Dr. Jack Aurora, Prestige Appointment

 EXECUTIVE SUMMARY

• Over 17 years of successful experience encompassing strategy development, program and project management, formulation development, technology transfer, trouble-shooting and process improvement with a realistic understanding of constraints and opportunities. Excellent credentials as a problem solver and innovator.
• Leadership experience in planning, developing and implementing newer and dynamic business focuses and strategic models
• Belongs to people and team development culture to develop strong, proactive, passionate leaders who deliver dramatic results and successes
• A Proactive, principle driven leader who utilizes outstanding technical and project management skills coupled with exemplary interpersonal, effective communication, influence and coaching skills to quickly bring about a winning business formula that exceeds expectations.
• Goal and result-oriented, determined and motivated to succeed and track record of successfully managing complex projects and coaching colleagues and direct reports. 
• Ability to take the initiative on challenging tasks and to accomplish tasks with tight deadlines with quick-thinking, intelligence, up-to-date scientific and patent knowledge and team spirit attributes. 
• Special talent for innovating drug delivery technologies and excellence in developing and implementing successful strategies in product development of challenging drugs.

   Patents, Publications, Presentations

• Patents Applications/awards                 7 (4 in US and 3 in Europe and Canada) 
• External Publications:                         15
• External Presentations:                        

2007- Present, Senior Director R&D, Perrigo Company

•  Responsible for directing and managing R&D team of 46 professionals at 3 different locations involved and responsible for formulation development, scale-up, clinical trial manufacturing and technical transfer to production sites.
•  Providing recommendation and support to business development and marketing research departments for new product strategy, portfolio management, new partners evaluation and acquisition strategy, planning and execution support.
•  Providing support to Operation for new equipment process train, up-gradation and capacity utilization and improvement strategies evaluation
• Directing intellectual property management for various projects,  platform technologies and other related programs
•  Responsible for providing support for CRO selection for development, process, scale-up and bio/clinical studies
•  Responsible for design, approval of BE/BA/clinical studies protocols and reports and review of regulatory submissions.

  2003- 2006, Director Pharmaceutical Research and Development, Pharmascience Inc. www.pharmascience.com

• Direct and manage R&D team of 55 professionals involved with formulation development, scale-up, pilot mfg. for clinical supply, technical transfer to production sites within and outside North America, Engineering support for building and equipment, Process Improvement and technical support to 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 implement strategic objectives within development pipeline: portfolio management, new partners selection process and acquisition planning
• Provided support to business development and new product selection steering committee to reengineer business processes for the generic prescription and consumer health care business within the company
• Provided business proposal and implementation plan for introduction of novel drug delivery systems with the pharmaceutical development unit
• Worked closely with senior management to identify operational issues and provided recommendations for implementation
• Created a new business model and program management strategy to implement new revised business processes and enhance overall financial performance by improving capacity utilization, and people skills via RONA initiatives
• Led several key development projects and successfully integrated the team resources to achieve rapid accomplishment of project goals while meeting the aggressive development time lines. Leadership was highly recognized on successful achievement of goals for several major projects.
• Directed development of intellectual property platforms including controlled-release, solubility enhancement, bioavailability enhancement, taste masking and fast melt technologies for improved oral absorption and life extension of existing molecules.
• Extensively investigated feasibility of drug delivery with amorphous drugs and the use of solid spray drying dispersion, hot-melt extrusion and precipitated materials and especially assessment of the drug-polymer interaction, physical stability and manufacturability. 
• Served as an internal expert on drug delivery technologies at the corporate level and has been consulted on formulation strategies and on the development of milestones for several projects resulting in IP and rapid resolution of formulation problems.
• Participated in the management steering committee for new business opportunities and to facilitate effective decision-making so as to ensure short and long term success and regulatory compliance.
• Participated and led due diligence and evaluations for potential acquisitions of sites and products.
• Supervised and coached Ph.D. scientists, postdocs and senior associates in independence, efficiency and career growth.

7/02 - 6/03, Director Galenics and Formulation Development, Labopharm Inc. www.labopharm.com

·         Managed small group of senior research staff responsible for performing formulation, process development, analytical development and coordination of clinical packaging and stability studies both within and outside the company.

·         Business presentation, interaction and negotiation with clients for getting new business contracts

·         Managed forecasting business model and ensured that all business processes and deliverables are consistent with client and budget expectations

·         Successfully oversaw a portfolio of projects led by project management team

·         Initiated, developed and implemented analytical tool to evaluate and to validate sustaining characteristics of the novel patented polymer. Resolved the commercial manufacturing issues with regard to acceptability/rejection of the novel polymer.

·         Participated in identification and support of external synergistic technologies and intellectual properties having a potential for expanding existing business opportunities.

1/98 - 7/02, Manager Formulation Development, Patheon Inc. www.patheon.com

·         Provided leadership to business units and directed activities to meet project needs and ensured client satisfaction

·         Led multi-site project teams and ensured timely deliverables with regard budget and quality

·         Led project initiation with SWOT and risk analyses to set directions so as to meet target expectations and deliverables

·         Participated and played a major role in business presentations and interaction with new clients for business growth and new opportunities

·         Participated in steering committee management to apprise of progress, remove roadblocks, review strategic directions and provide new and improved directions to meet targets

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

·         Directed development of nasal delivery system and worked with Pfeiffer of America and Valois of America for innovations in delivery improvement and bio-availability enhancement capabilities.

·         Directed the department preparation and participated in 2 FDA pre-approval inspections.

·         Lead role in design and supervision of new formulation lab and pilot facility. 50g to 5 kg formulation lab / 5-50 kg FDA inspected GMP pilot labs. Responsible 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 strategic objectives and performance metrics for administration, operations and product development areas.

·         Executed client presentations of service offerings, technical capabilities and product development proposals. Supported pricing structure for development and clinical mfg. activities. Supported in management of project management work plans and review of the quotations linked to instituted process map milestones.

·         Led regular project review and discussions with external clients for their development, clinical manufacturing, and audit support and budget management to support strategy objectives.

2/96 – 12/97, Assistant R&D Manager and Process Development Manager,

                      Tabuk Pharmaceutical Manufacturing Company, Tabuk, Saudia Arabia www.pharmalicensing.com/company/showall/2272/profile

·         Participated in construction, installation and set-up of a new R&D and manufacturing facility including equipment, technical staff and system design and implementation.

·         Participated in business contracts, negotiation and related interactions with vendors and external clients to promote business and achieve financial targets

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

·         Identifications and review of the critical process and raw material specifications that have a potential impact on success of the transfer during targeted launch of the products.

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

10/90 - 1/96, Research Scientist, Ranbaxy Research Laboratories, India www.ranbaxy.com

·         Responsible for development of solid, semi-solid and liquid dosage forms for domestic and international markets.

·         Initiated and led novel drug delivery development team with a focus on patentable or non-infringing controlled-release solid dosage system development.

·         Characterized drug diffusion behavior in HPMC gels and matrix swelling kinetics and the knowledge gained successfully led to the development and establishment of the matrix SR technology in-house.

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

·         Successful development and technology transfer of 4 modified release products to internal and outside manufacturing sites.

Academic Assignments

            11/07

·         Appointed as “Prestige Appointment” to the Pharmacy Practice Department at the University of Toledo, Toledo, Ohio. The focus of the assignment will be for advanced courses in delivery design and regulatory processes for approval with FDA

            10/03- present

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

10/01- 10/03

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

11/86- 5/89

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

EDUCATION

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

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

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

1981          Diploma Pharmacy, Board of Technical Education, India.

1979         Baccalaureate in science, University of Delhi, India.

AWARDS AND HONORS

2008         Appreciation award in recognition of outstanding contributions as an Invited Speaker by UNMC AAPS Student Chapter of University of Nebraska Medical Centre, Omaha, Nebraska

2007         Certificate in recognition of outstanding dedication, commitment, and support of the AAPS Visiting Scientist Program

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

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

1991         Cited in the Company’s house journal for significant research contribution in the  development of novel drug delivery systems.

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

1990         Invited participant for the scientific deliberations at the centre for biopharmaceutical sciences, University of Leiden, The Netherlands.

1990         Invited participant during scientific product development meetings at Bayer, FRG.

1986         Award of senior research fellowship for a period of 4 years by the University Grants Commission, Panjab University, India. 

1984         Award of junior research fellowship for 2 years by the University Grants Commission India.

1983         Best speaker award in a debate competition sponsored by Indian Pharmacological Society, India.

1981         Stood third place in order of merit in pharmacy diploma board examination in India.

PROFESSIONAL ACTIVITIES / ASSIGNMENTS

• External 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 (an association of leading physicians, scientists and other healthcare professionals) and Network of Advisors, an exclusive community of academic and industrial experts who provide consulting services to the financial industry on various aspects of Pharmaceutical Research and Technology.
• Member of visiting scientist program through AAPS.
• Invited speaker for specialized pharmaceutical topics with Institute of Validation Technology and other national and international institutions.
• Active contributor for editorial welcome (forward), panel review and “ask the editor” columns for scientific magazines.
• Member of brain storming session on drug delivery systems organized by Dept. of Biotechnology.
• Academic secretary of the Panjab University Pharmaceutical Society, India.
• Member of editorial board, library committee and organizer for various functions in school. 

PUBLICATIONS

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 Selection for bottle packaging of Pharmaceuticals, Tablets and capsules, 5(4), 26-31, 2007

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

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

5.    Aurora, J., Talwar, Naresh and Pathak, Vinayak, (2006) Colonic Drug Delivery Challenges and Opportunities: an overview, Touch Briefings, Future Drug Delivery 2006, 64,2006

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

7.    Aurora, J., Pathak,V. (2005) Oral Disintegrating Dosage Forms: An Overview, Drug Delivery Technology, 5(3), 2005

8.    Aurora, J., Pathak,V. (2004) The fate of drugs and drug development :An Overview, Drug Delivery Technology, 4(3), 2004

9.    Aurora, J. (2002).Development of Nasal Delivery Systems: A Review, 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 University ,Chandigarh (India).

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

12.  Baveja, S.K., K.V. Ranga Rao and Jagdish Arora (1988). Examination  of Natural Gums and Mucilages as sustaining materials in Tablet Dosage Forms, Indian Journal of Pharm. Sci., 50(2) : 89-92.

13.  Baveja, S.K., K.V. Ranga Rao and Jagdish Arora (1989). Examination 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 novel   method to measure the swelling front in Swelling Controlled Release  Systems, Indian Journal of Pharm. Sci. 53(4): 156-158.

ABSTRACTS

I presented the following papers (though listed as a co-author) at meetings of various professional societies:

1.            Baveja, S.K., K.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.K., K.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.K., K.V. Ranga Rao and Jagdish Arora. (1988). Zero - order  release 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.K., K.V. Ranga Rao and Jagdish Arora. (1989). Use of polysaccharides in controlled release of drugs. Abstract # C-5 Proceedings of the 5th Carbohydrate Conference, Jodhpur,November 1989.

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

6.            Bhupinder Singh, Jagdish Arora and Saranjit Singh. (1990)."Zorel"- A computer programme for the Evaluation of Drug Release from Controlled  Release Oral Dosage Forms. Abstract #C-26, Indian Journal of Pharm. sci., 1990, 52(1):51. Presented at the 41st Indian Pharmaceutical  Congress, Bombay, Dec.1989.

7.            Baveja, S.K., K.V. Ranga Rao and Jagdish Arora. (1990). Studies on Natural Gums as sustaining materials in Tablet Dosage Forms." 9th Pharmaceutical Technology Conference held at Veldhoven, The Netherlands in April, 1990.

8.            Baveja, S.K., K.V. Ranga Rao, Jagdish Arora and N.D.Mathur.(1990). Studies on Drug Release from Matrix Tablets containing Galactomannan Gums, 1990.Abstract D-12. International Symposium on Innovations in Pharmaceutical Science and Technology, Ahmedabad, India, Oct.1990.

9.            Baveja, S.K., K.V. Ranga Rao and Jagdish Arora. (1991). A Novel Method to measure    the Swelling Front in Swelling Controlled Release Systems, accepted for presentation at 42nd Indian Pharmaceutical Congress at Manipal, December,1991.

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

11.         S.Lai, P.Shah, J.Arora, C. Minchom and N. Barker (2000). Effect of concentration of Guaifenesin and poloxamer in the formulation of a cream product. Presented during AAPS  meeting in Indianapolis, Nov.2000

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

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

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

PROFESSIONAL AFFILIATIONS

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