Tuesday 16 November 2010
Hosted by: Clyde & Co
Organised by: Asia-Pacific Technology Network
Chair
- Dr Brian Tempest, Chairman Religare Capital Markets PLC
Speakers
- Alec Deighton, Senior Director QA and Compliance, PharmaNet Ltd
- Dr Mike James, Scientific and Technical Director, Cambridge Regulatory Services
- Jamila Joseph, General Manager, Reliance Life Sciences
- Gaurav Sharma, Director of Operations, ClinTec International
- Dr Nermeen Varawalla, President & CEO, ECCRO
Since 2007 there has been a massive increase in the number of clinical trials being held in India. Some of these are being carried out by global CROs, but a significant number is also being carried out by companies which are either Indian-owned, or are being driven by members of the Indian diaspora. In this seminar, we will look at the experiences of a range of CROs. The international CROS may argue that they bring global best practice to India, while the Indian CROs may argue that their deeper understanding of the Indian environment allows them to work more effectively in this field. Our five panellists represent a spectrum of experiences with the Indian market, and we would expect them to clarify the underlying issues.
Location: Clyde & Co LLP 51 Eastcheap, London, EC3M 1JP
Map and Directions: Please Click Here
Nearest tube station: Monument
Timing: Registration from 17:00: seminar from 17:30 - 19.15 (followed by refreshments)
Pricing:
- Free to Clyde & Co clients and APTN's annual supporters
- £40 + VAT (Executives)
- £20 + VAT (Asian citizens/institutions, officials, executives from Small Companies)
- £10 + VAT (Academics),
- Free for the Media
To Register your interest - please send your details (name, institutional affiliation, email address, phone number - and the category you come under) to biz22@aptn.org
DR BRIAN W TEMPEST CSci CChem MRSC BSc PhD
Dr Brian Tempest advises Companies, Banks, Investment Funds, Private Equity & High Net Worth Individuals on their Strategy in Asia based on his wide experience in China, Japan, South East Asia and India where he has lived for the last decade or more. Brian has worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until 2005. He was then Chief Mentor and Non Executive Director until 2008. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional Director- Far East and Regional Director- Middle East & Africa. Brian has worked in the Pharmaceutical Industry for the last 39 years and has managed Healthcare businesses in North America, South America, Europe, Africa, Middle East, Asia and India. Brian has also led many sessions at Investor Meetings held around the World. Brian is currently Independent Chairman of Religare Capital Markets which is responsible for the international global banking business of Religare, the leading Indian Bank. He is also an international advisor to MAPE the Indian M&A boutique and UNCTAD Switzerland. In addition he is a member of the SCRIP Global Awards Panel and is on the Editorial Board of the Journal of Generic Medicines. Brian speaks at global conferences on the challenges from India and China and more information on these presentations can be found at www.briantempest.com. Brian has a PhD from Lancaster University and is a member of the Royal Society of Medicine and the Royal Society of Chemistry. He is now Chairman of Hale & Tempest Co Ltd
Alec Deighton
Senior Director, Quality Assurance and Compliance, PharmaNet Ltd. Alec Deighton has over fifteen years experience in the Pharmaceutical Industry, since he called an end to his twenty four year career as a teacher of Biology. He initially worked as a CRA for Innovex where he learned the basics of clinical research. After that he moved into Clinical Auditing working successively at Europharm, ClinPharm, Ingenix and i3 Research. Alec joined PharmaNet in June 2004 and is currently responsible for quality assurance and compliance globally outside of North and South America. During his time in Clinical Quality Assurance Alec has had a wide experience in all aspects of clinical auditing and actively advises colleagues on the application of regulatory requirements and SOPs to their activities. Since 1998 he has had a close relationship with Clinical Research in India, having visited for training or auditing purposes on numerous occasions. With the growth of regulatory inspections Alec has hosted and trained others on the optimum methods of dealing with all aspects of inspections. He is and experienced presenter and trainer at Conferences, workshops and trainers covering topics related to GCP, Clinical Operations and Auditing theory and techniques. Most recently he has presented on “Ensuring Quality in Developing Countries” at the 2009 Euro DIA Conference and on “Hosting Regualtory Inspections” for a joint seminar for BARQA and ACDM. Alec is an active member of both the DIA and BARQA.
Mike James
April 2000 ¬ Date: Director of Cambridge Regulatory Services Limited Major projects completed to date: • Preparation of Module 3 and Quality Overall Summary for a centralised MAA for an AIDS treatment. • Preparation of Module 3 of a centralised MAA dossier from a BLA file, including the Quality Overall Summary, for a novel cell derived protein. • Preparation of responses to CPMP reasoned objections for Module 3 (Part II) of a biotechnology derived orphan drug submission. • Provision of advice on the development of a monoclonal antibody and the development of a novel animal derived protein to meet European regulatory authority expectations. • Review of two centralised biotechnology applications for potential questions; review and amendment of client’s proposed responses to questions received from the CPMP. • Co¬ordination and preparation of orphan drug submissions for Europe and USA for a biotechnology product. • Management of a centralised application for a biotechnology derived drug. • Preparation of three CTXs from IND dossiers and six from other data for biotechnology drugs. • Preparation of a Type II variation and expert statement to change the source of active ingredient for a centrally authorised product. • Preparation of a CTD format application for a biotechnology derived drug for submission in Eastern Europe and the EU. • Conversion into CTD format and updating of the quality information for two centrally approved biotechnology drugs to include a new method of manufacture of the drug substance. • Regulatory due diligence reviews for potential product acquisition for 2 biotechnology derived products and 3 vaccines. • Preparation and management of regulatory documentation for a Phase II/III multi-centre, multi¬country study of a vaccine candidate for HIV. Cambridge Regulatory are regulatory and not clinical but partner SIRO to offer a complete service.
Jamila Joseph
Jamila Joseph is General Manager at Reliance Life Sciences, India. She has 12 years of experience in the clinical research industry, half of which was spent at Quintiles, Inc., in Project Management, clinical monitoring, medical writing, GCP training and data management.
She joined Reliance, India’s largest private sector enterprise, to help set up clinical research operations and led the Phase II - IV trials group until 2008. Reliance Life Sciences is today a leading biotechnology company headquartered in India. Jamila is currently charged with the responsibility of building a European clinical research focus for the company. She is based in London.
In her time in the CRO industry, she has worked with major pharmaceutical, medical device and biotech companies in their product development programs which have involved more than a thousand clinical sites in India.
She has been a long-standing member of the Drug Information Association and is a scientific reviewer for Elsevier publications.
Dr Nermeen Varawalla
Dr Nermeen Varawalla is the founder and CEO of ECCRO, a leading India specialist CRO for international Phase II - IV clinical trials. Dr Varawalla is an acknowledged industry expert in the conduct of international clinical trials in India and has previously established and grown two businesses in this sector. Firstly, PerinClinical which she incubated and sold to PRA International in 2004, following which Dr Varawalla was a Vice President at PRA International for five years with leadership roles in Business Development, Scientific and Medical Affairs and Corporate Development. She led the establishment & growth of PRA India and has participated in the design & conduct of over 50 international clinical trials that have included emerging countries.
Dr Varawalla trained at Seth GS Medical College and KEM Hospital, University of Bombay and is a Fellow of the College of Physicians & Surgeons of India. She was Rhodes Fellow at the University of Oxford where she obtained a doctorate for molecular genetics research and is a Member of the Royal College of Obstetricians & Gynaecologists, UK. Dr. Varawalla obtained her MBA from INSEAD and joined Accenture’s Healthcare and Life Science business strategy consulting practice in London before engaging with the CRO sector. Dr Varawalla is a frequent invited speaker at industry conferences, serves on the editorial board of the Journal for Clinical Studies and is on the DIA Clinical Forum Programme Committee. She is board member of the Institute of Clinical Research UK, Asia Pacific Technology Network and a member of the UK Trade & Investment India Life Sciences and Healthcare Sector Working Group.