Biotech Consulting Support

Supporting & guiding biotechs

Since its inception over a decade ago, Alacrita has helped hundreds of biotech companies with a broad range of consulting services, positioning itself as an industry leader. Our unique structure with an experienced core team that leverages a subject-matter expert network of more than 350 functional specialist consultants, offers fast-growing biotech enterprises access to targeted expertise that can augment their capabilities and enable them to quickly and effectively meet the unique challenges they face. 

Working with Alacrita, biotech companies can access the same high-caliber expertise found in specialist consulting firms, but replicated across multiple disciplines in a single place. This allows us to provide a broad set of consulting services without any sacrifice in quality, while also permitting us to assemble multi-disciplinary expert teams and provide a multi-stage perspective that can improve project results by delivering better strategic insight.

Our biotech consultants bring extensive first-hand experience in their respective fields, enabling us to support clients with knowledge gained through actual industry work. Whether you're an early-stage startup, a growing development-stage enterprise or an established company with marketed products, we are well-positioned to effectively support your projects or team. 

We have experience working with a range of therapeutic areas and technologies:

The below list of recent projects can help illustrate the type of support we typically provide to biotechs:

Product Development

• Virtual Stewardship of a Targeted Cancer Therapy to an IND Submission: An early-stage biotech company developing a targeted cancer therapy engaged Alacrita to provide expertise to help them navigate an upcoming IND submission. An Alacrita partner and medical oncologist with over 25 years of industry experience in drug development was integrated virtually into their team as interim CMO.
  
  

• Medical oversight support for oncology clinical trials: A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United States.

• Indication strategy for reformulated chemotherapy: A biotech company developing improved versions of available chemotherapy drugs approached Alacrita for indication strategy support, seeking to sanity check and refine its current clinical development strategy and products' differentiation and clinical placement, as well as brainstorm other avenues to pursue.
  
  Click here for more information on our Product Development services

Strategy & Commercialization

• Commercialization options and roadmap for orphan drug: A publicly-listed biotech company preparing for commercialization of its lead asset had retained Alacrita to sketch out the relevant options for its European go to market strategy and to define the critical activities that needed to be undertaken in the ensuing pre-launch 18-24 month period.
  
  
• Indication opportunity assessment for a gene therapy: An early-stage, venture-backed, private biotechnology company developing a novel multi-gene therapy approach to addressing chronic, age-related diseases requested an opportunity mapping assessment and target indication prioritization to identify the optimal indication strategy for development and commercialization of the therapy.
  
  
• R&D pipeline planning for gene therapy company: A biotechnology company developing proprietary synthetic biology technology in gene therapy expression for several clients was looking to evolve its business model. The company engaged Alacrita to find a way to build their own internal cell and gene therapy (including gene editing) pipeline and to put together a plan in order to establish medical indications the technology could be applied to. 
  
  
• Opportunity mapping for hemojuvelin antibody: A US-based biotech company developing a novel biologic which impacts iron metabolism, wanted help deciding which disease and patient groups would make the best lead indication for development and commercialization.
  
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Business Development

• Due diligence on a novel T cell therapy and discovery platform: A VC investor wished to make an investment in a California-based preclinical biotechnology company with a discovery platform and novel T cell therapies for cancer and other diseases. Alacrita was commissioned to use its experience in cell therapeutics to perform a technical due diligence on the company to highlight any key risks and to propose mitigation strategies.
  
  
• Valuation of a re-purposed combination drug for Alzheimer's disease: Valuation of a re-purposed combination drug for Alzheimer's disease.
  
  

• Valuation of a cancer therapy for licensing deal: A biotech company developing small molecule drugs for oncology was in the process of licensing negotiations with a pharma company for its lead asset. The asset, set to enter the clinic in the next year, was being developed for four CNS cancer indications. The company asked Alacrita to develop a current and future valuation of the lead asset and model various deal term scenarios to guide ongoing licensing discussions.

• Screening for rare disease licensing opportunities: Our client, a commercial stage biotech company focused on rare and ultra-rare diseases was seeking to build its pipeline of development products. Whilst it had an established business development function in North America, it had limited business development capacity in Europe and therefore a more limited awareness of and reach into the academic, disease advocacy and early stage biotech networks in Europe.

  Alacrita was engaged to assist in identifying promising drug candidates, technologies and research capabilities which offered transformational potential in a selected group of rare and ultra-rare diseases.
  
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Case studies

I. Valuation of a re-purposed combination drug for Alzheimer's disease

Challenge: A clinical stage biotech company developing treatments for Alzheimer's disease was looking for a valuation of its Phase II-ready therapeutic drug. The drug was a re-purposed combination of two known drugs with a well-documented safety profile, however unlike most other Alzheimer's drugs in development, it was part of a small pool of pipeline drugs that claimed to be disease-modifying, and in particular its primary aim was to stop disease progression at the prodromal/mild disease stage.

The company was looking for Series A financing of £20m in venture investment in order to progress the drug through a Phase II clinical trial. To prepare for discussions with investors, Alacrita was asked to develop an independent valuation of the drug.

Solution: Given the historical failures of Alzheimer's drug development and therefore lack of benchmarks for probability of technical success, developing a risk-adjusted valuation for this product was particularly challenging. Alacrita's Monte Carlo approach to pharma valuations proved to be especially useful in this case, as we were able to develop a valuation range that truly reflected the risk associated with Alzheimer's drug development whilst at the same time appreciating the potential value in a differentiated product with a known safety profile that could stop the disease at an early stage.

II. Providing regulatory strategy for T-cell therapy

Challenge: Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether it had the capabilities to launch its lead product if it were to receive accelerated approval without partnering with larger companies and asked Alacrita for commercialization assistance. The overall objective of the project was to ensure the client was adequately prepared for the eventuality of an early commercialization event for the product. This included an assessment of the regulatory pathway for the product and any obstacles that had to be considered.

Solution:

Our assessment comprised three umbrella categories:

1. Marketing approval pathway and data requirements: As a prerequisite for commercialization, the marketing approval pathway and data requirements were evaluated based on the sponsor’s interactions with relevant regulatory authorities and development plans. Having a preferred marketing approval pathway agreed with the agency(ies) and well-defined data requirements and desired labelling for the application reduces risk to achieving a timely approval and, in turn, market launch, for a commercially viable product.
2. Regulatory strategy plans and execution: The second group of criteria evaluated organizational capabilities to analyze and mitigate development risks and to adequately resource, plan and execute a regulatory strategy leading to marketing approval.
3. Processes for post approval compliance: Lastly, the regulatory assessment examined the organization’s preparedness to support post-approval compliance requirements to maintain a product license.

A written report was provided to the client summarizing the findings from each analyses and highlighting areas for focus as they work towards

III. Commercialization options and roadmap for Orphan Drug

Challenge: A publicly-listed biotech company preparing for commercialization of its lead asset had already decided to launch the product directly in the USA but was not yet certain how to approach the European markets. The product, a therapeutic for a rare disease, was on track for pivotal trial readout in two years so commercial strategy for Europe had become a critical path issue. The client retained Alacrita to sketch out the relevant options for its European go to market strategy and to define the critical activities that needed to be undertaken in the ensuing pre-launch 18-24 month period.

Solution: Alacrita's commercialization team determined, unsurprisingly, that there were four options for European commercialization: Go-alone, Partial infrastructure, Outsource, Partner. Each had its own unique set of advantages and drawbacks and through a structured workshop with the company BoD the Alacrita team helped the client select its preferred option. At the same time, we set out the essential commercial & project management activities that would be required to underpin a viable launch, highlighting the market access and supply chain activities that urgently needed attention.

IV. IND-enabling studies plan for a small molecule in NASH

Challenge: A biotech developing a novel drug for NASH asked Alacrita to create a project plan outlining costs and timelines for preclinical IND-enabling studies.

Solution: We recommended the best animal models, such as DIAMOND and STAM, of NASH for evaluating the activity of the novel drug. We also identified the most suitable IND-enabling studies for this indication, specifically focusing on preclinical studies in module 2 of the IND which includes pharmacology (in vitro and in vivo pharmacodynamic test), ADME, toxicology, and pharmacokinetics. We also estimated the time and the cost for these preclinical studies.

V. Indication opportunity assessment for a gene therapy

Challenge: An early-stage, venture-backed, private biotechnology company developing a novel multi-gene therapy approach to addressing chronic, age-related diseases requested an opportunity mapping assessment and target indication prioritization to identify the optimal indication strategy for development and commercialization of the therapy.

Solution: Alacrita first assessed ~50 potential target indications that could benefit from the gene therapy based upon biological rationale and US patient prevalence as scoring metrics. Indications were sorted into biological families depending on the key drivers of disease (cardiovascular, metabolic, obesity, renal/liver). Due to the innovative and potentially disruptive nature of the client’s approach, it was recognized that the indication strategy should involve a development journey from an initial “gateway” indication (high scientific rationale, low disease prevalence) through to larger biologically-related larger patient populations once POC had been demonstrated.

Thus, we proposed a shortlist of potential ‘indication journeys’ for client consideration, in each case profiling the severity and progression of disease, the optimal stage of disease for treatment with the “preventative” gene therapy, preclinical models and likely costs to IND, current standards of care, clinical benchmarks, the estimated cost and requirements for clinical studies to POC and regulatory submission. Finally, we provided a recommendation on the best initial indication to prioritize and its associated downstream journey indications.