GUL BALWANI

**** ***** ***, ******, ** *****

ad0n0h@r.postjobfree.com

http://www.linkedin.com/in/gulbalwani

510-***-**** (M)

SUMMARY

Pharmaceutical Product Development and Manufacturing Leader having a blend of scientific and business acumen in managing scientific projects. Thirty plus years of experience and skills in the execution and management of all technical operations during drug/product/device development and manufacturing for small and large molecules. Authored CMC Module 3 regulatory documents and gained IND and NDA approvals resulting in successful clinical trials and commercialization of drug products for large international as well as small domestic and virtual companies. Experienced in developing, and implementing cost effective and timely regulatory and development strategies, prioritization, project management, driving product development teams for phase appropriate formulation and analytical method development, manufacturing process development, scale-up, technology transfers, process validation, and commercialization. Collaborated with Clinical Operations, Manufacturing, Analytical, Quality and Regulatory to ensure timely manufacture of CTM’s at internal and external sites as per clinical trial protocols. Ensured quality and safety of products manufactured in a cGMP environment. Ensured project timelines, resources, budgets and goals are aligned and met. Excellent leadership, collaboration, negotiation, communication and decision making skills in the selection and management of alliance with CMO’s, internal and external stake holders and technical staff as well as leading cross functional project teams in matrix organizations.

AREAS OF EXPERTISE

Extensive knowledge of Regulatory Guidelines and Requirements for product approvals. Have had successful CMC submissions and interactions with FDA and EMA. Efforts have resulted in approval of many drug products along with their commercial launches

Experience with small as well as large sized molecules from various therapeutic areas for the selection of drug candidates based on preformulation and toxicological studies

Formulation development and manufacture of CTM’s for “First in Man” Clinical Studies, development of formulations (solid orals, liquid orals, topicals, parenterals, nasal, pulmonary, and ophthalmic dosage forms) and drug delivery systems to the development of commercial manufacturing processes using DOE, PAT and QbD principles

Experienced in the development of injectable drug products for cytotoxic compounds using Liposome Technology, downstream Ultra/Diafiltration processes and Lyophilization

Experienced in the development of conventional solid oral dose products as well as controlled release dosage forms including matrix tablets, layering of tablets and pellets in fluid bed driers, spray drying, and the development of combination drug products. Experience in developing dissolution methods and conducting IVIVC studies using in-vivo pharmacokinetic data.

Experienced in developing drug-device combination drug products for parenteral, nasal and pulmonary drug delivery.

Conducted Quality Audits for the selection of CRO/CMO/CDMO’s and suppliers, managing alliance with external contractors throughout the development program. Successfully managed many drug substance manufacturing, product development, manufacturing process development, scale-up and process optimization projects. Transferred manufacturing technology from Pilot Plant to global manufacturing sites including CMO’s.

PROFESSIONAL EXPERIENCE

Self Employed Independent CMC Consultant 11/2022 to Present

SRI International, Menlo Park, CA 94025 11/2021 to 11/2022 Director, Clinical Manufacturing

Self Employed Independent CMC Consultant 02/2021 to 11/2021

Nanosyn, Inc., Hayward, CA 94544 06/2020 to 02/2021

Executive Director, Formulations

Responsible for leading the Department and Business for drug product contract development and manufacturing services while delivering high quality, regulatory compliant, cost effective services to clients in a timely manner.

BioElectron Technology Corp. (Now PTC Therapeutics), Mountain View, CA 3/2018 to 7/2019

Director, Product Development

Responsible for leading all pharmaceutical drug substance, formulation and product development activities for New Chemical Entities from the Discovery Group. Developed RFP’s for selecting and managing CDMO’s for all development activities leading to the timely manufacture and supply of clinical trial materials to support clinical studies. Designed and ensured supply chain logistics, development of commercial packaging, labeling, packaging insert, instructions for use and serialization at a 3PL organization for Vatiquinone. Executed scale-up and validation activities for commercial launch of Vatiquinone at the selected CMO. Provided all CMC documents for Regulatory filings in US and Europe.

Aquinox Pharmaceuticals, San Bruno, CA 11/2016 to 3/2018

Senior Director, Pharmaceutical Development

Responsible for leading all pharmaceutical development activities, manufacture of drug substance and clinical drug product supplies, design of scale-up to commercial manufacturing, selection and management of CMO’s, technical planning for process validation and commercial manufacturing at selected CMO for AQX-1125 tablets in Phase III clinical trials.

Astex Pharmaceuticals (subsidiary of Otsuka) Pleasanton, CA 5/2015 to 10/2016

Full Time CMC Consultant

Responsible for managing a porfolio of four anticancer drugs in Phase 1-III stages of development in a virtual company environment. Manage all development and manufacturing activities at CMO’s. Support drug substance, formulation and analytical method development, manufacture of CTM and provide all regulatory CMC documents.

Novartis (now GSK) Healthcare, Lincoln, NE 8/2012 to 5/2015

Global Process Technology Team Leader

Manage and lead the Global Manufacturing Process Technology Team to execute drug substance development, product reformulations, manufacturing process development and improvements. Scale-up and optimization of manufacturing processes. Technology transfer and validation of API’s and Drug Products manufactured at internal as well as external manufacturing sites. Planned the inventory for DS, DP and Components supplies to ensure demands/forecasts are met accordingly. Provide direction and guidance for compliance to Regulatory Requirements, Operational Excellence and Continuous Process Verification at all global manufacturing sites.

Eagle Pharmaceuticals, Woodcliff Lake, NJ 2/2012 to 8/2012

Sr. Director, Pharmaceutical Development

Management of all CMC related activities for the development and approval of parenteral drug products using the 505(b)(2) approach using outsourced resources at CMO’s. Managed all supply chain resources to ensure all components are available in a timely and cost effective manner at the CMO’s.

Celator Pharmaceuticals, Princeton, NJ (Now a subsidiary of Jazz Pharmaceuticals) 3/2010 to 2/2012

Director, Process Development

Development of technology for the manufacture of freeze-dried nano-sized liposomal formulations encapsulating cytotoxic drugs using Celator’s CombiPlex® drug delivery technology. Completed manufacturing process development, scale-up and technology transfer of Vyxeos® a FDC drug product (cytarabine and daunorubicin) liposome for Injection to Baxter, a CMO located in Germany.

Ensured Phase III readiness and support manufacturing of Phase III clinical supplies at the CMO. Provided all CMC documentation required for submissions to FDA and EMA resulting in approval by the FDA in 2017.

Medpointe Pharmaceuticals, North Brunswick, NJ (Now Meda Pharmaceuticals) 2002-2009

Director, Product and Process Development

Successfully led various multi-functional CMC project teams towards creating and maintaining PDP’s and TDP’s, selection and development of drug candidates, mapping and qualification of impurity profile, manufacture of drug substance and dosage forms, design and implementation of all product development activities including preformulation, formulation development and manufacturing process development, transfer of technology to global manufacturing sites including CMO’s for commercialization. Managed the manufacture, packaging, clinical release and delivery of clinical trial materials for all Phases of global clinical and POC studies. Managed CMC related activities to support Regulatory filings. Supported Business Development, Portfolio and Life Cycle Management in the assessment of new product opportunities, and conducting due diligence and vendor Quality Audits.

Products developed/launched included:

Astepro® 0.1% Nasal Spray

Astepro® 0.15% Once Daily Nasal Spray

Optivar® BFS Unit Dose Sterile Ophthalmic Solution.

Dymista® A Fixed Dose Combination Nasal Spray containing azelastine hydrochloride and fluticasone propionate was developed and launched for allergic rhinitis.

A Fixed Dose Combination Oral tablet dosage form containing carisoprodol and diclofenac sodium was developed for skeletal muscle pain.

A Fixed Dose Combination Topical gel containing carisoprodol and diclofenac was developed for skeletal muscle pain.

A Controlled Release solid oral drug product was developed and patented which incorporated an immediate drug release followed by sustained drug release for 12-hours for the treatment of skeletal muscle pain reaching Phase III Clinical Trials.

Successfully transferred the aseptic manufacture process for Optivar multidose sterile ophthalmic solution to Patheon’s manufacturing facility in Swindon, UK.

Transferred the manufacturing technology for Depen® Film Coated Tablets to Patheon’s facility in Cincinnati, OH.

Aradigm Corporation, Hayward, CA 1999-2002

Scientific Director & Project Manager

Provided team leadership in managing the project, budget and resources. Directed the development of a sterile formulation aseptically packaged into blisters, selection and qualification of the AERx® device, development of analytical methods and the manufacture of clinical supplies, managed the supply chain leading to the successful completion of Phase I clinical study for Biochemie who was interested in developing an inhalation drug delivery system utilizing Aradigm’s AERx Technology and Recombinant Human Interferon alpha-2b. The successful outcome of this research work was patented and then presented by me at the 2002 Annual CRS Meeting held in Seoul, Korea.

Member of the Insulin Core Team responsible for leading and managing the Sub Team for all the CMC activities related to drug substance manufacturing, sterile product formulation development, device development, aerosol performance characterization, specification development, aseptic manufacturing process, supply chain and dosage form development. Selected and verified qualifications of a sterile container closure system to meet USP Class VI requirements, scale-up and transfer of technology to the pilot plant including manufacture of Phase III clinical supplies for Novo Nordisk who was interested in developing an inhalation drug delivery system utilizing Aradigm’s AERx Inhalation Drug Delivery System and Recombinant Human Insulin.

Shaman Pharmaceuticals, S. San Francisco, CA (Now Napo Pharmaceuticals) 1996-1998

Director, Product Development

Directed Drug Discovery and Product Development activities for the selection and development of new chemical entities derived from natural resources. Directed preformulation, formulation development and toxicological evaluation, development of manufacturing processes for drug substance, manufacture of toxicological & clinical supplies. Development of manufacturing processes for drug product, transfer of technology, scale-up and validation activities using CRO’s and CMO’s. Supported Medical in the development of clinical protocols, clinical study documents and forms, training CRA’s and monitoring clinical studies. Provided Regulatory with all development reports and CMC Documentation required for filing IND/NDA’s. Developed Virend® a topical gel formulation for the treatment of Herpes and an enteric coated tablet dosage form for Crofelemer® under evaluation for the treatment of chronic diarrhea in HIV/AIDS patients which reached Phase III clinical trials and is now currently launched under Napo Pharmaceuticals.

Yamanouchi Pharmaceuticals, Hayward, CA 1995-1996

Sr. Project Manager

Marketed and sold Contract Manufacturing Services. Supported all activities for sales promotion and marketing of Yamanouchi’s proprietary drug delivery technologies. Managed all aspects of project planning, leading project teams, financial analysis, scheduling and coordination of interdepartmental activities, regulatory support, and resource analysis to ensure timely implementation of planned activities for client companies to accomplish their objectives within the constraints of time and cost. Typical projects included product development of traditional as well as new drug delivery systems, contract manufacture of clinical supplies for Yamanouchi’s compounds, transfer of technology, scale-up and support validation activities at the manufacturing site located in Norman, OK. Developed a lyophilized parenteral formulation for YM90K at Ben Venue Labs, a CDMO.

Wallace Laboratories, Cranbury, NJ (Now Meda Pharmaceuticals) 1991-1994

Group Leader

Responsible for managing a process development group and Pilot Plant activities involved in the evaluation of various manufacturing procedures, technologies and equipment. Optimization, scale-up and transfer of technology to manufacturing sites (NJ, IL, and Puerto Rico). Responsible for CMC activities required in support of Regulatory filings and PAI’s. Efforts resulted in the approval of Felbatol® tablets and Felbatol® oral suspension by the FDA.

FMC Corp. Princeton, NJ 1990-1991

Sr. Research Pharmacist

Managed the development laboratories and provided technical assistance worldwide to customers in the pharmaceutical industry needing help in the development of pharmaceutical drug products. Provided analytical and technical support to Quality Control, Marketing and Sales for FMC’s existing products. Developed spheronization technology to produce Avicel spheres for layering and coating process in fluid bed driers to produce controlled/extended release drug products.

E. R. Squibb, East Brunswick, NJ (Now Bristol Myers Squibb) 1987-1990

Research Investigator

Developed formulations for solid, semisolid, liquid drug products. Manufacturing processes were scaled-up and transferred to commercial manufacturing sites. Managed the technology transfer of multisource liquid and lyophilized parenteral products developed by Marsam at Cherry Hill, NJ to Squibb manufacturing sites. Compiled and provided CMC sections. Reviewed the ANDA’s for all the generic injectable products developed and transferred to Squibb manufacturing sites. Efforts resulted in the approval of 12 ANDA’s for Squibb-Marsam.

EDUCATION

M.S., Industrial Pharmacy, St. John's Univ., NY

M. Pharm., Pharmaceutical Chemistry, KMC, Manipal, India

B. Pharm., Pharmacy, KMC, Manipal, India

PROFESSIONAL TRAINING & DEVELOPMENT

Leadership and Strategy in Pharmaceutical and Biotech Industry, Harvard Business School.

European Filing & Registration Procedures, CfPIE.

Challenges in Leadership of Teams, MIT Professional Institute.

Improving your Project Management Skills: The Basics for Success conducted by AMA.

Course in Protein and Gene-based drugs: Product Development and Delivery challenges conducted by AAPS.

AAPS Workshop on Development and Registration of Drug Delivery Devices containing Biotechnology Products

PATENTS

Stabilized ophthalmic compositions for Enoxacin assigned to Warner Lambert/Parke Davis. Published 8/24/88.

Use of Hydroxyurea or 1-ethyl, hydroxyurea for the suppression of bone marrow assigned to Squibb. Filed 9/26/90.

Compositions and Methods of treatment with Proanthocyanidin polymer antidiarrheal compositions assigned to Shaman (now Napo Pharmaceuticals). Issued 1/29/08.

Methods of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer assigned to Shaman (now Napo Pharmaceuticals). Issued 3/11/08.

Antidiabetic compositions for Masoprocol to enhance bioavailability applied for by Shaman (now Napo Pharmaceuticals).

Use of Nordihydroguairetic acid to lower serum triglycerides, blood pressure and to treat Syndrome X applied for by Shaman (now Napo Pharmaceuticals).

Compositions, methods and systems for pulmonary delivery of recombinant human interferon alpha-2b assigned to Aradigm. Issued 12/14/04

Novel decongestant/antihistaminic/expectorant compositions applied for by MedPointe Pharmaceuticals (now Meda Pharmaceuticals).

Compositions comprising Azelastine and methods of use thereof applied for by MedPointe Pharmaceuticals (now Meda Pharmaceuticals).

Compositions comprising carisoprodol and methods of use thereof assigned to MedPointe Pharmaceuticals (now Meda Pharmaceuticals).

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