Dr. Nagesh Palepu, Ph.D
Founder and Chief Scientific Officer
Nagesh Palepu is a seasoned professional in pharmaceutical development, with a career spanning over 30 years working in big pharma, generics, and drug delivery companies. Currently, he serves as the founder and chief scientific officer of Rhoshan Pharmaceuticals and Innovative Pharma Solutions Pvt. Ltd.
After obtaining his MSc in Chemistry from the esteemed India Institute of Technology (IIT), Bombay in 1972, he immigrated to the United States and began his career at Pfizer in pharmaceutical research and development. After five years as a bench chemist, Dr. Palepu began his PhD studies in pharmaceutics at the University of Iowa. Upon graduation, he joined Bristol Myers (now BMS) as a research scientist primarily focused on anticancer drugs. He was a critical member of the team responsible for filing the New Drug Applications (NDAs) for carboplatin and injectable cephalosporin and the supplemental NDAs (sNDAs) for Platinol AQ and Mutamycin. In 1983, Dr. Palepu left Bristol Myers and joined Adria Laboratories in Columbus, Ohio as a section head of formulation development (though his sports loyalty remained with the Iowa Hawkeyes). At Adria, he successfully filed ten ANDAs (abbreviated new drug applications), the NDA for Zinecard, and the sNDA for Adriamycin RTU (ready-to-use). Dr. Palepu left Adria after five years and joined SmithKline Beecham (now GSK) where he oversaw development of three NDAs (Topotecan, Teveten, and Avandia). After 25 years working in global pharmaceutical giants, he joined Geneva Pharmaceuticals as vice president of Research & Development, where he was heavily involved in planning and executing strategic steps to grow Geneva (now Sandoz) into a major global generic company. An opportunity at an oncology-focused drug delivery company, Sonus Pharmaceuticals, relocated Dr. Palepu from Colorado to Seattle, Washington.
With over 30 years working in various sectors of the pharmaceutical industry under his belt, Dr. Palepu ventured out on his own and simultaneously founded a pharmaceutical consultancy (Hitha Solutions) and a research and development company (TherDose Pharma) in Hyderabad, India. He met future business partner Mr. Joseph Bohan during a consulting assignment, and they founded SciDose LLC in early 2006. Since its inception, SciDose has obtained FDA approval on four products and is awaiting approval on two more. The lifetime sales of SciDose’s approved products has exceeded $1B.
With Rhoshan Pharmaceuticals, Dr. Palepu is currently focused on the development and approval of an injectable aspirin product, focused on hospital cardiovascular use. RHO-11 is under clinical development, with FDA filing expected in 2021.
To provide Innovative formulation solutions by scientific design, Dr. Palepu founded Innovative Pharma Solutions Private Ltd in Hyderabad, India in 2019. Innovative Pharma provides optimal formulations to provide therapeutic advantage to the patients.
Over his career, Dr. Palepu has published over 25 journal articles and has granted over 100 US and International patents as inventor/co-inventor.
Ms. Bharathy Palepu
Business Operations – CEO
Bharathy Palepu is Business Operations – CEO of Innovative Pharma Solutions Pvt. Ltd. She is also serving an important role as Administrator at Hitha Solutions by overlooking administrative accountabilities, accounting responsibilities and also, holding role of a Public Relations Officer. She has been back bone and critical pillar of strength for all initiatives that Dr. Nagesh Palepu has undertaken over the past 30+ years.
As a leader adept at managing change, she has been Founder of a very successful travel agency. She functioned as a Supervisor at a telecommunications company. She also worked in banking industry for several years holding several critical positions. She also held teaching position at various colleges and also worked as a computer consultant.
With vast experience she has held a range of roles of increasing responsibility, which has enabled her to develop extensive Operational, functional, and quality operations expertise.
A MPA (Masters in Public Administration), Bharathy Palepu has been recognized by several International forums for her role as one of the leading women professionals.
Global Business Operations
Ms. Hitha Palepu
Head - Strategy Planning & Business Development
Hitha Palepu is an entrepreneur, investor, and writer. She is currently the CEO of Rhoshan Pharmaceuticals, a pharmaceutical company developing injectable presentations of oral drugs. She is also Head – Strategy Planning & Business Development at Innovative Pharma Solutions Pvt. Ltd
Hitha joined Rhoshan Pharmaceuticals in 2017 to focus on fundraising and strategic partnerships. The company’s lead product, RHO-11, is focused on the early treatment of the top and third leading killers (heart disease and stroke, respectively) with a focus on women patients. FDA approval for RHO-11 is expected in 2022.
At Innovative Pharma Solutions she is responsible for the global R&D business development, growth in profitability, understanding nuances of customer requirements with close oversight on project management, operations and service deliverables. She has proven experience in planning, execution and leadership of new business strategies.
Hitha is an active angel investor, focused on funding women-led and women-focused startup companies. She has invested in over 10 companies, and advises them on brand and digital strategy. Her portfolio includes MM.LaFleur, Girls’ Night In, Werk, and Messy.fm.
Hitha is also a lifestyle content creator, where she shares simple solutions to help women live their best lives. She is the creator of #5SmartReads, a daily curation of the 5 must-read stories that reaches over 30,000 readers. Her blog, Hitha On The Go, reached hundreds of thousands of readers worldwide and became known for its travel and productivity content. Her first book, How To Pack: Travel Smart for Any Trip was published by Clarkson Potter in 2017. It has been released worldwide, translated into German and Italian, and is currently in its 3rd printing with 50,000 copies in circulation. Hitha and the book were featured by the New York Times, People, Travel+Leisure, and Elle.
Hitha graduated from the University of Washington with degrees in biochemistry and history. She lives in New York City with her husband and two sons.
Mr. Joseph Bohan
CEO and Co-Founder of SciDose LLC
Joseph Bohan is CEO and Co-Founder of SciDose LLC, a specialty pharma company founded in 2006 that develops novel injectable products.
He is currently member of Technical Advisory Board for Innovative Pharma Solutions.
He is also Chairman of Theranomics, a specialty pharma company focused on a novel platform for infectious diseases and acute care products. Mr. Bohan serves as a Trustee for Cooley Dickinson Hospital, an affiliate of Massachusetts General Hospital as well as on the Partners Healthcare Oversight Board in Boston, Massachusetts. Prior to SciDose, he was responsible for Worldwide Business Development at Nektar Therapeutics from 2001-2005. Bohan has served on the Boards of several not-for-profit organizations such as Verite whose mission is to advocate for fair labor practices worldwide, and University of Massachusetts entrepreneurial programs for students.
Scientific Advisory Board
Dr. P. C Buxton Ph.D, B.Tech, C.Chem, MRSC
Technical Advisory Board
Chris has thirty years’ experience in drug product development within research based multinationals (GlaxoSmithKline and legacy companies) and ten years in developing injectable products for the generic market (oncology products with patents held on a number including Bendamustine and Cyclophosphamide
His Expertise lies in drug substance salt and crystal forms. He is a patent author for major APIs paroxetine and rosiglitazone. He is Proponent of good pharmaceutical characterization of NCEs.
He has Organic chemistry based approach to drug stability with Wide knowledge of use and validation of analytical methodologies for drug product stability testing. He has vast Familiarity with solid and liquid dosage forms in all phases of development.
Chris holds First degree and PhD from the University of Loughborough in UK in 1969 and 1973 respectively. His PhD is in mechanistic organic chemistry under the supervision of Dr H. Heaney. He is also Member of the Royal Society of Chemistry and a Chartered Chemist.
Dr. Leonore C. Witchey-Lakshmanan
Principal Consultant, Pharma CMC/IP
Dr. Witchey-Lakshmanan has applied her PhD in Chemical Engineering to pharmaceutical development in her entire career. Her career began in CMC at Merck Research Laboratories, adding human CMC activities at Schering-Plough Research Institute, and including generic and 505(b)(2) activities at the start-up GeneraMedix Inc. Her work included developing conventional and controlled release dosage forms in veterinary medicine, preparing antibody and gene therapy products and processes for human medicine for cancer and other rare diseases. She has several patents, has published papers, has edited text books, and authored chapters on pharmaceutical development practices.
For the last many years, Dr. Witchey has been an independent pharma consultant, serving companies both in the US and overseas in all aspects of Pharmaceutical Development. She is currently member of Technical Advisory Board for Innovative Pharma Solutions.
These activities have extended from drug substance characterization, to formulation and process development, to process scale up and launch to commercial markets, as well as assisting in the writing of regulatory documents and responding to regulatory queries required for these launches. She is also a registered patent agent, assisting pharma companies in developing and maintaining their patent portfolios, via technology review, intellectual property prosecution, etc.