Weave Clarity into
Clinical Pharamcology
With PharmaLoom, gain clear development stories that resonate with regulators and investors alike.
Origin
PharmaLoom was founded with a simple but ambitious vision: to weave clarity into one of the most complex fabrics in business today—the path of drug development.The pharmaceutical industry is a tapestry of many threads: breakthrough science, regulatory oversight, patient need, investor risk, and operational execution. Too often, these threads tangle. Promising therapies stall, timelines stretch, and capital is consumed not by failure of science, but by failure of coordination.
Diana Shuster
Diana Shuster, PhD, is a distinguished clinical pharmacologist and scientist with nearly two decades of experience guiding drug development across big pharma, CROs, site networks, and biotech companies. She has led clinical pharmacology, biomarker, and program strategies for CNS, renal/cardio-metabolic, infectious, and rare disease indications, earning recognition for her ability to integrate scientific rigor with pragmatic development planning. A published expert with 15 peer-reviewed articles, Diana has authored and reviewed IND submissions, regulatory briefing documents, and clinical study protocols while serving as a trusted voice in high-stakes regulatory interactions. Known as a persuasive and respectful communicator, she excels at translating complex PK/PD and biomarker data into clear development strategies that accelerate timelines and reduce risk. Her leadership style is rooted in collaboration and cross-functional excellence, building strong partnerships across clinical, regulatory, and operational teams.
Clyde Mead
Clyde Mead is an accomplished entrepreneur and executive leader with a proven record of acquiring, scaling, and flipping companies to multimillion-dollar profitability while building high-performing teams of more than 300 employees. Over the course of his career, he has led organizations in diverse industries including social services, restaurants, insurance, and professional consulting, consistently demonstrating the ability to identify opportunities, execute rapid turnarounds, and deliver sustainable growth.A strategist and builder by nature, Clyde specializes in organizational design, business development, and financial structuring, applying innovative approaches such as Profit First and design theory to accelerate results. His leadership style emphasizes intentional team development, diversity, and board-level alignment, with a track record of strengthening governance and guiding C-suite executives through turbulent transitions.
Consulting Services
At PharmaLoom, our clinical pharmacology consulting services are designed to weave clarity into every stage of development. We help sponsors build end-to-end clinical development roadmaps that balance timelines, budgets, and target product profiles while identifying go/no-go points and assessing risk across multiple pathways. Our team develops comprehensive clinical pharmacology strategies, designs and refines protocols for early-phase studies — from first-in-human through proof-of-concept, including DDI, ADME, FE/BE, and special population trials such as Asian bridging. We bring deep expertise in data analysis and modeling, from NCA and population PK to PK/PD simulations and drug–drug interaction modeling, delivering decision support and regulatory-ready outputs. Beyond the science, we provide scientific and regulatory writing support for IBs, INDs, protocols, SAPs, CSRs, and responses, ensuring communication with agencies is precise and persuasive. We also conduct risk assessments and gap analyses to guide dose selection, bridging approaches, and first-in-patient transitions. And because regulatory landscapes shift constantly, we monitor evolving guidance and deliver timely intelligence to keep development programs aligned and forward-looking.
Investor Due Dilligence
PharmaLoom supports investors with clear, science-driven insights that cut through the uncertainty of drug development. We provide due diligence on target assets, evaluating the strength of their clinical pharmacology packages, regulatory readiness, and development risk profiles. Our team delivers independent assessments of asset value — including timelines, probability of technical and regulatory success, and the financial implications of clinical strategies. We create development roadmaps and Target Product Profiles that benchmark opportunities against competitors and regulatory expectations, while our risk and gap analyses highlight missing data, dose selection challenges, and key inflection points that can alter valuation. With advanced PK/PD and population modeling, we simulate dosing regimens, special populations, and trial strategies, giving investors the foresight to anticipate outcomes and ROI. To keep decisions ahead of the curve, we provide regulatory intelligence briefs that track FDA and EMA shifts, and we extend this into portfolio-level strategy consulting to help investors compare and prioritize opportunities with the greatest probability of success.
$2-$5 Million
Average savings of $2–5M per asset by reducing failed dosing cohorts and avoiding rework through dose-finding simulations.
30%
Up to 30% faster from protocol draft to regulatory submission when adaptive PK/PD modeling informs study design.
>20%
Improved probability of regulatory success by 15–20% when programs integrate pharmacology-driven roadmaps and risk-based gap analyses.
Get Clarity Today
At PharmaLoom, we believe in weaving clarity into every conversation. Whether you’re a sponsor looking to accelerate your clinical program, an investor seeking diligence support, or a partner exploring collaboration, we’d love to hear from you.Fill out the form below and our team will respond within 24 hours.
PharmaLoom emerged to change this pattern. Our founders saw the need for a loom—an intelligent framework—that could interlace the diverse strands of clinical pharmacology, regulatory strategy, and modern business practice into a fabric both strong and adaptable.Drawing on decades of clinical pharmacology expertise, regulatory insight, and entrepreneurial leadership, we built a consulting firm that works at the intersection of precision science and pragmatic business. Every plan we deliver—whether a PK/PD model, a first-in-human protocol, or a portfolio-level development roadmap—is a woven piece designed for speed, resilience, and alignment with regulatory approval.Like skilled weavers, we bring order to complexity. Threads of data, strategy, and execution are pulled taut across the frame of regulatory requirements, then crossed with the investor’s demand for efficiency and return. The result: a clear, resilient fabric that carries our clients from molecule to market with strength, precision, and foresight
Get Clarity Today
At PharmaLoom, we believe in weaving clarity into every conversation. Whether you’re a sponsor looking to accelerate your clinical program, an investor seeking diligence support, or a partner exploring collaboration, we’d love to hear from you.Fill out the form below and our team will respond within 24 hours.
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