the Clinical trials (for R&D and marketed Products) from Phase II-IV, Observational studies and Bioequivalence studies. It also plays a strategic and operational role in the Life Cycle Management of products.
He has been with Sanofi since May 2006 and has handled various roles and responsibilities in these years. Prior to Sanofi, he has worked in a CRO and prior to that, in a Central Lab.
He is a Ph.D. in Pharmacology from Mumbai University and is experienced in the fields of Clinical Research, Clinical Quality Assurance & Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development.
General Manager (Medical Affairs) Clinical Trial Management department
A Pharmacologist with more than a decade of relevant industry experience:
- More than six years of ongoing dealing with projects in the field of ‘Clinical Research’ across multiple therapies at ‘Lambda Therapeutic Research Ltd’., Ahmedabad (Lambda).
- More than three years of experience as ‘Medical Advisor’ to medico-marketing divisions of leading pharmaceutical companies like Intas Pharmaceuticals Ltd. & Ranbaxy Laboratories Ltd.
- Certified for “Understanding FDA and the FDA Approval Process” by FDASmart Inc, USA.
- Passed CPD/CEU Test for GCP conducted by The Journal of Clinical Research and GCP.
- Completed 1 year ‘Industry Program in Clinical Trial, Research and Administration’ from Bioinformatics Institute of India, New Delhi.
- Certificate holder for having undergone ‘Clinical Trial Auditing Training Workshop’ issued by Pinnacle Healthcare, Mumbai.
General Manager – Medical Affairs (Lambda) (April 27, 2009 till date)
Key Responsibility Area:
- Review and approval of Protocol designs for Phase II, III and Patient P/K clinical studies, supervising development of documents like ICD, IB, Study Rationale, CTA dossier filing, defending research proposals and study results at SEC meetings, etc. for Clinical Trial Management Dept across different therapy areas including NDDS and biosimilar compound evaluation.
- Study feasibilities, medical training of project managers and site-personnel, investigator interactions, safety monitoring and addressing scientific queries from the stakeholders while ensuring regulatory compliance.
- Training coordinator for in-house GCP/GLP programs.
CEO & Medical Director
Dr Sambit Patnaik passed his MBBS from the SCB Medical College under Utkal University, Orissa and his MS in General Surgery from MGM Institute of Medical Sciences, Navi Mumbai. He is registered as a General Surgeon in the Maharashtra Medical Council.
Today he concentrates in anorectal subspeciality as the CEO & Medical Director of Clintech India where he also practices as a consultant minmal access colorectal surgeon which is his field of interest delivering services of office based and short stay daycare anorectal surgeries at Clintech India. Dr. Sambit Patnaik has co-conceptualized coloproctology surgeries at ClinTech, after his basic and advanced surgical training, as a one-stop office based surgical clinic for all common ano-rectal disorders. The concept is to create the ease and comfort of a simple “walk-in and walk- out” approach prevalent in dental clinics.
Along with the latest in the ano-rectal surgical multimodality treatment options for hemorrhoidal diseases/ fissures/ fistula, he is additionally trained in the unique technique of hemorrhoidolysis popularized in the US by Ultroid Inc. in Tampa, Florida, USA thereby putting him and the three branches of ClinTech as the only centre in the Asia Pacific region of the Ultroid Physician map.
The latest treatment options of Doppler guided modalities, minimal invasive surgeries like NOTES, TAMIS, TEMS, MSCH, VAAFT, CLIS are easily performed by Dr Patnaik. He is devoted to making hemorrhoidolysis a popular and successful non-invasive treatment of internal hemorrhoids with by using the Ultroid Hemorrhoid Management System.
With his commitment to educating public and health care providers alike, he organizes CME for doctors regularly on a weekly basis at the clinics and demonstrates the extreme usefulness of the technique thereby benefitting hundreds of doctors in and around Mumbai and Navi Mumbai.
He is strongly associated fellow of
(1) SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) as an International 3 member,
(2) European Society of Coloproctology,
(3) Association of Colon and Rectal Surgeons of India ACRSI,
(4) Indian Medical Association IMA,
(5) Association of Surgeons of India ASI,
(6) Association of Medical Consultants AMC (Mumbai),
(7) Association of Minimal Access Surgeons of India AMASI,
(8) The Bombay D-ward Medical Association
(9) A-ward Medical Association, Mumbai
(10) C-ward Medical Association, Mumbai
He is an active member of the Lions Club. He organizes regular anorectal camps as Visiting Consultant Minimal Access Colorectal Surgeon Nagpada Police Hospital for the benefit of the Mumbai and Maharashtra Police personnel.
He is als
General Manager - Medical Writing
Reliance Life Sciences
Mr. Kalpesh Shah is working as a General Manager for the Medical Writing group of Reliance Life Sciences Pvt. Ltd., Navi Mumbai. He is involved in developing the complete clinical plan of biosimilars to assess its pharmacokinetics, pharmacodynamics, immunogenicity, as well as efficacy and safety parameters for their successful launch in domestic as well as international markets. Mr. Kalpesh Shah has joined Reliance Life sciences Pvt. Ltd. in 2006 and started Medical writing group. He has over 14 years of experience in the pharmaceutical industry with a mix of Indian and Global Pharma companies viz. Torrent Research Centre, Intas pharmaceutical and Sanofi (India) Pvt. Ltd. etc. He is involved in the development of biosimlars for different therapeutic segments including Oncology, Rheumatology, Cardiovascular, Gynaecology, Renal disorders etc. Besides biosimilars, he is involved in designing Phase I to IV studies as well as adaptive sequential design studies for generic molecules. Mr. Kalpesh Shah has several publications to his credit in peer-reviewed journals.
Head - Medical Writing & Pharmacovigilance
Reliance Life Sciences
Partner In-Charge - Pharma LifeSciences
Nishith Desai Associates
Vice President Legal and General Counsel
Editor - Pharma / healthcare
The Economic Times
Vikas Dandekar is an experienced business journalist who has covered the pharma and biotech industry for nearly two decades. He is presently the Editor for pharma and healthcare vertical at The Economic Times. Prior to joining ET earlier this year, Vikas worked with Reed Elsevier, a globally reputed name for life science research publications. He was with CNBC TV18 for 7 years before moving to Reed Elsevier in 2008. Vikas started his reporting career on the pharmaceutical industry with The Indian Express in 1996. He takes special interest in the emerging biosimilars opportunity and has been a keen observer of the fast evolving regulations, both in developed as well as emerging markets.
VP & Head- Medical Services
- A Medical professional; M.D.in Pharmacology
- Currently working as Vice President & Head– Medical, Clinical & Regulatory affairs for Intas Pharmaceuticals Ltd.
- Working for healthcare industry since last 17 years; in leadership role since 10 years.
Demonstrated expertise in diversified functions like clinical research, regulatory affairs , medical affairs & pharmacovigilance
Global Clinical development
- Hands on experience of clinical development of Biosimilars, NCEs and NDDS molecules for India region , Europe & USA
- Have been involved in clinical development of 11 biosimilars , which have been commercialized in India
- Conducted phase III/IV clinical trials for number of molecules from diverse therapeutics segments like cardiovascular, diabetology, pain management, urology, oncology, neurology, rheumatology etc.
- Lead for clinical development of biosimilar products for Europe & USA
- Expertise in regulatory functions of Biosimilars, NCEs & NDDS
- Authored no. of dossiers for NDA ( new drug application), CTA ( clinical trial application), MA (marketing authorization) etc.
- Presented no. of proposals of clinical trials, marketing authorization to NDAC/SEC ( constituted by DCGI) of various therapeutic segments
- Spearheading medical affairs functions of 30 marketing divisions
- Leading from front for KOL engagement activities (Advisory board meets, CMEs etc.) across the therapeutic segments
- Spearheading pharmacovigilance functions for India Region
People & performance management:
- Leading a large team (26 Professionals) of medical advisors , clinical research & regulatory professionals.
Representing company at different platforms like conferences, govt. bodies etc.
General Manager Global Clinical Development and Pharmacovigilance
Dr. Sridhar has more than 15 years of experience in Global Clinical R&D in various therapeutic areas and has served leading positions in Novartis, Bharat Serums, Vivo Bio, SciTech and GVK. Currently he is the General Manager at Wockhardt Global Clinical Development leading Biosimilar’s and complex ANDAs portfolio. He is trained pharmacologist with a doctorate in Clinical Pharmacology and Therapeutics from Nizam’s Institute of Medical Sciences, Hyderabad.
Dr Sridhar has involved in various facets of drug development from basic to clinical research development strategies including drug safety. He has vast experience in early development studies in various dosage forms and dose ranging studies. He along with his team achieved many milestones successfully in various phases of global clinical development.
He has contributed to over 40 publications, made over 100 presentations at industry events and has authored two authentic books on Clinical Research and Monitoring Vascular Function. He is invited speaker at various national and international conferences viz., FIP, IPC, IPS, ISMS and ISCR etc. He is the recipient of young scientist award, Prof. U.K Seth National award for best clinical research in 2008 and subsequently received Above & Beyond awards for excellence in industry research and development.
Dr.Vandana Jolad Shivanagi is currently the Director of VIaTAL Pharma for Global Regulatory, Technical, Pharmacovigilance, GMP audits, Training and Business strategy solutions, based in Mumbai.
Dr. Vandana has actually worked in UK and EU for nearly 11years experience in Senior Management Regulatory, QA-related to Regulatory, plant-audits, Pharmacovigilance, clinical/biosimilars. Has closely worked with all EMEA/MHRA- authorities and successful getting several approvals and in taking company business ahead.
Dr.Vandana is an expert with semiregulated and unregulated markets as well and has personally visited Ministries of Health in various countries.
Dr Vandana is a Ph.D from University of Leeds, UK and B-Tech- from UDCT, Bombay, with an overall industrial experience of 23 years in Europe,Global and in India.
The exposure to different country Regulatory Authorities and its link to Indian growth in has given Dr.Vandana a wide perspective of the operations pharma- industry and training
Dr. Vandana has formed and setup UK companys’ Regulatory and Pharmacovigilance department from scratch and got approval for the companys first MHRA/EU PV inspection.
Getting Technical and Global Regulatory approvals from all Ministry of Healths are Dr.Vandanas’ forte
Today , She is with us as a Chairperson for the day and will also participate and share detailed information of differences of Biosimilars Regulatory Worlwide in a very crisp and potential way, that could ease our queries
Lambda Therapeutic Research is a leading full service CRO in the Clinical research domain. Headquartered in Ahmedabad (India), its global footprint encompasses strategically located offices in Mumbai (India), Poland (Europe), London (UK), USA and Canada (North America)
Since its inception in 1999, Lambda has grown both organically and inorganically and has gone on to establish a truly global presence. Its prime locations world-wide ensure ground level support in addition to easy access to a competent blend of human expertise and state-of-the-art infrastructure in the most efficient yet cost effective way. Lambda has BA/BE and Phase 1 facilities in India, Poland and Canada helmed by dedicated and experienced teams. It has recently commissioned Bio Analytical and Clinical Laboratory facilities and established a Business Development office in London (UK).
Lambda’s global infrastructure comprises of an impressive tally of 600+ clinical beds dedicated to Phase I clinical studies and bioequivalence studies. It has conducted more than 4800 Phase l, bioavailability / bioequivalence and/or drug-interaction studies of over 300 different chemical entities. Lambda’s database of adult male and female volunteers now exceeds 100,000 on a global level.
Lambda has extensive experience of conducting clinical studies in subjects of diverse sub groups, such as healthy and post menopausal female populations in addition to healthy male subject populations. It has conducted studies for its clients, for several regulatory agencies including ANVISA-Brazil, EMEA (Germany, Netherlands, France and other EU member state), UK-MHRA, TGA-Australia, AGES, TPS-Canada, USFDA and WHO. Since its inception, Lambda’s world-class facilities have consistently and successfully passed regulatory inspections by regulatory agencies such as DCGI, USFDA, ANVISA-Brazil, MHRA, Health Canada, AFSSAPS, Turkish-MoH and WHO
GNH India - A Global Full line Pharmaceutical Wholesalers with over 135,000 Product lines, supplying to over 180 countries World wide.
Specialising in Clinical Trial Supplies, Comparator supplies, Rescue Medication, Adjuvant therapeutics, Shortages, Hard to find lines, Hospital lines and Named Patient lines.
Operating from a WHO cGDP compliant warehouse with a well trained staff, under supervision of an on site QP.
Key advantages when working with GNH India:
1. Complete, audit-able paper trail to manufacturer
2. Shortest Pedigree to manufacturers
3. 21 CFR part 11 compliant Temperature monitoring and inventory management softwares
4. Validated Shipping systems
5. Counterfeit and fake prevention systems in place to maintain supply chain integrity
6. Instant availability of most drugs, including hard to find and name patient lines
Partner with a team of Pharma industry professional, partner with GNH India for all your requirements from India.
Syngene is India’s leading CRO, offering a suite of integrated, end-to-end discovery, development and manufacturing services. Our discovery and development services span multiple domains across small molecules, large molecules, antibody-drug conjugates and oligonucleotides. Our integrated discovery and development platforms help organizations conduct discovery (from hit to candidate selection), development (including pre-clinical and clinical studies, analytical and bio-analytical evaluation, formulation development and stability studies) and manufacturing (scale-up, pre-clinical and clinical supplies) under one roof with a distinctive economic advantage.
Syngene Clinical development services encompass clinical trials, BA/BE studies, bioanalytical testing, central lab services, medical writing, biostatistics and data management services, and pharmacovigilance services. We offer full-service solutions for clinical development of small molecules, biologics, nutraceuticals and medical devices. We provide bio-analytical services to support preclinical and clinical development programs of small molecules and biologics. Our bio-analytical lab is GLP-compliant, and specializes in immunogenicity and pharmacokinetic analysis of biologics such as monoclonal antibodies, recombinant proteins, enzymes, biomarkers and cytokines. Our facilities have been inspected by several regulatory agencies such as the FDA and EMA.
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
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LEX WITNESS – India’s 1st Magazine on Legal & Corporate Affairs
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Pharmaphorum is the primary facilitator of thought leadership and innovation within pharma. We support the next generation of pharmaceutical industry leaders through producing, curating and publishing media that will help pharma embrace the challenges of being a healthcare solutions provider in the 21st century.
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What are the benefits of attending?
- Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
- Enjoy our informal networking at drinks and lunch
- Meet the leading solution providers in the market to forge partnerships and discover solutions
- Receive electronic versions of the conference documentation for use of reference post-event.
- Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
- Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
- Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
- Delegates also benefit from discounted rates onfuture event attendance
For more information or to register at the event please contact us TODAY:
Contact Us Today
Email - email@example.com
Email - firstname.lastname@example.org
Tel: +91 44 64536444
CONFERENCE BOOKING DETAILS:-
Standard Price - 1 or 2 Delegates (INR 7,000 + Tax (14.5%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – email@example.com
Group Discounts - 3 or 4 Delegates - (INR 6,500 + Tax (14.5%) per delegate)
Group Discounts - 5 and above Delegates - (INR 5,500 + Tax (14.5%) per delegate)
Spot Registration on the day of the conference - 1 Day Conference - (INR 8,000 + Tax (14.5%) per delegate)
Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to –TEL: + 91 44 64536444. Email - firstname.lastname@example.org
27th November 2015, Kohinoor Continental Hotel, Mumbai, India
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Conference pictures can be viewed and downloaded at our official Virtue Insight facebook page
Link - Click Here