Meet Our Team of Experts

Science BD Strategist  

For biotech startups, a misaligned clinical strategy doesn’t just cost time - it risks investor confidence and market potential.  As a scientist-turned-clinical development leader, Mahsa bridges the gap between preclinical insights and impactful clinical outcomes.  Accelerating drug development timelines from ideation to successful phase I trials in under 5 years, Mahsa has seen firsthand how strategic alignment and actionable frameworks can make or break your path to market. 

Mahsa offers tailored team assessments and formal growth plans, strategically designed to align with your business goals and key venture capital inflection points.  With expertise in precision medicine, biomarker characterization, early-phase trials, and clinical development strategy, she aligns scientific depth with business clarity to optimize outcomes. She excels in translating complex scientific concepts into clear, actionable insights for diverse audiences, including internal stakeholders, board members, and investors.

Whether you need to define or refine your scientific narrative or equip your team to meet critical milestones, Mahsa provides the strategic guidance to position your business for enduring success.

CMO, Clinical Lead, Clinical Monitor

Barney has more than 25 years’ experience managing business and development operations in the pharmaceutical, medical device, biotechnology and CRO (Contract Research Organizatioon) industries. In particular, he has directed, or been directly involved in, development programs for more than 275 pharmaceutical, medical device, and biologics products. The products have addressed clinical targets in a broad range of therapeutic areas and the development programs have included more than 250 separate clinical trials in North America, Europe, Eastern Europe, Australia, New Zealand, South Africa and Asia.

Dr. King has served as a fractional or full time CMO, President and CEO, Head of Development, Vice President, Clinical Affairs, Vice President Regulatory Affairs, and Medical Monitor while working as a consultant.

Clinical Trial Management

Shari is a seasoned Clinical Operations Leader with over 20 years of experience in the biotechnology and pharmaceutical industries, committed to improving patient outcomes across a variety of therapeutic areas. With a proven track record in leading the successful development and execution of complex clinical trials, she specializes in clinical trial strategy, operational oversight, and team leadership.

Throughout her career, Shari has played a pivotal role in managing cross-functional teams, overseeing clinical trial processes from initiation to close-out, and ensuring compliance with regulatory standards. Her expertise spans clinical trial design, vendor and CRO management, GCP audits, and the implementation of operational efficiencies to streamline trial timelines and reduce costs.

Shari has successfully led global clinical trials in diverse therapeutic areas, including oncology, neurodegenerative disorders, regenerative medicine, burns and wounds, and rare diseases. She has consistently delivered trials on time and within budget, driving exceptional results. 

CMC

Ben has been in the Biologics CMC space for more than 20 years, holding a breadth of roles in regulatory, engineering, and manufacturing. Most recently he has contributed to the approval of several biosimilar products in immunology, oncology, and ophthalmology. 

He has held positions at Genentech and Coherus in addition to his consulting work. Graduating with two Stanford degrees, the Chemical Engineer in him is always scouting new paths for efficiency in drug development, analytics, and business improvement opportunities. 

Program Management

With nearly 40 years of experience, Dan excels at delivering complex programs and projects across healthcare, biotech/drug development, manufacturing, and technology. He has successfully managed programs with budgets exceeding $100 million and teams of up to 300 staff.

Value for Small Biotechs

Dan's extensive business acumen is particularly valuable for emerging biotech companies. He can seamlessly fill critical gaps in business operations by:

• Developing and managing RFPs
• Negotiating contracts
• Managing vendor relationships
• Securing and managing grants

These skills are essential for navigating the complexities of today's drug development landscape.

Building High-Performing Teams

Dan has a proven track record of building and leading successful Project Management Offices (PMOs) that handle hundreds of projects annually for large healthcare organizations.

Project Management Expertise

Dan is a passionate advocate for project management excellence. He has trained thousands of individuals for PMP, CAPM, and PMI-ACP certifications. He also shares his knowledge through:

• Co-authoring "Healthcare Project Management"
• Authoring "PMP Last Chance Review"
• Contributing articles to ProjectManagement.com
• Regularly presenting at international conferences

Industry Recognition

Dan's expertise is widely recognized. He has been featured as a Subject Matter Expert (SME) in PM Network magazine (circulation over 600,000) and has delivered numerous lectures, webinars, and presentations on PMOs, project management, and program management.

Clinical Pharmacology

 Joyce is a strong leader with over 25 years of industry experience dedicated to the discovery and development of therapeutics, including small molecules, peptides and biologics. 

Areas of expertise include nonclinical, ADME/DDI, early phase clinical trials, bioanalytical, biomarker and pharmacodynamic assays and related development and regulatory strategy. 

Previously served as Vice President / Dept Head for multiple small pharma companies and founded a highly successful consulting firm specializing in early development and clinical pharmacology consulting.  

Business, Finance

 Matt is a seasoned CPA with experience working across multiple industries, including biotech, especially focusing on small biotech organizations that are working to develop robust, scalable solutions that are audit ready.

Matt can serve as a fractional CFO or serve to assist current finance/accounting staff with setting up reliable, effective, and efficient accounting processes and systems that are ready to report accurate results for grant, tax, board, and other required financial purposes.

Clinical Trial Associate

Sierra is a detail-oriented Clinical Trial Associate with 5 years of experience supporting the successful execution of clinical trials across a range of therapeutic areas, including oncology, neurology, and orthopedics. Skilled in coordinating trial logistics, developing SOPs, managing documentation, and ensuring regulatory compliance, Sierra plays a key role in supporting clinical teams to ensure trials are executed efficiently and on schedule.

With a strong understanding of Good Clinical Practice (GCP) and ICH guidelines, Sierra contributes to site management, regulatory submissions, trial management file activities, and patient recruitment. She ensures that all trial-related activities are carried out with precision and integrity. Her ability to manage multiple tasks, collaborate with cross-functional teams, and communicate effectively with stakeholders has been instrumental in the successful completion of numerous clinical studies.

Sierra is passionate about advancing clinical research and dedicated to contributing to the development of new therapies that improve patient outcomes.

Toxicology & Pathology 

 As a double board-certified Toxicologist, and a Toxicologic Pathologist with expertise in digital pathology, Elizabeth is passionate about advancing safe and effective therapies through GLP-compliant preclinical drug development.  She is a certified laboratory animal DVM and has in depth knowledge about experimental pathology as well.  

She plays a key role in ensuring the safety and efficacy of new drug candidates by conducting comprehensive toxicological assessments and detailed microscopic evaluations.

Collaborating with interdisciplinary teams, Elizabeth provides critical guidance throughout the drug development process, from discovery to preclinical studies. She is driven by the potential to contribute to improved outcomes through rigorous scientific investigation of your drug candidates.  Over the past 20-years she has developed a special interest in ophthalmology and oncology drug development. 

Regulatory

Meredith brings over 33 years’ experience in the drug and device industry. She works with small/medium drug, biologic, and combination companies to successfully navigate global regulatory submissions, writing, intelligence, and strategy requirements. 

She has held senior regulatory positions at San Francisco Bay Area biotech companies writing INDs, NDAs, key meeting packages such as Pre-NDA and EOP2, negotiated NDA/BLA filings and providing key drug development strategic insights. In addition to US clients, she has been a US agent and strategist for Australian, Canadian, European, Japanese, and Israeli companies.

She is author of over 70 articles, 2 books (IND Submissions: A Primer and Regulatory Intelligence 101) and training thousands on how to write INDs and conduct strategy.

Biochemistry & Molecular Biology

 Rosie is a seasoned scientific leader dedicated to transforming cutting-edge research into real-world health solutions. She has led teams in developing groundbreaking medical diagnostic devices, including a rapid detection method for cardiac biomarkers. Her expertise in biochemistry, molecular biology, and whole genome sequencing has driven advancements in both research and clinical applications.  

With a strategic mindset and professional certifications in project management and organizational leadership, she fosters a collaborative environment where technical excellence meets innovative problem-solving. Dr. Gomex-Garcia's passion lies in bridging scientific discovery with impactful healthcare solutions, ensuring that innovation translates into meaningful medical advancements.