The K2 Network. Because it’s good to have friends.

It’s always good to have friends. Someone to help you move, give you a ride to the airport, or write that PMA submission.

The K2 Network is our group of friends. It’s a collection of independent consultants that have come together under the K2 Regulatory banner. Each has a unique set of experiences and skills that complement the services already provided by K2. The result is an even better experience for clients, allowing us to provide you with a more comprehensive portfolio of services. Below is a brief bio of the folks that are part of the K2 network. Prepare to be impressed.

To learn more about the expanded services we now provide through the K2 Network, just click on the contact link.

CHARLES PARNHAM

Charles and I first worked together on a project close to five years ago. Since then I’ve collaborated with Charles on a few projects here and there. He’s put a lot of quality systems in place over the years, and he always manages to strike the right balance between compliance and business needs. And he makes one heckuva nice brown ale. Here are the highlights:

  • Parnham, Inc: Independent Quality and Operations consultant for 10+ years. Established and certified Quality Management Systems (QSR & ISO 13485). Generated Risk Management Files, and Design History Files, and generated and executed Validation Master Plans. Worked with large medical device companies, IVD manufacturers, CAP/CLIA labs and start-ups.

  • Experien Group: Director of Quality Systems for consulting group. Acted as quality and project lead for companies making implantable devices, disposable catheters and blood collection devices.

  • NDC: Established, validated and relocated manufacturing lines. Created ISO 13485 quality systems, developed design dossier for CE Marked devices, and worked on FDA 510k submissions.

  • NeuColl: Designed, coded, tested and deployed inventory management system (MRP). Part of a team that successfully acheived FDA approval (PMA), as well as Canadian and CE approvals. Relocated Class III implantable to contract manufacturer.

  • LifeScan:Designed and installed pilot and full scale formulation facilities. Engineering Representative to the Business Team and Material Review Boards. Led development of product specification, testing methods and statistics.

  • Education: Ph.D., Biochemical Engineering, University of Colorado; Biochemical Engineering, University of Colorado; B.S., Chemical Engineering, VPI & SU, Blacksburg, VA

cindy van duker

I first met Cindy when we worked together at Myraqa. At Illumina, Cindy was part of our regulatory leadership team, focused on international markets, especially those in Asia-Pacific. She has a wealth of experience in regulatory, and has worked for some of the biggest names in the business, including Dade-Behring and Intel. Here’s a sampling:

  • Myraqa: Regulatory consultant providing expertise and advice to medical device and IVD clients regarding regulatory compliance and strategic planning.  Submitted PMAs, IDEs and pre-submissions to FDA.  Participated in FDA advisory committee meetings and meetings with Japan PMDA.

  • Volcano: Developed strategies for Class II and Class III cardiovascular medical device submissions. Participated in Pre-IDE meetings. Responsible for 510(k) submissions, CE marking, and coordinated Shonin submissions.

  • Intel: Developed and implemented a Quality System for regulatory planning and clinical trials for a new medical device division. Developed strategy for CE marking medical devices in Europe.

  • Dade-Behring: Managed 510(k) submissions to FDA for IVD product line. Participated in preparation of PMA submissions to FDA and CE marking of European product line. Lead team to re-register all product lines in Japan to maintain regulatory compliance.

  • Education:   M.S. in Biomedical Engineering, California State University, Sacramento; B.S. in Electrical and Electronic Engineering, California State University, Sacramento; B.S. in Biochemistry, University of California, Davis.

ClinPros LLC

ClinPros is an independent consulting firm currently flying under the K2 flag. I had the pleasure of managing this team while we were at Illumina. They are an incredibly talented, experienced and dedicated group of clinical professionals that can help companies develop and manage their clinical studies. I’m really pleased that they have decided to join the K2 family. A small sampling of their qualifications is listed below.

Tasha Kalista

  • Illumina: Responsible for planning, implementation, and management of global clinical trial programs in support of in vitro diagnostic testing utilizing clinical whole genome sequencing (cWGS) in the field of reproductive genetic health, oncology, rare disease and infectious disease.

  • Progyny: Implemented and managed clinical trial activities for a medical devices used for in vitro fertilization treatment. Developed study protocols, case report forms, monitoring plans, and training procedures required to conduct clinical trials

  • Natera: Responsible for forecasting, implementing and overseeing all clinical trials and post-market studies for in vitro diagnostic testing in the field of reproductive health.

  • Solta Medical: Oversaw the implementation and ongoing management of all internal and external clinical investigations and post-market studies for aesthetic medical device products.

  • Education: Master of Arts in Clinical Psychology, Columbia University, New York; Bachelor's Plus Program: Teaching Certificate Grades K-8, Bachelor of Arts in English and Creative Writing, Ashland University, Ashland OH

monica ransom

  • Convergent Genomics: Created and implemented strategic clinical evidence generation plan for an early-stage diagnostics company. Served as a key leader of the executive management organization and provided clinical development advice and counsel for FDA regulated diagnostics.

  • Teleflex Incorporated: Responsible for direction, administration and coordination of all activities in clinical affairs in accordance with established policies, goals and objectives.  Assisted the VP of RA, CA, QA in setting strategy and corporate objectives. Devised Clinical strategies to most efficiently and effectively conduct clinical trials. Oversaw the planning, conduct and monitoring of human clinical studies, assuring adherence to protocol and Good Clinical Practices.

  • Illumina: Responsible for ensuring IVD clinical program work activities achieve business outcome and meet timelines.      Managed a team of Research Clinical Monitors; conducted routine performance assessments and site audits. Developed clinical study protocols and support regulatory submissions. Managed vendors including: data management, CROs, laboratories and other clinical vendors. Lead harmonization of Clinical Standard Operating Procedures (SOPs) between Illumina sites.

  • Medtronic: Provided strategic oversight and operational leadership for neurovascular clinical programs. Oversaw all clinical activities across IDE programs and Post Market Studies (start-up to close out, including publication strategy related to both US and global clinical trials). Developed and implemented clinical strategies to support product development plans and timelines.

  • Education: Interdisciplinary Bachelor of Arts, University of California, Berkeley; Genetics and Genomics Certificate Program - Stanford University.

matthew saul

  • Convergent Genomics: Develop and maintain program timelines, ensuring the timely completion of study milestones and deliverables, including program-level reports and overseeing the preparation and review of study protocols, informed consent forms (ICFs), and clinical study reports (CSRs)

  • Promega: Conduct site qualification visits to assess the suitability of potential clinical trial sites based on protocol requirements, investigator capabilities, and infrastructure, and coordinate and conduct site initiation visits, interim monitoring visits, close-out visits, and study team meetings.

  • Illumina: Lead clinical data manager on multiple studies overseeing the process from initial database build to database lock and the development, design and testing of electronic Case Report Forms (eCRFs).

  • Nektar: Supported Phase II Oncology clinical trial and was responsible for the collection and dissemination of study enrollment rates, study specific test results, and progress of data entry to the clinical study team.

  • Education: Bachelors of Science, Emergency Medicine Administration - Utah Valley University, Orem, UT; Paramedic Program, University of Utah, Salt Lake City, UT