Senior Product Development Consultant & Contractor
May 2015 to Present
Asahi Kasei Pharma America Corporation
President Product Development & Chief Medical Officer
September 2011 to April 2015
President & Chief Medical Officer
June 2009 to September 2011
Vice President, Clinical Development, Medical & Regulatory Affairs
August 2006 to June 2009
Abt Associates Inc.
Division Vice President, Abt Associates Clinical Trials
1998 to 2006
Vice President, Clinical and Medical Operations
1996 to 1998
Director International Medical Operations
1995 to 1996
Boehringer Ingelheim Pharmaceuticals
Associate Director Clinical Research
1992 to 1994
Parexel International corporation
Director Medical Affairs
1990 to 1992
Candela laser Corp
Clinical Research Monitor
1988 to 1990
Provide pharmaceutical, clinical development, regulatory, medical affairs, strategic and due diligence consulting services to the biopharma community including medical monitor services and safety & pharmacovigilance management. Provide pharmaceutical, clinical development, regulatory, medical affairs, strategic and due diligence consulting services to the biopharma community including medical monitor services and safety & pharmacovigilance management.
What company does Inder MPH work for?
Inder MPH works for Kaul Consulting
What is Inder MPH's role at Kaul Consulting?
Inder MPH is Senior Product Development Consultant & Contractor
What industry does Inder MPH work in?
Inder MPH works in the Biotechnology industry.
Inder Kaul is a seasoned senior pharmaceutical industry executive with extensive worldwide research and development leadership experience for multiple therapeutic areas. Responsible for creating and implementing global drug development and regulatory strategies resulting in successful product registrations, and post marketing activities. Physician with over twenty six years of experience in drug, biologics, device, and diagnostics development programs including twelve years in a CRO (Clinical Research Organization) environment. His academic experience includes three years of faculty appointments. Dr. Kaul has extensive clinical experience in patient care, evaluation and testing, and knowledge of epidemiology and biostatistics. He also has extensive regulatory experience with FDA, EMA and Health Canada encompassing submissions and successful registrations. His managerial experience includes directing multiple clinical trials (Phase I-IV), including large, observational, longitudinal studies, often referred to as “registries”. He is proficient in program development as well as project management of INDs, IDEs, NDAs, BLAs, CTDs, PIPs, PSPs, SNDAs, S/NDSs, PMAs, and 510(k)s. He has worked in close partnership with the commercial organizations to ensure commercial success adhering to product labeling, promotional and advertising regulations.Senior Product Development Consultant & Contractor @ Provide pharmaceutical, clinical development, regulatory, medical affairs, strategic and due diligence consulting services to the biopharma community including medical monitor services and safety & pharmacovigilance management. From May 2015 to Present (6 months) Concord, MAPresident Product Development & Chief Medical Officer @ Artisan Pharma Inc., was acquired by Asahi Kasei Pharma (AKP) and became its fully owned subsidiary. An executive from AKP Japan was appointed as the CEO. Reports to the CEO. Dr. Kaul serves as the principal medical, regulatory and corporate development leader, and spokesperson for the company with the Board of Directors, regulatory agencies worldwide, KOLs, clinical investigators, licensors, licensees, strategic alliances, business partners, advisors and consultants, investors, members of the media and other third parties. He provides the strategic and tactical leadership in all facets of the ART-123 development including the Program Advisory Board (PAB), the Data Monitoring Committee (DMC), scientific awareness/conference strategy, a broad based publication planning and product life cycle management. Therapeutic area: Severe sepsis with coagulopathy/Disseminated Intravascular Coagulation (DIC). Product: ART-123, a soluble recombinant human thrombomodulin, marketed in Japan as Recomodulin® From September 2011 to April 2015 (3 years 8 months) Waltham, MAPresident & Chief Medical Officer @ This title became effective in December 2010 and in this position I reported to the Board of Directors. Joined the company as Chief Medical Officer and in that position reported initially to the CEO and then upon the CEO’s departure I reported to the Executive Chairman. Dr. Kaul served as the principal medical, regulatory and corporate development leader, and spokesperson for the company with the Board of Directors, regulatory agencies worldwide, KOLs, clinical investigators, licensors, licensees, strategic alliances, business partners, advisors and consultants, investors, members of the media and other third parties. He provided the strategic and tactical leadership in all facets of the ART-123 development including the Program Advisory Board (PAB), the Data Monitoring Committee (DMC), scientific awareness/conference strategy, a broad based publication planning and product life cycle management. Therapeutic area: Severe sepsis with coagulopathy/Disseminated Intravascular Coagulation (DIC). Product: ART-123, a soluble recombinant human thrombomodulin, marketed in Japan as Recomodulin®. From June 2009 to September 2011 (2 years 4 months) WalthamVice President, Clinical Development, Medical & Regulatory Affairs @ Reported to the CEO. In this position, Dr. Kaul served as a member of the Oscient Pharmaceuticals Operating Committee. He served as the lead medical, clinical, regulatory and product development representative of the company with the Board of Directors. His responsibilities included the development and leading new drug product development effort and provide the strategic and tactical leadership in all facets of drug development including regulatory approval, broad based publication planning, product launch, post launch support and product life cycle management including the implementation and maintenance of continuing medical programs (CME) and training of sales staff. This included strategic and operational direction for development, execution, monitoring and interpretation of Phase I-IV clinical studies. He worked in close partnership with the commercial organization to ensure commercial success adhering to product labeling, promotional and advertising regulations, and provided the leadership in identifying product in-licensing and acquisition priorities. Dr. Kaul served as the principal medical leader and spokesperson for the company with regulatory agencies worldwide, KOLs, clinical investigators, licensors, licensees, business partners, advisors and consultants, investors, members of the media and other third parties. Dr. Kaul oversaw the safety and pharmacovigilance function of the company and served as the lead safety officer. Therapeutic areas included Cardiovascular and Infectious Diseases. Products: ANTARA®, (a fenofibrate); FACTIVE®, (a fluoroquinolone); and Ramoplanin (a novel glycolipodepsipeptide antibiotic). From August 2006 to June 2009 (2 years 11 months) Waltham, MADivision Vice President, Abt Associates Clinical Trials @ In this position, Dr. Kaul led the growth and operations of this full-service Clinical Research Organization. He was also a member of the Abt Associates Management Committee (formerly the Executive Management Team). This Committee governed and managed all Company day-to-day operations. These senior-ranking managers were responsible for the implementation and management of strategies to meet the goals of the Company (as overseen by the Board of Directors). Maintained oversight of all clinical contracts held by the company including medical monitoring for the period 1998 – 2006. Lead medical monitor for the development program of Bosentan for the treatment of pulmonary arterial hypertension (PAH) and Laronidase for MPS. These products were later commercialized as Tracleer® and ALDURAZYME®. Therapeutic areas (1998 – 2006) included Cardiovascular, Infectious Diseases, Rheumatology, Hematology/Oncology, Women’s Health, Endocrinology, Gastrointestinal, CNS, Metabolic Disorders and Lysosomal Storage Disorders. From 1998 to 2006 (8 years) Lexington/Cambridge, MAVice President, Clinical and Medical Operations @ Reported to the Chief Operating Officer (COO). Responsibilities included oversight of all clinical contracts held by the company including medical monitoring; sign off on all integrated clinical/statistical reports; oversight, management, and overall coordination of clinical monitoring operations including attainment of quality and financial standards; personnel training and development; and sign off authority on all expenditures for the Clinical Affairs and Medical Affairs operating profit centers. As a member of the Management Committee, was responsible for participating in the oversight and determination of corporate policies and procedures. Assisted the Biostatistics and Regulatory Affairs Departments in providing complete product development services for a variety of companies. Provided technical support to the Business Development Department and provided expertise in the strategic planning, design, and management of non-clinical and clinical programs (Phase I - IV). Lead medical monitor for the development program of a fourth generation synthetic fluoroquinolone BAY 12-8039 for the treatment of acute bacterial infections and a phospahate binder Sevelamer carbonate in chronic kidney disease. These products were later commercialized as Cipro®, Moxafloxacin® and Renvela®, respectively. Therapeutic areas included Infectious Diseases, Rheumatology, Hematology/Oncology, Gastrointestinal, CNS, OB/GYN and Cardiovascular. From 1996 to 1998 (2 years) Natick, MADirector International Medical Operations @ Responsibilities included all international medical aspects related to the approval of drugs; post marketing activities of approved drugs; development of new products and line extensions; and reporting of these activities to the management of Searle. Interacted heavily with the management of the pharmaco-economics and outcomes groups. Therapeutic areas included Rheumatology and Gastrointestinal. From 1995 to 1996 (1 year) Skokie, ILAssociate Director Clinical Research @ Responsible for all medical and clinical aspects of activities related to the approval of an NDA for a non-nucleoside reverse transcriptase inhibitor nevirapine (Viramune®) in the area of HIV and reporting of these activities to the management of BIPI. Also worked with a murine monoclonal antibody (anti-ICAM-1) in the area of solid organ transplants. From 1992 to 1994 (2 years) Ridgefield, CTDirector Medical Affairs @ Ensured efficient and timely management of clinical trial projects at the divisional and interdivisional levels, with emphasis on issues affecting the scope of work, timelines and deliverables for projects. Involved with the operational aspects of clinical activities of the company and determined the clinical program content, timelines, budget and resources. Additional responsibilities included protocol development, efficacy and safety data analysis and study summary writing. Lead medical monitor for liver transplantation program for FK-506 (tacrolimus) and lead safety officer for antiretroviral nucleoside dideoxycytidine (ddC). Both products were commercialized as Prograf® and Zalcitabine®, respectively. Therapeutic areas included Immunology/Transplantation (FK506), Cytokines (anti-TNF), Nephrology (alkalinizing agent-Carbicarb) and Cardiovascular (ACE inhibitor). From 1990 to 1992 (2 years) Watham, MAClinical Research Monitor @ Managed the investigational programs for Gastrointestinal/Urology (calculi) and Dermatology (benign vascular and pigmented lesions) areas. Responsibilities included the design and review of protocols, the selection and monitoring of investigators, and the analysis and presentation of the clinical data. Supported the development and testing (in vitro and in vivo) of investigational devices and responsible for 510(k) s, IDEs, and PMA efforts. Actively involved with grant proposal writing (SBIRs, NIH, etc.) and provided support to Research and Development, Biomedical Engineering, and Marketing through regular communication, training, seminars, and presentations. From 1988 to 1990 (2 years) Wayland, MAMPH, Epidemiology & Biostatistics @ Harvard University From 1987 to 1988 Doctor of Medicine (MD), Anesthesiology @ University of Kashmir Inder MPH is skilled in: Clinical Development, Market Access, Clinical Research, GCP, Regulatory Affairs, Clinical Trials, Oncology, Biotechnology, Lifesciences, Pharmacovigilance, Drug Development, CRO, Pharmaceutical Industry, Medical Affairs, FDA, Medicine, Biopharmaceuticals, Managed Care, Diabetes, Neurology, Regulatory Submissions, Cardiology, Endocrinology, Infectious Diseases, IND, Medical Writing, Immunology, Hematology, Therapeutic Areas, CTMS, EDC, Clinical Data Management, Life Sciences, Medical Devices, Clinical Monitoring, Protocol, SOP, Dermatology, Rheumatology, Product Launch, ICH-GCP, Biostatistics, Management, Product Development, Strategic Planning, Leadership, Strategy, Drug Discovery, R&D
Introversion (I), Sensing (S), Thinking (T), Perceiving (P)
2 year(s), 7 month(s)
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