Targeted Support for Virtual Biotech Programs
Alacrita's value to virtual biotechs is founded on the first-hand experience of our subject-matter experts, consultants who have spent their careers discovering, developing, manufacturing and commercializing drug products. We leverage a purpose-built network of specialists who are brought into your program when their expertise matches your specific needs, providing precisely relevant support across R&D and business challenges while offering the speed and flexibility essential for virtual biotech operations.
Curated Network of Senior Specialized Consultants
Over 15 years, we have carefully assembled and vetted over 350 specialist consultants to ensure they have extensive expertise in their particular functional disciplines.
These are former CXOs, senior leadership, and functional heads from established pharma and biotech companies, typically bringing 25+ years of specialized experience in their respective fields and often focusing on specific therapeutic areas and product modalities.
Rapid Global Deployment
We can deploy consultants as quickly as necessary for urgent program needs, with experienced specialists available globally.
Our specialists work on specific consulting assignments where they can contribute materially — providing specialist consulting firm caliber expertise across multiple disciplines while maintaining the operational flexibility essential for virtual biotechs.
Born from Direct Experience
When you need a toxicology expert to respond to FDA questions, a contract QP to approve IMP batches, or a CMO for trial oversight, but lack the workload to justify full-time hires, you need flexible expertise that scales with your program.
Our founders faced this exact challenge while building a biotech company over 15 years ago. They assembled a network ranging from fractional team members to hourly specialists: toxicology technicians for CRO management, regulatory affairs professionals sharing workload with internal teams, clinical trials managers for day-to-day operations, and statistical advisors for trial design.
When their original CRO doubled their price between agreed proposal and contract signature, they assembled a network of specialists that delivered superior outcomes. This experience proved that carefully selected contractors can perform just as well—and sometimes even better—than traditional single-vendor approaches or premature full-time hires.
The Critical Expertise Gaps Virtual Biotechs Often Face
Early-stage biotechs often have the same core expertise requirements, and similarly, are rarely in position to justify permanent senior hires across each of these functions. The challenge isn't whether you need the capability, but how to access it when critical decisions need made.
Understanding Virtual Biotech Realities
Virtual biotechs face unique challenges that traditional consulting firms often miss. You need to maintain lean operations while accessing world-class expertise. You must make critical decisions with limited internal resources. Every hire and engagement decision impacts your runway and program timelines.
The consultants who succeed in virtual environments understand these constraints intimately. They know the difference between "nice to have" analysis and "must have" decisions. They've been in board meetings where every month of runway matters. They get that you need actionable recommendations, not comprehensive reports.
Companies that recognize which expertise gaps pose the highest risk to program advancement—and address them proactively with the right specialists—have the highest chance of success. We help you identify those critical needs and provide precisely matched expertise without the overhead of permanent hires.
Key Expertise Gaps We Fill
Clinical Development Strategy
Clinical protocol design and development strategy require experienced medical oversight well before companies can justify permanent CMO hires.
Our interim clinical leaders can fill this critical gap.
- Clinical development planning and protocol optimization for current regulatory environment
- FDA meeting strategy and clinical development roadmap preparation
- Clinical trial design incorporating adaptive approaches and regulatory pathway requirements
- Medical monitoring and safety oversight by board-certified physicians
- Clinical operations strategy and CRO management for efficient trial execution
Regulatory Strategy & Clinical Holds Prevention
Experienced regulatory oversight can help address some of the common pitfalls that lead to clinical holds.
Our consultants have had careers navigating FDA interactions and while regulatory outcomes remain unpredictable, their experience helps identify potential issues early and develop strategies to address them.
- Pre-IND strategy designed to maximize these scarce, high-stakes regulatory opportunities
- IND submission preparation by consultants who've guided multiple successful approvals
- Regulatory pathway planning incorporating current FDA priorities and review standards
- Breakthrough designation applications based on successful submission experience
- Global regulatory strategies that integrate FDA and EMA development approaches
CMC & Manufacturing Excellence
Manufacturing and quality issues are among the leading causes of FDA inspection observations and clinical holds.
Our CMC consultants work to help prevent costly delays by implementing strategies designed to meet regulatory expectations from development through approval.
- Manufacturing process development incorporating regulatory compliance and commercial viability
- Analytical method development and validation for complex biologics and advanced therapies
- Quality system implementation designed for FDA inspection readiness
- CMC regulatory strategy and submission preparation for IND applications
- Technology transfer and scale-up planning designed to minimize development risks
Preclinical Development & IND-Enabling Studies
Many IND clinical holds involve preclinical deficiencies that experienced toxicologists and pharmacologists can help identify and address.
Our goal is to help you design IND-enabling studies with the best chance of regulatory success.
- GLP toxicology study design incorporating FDA guidance for specific therapeutic modalities
- Safety pharmacology programs aligned with ICH requirements and regulatory expectations
- PK/PD modeling strategies supporting defensible dose selection for first-in-human studies
- Preclinical strategy and study coordination with CROs and academic collaborators
- Translational medicine approaches that bridge preclinical findings to clinical development
Case Study: Preclinical Strategy & Interim VP CMC for Discovery-Stage Microbiome Company
Challenge: A discovery-stage microbiome company developing treatments for inflammatory bowel disease needed both a senior preclinical immunologist to lead preclinical development and elaborate a preclinical research strategy, as well as Interim VP CMC support.
Solution: We developed the high-level strategy into a detailed workflow and subsequently assisted with implementation including putting in place the preclinical models required. Later, we also supplied a senior biologics manufacturing specialist to act as Interim VP CMC. Our manufacturing consultant assessed manufacturing options taking account of cost, quality control and regulatory considerations, devised a manufacturing strategy, and set up the initial CMC activities including processes for fermentation, harvesting and cryo-preservation for live biotherapeutic cultures. He also put in place quality systems and recruited the initial CMC team.
Case Study: Independent Review of Oncology Clinical Trial Data
Challenge: A small biopharmaceutical company asked for an independent review of data from a recently completed clinical trial. They needed a summary report for the company's management and board of directors. Due to an upcoming board meeting, this request had a tight deadline of only six days.
Solution: One of our medical oncologists with over 20 years of industry experience in clinical development led the project. Our report included analysis of the study population, baseline characteristics and imbalance between treatment groups; patient disposition by treatment group; drug exposure and dose modifications; efficacy data and benefit-risk assessment; safety profile including adverse events of special interest. Our consultant presented the findings to the company's board of directors and recommended the next steps for clinical development.
Interim Functional Leadership During Critical Development Phases
Virtual biotechs consistently need senior-level expertise across multiple functions, but timing and resource allocation often don't align with permanent hires. Our consultants provide strategic guidance and operational execution on substantive assignments that require experienced decision-making during critical development phases.
Interim CMC & Manufacturing Leadership
Manufacturing operations, quality systems, and regulatory strategies to support IND submissions and commercial readiness.
- Manufacturing strategy development and CDMO selection and management
- Quality system implementation and GMP compliance preparation
- CMC regulatory strategy and submission preparation
- Analytical method development and technology transfer oversight
- Team building and operational infrastructure establishment
Interim Chief Medical Officer
Board-certified physicians with extensive drug development experience across protocol development, FDA interactions, and trial oversight.
- Clinical protocol development and FDA interaction management
- Medical oversight of ongoing trials and safety monitoring
- Investor and board communication during funding processes
- Strategic medical guidance for partnership discussions
- Extensive drug development experience across therapeutic areas
Interim Regulatory Affairs Leadership
FDA and EMA interaction management, particularly for advanced therapeutics with complex approval pathways.
- Global regulatory strategy development and pathway planning
- FDA and EMA interaction management and submission oversight
- Breakthrough designation and fast track application guidance
- Regulatory team building and process establishment
- Cross-functional regulatory integration with CMC and clinical teams
Additional Interim Roles
Functional leadership across other areas essential to virtual biotech advancement, tailored to program needs and development stage.
- Interim Chief Scientific Officer for overall R&D strategy and execution
- Interim VP Clinical Operations for trial execution and CRO management
- Interim VP Business Development for partnership and licensing activities
- Interim VP Preclinical Development for IND-enabling study oversight
- Interim functional leads in toxicology, biostatistics, and medical affairs
Case Study: Interim Chief Medical Officer for Early-Stage I/O Biotech
Challenge: An early-stage biopharma company focused on immuno-oncology therapeutics experienced sudden CMO departure during critical development phases. The company needed interim support while recruiting for a permanent replacement.
Solution: Our interim CMO provided clinical development input on FIH trial design, contributed to IND preparation meetings, and joined executive team members for U.S. venture investor due diligence meetings that led to successful Series B financing. The interim CMO also assisted in evaluating candidates for the permanent position.
Case Study: Two-Year Interim CMO Engagement
Challenge: An oncology company developing a portfolio of first-in-class small molecules needed CMO leadership over two years. Three products were in Phase I clinical trials, with the lead candidate recruiting patients in hematologic malignancies.
Solution: We placed a board-certified oncologist with extensive biotech experience as interim CMO, spending significant time on-site weekly and embedding into the team. Key achievements included leading the oncology clinical team and helping recruit additional medical talent for permanent positions.
Advanced Therapeutics & Complex Modalities
Gene therapies, cell therapies, and other advanced modalities frequently require specialized knowledge that extends beyond traditional drug development expertise. These programs face unique regulatory pathways, manufacturing challenges, and clinical considerations that require consultants with hands-on experience in successful approvals.
Advanced Therapeutics Landscape
The regulatory landscape for advanced therapeutics continues evolving rapidly as FDA gains experience with these modalities. Companies developing gene therapies, cell therapies, or other complex biologics need consultants who've guided similar programs through successful regulatory approvals and understand both current requirements and emerging expectations.
Gene Therapy Development
Our gene therapy specialists provide comprehensive support across the development lifecycle:
- Vector development and optimization strategies incorporating manufacturing considerations
- FDA OTAT interactions and RMAT designation applications with successful submission experience
- Gene therapy-specific CMC development including potency assay validation
- Manufacturing strategy for viral vectors balancing cost, quality, and regulatory compliance
- Clinical development approaches tailored to gene therapy regulatory requirements
Cell Therapy Programs
Our cell therapy experts deliver specialized consulting services including:
- Cell therapy process development from research through commercial manufacturing
- Potency and identity assay development for complex cellular products
- Autologous and allogeneic manufacturing strategy and regulatory planning
- FDA guidance navigation for CAR-T and other engineered cell therapies
- Supply chain and logistics planning for temperature-sensitive cellular products
Other Complex Modalities
We provide expert consulting for advanced therapeutic platforms:
- Antibody-drug conjugates (ADCs) with specialized linker and payload considerations
- Microbiome therapeutics including live biotherapeutic products
- RNA therapeutics including mRNA and siRNA development strategies
- Combination products requiring integrated device and drug development
- Novel delivery systems and formulation challenges for advanced therapeutics
Case Study: Supporting a Virtual Gene Therapy Company with Preclinical, CMC, & Regulatory Strategy
Challenge: An early-stage biotechnology startup company reached out to Alacrita for critical support of its two lead AAV-delivered gene therapy programs. As a virtual company, the client needed expert analysis of ongoing experimental research and development planning of future preclinical PoC studies conducted by CROs and academic collaborators. The client also requested support for planning CMC and regulatory activities needed to progress these programs to IND.
Solution: An Alacrita consultant worked closely with gene therapy, regulatory, and CMC consultants from Alacrita's extensive expert network. We provided the client with ongoing technical data review, analysis, and preclinical development recommendations for both gene therapy programs including identification, timing, and design of preclinical animal model studies; efficacy, biodistribution, safety, and toxicology studies; identification of risk factors and mitigation strategies; research timelines with go/no-go decision points; coordination of studies with CROs and academic collaborators. Alacrita CMC and regulatory experts also assembled a CMC and regulatory roadmap for the client's two gene therapy programs through preclinical development and into clinical development.
Investor Readiness
Today's investment environment demands demonstration of not just compelling biology, but clear paths to regulatory approval and commercial success. Due diligence processes now extend beyond basic science to include manufacturing feasibility, regulatory pathway validation, and competitive positioning analysis.
What Investors Are Actually Looking For
Venture firms concentrate larger investments on fewer companies with experienced leadership teams, strong scientific data, and validated development strategies. Technical assessment now includes regulatory pathway validation and competitive positioning analysis that requires deep industry experience.
They want to see that you have the right expertise to navigate FDA interactions, not just promising biology.
What Pharma Partners Are Actually Looking For
Pharmaceutical partners expect demonstration of regulatory competence, experienced medical oversight, and robust CMC strategies before serious partnership discussions. Due diligence focuses heavily on manufacturing feasibility, FDA interaction history, and leadership team credibility.
They want to see that you have the right expertise guiding critical decisions, not just promising data. Partners want evidence that your team understands both the science and the business realities of drug development.
Investment Due Diligence Support
- Scientific data package optimization based on successful fundraising experience
- Competitive landscape analysis incorporating recent regulatory approvals and industry developments
- Development timeline and cost modeling with realistic risk-adjusted assumptions
- Regulatory pathway validation by consultants with track records of successful submissions
- Technical risk assessment with specific mitigation strategies proven in similar programs
Partnership Strategy and Execution
- Partner assessment and strategic fit evaluation based on successful deal experience
- Deal structure optimization including milestone and royalty strategies
- Due diligence support during partnership negotiations with regulatory and technical expertise
- Alliance management and ongoing partnership optimization
- Exit strategy planning and execution support
The most successful partnerships involve companies that approach collaboration from positions of scientific strength and strategic clarity. This means having compelling data, understanding market dynamics, and demonstrating execution capability before entering serious partnership discussions.
How We Actually Work With You
Effective virtual biotech consulting begins with realistic assessment of current capabilities and honest evaluation of development requirements. The companies that achieve the best results engage our consultants on substantive assignments where deep functional expertise makes a material difference to program outcomes.
This means identifying specific development challenges that require specialized knowledge and engaging consultants who can deliver strategic solutions and actionable recommendations. Our consultants work on assignments that advance programs toward key milestones based on real-world experience with similar development challenges.
Our Integrated Approach
- Comprehensive program assessment incorporating scientific, regulatory, and commercial realities
- Consultant selection based on specific functional expertise and proven track records in similar assignments
- Strategic consulting engagements designed to complement and enhance existing capabilities
- Performance measurement tied to specific program milestones and deliverable completion
- Flexible consulting arrangements that adapt to evolving program needs and development priorities
The most valuable consulting relationships are built on deep understanding of specific development challenges and continuity through critical program phases. A regulatory consultant who develops your Pre-IND strategy brings invaluable context to subsequent FDA interactions. A CMC consultant involved in process development can provide strategic guidance through manufacturing scale-up and commercial phases.
Specialized Consultants, Precisely Matched
Over the past 15 years, Alacrita has carefully assembled an extensive network of former CXOs, senior leadership, and functional heads from both large pharma and biotech companies. These consulting associates typically bring 25+ years of experience in their respective fields and often specialize in specific therapy areas and product modalities.
Our Consultant Vetting Process
Each consultant in our network has been personally interviewed by Alacrita partners and goes through a rigorous selection process. We verify their track record, review their specific therapeutic area expertise, and assess their ability to deliver results in virtual biotech environments.
We maintain detailed profiles of each consultant's experience including specific companies where they've worked, therapeutic programs they've led, regulatory submissions they've guided, and clinical trials they've overseen. This allows us to match consultants precisely to your program's needs.
When challenges arise that our consultants can't solve, we acknowledge limitations upfront and help identify alternative approaches or specialists who can address the specific issue.
Network Depth & Experience
Therapeutic Area Expertise
Our consultant network spans extensive therapeutic areas with deep, specialized knowledge:
- Oncology, Autoimmune/Immunology, Central Nervous System, Cardiovascular
- Orphan Diseases, Infectious Disease, Ophthalmology, Respiratory
- Endocrine & Metabolic, Digestive/GI, Women's Health, Urology
- Haematology, Dermatology, Musculoskeletal, Inflammation/Pain
Product Modality Experience
Our specialists have hands-on development experience across advanced therapeutic modalities:
- Cell Therapy, Gene Therapy, Antibodies & ADCs, Immunotherapy
- DNA/RNA therapeutics, Microbiome Drugs, Oncolytic Virus, Vaccines
- Small Molecules, Peptides, Proteins, Radiopharmaceuticals
- Drug Delivery Technology, Diagnostics, Biomarkers, Medical Devices
Flexible Engagement Models
- Project-based consulting for specific milestones and deliverables
- Retainer arrangements for ongoing strategic guidance and support
- Embedded team member integration for hands-on operational roles
- Interim leadership positions for 3-18 month strategic transitions
Accessible, Responsive & Flexible Support
- Immediate consultant deployment when critical issues arise
- US and European specialist availability for global regulatory requirements
- Flexible contract structures that align with virtual biotech operational needs
- Multi-time zone coverage for international development programs
What sets Alacrita apart is our capacity to build consulting teams with skills and experiences that precisely match client needs. Our specialists integrate into project teams and work on specific assignments where they can contribute materially. This allows companies to access specialist consulting firm caliber expertise across multiple disciplines in a single place, providing multi-disciplinary and multi-stage perspective that improves project results through better strategic insight.
Ready to discuss your program's needs?
Contact Alacrita to explore how our experienced consultants can support your development goals while maintaining the operational flexibility essential for virtual biotechs.