Tom Cosgrove is the Director of the Office of Manufacturing Quality (OMQ) within FDA's Center for Drug Evaluation and Research (CDER). In this role, he directs CDER's compliance activities with respect to CGMP and product quality. Before OMQ, Tom led CDER's Office of Unapproved Drugs and Labelling Compliance (OUDLC), where he was responsible for FDA's compliance divisions covering drug approval and labelling issues. Before joining CDER, Tom was a litigator in FDA's Office of Chief Counsel, and prior to FDA, Tom was an attorney at Covington & Burling in Washington, D.C. Tom clerked for Judge Catherine Blake on the United States District Court for the District of Maryland and earned his law degree from The University of Michigan Law School.

Mr. Subhanu Saxena has joined Cipla as the Global Chief Executive Officer (CEO) on February 1, 2013 and currently designated Managing Director & Global CEO. He has a Global Mindset, with "India connect" and is based in our head office in Mumbai, India. Subhanu reports to the Chairman and the Board of Directors of Cipla. He brings to Cipla a proven track record of the key requirements that the CEO's role demands.

Subhanu holds an MBA from INSEAD - France, Fontainebleau, and a BA (Hons) in Engineering Science from Oxford University, both with distinction. A citizen of the United Kingdom, and an India OCI cardholder, he is fluent in English, Hindi and Sanskrit, and has a good working knowledge of French, German and Russian. Outside of his professional life, Subhanu is a lecturer / teacher of Sanskrit and ancient Indian literature and has a love of Urdu poetry.

Subhanu comes from Novartis Pharma AG, where amongst a number of roles, he was CEO and President of Novartis UK. He, in his last role led the Global Commercial and Product Strategy function for Novartis Pharma. This role was a part of the Global Pharma Executive Committee ($30bn sales), where he had responsibility for Marketing, Sales, Global Medical Affairs and Health Economics.

Russell Wesdyk has had the privilege of serving patients for over 30 years. For approximately 25 of those years, Mr. Wesdyk worked in a variety of technical and business roles in the generic, biotech, and branded pharmaceutical industry. Subsequent to working at BMS, Lupin, and Genvec, his last industry role was as EVP of Corporate Development at Cempra Pharmaceuticals. He now works at FDA, serving as the Acting Director for OPQ's Office of Surveillance.

Mr. Wesdyk received a BS in Chemistry from Seton Hall University and an MBA from Fairleigh Dickinson. On the technical side, Russ has experience across a range of CMC areas with a focus in Quality Assurance, Formulation, Manufacturing and Scale-Up. On the business side, Mr. Wesdyk's background includes corporate development, strategic planning, and life cycle management. Mr. Wesdyk has published actively in the areas of quality, and formulation and manufacturing of controlled release dosage forms. More recently as a regulator, Russ served as CDER's lead negotiator in the GDUFA I process and is presently championing and leading CDER's surveillance and quality metrics initiative.

Dr. G N Singh, an alumnus of Banaras Hindu University, has made an outstanding contribution to the strengthening and efficient functioning of the Drug Regulatory Systems in India, which has added great value to the prestige and stature of the Indian Pharma Industry.

Dr. Singh after his Doctorate in Pharmaceutical Sciences from BHU in 1987, joined and worked for IDPL in their Formulation Plant, Gurgaon from 1989-2002, and as its R&D Head from 2001-02. In between he did his MBA from University of Hull (UK) in 1997, specializing in Human Resource Management, Marketing and Strategic Management. In 2002 he joined the Ministry of Health & Family Welfare as Director of the Indian Pharmacopoeia Laboratory, Ghaziabad. In 2009 he was chosen as the first Secretary-cum-Scientific Director of the newly created Indian Pharmacopoeia Commission (IPC). In 2012, he was given the additional charge of Drug Controller General (India) as Head of CDSCO.

Since February 2015, Dr. Mathew T Thomas serves as the Director of the U.S. FDA India Office. Prior to this posting, Dr. Thomas was the Director of the Division of Enforcement and Post-market Safety (DEPS), in U.S. FDA's Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), Office of Scientific Investigations (OSI). Dr. Thomas started his FDA career as a medical reviewer in CDER's Division of Metabolism and Endocrine Drug Products. He then moved to CDER's Division of Scientific Investigations (now OSI) where he participated in numerous inspections and official administrative actions and later led the Global Outreach and Collaboration Team for CDER. He has also served in the Office of Orphan Product Development in the Office of the Commissioner and in 2009 served as the Chair of FDA's Research In Human Subjects Committee (RIHSC or FDA's Institutional Review Board). In 2013 he took the role of a Branch Chief in the Division of Enforcement and Manufacturing within the Office of Compliance and Enforcement at the Center for Tobacco Products.

Dr. Thomas earned his medical degree from the University of Madras in India. He has completed a Fellowship in Lipid Disorders at the Medical College of Pennsylvania, Philadelphia; and a Fellowship in Clinical Pharmacology and Regulatory Sciences and a Certification in Public Health at the Georgetown University in Washington D.C. In 2015, he completed an Excellence in Government (EIG) fellowship program that is offered by the Partnership for Public Service in Washington D.C.

Mr. K L Sharma has diverse educational background with Masters in Economics, Bachelor Degree in Law and Second Master's Degree from University of York, UK.

His work experience is also diverse having worked in Ministry of Defence (1984-2004) and Cabinet Secretariat (2004-2014) before joining the Ministry of Health & Family Welfare.

He is a Guest Faculty with the Lal Bahadur National Academy of Administration on areas relating to policy formulation, Cabinet/Cabinet Committee Notes, Notes for the Committee of Secretaries for Phase IV and Phase III as also for induction of officers from State Civil Services to the IAS.

Gerald Heddell joined the MHRA as Director of the Inspection, Enforcement & Standards Division in 2005. Gerald is a microbiologist who is a Chartered Biologist and a member of the Royal Society of Biology and the Royal Society of Chemistry.

Since leaving the UK National Health Service in 1978, he has worked in a succession of progressively senior roles in manufacturing and quality assurance in the pharmaceutical industry. Gerald has experience in most aspects of pharmaceutical manufacture and control. This has included microbiological development, analytical laboratory management, quality assurance, business development, director of a large sterile manufacturing facility and, most recently, European Quality and Compliance Director for GlaxoSmithKline.

In his current position with the MHRA, Gerald's responsibilities focus on the quality of medicines in the UK and include a comprehensive surveillance, inspection and enforcement programme, the licensing of pharmaceutical manufacturers and wholesalers, defective medicines reporting, unlicensed imports, borderline products, medicines testing and the British Pharmacopoeia.

Gautam is the Managing Director of McKinsey's India office and is a leader of McKinsey's Pharmaceutical Practice in Asia and also leads McKinsey's Organization Practice in Asia. Gautam also led McKinsey's thinking and research on performance transformation over many years. This expertise is at the core of Gautam's client work e.g he has helped one of India's leading pharmaceutical companies define its ten-year vision, redesign its organization and upgrade its capabilities to execute the vision.

Gautam has a longstanding passion for improving healthcare. He is a co-founder and board member of the Public Health Foundation of India - an innovative public-private initiative to strengthen India's public health system.

Mr. Dilip G. Shah graduated from the premier business school in India, the Indian Institute of Management (IIM), Ahmedabad. He has 50 years of varied experience in the pharmaceutical industry. He has addressed several WTO workshops on TRIPS, WIPO seminars on IPRs and Public Health, WHO meetings on Access to Medicines and several other international meetings and conferences. He was a Member of the official Indian Delegation to WTO Ministerial Conference at Cancun. He also appeared before the U.S. International Trade Commission (USITC) and testified in Investigation No.332-543 Hearing in Washington DC in 2014.

Currently, he is the Secretary-General of the Indian Pharmaceutical Alliance (www.ipa-india.org), Member of the Expert Review Committee of Access to Medicine (ATM) Index (www.atmindex.org); Member of the CPhI International Advisory Board; Member of the Board of Advisors of Pharmabiz.com (Weekly); and Member of Task Forces and Expert Groups constituted by the Government of India for accelerating growth of the Indian pharmaceutical industry. He was Chair of the International Generic Pharmaceutical Alliance (IGPA) for two terms (2005-07) and (2010-11).

Mr. Shah is an independent director on the Boards of Fresenius Kabi Oncology Ltd, Anuh Pharma Ltd, Shaily Engineering Plastics Ltd and CEO of Vision Consulting Group (www.vision-india.com), a firm specialized in strategic planning. Before starting Vision in 1997, he was a Member of the Board of Directors of Pfizer-India for whom he worked for 30 years.

Brendan Cuddy joined the European Medicines Agency in October 2002 as a Scientific Administrator. In October 2014, he was appointed Head of Manufacturing and Quality Compliance Service.

The Manufacturing and Quality Compliance Service is responsible for inter alia, co-ordination of GMP inspections, co-ordination of assessments of quality defects and product recalls, co-ordination of sampling/testing for initial marketing authorisation and post-authorisation procedures involving centrally authorised medicinal products. The Service provides the Chairman and secretariat of the Good Manufacturing and Distribution Practices Inspector Working Group (GMDP IWG) and provides the secretariat for the joint CHMP/CVMP Quality Working Party.

Brendan is a Chemistry graduate and he holds a Masters Degree in Quality and Operations Management and a post-graduate diploma in pharmaceutical manufacturing technology.

Vikas Bhadoria is a Senior Partner in McKinsey’s Delhi Office and leads the Pharmaceutical and Medical Products (PMP) practice in India. He also leads McKinsey’s PMP Operations practice in Asia.

During the last 19 years, he has assisted Indian pharma companies in developing and implementing growth strategies, launching and building global businesses, transforming their organisation and culture, building capabilities and developing leaders. He has also led large-scale enterprise transformation and profit improvement programs, supply chain transformations and lean shop floor operations. He has been leading transformations to build a strong and preventive Quality by design culture, helping organisations upgrade their Quality management systems and driving comprehensive remediation efforts for plants dealing with serious Quality challenges.

On the global front, he also serves Multi-National global pharma companies to build strong emerging market strategies and leverage India for outsourcing and offshoring opportunities across the value chain. He has also supported India sourcing engagements for Global pharmacos, distributors and retailers.

Satish Reddy is the Chairman of Dr. Reddy's Laboratories. He joined the company in 1993 and since then has held positions of increasing responsibility. Satish led the organization's transition from a uni- focused manufacturer of APIs (active pharmaceutical ingredients) to a company that moved up the value-chain with a diverse product portfolio of Finished Dosage Formulations. He oversaw the expansion and establishing of a strong footprint for Dr.Reddy's finished dosage products in Russia, CIS countries and other emerging markets.

As an active member of major industry associations and governmental panels, Satish played a key role in shaping policies concerning the pharmaceutical sector as well as the economy, such as policy formulation on India's patent law, drug pricing and important amendments to the Drugs & Cosmetics Act. He is the President of the Indian Pharmaceutical Alliance, a premier industry association of leading research based Indian companies. Satish also chairs the Life Sciences Skill Development Council under The National Skill Development Corporation (NSDC), an organization, working in partnership with various stakeholder groups, to serve and address the skill shortfalls in the Life Sciences Sector across India. He is also the Chairman of the Board of Governors of NIPER Hyderabad and is Deputy Chair of the CII Southern Region. He was a member of the Drugs Technical Advisory Board of India, the Chairman of the Andhra Pradesh Chapter of the Confederation of Indian Industries (CII) and head of its National Committee on Pharmaceuticals. In May 2015, the Ministry of Labour and Employment, Government of India, nominated Satish as Chairman of the Board of Governors of the National Safety Council.

He holds a degree in Chemical Engineering from Osmania University, India, and an M.S. in Medicinal Chemistry from Purdue University, USA, where he received the 2009 Distinguished Alumnus Award from the School of Pharmacy and Pharmaceutical Sciences.

Samir Mehta is Chairman of Torrent Pharmaceuticals Ltd and Vice Chairman of the Torrent Group. Born in 1963, after his post-graduation in management studies, Mr Mehta delved into the nascent businesses of Torrent Group in 1986 and over the years has ably guided its well strategized growth with his analytical and professional approach.

Under his leadership, Torrent Pharma took several strategic initiatives, including forays into new therapies and geographies, large investments in product development infrastructure and capabilities, building state-of-the-art manufacturing facilities and inorganic growth through acquisitions, thus establishing Torrent as one of India’s fast growing and well respected Pharma majors. His emphasis on organisation design, execution and operational efficiencies has built a strong and globally competitive business platform in Torrent Pharma.

Nilesh Deshbandhu Gupta is a Chemical Engineer from the Institute of Chemical Technology, Mumbai and an MBA from the Wharton School, Philadelphia. He has been responsible for transforming and expanding Lupin's research programs globally and strengthening the Company's technical operations. As a part of the apex management, he has been instrumental in formulating and executing the core strategy that has helped Lupin emerge as a global generics and specialty major.

As Managing Director of Lupin, Nilesh Gupta is responsible for the Company's R&D, technical operations including global manufacturing and quality, supply chain as well as the commercial function for the India and Asia Pacific regions, which contribute close to 50% of the company’s global revenues of USD 2.5 billion.

Nilesh along with his sister Vinita Gupta, won the ‘Entrepreneur of the Year Award’ at the Forbes India Leadership Awards in 2016 as well as the Ernst & Young ‘Entrepreneur of the Year Award 2015’ in India.

Mark Birse joined the MHRA in 2002 and is currently the Head of the Inspectorate which comprises of over 70 Inspectors. Mark is a chemistry graduate with an MSc in pharmaceutical sciences. He previously worked in the pharmaceutical industry for over 10 years in a variety of roles including process technology, new product introduction and quality assurance and he is eligible to be named as a Qualified Person under Directive 2001/83/EC.

Jaidev Rajpal is a Partner in the Delhi Office of McKinsey and Company. Since joining the Firm, he has served clients in Medical Products and Pharma sectors as well as Industry associations on Quality, Compliance and Operational Transformation topics.

He has extensive experience in leading at-scale capability-building transformations in operations across different geographies globally, and leads McKinsey’s Asia Pharma and Medical Products and Operations practices as well as the Quality, Compliance and Remediation Service line.

He has led successful resolution of FDA warning letters in a very short time (~9 months) - through transformative quality-culture-and-capability-building efforts - at multiple leading Asian companies. He has been involved in network-wide Quality transformation at an Asian pharma company to develop and sustain capabilities on ‘any-time audit readiness’ and ‘product robustness’.

Prior to joining McKinsey, Jaidev worked as a practicing clinician. He is a Medical graduate from Grant Medical college, Mumbai, India and holds an MBA from Indian Institute of Management, Kozhikode, India.

Dilip Shanghvi, 64, is the Managing Director of world's 4th largest and India's top specialty generic pharmaceutical company, Sun Pharmaceutical Industries Ltd. Mr. Shanghvi is also Chairman and Managing Director of Sun Pharma Advanced Research Company Ltd. which is engaged in R&D of new innovative drugs and delivery systems. He is a former President of Indian Pharmaceutical Alliance. Mr. Shanghvi has been conferred with many awards and recognitions including, Padma Shri (Fourth highest civilian award by Govt. of India) in 2016, Forbes Entrepreneur for the year - 2014, Economic Times’ Business Leader of the Year (2014), CNN IBN’s Indian of the Year (Business) (2011), Business India's Businessman of the Year (2011) and Ernst and Young's World Entrepreneur of the Year (2011). He has also been awarded the Economic Times' Entrepreneur of the Year (2008), Business Standard’s CEO of the Year (2008) and CNBC TV 18's First Generation Entrepreneur of the Year (2007).

In 2017, he was made a trustee of the Rhodes Scholarship Program at Oxford University. In January 2018, the Indian government appointed Mr. Shanghvi to the Reserve Bank of India's 21-member central board committee. He is also chairman of the board of governors at Indian Institute of Technology (Bombay). In 2019, Mr. Shanghvi was conferred with an honorary doctorate by the Tel Aviv University, Israel’s largest and most comprehensive institution of higher learning.

David Keeling is a Senior Partner in McKinsey & Company’s Chicago Office.

David leads McKinsey’s global Pharmaceutical Quality and Operations Practices - a global group of about 300 consultants that focuses on improving operations and quality for biopharma clients. David’s clients are predominantly global leaders in the biopharmaceuticals and medical products industries.

David attended the University of Western Australia, where he received a Bachelor of Engineering degree in electrical engineering with first-class honors. He also holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University. Prior to joining McKinsey, David worked in high-tech, where he was responsible for product development, project management, and business management.

David lives in Chicago with his wife and four children.

Mr. Pankaj Patel is the Chairman of Zydus Cadila, an innovation-driven, global healthcare company with operations in more than 50 countries worldwide. With an experience spanning over 40 years in the Indian pharmaceutical industry, Mr. Patel combines both research and techno-commercial expertise.

Mr. Patel has been nominated as a Member of the Mission Steering Group (MSG), the highest policy making and steering body constituted under National Health Mission (NHM) and of the Drug Technical Advisory Board by Ministry of Health & Family Welfare, Govt. of India, New Delhi. He has also been nominated on the reconstituted Court of the Indian Institute of Science for the period 2018-2021. Mr. Patel is also on the Board of Invest India and The Indian Institute of Foreign Trade (IIFT).

Mr. Patel is a Past President of the Federation of Indian Chamber of Commerce & Industry (FICCI).

He is a Member of the Board of Governers of the Indian Institute of Management (IIM), Ahmedabad. He is also the Chairman of the Board of Governers and Society, IIM, Udaipur. Mr. Patel is currently on the Governing Board of The Ahmedabad University and the Chairman of the School of Life Sciences, Ahmedabad University. He is also a Member of the Board of Management of the Narsee Monjee Institute of Management Studies and a Member on the Governing Board of the Gujarat Law Society, Nirma University and the Anant National University, Ahmedabad.

Mr. Pankaj Patel is the Executive Chairman, Vice President and Trustee of the Gujarat Cancer Society and Chairman of the Gujarat Cancer and Research Institute, a Regional Cancer Centre and one of the largest cancer centres of India, reaching out to the needy and underprivileged cancer patients. He also officiates as the Chairman of the Deaf and Mute School, Ahmedabad.