Kamal Shahani, Managing Director, Cliniminds
Over 25 years of senior business leadership and consulting experience in healthcare & life sciences, clinical research, pharmacovigilance, business analytics, skill development, education & training industry.
Worked on senior management positions with Allied Research-Cetero US and India as Director-India and Consultant – Miami; Gribbles Pathology Australia as Director India; Dr. Lal PathLabs as General Manager and Australian Trade & Investment Commission as Business Development Manager, India for Healthcare vertical.
Have strong experience in business development, setting up and running green field projects in healthcare services, medical devices, diagnostics and clinical research, pharmacovigilance, business analytics industry in India and North America. Have worked with several global medical devices, healthcare and life sciences companies on their India market entry strategy.
Dr. Sandeep Bhatia, Medical Director & Senior Partner – Healthcare & Life Sciences – Director of Health Sciences Education & Training, Cliniminds
Dr. Sandeep Bhatia is Medical Affairs & Clinical Development leader with 15 years of Pharmaceutical experience.
Dr Sandeep has worked extensively in field of Oncology Medical Affairs and headed Medical Affairs department for Global Pharmaceutical companies. He was the Head of Oncology Medical Affairs for MSD India and also led Medical Affairs team for Roche, India. Apart from this he has gained significant experience by working in companies like Novartis , Sanofi & Mylan.
He has been strategic fuel behind rise of many big brands and business unit. He was amongst the first Pharmaceutical physician to talk about Immuno-Oncology and Immune Checkpoint Inhibitors in India.
Hands on experience of various facets of healthcare sector have proven his entrepreneurial skills and now he is a Medical Director & Senior Partner in Think-I as first generation entrepreneur.
By qualification Dr Sandeep Bhatia is a trained ENT and Head & Neck Surgeon and has clinical & surgical experience in Oncology.
Strengths : Ideation, Strategic, Achiever & Restorative.
Dr. Suneet Sood, MS (General Surgery) – Medical Advisor - Cliniminds
Dr. Sood completed his Medical Graduation (MBBS) from AIIMS, New Delhi in 1978 & Master’s in General Surgery (M.S.) from AIIMS, New Delhi in 1982.
Currently he is Clinical Associate Professor of Surgery, Faculty of Medicine, Jeffrey Cheah School of Medicine and Health Sciences, Monash University, Malaysia.
Dr. Sood comes with strong academic background. Some of his past positions are
Professor of Surgery, Faculty of Medicine, Universiti Teknologi MARA, Shah Alam, Selangor, and Consultant, Department of Surgery, Hospital Selayang, Malaysia.
Reader, Department of Surgery, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi
Professor, Department of Surgery and Head of Gastrointestinal Surgery services, Himalayan Institute of Medical Sciences, Dehradun, India.
Rajesh R. - Business Analytics / CI / HEOR
Rajesh R. has 14+ years of experience in Healthcare/Lifesciences Management consulting (Business Analytics, HEOR, Competitive Intelligence, Forecasting, Sales Force Effectiveness and Market Research) in healthcare and pharmaceutical industry including with leading business analytics and pharmaceutical companies.
He has hands-on experience of working with Top 15 global pharmaceutical companies in the areas of Competitive Intelligence and Market Research. He has been key in business development efforts in the pharma consulting domain.
He has developed keen interest in ever evolving Life Sciences & Healthcare technology and business landscape and how it can be leveraged to improve commercialization and consolidation for pharma players. Conducted several domestic and international workshops.
Dr. Devesh K - Director - Clinical Operations
Dr. Devesh is a seasoned clinical research professional and has successfully launched various organizations for different industries.
He is Meticulous, goal-oriented professional with hands on real time experience of End to End Clinical Trial Project Management, Data Management and Business Development for Clinical Trials. . Worked on more than 100 global and domestic trials and is an effective communicator with excellent relationship management skills, problem solving and organizational abilities.
A keen strategist with the ability to understand and articulate key opportunities in ever changing research industry. He has great proficiency in planning, organizing, executing & training subordinates on protocol based management and conduct of clinical trials.
He is a medical graduate and posses post graduation diploma in clinical research and certification on FDA IND and NDA approval process from FDA smart. His immense vast experience of more than a decade in industry brings a variety to Thinki for all research processes and trials.
Dr. Sheikh - Consultant- HEOR
Dr. Sheikh is a Medical Graduate and Masters in Public Health (Health policy, Economics and Finance).
He has vast experience of Health Economics both in working for State Health (Government) and Global MNC Pharmaceuticals.
His Areas of Expertise:
Health Policy and Planning and Analysis
Health Systems Research
R Programming language
Dr. Anu Dambalkar - Senior Drug Safety Physician
Senior Drug Safety Physician with over 7 years of pharmacovigilance and 3 years of clinical experience.
Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs); Periodic Adverse Drug Experience Reports (PADERs); Addendum to Clinical Overview (ACOs); Health Hazard Evaluations (HHEs)
Experienced in Case Analysis for Ad Hoc reports and Surveillance Analysis of Non Spontaneous Safety Data for PharmacoVigilance (SNAP)
Experienced in conducting medical review of PBRERs/PSURs, PADERs, HHEs, Ad Hoc Reports, SNAP and Safety Management Team (SMT) Slides which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments
Trained in Monthly Signal Reports and Drug Abuse Report for FDA
Maintaining a knowledge of the AE safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients’ procedures and international drug safety regulations. Maintaining an awareness of global regulatory reporting obligations.
Experienced in conducting medical review of PBRERs/PSURs, which includes checking the case for overall medical cohesiveness, checking the expectedness of adverse events, adding company causality and company comments.
Rahul Malia, Head – Placements & Corporate Business Development
A result oriented Professional with verifiable success of 22 years with insightful
experience in All India Sales & Marketing, Business Development & Distribution Management
of Pharmaceuticals/Chemicals/FMCG and Education Industry. Extensive experience in
exploring and developing new divisions, new markets, field force, C & Fs, dealers,
accelerating growth & achieving desired sales goals. Always an out-of-the-box thinker
with a proven track record of augmenting revenues, streamlining workflow and creating
team work environment. Stupendous communication & analytical skills, honed with
the ability to liaise at all levels of management. He is Bachelors in Science form
Delhi University and holds a law degree from Delhi University.
Presently heading Placements Department of Cliniminds students pan India and also
responsible for Corporate Business Development. In Cliniminds job involves analysing
markets to identify unmet corporate needs of companies and develop strategic plans.
Always ensures optimal implementation of these plans to achieve organization objectives.
Dr. Veepra Singh, Head – Academics & Faculty-Clinical Research at Cliniminds
Dr. Veepra,is a registered Dental graduate (BDS) from Lucknow. She has completed her Master’s in Community Medicine & Public Health (MPH) from Lucknow, and is a clinical Research Professional with over 9 years of experience in both national and International clinical trials. She possesses excellent communication skills along with clarity of fundamentals with perseverance to succeed.
She is a part of Cliniminds as the Head – Academics & Faculty-Clinical Research at CLINIMINDS (Institute of Health Sciences Training & Management) since July 2015.
The key responsibility areas includes management of Academics at all Cliniminds centre (India & Global), developing and updating training modules and content for Clinical Research and delivering training programs.
Prior to her role in Academics, she has worked for global clinical trials for pharmaceutical giants like Astrazeneca, GSK, Sanofi Aventis, Zydus etc. She also has good working knowledge of ICH-GCP, Sch-Y, USFDA, and various regulatory requirements in clinical research. Global clinical trial experience & good understanding on all Phases.
She has successfully cleared many audits and inspection by sponsors and regulatory bodies like DCGI.
Strong Project & People Management experience. Strong believe in creating environment for the growth of the team members by hard work and professional commitment & passion for success.
She has a broad background in clinical trial management of phase III and IV drug trials, managing projects & study teams right from start-up to close-out in various specialization in following therapeutic indications: - Oncology, Cardiology, Endocrinology, Ophthalmology, Pulmonology, Dermatology, Oncology, Surgery (done trials on abdominal infections, Allergic rhinitis, Vernal Keratoconjuctivitis, metastatic breast cancer, head and neck cancer, UTI infection to name a few). She is specialized in on-site data management and collection, patient recruitment activities.
Meeting client expectations on projects has always been priority agenda of her work during these last years.
Dr. Veepra has also successfully conducted almost 40 GCP &35Ethics Committee workshops and has trained over 4500 students into Clinical Research. She has also been invited to deliver lectures and conduct workshop/ seminars at various institutes and universities.
She also holds certification in IPR, Patents and Good Clinical Practices (E6 (R2))
She brings with her good management and administrative skills with experience as an outsource Auditor, along with a book on Glossary of Clinical Research and Ethics in Clinical Research.
KULDEEP KINJA, completed his Bachelor of Pharmacy from M.D University, Rohtak after which he completed his Master in Pharmacy with Pharmacology from NIMS University, Jaipur.
He started his career with Wipro Ltd as Pharmacovigilance Officer in Drug Safety Department. He is having more than 8 years of industry experience in different Pharmacovigilance processes with global companies. He has expertise in end to end Pharmacovigilance processes, trainings, operations and people management such as collecting, handling and processing Individual case safety reports (ICSRs) in different safety databases like Argus, SafetyEasy along with MedDRA coding and narrative writing, aggregate reporting, signal detection, risk management plans, talent acquisition& backfill, maintenance of training files, liasoning for client training, preparation & maintenance of training plan & requisite material, Client & Business Reviews, Internal & External Audits, SOP (Standard Operating Procedure) & BCP (Business Continuity Plan) Management, Client Reverts & Observation Handling, deviation handling &CAPA (Corrective & Preventive Actions) closures, Bottom Quartile Management (BQM), Quality Initiatives, Reconciliation Reports & Invoicing, Calculation & Maintenance of CPMs (Critical Process Metrics), Shift & Roster Management, Attrition Management, Quality Initiatives, Lean and CI projects, preparing and reviewing documents like QMP, SOPs, WI, DMP etc in Pharmacovigilance, imparting training and preparing training materials, audits and inspections (readiness, handling and post audit/inspection response completions), regulatory guidelines, pre-sales and client mining.
He is currently working with Tenet Health Edutech Pvt. Ltd. as Pharmacovigilance Trainer and Consultant and his key responsibilities includes developing modules and training material on pharmacovigilance as per the ever evolving changes in regulatory and industry guidelines, delivering end to end pharmacovigilance training, participating in business development activities related to any opportunities in pharmacovigilance domain.
Mr. Amit Dattatraya Nakhe
Mr. Amit is an energetic professional with sound academic background in Bachelor of Pharmacy and Post Graduate Diploma in Clinical Research. He is a highly motivated, efficient Lean Six Sigma Green Belt certified professional with a total 14 years of work experience in life sciences domain.
Mr. Nakhe has hands on experience of new process start up, transition and process improvement projects. He also has successfully faced both external and internal audits and inspections (MPA, MHRA and USFDA) on various occasions.
He possess excellent communication and collaboration skills to lead and the ability to work in diverse groups effectively. He has performed roles like Process Executive and team lead.
He is currently working as a Faculty at CLINIMINDS (Institute of Health Sciences Training & Management) and is responsible for developing and updating training modules and content for Clinical research &pharmacovigilance, Delivering training programs etc.
Mr. Amit has been associated with Watson Pharma Pvt. Ltd. & Macleod’s Pharmaceuticals as a CRA and was responsible for coordinating clinical studies in CRO units.
He also worked for Tata Consultancy Services for approximately 10 years, managing large teams in Life Sciences Division with hands on experience in Pharmacovigilance/Patient Safety for 2 big pharma clients. He has worked on Sapphire (Patient safety database) and Argus.
Mrs. Soja Jacob, a post graduate in Biotechnology, is an enthusiastic Clinical research professional with 5+ years working experience.
Soja has experience in Clinical Research Coordination, administration and management and project management support. She has the ability to support and manage the tasks of multiple clinical research studies and has an excellent working knowledge on the site operations. Mrs. Jacob has extensive experience in managing multi-centric trials (Indian & Global) not limited to: Feasibility, start-up, Site selection, Initiation, Monitoring, Close-out, Budget approval, Sponsor & Site communication, patient recruitment & retention services.
She also has experience in the training of students who wish to work in the clinical research field. Soja has a creative and positive outlook and makes learning smooth, interactive and easy to remember.
She is an expert in SDV, CRF review, and managing site master files.
Soja also has experience in handling eCRF such as Medidata RAVE, Oracle RDC, Oracle Inform, Medrio EDC, Clinion etc. She possess thorough understanding of global regulatory requirements.
Soja has developed SOPs for sites. Achieved certificates in Good clinical practice and for EDC use.
Gaurav Grover - General Manager
M.Pharm, seasoned Pharma Professional with over 19 years of industry experience to lead complete range of Pharmacovigilance (PV) Processes, Quality Assurance (QA) & Audits, Training and Clinical Research at Major Pharmaceutical corporations.
Extensive experience in ICSRs, Aggregate Report Writing, Literature Search, Risk Management Plan, QA, Audits & Inspection Preparedness, HAS tracking etc.
Extensive experience on major safety databases, viz. Argus and ArisG.
Worked as Deputy General Manager, Global PV Practice, Digital Ops – LS Delivery; Pharmacovigilance Manager, GDD & PS | NOVARTIS HEALTHCARE PRIVATE LIMITED; Consultant, Quality Projects Quality, Compliance and Training| APCER PHARMA INDIA LIMITED; Manager, Pharmacovigilance, Regulatory Affairs | ALCON LABORATORIES (INDIA) PVT. LTD.; Senior Research Scientist, Medical Affairs and Clinical Research | RANBAXY RESEARCH LABORATORIES LIMITED