Microbiome Consulting Support

We've consulted with clients on a range of microbiome drug development products & programs, and have advised investors and BD teams on individual assets, pipelines and companies in this rapidly evolving space. Our core team draws from an extensive network, which contains a number of senior consultants experienced with microbiome therapeutics. These specialists understand the unique challenges and complexities present in their development and commercialization. This allows us to field project teams that precisely match the microbiome expertise needs of your project. 

The support we can provide ranges from opportunity mapping and business strategy to regulatory affairs, preclinical and clinical support, to due diligence, valuations and licensing, partnering & dealmaking, among other consulting service.

Some of our recent experience in the microbiome field is outlined below. 

Recent Microbiome Projects:


  • Due diligence of phase-2 live biotherapeutic product: A developer of live biotherapeutic products (LBP) derived from stool donations had a lead product in phase 2 clinical trials for metabolic pathology secondary to hepatic pathology. An investor for whom Alacrita had previously worked on several assignments requested a due diligence focusing on the scientific rationale, the novel production technology, the regulatory position and commercial prospects.  

  • Clinical protocol review for a mircobiome product focused on oncology: A biopharma company developing microbiome therapeutics asked Alacrita to conduct a detailed protocol review of a clinical study designed for its lead asset in patients with advanced solid tumors including advanced melanoma, head and neck squamous cell cancer, and non-small cell lung cancer.

  • Regulatory strategy & pre-IND meeting support for a biotech: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in question was a massively multiplex composition that presented complex CMC and assay issues. 

  • Providing microbiome due diligence to an investor interested in the GI disease space: Our client, a mid-cap pharma, was planning to extend its portfolio in the gastrointestinal (GI) disease space. It was considering microbiome-based approaches, specifically live biotherapeutic products (LBP), technologies with which it was not familiar. Alacrita's assignment was in two parts: firstly, a review of investment trends in BP development companies and secondly an analysis of four speciality GI indications.

  • Providing high-level gap analysis of European market access: A US venture-funded biotech was planning a pivotal trial with a highly efficacious infectious disease therapy. It asked Alacrita’s pharma market access consultants to conduct a high-level ‘gap analysis’ to identify shortcomings in the proposed trial protocol from a European market access perspective.

  • Preclinical strategy for IBD therapeutic: For a microbiome company, Alacrita developed a preclinical research strategy for its inflammatory bowel disease program. We then developed the high level strategy into a detailed workflow and subsequently assisted with implementation including putting in place the preclinical models required.

  • CMC support for a discovery stage microbiome company: For a discovery stage microbiome company, Alacrita supplied a senior biologics manufacturing specialist to act as Interim VP CMC. Our consultant set up the initial CMC activities including processes for fermentation, harvesting and cryo-preservation for live biotherapeutic cultures, put in place quality systems and recruited the initial CMC team.

     

Selection of Microbiome Consulting Case Studies

Challenge: A developer of live biotherapeutic products (LBP) derived from stool donations had a lead product in phase 2 clinical trials for metaboilic pathology secondary to hepatic pathology. An investor for whom Alacrita had previoulsy worked on several assignments requested a due diligence focusing on the sceintific rationale, the novel production technology, the regulatory position and commercial prospects.

Solution: We deployed a team with experience of microbiome-based products across a variety of technologies and indications. The team reviewed all key documentation including:

  • Business plan including budgets;
  • Key research reports, scientific advisory board minutes, etc;
  • Regulatory correspondence including the application to conduct clinical trials;
  • Clinical trial protocols, investigator brochures and data where available;
  • Manufacturing process and analytical approach/validation status;
  • Plans for scale up to commercial scale and timing vs. clinical development milestones.

Our conclusions were that this company had successfully established a class-leading manufacturing technology coupled with state-of-the-art quality and analytical systems. The team had proven itself capable of overcoming several significant tecnical hurdles and was exceptionally well-placed considering the relative "youth" of the company.

Challenge: A biopharma company asked Alacrita to provide expert input on the clinical development of a microbiome therapeutic (LBP, live biotherapeutic product) in the context of first line and second line combination therapy of malignant melanoma.

Solution: One of our pharmaceutical oncologists provided high-level clinical development plans for both a first and second line therapy strategy. Our consultant provided an overview of the target indication, current standards of care, unmet therapeutic needs, a review of the therapeutic landscape (current and pileline) and clinical study designs including objectives, endpoints, patient selection criteria and sample size, timelines and information on estimated time to approval.

Challenge: A company with a microbiome-conditioning product was seeking the optimum strategic positioning to enable a trade sale to a major company. Unusually for a venture in this field, the company had conducted numerous laboratory, pre-clinical and clinical assessments of the product to support its direct-to-consumer sales model. We assessed the current positioning of the products in the consumer space (particularly by engaging with key product recommenders) and sought opportunities to broaden the position into the mainstream therapeutic arena, outlining the scope and depth of a data package needed to secure an Rx claim.

Solution: The company concluded that the resources required to transform itself into an Rx company exceeded its capacity, and moreover, Alacrita identified certain supply chain issues that would have formed a major impediment to traditional Rx distribution channels. The company decided to maintain its focus on its traditional core business activities.