Mr. Taranpreet Singh Lamba is presently working as Vice President of Intellectual Property and Product Portfolio Management in Glenmark Pharmaceuticals Limited, Mumbai. He has more than 18 years of rich experience in the patent matters with specific focus in managing patent portfolios, infringement analysis and litigations for various geographies like US, EP, India andEmerging Markets. He is also a Head of Global Product Portfolio in Glenmark for making future pipeline for Key markets including US, Europe, India and Emerging Markets in generic and branded generic space.

He is a pharmacy graduate and has done M. Tech in Pharmaceutical Technology from NIPER and has further also done specialization in patent law.

John Robert is a project leadership enthusiast with over two decades of experience, (yet still learning), in projects, engineering, and operations. He is currently “Associate VP of Project Management” at Sun Pharma; He has significant exposure in large-scale infrastructure projects and complex research program. John is an engineer and MBA by education. He has 360degree exposure as a consultant, project manager, leader and contractor, from a simple brick and mortar projects to complex innovation programs.

He is author of two books:

1. Spiral Staircase Project Management: A Framework to Succeed Complex-Cognitive Projects

2. Projects @ Relay Race: Deliver projects faster than you ever imagined

Dr. Ashok Kumar carried out his Ph.D. work at CDRI, Lucknow under the supervision of Padmashree Dr.Nitya Nand. This was followed by Post-Doctoral studies with Prof. Sir John Cornforth, a Chemistry Nobel Laureate, at the University of Sussex, England from 1981-1984.

He started his carrier with Alchemie Research Centre at ICI, Bombay in 1985 and served Lupin Laboratories before taking up the job with Ipca Laboratories Mumbai, a leading Pharma Company in the year 2000 and is presently heading the Centre for Research & Development of Ipca in the capacity of President.

He is a co-author in more than three dozen Papers published in peer reviewed International Journals, co-inventor in more than 100 patent applications filed, has presented scientific papers and keynotes in many International Conferences in addition to delivering invited talks at various Institutions / Conferences on R&D Management, Idea Management, Innovations, Philosophy of New Drug Discovery & Life and many more such topics.

Ms. Jamila Joseph is Senior Vice President at Reliance Life Sciences. She has more than 20 years of experience in drug development, beginning with 5 years at Quintiles. Currently, she heads innovative technologies including gene therapy at Reliance Life Sciences in Mumbai. She also oversees clinical research at Reliance. She has been a line manager and mentor to project, program and portfolio managers. She is Chairperson of the Indian Forum of the Research Quality Association (RQA), a member of the DIA, Medicine Working Group of the London Manifesto for Innovation, Diversity and Inclusion Council of Reliance, and a scientific reviewer for Elsevier and Bentham groups of journals. Ms. Joseph graduated in Microbiology and Biochemistry, has done an executive MBA, and holds two post-graduation degrees: in Biochemistry and Philosophy from Mumbai University. She taught Biochemistry at Mumbai University before moving to the pharma industry 20 years ago. She is an alumnus of IIM, Ahmedabad.

Shirish Belapure holds a post graduate degree in Pharmacy from Nagpur University and Management Certification from Indian Institute of Management (IIM) Ahmedabad. He has an experience of managing operations in Pharmaceuticals in the wide range of areas like formulation development, manufacturing, Quality Assurance, regulatory affairs of API & formulations, for about 39 years.

He is the former Managing Director of Zydus Hospira Oncology Pvt Ltd- a joint venture company between Zydus & Pfizer. Prior to this assignment he was working as President (Global Manufacturing) and was responsible for entire manufacturing network of Formulations and Projects globally for Zydus Cadila, which includes mfg. operations in multiple plants at India as well as at Brazil, Japan & USA.

He has several initiatives to his credit notably ͚Strategic Lean Integrated Manufacturing (SLIM)͛ operational excellence at Zydus Manufacturing, Automations to reduce human interventions in the processes, EBMR to make Zydus manufacturing fully compliant.

Dr. Udaykumar Rakibe has completed his M. Pharmacy & MBA from Pune University and is a PhD in Pharmacy from Dr. BAMU, Aurangabad. Dr. Rakibe was mandated and given the task to execute and spearhead the proactive remediation in 2006 by Ranbaxy Lab. Ltd. And in late 2011 he was recruited by Intas Pharma to create a self-sustaining quality management system and enhance inspection readiness. Further, in 2013 Dr. Rakibe was hand-picked & recruited by Wockhardt Ltd., as Senior Vice President – Quality, to turn around the Quality Management, lead and manage the remediation of Quality initiatives.

Dr. Rakibe is a quality professional with a dynamic career steering organization through complex Quality & Regulatory challenges, transitions, building an empowered and talented workforce in the 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 3 decades of hands-on and hard-core experience in the pharmaceutical regulatory environment. He has gained the domain experience in Quality by working 3 decades in Quality operations- half of which i.e. 15 years focusing and leading the Quality & Regulatory remediation. Dr. Rakibe has 7 years’ experience in Corporate Quality functions, overseeing the Developmental, Technology Transfer, & filing of – ANDA and DMF (Clinical, Analytical, Formulation, Devices). He has setup the Global Quality organization for the Contact Manufacturing in regulated and semi-regulated markets. Dr. Udaykumar Rakibe has worked as a senior member of the Quality Team and helped place the organisations in the next level or orbit - with Ranbaxy Labs Ltd., Dabur Pharma Ltd., Gland Pharma Ltd., Intas Pharma Ltd., and Wockhardt Ltd.

"Afsar Shaikh is an young, dynamic & experienced pharma professional with proven track record of successful project management. He has a vast experience in pharma project management leadership & problem solving for complex generics, contract manufacturing, 505(b)2 & NDDS. He has an indepth knowledge of regulatory pathway, competitive landscapes & successful track record of project delivery with ever changing regulations & technologies & has effectively contributed in process development for project management, stage gate & risk management process. He has sphere headed successful partnerships with CMO sites in Europe, India and USA. He has handled project management of multiple NDDS products from concept phase to Proof of Concept and investigational phase, catalyzing the adequate evaluation and participation at Product selection phase (PSC). Afsar has closely worked with Mackinsey, E&Y, Lachman and other top consultant companies to achieve organizational goals."

Mr. Jayesh Khatri is a Senior General Manager- Project management with Enaltec Labs Pvt. Ltd. In his current role, Jayesh is heading project management team and responsible for driving the formulation developmental projects. He is also one of the core member in new product selection committee. In his career spanning close to 14 years, he has managed large scale complex projects from development to commercial, Key Business Partners, Strategic Alliances & Joint ventures with Pharmaceutical firms.

He has started his journey working for Atul Ltd, Valsad as Shift in-charge in Asia's biggest dyes manufacturing plant and moved to pharma in 2005.

Prior to moving into Project Management in 2008, he has worked in API as well as Formulation R&D lab. He has leaded all types of projects such as API DMF filing, API cost reduction, API to Formulation integration projects, Formulation R&D Projects for US, EU and RoW markets, Site transfer projects, Inventory optimization, SAP implementation and Business transformation projects.

Prior joining Enaltec, Jayesh has served with companies like Dr.Reddys, Cipla, Glenmark, Atul Ltd. Jayesh has done MSc in Organic Chemistry in Gujarat and PGDBM through IMT Ghaziabad (part time). He has also attended advance project & portfolio management courses at premier institute like IIMB.

Mike Teiler received his training in Pharmacy at the Hebrew University of Jerusalem, where he earned his B.Pharm degree. After internships at Jerusalem’s ShaareTzedek Medical Center’s pharmacy and in community pharmacy, he immediately took his place in generic R&D formulation development at Abic Ltd., then Israel’s second largest pharma company. After Abic Ltd. was acquired by Teva, Mike moved to increasingly senior positions in Generic R&D and Portfolio Management, finally reaching the position of Vice President Generic R&D for the Teva International Group.

Mr. Teiler left Teva after 24 years to join Taro Pharmaceuticals (a Sun Pharma company) as Group Vice President, Portfolio Management where he created this role and established processes for candidate selection, R&D project management and global launch management. In addition Mike was responsible for the project management of Sun Pharma’s R&D, where he was responsible for introducing Critical Chain Project Management and led the implementation effort.

Today Mike is Principal Consultant with Pharm Portfolio Management focusing on candidate selection, project and portfolio strategies and creating processes and strategies to support company expansion into new products and territories.

Makarand Kulkarni Heads the Project management Office at Sanofi. He is a Versatile professional with diverse experience across categories & extensive international exposure, Pharmaceuticals & Consumer Health Care.

He has over 2 decades of diverse experience & exposure in managing portfolios ranging from Diabetes, Cardiovasculars, Women's Health & Mobility, to Consumer Healthcare & Nutraceuticals. Makarand has extensively worked on International projects and assignments across Europe & APAC. He has devised and implemented strategies, ensured the achievement of business development targets, addition of key accounts to the portfolio; successfully launched division & over 14 products including LCM initiatives in various categories.

Makarand has successfully lead key projects such as Beta Blocker steering committee for APAC , including major regional initiatives such as APAC Beta Blocker Advisory Board, Clinical Trails and Branding exercise

Global New product launch SOP, India strategy road map and is credited with Marketing Excellence initiatives in developing & rolling out global marketing processes.

Prior to Sanofi, Makarand has worked on various roles with leading companies like Cipla, Glenmark, Merck Serono and Pelthico.

Gautam Balakrishnan Heads the newly formed Smart City Business Unit in Tata Projects Ltd (a proud member of the Tata Group in existence since 1968 with annual revenues exceeding $800 Million). The Smart City team focuses on planning and deployment of e-enabled infrastructure solutions such as solid waste management, sewage treatment, public safety, homeland security, crime prevention, e-governance and multi-modal transportation. Also included is wide area communication (Wi-fi), remote education & heath-care. The mandate of the team is to enrich the lives of residents of cities both in India and abroad in as many ways as possible combining highest degree of innovation with maximal efficiency of resource utilization.

With over 10 years of rich experience in telecommunications consulting spanning across East Asia and with leadership roles in service delivery, Gautam has a unique understanding of the complexities and challenges posed by retrofitting existing cities with smart solution layers. The challenges of infrastructure creation are uniform across cities and domains. Prior to consulting Gautam was part of the team that rolled out a nationwide voice and data wireless telephony service (Tata Indicom now known as Tata Docomo).

Gautam was recruited to the prestigious Tata Administrative Service (TAS). The TAS is an elite cadre of executives groomed for leadership within the Tata Group (Revenues $105 Bn annually). Gautam was awarded ’50 most impactful smart city leaders’ in 2016 (Global Listing by World CSR Council) (Feb 2016).

Gautam is passionate about golf and flying. Gautam won the Mumbai round of the World Corporate Golf Challenge April 2016

Dr Deepa Arora is Vice President & Global Head of Drug Safety & Risk Management with Lupin Limited. She is a Physician with more than 20 years of experience in pharma industry and academia and has led different functions including drug safety, clinical development, Medical Information, post authorization studies and registries.

She is experience of building & nurturing multi-cultural, talented teams in Clinical Operations and PV. Set up Global Pharmacovigilance Systems for Indian MNCs. She efficiently works with cross-functional teams-- sales & marketing, QA, BD, regulatory affairs and clinical teams globally and handles project management of clinical trials in India, Europe & US.

With a proven track record of successfully turning risks into business opportunities, Deepa has collaborated with GCC to provide inputs for development of Biosimilar regulations and with ICMR for Development of Guidelines for 'Prevention & Management of ADRs associated with antitubercular drugs'.

Deepa has authored of the book "Pharmacovigilance- An Industry Perspective"; 2012. She is a faculty at training institutes for Clinical research and PV, successfully faced multiple authority GVP audits and PADE inspections

Dr Laila Fatima is working as an Assoc. Director - Project management with Dr Reddy’s Labs, Hyderabad. In her current role as a team lead, Laila is responsible for end- to- end planning and driving the formulation R & D projects , primarily oral solids and topical /dermatological generics space for the US and other emerging markets and India. In a career spanning of about 16 years, she has moved into different roles from Academics to Corporate and moving from formulation to core Project management.

She has the experience of managing different kinds of dosage forms for different country filings- which demand a good degree of technical expertise and capability to sort execution- related challenges.

Prior to joining Dr Reddys, she has worked with Sun Pharma and Wockhardt. Laila has done her M.Pharm from Pune University and Doctorate in Pharmaceutical Sciences from BITS, Pilani. She is also a certified PMP from PMI, USA.

Having a blend of techno-commercial skill (amalgamated with vast experience in API process research and development) presently Dr. Pranab Haldar is leading the integrated project management and program management of global projects. He is a sought after speaker on the topics of Project management, Self-management and personal development in addition to being a, mentor “connector” and coach internally at Dr Reddy’s and throughout the research institutes and academics.

After receiving Ph.D degree from prestigious Indian Institute of Technology (IIT), Kharagpur (INDIA), Dr Pranab has joined University of Alabama at Birmingham (UAB), USA as Postdoctoral Research Associate. Post completion of double post-doctorate in USA he returned to INDA and joined as R&D group Leader in DR Reddy’s API division He is also an alumnus of Banaras Hindu University.

Throughout his eighteen years of research (Academic and Industrial) and project management career, he has collaborated with no of eminent professors and industrial leaders in several versatile areas. This global experience and human interactions have driven him to move to pharma project management from the career of scientist.

His work was published in several high impact International journals and patents. Along with inter-continental program and project management, he has served as examiner of PhD thesis for Calcutta University as well as reviewers of no of international chemistry journals. Dr Pranab received “Young scientist” award in 2002 from Indian chemical society and his name was enlisted in Marquis (NJ, USA) “Who's Who in the World” for the year 2010.

Bishnu Bibha Mohanty is a Technical & Certified Project Manager. His career reflects over 18 + years of experience in multiple functions with expertise in all market Formulation Development Project Management, Global Biostudy Planning, Outsourced Projects Management, Regulatory Deficiency Management, API Development Project Management. He Heads the Project Management at Hetero Drugs and was associated with leading Pharma companies like Sun Pharma, Dr Reddy’s, Cipla, Wockhardt & Alkem. He has Successfully designed Multiple Trackers, Reports to understand project progress & constrain at Hetero drugs and is credited for implementation of project management concepts at organisations for the maiden time. He has successfully developed many generic products & having credit of international patent on some of product. Being a technical person his role & contribution in pharms project management is unique. He has successfully established project management department in multiple organizations to support both formulation & API projects.His in depth knowledge of project management tools,product development tracker & other reports design are highly appreciated by his current & previous organization as well.

As a member of Elder Projects, Pratik Sathe is currently responsible for manufacturing API operations covering project management from concept to commercialization and heading a group of R&D scientist working in the area of Process development, analytical development and technology transfer.

He has successfully contributed to the innovative process development activity from concept to commercialization in various product categories like, API Generic molecules, and Oncology (HPAI) covering wide therapeutic range for regulated & non regulated markets.

He is credited for developing API Generics and its intermediates, with customers & supplied those intermediates as well as potential drug candidates. He has scaled up & supplied final products on Non-infringing process to various pharma companies. He has an experience of Handling IPM department and looking after the IP issues related to Generics API, Oncology (HPAI) and CRAMS molecules etc. and has successfully filed several patents in Indian, PCT & USA Patent office.

Prior to Elder Pharma, Pratik was associated with, Parabolic Drugs Ltd, Orchid Chemicals & Pharmaceuticals Chennai, Medicorp Technologies Hyderabad, IPCA Labs Ratlam & Indore

Ravi Gaware has worked in the field of clinical research for about 15 years, across therapeutic indications & with Pharmaceuticals as well as CROs from across the globe. Currently, as Head-Project Management in Boehringer Ingelheim India Pvt. Ltd., and is responsible for complete oversight of clinical trial projects, budget, resource allocation & line mgt. of project managers (PMs).

Starting his career in Clinical Research in 2003, he has worked with global CROs like Quintiles, PPD and Pharmaceuticals like Altana Pharma and has received Excellence Awards & various star awards for the stellar performance. He has been a part of several national and international training programs & seminars in Clinical Research and People management skills in the past 13 years.

Dr. Archana Badhwar is a Ph.D in Biotechnology from National Centre for Cell Science, India's top ranking Institute. With 10 yrs of experience in cancer drug discovery with Piramal Life sciences, currently she is working as the Associate Director, Project Management for NDDS and India Market and also looks after the PM Office at Cipla. She has vast experience in the field of NCE drug development, preclinical research and Competitive Intelligence. In her Past roles, she has been the Project Leader on various cancer discovery programs responsible for strategy to pre-clinical to clinical programs and has commendable list of International publications and patents to her name.

Dr Ujwala Salvi is a Chief Executive Officer, at NUCLEON Therapeutics LLP, Mumbai (India). She is MBA in Finance from Indian Institute of Management (IIM), Kolkata & Doctorate in Applied Biology from Mumbai University, has over 15 years of experience across the Global Pharmaceutical/CRO, Tier I Medical Devices and BPO industry.

She is trained PVOI (QPPV in Pharmacovigilance) for Nucleon, with core experience in a wide range of Therapeutic Areas, and worked at all stages of clinical in development from Phase II to production of clinical documentation necessary for product license applications.

She has worked in large global operations, managed strategic relationships, and played a key role in winning new business, setting up off-shored partnerships and in identifying new BU service lines and growing existing ones.

Her areas of expertise include Pharmacovigilance, Clinical Trial operations, Clinical Data Management and feasibilities of new drug development and Analytics.

She is an industry expert, has been involved in key global industry forums such as the DIA, SCDM, CII and CPHI.

Working with Labindia Analytical Instruments Pvt. Ltd. as General Manager - Research and Development Having more than 25 years of experience in Analytical Instrumentation.

Responsibilities

• Product Design & Development.
• Production, Vendor development, Procurement & negotiation,
• Product Sales, Service Training and Customer Technical Support
• Software development and testing in compliance to Regulatory requirements – 21CFR Part11, EU11, USP, EP, IP, JP.
• Product QA/QC, Qualification, Validation & Application Support
• ISO 9001:2008, CE, UL Certification.
• Projects Successfully Completed - Instruments designed & deployed.

1. Tablet Dissolution Test Apparatus (with 21CFR Part 11 Compliance) – Basic standalone system and Automated Sampling System consisting of Piston Pump technology, Also available with Peristaltic Pump & Syringe Pump technology

2. Sample Processor – Dispensing and Dilution.

3. Automatic Tablet Hardness Tester: Multi-parameter with Width, Thickness, Length, Hardness measurement & Balance connectivity.

4. Tablet Physical Parameters testing: Friability, Disintegration & Tapped Density.

5. Automatic Titrator & Karl Fischer Titrator (with 21CFR Part 11 Compliance).

6. Automatic Melting Point & Range apparatus.

7. pH and Conductivity meters

8. EDC21 – Ethernet Data Capture Software with 21CFR Part 11 Compliance.