With over a decade of experience in the life science industry, spanning devices, drugs, veterinary products, and diagnostics, I have gained a rare perspective on what it takes to bring an innovative product from concept to commercialization. I specialize in coaching early stage companies through stakeholder and ecosystem discovery, allowing them to gain traction and develop an investable technology and business model. I also love to roll up my sleeves to help companies at all stages meet urgent medical, scientific, regulatory, and clinical project deadlines, leveraging my broad experience and expertise to rapidly get up to speed and produce high quality deliverables.
Clinical Operations requires a leader who is incredibly organized, can consider the big picture while maintaining impeccable attention to detail, can spot and manage potential problems before they materialize or become intractable, and who has an appreciation of the importance of the work beyond the scope of the job description and SOPs. My background in project management, clinical science, medical affairs, regulatory affairs, and clinical operations gives me a unique perspective on the impact that data quality and integrity has on patient safety, regulatory compliance and approval, adoption by the medical community, and reimbursement. Examples of support I can provide includes:
- Clinical Trial Management
- CRO and Vendor Management
- Contract Review
- Identification and Engagement with Key Resources (CROs, data management systems, biostatisticians, regulatory legal counsel, etc).
- Real World Evidence
- Clinical Quality
- CEC Management
Regulatory submissions are arguably the most important milestones that life science companies face. Medicine and biology can be notoriously uncooperative, and the focus of any regluatory approval or authorization should be on the data and its implications, not deficiencies in the submission. A submission that is complete, consistent, follows GXP guidelines, and is aligned with previous communications with FDA, is essential for success. Support Araneae can provide includes:
- Authorship of non-clinical and clinical sections of submissions including investigator's brochures, study summaries, labeling, etc
- Gap Analysis prior to submission to ensure completeness, GXP compliance, alignment with FDA input and guidelines
- Responses to deficiency letters
- FDA meeting support
At some point, you will reach an inflection point at which your workload goes from barely manageable to impossible. You will need someone efficient, competent, and fearless to hand things off to--someone like you!--but you can't afford, or don't need, a full time hire. There is nothing I like better than a juicy project to which I can add real value and, like the pop-off valve on an anesthesia machine, release the pressure when (or preferably, before) you are at risk of not meeting key deadlines and milestones. Examples of support can provide includes:
- Executive Coaching
- Pitch Deck and Executive Summary Development and Review
- Target Product Profile Development
- Accelerator Application Strategy
- Competitive Landscape Analysis
- Funding Opportunity Strategy and Analysis
- Resource and Key Talent Identification (SAB/MAB/KOL, CROs, etc)
- Project Management
- Business Development
- CxO/VPx/Director X/Chief of Staff - Providing leadership, expertise, and structure on an interim basis for Clinical, Regulatory, and Medical Affairs.
- Let's talk - how can I help you?
At the heart of every scientist is a desire to design, analyze, and interpret high-impact studies. The study design must consider not only the endpoints that support safety and efficacy for regulatory approval, but also the competitive landscape and needs of payers, product prescribers, and patients. Once the study is completed, the analysis and interpretation of the clinical data collected is one of the most exciting roles in medical research--like the big reveals Apple is famous for. A successful Clinical Science leader is organized, resourceful, an excellent project manager, and extremely high-throughput, producing reports as quickly as possible once the data are available. I have been engaged in Clinical Science efforts both pre-and postmarket for the better part of the last decade, and am happy to support you in the following areas:
- Clinical Protocol Development
- Preclinical and Clinical Study Reports
- Annual Reports
- Health Hazard Evaluations
- Clinical Evaluation Plans/Clinical Evaluation Reports
- Adverse Event Analysis
- Risk/Benefit Analysis
- Regulatory Submissions
As an entrepreneur, and as a mentor to numerous early-stage companies, I know what it takes to be capital-efficient, develop a clear strategic and tactical plan, and initiate a successful fundraising campaign. Support I can provide includes:
- CxO/VPx/Director X - providing leadership, expertise, and structure on an interim basis for clinical, regulatory, and medical affairs
- Pitch deck and executive summary development and review
- Target product profiles
- Accelerator application strategy and completion of application submissions
- Competitive landscape analysis
- Funding opportunity strategy and analysis
Araneae Biotech Consulting LLC has not received any reviews.
Araneae Biotech Consulting LLC has not received any endorsements.