Leadership

|Leadership
Leadership 2018-05-31T14:06:45+00:00
Stephen Sullivan
Stephen SullivanChairman of the Board

Stephen Sullivan has been Chairman of Firma Clinical Research since January of 2016 when Thompson Street Capital Partners made its investment in H2O Clinical. Mr. Sullivan also led the acquisition of Pharma Start and the rebranding process to form Firma Clinical Research. He is also the founder of CRO Advisors LLC and has advised TSCP on several acquisitions and integrations. He brings over 18 years of pharma service experience as head of Covance Clinical Services from 1999-2006 and CEO of Harlan Laboratories from 2006 to 2010. Previously, he was Chairman and CEO of Xenometrix, a biotech company, and spent many years in senior management positions at Abbott Laboratories. Mr. Sullivan is an Adjunct Professor at Georgetown University where he created and teaches the course “Drug Development from Discovery to Post-approval” in the Masters of Biotechnology Program. Mr. Sullivan is a former Marine Officer and received his BS from the University of Dayton and MBA from Rutgers University.

Eugenia Henry, Ph.D.
Eugenia Henry, Ph.D.President, Biostatistics and Data Management Services, Board of Directors

Dr. Henry brings more than 29 years of both hands-on and senior level clinical research experience in large pharmaceutical, biotechnology and contract research organizations. Eugenia has served as a statistical consultant and DMC member for many clients and has vast experience in communicating with the FDA for design and statistical issues. To date, Dr. Henry has been actively involved in 56 NDA/sNDA/ANDA/PMA submissions with 52 approvals.

Dr. Henry has leveraged her extensive expertise to create successful data management and statistical services companies such as HHI Clinical Research and Statistical Services which was sold to InVentiv in 2004. Dr. Henry then co-founded H2O Clinical Research in 2011 which merged with Pharma Start in 2016 and was rebranded to Firma Clinical Research in 2017. She has also served in similar roles at Pfizer as the head of Biostatistics and Data Management for the Department of Clinical Pharmacology and Experimental Medicine and at Novartis as the head of Biostatistics and Data Management for Medical Affairs. Dr. Henry received her Ph.D. in Biostatistics from the University of Missouri, Columbia.

Earl Webb Henry, M.D.
Earl Webb Henry, M.D.Chief Medical Officer, Board of Directors

As the company’s Chief Medical Officer, Dr. Henry will provide leadership and direction for Firma’s clinical development programs.

In 2011, Dr. Henry co-founded H2O Clinical which was rebranded to Firma Clinical Research in 2017. Prior to H2O, Dr. Henry served as the co-Chief Medical Officer of InVentiv Health and Chief Medical Officer of InVentiv Clinical Solutions.

Before InVentiv, Dr. Henry was Head of Clinical Research and Regulatory Affairs at Cephalon, Inc., Head of Clinical Research at Guilford Pharmaceuticals, and Global Head of Central Nervous System Clinical Research at the Sandoz Research Institute. Dr. Henry started his pharmaceutical career at Pfizer Central Research.

Dr. Henry received his medical degree from the University of Chicago (Pritzker) School of Medicine and his bachelor’s degree in Chemistry from the University of Illinois. He was a medical intern at the University of Chicago Hospitals and Clinics and trained in neurology and neuropathology at the Longwood Neurology Program in Boston, which included the Peter Bent Brigham Hospital, Beth Israel Hospital, and Boston Children’s Hospital. Prior to joining Pfizer, Dr. Henry was on staff at Boston Children’s Hospital and Harvard Medical School.

Michael Keens
Michael KeensChief Operating Officer
Mr. Keens serves as Chief Operating Officer for Firma Clinical Research, with leadership and oversight responsibilities for the Clinical Operations, Remote Visit Services, Medical Writing/Clinical Pharmacology, Regulatory, and Business Development staff and client deliverables. He has extensive experience within the industry, including roles in Clinical Operations, Project Management, Consulting, and Business Development leadership across both large global and growing CROs. Mr. Keens leverages his knowledge and landscape experience to help Biotech and Pharmaceutical Sponsors identify project/program needs and examine how Firma may deploy expertise and resources to support these needs to achieve their drug development goals. Mr. Keens earned his undergraduate degree in Biology/Psychology from James Madison University, and his Master’s degree in Public Health from The University of Virginia.
Darcy Forman
Darcy FormanVice President, Global Clinical Operations

As the Vice President of Global Clinical Operations, Ms. Forman has oversight and leadership responsibility for the Clinical Operations team including service line deliverables and service enhancements. Ms. Forman started her career at Pfizer Pharmaceuticals as a bench scientist before transitioning into a role in Pfizer’s clinical research division. Ms Forman continued her career with ascending clinical operations and project management positions at various CROs spanning large, mid-size and niche including i3 Research (now Inventiv/INC), Health Decisions and Clinipace. Over her career, Ms Forman has fostered her passion for innovation and intelligent operational strategy by bringing metric driven decision making to each role and organization.

Ms. Forman holds an BA in Chemistry from Lake Forest College.

Lisa Gorman
Lisa GormanVice President, Remote Visit Services

As Vice President of Remote Visit Services (RVS) Lisa Gorman is responsible for the daily activities, oversight, and continued growth of Firma’s RVS team.  She is an experienced operations leader with more than 20 years in the drug development industry and success in team and organizational development.

Prior to joining Firma, Ms. Gorman served as an Executive Director of Clinical Development at Syneos Health (formerly INC Research).  As Executive Director, she had accountability for the Global Clinical Operations Management (GCOM), Clinical Training Institute (CTI) and Resourcing (GRT) departments. Ms. Gorman also has previous experience as Associate Director, Clinical Operations for a stand alone Clinical Pharmacology Unit, as well as leadership within global clinical project management, oversight of NIH funded research grants within an academic medical center, and project management and client support within a central laboratory provider.

She obtained her BA from the College of Mount St Joseph and her AAS from Cincinnati State Technical College in Cincinnati, OH.

Kathy Andersen
Kathy AndersenVice President, Human Resources

Ms. Andersen brings more than 28 years of both hands-on and senior level human resources experience with healthcare, pharmaceutical, and biotechnology organizations.

Ms. Andersen has leveraged her extensive expertise to help build and lead human resources teams that have enabled growth and operational improvement.  She has served in similar roles at larger organizations such as Pepsi-Cola Company, Cardinal Health, Gap Inc., Harley-Davidson Financial Services and Horizon Pharma.  More recently, she has partnered with privately-held firms such as Adello Biologics LLC, and has been a consultant to Lundbeck, LLC and Surgical Solutions, LLC.  Ms. Andersen earned a B.S. in Business/Labor Relations from Marist College and an M.S. in Human Resources from Mercy College.

Klaus Goodwin, ESQM, LSS, BB
Klaus Goodwin, ESQM, LSS, BBSenior Director, Head of Quality

As Head of Quality for Firma Clinical Research, Klaus is responsible for Firma’s global Quality and Compliance strategy and program, the execution and enhancement of its established Quality Framework and Quality Management System, as well as the maintenance of the company’s ISO 9001:2015 certification.

Klaus has been working in the clinical research and (bio-)pharmaceutical industry for about 20 years, and is a certified European Quality Systems Manager and Lean Six Sigma Black Belt. He assumed local and global responsibilities in building and improving Quality Management Systems (QMS) across a variety of operational functions within PAREXEL International, served as Director R&D Compliance, Global Head Quality Systems with Biogen, and Director, Clinical Compliance, Process & Procedures with Regeneron Pharmaceuticals.

Most recently Klaus served as Head of Quality Assurance (GCP) with Indivior Inc. where he strategically defined and oversaw the execution of their global GCP Audit and Inspection Readiness program, and led inspection readiness for two NDA filings for which one of the drugs gained FDA approval in Nov 2017. Klaus has also served as part of Avoca Quality Consortium Leadership Advisory Boards on Quality Management Framework and Inspection Readiness.

Matt Scherrer
Matt ScherrerBoard of Directors, Firma Clinical Research Managing Director, Thompson Street Capital Partners

Matt Scherrer has been a member of the Board at Firma Clinical Research since January of 2016. He is a Managing Director at Thompson Street Capital Partners where he leads investments in healthcare services. Mr. Scherrer has been at Thompson Street since 2007. Previously, he served in the US Army as an Infantry officer. He holds an undergraduate degree from Princeton University and an MBA from Harvard Business School.

Chrissy Fleming, Ph.D.
Chrissy Fleming, Ph.D. Founder, Consultant, Advisor

Dr. Christina Fleming assists in providing Firma’s strategic direction by leveraging her 20+ years of biopharmaceutical and clinical research organization (CRO) industry experience. Her experience includes building, managing and leading the clinical development, medical writing, and pharmacovigilance divisions at Searle (formerly Pharmacia, now Pfizer), TAP (now Takeda), Neopharm, Inc., and Baxter Healthcare as well as developing the outsourcing and consulting services at several CROs. This experience led her to create and develop Pharma Start into a highly successful and unique outsourcing organization. Pharma Start merged with H2O Clinical in 2016 and was rebranded to Firma Clinical Research in 2017.

Dr. Fleming is a 2010 recipient of PharmaVoice’s Top 100 Most Inspiring People in the Life Sciences Industry award and is a member of DIA, AMWA, and RAPS. Dr. Fleming earned her Bachelor of Science (BS) in Biology at Saint Mary’s College and her Doctor of Philosophy (Ph.D.) in Pharmacology from the University of Illinois at Chicago.