Meet The Team
The Avoca Group is comprised of industry veterans, quality experts, and leaders in their field.
Patricia LeuchtenFounder and CEO
Patricia Leuchten is Founder and CEO of The Avoca Group. She has more than 25 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing and strategic alliances.
In 1999, she founded The Avoca Group, a consulting and research firm specializing in clinical outsourcing, alliance management and quality management in outsourced clinical trials. The Avoca Group has played an important role in the industry as the first consulting firm to track trends in clinical outsourcing and to measure the health of relationships between sponsors and CROs.
In 2011, Patricia launched the Avoca Quality Consortium® a member-based pre-competitive collaborative comprised of clinical operations, quality, and outsourcing professionals from pharma, biotech, CROs, and clinical service providers. Since its inception, the rapidly growing Avoca Quality Consortium is transforming clinical trial execution by driving efficiency, improving quality, and mitigating risk in outsourced clinical trials.
Most recently, in 2017, Patricia launched the Diligent® Qualification Platform, an innovative technology initiative designed to increase efficiency and shorten timelines for clinical trial execution by centralizing vendor qualification activities.
Patricia is a frequent speaker and writer on topics surrounding clinical outsourcing, strategic alliances, quality management and relationship management in the pharmaceutical industry.
Dennis Salotti, MS, MBA, CCRAChief Operating Officer
Dennis Salotti is COO of The Avoca Group and lead for the Diligent® Qualification Platform, the clinical research industry’s first centralized platform for clinical service provider qualification.
With more than 16 years in the pharmaceutical industry as a sponsor, provider and consultant, Dennis has experience that spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations and strategic management.
Prior to joining The Avoca Group, Dennis was Director of Operations for WriteResult, an eCOA provider, where he was responsible for client delivery across the portfolio of global clinical trials. He has previously held positions in research and clinical operations for Pfizer and Merck.
Dennis is an Adjunct faculty instructor for Drexel University College of Medicine’s graduate program in Clinical Research Organization Management, and a Member of the Board of Trustees for the Diabetes Foundation. His educational credentials include an MS in Clinical Research Organization Management from Drexel University, an MBA in Technology Management from the New Jersey Institute of Technology, and a BS in Biology from Sacred Heart University.
Janice Hutt, MBAVice President, Client Engagement
Janice Hutt has been part of The Avoca Group’s leadership team for over 18 years. In her current role, she works closely with the Avoca Quality Consortium’s (AQC) members to understand their needs, align on vision, and ensure continued engagement. Janice’s expertise enables sponsors and service providers to foster environments of mutual understanding, enhanced collaboration, and increased commitment to quality, resulting in improved program outcomes.
Janice brings over thirty years of experience in the pharmaceutical and pharmaceutical services industries. Prior to joining Avoca, Janice spent eight years working for various CROs, and before then, spent several years in clinical research at Merck.
Janice holds a master’s degree in education from Acadia University and a bachelor’s degree in biology and chemistry from Rider University.
Crissy MacDonald, PhDExecutive Director, Client Delivery
As leader of the Avoca Group’s Integrated Consulting and overseer of the Avoca Quality Consortium workstreams, Crissy MacDonald provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group.
Crissy has 12 years of pharmaceutical industry experience with expertise in clinical research, process development and strategic management. Her previous professional roles have touched every stage of the clinical trials process, from pre-clinical research through late-stage clinical development.
As the Director of Clinical Project Management at a global oncology-focused CRO, Crissy ensured operational excellence within the project management group across a portfolio of studies. She participated on the Steering Committee of each study to analyze trial progress and mitigate newly identified trial risks. She developed and evaluated study performance metrics against agreed-upon budget deliverables and timelines, and drove the development of clinical SOPs consistent with industry regulations. At various CROs, Crissy managed and coordinated the efforts of cross-functional project teams to support milestone achievement while implementing continuous improvement activities for internal and external risk mitigation.
Crissy earned a PhD in biomedical engineering from Drexel University and a bachelor’s degree from Lafayette College.
Christine Albano, MBAVice President, Finance and Business Administration
Christine Albano has over 20 years of finance, strategy, and alliance management experience, including 10 years within the pharmaceutical industry. She directs The Avoca Group’s company processes and activities for Finance, Contracts, and Human Resources, and provides client consulting in the area of vendor oversight and relationship management.
Prior to joining The Avoca Group, Christine participated in large pharmacy integrations, giving her a deep understanding of change management. She worked for both a large sponsor organization and a small CRO where she was responsible for alliance management, project finance management for clinical trials, contract negotiations, and general business administration operations. She also held an executive position in a manufacturing company during the housing market decline. She led critical finance activities through company divestitures, factory shut downs, acquisitions, restructurings, and fund raising as the Corporate Controller and Assistant Secretary of American Standard Brands.
Christine earned a Bachelor’s degree in Accounting and an MBA in Finance from Rider University, where she assisted in the development of the university’s Healthcare Management curriculum.
Dawn R. AuerbachExecutive Director, Client Development
Dawn Auerbach is the Executive Director of Avoca’s Client Development team. She is responsible for The Avoca Group’s sales processes and for driving new business within the organization. Dawn leads activities to develop proposals and deliver presentations. She is also actively engaged in contract assessment and developing new services based on discovered market opportunities in order to meet the needs of our prospective clients. Dawn and her team partner with other Avoca team members to build strong relationships with existing Avoca Quality Consortium Members and Avoca clients.
Dawn brings to Avoca over 25 years of experience in product development, relationship management, contract negotiations, strategic positioning, and clinical market research. She earned her Master of Public Administration in Healthcare and Finance from New York University and a Bachelor of Science in Psychology from the State University College at Oneonta.
Kristen Jonathan BennettAssociate Director, Client Delivery
A member of the Avoca Group’s integrated consulting and Avoca Quality Consortium® workstreams, Kristen Bennett provides consulting services to top pharmaceutical, biotech, and contract research organizations, and oversees client deliverables, systems, and processes across The Avoca Group.
Kristen has 12 years of clinical trial experience with expertise in clinical trial execution, process development, and strategic management. Her previous professional roles include project, data, and site management.
Kristen’s clinical research career began as a clinical research coordinator at a large academic oncology institution where she was responsible for the recruitment, intervention, data collection, laboratory, and data analysis for studies across multiple therapeutic areas. Kristen transitioned into a research supervisory role with the primary responsibility of developing and providing education, orientation, and continuing education programs relative to conducting research protocols. Kristen has also co-authored several scientific abstracts/poster presentations.
As project manager at various CROs, Kristen ensured operational excellence within the project management group across a portfolio of studies. She participated on the Steering Committee of each study to analyze trial progress and mitigate newly identified trial risks. She also developed and evaluated study performance metrics against agreed-upon budget deliverables and timelines. Additionally, Kristen managed and coordinated the efforts of cross-functional project teams to support milestone achievement while implementing continuous improvement activities for internal and external risk mitigation.
Kristen holds a bachelor’s degree in Biology from Kutztown University of Pennsylvania.
Rose HunsickerSenior Manager, Client Development
As a member of The Avoca Group’s Client Development team, Rose is responsible for outreach, proposal development, and presentations to new clients and for the recruitment of new members to the Avoca Quality Consortium. In her role, Rose is responsible for supporting the sales process and building strong client relationships with existing clients.
Prior to joining The Avoca Group, Rose drove new business development initiatives for a full-service CRO, partnering with pharmaceutical and medical device companies. Rose’s industry experience includes business development roles within the patient recruitment space as well as other niche clinical research service providers.
Rose earned a bachelor’s of science degree in Marketing and International Business from Villanova University.
Lori JonesAssociate Director, Marketing and Client Engagement
Lori Jones is responsible for the strategy and implementation of marketing initiatives for The Avoca Group. She has more than 25 years’ experience in marketing. Prior to joining The Avoca Group, Lori was Marketing Manager for Bioclinica’s Global Clinical Research. She also owned and operated a pharmaceutical marketing agency for several years.
Caryn Laermer, MBAExecutive Director, Client Engagement
Caryn Laermer is Executive Director of Client Engagement for The Avoca Group. She oversees strategies, initiatives, and communications; manages member engagement and recruitment; and organizes the Summit and other Consortium meetings.
Before joining The Avoca Group, Caryn served as Vice President, Derivatives Group at Donaldson, Lufkin & Jenrette (now Credit Suisse), where she specialized in the sales and trading of stock options, foreign currency derivatives, and futures.
Caryn graduated from Tufts University with a BA in Economics. She is a member of Omicron Delta Epsilon, Economics Honor Society, and holds an MBA in Finance from New York University.
Beth Listhaus, PhDManager, Client Development
Beth Listhaus is responsible for maintaining healthy client relationships and cultivating new business opportunities at The Avoca Group. She also conducts client research. Prior to joining The Avoca Group, Beth served as Associate Professor of Psychology at Dominican College where she chaired the Psychology Department.
Beth holds a PhD from Fordham University and a Bachelor’s degree from State University of NY at StonyBrook.
Jenn LoaizaMarketing Coordinator
Jenn Loaiza is responsible for coordinating communications and engagement with The Avoca Group’s clients and Avoca Quality Consortium® Members. Jenn also assists with client deliverables related to the company’s Research and Consulting services.
Jenn is currently working towards her Bachelor’s degrees in Marketing and Management from Kutztown University and holds an Associate’s degree in Visual Communications from Lehigh Valley College.
Lisa McKay, MBAExecutive Director, Project Management and Client Engagement
Lisa McKay is Executive Director of Project Management and Client Engagement for The Avoca Group. She oversees the Survey Research project management team and works with AQC Members in a Client Engagement role.
Before joining The Avoca Group, Lisa held executive level roles in Marketing and Business Planning both as an employee of entrepreneurial companies and as an independent consultant and mentor to early stage technology companies.
Lisa earned a BS in Biology from Bowling Green State University and holds an MBA from the University of Connecticut.
Jane Arce, MSc PharmSenior Consultant
Jane Arce is a GCP, Quality, and Compliance professional with more than 20 years of industry experience. Her background includes building and maintaining Quality Systems, Clinical Operations, and SOPs for small and midsize pharma and biotech companies. She has been a Clinical Research Manager, Director of Clinical Operations, and Clinical Trial Manager, and currently advises companies on all aspects of GCP including training in GCP, Compliance, and SOPs. Jane also consults clients in the areas of trial management, GAP analysis, audits, vendor selection, and vendor management.
Jane earned a Master of Science in Pharmaceutical Sciences from the Royal Danish Pharmacy School in Denmark. She resides with her family in the eastern part of the United States.
Denise Calaprice, PhDSenior Consultant
After receiving her Bachelor’s degree in Biology from Harvard University and her MS and PhD from Princeton, Dr. Denise Calaprice entered the world of clinical research as an NIH fellow at Columbia University’s College of Physicians and Surgeons in 1994. Over the subsequent decades, she acquired extensive experience in directing clinical research programs and in creating innovative development and operational strategies in a variety of settings, including academia, government, a CRO, a large global pharmaceutical company, and a small biotechnology company.
In her 14 years with The Avoca Group, Denise has provided support to pharmaceutical companies, clinical service providers, university investigators, industry consortia, and government agencies engaged in clinical research, with a focus on partnering strategies, relationship management, metric development, protocol quality, patient engagement, risk management, “lean” development strategies, and business data analysis. Among her many accomplishments, Denise has developed a novel quality metrics taxonomy that has been adopted by top pharma organizations, and led development of the Avoca Patient Engagement Playbook.
Joseph FortunatoSenior Director, Client Delivery
Joseph Fortunato is Senior Director of Client Delivery for The Avoca Group. His 40 years of experience in clinical research include 17 years in large pharma and 19 years at CROs, and experience supporting trials at clinical sites. Joseph has an extensive background that includes experience in: quality assurance and compliance; quality management systems and quality metrics; developing and implementing a quality culture; inspection readiness support and preparation; organizational change management and staff development; and delivering excellent customer satisfaction.
Joseph joins Avoca from inVentiv Health where he served as Senior Vice President of Quality Assurance and Regulatory Compliance.
Joseph has been a member of the Association of CROs (ACRO) Ethics and Regulatory Committee since 2013 and became chairman of the committee in 2016.
Janis Hall, MBASenior Consultant
Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO, and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), she was responsible for R&D sourcing, contracting, and supplier alliance management.
As Senior Consultant with The Avoca Group, Janis developed many of the quality oversight tools within the Avoca Quality Consortium® Knowledge Center. She is the mastermind behind the Oversight Capability and Maturity Model® (OCMM) and Provider Qualification work streams, and a key contributor to Avoca’s Diligent® Vendor Qualification Platform.
Janis has been a chair, invited speaker, and panelist at numerous conferences. She holds an MBA from the University of Delaware and a BS in Chemistry from Towson University.
Ellen KelsoSenior Consultant
Ellen Kelso provides executive level consulting for Quality Management, Good Clinical Practices (GCP), risk management, and regulatory strategies and documentation for The Avoca Group. Throughout the course of her career, she has developed deep expertise in clinical development, regulatory affairs, and human subject protections. Her passion is for creating space for efficient operations and effective human interaction, and for harnessing people’s collective knowledge to achieve critical business objectives.
After working within the pharma industry for many years, Ellen founded the Goodwyn Institutional Review Board, which offered review and protection in various types of human subjects’ research, including initial and ongoing review of clinical research protocols and investigative sites.
Ellen holds a bachelor’s degree in Microbiology from Indiana University. She has been published multiple times, and is a member of the Board of Trustees for the Beechwood Foundation for Neurologic Injuries and Disorders.
Barbara L. Maley, BSSenior Consultant
Barb Maley is a Quality Assurance professional with 29 years of research experience including 24 years within the pharmaceutical industry (GLP and GCP) and 16 years hands-on experience within Quality Assurance and Continuous Improvement.
Barb has extensive experience providing quality consultation and execution of process-based data mapping/traceability and auditing. She also has detailed knowledge of GCP, Quality Systems Management, Clinical and post-marketing Promotional Material Regulations, Inspection support through inspection hosting, development/provision of regulatory inspection responses and mock inspection activities.
She earned a Bachelor of Science in Biology from State University of New York College at Oswego.
Theresa MasonSenior Consultant
Theresa Mason retired from Eli Lilly and Company in March 2015, following a 32-year career with the company. During that time, she played a key role in establishing an outsourcing group to support Lilly’s Product Development organization. She received Lilly’s “Top 100 Innovators” award in 2015 in recognition of her work in developing and implementing outsourcing business processes and IT tools.
Prior to her role in outsourcing, Theresa led Lilly’s R&D Portfolio Management and Decision Analysis organization for six years. She and her team provided R&D project selection recommendations and decision consulting for senior management. Theresa also held strategy roles in both R&D and Manufacturing, as well as leadership roles in Engineering and Manufacturing (Antibiotic API).
Theresa has been a speaker and panelist at several conferences. She holds a B.S. degree in Chemical Engineering from the University of Dayton and has additional training in Decision Analysis, Systems Management, and Six Sigma.
Irene Catherine Michas, BA, MSc, PhDSenior Consultant
Dr. Irene Michas acts as a subject matter expert for the Avoca Quality Consortium® and as a consultant on pharmaceutical quality. With a background in the pharmaceutical, biotech, and CRO industries, she brings extensive experience to diverse pharmaceutical development activities, including regulated business process development, business process and systems training, audits and regulatory inspections, product licensing agreements, clinical research and development, data management, personnel and contractor recruitment and onboarding, and the management and implementation of global projects and initiatives. Until March 2017, Irene was a senior leader within Pfizer’s pharmacovigilance organization, where she held the role of Regional Safety Lead.
Irene holds a PhD in Psychology and an MSc in Research Methods in Psychology from the University of Reading in the United Kingdom, as well as a Bachelor’s degree from the University of Pennsylvania.
Jay A. TurpenSenior Consultant
Jay Turpen is a Senior Consultant with The Avoca Group. He has been in the pharmaceutical industry for 29 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new drug candidates.
His pharma experience started in GMP of small molecule and large molecule (biologic) active pharmaceutical ingredients (API). Jay has been involved in leading multiple clinical teams responsible for the clinical development and NDA preparation for multiple molecules in osteoporosis, diabetes, cardiovascular, neuroscience, and immunology. Jay also led a transformation effort for his company’s CLO organization that effected processes, systems, job definitions/descriptions, and organizational leadership to meet both GLP and GCP requirements.
Most recently, Jay was Senior Director for Clinical Project Management (CPM) where he was responsible for the clinical development for Alzheimer’s disease, autoimmune diseases, men’s health, pain, and other neuroscience indications. This CPM organization, under Jay’s leadership, successfully completed multiple NDA submissions, regulatory agency inspections, and received regulatory approvals for small molecule and biologic products demonstrating thorough GCP compliance. Jay retired from Eli Lilly & Co. at the end of 2017 where he was Sr. Director, Clinical Project Management – Biomedicines.
Steven WhittakerSenior Consultant; Executive Director, the Avoca Quality Consortium, 2011-2018
Steve Whittaker is a Senior Consultant with The Avoca Group, and former Executive Director of the Avoca Quality Consortium. He is also a lead consultant for the pharmaceutical, biotech, and CRO industries providing expertise in project management, pharmaceutical development, clinical development, outsourcing strategies and execution plans. His experience through years of drug development leadership roles, combined with his established professional network across these industries, provides unique and valuable insights for organizational leaders.
Steve served as Executive Director of the Avoca Quality Consortium from 2011-2018, and for 14 consecutive years on the Advisory Board for the annual Partnerships in Clinical Trials program, chairing the board for two years. In addition, he has moderated numerous quarterly Clinical Research Consortium forums, developing strategic agendas and facilitating the exchange of leadership concepts between clinical development executives across top-tier pharmaceutical and biotech organizations.
In 2009, Steve retired from Eli Lilly and Company, where he served as Chief Operating Officer/Sr. Director of Operations and Project Management for the Cardiovascular/Acute Care Platform. As the leader of the Global Clinical Research Sourcing Office, Steve established Lilly’s first corporate strategy and operational design for outsourcing global clinical development to CRO preferred partners. This included the selection and initial implementation of the preferred partner approach for global, full-service CRO capabilities. Steve also led Lilly’s Project Management Center of Excellence, establishing standards for leaders of project development.
Rebecca Wolfe, CCPM Expert, PMPSenior Consultant
In her current position, Rebecca Wolfe is responsible for CRO and pharmaceutical company engagements, and helps to establish Project Management Offices and to implement Clinical Quality Risk Management Systems and lean and virtual outsourcing. She is also a frequent contributor to the development of Avoca Quality Consortium® leading practices.
In May 2014, Rebecca retired from Eli Lilly and Company where she was a Program Manager Consultant in the Project Management Center of Excellence. She continues professional development activities to maintain her Project Management Professional Certifications.