Paul J. Allard
Bethlehem,NH
Summary
Visionary Founder and former CEO who transformed Lakeside Life Science from a startup into a leading clinical research and laboratory organization. Achieved significant revenue growth through strategic business development, pricing, and contract negotiation. Demonstrated expertise in clinical operations, quality systems, and regulatory strategy, ensuring successful client delivery and operational excellence.
Overview
1
1
Certification
11
11
years of professional experience
Work History
Chief Executive Officer
Lakeside Life Science
Belmont, NH
06.2021 - 12.2025
- Drove nearly 300% revenue growth over three years through organic expansion, with no investors or loans.
- Led execution of 20+ medical device FDA pre-submissions and 5 FDA submissions over the last five years.
- Led implementation of 65+ medical device clinical trials and 200+ preclinical trials.
- Directed proposal development, pricing strategy, and sales efforts to close 35% of pipeline.
- Managed $75 million sales pipeline, enhancing forecast accuracy and alignment with market trends.
- Directed software development for medical device regulatory strategy, improving operational efficiency and supporting strategic growth.
- Strengthened relationships with industry partners and competitors, facilitating collaboration on strategic objectives.
- Partnered with leading regulatory law experts to keep FDA communications relevant and compliant.
- Negotiated partnership terms and managed strategic business relationships through contract delivery.
- Led executive planning for product development and funding, driving alignment with strategic market growth initiatives.
- Coached senior managers to improve effectiveness and policy enforcement, increasing employee satisfaction and performance.
Chief Operating Officer
HealthyID
Kansas City, KS
10.2020 - 06.2021
- Developed and updated short- and long-term strategies to support growth and profitability.
- Refined organizational structure to simplify workflows and clarify roles, enhancing operational efficiency.
- Developed financial projections and investor proposals, facilitating strategic funding decisions.
- Negotiated contracts with partners and vendors, optimizing allocation of investment funds.
- Supported recruitment and development of strategic alliances to better use existing talent and capabilities.
- Worked with leadership on budgets, forecasts, and operating plans.
- Maintained productive relationships and clear communication across the organization.
- Shaped solutions and approaches using trends in customer markets and industries.
- Built clinical trial plan to track inflammatory responses tied to diet, exercise, and meditation.
Chief Operating Officer
Lakeside Life Science
06.2017 - 06.2021
- Directed Lakeside Life Science operations across quality, supply chain, and finance teams.
- Supported business strategy development and implementation that increased revenue 4x in less than four years.
- Coordinated cross-functional planning for production, vendor, and inventory workflows to optimize operational efficiency.
- Implemented CRM system to enhance tracking of pipeline and sales activity.
- Developed and rolled out patient enrollment strategy.
- Worked with hospital executives and physicians while handling face-to-face patient interactions.
- Developed comprehensive marketing strategy to guide brand positioning.
Clinical Nurse (Per Diem)
Behavioral Health, Franklin Regional Hospital
03.2017 - 03.2019
- Assessed behavioral health patients for safety, symptoms, and care needs.
- Coordinated with psychiatrists, therapists, and social workers to create comprehensive care plans tailored to patient needs.
- Facilitated multidisciplinary team reviews of patient data to enhance care plan development.
- Assisted with crisis intervention using calm communication and de-escalation techniques.
- Built strong rapport with patients to maintain a therapeutic environment.
- Used technical procedures and proper equipment safely and accurately.
- Kept current on health system initiatives and applied evidence-based practice and research into care routines.
- Instructed family members and caregivers on patient care to improve understanding and compliance.
- Supported patient advocacy efforts to enhance safety and uphold rights in healthcare settings.
Director of Operations
Lakeside Life Science
Gilford, New Hampshire
01.2015 - 06.2017
- Co-founded Lakeside Life Science in 2015 and helped establish core business operations.
- Managed daily operations for life science services and internal business functions, ensuring alignment with strategic goals.
- Led cross-functional teams in sales, clinical operations, accounting, and IT to enhance collaboration and streamline processes.
- Oversaw product line management, coordinated with partners, and optimized shipping and receiving workflows to improve operational efficiency.
- Directed multiple clinical studies for companies in the in vitro diagnostic sector.
- Created SOPs to support safe, compliant operational processes.
- Planned staffing coverage and resource allocation across operational departments.
- Supervised day-to-day performance of large, multi-department staff.
Education
Associate's degree, Registered Nurse (R.N.) - Nursing
Lakes Region Community College
Laconia, NH05-2017
Master of Science in Nursing - Nurse Leadership and Administration
Herzing University
Dearborn, MI12-2025
Skills
- FDA submissions
- Regulatory compliance
- Regulatory strategy
- Device software development
- Quality improvement
- Business development
- Proposal development
- Contract negotiation
- CRM implementation
- Data analytics
- Leadership strategy
- Staff development
Certification
- Registered Nurse, NH License #076085-21
BLS Certification
Good Clinical Practice (CenterWatch)
ISO 13485 Quality Management Systems (Internal Auditor Training)
Awards and Recognition
- President's Award for Excellence in Liberal Arts (2015)
- Award for Excellence in Psychology (2013)
- Phi Theta Kappa International Honor Society
Publications, Presentations, and Podcasts
- Allard, W. J, Ph.D., & Allard, P, RN. (2019). Potential Impact of the VALID Act on IVD Manufacturers. Journal of Precision Medicine. https://www.thejournalofprecisionmedicine.com/the-journal-of-precision-medicine/potential-impact-of-the-valid-act-on-ivd-manufacturers/
- Allard, W. J, Ph.D, & Allard, P, RN. (2019). Will DAIA resolve the ambiguities of regulating in vitro clinical tests?. Journal of Precision Medicine. https://www.thejournalofprecisionmedicine.com/wp-content/uploads/Will-DAIA-resolve-the-ambiguities-of-regulating-in-vitro-clinical-tests-1.pdf
- Paul J. Allard (December, 2017, 6) Regulatory Considerations for US FDA Submissions for Companion Diagnostic Tests. Companion Diagnostic Forum. Princeton, NJ
- Paul J. Allard (September, 2018, 24) Connecting Patients with Biomedical Research Biospecimen Basics. Companion Diagnostic Forum. Princeton, NJ
- Paul J. Allard (September, 2023, 7) Point of Care and CDx: The market needs it, but is the Technology Ready?. World CB & CBx Conference. Boston, MA
- Podcast Guest (2025) The Curious Case for LDTs. What Now? A discussion on Laboratory Developed Tests, regulation, and the evolving FDA landscape. Featured speakers: Jeff Gibbs, Jeffrey Allard, PhD, and Paul Allard
Clinical Studies
- A Multisite Prospective Study to Collect Biospecimens from Patients with Colorectal Cancer for Research and Development of In Vitro Diagnostic Tests (Serum)
- A Multisite Prospective Study to Collect Biospecimens from Patients with Colon Cancer for Research and Development of In Vitro Diagnostic Tests (Tissue)
- Determination of Optimal Threshold for M30 Apoptosense ELISA Assay Results to Detect Apoptosis in Serum from Alcoholic Hepatitis Patients
- Estimation of M30 Apoptosense, M65 and M65 EpiDeath ELISA Assay Concentrations in Serum from Patients with NAFL and NASH
- Evaluation of Diagnostic Performance of M30, M65 and M65 EpiDeath ELISA Assays in Alcoholic Hepatitis
- Evaluation of Diagnostic Performance of M30, M65 and M65 EpiDeath ELISA Assays in Non-Alcoholic Steatohepatitis (NASH)
- Use of Peripheral Blood from Healthy Volunteers for Quality Control and Development of Cell-Free DNA Isolation and Characterization Methods
- Evaluation of Diagnostic Performance of M30, M65 and M65 EpiDeath ELISA Assays to Stratify NASH from Simple Steatosis
- Evaluation of Diagnostic Performance of SkylineDx MMprofiler Assay for Risk Stratification in Newly Diagnosed Multiple Myeloma
- Pilot Study to Determine Optimal Cut-Point for M30, M65 and M65 EpiDeath ELISA Assays in NASH
- Prospective Collection of Blood Samples from Patients with Metastatic Breast Cancer for Development of Circulating Tumor Cell Assays
- Optimization of Assays for Isolation and Analysis of Circulating Tumor Cells and Cell-Free DNA in Non-Small Cell Lung Cancer
- Comparison Study of Gene Variants Detected by the ONCOReveal Lung and Colon Cancer Test
- Determination of Reference Ranges for M30, M65 and M65 EpiDeath ELISA Assays in Healthy Donor Populations
- Evaluation of PSA Assay Performance (Siemens)
- Evaluation of Intact FGF23 Assay for Detection of X-Linked Hypophosphatemia in Children
- Determination of Reference Range for Intact FGF23 Assay in Healthy Donors
- Evaluation of M30, M65 and M65 EpiDeath ELISA Assays in NAFLD/NASH Cohorts
- Evaluation of Intact FGF23 Assay for Prediction of Chronic Kidney Disease in Elderly Patients
- Evaluation of Intact FGF23 Assay for Detection of FGF23-Dependent Hypophosphatemia
- Evaluation of Rapid Diagnostic Tests for Influenza A and B
- Biomarker Exploration in Patients with Castrate Sensitive and Castrate Resistant Metastatic Prostate Cancer
- Liquid Biopsy Gene Panel Exploration in Metastatic Prostate Cancer (LIBERATE Trial)
- Evaluation of M30 Apoptosense ELISA Assay for Prediction of Overall Survival in Alcoholic Hepatitis
- Clinical Evaluation of CellSecure Preservative Tube for Preservation of Circulating Tumor Cells, DNA, and RNA
- Clinical Evaluation of Nano-CTC Chip for Detection of Lung Cancer
- Novel PCR Test for Lung Cancer
- Evaluation of Point-of-Care SARS-CoV-2 Antibody Test in Whole Blood
- Circulating Multiple Myeloma Cells for Diagnosis, Characterization, and Prediction of Relapse
- Clinical Evaluation of Nano-CTC Chip for Detection of Late-Stage Breast, Lung, Prostate, and Colorectal Cancer
Regulatory Strategy
- Led regulatory strategy and submission activities across four PMA programs, two De Novo pathways, one EUA, and multiple FDA Pre-Submissions for oncology, molecular diagnostic, infectious-disease, and biomarker-based IVD products.
- Directed development of clinical and analytical validation strategies, including intended-use refinement, clinical protocols, nonclinical studies, performance thresholds, software classification, and regulatory pathway determination.
- Managed FDA meetings, briefing packages, amendments, deficiency responses, and agency correspondence across multiple review cycles.
- Guided programs through significant regulatory transitions, including modular-to-traditional PMA conversion, expanded-indication planning, regulatory repositioning, and submission lifecycle closure.
Timeline
Chief Executive Officer
Lakeside Life Science
06.2021 - 12.2025
Chief Operating Officer
HealthyID
10.2020 - 06.2021
Chief Operating Officer
Lakeside Life Science
06.2017 - 06.2021
Clinical Nurse (Per Diem)
Behavioral Health, Franklin Regional Hospital
03.2017 - 03.2019
Director of Operations
Lakeside Life Science
01.2015 - 06.2017
Associate's degree, Registered Nurse (R.N.) - Nursing
Lakes Region Community College
Master of Science in Nursing - Nurse Leadership and Administration
Herzing University