Satish Khanna, a Chemical Engineer by academics, Ex Group President of Bilakhia Group (Micro Inks, Mitsu Industries) and Lupin Ltd is a professional turned mentor to upcoming entrepreneurs.

Has professional experience spanning over 40 years covering Multinationals, large Indian conglomerate groups and upcoming fast growing young companies. While in professional career he has handled direct corporate responsibilities in functions like Manufacturing, Works Management, Human Resource Management, Long term Strategic Planning, International Business development and Mergers and Acquisitions.

Satish Khanna has created global leadership position in chosen business activity while in Mitsu Industries and has scripted an unprecedented turn around story in the field of API business whilst in Lupin Ltd.

He is now busy working with around a dozen young aggressive Entrepreneurs to create future valuable business entities.

Earlier he has brought Six large Indian Pharma companies (Annual Sales approaching 10 Billion $) on a common platform to Co-create Operational Excellence through an initiative LAZORR, leveraging his net-working abilities.

He has also authored three books that include ‘The Future Manager’ and “Dreamaction” both published by McGraw Hill and “The Rising Indiaprenuer” published by Mac Milan.

Alumni of Punjab university, Chandigarh, IIM Ahmedabad, IMD Lausanne, Harvard Boston, INSEAD Fontainebleau and Sophia Tokyo.

Satish Khanna is now a mentor, advisor and also an active investor. He also is a part of the Strategic Advisory Board of many companies in India and abroad.

K Anand is post graduate in Analytical Chemistry by training from University of Bombay. He has been a senior Pharma Industry professional for over 35 years in the area of Quality and Regulatory Affairs.

K Anand has risen from ranks in Quality, and has been instrumental in setting up International Quality standards from the start-up phase in large reputed Pharma companies like Lupin, Glenmark and Famy Care (now Mylan). He also has the distinction of integrating Quality and Regulatory Affairs functions in Glenmark, Famy Care, Cadila Healthcare (Zydus) and Dr Reddy’s Laboratories which has paid rich dividends in efficiency of filing DMFs, ANDAs, Deficiency management, adoption of QbD approaches in development/scale up besides upgrading the Quality Management processes.

He has led large teams in all these Companies to successful regulatory inspections (US, EU, MCC, TGA, ANVISA, WHO Geneva….etc) on several occasions and has built robust and sustainable compliance ethics, data integrity policies, continuous improvement of cGMP systems. He has immensely contributed to the development of skill level of subordinates/teams to meet the challenges of ever changing/evolving GMP systems. He has deep understanding of complexities in related functions of Pharma business like Development, Manufacturing, Marketing/customer expectations, which helps in taking a 360 deg approach to finding solutions to complex problems.

K Anand’s core competence has been to evolve QbD approaches during Development & Regulatory Filing of Dossiers, Efficient deficiency management, Life cycle management of products, Good Laboratory Practices implementation, Development of robust and sustainable Quality Management Systems, preparing facilities for “Any Time Readiness” of Regulatory inspections, post inspectional Remediation plans for implementing CAPAs, People development for competency build up.

K Anand enjoys great respect within Pharmaceutical industry in India for his contribution to team building, transparency in GMP, ability to liaise with Regulators effectively on handling complex problems. He has also earned credibility with International and National Regulatory agencies for effective liaison for the cause of product Quality and GMP systems.

Mahesh Kulkarni holds Masters degree in Microbiology with over 25 years of experience in Pharmaceutical Industry of high reputation such as Johnson & Johnson, Baxter Healthcare, Biological E, Hospira and Dr.Reddys Laboratories. He has wide exposure in the area of Quality and Regulatory, Technology Transfer and Technical Operation functions of APIs, Formulations, Injectable products, Medical Devices and Biologicals / Vaccines Industries in India and abroad.

He has vast experience / expertise in Green field project management from technical standpoint to ensure that Validations, Qualifications, QMS readiness, are undertaken efficiently with minimum risk to regulatory compliance expectations. He has in-depth knowledge and experience in designing and bringing up Quality functions of site/s for Pharmaceutical formulations, Injections and biologics / vaccines with required bandwidth, to meet regulatory expectations which include preparation of high level Blue Print and road map intended for the top management in the language of working plan that drives flawless execution on the floor - “One plan concept”.

Hands on experience in preparation of the entire organization for successful PAI, through top down approach and SME preparedness. Hosting regulatory inspections and creating pool of SMEs who can drive future inspections for the plant/s. This includes formation of Cross Functional Teams at organizational level to support execution of submission / clinical batches and provide leadership in various regulatory dossier submissions like NDA, DMF, ANDA, BLA.

Has championed design of pre-clinical and clinical strategy and packages to ensure that each milestone is backed up with requisite plan B to swiftly change gears during product development and commercialization life cycle.

Mahesh has led the entire remediation life cycle during Warning Letters / Import Alert situations starting from crafting the remediation plan to bringing site/s back to Approval status of large Organizations. Championed more than a dozen critical regulatory responses and status updates, got the re-inspection conducted within 12-18 months, and got EIRs issued successfully.

He also has proven leadership in Techno-commercial Area in his career where he has demonstrated three fold capacity enhancement of vaccines for a niche vaccine with minimum additional investment, through effective liaison (Single Point Accountability) with Indian and international regulatory authorities which contributed to 3 fold increase in top line revenue and 4 fold rise in bottom line.

Mahesh has worked with Indian regulatory authority to make necessary inclusions in retain sample requirements of all medical devices which gave upside of US$ 2.1 million annually in bottom line of the business, while working with American device manufacturing company.

Mahesh has expertise in Quality Culture Transformation at Organizational level. He is founder of talent management initiative, “Quality Leadership Development”. He is currently working as an expert in Parenteral products at Indian Pharmacopeia Commission. He is an associate member of IMDRA and an empaneled member for Indian NRA Inspectors (DCGI/CDSCO) on Risk “Based Inspections”.

Sanjeev Khanna, graduate in Commerce and Chartered accountant from ICAI having senior level cross sectional industry exposure, in large Indian and Multinational companies, FMCG, Engineering, Distribution and Speciality Chemicals.

Having strong managerial background and progressive experience.Last worked as CFO of listed company. During his professional career he worked with large companies like Shaw Wallace, MAN (German Engineering Company), Bharti and Pepsi.

Having three decades of experience spanning the entire gamut of finance like Audit, Treasury, Mergers & Acquisitions, financial planning, leadership for a project team, strategic initiative and handling commercial aspects of business.