ANKA G. EHRHARDT Bristol-Myers Squibb (USA)
JOHN LAMBERT PAREXEL International (UK)
PATRICK LARCIER Voisin Consulting Life Sciences (France)
BHASWAT CHAKRABORTY Cadila
HEMA BAJAJ Sanofi Aventis
ANISH DESAI Johnson & Johnson
KAVYA KADAM Cipla BioTec
PIYUSH GUPTA GNH India
SAMBIT PATNAIK Clintech India
CHANDRA SEKHAR Reliance Life Sciences
ROHIT ARORA Abbott
NARESH TONDARE Glenmark Pharmaceuticals
MURTUZA BUGHEDIWALA Sanofi
ANAY SHUKLA Nishith Desai Associates
YASHESH MEHTA Sciformix
SHILPA RAUT Novartis
DEEPTI SANGHAVI Tata Consultancy Services
UMAKANTA SAHOO Cytel
AMEY MANE Janssen India (Pharmaceutical companies of Johnson & Johnson)
SANKET SAWANT SIRO Clinpharm
ASHWANI PANDITA Glenmark Pharmaceuticals
24th May 2016, The Lalit Hotel, Mumbai, India
“A critical guide for successfully conducting clinical trials”
- Conference Info
- Day One
- Press Release
- Sponsorship Opportunity
The clinical trial market in India looks very lucrative. India has several unique features for being a hot spot for the clinical trial market. As a signatory to the World Trade Organization agreements, India is looked upon as a favorable destination for conducting global clinical trials. There are many opportunities and challenges for conducting global clinical trials in India. In a majority of cases, these drugs are aimed at providing answers to unmet medical needs.
Clinical research is important not only for developing medicines for emerging health concerns (such as antibiotic resistant pathogens, H1N1, Dengue, , etc.) also for finding safe and better medicines for entrenched diseases such as HIV, Malaria, tuberculosis (especially drug resistant TB) Diabetes, Hypertension, Cancer, heart failure etc. India, with its large patient population, and limited resource has significant unfilled health needs. We should make the newest and best treatment option to be avail to the population and to the patient’s globally. For this, India must proactively take part in conducting clinical research (“Research for India”) and assume leadership role globally (“made for the world”). As we are operating in a new regulatory and operational environment, we have a great task ahead of us – strengthening the sites, Investigators, Ethics Committees and empowering the patient who is the center of the clinical research enterprise.
Our world is changing as we focus more on biotech, personalized medicine, biomarkers, rare diseases and orphan indications. With this comes many challenges that we have only rarely faced in the past. As we focus more on the patient, stability and formulation hurdles arise. There is a growing need for forecasting and planning improvements and temperature control of distribution into truly emerging markets. It is essential we come together to learn not only how our colleagues are handling these issues, but are how they are ingeniously overcoming them.
It gives us immense pleasure in welcoming you to the 7th Annual Clinical Trials Summit 2016. I wish and pray that all our efforts will be beneficial to our industries and to our country at large
KEY THEMES DISCUSSED IN THIS CONFERENCE:-
- Insights, Implications, Impact and Implementation of risk management in trial conduct
- Tracking returns, Reconciliation & Destruction to manage costs
- Reduce significant costs through successful embedding of modulation and simulation in the clinical supply chain
- Underlining the benefits and implications of drug pooling in the clinical supply chain
- Marketing for your clinical research practice
- Insurance coverage: How the ACA changed access to clinical trials
- Regulatory updates and Good Clinical Practice (GCP) auditing techniques
- Developing a standardized tool to improve patient comprehension during consent
- Insight and practical tips on how to work with all payer types to obtain coverage of clinical trial routine costs.
- ACA, Medicare, Medicaid and state requirements regarding coverage of clinical trials.
- Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practices
- Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
- Overcoming challenges faced in regulatory approval processes – obtaining drug/ clinical supplies import and export licenses in Asia
- Margin of safety: Identifying ideal clinical sites and strategizing patient recruitment and clinical sites management in India to develop appropriate clinical studies
- Next generations of clinical trials – How big will the market be?
- Be part of a major networking opportunity
WHO SHOULD ATTEND:-
CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of:
- Clinical Research & Development
- Clinical Research Services
- Clinical Operations
- Clinical Data Management
- Clinical IT
- Clinical Trials
- Medical Affairs
- Regulatory Affairs
- Quality control / Assurance/GCP
- Clinical Study Design
- Safety Surveillance
- Subject Recruitment
- E-Clinical Systems
WHY SHOULD YOU ATTEND?
7th Annual Clinical Trials Summit 2016 - “A critical guide for successfully conducting clinical trials” - 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 expand your knowledge of the latest business models and strategies in the high-level conference. Show casing the products of tomorrow in the co-located exhibition.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
MARKET OVERVIEW & ANALYSIS
09:30 – India’s current challenge: Empowering ethics committees
- Current regulatory milieu and expectations
- Quality issues in ethics committee functioning
- Paradigm shift towards accreditation
- How to empowering ethics committees
ARUN BHATT, Consultant – Clinical Research & Development
10:10 – Comparators - The “Check Nut” in Clinical trial
- Reverse planning - Comparator Sourcing for clinical trials
- Don’t be a victim of “Comparator Outages”
- Pedigree and Traceability - How to ensure your comparator is actually a “Comparator"
- Difference between Comparators for SRA and ROW markets.
PIYUSH GUPTA, Associate Director, GNH India
10:50 – Morning Coffee/Tea & Discussion
CHALLENGES & OPPORTUNITIES
11:10 – DISCUSSION WITH EXPERTS: Insights, Implications, Impact and Implementation of risk management in trial conduct
- Operations management for Sponsors and CRO’s
- Transitioning from traditional trial planning practices to the recommended risk-based approach to trial conduct
- Sponsors, CRO’s and Sites to understand the new model if optimal risk management is to be attained.
- Effective, model that ensures consistent, repeatable, effective and efficient processes
- A study life cycle if trial risks are to be identified, assessed, optimally mitigated and managed
- Clinical trial regulations in India: Challenges, Reforms and way forward
- Multitude of changes in market challenges and continued focus on cost/quality
- Prioritization and execution of a structured framework if successful implementation and management is to be attained.
AMEY MANE, General Manager- Medical Affairs, Janssen India (Pharmaceutical companies of Johnson & Johnson)
NARESH TONDARE, Head– India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
MURTUZA BUGHEDIWALA, Associate Director, Project Management & Strategic Initiatives, Sanofi
DEEPTI SANGHAVI, Assistant Manager-Medical Writing, Tata Consultancy Services
SHILPA RAUT, Regional Training Head - Asia, Middle East and Africa Cluster, Novartis
11:50 – Overview of Compassionate Programs/Expanded Access Programs: Opportunities and Challenges
- Introduction and Legal Basis And Purpose EU/US
- Scope And General Principles
- Initiation And Request
- Regulatory Opinion For Compassionate Use
- From Opinions On Conditions Of Compassionate Use To Opinions On MAA/NDA
- Fees For Compassionate Use
- Opportunities & Challenges
- Few Examples-Success stories
Patrick Larcier, Vice President, Drug Development & Vigilance Operations, Voisin Consulting Life Sciences (France)
12:20 – Networking luncheon
Afternoon Chair person
SAMBIT PATNAIK, CEO & Medical Director, Clintech India
13:30 – After the Study is Before the Study
Besides the direct target-relevant insights clinical studies are designed to provide, the increasing implementation of exploratory biomarkers offers additional important learnings from clinical trials.
- The most desired additional information are new biomarkers
- New insights into mechanistic findings also significantly increase the gain from a study
- And – often overlooked- learnings for improvements in future studies
In the hot field of immune-oncology, one biomarker technology of fast growing impact is flow cytometry. In this presentation, flow cytometry biomarker work examples will be used to illustrate the path to maximize the impact of clinical studies.
ANKA G. EHRHARDT, Director Clinical Cytometry, Biomarker Technologies, ECTR, Bristol-Myers Squibb (USA)
14:00 – DISCUSSION WITH EXPERTS: Marketing for your clinical research practice
- Clinical trials marketing plans, campaign development, and performance indicators to achieve optimal campaign success.
- Basic marketing strategy; and, discuss site-marketing methods including new media and regulations for their use
- Branding and reach to grow your site; in-house ad creation; website analytics; conversion rates; and more.
- The cost benefit of marketing including study acquisition; ROI; and negotiating budgets with sponsors and media vendors.
- Time-tested marketing templates and tools to drive patient, community, and industry engagement.
UMAKANTA SAHOO, Director, Cytel
ANISH DESAI, Director Medical Affairs, Clinical Ops. & Device safety, Johnson & Johnson
SANKET SAWANT, Strategy & Business Development Partner, SIRO Clinpharm
BHASWAT CHAKRABORTY, Senior VP & Chair, Research and Development, Cadila KAVYA KADAM, Head - Global Clinical Operations, Cipla BioTec
YASHESH MEHTA, Director Delivery Partner, Sciformix
14:50 – Risk Management in Early Clinical Development - A CRO Perspective
JOHN LAMBERT, Chief Medical Officer Early Phase, PAREXEL International (UK)
15:20 – Afternoon Tea/Coffee
15:40 – Data Integrity concepts in clinical trials
- Importance of Data Integrity
- Quality by Design (QbD) approach
- Effective CAPA (Corrective and Preventive Action)
- Role of Quality Metrics
CHANDRA SEKHAR, Vice President Quality, Reliance Life Sciences
16:10 – DISCUSSION WITH EXPERTS: Regulatory updates and Good Clinical Practice (GCP) auditing techniques
- Good Clinical Practice (GCP) Quality Assurance (QA)
- FDA regulatory requirement, within the clinical arena
- ICH E6 GCP guidelines and ISO 14155 sections on GCP QA and expectations that GCP auditing will occur
- Utilizing a GCP QA program
- How to build quality into a clinical trials program? Using case studies, simulations and actual findings
- Real world evidence on clinical trials
- How to approach clinical trials compliance? What to expect during an inspection and how to take appropriate corrective action to avoid regulatory issues?
- GCP auditing and how to develop a GCP audit plan and GCP audit report
ANAY SHUKLA, Senior Member, Pharma Healthcare Team, Nishith Desai Associates
ASHWANI PANDITA, Dy. General Manager Quality Management & Training, Global Clinical Research Operations, Glenmark Pharmaceuticals
HEMA BAJAJ, Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer, Sanofi
ROHIT ARORA, Head - Medical & Scientific Affairs, Abbott
16:50 – Chairperson’s closing remarks and end of conference
17:00 – 18:00 - Networking Drinks Session
NOW SOURCE COMPARATORS / BIOSIMILARS WITH CONFIDENCE FROM INDIA - Mumbai, India - February 8, 2016
Sourcing Comparators / Biosimilars have always been an Achilles heel in any Clinical trial. These seeming simple products are the “Check Nuts” that can make the entire trial go haywire if supply is delayed. The challenge of sourcing Comparators / Biosimilars gets compounded specially for large multi centric trials.
Traditional source markets such as US / EU have seen increased regulations and tightening of supply chain thereby severely constricting supply. Each vial or pack can now be tracked by the manufacturer / brand owner through the entire supply chain under the new barcoding systems. Thereby making it extremely difficult to divert stock for Trials without alerting the innovator or brand owners.
Emerging markets such as India have always posed a challenge due concerns about similarly or equivalence with the innovator sold in US / EU markets.
One company stands out as a pioneer in Clinical trial supplies from India and is working to change this perception by putting out facts in the open. GNH India has been successfully supplying to a number of Global trials with comparator / biosimilars sourced from the Indian market.
We spoke to Dr. Piyush Gupta, MBBS, MBA - Associate Director - Business Development at GNH.
Dr. Gupta says “There’s a mind set at play here. People think that if a product / brand is being sold in India it’s going to of poor quality and standard. This is absolutely untrue in the pharma business. No manufacturer is going to risk is reputation, brand and most importantly violate laws and sell substandard products in India”.
To prove his point Dr. Gupta say : CoPP (Certificate of Pharmaceutical Products) an essential requirement to register any new drug in any country including India is the key. At the time of registering (introducing) a new product in India the Innovator / Brand has to provide a CoPP from the FDA (Food and Drug Administration) of the Originating Country (Country where the product is manufactured).
A CoPP issued by FDA of Origin country essentially states that product being supplied (exported) is the exact same in specification as the one being in country of Origin. Without this CoPP from FDA of Origin, FDA of importing country will not allow registration of a brand / innovator / Generic in importing country.
This fact is very well known to the manufacturers but regretfully not to the Clinical trial industry, which largely runs on Out sourced contracts.
GNH India is an Award winning Global full-line wholesaler Audited by SGS France for WHO cGSDP practise and carries over 135,000 product lines, shipping to over 180 countries wold wide.
Contact: Ms. Saba Malim,
Level 8, Vibgyor Towers, Mumbai 400098
Tel + 91 22 2431 1829
ANKA G. EHRHARDT
Director Clinical Cytometry, Biomarker Technologies, ECTR
Bristol-Myers Squibb (USA)
Dr. AnkaEhrhardt is a biophysicist with a doctorate in physiology. She is currently working in the United States for Bristol-Myers Squibb. Previously, Dr. Ehrhardt headed a technology laboratory at Merck, covering comprehensive instrumentation in high tech fields such as fluorescence, imaging, flow cytometry, electrophysiology and luminescence for the entire range from early discovery to late stage clinical trials across all disease areas.
In her current position at BMS, Dr. Ehrhardt directs the Clinical Cytometry, covering a large portfolio across disease area clinical studies. Her work focuses on biomarkers as tools to drive the development of urgently needed new medicines. This includes optimizing biomarkers to gather clear data driving fast well founded decision making, and maximizing the information gathered from clinical samples to support hypothesis generation.
Dr. Ehrhardt is on the board of directors of different industry organizations, fostering innovation and collaboration between industry, academia and government organizations.
Chief Medical Officer Early Phase
PAREXEL International (UK)
Dr Lambert is Vice President, Chief Medical Officer and heads the Global Medical Sciences and Consulting group for PAREXEL Early Phase. Prior to his current role, he worked for PAREXEL International as Senior Director and then Vice President PAREXEL Early Phase, London, United Kingdom (UK), for 8 years, and has been with the company since 2000. Dr Lambert is based in the London Early Phase Clinical Unit and provides additional medical and scientific oversight of studies including overseeing the safety of the study participants.
Dr Lambert provides a broad range of expert consulting services to clients for early drug development. This includes the development of a clinical development plan with focus on time and cost savings; selection of compound specific biomarkers for early proof-of-mechanism; selection of compound specific safety parameters and preparation of relevant documents including the protocol and Investigator's Brochure.
With more than 37 years' medical experience, Dr Lambert has worked in Australia, Canada and the UK, and he has over 18 years' experience working in CROs, holding positions including Director of Medical Affairs and Chief Medical Officer. He has extensive clinical experience and is trained and certified in Internal Medicine, Gastroenterology, Pharmaceutical Medicine and Clinical Pharmacology. He has worked as Principal Investigator on over 80 clinical studies including new biologicals and biosimilars.
Among various industry affiliations, Dr Lambert is a member of the British Association of Pharmaceutical Physicians, American Gastroenterology Association, Fellow of the Faculty of Pharmaceutical Medicine, Member of the American College of Clinical Pharmacology and Fellow of Royal Australian College of Physicians, in addition to being a member of other international associations.
He holds a MBBS and a MMed from the University of Melbourne; a PhD from Monash University, Melbourne; and a Dip Pharm Med from the University of Wales, Faculty of Pharmaceutical Medicine.
Dr Lambert has published extensively, including peer reviewed articles, abstracts, and book chapters.
Vice President, Drug Development & Vigilance Operations
Voisin Consulting Life Sciences (France)
Patrick Larcier leads the Clinical Development and Pharmacovigilance activities, focusing on the development of drugs and biologics, as well as Companion Diagnostic (CDx) tests. Patrick brings a global view in product development. His expertise lies in the design and implementation of regulatory strategies at all stages of clinical development for complex and innovative medicinal products as well as new chemical entities. Patrick leads a multidisciplinary team who designs clinical development plans and clinical protocols and prepares and manages clinical trial applications for all clinical phases. The co-development of IVDs and drugs is his most recent area of interest.
Patrick works specifically on:
- All phases of clinical development (First-in human to Phase 3 studies),
- The interactions with EU Regulatory Agencies and FDA to obtain advice and feedback on developments plans (via Scientific Advice/Protocol Assistance procedures qualification procedures, pre IND, End of Phase 2 meetings, pre-submission meetings, …).
Within the framework of these regulatory activities, Patrick has worked extensively with key opinion leaders (KOLs), in the context of managing expert panels and collecting scientific and medical advices on the development plans.
Patrick has significant experience in the development of various antibioics (Clamoxyl®, Augmentin®, Orelox®, Klacid® and Bactroban®), antiviral (Famvir®), preventive vaccines (Engerix B®, Havrix®), therapeutic vaccines (Tat Toxoid, E7 Toxoid, Interferon-α and TGF-β Kinoids, Vac3S vaccine) and auto-immune therapies (Interferon-β, natalizumab, anti-TNFα therapies baminercept and rituximab) in various therapeutic indications.
Prior to joining VCLS, Patrick was Vice-President, Clinical and Regulatory Affairs at TcLand Expression and Vice-President, Drug Development, at Neovacs. Before, Patrick was Associate Director, Regulatory Affairs, at Biogen International, and worked at Quintiles, as Senior Project Manager, and Parexel, as Project Manager. Patrick was also Clinical Trial Manager at SmithKline Beecham International, and worked as a CRA at Roussel Uclaf and Abbott International Laboratories.
Patrick obtained his Pharm. D., from the University of Dijon (France), a Certificate in Methodology of Clinical Trials (CESAM) and a degree in Humanitarian and Tropical Medicine at the ‘Pierre et Marie’ Curie University in Paris, France. Patrick also holds a Master of Business Administration from the ESSEC Business School (Paris).
Patrick is based in our Paris office.
Consultant - Clinical Research & Development
Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases.
Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited.
Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.
In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research.
Dr Bhatt is the recipient of Drug Information Association outstanding Service award 2012 for his immense contributions in his field of specialization.
Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013.
Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials.
Dr Bhatt has more than 100 publications in national and international journals. He runs a regular monthly column on “Good Clinical Practice – Question Answers” and has published a book “Clinical Trials and “Good Clinical Practice in India – Questions and Answers”.
Senior VP & Chair, Research and Development Core Committee
Dr. Bhaswat S. Chakraborty graduated with a B.Pharm. (Hons.) from Banaras Hindu University and a PhD in Clinical Pharmacology from University of Saskatchewan, Canada.
Following his post doctoral fellowship and a brief spell of teaching at University of Saskatchewan, Saskatoon, Canada, Dr. Chakraborty joined the Health Protection Branch, Ministry of Health, Government of Canada (Canadian FDA) in Ottawa and served as a Senior Clinical Reviewer and Acting Department Head of the Biopharmaceutics Evaluation Division. In this role, he has evaluated more than 300 ANDAs and 20 NDAs.
Thereafter, he was the Director of Biopharmaceutics at Biovail Corporation International, Toronto. Till date, he has designed and investigated ~810 BE/Phase I and 78 higher Phase Clinical Studies for the FDA, TPP, EU and other Agencies.
Recipient of many prestigious research grants, Dr. Chakraborty is currently the Senior Vice President and Chairman of Research & Development Science Core Committee at Cadila Pharmaceuticals Ltd., Ahmedabad. He is also an author and co-author of more than 110 scientific papers and abstracts in refereed international journals.
An eminent speaker, Dr. Chakraborty is an Honorary Professor and External Examiner to a few universities; editorial board member of three international journals; reviewer of many professional journal manuscripts, and also on the board of several Institutes and Universities in India and USA in various capacities. He has supervised 24 Masters and 5 PhD students. He is also the current Chair of Pharma & Healthcare Panel of Confederation of Indian Industries, Gujarat.
Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer
- Senior professional with 11 plus years’ experience in Medical Quality and Marketing Compliance spreading across Promotional Ethics and Compliance, Product Quality, Drug safety, and Quality processes.
- Currently heading affiliate quality systems for Sanofi India Pharma and lead Clinical Quality and Marketing Compliance for Sanofi, India for 9 years.
- Have been instrumental in setting up novel electronic Transparency Platforms and implementing Quality/Compliance Systems at Sanofi India, in accordance with Sanofi Global Quality Policies, Quality Directives, Standards, International and local regulatory requirements.
- Areas of expertise include Quality Management, Project Management, Quality Assurance, Pharmacovigilance, Ethical Compliance, Business Excellence, Learning and Development.
HIGHLIGHTS of EXPERIENCE
- Marketing Ethics and Compliance: ensure compliance with industry standards like MCI rules, DoP, IFPMA, OPPI guidelines for ethical promotion, ethical interaction with healthcare professionals, medical institutions, patient organizations and implementation of transparency policy across all Sanofi Franchise (Pharma, Pasteur, Genzyme and Shantha Biothenics).
- Organizational Quality Management for Pharmacovigilance and other departments: Ensure Quality organization and management of Quality Documents to support Quality and Compliance Program for Pharmacovigilance, Medical Affairs Quality, and other departments.
- Project management: participate and lead team for business critical projects from start-ups to implementation for affiliate and region.
- Quality Management: Ensure Quality audits/ checks are conducted and hosted - internal and external customer audits, and inspections including company audits, system audits, process audits, site audits, and certification audits (e.g.; ISO certification, etc.)
- Training and tracking: ensure training of PV, Quality and Medical on company standards, and external stakeholders (KOLs, investigator teams, ethic committee members, etc.) across hospitals and institutions, on industry standards and regulations.
- Data analysis and reporting: Perform quality assurance consulting projects, data analysis and reporting for process improvements, product quality, PTCs.
- Team Management and Development: training and mentoring Pharmacovigilance and Quality, Medical Affairs team members; planning, assign
Director Medical Affairs,Clinical Operations & Device Safety
Johnson & Johnson
Anish is an accomplished physician executive with proven leadership skills, strong business acumen, and a deep understanding of the Pharmaceutical & medical device industry. Recognized for driving positive change, delivering solutions, and nurturing strong relationships in the medical community. He has been providing the vision, leadership and direction to achieve Medical, Clinical and Strategic excellence at management board level
Anish has completed his M.B.B.S. from Grant Medical College and J.J. Hospital Mumbai and M.D. from Seth G.S. Medical College and KEM Hospital Mumbai.
Anish was also a lecturer in the same institute. Anish also hold a Fellowship of American College of Clinical Pharmacology (USA) and The Royal Society of Medicine in London.
He has been trained by ICMR in Clinical Pharmacology.
He is the member of Board of studies of Maharashtra University of Health Sciences (MUHS) for Pharmaceutical Medicine. He is also a visiting faculty for Pharmaceutical Medicine at IDD KEMH.
Anish has an overall experience of over 24 yrs in Pharmaceutical and Medical Device Industry, Academia and Research.
Anish currently is Director - Medical Affairs, Clinical Operations & Medical Safety at Johnson & Johnson Medical.
Prior to this he was with Bayer Healthcare, Bayer Schering Pharma, Mumbai where he was working as Head of R&D/Medical Director handling Medical Affairs, Clinical Operations, Regulatory Affairs and Pharmacovigilance & was responsible for new product registration and Clinical Development for local and global requirements.
Anish has more than 120 publications in Indian and International journals and conferences. Anish is one of the editors of the book titled “Regulatory Requirements for Drug Development and Clinical Research” published by ICMR in 2013.
Anish is recipient of Charles R. Ream, MD, Award for Excellence and U.K. Sheth Award for Best Paper. Anish is a Visiting Faculty for Clinical Research at several teaching institutes.
Head - Global Clinical Operations
Piyush Gupta, MBBS, MBA, is an Associate Director at GNH India, since November 2009. Here he is responsible for exports to RoW (Rest of the World) Markets covering over 180 countries globally.
Main lines of business for GNH India are Clinical Trial supplies, Branded lines, Generics and hospital supplies.
Previously, he was the Director for Emerging Markets at Indigene Pharmaceuticals Inc., US. Dr. Gupta was responsible for establishing business presence in world markets like CIS, Middle East, Europe and Asia Pacific.
Dr. Gupta is a Council Member at GLG (Gerson Lehman Group) USA for their healthcare practise and advices investment bankers on Indian markets for the group.
With over 13 years of experience in Pharmaceutical Business, International Sales and Marketing, Business Development, Distribution Management across industry verticals for product categories like Patented Rx, Branded Generics, Bio-similars, Biotech, Pre-Rx, Consumer products, FMCG products and medical devices.
CEO & Medical Director
Dr Sambit Patnaik was awarded the best colorectal surgeon in India by the Minister of Health and Family Welfare 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
Vice President Quality (Pharma)
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.
Head - Medical & Scientific Affairs
Head - India and Nepal Regulatory Affairs
Dr. Naresh Tondare is a Regulatory Expert with 11 years of experience in the areas of Regulatory Affairs/strategy, Product/Formulation Development, New Drug Delivery/Technologies and Clinical Research.
He has completed a post graduate degree (MD) in Ayurvedic/Herbal Pharmacology and Pharmaceutical from Govt. Ayurvedic Medical College in 2004. He has also completed a PGDIM from School of Management Studies (SOMS), New Delhi in 2009 and a Black Belt in Six Sigma (BBSS) programme from Indian Statistical Institute (ISI) in 2008.
Currently, he is working with Glenmark Pharmaceuticals Ltd, Mumbai as a Head- India and Nepal Regulatory Affairs (Senior Manager) since 2011. He is responsible and accountable for regulatory strategy and regulatory submissions of New Drug, NCE, Subsequent New Drug, OTC, Food Supplements, Herbal Products and Cosmetics for India and Nepal Region. Prior to Glenmark, he has worked with several organizations such as AccuMED, SmartAnalyst etc.
Associate Director, Project Management & Strategic Initiatives
Senior Member, Pharma Healthcare Team
Nishith Desai Associates
Director Delivery Partner
Dr. Yashesh Mehta is the Director Delivery Partner at Sciformix Technologies Pvt. Ltd. Sciformix as we know is a KPO operating in the field of clinical research providing end to end product development services. Dr. Mehta is a PhD in Immunohematology from Mumbai University. His Clinical Trials experience spans over 16+ years with the unique experience of having worked with site, sponsor as well as service provider organization. He has been associated with reputed organizations like Eli Lilly, Quintiles, Reliance Clinical Research, inVentiv and Cytespace prior to joining Sciformix. In his senior management roles over these years he has been directly and indirectly supporting business development for the service provider organizations.
Regional Training Head - Asia, Middle East and Africa Cluster
Shilpa Raut is a post-graduate in Pharmacy with Quality Assurance Program as a speciality and has a total work experience of 20 years. 6 years as a Lecturer in Pharmaceutical colleges and more than 13 years of experience in different aspects of clinical research such as Clinical Operations, Clinical Services, Quality Assurance and Training in Pharma and CRO Industry out of which completed 8 years at Novartis.
Presently, employed with Novartis India in their International Clinical Research Organization (ICRO) as a ‘Regional Training Head – Asia, Middle East and Africa Cluster & China, ’ and responsible for strategic designing of training courses and modules with hands-on experience of rolling out risk based monitoring across countries. She is also currently an active member acting as a co-chair for the Training Council at Indian Society for Clinical Research since 2013.
She has also worked in an NGO managing Vaccine Projects conducted by ICMR, and Government of India and funded by Bill and Melinda Gates Foundation. She had a unique opportunity of working with the DCGI offices, ICMR and DBT in providing technical inputs for ‘Mapping of Indian Regulatory Systems for New Drug Approvals’. A project funded by Bill and Melinda Gates Foundation.
During her career, she has been coveted with various awards to name a few
- 'Best Project Manager' for the year 2009-2010 by ISCR (Indian Society For Clinical Research)
- ‘Advancing Global Health’ award recognizing the excellence and wide spread reach of PATH as part of PATH’s Vision Awards for the Japanese Encephalitis project in the year 2008
- ‘Innovator’s Award’ for the Indian Regulatory Systems Project as part of PATH’s Vision Awards in the year 2008
CPO Excellence awards – Gold and Silver categories for managing global audits
Assistant Manager-Medical Writing
Tata Consultancy Services
Dr. Deepti Sanghavi has more than 10 years of experience in clinical research which includes medical writing and project management experience, handling studies across different therapeutic indications and phases. Currently, she is leading a team in Tata Consultancy Services. Previously, she has worked in Quintiles, Wockhardt & Siro Clinpharm in different niche areas like handling Thorough QT & biosimilar studies, drafting and reviewing protocols, clinical study reports, and publications; conceptualizing study designs, engaging in proposals, contracts/budgets, regulatory submissions, site monitoring, training & mentoring. Dr. Deepti has been a speaker in national/ international conferences, and has been involved in training several students on various clinical research topics.
Dr Sahoo is currently working as Director for Cytel. He has worked in industry for some of the national and international organization such as; Core Healthcare, Quintiles, Sterling (PRA), ClinInvent, Chiltern and his last stint was with EPS Singapore.
Dr Sahoo is a graduate in Bioscience and a post graduate MBA and a Doctorate - PhD in Management. He has also been awarded a Diploma on Management and Marketing with Special emphasis on the Biopharmaceutical Industry by the Krieger Research Institute, Canada. He holds 2 other Diplomas; one in Medical Rehabilitation and the other in Exports Management. He is an experienced clinical research professional with over 23 years of experience in Food & Nutrition, pharmaceutical, Life science industry. He has worked in various senior management and regional / country head positions in APAC region. He is a visiting faculty to a number of institutions teaching project management and monitoring, research methodology and logistics and distribution and has published few to books and articles in peer reviewed publications.
General Manager - Medical Affairs
Janssen India (Pharmaceutical companies of Johnson & Johnson)
Amey Mane is currently General Manager-Medical Affairs at Janssen India(Pharmaceutical companies of Johnson & Johnson). He is a clinical pharmacologist with 14 years of experience in multinational and Indian pharma.He has handled diverse responsibilities in medical affairs,clinical research, medical writing and pharmacovigilance. He has >10 international publications in vaccine, pharmacovigilance, epidemiology and clinical research domains. He has handled to different therapeutic areas like Diabetes, Neurology, Oncology, Cardiovascular, Vaccines, Nephrology, Immunology, Rheumatology, biosimilars and generic drugs.
Strategy & Business Development Partner
Dr. Sanket Sawant is a medical graduate with masters in management studies from K.J. Somaiya (specialization in marketing). An overall experience of over 9 years including experience of marketing and selling varied services across the entire portfolio of the drug development cycle including clinical trial operations, data management, medical writing, biostatistics, pharmacovigilance, licensing and regulatory consulting across phase I-IV trials, PMS, medical device trials. Started his career in the clinical research industry as a medical writer and grew up the ladder to be a full time business development professional. Currently, he is associated with SIRO Clinpharm as Strategy and business development partner and in the past have worked with companies like Sciformix and TCS. A diverse background spanning across service delivery, project management, and business-development disciplines underscores my expertise in engaging decision makers and formulating winning pre-sales and sales strategies and solutions.
Dy. General Manager Quality Management & Training, Global Clinical Research Operations
Ashwani Pandita is associated with the clinical research industry in India for more than 14 years. He has worked at various levels in the CRO space as well as in the sponsor companies.
Ashwani is a pharmacist by education. He has studied pharmacy at Nagpur University and also has a Master’s in Quality Management from BITS Pilani in India.
Ashwani has also earned the credentials of Registered Quality Assurance Professional in GCP from the Society of Quality Assurance, USA.
Currently, Ashwani is associated with Glenmark Pharmaceuticals Limited in India, as Dy. General Manager and Head of Clinical Quality Management & Training.
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.
Norwich Clinical Services (NCS) is a Global Contract Research Organization (CRO) Providing Clinical Research – Phase I-IV, Biostudies, Bioanalytical, Pharmacovigilance and Training Services.
We have excellent infrastructure, and exceptional expertise to conduct, Bioavailability and Bio-equivalence studies, Pharmacokinetic study in patients & healthy volunteers, Drug metabolism studies, Dose proportionality studies, Multiple dose studies and Clinical developmental programs.
Our facilities have been inspected/audited by most global regulatory agencies such as FDA, WHO, MOH Turkey, EMA and DCGI/ CDSCO- INDIA.
All our services are conducted in strict conformity with the latest GCP, GLP and 21 CFR (part 11) and all other applicable guidance.
NCS provides a complete offering of GCP and GLP compliant, reliable services in Phase I, II, III and IV. Our primary goal is collecting reliable, quality data while establishing safety and efficacy in study subjects and patients. Our hospital based location provides unique access to patients, equipment and if necessary, hospital services.
Our in-house quality and regulatory team ensure compliance to the protocol and ICH GCP guidelines.
NCS’s integrated approach to Clinical Trials ensures that sponsors benefit from the entire spectrum of services. The team is experienced in diverse therapeutic classes.
• Women's Health
• Infectious Disease
• Rheumatoid Arthritis
• Nutritional Health
INTEGRATED FULL SERVICE CLINICAL TRIALS
• Protocol, ICD and Trial Documents preparation
• RF designing and finalization
• Regulatory Approvals/Notifications
• Assistance with EC Dossier and Approvals
STUDY CONDUCT ACTIVITIES
• Site Training & Initiation
• Site Monitoring
• Project management
• Investigation Site Training
• Investigator Meetings and Payments
• Quality Assurance
• Data Management
• Statistical Services
STUDY CLOSURE ACTIVITIES
• Query resolution
• Database Lock
• Site follow up
• Site close out
• Clinical Study Report preparation and finalization
TRIALS CONDUCTED IN COMPLIANCE WITH
• ICH GCP Guidelines
• Quality Control Checks
• Regulatory Guidelines
We combine comprehensive services, exceptional customer focus to offer a complete range of Clinical & Pharmacovigilance Services.
AlphaMD Pvt. Ltd.
With a vision to transform the manner in which life sciences and analytics services are provided to pharmaceutical industry, AlphaMD was started by experienced leaders and subject matter experts from pharmaceutical, consulting and financial industries.
AlphaMD comprises of following 2 divisions:
• AlphaMD LifeSciences &
• AlphaMD Analytics
At AlphaMD, our focus is on providing end to end integrated services to pharmaceutical organisation and enable them to focus on their core work by being their partner providing technical know-how and subject matter expertise.
Our divisions focus on different needs of pharmaceutical organisations, leveraging the synergies as and when required, which formulates the basis for both the divisions to peacefully co-exist focused on growth.
DDi, a prominent technology partner to the life sciences industry has built its solution competency with a unique blend of functional and domain expertise to serve the technology needs of global clients. Our Products that are in Clinical and Regulatory are fully validated and provide best ROI. Our solutions include ClinMetanoia (vendor oversight, trial optimization) & TULA (Risk Management), MPDsmart (idmp).
SIRO Clinpharm Pvt. Ltd., winner of “Best Clinical Research Company” of the year in the Healthcare and Fitness Leadership Awards 2016 organized by the CMO Asia and Stars of the Industry Group and two times winner of the Frost & Sullivan “Indian Clinical Research Organization of the year” award, is a drug development solutions provider to the global healthcare industry across differentiated segments such as pharma, biotech, generics, biologicals, consumer healthcare, nutraceuticals and medical devices. SIRO offers a full spectrum of services that suits clinical development plans, right from early phase to post-marketing, thereby ensuring a complete life-cycle management of the healthcare product. With a successful track record of about 20 years, our subject expertise gives us an edge in clinical operations, clinical trial supplies management, medical services, medical writing, pharmacovigilance, clinical data management, biostatistics & statistical programming, data analytics and medical communications. At the heart of SIRO’s success lies one idea - “solutions simplified” and it is this idea that mobilizes our entire team to deliver simple, novel and customized solutions, anchoring our clients to us.
For further details, please write to us at:
Or visit us at www.siroclinpharm.com
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.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
LEX WITNESS – India’s 1st Magazine on Legal & Corporate Affairs
LEX WITNESS vows to be a high quality monthly magazine with the powers of fresh and original content that would deal exclusively with subjects pertaining to legality. Country's top notch practitioners and experts are being invited to contribute in WITNESS with what we feel is relevant to all stakeholders in this profession, aiming at brainstorming between the legal luminaries and hence bettering this practice in all its aspects.
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Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.
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The Lalit Hotel
Address: Sahar Airport Road, Andheri East, Opp. Hotel Leela, Mumbai, Maharashtra - 400059
Phone: +44 22 6699 2222
Testimonials from our past Biosimilars Congregations
Great conference for networking and relationship - Officer, Spilcsun Pharma
1. Very useful to network with sponsors and CRO
2. Good place to know the progress of competition - Manager - eclinical, DDi
It was good & interadity sessions - Quality lead, PV, Sciformix Tech pvt.ltd
Over all good - Safety physician, Sciformix
Conference pictures can be viewed and downloaded at our official Virtue Insight facebook page
Link - Click Here