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Sudhi Gautam
Doctor, Scientist, Technologist Motivator

A versatile, high-energy Medical Doctor-Bioengineer-Technologist-Educationist with a infectious enthusiasm which brings a lot of fresh positive energy.

www.MedTech Bridge.com


Consulting expertise and interests in:
Blood Device, Artificial Organs
Biomaterials, Blood Devices
Biochips, Biosensors
Medical Informatics, Clinical Trials

Medical Hardware & Softrware Outsourcing>

PROFILE

Dr. SUDHI GAUTAM
Founder & Medical Director
Medtech Bridge
408 569 9521(cell) / sudhi1@yahoo.com

MEDICAL DIRECTOR, MedTech Bridge

***Over 15 years of versatile and unique career progress through various industries including Artificial Organs, Medical devices, Healthcare Technology, Information, Database & Internet Technology, Medical Education, Teaching & Management of Medical research.

*** Doubled revenues to $1.5 million in just 9 months as Medical Director in this medical education company. Initiated and created new medical programs. Designed and developed medical educational/training materials, symposia/seminars and made presentations at International Medical Conferences/Symposia. Reviewed promotional and clinical research materials. Managed budget and P& L responsibility. Initiated the accreditation and licensing of medical programs;

*** Strong Artificial Organs and medical device/drugs experience. Successfully tissue-engineered Biohybrid Artificial Kidney for Acute Renal Failure. Tissue engineering of living porcine kidney proximal tubule cells grown along the inner diameters of hollow fibers; this device is currently undergoing clinical trials.

*** Consultant on Medical Affairs functions with herbal pharmaceutical and medical device companies. Familiarity with pre-IND, IND and NDA requirements. Experience with various phases of device development (preclinical, clinical studies, protocols, safety/functionality of the device). International exposure presenting to business organizations and Review Committees.

Strong Comprehensive general management skills. Conceptualized and developed a solid marketing strategies for product lines. Developed business plans, strategies, studied customer requirements for existing/potential new products for a $ 2 million account. Provided leadership and trained sales personnel.

** Initiated and fostered business relationships with key thought leaders; Managed Clinical Information Specialists; Successfully bridged the crucial gap between Medical Affairs, Regulatory and Marketing. Key interface with thought leaders and HMOs.

Oversaw and managed a staff of over 15 across multiple departments; As the medical director have motivated students, instructors, employees and managed a competent and inspired staff. Excellent field experience and unique presentation skills. Strong people management expertise including analytical evaluation, organization, delegation, team and resource management. Managed conflict.

***Nephrology NRSA award by NIH. . Strong research proposal writing skills. Well-published medical device researcher. Contributed chapters in 2 books and over 10 International peer-reviewed research journals. Have written proposals and been awarded grants by NIH and Council of Scientific & Industrial Research. Have organized conferences/symposia.

Investigated the design and development of membrane-based extracorporeal blood purification devices for the removal of immune-complexes in autoimmune diseases such as Systemic Lupus Erythematosis (SLE). I have a passion for and strong experience in developing new innovative membrane-based medical devices.

***As a Ear, Nose & Throat surgeon, have solid experience in performing various types of surgeries and clinical trials/research/studies. Experienced in Clinical and pre-clinical trials. Knowledge of Good Clinical Practices (GCP) and FDA Guidelines and Regulations. Served as an efficient liaison in a Clinical Trials study on Drug interactions in Diabetes Mellitus.

** Strong experience in Clinical Information Systems, Database and claims codes CPT, ICD-9. Worked on the documentation of a USRDS clinical database, part of the NIH, USA.

** Project Management abilities including analytical evaluation, organization, delegation, team and resource management. As the administrative head of an oilrig, motivated employees and managed a competent and inspired staff. Managed conflict.


WORK EXPERIENCE

MEDICAL DIRECTOR, MedTech Bridge, Milpitas, CA 2004- Present
CONSULTANT & ADVISER, GIRVAN Tech Incubator

MEDICAL PROJECTS MANAGER, SSCI, San Jose                                                2003-2004

·         Principal interface with the customer.  Key leadership position. Managed client relationships.

·         Quick technology assessment, presenting company capabilities to prospective clients, writing compelling proposals and closing project sales. 

·         Collaborative, creative and easy to work.  Responsible for coaching, motivating and recognizing individuals.  Project/people management abilities to drive product decisions.

·         Self-starter, independent with strong analytical and excellent interpersonal skills.  Motivated creative and out-of-the-box thinker. Quick learner effective in a rapidly changing environment.

 

MEDICAL DIRECTOR       US Education, East Bay, CA                               2002- 2003

·         Presently in a leadership role as the department director of medical in a vocational medical training institute. Current responsibilities include development and coordination of medical education programs, identifying and recruit teaching faculty, externship co-ordinators, budgeting and developing good student-friendly study habits. Supervising 15 direct reports. Specifically responsibilities include:

·         Providing vision and leadership for a diverse, dynamic and innovative community of faculty, staff and students. Interviewing, hiring, training and evaluating faculty and staff.

·         Supporting a climate that promotes innovation and improved service and develop processes that are student-friendly and supportive of student success.

·         Assisting in the development of partnerships with hospitals and healthcare centers such as Highland, Summit, Alta Bates, Kaiser Permanante and others.

·         Developing new program ideas that fit the college's strategic needs and interests. Work with junior staff to help them grow towards greater responsibility.

·         Provided direction, planning, execution of medical and biotech programs. Ensured budget, scheduling, staffing, and performance requirements are met.  Served as medical monitor, providing medical oversight for program(s) and review.  Provided medical expertise and assisted Sales/ Marketing in commercializing new programs. Contributed to the preparation and implementation of specific training programs for internal and external staff.  Strong people management skills including recruiting high caliber candidates, developing employees, creating teams, communicating performance.

 

CEO, ZEPHYR INFORMATIX INC, Union City, CA                                         2001-2002

·         Developed business plans, strategies, studied customer requirements for existing/potential new herbal pharmaceutical products for a  $ 3 million account (Herbalworldwide Inc). Analyzed market intelligence on competitive product offerings to provide information on market segmentation, market share, customer perceptions and international market trends.

·         Strategic pivotal role in global product launch. Represented  the company’s views as primary spokesman on clinical development, strategy, and study results. Developed and responsible for a team to conduct all phases of clinical development. Presented and defended  the company’s clinical strategy. Played a clinical/scientific leadership role.

·         Prepared and delivered presentations at trade shows. Reviewed product labeling to ensure information is appropriate for intended audience. Provided marketing and technical support at trade show and conventions. Created users groups conducted users’ meetings, workshops and panel discussions. Excelled in utilizing various forms of electronic medium including the worldwide web for promotional activities.

 

Sudhi Gautam …..408 569 9521/sudhi1@yahoo.com                                                                   page 3 of 4

 

BLOOD RESEARCH EXPERIENCE

Researcher, Nephros Therapeutics and University of Michigan, Ann Arbor                  1996-1998

·         Accomplished the pre-clinical research evaluation and animal studies for a NIH project on extracorporeal devices. Responsible for the design of a safe and effective extracorporeal system for deheparinization of blood using a hollow fiber membrane system for application during cardiac surgeries and hemodialysis. Involved in all stages of clinical research that involve design, implementation and conduct of preclinical and clinical trials including protocol/study design,  selection of and communication with investigators/study sites,  safety assessment, data analysis,  preparation of study reports, and materials for regulatory agencies.

 

·         Accomplished pre-clinical research evaluation and testing of the safety and functionality of a bioartificial renal assist device, a hemofilter seeded with cultured and gene injected proximal tubule cells, on several uremic dogs. Wrote grant proposals and was awarded NIH fellowship in Nephrology by the NIH. Evaluated the hemocompatibility of a membrane-based device.

 

Doctoral Research, Indian Institute of Technology, Bombay                                            1990-1995

·         Ph.D. research focused on new therapeutic modalities of blood manipulation for treatment of specific human disease states unresponsive to conventional therapies. Investigated the design of disease-specific immunoapheretic device using membrane technology. 

·        Advocated hemorrheological fingerprinting as a sensitive monitor of hemocompatibility and the safety of blood manipulation process. Taught cardiovascular and clinical hemorrheology to graduate students and doctors. Managed resources, staff and a biomedical lab, directed several research projects and taught graduate engineering students during this time. Wrote proposals and awarded grants.

 

CLINICAL INFORMATION SYSTEMS EXPERIENCE

Database Administrator, XUMA Inc, San Francisco, CA                                                 1999-2001                                      

·         Business coordination with clients in this ASP startup of 450 employees.

·         Created the group’s mission statement and vision.  Developed database standards & policies. 

·         Researched new technologies and their marketability. Strong team playing and delegation.

 

Clinical Reporting Analyst, Oceania Inc, Redwood City, CA                                          1998-1999

·         Reporting of computerized patient records on Crystal Reports and design of databases. Oceania developed healthcare administrative and patient management systems for HMOs such as Kaiser Permanante.

 

HEALTHCARE WORK EXPERIENCE                                                              1983-1989

Healthcare Organizations                                                                                               as M.D

·         Clinician- Surgeon: As an ENT surgeon and head resident doctor in Ear, Nose and Throat surgery in B.J.Wadia Hospital for Children, Bombay, managed the whole department. Effected the smooth functioning of the operating, emergency rooms and outpatient facility. Planned and carried out community health awareness programs. Led weekly staff meetings.

·         Heavy  clinical experience (protocol development, study site selection, data review and analysis, regulatory interface, etc.) and hematology knowledge.  Oversaw  Clinical Operations, monitoring,  Safety Assessment,  Clinical Research, Medical Writing.

·         Medical Officer: As a medical officer in Essar Gujarat Ltd., was the general administrative manager and head of the entire staffs that numbered around 70.  I was incharge of the overall management of the day-to-day work of the oilrig camp including general administration.

 

Sudhi Gautam …..408 569 9521/ sudhi1@yahoo.com                                                    page 4 of 4

 

 

SELECT PRESENTATIONS IN INTERNATIONAL CONFERENCES

9th Intl Conf on Biorheology/II Intl Conf of Clinical Hemorheology, Big Sky, MT, 1995

·         `Can the anomalous behavior of human blood be exploited to characterize biomaterials?'

·         ` A study of hemorheological, hematological & biochemical parameters in renal failure'

·         ` A study of membrane blockage, evaluation & monitoring of plasmapheresis'

American Institute of Chemical Engineers' National Summer Meet, Boston, 1995.

·         `Membranes in the therapeutic management of diseases with circulating immune complexes’

·         `Separation of cutting oil from simulated oily effluents using ultrafiltration: a new model to predict the permeate flux'.

International conference on Particle Science & Technology, Pune, 1995

·         `Particle size characterization of circulating immune complexes for separation by a membrane-based extracorporeal device’ at the Engineering Research Foundations'.

 

 

SELECTED PUBLICATIONS & BOOK CONTRIBUTIONS

1.       Sudarshan Gautam & David Humes (2001) “Renal Replacement Therapy” in “Handbook of Cell Encapsulation Technology and Therapeutics”,  Willem Kuhtreiber [Ed] pages 287-299.    

2.       Gautam, S.K., Kamat, M.V., & Basu, S (1995) “Is There a Case for Hemorheological Screening in the Hemocompatibility Testing of Biomaterials?” Biomedical Materials & Engineering  vol.  5:3, pages 141-149, Pergamon Press.

3.   Gautam, S.K. & Pandya, V. (1998) “Crossflow microfiltration of blood by an extracorporeal

      device-a study in parameterization” Transfusion Science   Vol. 18 : 2.

4.       Gautam, S.K.(1996) “Studies in the Development of Membrane-Based Extracorporeal Devices for the therapeutic management of Diseases with Circulating Pathomolecules” in 

      “Biofunctional Membranes” Allan Butterfield [Ed.] pages 237-258, Plenum Press.

5.       Gautam, S.K., Jindal, S., Kudva, C & Basu, S. (1995) “Exploiting Temperature-Dependence to improve Selectivity in Membrane-Based Plasmapheresis” Transfusion Science  Vol 16 : 2,

      Elsevier Science, Exeter.

 

 

PROFESSIONAL  & RESEARCH ACCOMPLISHMENTS, HONORS, AWARDS

·         Large animal testing and evaluation of a Bioartificial Renal Assist Device.

·         Research on development of membrane-based devices for therapeutic blood manipulation.

·         Screening of human blood for hemocompatibility evaluation of biomaterials and implants.

·         Taught various invited courses in medical and engineering schools in universities.

·         National Research Service Award in Nephrology, NIH and Research Grants by CSIR.

·         Chapters in 2 books and publications in over 10 peer-reviewed International journals.

 

TECHNICAL AND SOFTWARE SKILLS

Oracle Products:             RDBMS 8i,8.0.5, 8.0.4   OEM,  SQL Plus, Server Manager,

Operating Systems:        Unix OS, DOS, WindowsNT 4.0, and Windows 95/98

Reporting Tools:             Oracle Reports 2.5,  Seagate Crystal Reports

Other Products:              MS powerpoint,   Outlook Exp, MS Access, ERwin,VISIO,

Programming:                 Korn Shell programming, SQL, SAS, Excel


Oil
Watercolor

Email me at: sudhinet2002@yahoo.com