Oncology clinical development planning, strategy & hands-on support 


For more than 15 years, we've been helping innovative biotech and pharma companies bring oncology therapeutics to market, helping them navigate the many complexities in the drug development process by crafting clinical development plans and strategies and by providing hands-on support, from early-stage to commercialization. Our expertise spans a wide array of tumors and mechanisms, including next-generation and targeted therapies.

Our firm is led by partners with over 30 years of experience in oncology drug development. Their leadership, combined with our carefully-assembled network of specialized oncology consultants, allows us to provide unparalleled support at every stage of an oncology program, including:

Our oncology-focused preclinical and clinical development services include the follow:


Oncology Preclinical Strategy

  • Target identification and validation within the oncology landscape.
  • Design and execution of preclinical studies specifically for oncology indications.
  • Biomarker development to identify responsive patient populations in oncology trials
  • Regulatory strategy development tailored to the oncology regulatory environment.
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Oncology Clinical Development Planning and Execution:

  • Design and protocol development for oncology clinical trials, including innovative trial designs.
  • Patient selection and recruitment strategies optimized for oncology indications.
  • Data management and analysis expertise specific to oncology clinical trials.
  • Safety monitoring and pharmacovigilance tailored to the unique safety profile of oncology drugs.
  • Regulatory submissions and interactions focused on oncology-specific requirements.
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We have experience working with a wide range of product modalities, in a host of oncology indications, including:


Recent oncology clinical planning & strategy projects

  • 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.

  • Providing clinical and medical support in immuno-oncology: A leading immuno-oncology biotech company with a pipeline of novel, first-in-class clinical stage assets needed medical support for multiple clinical and medical affairs activities in Europe and the United States. Our support included providing advice and assistance with the following: clinical strategy and execution of the clinical development plans for the company’s drug candidates; drug safety and pharmacovigilance; and fostering existing and future relationships with key opinion leaders, medical advisors and medical advisory boards. We also assessed portfolio expansion opportunities and other corporate development activities from a clinical development and medical perspective.

  • Clinical development planning & strategy for a novel immune-boosting biologic in cancer treatment: A leading private US academic institution had created a therapeutics accelerator program to support early discoveries and facilitate industry partnerships of its assets. Its current focus was a project developing an agonist antibody immune booster for applications in cancer and it required support to guide the next steps of development. As part of an ongoing collaboration, Alacrita was commissioned by the University to perform a data gap analysis and to provide a roadmap for generating key data that would be required for securing future investment.

  • Appealing FDA refusal of an orphan drug designation application: A biopharmaceutical company was seeking assistance to prepare a response to the FDA’s initial refusal of its orphan drug designation application for its novel CAR-T therapy intended for use in an orphan subset of a non-orphan condition.

  • Clinical development strategy & fundraising support for an oncology start-up: After a seed investment, a startup biotech had built an IP portfolio in the field of glucosinolates, chemicals found in brassica vegetables, that are potent inducers of cytoprotective enzymes and inhibitors of carcinogenesis. The company was preparing for a Series A financing to support the preclinical and early clinical development of the company’s lead compound and was putting together a business plan to underpin this process. They asked us to provide a rational development strategy based on the research data accumulated to date, which suggested that the compound could have efficacy in a broad range of cancer types. The challenge was to identify the lead indication with the strongest scientific, clinical and commercial rationale.


Oncology clinical development case studies

For a leading University with an early stage novel small molecule to treat prostate cancer, Alacrita was asked to validate a development plan in order to support activities for securing investor, translational grant-funder and/or pharma partner confidence.

Alacrita reviewed all the documentation already provided by the academic inventor and any available publications validating the target. We held a teleconference with the core team to get a detailed understanding of the project, the nature of the ‘hit’ generation work and the ‘hit’ molecules generated to date, available in vitro and cell-based assays and in silico models, and the basis for the projected costings for discovery, pre-clinical development and Phase I and II clinical trials, as prepared by the team. We found that although evidence to date had been generated for metastatic prostate cancer, this particular target was known to be overexpressed in other cancers and therefore our consultants proposed exploration of small molecule in a range of tumour types, both in vitro and later in vivo. We developed outline clinical development strategy and plans, costings and timelines, based on our experience and appropriate industry standard metrics, for:
- Hit-to-lead medicinal chemistry, computational chemistry and screening (in vitro activity and preliminary ADME screens);
- Lead optimisation medicinal chemistry, computational chemistry and screening (in vitro and in vivo activity and ADME/DMPK screening);
- Pre-clinical development, including non-GMP then GMP, pharmacology and toxicology;
- CMC (process development, non-GMP and GMP batch manufacture, formulation development and trial supplies); and
- Early clinical development to clinical proof-of-concept (Phase I safety trial and Phase IIa study).

A privately-held European biopharma company focused on immuno-oncology therapeutics, in collaboration with academic investigators and inventors, was developing small molecule and monoclonal antibody agents for three targets of high interest in the I/O field. The company had a sudden departure of their Chief Medical Officer and needed interim support while recruiting for a permanent replacement. Alacrita was engaged to provide that expertise.


Alacrita provided Chief Medical Officer support for the client, and assisted on several activities such as:- Provided clinical development input on the design of a FIH trial and clinical development plan for a differentiated small molecule that targeted a receptor of high interest in the I/O field.  This study included dose-escalation for the novel agent as monotherapy and in combination with the anti-PD-1 antibody Keytruda (pembrolizumab).  The agent was being developed in collaboration with a non-profit cancer research organization.  The phase 1 trial was to be conducted at a prominent U.S. academic center. Alacrita contributed to joint team meetings regarding the FIH trial and IND preparation as well as meetings with the KOL-lead investigator;- Provided input on the clinical development plan and FIH study design for the next-most advanced agent in the company’s portfolio; - Joined the company’s executive team members for a meeting with U.S. venture investors during due diligence, which led to a successful Series B financing;- Assisted in evaluating and interviewing candidates for the permanent CMO position.