EU value proposition and market access plan for orphan disease drug

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...
Learn More

Preclinical & clinical asset pipeline valuation

Challenge: A young biotech company with a portfolio of clinical and pre-clinical stage bispecific antibodies (BsAb) to treat various cancers was in the process of completing a Series A funding round....
Learn More

Regulatory strategy for a novel drug delivery technology

Challenge: Our client was developing a highly novel and versatile intracellular delivery vehicle which could readily penetrate cells without compromising membrane integrity or inducing cytotoxicity....
Learn More

Gap analysis for a CTA submission in the UK

Challenge: Our client was developing a novel iron treatment with potential to be best-in-class for iron deficiency anemia (IDA). The product used nanotechnology to mimic the natural structure of...
Learn More

Regulatory support in obtaining EU Orphan Drug Designation for a gene therapy

Challenge: Our client was a biotechnology company developing life-enhancing gene therapies designed to restore vision in patients suffering from blindness due to inherited retinal diseases. The...
Learn More

US market access plan for antibody launch

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...
Learn More

Presenting technology & clinical programs at ASH & SABCS

Challenge A biotech company focused on developing therapeutics for oncology indications was looking to contract a clinical consultant to support their in-house team in presenting its technology and...
Learn More

Business plan and fundraising for cell therapy company

Challenge An early stage, European cell therapy company focused on developing novel off-the-shelf NK cell therapy solutions for the treatment of a variety of cancers had developed a platform...
Learn More

Gap analysis & pre-IND meeting preparation for preclinical compound

Challenge: Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with disruption of...
Learn More

Investor pitch deck for biotech developing non-opioid analgesic

Challenge A start-up US biotech developing a non-opioid analgesic drug and delivery device was preparing to raise its first round of external funding. They engaged Alacrita to help frame the target...
Learn More

Asset scouting for in-licensing opportunities in fibrosis

Challenge: A biotech company focused on developing therapeutics for fibrotic diseases was looking at acquisitions or in-licensing as a way to grow its development pipeline with additional assets....
Learn More

Business plan for opioid overdose detection device

Challenge Our client was a start-up looking to raise external venture capital funding for development of a biosensor for early detection of opioid overdose. The company had drafted a business plan...
Learn More