Qualification:

MBBS (Mumbai University)

Work Experience:

Previously:

1) AS MEDICAL OFFICER (1990 till 2009)
Worked in the Thoracic Surgery Department of G.T.B. Hospital Sewri as a Surgical MO since 1990.

Was involved in Pre-Operative, Intra Operative and Post Operative management of the patient who has under gone Surpa-Major Thoracic Surgery at GTB Hospital.

2) AS CHIEF MEDICAL OFFICER (2009 to March 2018)
In charge of the Thoracic Surgical Department. This is an Administrative post.  
Role is to work out logistics and administrative coordination with the higher up authority to deliver the best for the patient.

Also involved with the Pre Operative, Intra Operative and Post Operative care of the patient who has under gone Surpa Major Thoracic Surgery in GTB Hospital.

Types of surgery done are Supra Major Thoracic Surgeries on patients having complication of Pulmonary TB
a) Pneumonectomy
b) Lobectomy
c) Decortication
d) Thoracoplasty
e) Neck Blok Dissection for Extra Pulmonary TB.
f) Minor surgical procedure like Insertion of Intercostal tubes, Pleural tapings and Biopsies
g) Diagnostic procedures like Bronchoscopy  

Thoracic Surgery had come to a standstill in 2006 due to no doctors available (all had retired). Hence to keep this department running, it was with great efforts that the retired surgical team had to be brought back to restart the rare Supra Major Thoracic Surgery which played a very important role in treatment of failure cases of Drug Resistant TB.

He was actively involved in restarting the shut down Surgical Unit of GTB Hospitals in 2012.  

Apart from the above he was also administratively in charge of the Pharmacy / Medical record department.  

Added to this the Maintenance department was also under him.

3) AS MEDICAL SUPERINTENDENT (Apr 2018 till Dec 2020)
Administratively In-charge of the entire Hospital.

Site Principal Investigator for the short course BEAT Trial conducted by ICMR (recruited patients in the shortest possible time).

Encroached the GTB Hospital team for faster recruitment of patients in Bedaquillin program.

Other Qualification:

PROFESSIONAL DIPLOMA IN CLINICAL RESEARCH – 2004

As an experienced Clinical and CRO research Professional, Dr. Lalit Anande has a rich and diverse experience both as a clinician and a researcher. He has an in-depth exposure to a wide spectrum of activities associated with the successful completion of BA/BE trials catering to various Regulatory body’s like FDA, EMEA, ANVISA, WHO, MCC, AFFASPS etc.

He has served in various capacities in a number of pharmaceutical industries carrying out clinical trials for various drug targets for diseases like Diabetes, Hypertension, Tuberculosis, Hyperlipidemia, Epilepsy, H I V, Immunomodulators, etc. conforming to the GMP/GLP norms and ethical guidelines. He has put in nearly 24 years in this industry and CRO focussing on Bioequivalence and Bioavailability studies are his forte.  

Extensive knowledge of Protocol Designing and submission of Ethical committee approval reports.  

Knowledge of compliance with applicable regulatory requirements like confidentiality agreement, protocol acceptance, roles and responsibilities, grants and payments etc.  Training of staff in current GCP norms.

Overall management of the entire trial catering to all the issues related to subject enrolment, consent forms, dosage, scrutinizing of pathological and blood samples and also adverse events if any.  

Management of entire Trial for conduction of Osteoarthritis in coordination with Rheumatologist.  

Helping with audits and financial management.

Maintaining two-way flow of information with the sponsors of the trials and successful attainment of goals for CRO’s.  

Apt at ensuring confidentiality of trial subjects and integrity of trial data throughout the course of trial and thereafter.

Screening, Recording ECG, Handling emergencies and adverse event monitoring during conduct of the Study.

Compilation of raw data and related documentation and Medical care of the Study subjects have also been the areas of work.

PROFESSIONAL EXPERIENCE AND SIGNIFICANT ACHIEVEMENTS

1. Medical Director (2009 to 2014) –
STANDEV RESEARCH Pvt Ltd Chembur Mumbai

2. Head Technical Operations (Dec 2007 – 2009) –
Ace Biomed Pvt Ltd, Powai, Mumbai, Maharashtra, India

Heading an integrated team delivering Clinical trials including Bioavailability / Bioequivalence studies. Establishing new contracts with Pharmaceuticals (domestic and international), monitoring programmes, gathering right resources for the contract in terms of staff and operatives, health and safety issues of subjects and successful delivery of projects.  

Responsible for all commercial aspects of new contracts including initial negotiations and tendering.  Built a sound construction team that worked for both the client and business.

3. Co-Investigator (Jan 2006 – Dec 2007)
Bombay Bioresearch Centre, Govandi, Mumbai, Maharashtra, India

Part of a team responsible for clinical operations at forefront. Upgrading the team members in GCP norms.  

Improving protocols for trials involving BA/ BE

Adhering to the functional responsibilities of Co-investigator as per GCP.

4. Consultant (Dec 2005 – Feb 2006) –
Macleod’s Pharmaceutical Ltd., Andheri, Mumbai, Maharashtra, India

Upgrading and implementing current trends of BA/ BE studies. Also, upgraded the system of clinical operations for delivering projects efficiently. Optimising the need of Phlebotomist and medical team in clinical operations.

5. Principal Investigator (Jan 2005 -March 2007) –
Clinisearch Pvt. Ltd., C.B.D Belapur, Mumbai, Maharashtra, India

Leading a team of medical professionals involved in clinical trials. Promoted Good clinical practices in the conduct of clinical investigations.  

Demonstrating the proper education, training and experience to conduct clinical trials.  
Ensuring Protocol compliance by assuring overall protocol feasibility.
Ensuring initial and ongoing review by duly constituted Ethics committee.
Determining adequate resources are available to conduct the study. Managing the medical care and rights of the subjects.
Directing Site operations and maintaining professional and technical knowledge.

6. Principal Investigator (Dec 2004 – June 2006) –
Sitec Laboratoires Pvt Ltd (Vikhroli, Mumbai, Maharashtra India) CRO belonging to Cipla Pharmaceuticals

Responsabilites as above

7. Medical Director (Dec 2004 – Aug 2005)
Ashco Laboratory, Division of Ashco Industries Ltd Andheri, Mumbai, Maharashtra India

As a Clinical leader of medical group and technical staff, developed and implemented policies, procedures and best practices. Assured the facility is in compliance with all national, state and local regulatory norms.  

Recruiting staff to maintain system of clinical operations.
Maintaining consistent quality of care to staff members and subjects participating in trials.

8. Principal Investigator Dec 2000- Dec 2004
Medlar Laboratories Pvt Ltd.,Vikhroli, Mumbai, Maharashtra India

In addition to the responsibilities mentioned above, mandated the procedures for clinical staff to actively participate in group discussions and presentations.

9. Asst Medical Director Sep 1990 – Dec 2007
Therapeutic Drug Monitoring Laboratory Sion, Mumbai, Maharashtra India

As a team member involved in clinical trials since its progressive phase. Actively developing and imparting training to research professional and medical staff on developing regulations.

10. Head Technical Operations Dec 2007 Jan 2010
Acebiomed Pvt Ltd, Powai Maharashtra Mumbai India

In charge of the overall technical operations of the CRO which conducted Phase 3 and 4 trials.

PRESENTLY

Sr. Medical Advisor & Pvt Health Practitioner

OCCUMARINE HEALTH CLINIC https://occumarinehealth.com/
API House, Plot No-98/B, Sector -15, Near Electricity Sub-Station, CBD Belapur, Navi Mumbai, PIN 400614

Specialty in Drug Resistant TB & its complication conducting ANTIOXIDANT THERAPHY.

ACHIEVEMENTS

Selected as MUMBAI HEROS by Mumbai Mirror of Times group in 2017  
Awarded by Hon Governor of Bihar an award for Philanthropic work in field of Tuberculosis on Doctors day in 2018  
Invited at various forums and collages (Mumbai /Maharashtra & other States) for a guest lecture on the subject of Tuberculosis  
Special Guest on a National TV show TICKING TIME BOMB SATYAMEV JAYTE in 2014.