Endocrine & Metabolic Consulting Support

We support clients on a range of drug development products and programs focused on endocrine and metabolic diseases, and advise healthcare investors and business development teams on individual assets, pipelines and companies in this promising space. Our core team draws from an extended consulting network, which has over 75 senior consultants experienced in this disease area. These specialists understand the unique and complex set of challenges present in their development and commercialization and can help you effectively navigate through them. Our extensive resources in this space allow us to field project teams that precisely match the expertise needs of each 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.

Number of consultants with endocrine & metabolic disease area expertise, by discipline and by education:



Recent Consulting Projects in this disease area:

  • Providing expert due diligence for the reformulation of a marketed biologic: An established European pharma company needed an opportunity assessment for a reformulation of a marketed biologic. We quantified the market opportunity and assessed the market positioning and unique selling propositions (USPs) of the target product. We also reviewed the competitive environment, assessing sales and pricing of competitor products (based on IMS data) and likely competitive responses from established players in the market.

  • Providing an Interim Medical Director: For a European pharmaceutical company, one of Alacrita’s consultants acted as medical director for the registration of a new agent in a neuroendocrine indication in territories outside the US. Alacrita was brought in by the client five months before the planned MAA submission date after the internal medical director and other key team members unexpectedly left the company and could not be replaced internally.

  • Providing due diligence support for a clinical stage, type 1 diabetes immunotherapy project: A clinical stage, type 1 diabetes immunotherapy project needed convincing partnering materials and advice on data room structure and due diligence preparations. We overhauled the presentation of the project, highlighting the mechanism-based approach to treating and preventing type 1 diabetes, and the scientific rationale of the approach being taken.  The presentation was professional, with consistent style and encompassed scientific rationale, clinical data and supporting preclinical data. We benchmarked it against other competing therapies, IP and future product development strategies. In the ensuing six months, a partnering deal was completed with Big Pharma.

  • Modeling front-loaded deal vs. risk sharing for molecular design collaboration: AA drug discovery company was in discussions with a big pharma about collaborating on a number of strategies that would deliver at least one quality clinical candidate. The pharma company had offered two types of deal: a front-loaded arrangement with R&D costs and milestones up to candidate delivery, and a risk-sharing deal where some of the compensation was to be back-loaded with milestones payable up to market, and possible royalties on net sales. The client asked us to assess its deal-making strategy, develop valuation models and advise on the negotiation strategy with its prospective partner. 


Selection of Endocrine & Metabolic Consulting Case Studies

Challenge: Our client was a company on which we had conducted due diligence for an investor approached us for support with a potential deal with an AI discovery company. The concept was to harness the potential of signatures identified by the AL/ML algorithm to create specific microbial cocktails aimed at specific disease indications. The client recognized that this was a somewhat speculative, blue-sky project, but with low initial outlay and a potentially lucrative project opportunity. Our client requested support in benchmarking relevant deal terms and formulating structures and negotiating positions that he could propose to his board and potentially to the prospective partner.

Solution: Alacrita worked with a veteran dealmaker who collated the (few) relevant deal benchmarks that could be used/adapted for this purpose. She proposed a standard back-loaded deal structure and set out a range of approaches to negotiations. During this process, the Alacrita Managing Partner working alongside pointed out the technical uncertainties and potential shortcomings of the approach and found a number of publications that suggested the insights presented by the AI partner were not previously unknown.

Challenge: On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in territories outside the US. Alacrita was brought in by the client five months before the planned MAA submission date after the internal medical director and other key team members unexpectedly left the company and could not be replaced internally.

Solution: During the five-month period, the team finalised the study reports, wrote the overview and the SmPC for the submission as well as preparing an ODD application (which was granted). The team received numerous questions from the rapporteur and co rapporteur and the same team worked on the responses to questions, including new statistical analyses of the clinical data. The Alacrita medic represented the company in regulatory agency meetings and the product was successfully steered through regulatory approval. Following this, submissions were prepared for other non-US territories and the dossier was transitioned to the client’s commercial team.

Challenge: Our client was developing an oral form of an approved biologic drug for endocrine disorders which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II trial in an orphan indication was underway in the client's home country. Preparations were underway to initiate cinical trials in Europe and US. The client required assistance in assembling and submitting an Orphan drug designation application to the EMA.

Solution: Alacrita prepared the EU application form for the submission, with a particular focus on sections A-E including medical plausibility, literature data on disease prevalence, summary of available treatments, arguments regarding significant benefit, and design of the proposed clinical development program. We published and submitted the draft application and were on-hand to help with changes required during validation before submitting the final application to the regulator.