At Southwood Research, we are proud to work with many new biotech companies, as well as some of the world’s largest pharmaceutical organisations. You’ll find a selection of our recent projects below.  Contact us.

New Biologic Therapy

Therapeutic Area(s):
Urology and Gastroenterology

Solution Area(s):
Clinical Research, Publications


Problem Statement

A UK Pharmaceutical company required assistance in running a clinical trial across almost 30 sites. The client also required help developing and implementing a publication plan alongside the study.

Solution

Southwood Research managed the set up and conduct of the trial across all sites, and developed the publication strategy for communication of results.

Results

The clinical trial was completed successfully with positive results reported. Two manuscripts were published from the results and a number of abstracts were presented at international congresses.

Novel Oncology Drug Candidate

Therapeutic Area(s):
Haematology & Oncology

Solution Area(s):
Regulatory Affairs, Submission Management


Problem Statement

A US Pharmaceutical company required assistance with their Global Regulatory activities leading up to simultaneous NDA and MAA submissions.

Solution

Southwood Research developed the global regulatory strategy, providing clear milestones up until the point of submission. Southwood then worked on the preparation and submission of the required regulatory documentation to FDA and EMA.

Results

Southwood Research became an integral partner to the global regulatory activities of their client.

Novel Anti-Cancer Approach

Therapeutic Area(s):
Haematology & Oncology

Solution Area(s):
Clinical Research


Problem Statement

An EU Pharmaceutical company wanted to initiate their first-in-man study and required assistance to write their investigator brochure.

Solution

Southwood Research collated required documentation from both publications, historical data and study reports and delivered the investigator brochure ahead of schedule.

Results

The company were able to initiate their first-in-man trial, after a successful review of trial documentation by the local regulatory authorities.

Next Generation Sequencing Study

Therapeutic Area(s):
Haematology & Oncology, Orphan Diseases

Solution Area(s):
Clinical Research


Problem Statement

A UK Pharmaceutical company required assistance in setting up and managing a laboratory based research study.

Solution

Southwood took the lead on all pre-trial set up activities, leading the ethics and regulatory submissions, as well as designing the case report form and trial database.

Results

The trial was initiated promptly, and patients were quickly eligible for inclusion.

First in Class Oncology Therapy

Therapeutic Area(s):
Haematology & Oncology, Orphan Diseases

Solution Area(s):
Orphan Strategy & Execution, Regulatory Affairs, Scientific Advice, Submission Management


Problem Statement

A US Pharmaceutical company required assistance in submitting an Orphan Application in the EU.

Solution

Southwood Research drafted the submission and advised on additional data requirements to support medical plausibility. These requirements were beyond those identified for the US orphan application and were deemed critical to increase the probability of success for the EU application. Southwood Research also managed the pre-submission meeting which was arranged with the COMP.

Results

The orphan application was filed on time and incorporating the feedback from the COMP. An orphan designation was granted successfully.

What happened next

Southwood Research were asked to deliver the subsequent MAA filing, including all of the pre-submission activities and preparing the EU dossier for submission.

Orphan Metabolic Biologic

Therapeutic Area(s):
General Medicine, Orphan Diseases, Paediatrics

Solution Area(s):
Orphan Strategy & Execution, Regulatory Affairs


Problem Statement

A US biotech company required help with addressing issues arising during the latter stages of agreeing the initial paediatric investigation plan (PIP). The Marketing Authorisation Application was pending within 6 months.

Solution

Southwood Research worked with the company to secure a favourable outcome of the initial PIP procedure. We then completed a gap analysis to prepare for the pre-MAA PIP compliance check. We filed a modification to the PIP to ensure the PIP compliance check could be completed successfully and the MAA could be validated upon submission.

What happened next

Southwood Research was retained by the company to assist in completing Modules 1 and 2 of the dossier – we very quickly became pivotal to the submission, which was filed successfully and passed validation. We were also retained throughout the duration of the procedure to manage responses to questions.

Southwood Research were also asked to help draft the clinical and regulatory life-cycle management plan, including assessing study feasibility and regulatory timelines and probability of success.

Orphan Ophthalmology Therapy

Therapeutic Area(s):
Ophthalmology, Orphan Diseases

Solution Area(s):
Orphan Strategy & Execution, Regulatory Affairs, Scientific Advice


Problem Statement

A US pharmaceutical company approached Southwood Research to support and FDA Type B meeting to discuss Phase 3 study design.

Solution

We completed an in-depth review of the prior regulatory advice portfolio and were instrumental to preparing the briefing book for the FDA meeting. We also attended the rehearsals and the meeting with the FDA.

Results

The briefing book was submitted on time, despite tight timelines. The advice from the FDA did not negatively impact the clinical development plan.

What happened next

Southwood Research were asked to submit for protocol assistance to seek advice on the same Phase 3 study, based on how successfully we had supported the FDA submission.

We were also asked to help assess clinical feasibility for the proposed Phase 3 study, in addition to evaluating Regulatory strategy and timelines. Based on our review of prior EU advice, we were able to propose a novel regulatory strategy – adding significant value to the product.

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