Pathfinder Pharmaceuticals is led by a team of three highly experienced scientists, who share a vision for inventing better drugs.
Karen R. Romines, Ph.D. Dr. Romines is a medicinal chemist with over 16 years of experience in drug discovery and development at The Upjohn Company and GlaxoSmithKline. She has a track record of creating structural innovations that lead to clinical candidates. For example, early in her career at The Upjohn Company, she used mid-sized cycloakyl rings to dramatically improve the potency of HIV protease inhibitors, leading to a clinical candidate. She is an inventor on 9 US patents, and her research contributions have led to multiple clinical candidates, including the approved HIV protease inhibitor tipranavir.
Dr. Romines’ career has not been limited to medicinal chemistry. She has also held Director level positions in Viral Diseases Strategy and as head of the Department for Oncogenic and Emerging Viruses. In these roles, she built GSK’s early stage portfolio from a single screening program to a full complement of nine projects. In addition, she worked with scientific, clinical, and business experts across the viral diseases franchise to introduce new disease areas and targets. Some of her efforts also focused outside of GSK, as she collaborated closely with the business development group to evaluate potential in-licensing opportunities. This has given Dr. Romines a rare combination of significant experience in the chemistry, biology, and business of drug discovery, as well as invaluable insight into the entire drug discovery and development process.
Dr. Romines holds a Ph.D. in organic chemistry from the Massachusetts Institute of Technology. She has authored 18 publications in peer-reviewed journals, as well as HIV review articles. She has also authored an upcoming book chapter on tipranavir and co-authored a book chapter describing HIV drug discovery.
Selected References: • Romines, K.R., et al. “Structure-Activity Relationship Studies of Novel Benzophenones Leading to the Discovery of a Potent, Next Generation HIV Nonnucleoside Reverse Transcriptase Inhibitor,” J. Med. Chem. 2006, 49:727-739. • Judge, T.M., et al. "Asymmetric Syntheses and Absolute Stereochemistry of 5,6-Dihydro-α-pyrones, A New Class of Potent HIV Protease Inhibitors," J. Am. Chem. Soc., 1997, 119:3627-3628. • Romines, K.R., et al. "Use of Medium-Sized Cycloalkyl Rings to Enhance Secondary Binding: Discovery of a New Class of HIV Protease Inhibitors," J. Med. Chem., 1995, 38:1884-1891.
Karen K. Biron, Ph.D. Dr. Biron is an internationally-recognized virologist. In her 29-year career at GlaxoSmithKline and predecessor companies, she made key contributions to the development of acyclovir and valacyclovir, including expanding the approved indications for both of these drugs. Dr. Biron went on to make key contributions in new approaches to cytomegalovirus (CMV) therapy. As a result of the collaboration she formed with University of Michigan scientists, her team discovered a pair of benzimidazole CMV inhibitors which progressed to clinical evaluation. Dr. Biron not only shepherded these compounds through development, but her collaborative team also elucidated the two different mechanisms of action of the drugs. One of these compounds, maribavir, is now in phase 3 development.
Dr. Biron’s expertise extends beyond drug discovery to clinical development. As the head of clinical virology at GSK, she gained significant experience in clinical trial design and regulatory requirements. Her team oversaw the clinical development of herpes and HIV drug candidates and conducted post-marketing virology analyses. They became experts in the mechanisms of drug resistance, and again Dr. Biron’s ability to work across the pharmaceutical R&D spectrum benefited many patients, as she led her team in using key resistance data to shape next-generation drug candidates.
Dr. Biron’s professional influence reaches far beyond her own research group. She is a past president and board member of the International Society of Antiviral Research; she has served on the NIH AIDS and Related Research Study Section review panel; she participated in the National Academy Workshop on Smallpox to aid in developing the antiviral research strategy for biodefense; and she has served on the editorial boards of several scientific journals. Dr. Biron holds a Ph.D. in microbiology and virology from Rutgers University, and has authored 62 publications in peer-reviewed journals, as well as a number of invited reviews and book chapters. In 2009, Dr. Biron’s research was recognized by the International Society for Antiviral Research with the Gertrude Elion Senior Investigator Research Award.
Selected References: • Biron, K.K., et al. “Potent and Selective Inhibition of Human Cytomegalovirus Replication by 1263W94, a Benzimidazole L-Riboside with a Unique Mode of Action.” Antimicrob. Agents Chemother., 2002; 46: 2365-72. • Sullivan, V., et al. “A protein kinase homolog controls ganciclovir phosphorylation in human cytomegalovirus-infected cells.” Nature, 1992, 358:162-164. • Safrin, S., et al., "Foscarnet therapy in five patients with AIDS and acyclovir-resistant varicella zoster virus infection." Ann. Intern. Med. 1991;115:19. • Biron, K.K. and Elion, G.B. “In vitro susceptibility of varicella zoster virus to acyclovir.” Antimicrob. Agents Chemother. 1980, 18:443-447.
Robert J. Harvey, Ph.D Dr. Harvey is an expert in drug discovery and drug mechanism of action studies with 40 years of experience at GlaxoSmithKline and predecessor companies. His primary research interest is how viruses evade the defenses of the host cell in order to replicate, and at Pathfinder, he uses his understanding of such targets to invent novel, broad-spectrum antiviral agents.
Dr. Harvey has applied his expertise in cell physiology, molecular biology, and enzyme and pathway kinetics to the discovery of antibacterial, antiviral, and anticancer agents. For example, he identified the most vulnerable enzymes in the folate pathway, and his work led to the discovery of antimicrobial and anticancer agents. The latter advanced to clinical studies. Dr. Harvey has also increased research efficiency by introducing automated data collection and processing into the drug discovery process. More recently, he played key roles in a number of virology discovery efforts and mechanism of action studies, including identifying maribavir, a cytomegalovirus drug now in phase 3, and elucidating the mechanism of action of BDCRB.
Pathfinder Pharmaceuticals is not Dr. Harvey’s first experience starting an organization. In 1993, he founded TASCA, a non-profit organization which improves public health in Nicaragua. Working with the Nicaraguan Ministry of Health, TASCA has established two regional public health laboratories and several rural water-testing laboratories, and the organization continues to support five laboratories with supplies, equipment and training of technicians. It also operates a successful scholarship program to train Nicaraguan health workers.
Dr. Harvey holds a Ph.D. in microbiology from University of California and has authored 56 publications in peer-reviewed journals.
Selected References: • Harvey, R. et al. “GSK983: A Novel Compound with Broad-Spectrum Antiviral Activity,” Antiviral Res. 2009, 82:1-11. • Selleseth, D.W., et al. “Interactions of 1263W94 with other antiviral agents in inhibition of human cytomegalovirus replication.” Antimicrob. Agents Chemother. 2003, 4:1468-71. • Underwood, M.R., et al. "Inhibition of human cytomegalovirus DNA maturation by a benzimidazole ribonucleoside is mediated through the UL89 gene product." J. Virology, 1998, 72: 717-725. • Dev, I. K., and Harvey, R. J. “A complex of N5,N10-methylenetetrahydrofolate dehydrogenase and N5,N10--methenyltetrahydrofolate cyclohydrolase in Escherichia coli. Purification, subunit structure, and allosteric inhibition by N10-formyltetrahydrofolate.” J. Biol. Chem. 1978, 253:4245-53.
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