Expert in Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
Expert ID: 724877 India
As part of this summary is described his getting his R & D team at Wockhardt Limited, to initiate, develop and have a product named Nadoxin put on the market, since the last few years for the indication of acne and other dermatological infections.. Its sales are reported to be pretty good. A US patent application/s for related combination products have been filed with him as co-inventor during his term as Director, R & D of the company. The process for the API for this product was initially developed in the Chemistry division of the Drug Development group and then produced in the Bulk Drug Facility of the R & D Centre.
Line-extension combination products of the active ingredient of Nadoxin have also been developed, introduced in the market and become commercial successes.
He has set up Kilo lab facilities in his roles as Head, Drug Development of Hoechst India Limited, Mumbai and as Director R & D of two Research Centres viz. Sun Pharma Advanced Research Centre, Baroda and Wockhardt Limited Research Centre, Aurungabad. He has had operational procedures developed and transferred to the Bulk Drug Production facilities. Several APIs and chemical intermediates have been produced in kilo quantities either for captive consumption or for export or both.
He has set up, as Director R & D during the period 1997-2004, a Drug Discovery department at the Research Centre of Wockhardt Limited, at which the focus of the programme is the discovery of anti-infective agents. Several new antibiotics have been discovered and published at ICAAC meetings and in reputed journals. WCK 771, as an injectable, is in clinical phase II as an anti-MRSA agent. A prodrug successor of the active ingredient, WCK 2349, is scheduled for clinical phase trials. An anti-pneumococcal antibiotic, WCK 1152, is undergoing clinical phase I trials. A novel oxazolidinone antibiotic, with favourable attributes in comparison with contemporary clinically used drugs, is also scheduled to enter clinical trials. Research on other classes of antibiotics was also initiated.
Early in the programme, a topical product for acne and other dermatological infections, named Nadoxin, has been developed and introduced in the market, now since a few years. Several line-extension combination products of Nadoxin have also been protected by patent applications and been introduced in the market with very good commercial success.
He has set up Chemical Analysis and Spectroscopy Departments and facilities at the Research Centres of Hoechst India Limited, Mumbai Sun Pharmaceuticals Limited, Baroda and Wockhardt Limited Research Centre, Aurungabad, for the benefit of his R & D teams.
He has discovered the natural product named Forskolin which has found use by well-known cosmetic companies such as L'Oreal, Estee Lauder and others as an ingredient for cosmetic usage.
He has also guided a few companies, like CavinKare, Chennai, in drafting their patent applications for cosmeceutical products.
He has set up Drug Discovery & Development Departments and units in his roles as Head, Drug Development of Hoechst India Limited and as Director R&D of two Research Centres viz. Sun Pharma Advanced Research Centre and Wockhardt Limited Research Centre. All of these terms "crude drug, drug, drug development, drug regulation, investigational drug, investigational drug procedures, new drug, pharmaceutical product, therapeutic drug," are all terms that form part of that role.
He has written patent applications since 1972 and is named as the co-inventor of >200 patent applications. He has drafted the claims of all these applications. He has collaborated with national and international patent attorneys in drafting the claims. Some US legal attorney companies with whom he has collaborated are Ladas & Parry, New York.
Claim Chart, Claim Construction, Claim Substantiation are all part of this extensive experience.
He has installed Intellectual Property Cells in the different Research Centres at which he was Director, R & D.
His expertise in intellectual property extends to legal patenting, patent prosecution, patent specification, and trademarks.
He set up the Hoechst Research Centre, during the period 1970 to 1992, first as Head, Discovery Chemistry, then as Dy. Head Research and in addition later as Head, Drug Development, to discover new chemical entities (NCEs) from herbs/ medicinal plants, by semi-synthesis and total synthesis Strategies were devised and operationalised, which can be found in several of his publications. Two highly acclaimed drugs that were discovered by his team are Forskolin (as a unique adenylate cyclase activator and a protein phosphatase 2A activator with multiple uses in market introduction) and Flavopiridol (as a cyclin-dependent kinase 2A inhibitor to be useful as chemotherapy for prostate cancer as described in advanced clinical phase II trials). Several other NCEs have been discovered and developed to different phases of preclinical and clinical development, all documented in the scientific and patented literature. Natural product chemistry, organic chemistry, qualitative organic chemistry, synthetic organic chemistry, analytical chemistry were all techniques used to discover several bioactive compounds.
He has, as Director R & D, set up the Sun Pharma Advanced Research Centre, Baroda, India during the period 1994-1997, with its departments of SyntheticChemistry, Bulk Drug Process Development, Formulations development, Biotechnology, Analytical Chemistry & Spectroscopy, Medical and an IP Cell, to provide generic drugs for domestic sale & export
He has, as Director R & D during 1997 - 2004, set up a Drug Discovery Department, with sub-departments of Chemistry, Pharmacology, Toxicology, Analytical, Informatics & Intellectual Property,.at the Wockhardt Research Centre, Aurangabad with the objective of discovering and developing new drugs in the therapeutic area of anti-infectives. He also administered and coordinated the ongoing R & D departments of Bulk Drug Production, Formulations Development and Biotechnology.
He is the author of a report for the Swiss Business HUB on providing to a Swiss Pharma SME a procedure and list of expert agents to register/renew a new product at the Drugs Controller General of India.He was the co-ordinator for a French company in providing a list of Indian pharma companies who would be interested in the French company's drug delivery technologies He is the Advisor to the Director, University of Chemical Technology (UICT), Mumbai for installing an IP Policy at the UICTHe is an Advisor to the Director, University of Chemical Technology (UICT), Mumbai for setting up a Chemical Technopreneurship HUB - Business Incubator at the UICT. The Incubator is proposed to to be a Govt-Industry-Academia collaborative operationHe has been Consultant to Marbert AG, Germany and Schwarzkopf, Germany for their cosmetics and natural hair dyes businesses respectively.
|Year: 1962||Degree: Ph.D.||Subject: Organic Chemistry||Institution: St. Xavier's College, University of Bombay|
|Year: 1956||Degree: M.Sc.||Subject: Organic Chemistry||Institution: St. Xavier's College, University of Bombay|
|Year:||Degree: B. Sc.||Subject: Chemistry - Physics||Institution: St. Xavier's College, Univ. of Bombay|
|Year: 1978||Degree: Alumnus||Subject: R & D Management||Institution: Centre for Education in International Management, Geneva, Switzerland|
|Years: 2006 to Present||Employer: Undisclosed||Title: Adj. Professor (Hon.)||Department: Pharmaceutical Sciences & Technology||Responsibilities: He is to interact with the faculty and students of Chemistry, Chemical Technology, Pharmaceutical Sciences, particularly Medicinal Chemistry.
He teaches post grad. courses in Pharm. Sciences & Tech. and guides MSc/Ph.D cross-disciplinary research; also offers & teaches Intellectual Property (IP) courses, as well as conducts IP workshops.
-advise Director, UICT on (a) installing a UICT IP Policy and a Chair for IP with himself being the potential first incumbent (b) creating & setting up a new govt.-industry -academia collaborative Centre of Excellence on a "Chemical Technopreneurship HUB - Business Incubator" at the Institute.
|Years: 1997 to 2004||Employer: Wockhardt Limited||Title: Director R & D||Department: Research Centre||Responsibilities: He is responsible for setting up and directing a new Department of Drug Discovery at the Research Centre ast Aurangabad and for directing/administering the existing activities of the Departments of Formulations ( Galenicals)Development, of Active Pharmaceutical Ingredient (Bulk Drug) Production & of Biotechnology|
|Years: 1994 to 1997||Employer: Sun Pharmaceuticals Limited||Title: Director R & D||Department: Sun Pharma Advanced Research Centre (SPARC)||Responsibilities: He is responsible for setting up and directing the newly constructed / inaugurated SPARC at Baroda and setting up and directing a new Department of Drug Discovery, and for directing/administering the existing activities of the Departments of Formulations ( Galenicals)Development, of Active Pharmaceutical Ingredient (Bulk Drug) Production, of Analytical Chemistry, of Biotechnology, and of Medical Services|
|Years: 1993 to 1995||Employer: Hoechst AG, Frankfurt/ Hoechst India Limited||Title: Consultant||Department: Corporate||Responsibilities: Consultant/Advisor to Hoechst AG's Frankfurt associated companies in Germany, viz. Marbert, Duesseldorf and Schwarzkopf, Hamburg|
|Years: 1980 to 1992||Employer: Hoechst India Limited||Title: Head, Drug Development/ Dy. Head, Research||Department: Research Centre||Responsibilities: He is responsible for setting up and directing a new Department of Drug Development, including a Kilo Scale Facility, while continuing directing/administering the activities of the existing Drug Discovery Departments of Chemistry, Pharmacology, Microbiology, Parasitology & Analytical Chemistry,|
|Years: 1970 to 1986||Employer: Hoechst India Limited||Title: Head, Chemistry Research||Department: Research Centre||Responsibilities: He is responsible jointly with others for setting up a new Research Centre at Mulund, inaugurating and directing the newly constructed and setting up, administering and directing the research of a new Department of Drug Discovery Chemical Research to discover new chemical entities from natural products and by synthesis|
|Years: 1969 to 1970||Employer: Caius Research Laboratory||Title: Scientist||Department: Research||Responsibilities: To direct the research programmes of the facility|
|Years: 1965 to 1969||Employer: Drexel Inst. of Technology, Philadelphia, Pa, USA & University of Liverpool, England||Title: American Cancer Society & NIH Res. Fellow, USA/Hoffman La Roche Research Fellow, Liverpool||Department: Biological Sciences, USA /Biochemistry, Liverpool||Responsibilities: To undertake research first for Prof. W. R. Nes at Univ. of Mississippi and at Drexel Inst. of Technology, Philadelphia, Pa. 19104 and then for Prof. T. W. Goodwin, Head of the Dept. of Biochemistry, Liverpool, England|
|Years: 2007 to Present||Agency: Swiss Consulate General of India||Role: Consultant, Pool of Experts, Swiss Business HUB||Description: He is a consultant on matters pertaining to the pharmaceutical industry and writes advisory reports|
|Years: 2007 to Present||Agency: OSEC Business Network||Role: Consultant, Pool of Experts||Description: He is a consultant on matters pertaining to the pharmaceutical industry and writes advisory reports|
|Years: 1997 to Present||Agency: India Patent Office||Role: Patent Attorney/Agent||Description: He drafts patent applications, has them filed, and represents/appears on behalf of clients at the Patent Office in respect of examination, prosecutionand infringement proceedings.|
|Years||Country / Region||Summary|
|Years: 1978 to 1978||Country / Region: Germany/Frankfurt||Summary: He was delegated to work at Hoechst AG, Frankfurt for a period of ca. 6 months. The dates above are approximate.|
|Years: 1974 to 1975||Country / Region: Germany/Frankfurt||Summary: He was delegated to work at Hoechst AG, Frankfurt for a period of ca. 6 months. The dates above are approximate.|
|Associations / Societies|
|He is or has been:
2008 - Member, IUPAC Div VII, Chemistry & Human Health-Sub Committee on Medicinal Chemistry and Drug Development;
1996-1998 & 1998-2000, Member, IUPAC (Medicinal Chemistry ) Committee;
1995, Member Technology, Information, Forecasting and Assessment Council (TIFAC), Government of India;
1982- 1992 Member of different Executive Committees of chemical societies and University Boards of studies.
-Co-editor, Pharmaco-Chemistry Library Elsevier Press, The Netherlands
|Licenses / Certifications|
|Alumunus of the International Institute of Management Geneva & Lausanne, Switzerland|
|Pool of Experts, Swiss Business HUB, Swiss Consulate General of India, and OSEC Business Network Switzerland|
|Publications and Patents Summary|
|He has about 80 publications in reputed scientific journals and books. He is named as co-inventor on about 200 patents. He has guided the discovery and destiny of several drug molecules, some of which have been launched in the market, and others have attracted high international interest and acclamation.|
|Expert Witness Experience|
|He has (a) successfully defended an Exclusive Marketing Rights( EMR) patent application at the Office of the Controller-General of Patents & Trade Marks, India, (b) advised a firm of solicitors defending a court case in the Bombay High Court on the grant of a patent, (c) appeared at the US Patent Office Washington U.S.A. to defend an Examiner's queries on a patent application, (d) drafted patent applications for national and international patent attorneys, and collaborated with them on the prosecution, defense & grant of patents (e) written & negotiated license agreements with potential licensors of discovered novel chemical and molecular entities (NCEs & NMEs ).|
|Training / Seminars|
|He has recently concluded organising and conducting two Workshops, one entitled "PATENTS - Expand Your Intellectual Property(tm)", sponsored by the University Alumni Association and a second one, entitled "Coping With Patent Writing - Expand Your Intellectual Property(tm)", sponsored by the Indian Drug Manufacturers' Association.
He has participated in and delivered lectures at several national & international conferences and seminars on the themes of Drug Discovery & Development, of Teaching & Training in Medicinal Chemistry and of Intellectual Property ( kindly see attached list of publications separately submitted)
|He is a provider and supplier of the novel compound named forskolin and its several analogues, naturally occurring and semi-synthetic.
He has organised for a European company a list of Indian companies who are interested to license the orginator's drug delivery technologies.
He has written and provided a report for a European company to enable their identifying an agent who can register/renew their drug applications at the Drugs Controller General of India's office.
|He has >45 years experience of the pharmaceutical industry, both in India and globally, also extending to the fields of the chemical and biotechnology industries. Cosmeceuticals, nutraceuticals and natural products are additional strengths.
His strengths are in Pharmaceutical Research Management, New Drug Discovery & Development, Process Development for APIs, Co-ordinating Formulation& Development and Biotechnology, Portfolio composition and Goal-setting, Creative Team-Building to Organic Entity, Profit Centre Focus, Coordination of Govt-Regulatory-Industry-Academia collaborations & Funding.
He is co-inventor of > 200 national and international patents.
In the education field, he teaches and guides postgraduate & doctoral students and postdoctoral fellows in medicinal chemistry and intellectual property.
|Other Relevant Experience|
|He is an agent for patents at the Patent Offices in India, and via his legal contacts for patents abroad. He expects to be soon registered as a Trade Marks agent.|
|English||He is highly proficient|
|German||He is somewhat proficient in speaking, less so in reading other than scientific literature and correspondence, and even less in writing grammatically correct German|
|French||He is proficient in reading scientific literature and simple general literature and correspondence. Under duress, he can speak broken French, and also write simple sentences|
|Hindi||He is familiar with all aspects of the language|
Fields of Expertise
acne product, drug, drug development, Food and Drug Administration regulation, investigational drug, new drug, active pharmaceutical ingredient, pharmaceutical design, antibiotic, chemical analysis, cosmetic product, crude drug, intellectual property, claim (patent), new drug application, patent trolling, natural product chemistry, pharmaceutical chemistry, pharmaceutical industry, pharmaceutical research, pharmaceutical research and development, technology development, substantiation, solicitors, ocular microbiology, protein drug delivery, protein drug, investigational drug procedures, abbreviated new drug application, herbal medicine, patent claim chart, patent claim construction brief, Doctrine of Equivalents, patent prosecution, patent specification, patent claim construction, copyright law, copyright infringement, advertising claim substantiation, alternative medicine, pharmaceutical technology, bulk drug, compliance testing, benzodiazepine, synthetic organic chemistry, over-the-counter topical drug product development, over-the-counter drug product development, prescription drug, Food and Drug Administration compliance, alkyl halide, diuretic drug, amine analysis, cephalosporin, ophthalmic pharmaceutical product, aminoglycoside antibiotic, chlorine analysis, generic drug, betaine, beclomethasone dipropionate, antiparasitic agent, cytotoxic drug, medicinal herb, injectable pharmaceutical product, inotropic drug, immunosuppressive drug, beta-naphthol, chemotherapeutic drug, solid pharmaceutical product, cosmetic exported product, bronchodilator drug, chemical intermediate, acne product, copyright, topical drug, inventology, biological response modifier, addition reaction, drug analysis, benzophenone, pharmaceutics, antihypertensive drug, drug dosage form development, drug delivery, computer-aided drug design, Food and Drug Administration, trademark, legal patenting, drug regulation, pharmaceutical drug, beta-lactam antibiotic, qualitative organic chemistry, pharmacokinetics, organic chemistry, ocular drug delivery, injectable drug, expectorant drug, drug therapy, applied organic chemistry, anti-inflammatory drug, acetic acid