Cross Functional Global Regulatory

Mandar V. Shah, Ph.D.

Rockaway, NJ ***** 973-***-****

Email: ***********@*****.***

https://www.linkedin.com/in/mandarshah

Drug Formulation Development Situational Leadership by Influence Innovation Portfolio and Program Management Evergreening of Patents Scientific & Business Collaboration

Scientific thought leader with 20+ years’ experience guiding operational strategy and clinical study execution.

A highly motivated, result-driven pharmaceutical professional with expertise in developing RX, generic, OTC, and surgical products for pharmaceutical companies across the US and India. Expertise in leading high-performing cross-functional teams in matrix environment; developing and filing innovative and generic sterile products; and managing pre-clinical (in vitro, in vivo), and clinical studies with CROs. Broad business background, skilled in aligning business objectives with practical pharmaceutical solutions, managing R&D, integrating multi-site projects, managing CMO network, its processes in hands-on manner, aligning culturally diverse teams and building communication environments that drive organizational success.

Empowering communicator who facilitates as a strong business partner with senior leadership teams; specializes in ‘Evergreening of Patents’ for known drugs, development of non-infringing formulation, difficult-to-formulate and difficult-to-manufacture generic products. Looking to leverage advanced education, career experience, and dedication to drive excellence across the workplace in the next phase of a rewarding career.

Developed commercial formulations of two NCEs, Sotalol and Etoposide, at BMS; improved viscoelastics and irrigating solution formulations at Alcon for cataract surgery and formulated several sterile generic products with some innovative products. History of delivering usable patents across continuum.

Product Development

Program/Project Management

Regulatory & IP Strategy

Expert in Sterile Product Development

FD of Dosage Forms

NCE Development

Team Leadership & Scientific Mentoring

Pre-clinical & Clinical Strategies

Technology Screening

Business Case Development

CFT Management & Leadership

Risk Assessment &Mitigation

CDMO & CRO Management

Due Diligence

Influence Decision Making

Stakeholder & Vendor Relations

Data Management & Analytics

Filing ANDAs & 505(b)(2)

Global Regulatory Compliance

Market Dynamics & Intelligence

KOL Development

Evergreening of Patents

Non-infringing formulations

PROFESSIONAL EXPERIENCE:

Odin Pharmaceuticals/Somerset Therapeutics, Somerset, NJ

Vice President, R&D (Injectable and Ophthalmic Generic and Innovative Products) April 2017 to August 2023

Related Skills: Strategic Planning, Project Management, Technical Issue Resolution, People Management, Leadership Support, R&D, Nano-Emulsion & Nano-Suspension Development, Product Development, CMO/CDMO Relations, New Product Launches, Manufacturing, Product Conceptualization, Product Formulation, Pre-Clinical Studies, Clinical Studies, NDA Filings, 505(b)(2) Filings, Regulatory Compliance, Quality Assurance, Contractual Agreements, Negotiation, cGMP Regulations, Mentorship, Literature Reviews, QbD Studies, Stability Studies, Scale-Up, Process Optimization, Operation Management, budget.

Directed early- and late-stage drug product and formulation development to support CMC activities. Advanced productive global partnerships and created strong internal connections based on trust, technical expertise, effective planning, resource management, and clear communication. Coordinated meetings, interpreted technical data, planned experimental design, and influenced decision making.

Managed up to 60 concurrent injectable/ophthalmic projects in India and U.S.; collaborated with 65 scientists and research professionals to build innovative and generic products portfolio valued at $800+M.

Directed seven innovative projects to reduce dosing frequency of ophthalmic products or convert freeze-dried products to ready-to-use solution products and developed non-infringing formulations; obtained patents, carried out pre-clinical and clinical studies. These projects are valued at $300+M.

Managed $20M R&D budget and filed 12 ANDAs in first 12 months (200% increase from the previous year); subsequently filed up to 17 ANDAs YOY. Also managed continuous improvement projects.

Assisted team with solving process development issues, such as packaging challenges of ophthalmic bottles, improving nitrogen purging for injectables, resolving order of addition, increasing batch size, fixing lot-to-lot variability of incoming materials, etc. Also carried out risk assessment and risk mitigation of the projects.

Responded to FDA queries and received 30 approvals in first three years. In 2020, company received warning letter from FDA and could not obtain any additional approvals; however, almost 50 additional approvals will be approved once facility issues are resolved.

Mentored /coached junior researchers and championed career succession; reduced attrition rate in R&D Division from 12% to less than 5%.

West-Ward Pharmaceuticals Corp., Cherry Hill, NJ

Sr. Director, R&D (Semi-Solid Generic Products) September 2016 to March 2017

Related Skills: External development, virtual CDMO management, In-License & Out-License Agreements, Negotiation, Strategic Planning, Leadership.

Reported to COO and with BD, virtually managed 23 projects at CDMO; portfolio size was ~ $250M. At CDMO, carried out product development, IVRT and BE studies; For scale-up, carried out process optimization. The objective was to deliver products for global success in a timely manner as per the pre-defined scope and within budget.

Played a significant role in relationship management and built key relationships with CDMO partners; developed the confidence of senior management to carry out course correction for multiple projects.

Provided timely reports, made presentations to senior management regarding project status; provided insights; and defined short-term objectives and goals to ensure positive outcomes and measurable results were obtained.

Sentiss Pharma Pvt. Ltd., Gurugram, India

Vice President to CSO (Ophthalmic and Inhalation Generic and Innovative Products) August 2012 to September 2016

Related Skills: Generic Product Development, Scale-up and Process Optimization, Product Pipeline Growth, In-License & Out-License Agreements, Conflict Management, COG Reductions, RA Compliance, RA strategy, budget projection and management, Dossiers, Clinical Trials, Negotiation, Leadership.

Successfully led 40+ scientists in multiple functions, including R&D, Product Development, Analytical Development, and Medical Affairs. Developed generic and innovative products, defined product pipeline, supported to in-license and out-license technology, assisted in resolving manufacturing issues and helped plant reduce COGs.

Played instrumental role in earning “Most Innovative Company of the Year” (Business Week/Yes Bank) in mid-sized company category in India.

Collaborated with BD to identify target compounds, select global sourcing contractors, reverse engineer products, develop final formulations, scale-up manufacturing, and file dossiers.

Guided up to 40 scientists, launched products in Russia and increased sales by 25% YOY with very small R&D budget.

At Sentiss Research Center, oversaw filing of 10 ANDAs in U.S and 15 regulatory filings in Russia/CIS countries; obtained CE mark for 4 products and planned clinical trials for two 505(b)(2) products.

Reduced R&D’s failure rate from one in three projects to one in nine projects (including Para IV projects).

Johnson & Johnson Family of Consumer Companies, Morris Plains, NJ

Senior Manager (Ophthalmic, & Topical Consumer Products) December 2006 to February 2012

Related Skills: Strategic Risk Assessment and Risk Mitigation, Technical Issue Resolution, Product Development, CMO/CDMO Relations, New Product Launches, Manufacturing, Product Conceptualization, Product Formulation, Pre-Clinical Studies, Clinical Studies, GMP Compliance, Negotiation, cGMP Regulations, Coaching, Literature Reviews, QbD Studies, Stability Studies.

Provided outstanding direction in the development of next-generation products/claims for many popular brands such as, Visine, BenGay, Neosporin, Cortaid, Benadryl, and Caladryl. Transitioned from Eye Care into Topical Healthcare. Developed product concepts, managed timelines, cross-functional teams, and budgets.

Interpreted market research data and developed strategies for launching the first Multi-Symptom eye drop, Visine Totality. This launch increased the sale of Visine® brand by about 30% at that time.

Successfully met internal/external customers' needs in developing a new gentle yet effective preservative for Visine; and negotiated regulatory strategy to move products through the monograph route. The strategy relied on in vitro and in vivo data with limited human exposure.

Effectively led and managed the team through change/transformation (J&J had acquired Pfizer Consumer Healthcare), coached and developed scientists, created opportunities and nurtured an environment of collaboration to meet product and organization’s vision and goals.

Facilitated to resolve technical and non-technical issues regarding the launch of a line of eczema products for the Neosporin brand and a cold therapy product for BenGay.

Completed line extension projects for BenGay®, Neosporin®, and Cortaid® brands. This added respective brand sales of up to 20% and stopped market decline.

Facilitated new eczema product line launch for Neosporin® brand and cold therapy products for BenGay®.

Pfizer Consumer Healthcare, Morris Plains, NJ

Senior Research Associate (Ophthalmic Consumer Products) August 2004 to December 2006

Related Skills: Product Conceptualization, Product Pipeline Growth, In-License & Out-License technology, Matrix Environment, Cross-Functional Team, Dossiers, Clinical Trials, Negotiation.

Carried out evaluation of technologies to identify and plan next generation of $100+M consumer eye care products.

Collaborated with BD and Marketing professionals to select proprietary hyaluronic-polylysine (HA-PLL) conjugate technology for dry eye; identified and contracted labs to synthesize API and improved synthetic yield from 30% to 80% to make technology commercially viable and initiated pre-clinical trial.

Drafted CMC section for 510(k) application of new ophthalmic spray bottle and responded to FDA queries; submitted formulation-based patent for self-preserving solutions utilizing known concepts of pH, buffers, chelating agent, antioxidants, osmolality, and polymers for innovative technology.

Alcon Research Ltd., Fort Worth, TX

Sr. Scientist I to Sr. Scientist III – Product Development (Ophthalmic Surgical Products) August 1996 to August 2004

Related Skills: Product Conceptualization, Irrigating – Parenteral Products Development, Matrix Environment, Cross-Functional Team, Dossiers, Clinical Trials, Negotiation.

Supervised two scientists, developed product concept and actual products.

Developed a new product concept of viscous irrigating solution, which was very successful in clinical trials and achieved all the targeted end points. Received two patents for the product, filed NDA and was approved by FDA.

Was a Project Leader and innovator for development of new irrigating solutions and viscoelastics for ocular surgeries, mainly cataract. Planned its Regulatory strategy, promoted collaborative teamwork, motivated team members to reach performance goals in timely manner and ensured open communication channels with scientists from multi-disciplinary functions.

Launched silicon oil for retinal detachment.

Resolved incompatibilities between calcium chloride and bicarbonate buffer during terminal sterilization. Also stabilized glutathione disulfide (GSSG) with the help of histidine during terminal sterilization for ocular irrigating solution. Two patents have been applied for the work.

Stabilized an ocular irrigating solution containing an unstable compound AL-8417 (NCE) with the help of ascorbic acid. Filed patent application to stabilize the compound. Filed IND and took it to Phase II CT. However, the compound demonstrated a lack of adequate efficacy in clinical trials, so it was not pursued further.

Drafted CMC section for various regulatory submissions such as IND, NDA and MAA for AL-8417 and Viscous irrigating solution. Obtained CE Mark for some products classified as surgical devices in Europe.

Additional experience:

Product Development Scientist (Antiacid tablets and Oral Suspension) at Guardian Drug Company in NJ

Group Leader for Non-Solids Formulations Group (Generic Oral Liquids and Injectable Products) at Ranbaxy Labs in India

Research Investigator I (New Drugs - Oral and Injectable Solutions) at Bristol-Myers Squibb in Evansville, IN.

EDUCATION & CREDENTIALS:

Doctor of Philosophy in Pharmaceutical Chemistry, The University of Kansas, Lawrence, KS

GPA: 3.8

Master of Science in Pharmaceutics, Northeast Louisiana University, Monroe, LA

GPA: 3.9

Bachelor of Pharmacy, L. M. College of Pharmacy, Gujarat University, India

Graduated first in class (equivalent to GPA of 3.6) and fifth rank in the University.

Certifications:

Project Management Professional, Project Management Institute (No. 1529683) (2012 to 2014)

Management Fundamentals I & II, Johnson & Johnson (2010)

Awards:

Most Innovative Company of The Year Award, Sentiss Pharma (2014)

Innovation Circle Award, Pfizer Consumer Healthcare (2006)

SELECTED PATENTS:

1.Shah M. V., Parthasarathi K., Subramanian I., Subramanian V. & Trehan A. ‘Buffer-Free Stable Ophthalmological Compositions of Ketorolac and Phenylephrine and Applications Thereof’ US Patent No. 11,696,910-B2 (2023).

2.Shah M. V., Subramanian I., Subramanian V., Trehan A. & Doshi O.P. ‘Triamcinolone and Moxifloxacin Methods’ US Patent No. 11,510,930-B2 (2023).

3.Shah M. V., Subramanian V., Subramanian I., ‘Tobramycin Compound Conjugates and Derivate Compositions’ US Patent No. 11,344,566-B2 (2022).

4.Shah M. V. & Bahri D., ‘Ophthalmic solution’ US Patent No. 11,285,163-B2 (2022).

5.Shah M. V., Subramanian V., Subramanian I., Trehan A., ‘Efficient Tobramycin Compound Conjugate Compositions’ US Patent No. 11,298,368-B2 (2022).

6.Shah M. V., Subramanian V., Subramanian I., Trehan A., ‘Triamcinolone and Moxifloxacin Compositions’ US Patent No. 11,298,315-B2 (2022).

7.Shah M. V., Subramanian V., Subramanian I., Trehan A., ‘Effective Benzalkonium Chloride-Free Bimatoprost Ophthalmic Compositions’, US Patent Publication No. 2021/0177780 A1.

8.Shah M. V., Subramanian V., Subramanian I., Trehan A., ‘Low Benzalkonium Chloride Bimatoprost Ophthalmic compositions with Effective Penetration and Preservative Properties’, US Patent Publication No. 2021/0177863 A1.

9.Shah M. V. & Bahri D. ‘Pharmaceutical Composition Comprising Brinzolamide’; US Patent No. 10,632,198-B2 (2020).

10.Shah M.V & Bahri D.; ‘Topical Brimonidine Tartrate Ophthalmic Solution’, Sentiss Pharma Pvt. Ltd., US Patent No. 10,517,869-B2 (2019).

11.Shah M. V., Bahri D. & Pandit D; ‘Process for Manufacturing Sterile Ophthalmic Pharmaceutical Suspension’, Sentiss Pharma Pvt. Ltd., US Patent No. 10,463,674-B2 (2019).

12.Shah M. V., Pandit D. & Bahri D.; ‘Pharmaceutical Composition Comprising Brinzolamide’, Sentiss Pharma Pvt. Ltd., US Patent No. 9,820,991-B2 (2017).

13.Shah M. V., Bahri D., Kumar M.; ‘Preservative-free Ophthalmic Pharmaceutical Formulation’, Sentiss Pharma Pvt. Ltd., US Patent No. 9801813-B2 (2017).

14.Shah P. S. & Shah M. V.; ‘Antispasmodic 1,2-diols and 1,2,3-triols’; Prima Innovations, LLC, US Patent No. 885,3189 B2 (2014).

15.Shah M. V., ‘Soothing Agents’; McNeil PPC; US Patent Publication No., 2012-213,717.

16.Shah M. V., Bullock J.P., Weiner A. L., Dollinger H. & Patel S. B., ‘Intraocular Irrigating Solution and Methods for Treating Corneal Edema’; Alcon Research Ltd., US Patent Publication no. 2009-264,375 A1.

17.Shah M. V, ‘Surface Modified Viscoelastics for Ocular Surgery’; Alcon Inc., US Patent No., 7,578,809 B2 (2009).

18.Shah M. V., Bullock J.P., Weiner A. L., Dollinger H. & Patel S. B., ‘Stabilized Glycerophosphate Containing Surgical Irrigating Solution’; Alcon Research Ltd., US Patent Publication no. 2009-239,957 A1.

19.Shah M. V., ‘Dilution Resistant Viscoelastic Compositions’; Alcon Inc., US Patent No., 7,363,928 B2 (2008).

20.Shah M. V., Sussman G., Cohen D. & Doshi U., ‘Solution for Removing Cataract via Liquefracture’; Alcon Research Ltd., US Patent No. 7,169,755 B2 (2007).

21.Shah M. V., Doshi U. & Holeva K., ‘Self-Preserving Compositions’; Warner Lambert Company LLC, NJ; US Publication No., 2007/0297990 A1.

22.Shah M. V., Boukhny M., Garner W., Markwardt K. & Doshi U., ‘Intraocular Irrigating Solution Having Improved Flow Characteristics’; Alcon Research Ltd., US Patent No. 7,084,130 B2 (2006).

23.Shah M. V., Doshi U. & Liao J., ‘Stable, Surgical Irrigating Solutions’; Alcon Research, Ltd., US Patent Publication No. 0,138,499 A1 (2003).

24.Asgharian B., Cagle G., Shah M. V. & Markwardt K., ‘Ophthalmic compositions containing galactomannan polymers and borate’; Alcon Manufacturing Ltd., US Patent No. 6,486,138 B1 (2002).

25.Bawa R., Hall R. E., Kabra B. P., Teague J., Cagle G. D., Markwardt K. & Shah M. V., ‘Gelling ophthalmic compositions containing xanthan gum’; Alcon Manufacturing Ltd., US Patent No. 6,261,547 B1 (2001).

26.Shah M. V. ‘Stability of Vitamin D3-Palmitate in Oral Liquid Multi-Vitamin Formulations’; Bristol-Myers Squibb, US Patent No. 5,478,816 (1995).

PUBLICATIONS:

1.Shah M. V., DeGennaro M. D., & Suryakasuma H. (1987). An evaluation of albumin microcapsules prepared using a multiple emulsion technique. J. Microencapsulation, 4, 223-238.

2.Ahmed I., Gokhale R. D., Shah M. V. & Patton T. (1987). Physicochemical determinants of drug diffusion across conjuctiva, sclera and cornea. J. Pharm. Sci., 76, 583-586.

3.Shah M. V., Audus K. L. & Borchardt R. T. (1989). The application bovine microvessel endothelial cell monolayers grown onto polycarbonate membranes in vitro to estimate potential permeability of solutes across the blood-brain barrier. Pharm. Res. 6, 624-627.

PODIUM PRESENTATIONS:

1.Ahmed I., Gokhale R. D., Shah M. V. & Patton T. (1985). Physicochemical determinants of drug diffusion across conjuctiva, sclera and cornea. Presented at 39th A.Ph.A. National Meeting in Minneapolis, MN, October 20-24, 1985.

2.Shah M. V. & Borchardt R. T. (1989). Characterization of nucleoside transport system in bovine brain microvessel endothelial cell monolayers. Presented at 4th AAPS Annual Meeting in Atlanta, GA, October 22-26, 1989.

3.Shah M. V., Pulliah K. C., Chu C. C. & Borchardt R. T. (1990). Implications of phosphorylation of nucleosides on their transport across the blood-brain barrier. Presented at the 5th AAPS Annual Meeting in Las Vegas, Nov. 4-8 (1990).

4.Shah M. V. (2012). Evergreening of Patents (secondary patents). Presented at Drug Delivery and Formulation Summit, Berlin, Germany, January 16-18, 2012.

5.Shah M.V. (2014). Patenting of Complex Generics. Presented at Select Bioscience Conference, Mumbai, India, Mar. 24-25, 2014.

POSTER PRESENTATIONS:

1.Shah M. V., DeGennaro M. D., & Suryakasuma H. (1985). An evaluation of albumin microcapsules prepared using a multiple emulsion technique. Presented at A.Ph.A. Midwest Regional Meeting in Chicago, IL, May 18-21, 1985.

2.Shah M. V., Scriba G. K. E., Audus K. L., & Borchardt R. T. (1988). The use of polycarbonate membrane supports in studying the potential permeability of solutes across the bovine brain microvessel endothelial cell monolayers. Presented at 3rd AAPS Annual Meeting in Orlando, FL, October 30-November 3, 1988.

3.Shah M. V. & Doshi U. (1999). Development of stable intraocular irrigating solution of a new chemical entity, AL-8417. Presented at 14th AAPS Annual Meeting in New Orleans, LA, November 14-18, 1999.

4.Shah M. V. (2012). Evergreening of Patents. Presented at Annual Meeting of Drug Delivery and Technology in Berlin, Germany, January 16-18, 2012.

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