Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

What We Do

IMPACT’s Management Team

markMark Cierpial, PhD, RAC
Chief Executive Officer

Mark Cierpial, PhD, RAC is the Chief Executive Officer at IMPACT.  In addition to running the day-to-day business operations of the company, Mark consults with clients on strategic regulatory issues facing their drug and biologic development programs, and interacts with the FDA on their behalf on a regular basis.

Mark has worked in the pharmaceutical industry for over 20 years, starting his career as a Clinical Research Scientist at Burroughs-Wellcome Co. (now GlaxoSmithKline) in 1992.

During his career, Mark has worked in big pharma, small pharma, and CRO settings. His positions have included Chief Operating Officer at Lineberry Research Associates, where he oversaw all aspects of clinical, regulatory, biometrics, and quality assurance operations; Vice President of Regulatory Affairs and Strategic Drug Development Services at SRA International (formerly Constella Group), where he was responsible for the provision of global regulatory affairs, medical writing, and drug development services; and Vice President of Regulatory Affairs at Inspire Pharmaceuticals.

Mark received his PhD in Psychology from the University of Virginia and was a postdoctoral fellow then Research Assistant Professor in the Department of Psychiatry at the Duke University Medical Center.

In his free time, Mark enjoys all kinds of boating on the lakes and rivers of North Carolina and Virginia.  He’s somewhat of a political junkie, even though it frustrates him to no-end. As a transplanted yankee from Massachusetts, he supports the professional sports teams from Boston, also frustrating at times.

markTimothy Garver, PhD
Executive Vice President and Chief Operating Officer

Timothy Garver, PhD, is the Executive Vice President and Chief Operating Officer and a co-founder of IMPACT. In addition to helping manage IMPACT’s operational activities as well as its stellar staff, Tim still spends a significant amount of his time on day-to-day project work in support of IMPACT’s clients.

Prior to joining IMPACT, Tim served as the Senior Director of Regulatory Affairs and Strategic Drug Development Services at SRA International and its legacy companies (Lineberry Research Associates and Constella Group).  Overall, he has 17 years of medical writing, clinical research, regulatory affairs, and strategic consulting experience for both drugs and biologics.

During his career, Tim has played a key role in more than 25 marketing applications (NDAs/BLAs/MAAs) across a variety of therapeutic fields, and he has extensive experience authoring all types of regulatory documents (CSRs, IBs, protocols, IND components, etc.) as well as briefing documents for both Regulatory Agency and Advisory Committee Meetings.  Tim also routinely provides project management and drug development consulting services for IMPACT’s clients.

Tim received his PhD in Pharmacology from Penn State University and was a Howard Hughes Medical Institute postdoctoral fellow in the Department of Biochemistry and Cell Biology at the Duke University Medical Center.

In his free time, you can find Tim supporting his 3 children’s various athletic activities, hitting the pavement each morning for his daily run along the streets of Apex, spending as much time as possible on Bald Head Island, and passionately rooting for every sports team from Pittsburgh who proudly don the “Black-N-Gold”.

markKathryn Elks, RAC
Principal Consultant, Regulatory Operations

Kathryn Elks is a Principal Consultant in the Regulatory Operations department at IMPACT. Kathy was instrumental in implementing the electronic publishing services at IMPACT. Kathy spends a significant amount of her time on day-to-day project work for IMPACT’s clients, and also serves as a project manager for IND and NDA applications.

Kathy has over 28 years of experience in the pharmaceutical industry with 18 years in Pharmaceutical Development and 10 years in regulatory operations. Her career began with a 15-year tenure at the former Burroughs Wellcome Co. (later Glaxo Wellcome, then GlaxoSmithKline), where she worked in a Pharmaceutical Development laboratory performing research on Wellcome’s compounds.  Following her years in the laboratory, she joined the Regulatory Operations group at EMD Pharmaceuticals (US subsidiary of Merck, KGaA) where she worked on the successful NDA for Cyanokit®, which was the second drug in the US to be approved under the Animal Efficacy Rule.  Her publishing experience includes INDs, NDAs, IBs, CSRs, annual reports, and FDA meeting packages.  She has also worked on European submissions as part of an international project team.

Kathy has extensive experience in electronic publishing and has led the initiative at several pharmaceutical companies and a CRO in converting their regulatory submissions from a “paper-based” system to an electronic process that is compliant with US FDA requirements.  These companies include SRA International, Inc. (previously Constella Group and Lineberry Research Associates), BioCryst Pharmaceuticals, Inc. and most recently Chimerix, Inc. Kathy is well recognized in the eCTD publishing community and is the co-founder of the Electronic Concepts Technical Discussion (ECTD) Group – a professional organization created in 2009 with a current membership of 70 people.  In the past Kathy has also served on the Customer Advisory Board for one of the industry’s leading eCTD software providers.

Kathy has a BS in Business Administration from North Carolina Wesleyan College, Rocky Mount, NC.  She also earned her US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS) in 2007.

Kathy is a native North Carolinian who enjoys spending time on the Pamlico River with her husband and 3 grown sons.  In addition, Kathy enjoys traveling, gardening, and working on home improvement projects.

markJeff Golden
Associate Director, Regulatory Operations

Jeff Golden is the Associate Director of Regulatory Operations at IMPACT. Jeff’s primary responsibilities include overseeing the Regulatory Operations function at IMPACT as well as day-to-day project work for IMPACT’s clients.

Jeff has 15 years of experience in the pharmaceutical industry with 12 in Regulatory Operations. His career began at Fujisawa (later Astellas Pharma US) where he worked in the central document room preparing documents for electronic submission and archive. His career in Regulatory Operations began when he joined TAP Pharmaceuticals (joint venture of Abbott Laboratories and Takeda Pharmaceuticals; later Takeda Pharmaceuticals) where he served as a publisher on the company’s first NDA in eCTD format for Uloric®. During his years of service at Takeda Jeff successfully managed the publishing and submission management activities to approval for some of the company’s priority programs, including Uloric®, KAPIDEX™ and the Alogliptin family of products. Following his years at Takeda, Jeff joined the Regulatory Operations group at Chimerix, Inc. where he served as the head of Regulatory Operations managing the day-to-day submissions and project planning activities for their upcoming marketing application.

In addition to Jeff’s extensive experience working on US applications, he has published numerous applications for the rest of the world. During his tenure at Takeda, Jeff published new drug applications in the Americas, Europe, Asia and Africa. In addition to his experience with major applications, Jeff has experience with preparing and publishing clinical study reports, briefing packages, and advisory meeting packages.

Jeff is recognized in the eCTD publishing community and is a member of the local Electronic Concepts Technical Discussion (ECTD) Group and IRISS Global Submission Group. Jeff has a BS in Business Management from Elmhurst College, Elmhurst, IL.

When he’s not at work, Jeff enjoys spending time in his woodshop, exploring all the great parks and greenways with his wife and two young sons, and cheering for his Chicago teams, especially the Cubs.

markJennifer Moen, PhD, RAC
Associate Director, Medical Writing and Corporate Communications

Jennifer Moen, PhD, RAC is the Associate Director of Medical Writing and Corporate Communications at IMPACT. Jennifer’s primary responsibilities include managing and authoring regulatory medical writing projects, managing a group of IMPACT’s Clinical Research Scientists, as well as overseeing internal and external communications for the company.

Jennifer has over 12 years of regulatory medical writing experience. Prior to joining IMPACT, she was an Associate Director of Clinical Submissions Writing at UCB Biosciences, Inc. and a Senior Clinical Research Scientist at SRA International and its legacy companies (Constella Group and Lineberry Research Associates).

During her career, Jennifer has authored numerous CSRs and other types of regulatory documents, including clinical sections of marketing applications, protocols, IBs, and regulatory agency briefing documents. Jennifer also has experience in line management, recruiting, and proposal development.

Jennifer’s background includes a BS in chemistry from Roanoke College and a PhD in chemistry from the University of North Carolina at Chapel Hill. Her postdoctoral work in New Zealand included conducting a clinical trial to study blood coagulation in people with diabetes. Jennifer obtained her Regulatory Affairs Certification (RAC) in 2005.

Outside of work, Jennifer can be found gardening, blogging, supporting her beloved Tarheel basketball team, or traveling around the world. Ask her about her latest trip!

markKimberly Nice, PhD
Associate Director, Medical Writing and Submissions Management

Kimberly Nice, PhD is the Associate Director of Medical Writing and Submissions Management at IMPACT.  Kim’s primary responsibilities include managing and authoring regulatory medical writing projects, medical writing mentoring, and leading IMPACT’s training program.

Kim has over 12 years of regulatory medical writing experience.  Prior to joining IMPACT, she was a group manager and Senior Clinical Research Scientist for Regulatory Affairs and Strategic Drug Development Services at SRA International and its legacy companies (Constella Group and Lineberry Research Associates).

During her career, Kim has authored more than 60 CSRs and has experience authoring all types of regulatory documents, including clinical sections of marketing applications, protocols, IBs, and regulatory agency briefing documents. Kim is also routinely involved in managing large regulatory medical writing and consulting projects.

Dr. Nice has 3 years of postdoctoral training in reproductive biology and contraception at the University of Virginia Medical Center.  Kim has a diverse scientific background having earned a BS in Biotechnology from the University of Kentucky, an MS in Reproductive Physiology from Kansas State University, and a PhD in Pharmacology from the University of Texas Health Science Center at San Antonio. She also has 3 years of postdoctoral training in reproductive biology and contraception from the University of Virginia Medical Center.

When she’s not working, you can usually find her in the kitchen baking any variety of dessert or working on yet another home remodeling project.  She also spends as much time as she can on the NC coast boating and fishing (more accurately – just dropping the line in the water while her husband does all the real work) and exploring the interesting marine life.

nancyNancy Gasper-Smith, PhD, RAC
Senior Manager, Medical Writing and Submissions Management

Nancy Gasper-Smith, PhD, RAC is the Senior Manager of Medical Writing and Submissions Management at IMPACT. Nancy’s primary responsibilities include managing and authoring regulatory medical writing projects, medical writing mentoring, and managing a group of IMPACT’s Clinical Research Scientists.

Nancy has over 7 years of regulatory medical writing experience. Prior to joining IMPACT, she was a Senior Medical Writer and Scientific Communications Specialist with i3 Statprobe and a Clinical Research Scientist at
SRA International and its legacy company (Constella Group).

During her career, Nancy has authored over 30 CSRs and has experience authoring many types of regulatory documents, including clinical sections of marketing applications, protocols, IBs, IND applications, and regulatory agency briefing documents. Nancy has also served as the Project Manager for a Strategic Partnership involving writing and compilation of 25 to 30 CSRs yearly (see case study).

Nancy’s background includes a BS in biology and a PhD in biomedical science and biotechnology from the University of North Carolina at Charlotte. Her graduate work in immunology continued with a year of postdoctoral work at Duke University’s Human Vaccine Institute. After transitioning into clinical research, Nancy obtained her Regulatory Affairs Certification (RAC) in 2008.

Outside of work, Nancy enjoys spending time with her husband and young daughter. When she’s not working on her backyard koi pond or a home improvement project, she’s splitting her vacation time between the Delaware shore and the Adirondack Mountains of upstate New York.

EricaErica Allen, PhD, RAC
Senior Manager, Medical Writing and Program Management

Erica Allen, PhD, RAC is the Senior Manager of Medical Writing and Program Management at IMPACT. Erica’s primary responsibilities include serving as a program manager on various early-stage development programs, managing and authoring medical writing projects, and managing a group of IMPACT’s Clinical Research Scientists.

Erica has over 8 years of regulatory affairs, medical writing, and program management experience. Prior to joining IMPACT, she was a Clinical Research Scientist for Regulatory Affairs and Strategic Drug Development Services at SRA International and its legacy company (Constella Group).

Erica has extensive experience in project and program management, largely working with early‑stage drug development companies at the pre-IND and IND stage of development. She has also been involved in managing and/or authoring a wide variety of regulatory documents, including IND/NDA components, CSRs, protocols, IBs, and regulatory agency briefing documents.

Erica received a BS in Microbiology with honors in Cell Biology and Molecular Genetics from the University of Maryland, College Park and a PhD in Cellular and Molecular Medicine from Johns Hopkins. She also earned her US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society in 2008.

When she’s not working, Erica can usually be found at the ice rink cheering on her son’s hockey team or at the stables watching her daughter ride horses. She also enjoys traveling whenever the opportunity arises.

ElainaElaina Howard, PhD, RAC
Manager, Medical Writing and Submissions Management

Elaina Howard, PhD, RAC is a Manager of Medical Writing and Submissions Management at IMPACT. Elaina’s primary responsibilities include managing and authoring regulatory medical writing projects, medical writing mentoring, managing a group of IMPACT’s Clinical Research Scientists, and serving as a member of the Corporate Communications team.

Elaina has over 5 years of regulatory medical writing experience. During her career, Elaina has authored over 20 CSRs and has experience authoring many types of regulatory documents, including clinical sections of marketing applications, protocols, IBs, annual reports, and regulatory agency briefing documents. In addition, she has experience in IND submission and maintenance. Elaina has also served as the Project Manager for a Strategic Partnership involving writing and compilation of 25 to 30 CSRs yearly (see case study).

Elaina earned a BS in psychology from the University of North Carolina at Chapel Hill and a PhD in neuroscience from the University of Texas at Austin. Her graduate work in the neurochemistry of addiction continued with two years of postdoctoral work at UNC-CH. After transitioning into clinical research, Elaina obtained her Regulatory Affairs Certification (RAC) in 2012.

Outside of work, Elaina enjoys spending time with her husband and 2 young sons. When she’s not at local museums or playgrounds with her boys, she’s watching college basketball (go heels!), practicing yoga, experimenting with new recipes, or trying out a new vacation spot.

LoriLori Davis, PhD, RAC
Principal Clinical Research Scientist

Lori Davis, PhD, RAC is a Principal Clinical Research Scientist at IMPACT. Lori’s primary responsibilities include managing and authoring regulatory writing projects and submission work, mentoring, and training IMPACT’s new hires on quality control.

Lori has 5 years of regulatory medical writing experience. Prior to joining IMPACT, Lori was a contract Staff Toxicologist at ILS, Inc., supporting endocrine disruptor work for the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).

During her career, Lori has authored numerous CSRs and other types of regulatory documents, including clinical sections of marketing and IND applications, protocols, IBs, annual reports, and briefing documents for regulatory agencies.

Lori received her BS in Physiology and MS in Biology from California State University at Long Beach, and her PhD in Zoology at the University of Hawaii at Manoa. She completed post‑doctoral fellowships at the Hawaii Institute of Marine Biology, where she also concurrently managed the Fish Endocrinology and Environmental Physiology Lab, and at the US EPA Endocrine Toxicology Branch. Lori earned her US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society in 2012.

In her free time, Lori enjoys traveling, spending time outdoors, and volunteering with her 2 therapy dogs (she also has a third dog who needs therapy).

ChristinaChristina Williams, PhD, RAC
Principal Clinical Research Scientist

Christina (Chrissy) Williams, PhD, RAC is a Principal Clinical Research Scientist at IMPACT. Chrissy’s primary responsibilities include managing and authoring regulatory medical writing projects.

Chrissy has over 14 years of experience in regulatory affairs and medical writing. Prior to joining IMPACT, she was an Associate Director of Clinical Submissions Writing at UCB Biosciences, Inc. and a Senior Regulatory Scientist at CATO Research.

During her career, Chrissy has authored clinical sections of US and EU marketing applications as well as labeling updates, protocols, CSRs, IBs, US and EU regulatory agency briefing documents, and responses to US, EU, and rest of world regulatory agency questions. Chrissy also has experience in marketing application submission planning and management, line management, recruiting, and proposal development.

Chrissy’s background includes a MA in Biological Psychology from St. Mary’s College of Maryland and a PhD in Biological Psychology from the University of North Carolina at Chapel Hill. She completed her postdoctoral work in the Department of Pharmacology and Cancer Biology at Duke University Medical Center. Chrissy obtained her US Regulatory Affairs Certification (RAC) in 2003.

Outside of work, Chrissy can be found reading, traveling, cheering on her children at various events, and supporting the UNC Tarheels!