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Sustained release dosage forms thesis proposal

Sustained release dosage forms thesis proposal for editorial

  • Over 17 many years of effective experience encompassing strategy development, program and project management software, formulation development, technology transfer, trouble-shooting and process improvement having a realistic knowledge of constraints and possibilities. Excellent credentials as being an issue solver and innovator.
  • Leadership experience of planning, developing and applying newer and dynamic business focuses and proper models
  • Is associated with people and team building events culture to build up strong, positive, passionate leaders who deliver dramatic results and successes
  • AProactive, principle driven leader who utilizes outstanding technical and project management software skills along with exemplary interpersonal, effective communication, influence and training skills to rapidly produce a fantastic business formula that exceeds expectations.
  • Goal and result-oriented, determined and motivated to achieve success and history of effectively managing complex projects and training colleagues and direct reports.
  • Ability to accept initiative on challenging tasks and also to accomplish tasks with tight deadlines with quick-thinking, intelligence, up-to-date scientific and patent understanding and cohesion attributes.
  • Special talent for innovating drug delivery technologies and excellence in developing and applying effective strategies in product of challenging drugs.
Patents, Publications, Presentations
  • Patents Applications/awards 7 (4 in US and three in Europe and Canada)
  • Exterior Publications: 15
  • Exterior Presentations:

2007- Present, Senior Director RD, Perrigo Company

  • Accountable for directing and managing RD group of 46 professionals at 3 different locations involved and accountable for formulation development, scale-up, medical trial manufacturing and technical transfer to production sites.
  • Supplying recommendation and support to business development and marketing research departments for brand new product strategy, portfolio management, new partners evaluation and acquisition strategy, planning and execution support.
  • Supplying support to Operation for brand new equipment process train, up-gradation and capacity utilization and improvement strategies evaluation
  • Directing ip management for a number of projects, platform technologies and other associated programs
  • Accountable for supplying support for CRO choice for development, process, scale-up and bio/studies
  • Accountable for design, approval of BE/BA/studies protocols and reports and overview of regulatory submissions.

Sustained release dosage forms thesis proposal Nanoparticulate Drug Delivery- Fantasy

2003- 2006, Director Pharmaceutical Development and research, Pharmascience Corporation. world wide web.pharmascience.com

  • Direct and manage RD group of 55 professionals associated with formulation development, scale-up, pilot mfg. for clinical supply, technical transfer to production sites within and outdoors The United States, Engineering support for building and equipment, Process Improvement and tech support team to any or all production sites (NA and Europe) during routine mfg. Managing department budget of 5 million USD.
  • Provided recommendations and support to senior management steering committee to apply proper objectives within development pipeline: portfolio management, new partners buying process and acquisition planning
  • Provided support to business development and cool product selection steering committee to reengineer business systems for the generic prescription and consumer healthcare business within the organization
  • Provided business proposal and implementation arrange for introduction of novel drug delivery systems using the pharmaceutical development unit
  • Labored carefully with senior management to recognize operational issues and provided strategies for implementation
  • Produced a brand new business design and program management technique to implement new revised business processes and enhance overall financial performance by improving capacity utilization, and individuals skills via RONA initiatives
  • Brought several key development projects and effectively integrated they sources to attain rapid accomplishment of project goals while meeting the aggressive development time lines. Leadership was highly recognized on effective achievement of goals for many major projects.
  • Directed growth and development of ip platforms including controlled-release, solubility enhancement, bioavailability enhancement, taste masking and fast melt technologies for improved dental absorption and existence extension of existing molecules.
  • Extensively investigated practicality of drug delivery with amorphous drugs and using solid spray drying dispersion, hot-melt extrusion and precipitated materials and particularly assessment from the drug-polymer interaction, physical stability and manufacturability.
  • Offered being an internal expert on drug delivery technologies in the corporate level and it has been consulted on formulation strategies as well as on the introduction of milestones for many projects leading to IP and rapid resolution of formulation problems.
  • Took part in the management steering committee for brand new business possibilities and also to facilitate effective decision-making in order to ensure short and lengthy term success and regulatory compliance.
  • Participated and brought research and evaluations for potential acquisitions of websites and merchandise.
  • Supervised and coached Ph.D. scientists, postdocs and senior associates in independence, efficiency and career growth.

Sustained release dosage forms thesis proposal of novel drug delivery

7/02 – 6/03, Director Galenics and Formulation Development, Labopharm Corporation. world wide web.labopharm.com

· Managed select few of senior research staff accountable for performing formulation, process development, analytical development and coordination of clinical packaging and stability studies both within and outdoors the organization.

· Presentation, interaction and settlement with clients to get start up business contracts

· Managed forecasting business design and ensured that business processes and deliverables are in line with client and budget expectations

· Effectively oversaw a portfolio of projects brought by project management software team

· Initiated, developed and implemented analytical tool to judge and also to validate sustaining characteristics from the novel patented polymer. Resolved the commercial manufacturing issues regarding acceptability/rejection from the novel polymer.

· Took part in identification and support of exterior synergistic technologies and intellectual qualities getting a possible for expanding existing business possibilities.

· Provided leadership to sections and directed activities to satisfy project needs and ensured customer happiness

· Brought multi-site project teams and ensured timely deliverables in regards budget and quality

· Brought project initiation with SWOT and risk analyses to create directions in order to meet target expectations and deliverables

· Participated and performed a significant role running a business presentations and interaction with new customers for business growth and new possibilities

· Took part in steering committee management to apprise of progress, remove roadblocks, review proper directions and supply new and improved directions to satisfy targets

· Performed a significant role in formulation design and process development for various promising small to large molecules for phase I, II and III clinical development phases. Supported scale-up and validation activities implementation and management.

· Directed growth and development of nasal delivery system and labored with Pfeiffer of the usa and Valois of the usa for innovations in delivery improvement and bio-availability enhancement abilities.

· Directed the department preparation and took part in 2 Food and drug administration pre-approval inspections.

· Lead role in design and supervision of recent formulation lab and pilot facility. 50g to five kg formulation lab / 5-50 kg Food and drug administration inspected GMP pilot labs. Accountable for engineering contract, equipment specifications, installation and qualification support.

· System development and institution. Directed and implemented SOP documentation controls, inventory control, material handling, sampling and lab documentation control system.

· Developed proper objectives and gratifaction metrics for administration, operations and product areas.

· Performed client presentations and services information choices, technical abilities and product proposals. Supported prices structure for development and clinical mfg. activities. Supported in control over project management software work plans and overview of the quotes associated with implemented process map milestones.

· Brought regular project review and discussions with exterior clients for his or her development, clinical manufacturing, and audit support and budget management to aid strategy objectives.

2/96 – 12/97,Assistant RD Manager and Process Development Manager,

· Took part in construction, installation and hang-from a brand new RD and factory including equipment, technical staff and system design and implementation.

· Took part in business contracts, settlement and related interactions with vendors and exterior clients to advertise business and get financial targets

· Managed formulation growth and development of generic solid, semi-solid and liquid products and execution of related process development and validation activities to aid commercial launch from the products inside a tight timeline.

· Identifications and overview of the critical process and raw material specifications which have a possible effect on success from the transfer during targeted launch from the products.

· Submission and implementation of process Improvement projects for that commercial products.

10/90 – 1/96,Research Researcher, Ranbaxy Research Laboratories, India world wide web.ranbaxy.com

· Accountable for growth and development of solid, semi-solid and liquid dosage forms for domestic and worldwide markets.

· Initiated and brought novel drug delivery team of developers having a concentrate on patentable or non-infringing controlled-release solid dosage system development.

· Characterised drug diffusion behavior in HPMC gels and matrix swelling kinetics and also the understanding acquired effectively brought towards the development and establishment from the matrix SR technology in-house.

· Labored with Glatt Germany for equipment design modifications and process development for in-house particle coating platform technology development.

· Effective development and technology change in 4 modified release products to internal and outdoors manufacturing sites.

· Hired as “Prestige Appointment” towards the Pharmacy Practice Department in the College of Toledo, Toledo, Ohio. The main focus from the assignment is going to be for advanced courses in delivery design and regulatory systems for approval with Food and drug administration

· Adjunct facility member with Toronto Institute of Pharmaceutical Technology. Centered on delivering advanced level courses in drug development and regulatory approval process.

· Instructor Seneca College of Applied Art and Technology. Trained part-time diploma courses in formulation development including lab courses and technical production design process.

  • Teaching Assistant for undergraduate students in Pharmacy School, Panjab College, India.

EDUCATION

1991 Ph.D. in Pharmaceutical Development, Dept. Pharm. Sciences, Panjab College, India

1986 MS Pharmaceutics, Dept. Pharm. Sciences, Panjab College, Chandigarh, India

1984 Baccalaureate in Pharmacy, College of Pharmacy, College of Delhi, India

1981 Diploma Pharmacy, Board of Technical Education, India.

1979 Baccalaureate in science, College of Delhi, India.

AWARDS AND HONORS

2008 Appreciation award in recognition of remarkable contributions being an Asked Speaker by UNMC AAPS Student Chapter of College of Nebraska Medical Center, Omaha, Nebraska

2007 Certificate in recognition of remarkable dedication, commitment, and support from the AAPS Visiting Researcher Program

2003 Person receiving excellence in pharmaceutical sciences award from Toronto institute of pharmaceutical technology, Canada.

1993 Certificate of appreciation for recognition of performance and contribution towards the company’s growth.

1991 Reported within the Company’s house journal for significant research contribution in the introduction of novel drug delivery systems.

1990 Excellent presentation for that research paper presented during 9 th Pharmaceutical Technology conference within the Netherlands.

1990 Asked participant for that scientific deliberations in the center for biopharmaceutical sciences, College of Leiden, Holland.

1990 Asked participant during scientific product conferences at Bayer, FRG.

1986 Award of senior research fellowship for four years through the College Grants Commission, Panjab College, India.

1984 Award of junior research fellowship for just two years through the College Grants Commission India.

1983 Best speaker award inside a debate competition backed by Indian Medicinal Society, India.

1981 Was third devote order of merit in pharmacy diploma board examination in India.

PROFESSIONAL ACTIVITIES / ASSIGNMENTS

  • Exterior examiner for Ph.D. thesis evaluation from National Institute of Pharmaceutical Education and Research (NIPER) India.
  • Editorial advisory board member for Drug Delivery Technology, Contract Pharma, Business Briefing, Pharma Tech and Business Briefing, Future Drug Discovery, U.K.
  • Consultant with Council of Healthcare Advisors (a connection of leading physicians, scientists along with other medical professionals) and Network of Advisors, a unique community of educational and industrial pros who provide talking to services to the loan industry on various facets of Pharmaceutical Research and Technology.
  • Person in visiting researcher program through AAPS.
  • Asked speaker for specialised pharmaceutical topics with Institute of Validation Technology along with other national and worldwide institutions.
  • Active contributor for editorial welcome (forward), panel review and “ask the editor” posts for scientific magazines.
  • Person in brain storming session on drug delivery systems organized by Dept. of Biotechnology.
  • Academic secretary from the Panjab College Pharmaceutical Society, India.
  • Person in editorial board, library committee and organizer for a number of functions in class.

1. Aurora, J. (2007) Nanoparticulate Drug Delivery- Fantasy to Reality, Drug Delivery 2007 (Touch Briefings 2007), 50-52, 2007

2. Aurora, J. Talwar Naresh, Pathak Vinayak, Rasik Patel, and Ketan Prajapati, (2007) Dessicant Choice for bottle packaging of Pharmaceuticals, Tablets and capsules, 5(4), 26-31, 2007

3. Aurora, J. (2006) Outsourcing –Recent Trends and Possibilities, Touch Briefings, Drug Discovery 2006,7, 2006.

4. Aurora, J. Talwar, Naresh and Pathak, Vinayak, (2006) Colonic Drug Delivery Challenges and Possibilities: a summary, Touch Briefings, European Gastroenterology Reviews 2006, 10, 2006.

5. Aurora, J. Talwar, Naresh and Pathak, Vinayak, (2006) Colonic Drug Delivery Challenges and Possibilities: a summary, Touch Briefings, Future Drug Delivery 2006, 64,2006

6. Aurora, J. (2006) Delivery of Proteins and Peptides – Challenges and Possibilities, Business Briefing, Future Drug Discovery, 38, 2006

7. Aurora, J. Pathak,V. (2005) Dental Disintegrating Dosage Forms: A Summary, Drug Delivery Technology, 5(3), 2005

8. Aurora, J. Pathak,V. (2004) The fate of medication and drug development :A Summary, Drug Delivery Technology, 4(3), 2004

9. Aurora, J. (2002).Growth and development of Nasal Delivery Systems: An Evaluation, Drug Delivery Technology, 2(7), 2002

10. Arora, J. (1990) Studies on Natural Gums for Sustained Drug Release from tablet dosage forms. Ph.D. thesis, Panjab College ,Chandigarh (India).

11. Arora, J. (1986). Screening of Natural Gums and Mucilages as Sustaining Materials in Tablet Dosage Forms. M.Pharm. Thesis, Panjab College, Chandigarh, India.

12. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora (1988). Study of Natural Gums and Mucilages as sustaining materials in Tablet Dosage Forms, Indian Journal of Pharm. Sci. 50(2). 89-92.

13. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora (1989). Study of Natural Gums and Mucilages as sustaining materials in Tablet Dosage Forms, Part-II. Indian Journal of Pharm. Sci. 51(4): 115-118.

14. Baveja, S.K. Ranga Rao, K.V. Arora, J, Mathur, N.K. and Vinayak, V.K. (1991). Chemical Investigations of some Galactomannan Gums as matrix tablets for Sustained Drug Delivery. Indian Journal of Chemistry, Section B, 30B(2), 133-137.

15. Baveja, S.K.,Ranga Rao, K.V. Arora, J. and Dhir, S.(1991). A manuscript approach to appraise the swelling front in Swelling Controlled Release Systems, Indian Journal of Pharm. Sci. 53(4): 156-158.

I presented the next papers (though listed like a co-author) at conferences of numerous professional societies:

1. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1986). Screening of Natural Gums/Mucilages as sustaining materials in Tablet Dosage Forms. Abstract #P17, Indian Journal of Pharm. Sci. 1986, 48(5):161. 37th Indian Pharmaceutical Congress held at New Delhi in 1985.

2. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1987). Screening of Natural Gums/Mucilages as sustaining materials in Tablet Dosage Forms, Part-II. Abstract F24. Indian Journal of Pharm. Sci. 1987, 49(3):130. Presented at 38th Indian Pharmaceutical Congress held at Ahmedabad in 1986.

3. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1988). Zero – order discharge of soluble drug from Tablets of Natural Matrices. Abstract #E11, Indian Journal of Pharm. Sci.,1988, 50(3):203. Presented at 39th Indian Pharmaceutical Congress held at Madras.

4. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1989). Utilization of polysaccharides in controlled discharge of drugs. Abstract # C-5 Proceedings from the fifth Carb Conference, Jodhpur,November 1989.

5. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1989). Swelling and erosion controlled natural matrices for zero-order discharge of water soluble drug. Abstract #CK36, Indian Journal of Pharm. Sci. 1990, 52(1):79. 41st Indian Pharmaceutial Congress, Bombay, 12 ,.1989.

6. Bhupinder Singh, Jagdish Arora and Saranjit Singh. (1990).”Zorel”- A pc programme for that Look at Drug Release from Controlled Release Dental Dosage Forms. Abstract #C-26, Indian Journal of Pharm. sci. 1990, 52(1):51. Presented in the 41st Indian Pharmaceutical Congress, Bombay, 12 ,.1989.

7. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1990). Studies on Natural Gums as sustaining materials in Tablet Dosage Forms.” ninth Pharmaceutical Technology Conference held at Veldhoven, Holland in April, 1990.

8. Baveja, S.KKay.Sixth is v. Ranga Rao, Jagdish Arora and N.D.Mathur.(1990). Studies on Drug Release from Matrix Tablets that contains Galactomannan Gums, 1990.Abstract D-12. Worldwide Symposium on Innovations in Pharmaceutical Science, Ahmedabad, India, March.1990.

9. Baveja, S.KKay.Sixth is v. Ranga Rao and Jagdish Arora. (1991). A Manuscript Approach to appraise the Swelling Front in Swelling Controlled Release Systems, recognized for presentation at 42nd Indian Pharmaceutical Congress at Manipal, December,1991.

10. Jagdish Arora and H. Sen (1994). Pharmaceutical Pelletization Technology, recognized for poster presentation during 3rd European Symposium on Controlled Drug Delivery locked in Holland in April, 1994.

11. S.Lai, P.Shah, J.Arora, C. Minchom and N. Barker (2000). Aftereffect of power of Guaifenesin and poloxamer within the formulation of the cream product. Presented during AAPS meeting in Indiana, November.2000

12. S.Chowdari, J.Huang, K.Chow, C.Minchom, M.Vachon, A.Mishra and J.Aurora (2002). Cold film coating of temperature and moisture sensitive tablets. Presented during AAPS meeting in Toronto, November.2002

13. S.Chowdari, J.Huang, K.Chow, C.Minchom and J.Aurora (2002). Situation Study: The formulation growth and development of high dose tablets of the poorly soluble and poorly compressible drug substance. Presented during AAPS meeting in Toronto, November.2002

14. R. Patel, V. Pathak, N. Talwar and J. Aurora, (2006). Development and process optimization of sustained release tablet formulation of the water insoluble drug by high shear granulation process. Presented during AAPS meeting in Dallas, Texas, November.2006

  • American Association of Pharmaceutical Scientists
  • Controlled Release Society
  • Generic Pharmaceutical Association


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