Our Team

Dr. Finn co-founded RRD in 2002. Until the acquisition of RRD by Uniphar Group Plc in late 2020, he served as the Chairman and Chief Executive Officer and is one of the architects of RRD’s unique Product Development Team (PDT) partnership model. Dr. Finn is responsible for working with biopharmaceutical company partners and product development teams to create optimal development strategies and provides oversight and strategic input to partner programs. Dr. Finn has more than 35 years of experience in the research, development, and government regulation of biological and pharmaceutical products covering a wide range of product types and therapeutic indications. Dr. Finn began his career as a Staff Fellow at FDA, Center for Biologics Evaluation and Research. He then entered industry, where he has held senior positions of increasing responsibility in regulatory affairs and product development. Dr. Finn worked for several companies prior to co-founding RRD in 2002, including Lederle-Praxis Biologicals (Wyeth), Miles Pharmaceuticals (Bayer), Genetics Institute (Wyeth), BRI International, and Quintiles (IQVIA). Dr. Finn received a PhD in Biology from Georgetown University and a BS in Zoology from the University of Maryland.

Eric K. Rowinsky, MD, is principally focused on the comprehensive development and registration strategies of cancer therapeutics of all types. Dr. Rowinsky is the Editor-in-Chief of Investigational New Drugs, an Editorial Board Member of Cancer Research and several other oncology journals and has published approximately 315 manuscripts in both the nonclinical and clinical research fields. He has also served on the Board of Directors, Scientific Advisory Board and Project Advisory Boards of many pharmaceutical and biotechnology companies, as well investor groups, and has advised and/or presented aspects of NDAs to the FDA on many occasions. Since 2015, Dr. Rowinsky has served as an Executive Director and President at Rgenix Inc., a life sciences company focused on discovering new cancer targets using a novel microRNA platform, as well as the Chief Scientific Officer of ClearPath Development Co., which rapidly advances development stage therapeutic assets to pre-defined human Proof-of-Concept milestones. From 2012-2015, Dr. Rowinsky served as the Head of Research and Development, Executive Vice President, and Chief Medical Officer, at Stemline Therapeutics, Inc. From 2010-2011, he was the Chief Executive Officer of Primrose Therapeutics, which developed a small molecule therapeutics for polycystic kidney disease until acquired. From 2004-2010, he was an Executive Vice President of ImClone Systems, which became a wholly-owned subsidiary of Eli Lilly after its acquisition. At ImClone, Dr. Rowinsky and his team, developed and registered cetuximab (Erbitux), ramucirumab in five indications, and two other monoclonal antibodies in North America and elsewhere. Prior to joining ImClone in 2005, Dr. Rowinsky was a longstanding NCI principal investigator on U01 anticancer drug development grants and integrally involved in pivotal clinical and nonclinical investigations which lead to the development and registration of a wide variety of cytotoxic and targeted anticancer therapeutics. He has been an Adjuvant Professor of Medicine at New York University School of Medicine since 2005. From 1996-2004, Dr. Rowinsky served as the Director of Clinical Research and later Director of the Institute for Drug Development of the Cancer Therapy and Research Center in San Antonio where he held the SBC Endowed Chair for Early Drug Development from 1996-2005 and was a lead investigator on early developmental studies of many classes of targeted therapeutics such as erlotinib, gefitinib, panitumumab, temsirolimus, ridaforolimus, trabectedin, and many other agents. During that time, he was also a Clinical Professor of Medicine in the Division of Medical Oncology at the University of Texas Health Science Center at San Antonio. From 1987 to 1996, Dr. Rowinsky served as an Associate Professor of Oncology at the Johns Hopkins University School of Medicine where he performed seminal clinical development and pharmacologic studies on paclitaxel, docetaxel, irinotecan, topotecan, among other agents, some of which lead to the registration of these products in various indications. Dr. Rowinsky received his BA degree from New York University and his MD from the Vanderbilt University School of Medicine. Following his residency in internal medicine at the University of California, he completed fellowship training in medical oncology and clinical pharmacology at the Johns Hopkins University School of Medicine. Dr. Rowinsky’s honors include receipt of the career development award of the American Cancer Society and the 6th Annual Emil J. Freireich Award for outstanding achievement of a young researcher in clinical cancer therapeutics. He has also served on the Board of Scientific Counselors of the NCI. Dr. Rowinsky is on the board of directors of several public companies.

Ms. Krane has over 30 years of experience in drug development, including Regulatory Affairs and Chemistry, Manufacturing, and Controls. Ms. Krane, SVP, Program Leadership & Regulatory Affairs, held the position of Senior Technical Advisor at RRD for the previous 15 years, where she was responsible for advising clients and internal development teams on optimal development strategies for both biologics and small molecules. Her prior appointment was at Ariad Pharmaceuticals, Inc. where she was Vice President of Regulatory Affairs and Corporate Quality. Previously, Ms. Krane held management level positions at several biotechnology companies, including Genetics Institute and Wyeth Pharmaceuticals, where she was Regulatory Therapeutic Head for the development of Hematology and Oncology investigational and marketed products. Ms. Krane has broad drug development experience in multiple therapeutic areas including hematology/oncology, cell and gene therapy, personalized cancer vaccines, immune-oncology, neurology, endocrinology, pulmonary, special pathogens, rheumatology, cardiovascular disease and inflammation. She has developed successful global product registration strategies for several hematology and oncology products and has extensive submission experience developing IND, BLA, MAA, NDA, NDS, Orphan Designation, Fast Track, Special Protocol Assessment, and European Scientific Advice applications. Ms. Krane holds a BS in Microbiology from the University of Massachusetts.

Dr. Thomas brings 30 years of experience in global clinical development with a focus on operational excellence in the biotech and CRO industries. He started his career at BRI International, involved in early-phase development of numerous pharmaceutical products and medical devices. In addition, Dr. Thomas held leadership positions at Quintiles, Anges MG, and IOMAI / Intercell AG, advancing the early-stage development of several clinical candidates. Most recently, he served as Vice President, Clinical Operations, at Novavax, Inc., where he was responsible for building the company’s clinical operations infrastructure for Phase 1 through Phase 3 global clinical trial execution strategies, supporting Pandemic and Seasonal influenza, Ebola, and Respiratory Syncytial Virus (RSV) programs. Dr. Thomas holds a PhD in Biochemistry and Physiology from the University of Reading, UK. Following graduation, he spent 3 years as a MacArthur Foundation Postdoctoral Fellow in the Biological Psychiatry Branch of the National Institute of Mental Health, NIH.

Mr. Nwachukwu has over 15 years of global experience in health technology innovation, operations, risk quantification, and market access strategies for biologics, vaccines, immunotherapies, and digital technologies. He has experience in more than 20 countries building quality systems, sustainable pharmaceutical manufacturing operations, providing oversight for clinical trials, and managing cross-functional teams to meet program objectives. Mr. Nwachukwu has additional experience including interfacing with regulatory agencies and working across disciplines in several technical and clinical areas to ensure programs and systems deliver healthcare interventions and outcomes. Mr. Nwachukwu has an extensive academic background including a Master of Science in Regulatory Affairs from Northeastern University, a Master of Science in Evidence-based Medicine from the University of Oxford, and a Master of Healthcare Delivery Science from the Tuck School of Business at Dartmouth College. He holds the RAC certification and is a Fellow of Royal Society of Public Health of England. Specialties: Due Diligence, Pharmaceutical Manufacturing, Financial & Operational Analysis, Risk Quantification, Clinical Development, Economic Evaluations, Regulatory Submissions, Regulatory Audits, Quality Systems, Contract Negotiations, and Healthcare Compliance. Mr. Nwachukwu has professional experience in the following countries: United States, Korea, Denmark, England, Scotland, Mexico, India, Italy, Germany, Nigeria, Serbia, Senegal, Switzerland, Russia, and Canada.

Dr. DiGiacinto has more than 24 years of experience in drug development, focused in clinical pharmacology, biopharmaceutics, PK/PD, and regulatory affairs with small molecules and biologics via traditional 505(b)(1), 505(b)(2), BLA, and biosimilar pathways across a broad range of therapeutic areas. Dr. DiGiacinto began her career at the FDA, Division of Antiviral Products where she served as a Clinical Pharmacology Reviewer for seven years. Following, FDA, she joined Salamandra, LLC where she spent six years as a Senior Clinical Pharmacology Consultant. As head of RRD’s Clinical Pharmacology & Pharmacometrics Team, Dr. DiGiacinto is responsible for developing strategy and providing management oversight of clinical pharmacology programs on behalf of RRD’s Partners, including oversight of pharmacometric projects (modeling & simulation / population PK/PD), and working closely with RRD’s internal cross-functional product development teams to ensure program expectations are met. DiGiacinto received her PharmD from University of Nebraska Medical Center (UNMC) – College of Pharmacy. Following graduation, she went on to complete a Pharmacy Practice Residency at UNMC and then completed a 2-year Clinical Pharmacology Fellowship at University of Illinois College of Medicine, which was funded by FDA.

Siobhán joined Uniphar in 2009 and has worked in various finance roles across the Group. Prior to working in Uniphar, she gained industry experience in telecommunication, leasing, and pharmaceutical manufacturing. Siobhán is a Chartered Management Accountant.

Formerly a member of the senior management team at Topaz Energy Limited, he was appointed Chief Financial Officer of Uniphar Group in 2010. Previous to this, Mr. Dolphin held various senior financial positions with Shell. Mr. Dolphin is an EY trained Chartered Accountant.

Dr. Berry has 23 years of experience in the pharmaceutical industry, specializing in the clinical pharmacology and pharmacometrics fields. Dr. Berry’s extensive background in PK/PD data analysis has focused on performing population PK/PD modeling and clinical trial simulation methodologies to optimize dose selection and study design. His work can be found in numerous therapeutic areas, with various types of formulations, both in small- and large-molecules, from nonclinical through Phase 3, NDA submissions, and post-marketing activities. Dr. Berry is also involved in the development of precision dosing applications for individualizing pharmacotherapy, building high performance computing solutions, and writing R packages for non-linear mixed effects modeling. Dr. Berry has authored numerous publications and presentations in the pharmacometrics discipline, while also mentoring students, fellows, and colleagues through various workshops and training seminars. Dr. Berry obtained his PharmD from the University of Missouri-Kansas City, School of Pharmacy, completed a 2-year Post-Doctoral PK/PD Fellowship with the University of North Carolina, and a 2-year Pharmacometrics Fellowship with the Center for Drug Development Science at Georgetown University, before spending nearly 18 years working in IQVIA’s (formerly Quintiles) Clinical Pharmacology/PK and Innovation Groups.

Justus Bingham has over 20 years of experience in the pharmaceutical industry. He specializes in clinical pharmacology, pharmacokinetics and pharmacometrics, with expertise in modeling and simulation. At CV Therapeutics, he managed PK/PD for the company’s pipeline in all development phases. Mr. Bingham has experience in both small and large molecule pharmaceutical research and development, having worked at Eli Lilly, CV Therapeutics, Genentech, Certara and Gilead. Expertise he has provided to clients include PK/PD analysis, clinical pharmacology, study design, modeling and simulation, regulatory matters, statistics, drug development strategy, and financial modeling. He has been involved in the development of more than 100 compounds across a wide range of therapeutic areas including cardiovascular, endocrinology, oncology, anti-viral, anti-infective, anti-inflammatory, and CNS. He has extensive experience in the design, analysis, and reporting of clinical pharmacology studies, including population PK/PD, PK/PD modeling and simulation, and clinical trial simulation. He has been involved in the preparation of numerous regulatory submissions including INDs, NDAs, and BLAs. Since 2019, Mr. Bingham has co-founded or taken executive roles with multiple biotech and pharma companies, as well as an Advisory Board member for Outcomeus and Proove Genomics.

Mr. DeMuth has more than 30 years of experience working as a lead statistician on clinical trials in support of pharmaceutical, medical device, and biologic products. He previously owned and operated a CRO for 17 years.   Mr. DeMuth has worked with several hundred companies across numerous therapeutic areas and supported many approved products.

Masaki Doi, PhD advises partner companies on identifying and licensing highly interesting product candidates for ClearPath’s unique development model. Dr. Doi has over 30 years’ experience in the global pharmaceutical industry, including senior positions at Yamanouchi, Astellas and Illumina. He has been involved in over 20 licensing and 5 merger and acquisition transactions, including those with biotechs such as Medivation, OSI, Agensys, Seattle Genetics, Regeneron, Fibrogen, Tularik, Protein Design Lab, Genetics Institute and with large pharma, such as Astra-Zeneca and G.D. Searle (now Pfizer). Dr. Doi was responsible for licensing Xtandi® (enzalutamide) for the treatment of mCRPC prostate cancer, with 2015 sales of $1.87 billion. Dr. Doi founded and managed Yamanouchi Venture Capital (now Astellas Venture Management) in Palo Alto, CA from 2001 to 2003.

William (Bill) Heydorn, RPh, PhD, is a consultant to RRD in the role of Strategic Technical Lead focusing on nonclinical and clinical drug development, pharmaceutical operations, project management, and regulatory affairs. Dr. Heydorn has strong therapeutic experience in gastroenterology, diabetes, central nervous system disorders (both psychiatry and neurology), acute and chronic pain, cardiovascular, oncology, asthma/allergy, immunology, osteoporosis, and ophthalmology. He has broad-based experience across multiple phases of drug development, from pre-IND candidate selection to NDA filing and post-marketing activities. Dr. Heydorn served as a Pharmacologist at the FDA’s Division of Neuropharmacological Drug Products for three years. In addition, Dr. Heydorn has held senior positions at multiple biopharmaceutical and pharmaceutical organizations including, most recently, Lexicon Pharmaceuticals, Forest Laboratories, and Synaptic Pharmaceutical Corporation. He received a Bachelor of Science in Pharmacy from the Philadelphia College of Pharmacy and Science (graduating Magna Cum Laude) and a PhD in Pharmacology from the University of Pennsylvania School of Medicine.

Dr. Hogeland has over 18 years of experience in Clinical Pharmacology and Pharmacometrics with a broad background in PK/PD data analysis, modeling and simulation. Dr. Hogeland has extensive experience in planning, executing, and analyzing nonclinical and clinical pharmacology studies across numerous therapeutic areas from nonclinical IND enabling studies through Phase 1 to late-stage studies leading to market registration (small molecule compounds and biologics). Dr. Hogeland has held Pharmacokineticist, Clinical Pharmacology, and Pharmacometrician positions in industry at large and small CROs; as well as, at a biopharma company. In these positions, he performed modeling and simulation for pharmaceutical compounds in pre-clinical, Phase 1, Phase 2 and Phase 3 of development. Dr. Hogeland has authored, reviewed, and contributed to a large number of PK(/PD) study reports, clinical study reports, clinical protocols, analysis plans, meeting briefing packets, investigator brochures, and IND annual reports. He has provided scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for both Phase 1 and late phase clinical trials. While at the biopharma company, he was responsible for defining the comprehensive clinical pharmacology development path and strategies for a program compound. In these positions he has also provided clinical pharmacology/PKPD data in support of regulatory documents, agency interactions, and business development efforts. Dr. Hogeland has extensive knowledge of a variety of software used in support of pharmacometric modeling including NONMEM®, Phoenix™ WinNonlin®, and the S/R programming language and RStudio IDE for dataset creation, statistical analysis, simulation, and visualization. Dr. Hogeland received a BA in Chemistry at Nebraska Wesleyan University and his PharmD from the University of Nebraska Medical Center (UNMC) – College of Pharmacy. Following graduation, he went on to complete a Pharmacy Practice Residency at the University of Iowa Hospitals and Clinics and then completed a 2-year Clinical Pharmacokinetics/Pharmacodynamics Post-Doctoral Fellowship in the Division of Pharmacotherapy and Experimental Therapeutics at the University of North Carolina at Chapel Hill.

Dr. Richard Kenney has established an accomplished career in vaccine development, both in infectious disease applications and in immuno-oncology. Dr. Kenney is currently consulting at RRD as Strategic Medical Lead Consultant and is the Chief Medical Officer for Sonnet BioTherapeutics, which is developing innovative targeted biologic drugs with enhanced single- or bi-specific mechanisms. He previously served as Chief Development Officer for X-Vax Technology, advancing a next-generation vaccine for herpes, and as Chief Medical Officer of Immune Design Corp, where he led the clinical development, pharmacovigilance, and regulatory affairs groups to advance the development and commercialization of the company’s immunotherapeutic cancer vaccines. Previously, he served as Chief Medical Officer of Crucell Holland BV, where he directed the clinical development of a broad platform of experimental and licensed vaccines, and as Senior Vice President, Clinical Development for Vical Inc. He held key positions in vaccine development at GlaxoSmithKline, where he managed large-scale programs in influenza vaccine development. Before moving to industry, he was a tenured research scientist at FDA/CBER. Dr. Kenney earned his MD degree at Harvard Medical School, then trained in Internal Medicine at Duke University and in Infectious Diseases at NIH/NIAID.

Dr. Kumi has over 25 years of experience in the development of medicinal products across multiple therapeutic areas in a wide range of product types, including small and large molecules, and combination products. Dr. Kumi’s core competencies and expertise span US and Global regulatory affairs strategy and compliance, product development, due diligence, and regulatory submissions through market approval with multiple regulatory authorities, including the US, Canada, Europe and Japan. Dr. Kumi began his career at the US FDA, where he served as a Clinical Pharmacology Reviewer for over 11 years in the Antiviral and CardioRenal Product Divisions. Following his tenure at the FDA, he joined the pharmaceutical/biopharma industry where he has held roles of increasing responsibility in companies including, Boehringer Ingelheim, Regeneron, Insmed and Delcath. Dr. Kumi’s industry experience is complemented by his experience as a regulatory affairs consultant with consulting firms and as an independent consultant, where he provided regulatory leadership to small and large companies. As Executive Director, Dr. Kumi will be responsible for overseeing US and global regulatory affairs strategy and operational execution of regulatory submissions on behalf of RRD’s partners. Dr. Kumi received his PhD in Pharmaceutics from the University of Houston and a BSc in Chemistry (minor Biochemistry) from the University of Ghana, Legon. Following his PhD, he completed a Post-Doctoral Fellowship at Virotex Pharmaceuticals in The Woodlands, TX.

Dr. Leney advises RRD clients on strategic and operational issues related to the development, manufacturing and testing of investigational drugs. He served as Vice President of Development, for the ClearPath Vaccines Company, an RRD subsidiary development company prior to transitioning to his current role. Dr Leney worked for over a decade at MassBiologics. As Deputy Director of MassBiologics he participated in the development, manufacturing, testing and clinical trials of both commercial and investigational biologics sponsored by both MassBiologics and commercial clients, overseeing Validation, Clinical Data Management, Quality Control, Regulatory Affairs, and Quality Assurance and also held a faculty appointment as an Assistant Professor of Medicine at the University of Massachusetts and member of the Center for Clinical & Translational Science. Dr. Leney previously worked as an investigator for the United States Department of Defense earning the Joint Chiefs Civilian Service Commendation. He taught as a Adjunct Professor of Forensic Biology at Chaminade University of Honolulu, as a faculty member at the University of Oxford, and visiting lecturer at the University of Cambridge. He previously worked a as field biologist in Tanzania for the Society for Environmental Exploration. Dr. Leney received a BSc (Biological Sciences) with First Class Honours in Zoology from the University of Edinburgh, a PhD from the University of Cambridge (Mathematical and Evolutionary Biology & Anthropology), held the Cox Fellowship at New College, University of Oxford, was a European Union Marie Curie Fellow in Athens, Greece and a Fellow of the Oak Ridge Institute for Science & Education, assigned to the US Army, Central Identification Laboratory.

Suresh Mallikaarjun, PhD, FCP, obtained his B.Pharm degree from the University of Bombay in 1978 and his PhD in Pharmacokinetics from Virginia Commonwealth University, Richmond, Virginia, USA. In 1988, he joined the FDA as a Pharmacokinetic Reviewer responsible for reviewing INDs, NDAs, protocols, briefing packages, labeling, etc. in various therapeutic areas. He then moved to Procter and Gamble Pharmaceuticals in Cincinnati, Ohio as a Senior Scientist, Clinical Pharmacology and Pharmacokinetics in 1993, where he was part of the team that developed the first approved treatment for H. pylori. Subsequently in 1996, he started at Otsuka America Pharmaceuticals as a Senior Pharmacokineticist, where he assumed positions of increasing responsibility and retired in 2020 as a Senior Director in Clinical Pharmacology. He is currently the owner and Principal of his consulting company, Pharmaconsultants, LLC. He has over 34 years of in-depth experience in the utilization of clinical pharmacology in all stages of drug development and has been involved in multiple INDs and NDAs in several therapeutic areas, i.e., central nervous system, cardiovascular, respiratory, anti-infective and oncology. He is a diplomate of the American Board of Clinical Pharmacology and is a Fellow of the American Association of Clinical Pharmacology.

Mr. Raymond has extensive experience with program design, protocol preparation, study implementation, and the analysis and interpretation of results, and has provided significant support in the preparation of INDs, NDAs, ANDAs, BLAs, and ex-US submissions. Prior to forming R-Squared Solutions, LLC in 2011, Mr. Raymond was Group Director, Global Biometric Sciences for Early Development Immunology/Oncology, at Bristol-Myers Squibb.

Laura Redden, MD, PhD has extensive experience in global product development and registration programs, medical affairs, and clinical pharmacology. Dr. Redden is a physician/scientist with solid working experience across various therapeutic areas including but not limited to clinical pharmacology, neuroscience, immunology/rheumatology, and medical devices. She has more than 20 years of clinical research and development experience in both academic and industry settings. Her experience spans from early phase development to post-marketing (Phases 1-4, including filing of INDs, NDAs, and BLAs). Dr. Redden has held several global executive and managerial positions including Project Director/Global Project Head of the Humira® rheumatology and device teams at Abbott Laboratories, Vice president of Medical Services at Advanced Clinical, LLC, and Executive Medical Director/Clinical Science Head of the Immunology team at Takeda Pharmaceuticals. Dr. Redden received her medical degree from the University of Guadalajara in Mexico, and her doctoral degree in Clinical Pharmacology from the University of Toronto, Canada.

David West, PhD, MPH has extensive experience as a senior advisor to medical device companies in their development and regulation of novel medical devices and device / drug / biologic combination products. Prior to the formation of Device Development and Regulatory Consulting, LLC (DDRC), from 1994 to 2013, Dr. West served principally as Vice President, Medical Device Development, at Quintiles. He has assisted domestic and international medical device companies develop and implement strategic and regulatory plans for medical devices and combination products. Dr. West has been providing clients strategic and regulatory guidance and support throughout the product development and regulatory approval processes, identifying and reviewing both non-clinical and clinical studies and offering expert assistance in the preparation of PMA, IDE, PDP, 510(k), De Novo, Section 513(g), and RFD submissions to FDA, as well as helping management of company communications and interactions with the Agency. Dr. West offers clients the benefit of 26 years of service as a commissioned officer in the US Public Health Service, including 11 years in senior management positions at FDA. From 1989 to 1993 Dr. West was Deputy Director of Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), FDA. From 1985 to 1989, he was Associate Director, ODE. In these two positions he was responsible for planning, managing and directing programs to ensure the safety and effectiveness of medical devices, including extensive review of IDE, PMA and 510(k) applications. During his tenure in these two positions, he exercised final FDA review and signature authority of for virtually all IDE and PMA applications, and for precedent-setting, complex or potentially controversial 510(k)s. Dr. West was a principal architect of the decision framework for FDA’s evaluation and regulation of combination products of medical devices, drugs, and/or biologics and served on FDA’s first Combination Products Task Force. Dr. West earned his PhD in Environmental Health (major) and Epidemiology (minor) at the University of Minnesota; his MPH at the School of Public Health, University of Minnesota; and his BS in Mechanical Engineering at the University of California, Santa Barbara.

Dr. Willett has more than 30 years of clinical research experience and serves as a consultant in clinical pharmacology, pharmacokinetics, regulatory affairs, and medical writing. Dr. Willett started his career as a clinical pharmacist in a progressive hospital providing critical care, cardiology, infectious disease, nutritional team support, and therapeutic drug monitoring. He transitioned into the biopharmaceutical industry and was involved in all phases of clinical research and multiple product launches at Marion Laboratories and Bristol-Myers Squibb.

Dr. Willett has more than 30 years of clinical research experience and serves as a consultant in clinical pharmacology, pharmacokinetics, regulatory affairs, and medical writing. Dr. Willett started his career as a clinical pharmacist in a progressive hospital providing critical care, cardiology, infectious disease, nutritional team support, and therapeutic drug monitoring. He transitioned into the biopharmaceutical industry and was involved in all phases of clinical research and multiple product launches at Marion Laboratories and Bristol-Myers Squibb.

Dr. Zunich is a board-certified physician in Internal Medicine with subspecialty training in Allergy and Immunology. She has over 25 years of experience in the pharmaceutical industry and more than 30 years of overall experience in clinical trials and drug development. She assists clients in the strategic planning and implementation of development programs with an emphasis on clinical and regulatory support. Dr. Zunich is a founding member of Iasis Partners, LLC, a drug development consultancy.

Ms. Allan has over twenty (20) years of data management experience in phase I-IV studies. Ms. Allan is the Director, Data Management, at RRD. Ms. Allan provides oversight and management of data management (DM) and electronic data capture (EDC) Service Providers contracted to provide services for RRD sponsors and assures timely receipt of high-quality deliverables from the Service Providers. She has worked in various therapeutic areas including Gastroenterology, Neurology, Immunology, Hematology, Infectious Disease, Oncology, Respiratory, Cardio-Metabolic Diseases, and Genitourinary. Prior to working at RRD, Ms. Allan worked at PRA Health Sciences and Lilly Venture (i3 Statprobe). Areas of responsibility included all aspects of data management, creating and maintaining standard operating procedures (SOPs), and process improvement. In 2005, Ms. Allan assisted in launching the Early Development Services (EDS) business unit within PRA Health Sciences. Ms. Allan holds a BA in Marine Science and Biology from the University of San Diego.

Ms. Burnett has more than 30 years of experience in clinical research, primarily in the preparation and management of clinical and regulatory documents for FDA submission. Ms. Burnett is the Senior Director, Medical Writing at RRD. She is responsible for overseeing the medical writing activities at RRD, including writing, document review/quality control, and management of writing contractors assigned to programs. Prior to RRD she held the title of Director, Medical Writing at Quintiles Inc., and before that held positions in medical writing and clinical research at BRI International. Ms. Burnett has broad experience in multiple therapeutic areas. She has extensive FDA submission experience, including IND, 505(b)(2) NDA, Orphan Designation, and Fast Track applications; FDA meeting briefing packages; and clinical protocols and clinical study reports. Ms. Burnett received an MA in English from George Mason University and a BA in English from Vassar College.

Ms. Carr has more than 25 years of clinical development and operations experience in managing, executing and overseeing execution of first in man studies, global Phase 2 studies in hepatic fibrosis and idiopathic pulmonary fibrosis as well as Phase 2 studies in osteoarthritis, rheumatoid arthritis, sinusitis, and erectile dysfunction. Prior to joining RRD, she held multiple titles at Quintiles/BRI, including Senior Director of Clinical Operations and Senior Director of Clinical Monitoring. She also held previous positions with Social and Scientific Systems, Inc. and George Washington University. Ms. Carr attended the University of Reading in Reading, England, received her BA in Biology from Randolph-Macon Woman’s College, Lynchburg, VA, and then pursued her MS in Microbiology from George Washington University, Washington DC. Ms. Carr has been published a number of times including publications in Cancer Chemotherapy and Pharmacology and the Journal of Clinical Oncology.

Mr. Paulovits possesses over 20 years of varied experience in the Pharma/CRO space, including progressive leadership positions in global clinical team management, clinical monitoring, quality assurance auditing, global study start-up management, vendor management, CRO oversight, and pharmaceutical consulting. He began his career in 2000 as a research data coordinator working with sales, marketing and scientific divisions of pharmaceutical companies. He advanced to Quintiles as a clinical trial associate, where he managed study start-up, including daily interaction with clinical research sites, internal, clinical & project management teams and clinical sponsors. He provided oversight of the non-clinical aspects of complex, multifaceted programs for assigned divisions and/or trials. At PPD, he was senior clinical trial manager, clinical research associate, clinical regulatory specialist, research coordinator manager and clinical trial associate. At PRA International, Mr. Paulovits was Quality Assurance Auditor, where he performed contracted and internal operational audits according to client expectations and/or PRA SOPs, particularly numerous investigation site audits. Since 2012 he has assumed various roles as leader of global Phase II-IV studies. At inVentiv Health Clinical, Mr. Paulovits lead extensive start-up efforts as a Global Study Start Up Manager. At RRD, Mr. Paulovits works with all relevant functional areas to assure that clinical studies are being conducted according to Good Clinical Practice (GCP) and RRD SOPs. He collaborates with PMP to develop standardized requests for clinical proposals including key assumptions and expected performance metrics that can be used to evaluate proposals from Service Providers on an “apples to apples” basis. Additionally, he oversees quality management of a clinical program in collaboration with Quality Assurance in compliance with RRD SOPs. Mr. Paulovits received a BA degree in Sports Science in 2006 from the University of North Carolina at Chapel Hill.

Ms. Ward has over 25 years of extensive hands-on management and regulatory submission experience in the US with the preparation of INDs, NDAs, DMFs, Orphan Drug Designation Applications, Fast Track Designation Requests, Special Protocol Assessments and FDA regulatory meetings. Ms. Ward has broad regulatory affairs, clinical and nonclinical expertise, and focuses on strategic investigational and combination product development. She has also performed due diligence activities for potential NMEs. Ex-US experience includes preparation, submission and maintenance of CTAs in EU, Canada, South American countries, South Africa, and other countries, as well as obtaining Canadian Scientific Advice. Her product development experience has been focused in several therapeutic areas including oncology, neurology, psychiatry, pulmonary, dermatology, renal, vaccine, HIV, diabetes, cardiovascular and gastroenterology. Most recently, Ms. Ward was head of US Regulatory Affairs at Asubio Pharmaceuticals, Inc. (nka Daiichi Sankyo, Inc.) where she was responsible for regulatory strategy, health authority interactions, and regulatory operation submission support for US and ex-US clinical trials. Previously, she held regulatory affairs management positions at Quintiles (nka IQVIA) and Sanofi-Synthelabo Research Inc. (nka Sanofi SA) where she held similar regulatory affairs responsibilities. Ms. Ward also held industry positions in nonclinical pharmacology and clinical where she was responsibility for designing, conducting, and reporting studies. Ms. Ward graduated from Cook College, Rutgers University and received an MS in physiology from Hahnemann Medical College and an MBA from Fairleigh Dickinson University in pharmaceutical studies.

Ms. Zemo has over 25 years of experience in drug development services, including various program management and leadership positions. Ms. Zemo is the Senior Director of Program Management and Planning (PMP) at RRD. She is responsible for developing and implementing long-term strategies for program management across the company and establishing program management policies and procedures to align with corporate and customer strategic direction. She is also responsible for supporting the design and implementation of program plans with adherence to timelines and budgets; contributes to contract negotiations with vendors; and monitors and coordinates efforts of the program team. Prior to RRD, Ms. Zemo served as Senior Program Manager for ClearPath Vaccines Company (CVC) overseeing multidisciplinary project teams to assure accurate and timely completion of all CVC study project activities. Ms. Zemo held the title of Senior Project Manager at Dynport Vaccine Company leading and coordinating multi‐million dollar, complex, biopharmaceutical development candidates for the Government. Prior to becoming a program manager, Ms. Zemo held positions of increasing responsibility including Risk Manager and at Bridge Global Pharmaceutical Services, Inc., as Manager of Toxicology Support Services. Ms. Zemo received a BS in Biology from the University of Maryland and Project Management Professional Certification from the Project Management Institute.