Cancer clinical development strategy

Oncology Scientific Advisory Board

An emerging drug discovery company, with a core expertise in molecular modelling, had developed a small molecule inhibitor of a novel cancer metabolism target. The company was looking to nominate a development lead and sought input into what additional experiments would be required and what clinical strategies they could be considering. Alacrita's expert oncology consultants participated in and chaired a scientific advisory board meeting with the company. We reviewed the data the company had generated to date, along with some data from a close competitor. We suggested several additional preclinical strategies that would be important to differentiate our client's molecule against the competition. We provided feedback on the client's clinical strategy, confirming that a niche, targeted development strategy in a tumor type with significant unmet need would befit the capabilities of our client while at the same time, if successful, generate substantial value. As the preclinical program progresses Alacrita continues to review, provide feedback and suggest next steps for our client.

Defining a clinical strategy in oncology

A venture-capital backed platform technology company wanted to develop its internal pipeline of therapeutic candidates, while allowing prospective partners to access the technology platform through selected R&D collaborations. Alacrita’s oncology consultant was asked to create a detailed timeline and gap analysis for the company’s initial IND filing and phase 0-1 clinical trial launch.  This involved:

• Review of relevant documents, including the technology; pre-existing corporate, scientific, and clinical goals; and any pre-clinical data;
• Follow up interviews with key stakeholders including company founders, CEO and the internal R&D team;
• Review of potential target cancer indications and understanding of up-to-date Standards of Care in these indications;
• Review of relevant biomarkers to inform PK/PD activity and patient enrichment strategies;
• Prepare a clinical development plan including prioritization of target indications, design of phase 0-2a clinical trials and proposal for clinical trial investigators and sites; and
• Develop an interval-to-IND filing gap analysis.

Alacrita’s oncology consultant presented to the Board and was retained as an ongoing medical advisor to the company.

Clinical strategy for a novel cancer agent

 Alacrita’s expert medical team is providing ongoing medical advisory services to a biopharmaceutical company developing a first in class oncology asset. We advanced the company’s clinical development strategy for its lead program, supported pre-clinical and clinical program needs, made recommendations on clinical trial design and participated in FDA document preparation and meetings.

Chief Medical Officer support

Alacrita is supporting a venture-backed immuno-oncology company with interim Chief Medical Officer support. Responsibilities include:

• Provide strategic and operational leadership regarding the clinical development of its pipeline;
• Support corporate activities such as meetings with investors or potential pharma partners;
• Supervise company employees or consultants in areas such as clinical operations or regulatory affairs; and
• Organize clinical advisory board meetings and interactions with Key Opinion Leaders in support of the company’s objectives.

Chief Medical Officer consulting

An Alacrita oncologist is working as an advisor to the CMO in an oncology-focused biopharma company that is developing a pipeline of kinase inhibitors in early and late stage development.  Activities have included working in life-cycle management team to plan for supplemental indications, contributing to protocol development and arranging meetings with key opinion leaders to discuss ideas for investigator-sponsored studies.