Support for pharmaceutical companies
Over the course of the past decade, Alacrita has helped pharmaceutical companies effectively overcome a broad range of challenges, augmenting their capabilities with specialized knowledge and skills that may not be available within their organizations. Our unique structure, which combines a highly-experienced core team with a subject-matter expert network of over 250 functional specialist consultants, offers access to targeted expertise, across therapeutic areas and technologies.
Working with Alacrita, you 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 sacrificing quality or depth of knowledge, further strengthened by the extensive first-hand experience, in their respective fields, that our pharma consultants bring.
Featured areas of support
Due Diligence: Our ability to draw highly-experienced, specialized experts from our network, allows us to build consulting teams with backgrounds in precisely the therapeutic area and technology of a particular DD. This enables us to provide a final assessment that fully considers the unique aspects of the due diligence target. More info
Clinical Development: Our team has extensive experience planning and implementing clinical development programs. Within our expert network, we have over 200+ MDs globally, the majority of whom are clinical development experts, some of the them CMO-level caliber. Others specialize in medical affairs. Our team’s work spans most strategic aspects of clinical development as well as operational support on a selective basis. More info
Asset Scouting: Alacrita frequently supports companies with their search and evaluation activities. Our scouting support is often structured to integrate with the client’s business development team, bolstering internal efforts and generating a consistent flow of new and exciting opportunities. We often tap into our wide-reaching network to find very early-stage assets that are not yet widely known to the industry. Past and current clients have engaged us to boost development product pipelines with external innovation and to broker interactions with suitable companies. We also frequently provide landscape analyses of potential acquisition and licensing opportunities for easier review and to streamline internal decision-making. Our hands-on support can provide identification, due diligence and in-licensing of assets of any stage. More info
We have experience working with a range of therapeutic areas and technologies:
Our complete suite of services
Alacrita offers clients a comprehensive level of support that combines the capabilities of the firm's core team with the extensive skillset of our expert network.
The below list of recent projects can help illustrate the range of support we typically provide to pharmaceutical companies:
- Interim Medical Director: On behalf of a publicly-traded pharmaceutical company, one of Alacrita’s senior medics acted as medical director for the registration of a new agent in a neuroendocrine indication in territories outside the USA. 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..
Interim medical support for clinical development: A major European pharmaceutical company required interim medical support for clinical development activities over a three-year period. Alacrita was engaged to provide the expertise.
Acting as clinical directors, Alacrita’s European medical professionals undertook: Provision of strategic development advice in first-line pancreatic cancer, small cell lung cancer and other indications; Protocol review and development in oncology indications; Data review: data coding review and patient profile review; Trial oversight; and Clinical study report writing oversight and manuscript creation.
Supporting BLA submission for a novel antibody-based therapeutic: Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum residual disease following debulking surgery and standard chemotherapy. The Phase III trial design had been agreed with the FDA under the SPA procedure and the client had gained fast-track status. In addition, the client had received EMA scientific advice and intended to file for conditional MAA approval, subject to satisfactory Phase III results. Although our client was a fully integrated pharma company, and had significant regulatory experience with small molecules, this was the company’s first biological product candidate to reach the registration stage.
The company was therefore seeking to supplement its existing in-house capabilities with the appropriate external biologics regulatory expertise. Specifically, the company needed to gain a better understanding of the BLA process, clarify the level of detail needed for the various sections of the license application and obtain high-level review and sign-off of the regulatory dossier.
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Strategy & Commercialization
- Commercial supply chain for US launch of a blood cancer drug: Our client was a publicly-traded clinical-stage biopharmaceutical company using an epigenetic approach modulate gene expression in tumor and immune cells to treat cancer. Their lead program was a small molecule inhibitor in late-stage clinical development for a hematological malignancy. In preparation for regulatory approval and launch in US, Alacrita was asked for support to help design and create a roadmap for setting up a commercial supply chain for the drug. The company had an upstream supply chain in place (API, DS, and DP manufacture), but no downstream elements yet in place..
- Opportunity assessment for the reformulation of a marketed biologic: An established 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.
- Opportunity mapping and prioritization of new R&D programs: A clinical stage pharmaceutical company was interested in leveraging their existing antivirals drug discovery and development capabilities to expand the company’s future product pipeline. To that end, they requested a comprehensive and methodical strategic assessment of the viral disease landscape and the prioritization and profiling of commercial opportunities therein..
- Assessment of market and commercial opportunity for a prescription surgical product: A publicly traded specialty pharma company was considering acquiring a company developing a prescription product for use by surgeons. We were asked to conduct an assessment of the market and commercial opportunity for the products being developed by the target company.
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- Providing due diligence of a Phase lll oncology program: A major pharmaceutical company asked us for support in the due diligence and assessment of a Phase III in-licensing opportunity. The drug in question had met its primary endpoint in a pancreatic cancer Phase III clinical trial and our client was seeking ex-US rights to the program.
- Due diligence on three late-stage clinical assets in nephrology: A specialty pharma company was considering in-licensing three late-stage clinical assets in nephrology and requested expert input from Alacrita to supplement its internal DD team. Alacrita provided specialist medical and regulatory input to the due diligence. There was an element of "which of the three assets was best" to the due diligence, but the core of the assignment focused on the relevant asset-specific issues that became apparent during the analysis. The Alacrita team completed the analysis on time and on budget.
- Scouting in-licensing targets in inflammation and fibrosis: A pharmaceutical company with marketed therapeutics in several respiratory disorders wanted to supplement its internal pipeline with external innovation. The company had already searched for potential partners in its home territory, but had not identified any suitable discovery/preclinical-stage assets in its indications of interest. It did not have the internal capacity to continue a search of international markets, so engaged Alacrita to identify other potential partners and assets, with a particular focus in the US and Europe.
US and European partner outreach for Asian pharma companiesl: A South Korean consulting firm required support in exploratory partner outreach in the US and Europe. Alacrita was commissioned to use its expertise in pharma licensing and deal-making in these territories to gain an initial read on potential ‘partnerability’ on behalf of the consulting firm for two South Korean pharma companies.
Business development for small molecule therapeutic in oncology: A pharmaceutical company reached out to Alacrita for assistance with finding a pharma partner for the clinical development of their small molecule oncology asset.
Alacrita consultants first developed a long list of approximately 125 WW public and private possible prospective partners with experience in oncology clinical development and a market cap of >$100M. We subsequently triaged the long list in order to force rank companies according to their strategic attractiveness. We allocated a weighted score to pre-defined filters, enabling us to rank the long list of companies using a ‘Strategic Fit Score’ and apportion them into tiers. Finally, Alacrita supported the crafting of an effective outreach email and provided further assistance with company contact emails, arranging face-to-face meetings, and sharing a non-confidential presentation to gauge interest.
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I. Scouting for in-licensing opportunities in oncology, autoimmune diseases and infection
Challenge: Since 2013, Alacrita has been engaged by a well-capitalized Swiss pharma company to scout and identify early stage in-licensing opportunities from the US and UK. Therapeutic areas of interest for our client have included oncology, autoimmune diseases and anti-infectives. Our focus has been to identify new opportunities that are not currently on their radar or easily identifiable through existing industry pipeline databases.
Solution: Alacrita works in close conjunction with the pharma company's internal team of business development professionals, who have benefited from utilizing our wide-reaching network to tap in to very early stage opportunities that are not yet widely known to the industry. Our approach includes maintaining long-term relationships with early stage biotechs, mid-size pharma companies and university technology transfer offices to ensure we are among the first to be made aware of the types of early stage opportunities our client is interested in. We use various channels to do this including regular attendance at relevant scientific meetings and medical conferences, leveraging investor meetings or presentations about non-dilutive financing, searching new and recent literature, and outreach and networking with our industry contacts.
An example of an oncology BD transaction sourced by Alacrita's experts for this client is a small molecule cell cycle checkpoint regulator for which a deal was closed with a biopharma company to collaborate on development of the asset.
II. New in-licensing opportunities in urology, hepatology, GI disorders and reproductive healthH
Challenge: A pharmaceutical company that pioneered peptide pharmaceutical products, and a leader in reproductive medicine and women’s health, had recently made the strategic decision to supplement its internal development pipeline through a focused in-licensing effort. The company already had innovation sourcing teams in place and covering Europe, China, and West Coast US, but recognized that additional US scouting resources would enhance the in-licensing efforts. Alacrita was therefore engaged to conduct scouting activities from Boston, and focusing on therapeutic assets and biomarkers in urology, hepatology, inflammatory bowel disease and reproductive health.
Solution: We worked closely with the client’s R&D leadership to identify important drug targets and biological pathways of interest to focus the search. We scouted for assets that were first-in-class and significantly differentiated from currently approved medicines, with a focus on drug discovery to Phase 1 clinical development. We took an iterative approach to the search, by adjusting search criteria to align with the client’s evolving interests throughout the engagement.
III. Due diligence of a clinical stage therapeutic for rare paediatric neurodegenerative disorders
Challenge: A pharma company developing a first-in-class therapeutic to treat rare paediatric neurodegenerative disorders was nearing NDA approval in multiple indications and was ready to initiate fund raising activities to support its next steps. Alacrita had previously been commissioned by an investor to conduct due diligence on the company for an earlier funding round. This time, we were approached directly by the pharma company to perform an updated due diligence exercise and develop an independent report of the company’s progress for other potential investors.
Solution: Our neurology expert reviewed all of the available clinical data for the company’s lead product and developed an opinion on the strength of the data and the likelihood of approval in each indication. Using these outputs, our market analysis expert quantified the commercial potential in each indication. We presented our findings to the pharma company, which subsequently used the output of the due diligence to engage with potential investors.
IV. Technology landscape, preclinical planning, and due diligence of research collaboration partner
Challenge: A public pharma company requested Alacrita’s support in evaluating a potential partnership with a gene editing company to co-develop gene therapy approaches for disorders involving the complement pathway. Alacrita was also asked to draft key documents to include in the proposed contract.
Solution: Alacrita consultants and experts from our network provided a due diligence on the intended partner’s capabilities and their proposed approaches for targeting the complement pathway. We identified risks and provided mitigation strategies and recommendations, with the goal in mind of ensuring the partnership would have the greatest potential to be productive prior to entering a collaboration. An overview of the global gene editing technology landscape was also provided, including strengths and weaknesses of current approaches, to determine whether the proposed gene editing strategy could be achievable using any alternative technologies. Relying on our considerable drug development expertise, we contributed to the production of three documents for inclusion in the proposed contract: high-level research plans for the initial programs, a draft set of development candidate criteria and go/no-go thresholds, and data package requirements to support a candidate selection decision for programs in the research plan.
V. Medical and technical support for a European pharmaceutical company
Challenge: A European pharmaceutical company required medical, clinical and technical expertise for radoipharmaceuticals, theranostic development and medical imaging. Alacrita was engaged to provide the necessary support..
Solution: The Alacrita team provided expertise that was not available within the client organization, and support for a portfolio of molecules spanning Phase I and Phase II clinical trials was critical to the timely execution of the development plan. Alacrita provided this support over a period of three years.
The following support was provided:
- Provided strategic and scientific expertise into radiopharmaceutical and theranostic development and medical imaging
- Helped design and develop protocols/studies with imaging as a primary or secondary endpoint
- Recommended, built consensus and then designed Phase II protocol for the first multi-center study which was designed to answer the FDA pre-IND questions.
- Critically reviewed and helped design all medical imaging assessments for oncology teams across four protocols
- Evaluated the program and ROI and recommended a companion diagnostic development pathway.
- Supported the evaluation and operational management of the imaging core labs (ICL) in studies where medical imaging was being used, including careful review and editing of Imaging Charters and Image acquisition guidelines.
- Acted as interim senior clinical development leader for a Phase I trial
- Provided input to and implemented the strategic direction and tactical execution of drug development trials
- Wrote the protocols and provide insight into all the imaging endpoints.
- Developed the concept of modified Ga RECIST, modified Ga PERCIST and volumetric assessments in the protocols to ensure the theranostic approach would be fully elucidated any abscopal effects would be seen.
- Provided scientific expertise, strategic and operational input to external innovation and due diligence activities as requested.
- Supported the regulatory teams in representing the company in regulatory agency and health authority relations including:
- Wrote the initial response to the FDA re the IND
- Supported and wrote some of the sections for the IND
- Developed and wrote a significant part of the questions to the FDA briefing book for the FDA to support the approach for a companion diagnostic
- Suggested the opportunity to meet with the FDA as part of a Critical Path for Innovation meeting (CPIM) and developed the document submitted to the FDA and slides for the possible meeting.