Lisa Cencia Rohan, PhD
Professor, Department of Pharmaceutical Sciences, School of Pharmacy, Department of Obstetrics, Gynecology & Reproductive Sciences, School of Medicine, Clinical and Translational Science Institute at the University of Pittsburgh
Considering “what women want and will use” is critical in designing effective pharmaceutical products for women. Our lab is developing innovative, safe, effective and acceptable drug delivery systems which meet the varied and changing needs of women across the world.
Lisa Cencia Rohan, PhD
Research in Brief
The focus of the Pharmaceutics Laboratory lies in the area of design of drug delivery and targeting systems. Several research topics are being pursued. The primary focus of the research in the lab is centered on the design of drug delivery systems for application in the areas of infectious disease, irritable bowel syndrome, and gynecologic oncology.
A major research program in the lab focuses on the development of microbicide products. HIV infection is a significant health problem worldwide with infection rates reaching pandemic levels. Heterosexual transmission has become a predominant route of infection for this disease. In heterosexually acquired cases of HIV, women are more susceptible to infection than men. Women account for nearly 50% of the people worldwide who are infected with HIV.
Microbicides are topical drug delivery systems that can be used to prevent transmission of sexually transmitted infections (STIs) including Human Immunodeficiency Virus (HIV). One important facet of such a product is that it would provide a female controlled method of prevention. According to the Centers for Disease Control there are approximately 20 million new cases of STIs reported in the US each year. Statistics from the CDC shows that our youth remain most at risk for STI infection. The HIV pandemic also continues to impact global health with two million people becoming HIV infected in 2014 according to UNAIDS. Men and women urgently need infection prevention technology that is within their personal control. Microbicides would provide such a technology. The research in the Pharmaceutics lab focuses on the development of delivery systems for microbicide drug candidates including small molecules, natural products, peptides & proteins, as well as genetically altered bacteria and probiotics. These systems range from traditional pharmaceutical products to novel vaginal drug delivery systems, which incorporate nanoparticulate technology or quick dissolve polymeric films. The lab has further extended their developed polymeric film technology to design vaccine products which do not require cold chain storage. This is critical for vaccine distribution in low resource settings. Projects in the lab also include the development of film products which combine HIV prevention drugs with contraceptive agents to provide women with multi-purpose pharmaceutical products. The lab collaborates with academic, not-for-profit, and industrial groups around the world in their pharmaceutical product development efforts.
In addition to product development efforts, the Pharmaceutics lab is currently studying the role of the chemical, physical, and biological properties of vaginal and cervical tissues and fluids in the development of vaginal and cervical products and developing in vitro model systems for use in the design of microbicide products. The lab has a specific interest in understanding drug transport and permeability through tissues. They have established models in female reproductive tract tissues to assist in development of vaginal products for women and have developed novel models to study the potential of new drug candidates for irritable bowel syndrome. The lab was the first to identify essential transporters and metabolizing enzymes in female reproductive tissues. The lab has also designed biologically relevant dissolution methods to better predict how drug products will function when used. This information is essential for the design of safe and effective vaginal products for a range of therapeutic areas.
Other research areas with which the lab has been involved includes the development and optimization of imaging techniques for sentinel node identification in cervical cancer as well as the development of novel delivery systems for chemotherapeutic agents.
Prior to her academic career, Dr. Rohan was employed in the pharmaceutical industry. Her experience there covered all aspects of product development including preformulation, formulation development and assessment, scale up, and clinical studies. She has been working in the area of product development for women’s health issues for the past 17 years. Her expertise lies in the design of drug delivery systems and the assessment of such systems with respect to safety, functionality, and efficacy.
The pharmaceutics laboratory at Magee is dedicated to identifying essential criteria for the design of drug delivery systems specific for women’s health issues. We are using this information to develop new products for women. Pharmaceutics involves the development of essential information that can be used to design drug delivery systems or dosage forms. Our focus is to get drugs to their target for action in a patient acceptable and safe manner while enhancing drug efficacy. Drug delivery research in the pharmaceutics laboratory covers a broad range of therapeutic areas. Specific areas include infectious disease, gynecologic health and oncology, vaccines, irritable bowel syndrome, and oral health. A major focus of research in the lab has been toward the development of products intended to prevent sexually transmitted infections including HIV. Specifically they are developing products that can prevent or reduce transmission of sexually- transmitted infections when applied to the vagina or rectum. Microbicide products would offer a female controlled method for prevention. HIV infection is a significant health problem worldwide with infection rates reaching pandemic levels. A number of products designed in the Pharmaceutics lab have been progressed from the bench to first in human clinical evaluation. The Pharmaceutics lab is involved in all aspects of pharmaceutical product development from preformulation and formulation development to formulation assessment, manufacturing, and scale-up.
In order to successfully design such drug delivery systems it is essential to have a full understanding of the female genital mucosa (vagina and ectocervix). Due to the anatomy and physiology of the female reproductive tract, women are twice as likely to become infected with the HIV/AIDS virus.
The Pharmaceutics Laboratory is conducting research in this area to better understand aspects which are needed for development of safe and effective vaginal products. The Pharmaceutics Laboratory is currently working on a number of funded research projects in the area of microbicide product development. Several of these projects are listed below.
1U19AI120249 (Program Co-PI with Hillier, S.; Project 1 PI; Project 4 PI) NIH/NIAID “Film Antirotroviral Microbicide Evaluation (FAME)”
Microbicides are products which are being developed for the prevention of HIV. This multiproject program will develop a new formulation of the antiretroviral drug MK-2048 that women will use just once weekly to prevent HIV infection transmitted through unprotected vaginal intercourse. The program includes laboratory, animal model and clinical trials to achieve these goals over 5 years.
U01FD005447 (PI; Co:Is: Little, S and Sfeir C) FDA “A biorelevant Dissolution Method for Particulate Dosage Forms in the Periodontal Pocket”
Currently there is no available standard dissolution system which can be applied to “prove” bioequivalence for long acting periodontal drug products. Dissolution testing is a key component in any pharmaceutical product development program. It provides data which describes how reproducibly drug is released from a product and can be used to predict drug release in the body. The goal of this proposal is to design a dissolution testing method which mimics the environment in periodontal pocket of the human body. This method can become a standard method used to test bioequivalence for generic products intended to treat periodontal disease.
OPP1110953 (PI ) Bill & Melinda Gates Foundation “Continued Assessment of Films for Multi-purpose Prevention Technology (MPT) Development”
These studies serve to generate critical gap activities toward the application of vaginal polymeric thin film dosage forms to address female sexual and reproductive health issues. Specifically, the utility of this platform for on demand multi-purpose technologies (MPT) will be established.
UM1 A1106707 (Central Laboratory: Co-Director, Comparative Assessment Core; Program PI: Dezzutti, C) NIH “Laboratory Center (LC): Microbicide Trials Network
Within the Central Lab Core of the MTN, the Pharmaceutics Lab is responsible for all product related issues with respect to clinical protocol implementation.
U19 A1113182 (Core PI; Program PI: Palmer,K) NIH/NIAID “Griffithsin-based Rectal Microbicides for PREvention of Viral ENTry (PREVENT)
The goal of the PREVENT Program is to develop a Griffithsin rectal gel that could be used prior to receptive anal intercourse (RAI) to reduce the risk of HIV infection.
R01 A1116292 (Co-Investigator; PI: Hladik, F) NIH/NIAID “Systems and Carcinogenic Impact Assessment of Topical Microbicides on Human Mucosa”
- Bunge KE, Dezzutti CS, Rohan LC, Hendrix CW, Marzinke MA, Richardson-Harman N, Moncla BJ, Devlin B, Meyn LA, Spiegel HM, Hillier SL. A Phase 1 trial to assess the safety, acceptability, pharmacokinetics and pharmacodynamics of a novel dapivirine vaginal film. J Acquir Immune Defic Syndr. 2015 Nov 11. PMID:26565716
- Kramzer LF, Cohen J, Schubert J, Dezzutti CS, Moncla BJ, Friend D, Rohan LC. Assessing the potential of the Woman’s Condom for vaginal drug delivery. Contraception. 2015 Sep;92(3):254-60. PMID: 25998936; PMCID: PMC4563346.
- Zhang W, Parniak MA, Sarafianos SG, Empey PE, Rohan LC. In vitro transport characteristic of EFdA, a novel nucleoside reverse transcriptase inhibitor using Caco-2 and MDCKII cell monolayers. Eur J Pharmacol. 2014 Jun 5;732:86-95. doi: 10.1016/j.ejphar.2014.03.022. Epub 2014 Mar 29. PMID: 24690257.
- Hu M, Patel SK, Zhou T, Rohan LC. Drug transporters in tissues and cells relevant to sexual transmission of HIV: Implications for drug delivery. J Control Release. 2015 Aug 13. PMID:26278511.
- Wang L, Schnaare RL, Dezzutti C, Anton PA, Rohan LC. Rectal microbicides: clinically relevant approach to the design of rectal specific placebo formulations. AIDS Res Ther. 2011 Mar 7;8:12. doi: 10.1186/1742-6405-8-12. PMID: 21385339.
- Holt JD, Cameron D, Dias N, Holding J, Muntendam A, Oostebring F, Dreier P, Rohan L, Nuttall J. The sheep as a model of preclinical safety and pharmacokinetic evaluations of candidate microbicides. Antimicrob Agents Chemother. 2015 Jul;59(7):3761-70. PMID: 25845860; PMCID: PMC4468677.
- Akil A, Agashe H, Dezzutti CS, Moncla BJ, Hillier SL, Devlin B, Shi Y, Uranker K, Rohan LC. Formulation and characterization of polymeri films containing combinations of antiretrovirals (ARVs) for HIV prevention. Pharm Res. 2015 Feb;32(2):458-68. doi: 10.1007/s11095-014-1474-4. Epub 2014 Jul 31. PMID: 25079391.
For additional publications, visit Pubmed.
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