Team
Eve del Rio, M.D., Ph.D.
Company Founder and President
As a 35-year clinical research/regulatory professional, I have worked in many therapeutic areas and in all phases of drug development for submissions to U.S. Food and Drug Administration Center for Drug Evaluation and Research (FDA CDER) submissions, including, but not limited to:
- dermatology
- infectious disease
- antivirals
- cardiovascular
- pulmonary, and
- Rx-to-OTC switches.
- neurology
I also have experience in submissions to:
- Center for Biologics Evaluation and Research (CBER)
- Office of Vaccines Research and Review (OVRR), and
- Center for Devices and Radiological Health (CDRH).
My broad experience of working in dermatology on many projects has resulted in careful attention to nuances engendered from years of dermatological product development experiences. This experience can significantly enhance the likelihood of favorable interactions with the FDA. Having worked on more than 40 dermatology programs (such as, but not limited to, all tinea indications, including onychomycosis, herpes simplex virus (HSV), psoriasis, atopic dermatitis, alopecia, wound care, actinic keratosis, acne, mitigation of fine lines, hyperpigmentation, rosacea), and 100+ programs overall, I am highly qualified to complete dermatological drug development from inception through implementation and follow-up.
My work on validating clinical trial methods based on Good Clinical Practice (GCP) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)-compliant clinical trials has been published in peer-reviewed journals. I also chaired international clinical team meetings and investigators' meetings, led a clinical research staff, and managed a substantial R&D budget.
My experience as a Quality Assurance auditor afforded me the knowledge and understanding of GCPs and compliance with FDA regulations and guidelines.
I have also served as a medical and regulatory consultant for Pfizer Pharmaceuticals (17 years), Pfizer Consumer HealthCare (7 years), and Glaxo Smithkline (10 years), the latter continuing specifically for Rx-to-OTC switches and dermatology. I earned an M.D. and a Ph.D. from Columbia University College of Physicians and Surgeons in 1991, with residencies and fellowships in emergency medicine, clinical immunology and dermatology from Columbia Presbyterian and Mt. Sinai Hospital. I also hold a B.A. in zoology from Drew University, Madison, N.J., in 1984.
2001‒present: Rio Pharmaceutical Services, LLC
As founder and president, I have operated this full-service pharmaceutical and regulatory consulting practice successfully for more than 20 years. We write strategic documents, such as briefing packages that cover across the entire drug, biologic, and device development/approval spectrum of the pharmaceutical industry, including pre-IND, end of Phase 2, and pre-NDA.
RPS also consults on clinical development plans, white papers, expert panel meetings, and preparation for advisory panels, as well as specializes in writing clinical and safety sections for investigational new drug applications (INDs), pre-submission documents for devices (formerly investigational device exemptions, or IDEs), new drug applications (NDAs), biologics license applications (BLAs), and pre-market approvals (PMAs), all in Electronic Common Technical Document (eCTD) format.
1986‒2001: Executive Experience in Pharmaceutical Clinical Research and Operations
Prior to building a full-service pharmaceutical and medical device consulting practice, I was vice president, clinical research and operations, for a disease/medication management service and specialty pharmacy/data management operation that optimized and rationalized drug therapy, founded in 2001 (Opt-e-scrip). The company's line of business included the retail sale of prescription drugs, proprietary drugs, and non-prescription medicines.
From 1997 through 2000, as Director of Clinical Research and Operations for Novartis Consumer Health, while working on Lamisil, I had global clinical research and clinical operations responsibilities for global dermatology, as well as all US switch and direct-to-OTC responsibilities. I conducted research and drafted FDA submissions in several areas of new pharmaceuticals, developing global regulatory and clinical strategies to support Rx-to-OTC switch applications. I also attended and participated in relevant regulatory meetings at FDA, while also writing the briefing packages and drug-development plans.
From 1996 through 1997, as assistant director of clinical research and operations for SmithKline Beecham (since December 2000, part of GlaxoSmithKline), I also had global clinical research and clinical operations responsibilities for dermatology, cough/cold and smoking cessation. I worked on the Denavir (penciclovir) switch for herpes labialis (cold sores), bringing the submission to the advisory stage with FDA, where I actively engaged with FDA’s antiviral division, as well as its nonprescription drug division. In this process, I worked directly with the leading medical experts in herpes simplex labialis (recurrent HSV).
From 1994 through 1996, as senior research scientist for Wyeth, a division of American Home Products Corp, I conducted research and drafted FDA submissions in several areas of new pharmaceuticals, while also developing global regulatory and clinical strategies to support Rx-to-OTC switch applications.
From 1991 through 1993, I worked at Whitehall-Robins Healthcare, a division of American Home Products Corp., where I reported to Regulatory as Quality Assurance (GCP) auditor for two years. In this role I conducted both internal and external investigational site audits to ensure compliance with FDA regulations, after which I shifted to a position in clinical research & operations as a research scientist (see above), moving up to work on Rx-to OTC-switches and direct-to-OTC products. In other words, I not only have the experience to carefully review audit reports, but also experience in clinical research and clinical operations, in addition to fully understanding FDA’s Nonprescription Drug division.
Prior to 1991, I worked as a senior research scientist at Serex Immunodiagnostics developing in vitro diagnostics as a pre-doctoral candidate for my thesis at Columbia University Vagelos College of Physicians and Surgeons.
Donald P. Reitberg, PharmD.
Donald P. Reitberg, PharmD, has 30+ years of experience in the pharmaceutical industry. He is a registered pharmacist, pharmacologist, pharmacokinetics and clinical research/regulatory professional who has worked in many therapeutic areas and in all phases of drug development.
Prior to working as a consultant and developing start-up companies, Don served as Vice President of Scientific Affairs for Novartis, where he managed all aspects of new product development and support for existing products. He also served as a clinical research/medical affairs director for Pfizer, Sterling Drug, SmithKline Beecham, and American Home Products.
Dr. Reitberg received his B.S. degree in Pharmacy from the University of Utah, Salt Lake City, UT, and his Doctor of Pharmacy degree from the State University of New York at Buffalo (SUNYAB), Buffalo, NY. He completed a fellowship in pharmacokinetics, clinical pharmacology and clinical trials management at Millard Fillmore Hospital jointly with SUNYAB, Buffalo, NY. He is a member of the American Society for Clinical Pharmacology and Therapeutics and the American Pharmaceutical Association.
Robert Smith, PhD
Robert Smith, PhD, has 30+ years of experience in the pharmaceutical industry, providing or supervising statistical support for clinical trial design, analysis, and reporting in many therapeutic areas and in all phases of drug development, including life-cycle management. He contributed to several marketing applications, also serving as unblinded statistical liaison and voting member to Data Monitoring Committees.
Bob was Director of Global Biometric Sciences at Bristol-Myers Squibb, where he oversaw the statistical and clinical programming support for all clinical pharmacology and translational medicine studies. He began his pharmaceutical career as Manager of Biostatistics for CIBA-Geigy.
Dr. Smith received his Master of Science degree in Mathematics from Syracuse University, Syracuse, NY, and his Doctor of Philosophy degree in Statistics from the University of North Carolina at Chapel Hill. He is a member of the Biopharmaceutical and Biometric Sections of the American Statistical Association, as well as the Eastern North American Region (ENAR) of the International Biometric Society.
Gary W. Wolfe, PhD, DABT
Gary W. Wolfe, PhD, DABT, is an independent nonclinical toxicology consultant focusing on pharmacology/toxicology. Dr. Wolfe received his MS in 1976 and PhD in 1978 from Purdue University in Pharmacology and Toxicology. He joined Hazleton Labs (Covance) that year as a study director and then as Director of Toxicology. Dr. Wolfe then worked at R.O.W. Sciences and TherImmune Laboratories (GeneLogic Labs) as study director and then as Senior Vice President and Chief Scientific Officer. He was also Principal Investigator for the National Toxicology Program’s General Toxicology and Reproductive Assessment by Continuous Breeding Programs for 15+ years. Following GeneLogic Labs, Dr. Wolfe was nonclinical consultant at Summit Drug Development and Aclairo Pharmaceutical Development Group, providing scientific/regulatory advice. He has been an independent nonclinical consultant the past 10 years, involved in designing drug development programs and outsourcing nonclinical studies at domestic and international contract research laboratories. Dr. Wolfe is a board-certified toxicologist and member of the Society of Toxicology, the American College of Toxicology, and the Teratology Society.
Juan Martinez
Juan Martinez has 30+ years of clinical research experience. He started at the Papanicolaou Cancer Research Institute in Miami, FL, where he was involved in basic multiple sclerosis research. He next worked in drug analysis and clinical labs for the University of Miami, Division of Clinical Pharmacology, where he managed their 48-bed Phase I Unit. Juan subsequently managed Hazleton Laboratories’ Cosmetic and Proprietary Products Division, then was Branch Manager of Hill Top Research’s West Palm Beach site (consumer products testing for health and beauty care, oral care, and microbiology).
After HTR moved into pharmaceuticals (and was acquired by Radiant Research), he was named Director, and then Director of Clinical Services (business development, site selection, project feasibility, project management). Juan currently handles contract work for CROs and biopharmaceutical clients. He has 13 publications in well-known pharmaceutical and consumer-sector journals, and has presented clinical study results at national meetings, also participating in expert panel discussions for Denavir. Juan holds a B.S. degree in chemistry from University of Miami, and has completed work in behavioral medicine towards a master’s degree.
Leo Letendre, PhD
Leo Letendre is happy to collaborate with Rio Pharmaceutical Services after a distinguished industrial career spanning more than 38 years, with emphasis on both analytical and commercial process development in the pharmaceutical arena. Most recently, Leo established the bioconjugation process development group within Pfizer at its Pearl River site. Leo holds 17 patents including key patents related to the commercial preparation of Celebrex®, Dynastat™, Inspra™, Mylotarg™ and Besponsa®.
Additionally, Leo contributed to the development of several clinical antibody drug conjugate and vaccine candidates. He has had extensive experience in developing regulatory filings for both small molecules and bioconjugates. Leo is currently the Principal of Leo Letendre Consulting, LLC.
David R. Bristol, PhD
Dr. Bristol has been a statistical consultant for more than 15 years, following more than 20 years in the pharmaceutical industry. He was Director of Biostatistics at Purdue Pharma, after positions of increasing responsibility at other companies, providing or supervising statistical design, analysis, and reporting for clinical trials in several therapeutic areas, including cardiovascular, oncology, and infectious diseases.
As a consultant, David has provided statistical support of design and review for clinical trials in oncology, cardiovascular, anti-inflammatory, neurology, ophthalmology, dermatology, and many other therapeutic areas, and has served on more than 30 DSMBs in various therapeutic areas. He is the author or co-author of more than 40 statistical articles, primarily on clinical trials methodology, and has given more than 80 presentations at professional meetings.
Dr. Bristol received his PhD in Statistics from SUNY at Buffalo and his MS in Statistics from Michigan State University. He received his BS in Mathematics - Secondary Education from State University College, Fredonia, NY.
Helmut H. Albrecht, MD, MS, FFPM
Dr. Albrecht is a pharmaceutical physician with more than 25 years’ experience in leadership roles focused on innovation, product development & regulatory strategy, technology and opportunity assessments as well as medical marketing support.
He has worked in multiple therapeutic areas, including respiratory medicine, dermatology, gastroenterology, Gyn/OB and oncology. Besides the research for his doctoral thesis related to hepatic dysfunction in patients with various malignancies, his oncology experience includes the role of Medial Monitor and Safety Physician for several clinical trials in patients with B-cell non-Hodgkin’s lymphoma and acute myeloid leukemia.
Throughout his career in the pharmaceutical industry Dr. Albrecht filled positions of Senior VP for R&D at Adams Respiratory Therapeutics and VP in US and global leadership roles in R&D at Novartis Consumer Health. Earlier in his career he held key positions in the areas of pharmaceutical medicine in the Rx & OTC drug development space at SmithKline Beecham, Procter & Gamble, and Altana Pharma in Germany and North America.
Dr. Albrecht has an MD degree from the Universities of Heidelberg and Hamburg, a Master of Science in Management & Policy, and other certified qualifications in Health Care Management and Pharmaceutical Medicine. He is a fellow and former board member of the Faculty of Pharmaceutical Medicine (RCP) in the UK. Industry Liaison Representative (ILR), FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC): 2012 – 2015, alternate ILR: 2016-2019, ILR: 2020 - 2023. In 2014, Dr. Albrecht was named adjunct Associate Professor at the Dept. of Cellular Biology & Pharmacology, H. Wertheim College of Medicine, Florida International University (FIU).
Email: Helmut@H2A-Associates.com / Helmut.Albrecht@FIU.edu
Andrew M. O’Hearn, MA
Andy is associate director, communications and change management, for a leading pharmaceutical company (supporting the data sciences and analytics function). He is also a LinkedIn master networker, trainer, and coach, with more than 6,600 connections, including internationally known thought leaders, authors, and communications influencers.
Andy’s specialties include corporate storytelling / narrative / culture, social dynamics, behavioral economics, data visualization, search strategies, leadership, future trends, web usability, and crisis communications.
His career coaching places special emphasis on underserved niches such as women in leadership, BIPOC change agents, and cross-generational mentoring, as well as both gifted learners and the learning-challenged. You can connect with him at: https://www.linkedin.com/in/andyohearn/
Michael W. Rooney, PhD, MS
Dr. Michael Rooney has more than 25 years of Phase I-IV clinical research experience in multiple therapeutic areas. Dr. Rooney has held positions as Lead Medical/Regulatory Writer and Clinical Scientist, Senior Regulatory Writer, Senior Medical Writer, Clinical Research Consultant, Assistant Professor of Anesthesiology, Postdoctoral Fellow, Research Associate and Instructor. Dr. Rooney holds a PhD in Biomedical Engineering from Northwestern University and a Master of Science in Bioengineering from the University of Illinois.