Pharma Products & Business Development

The Product & Business Development business unit was set up to enhance the value of the technical skills present at m-Squared, in the development of the pharmaceutical product understood as a set of processes:

  • Preclinical and clinical research and development;
  • Pharmaceutical development;
  • Regulatory strategy;
  • Marketing phases.

The new business unit offers its services to companies operating in the development of new pharmaceutical and biotech products (new chemical entities, repurposing or reformulation) or intending to renew their commercial portfolio and sets itself the objective of becoming a technical and operational reference capable of strategically supporting its own
partners in the various decision-making phases of the development cycle:

  • Definition of the Target Product Profile;
  • Elaboration of the development plan;
  • Identification of the regulatory strategy;
  • Marketing strategy;
  • In and out licensing.

A) Product development status: identification of treatment targets.

Business proposal: strategic product consulting.
1) opportunity identification;
2) project analysis;
a. identification of competitors (under development and on the market)
3) analysis of intellectual property;
4) definition of the Target Product Profile and development plan (preclinical; CMC; clinical);
5) identification of technical partners for developing the project.

  • preclinical CROs;
  • Supply chain; technology transfer; scale up; clinical validation;
  • Regulatory consulting.

6) creation/consolidation of business plans;

7) presentation to investors;

8) negotiations.

B) Product development status: identification and preclinical characterization of substances active on
identified treatment targets.

1) opportunity identification;
2) project analysis;
a. identification of competitors (on the market, under development).
3) analysis of intellectual property;
4) elaboration of the development plan (preclinical; CMC; clinical); a clinical CRO or a
medical supervisor is required;
5) identification of technical partners for the technical development of the project:

  • preclinical CROs;
  • Supply chain; technology transfer; scale up; clinical validation;
  • Regulatory consulting.

6) creation/consolidation of business plans;
7) presentation to investors;
8) negotiations.

C) Product development status: identification of preclinical regulatory development

1) opportunity identification;
2) project profitability analysis;
3) elaboration of the development plan;
4) identification of technical partners;
5) regulatory product and regional strategy;
6) creation/consolidation of business plans;
7) Business Development of the product/dossier (national/international);
8) identification of trade and development partners;
9) negotiations.

D) Product development status: identification of CMC development 

1) opportunity identification;
2) project profitability analysis (market);
3) elaboration of the development plan (preclinical);
4) identification of technical partners (preclinical, CMC);
5) regulatory product and regional strategy;
6) creation/consolidation of business plans;
7) Business Development of the product/dossier (national/international);

8) identification of trade and development partners;
9) negotiations.

E) Identification of registration processes

1) dossier analysis;
2) regulatory product and regional strategy;
3) Business Development of the product/dossier (national/international);
4) identification of trade and development partners;
5) negotiations;

F) Identification and quantification of the value of pharmaceutical assets with different development 

1) Business Development of the product/dossier (national/international)

G) Identification, qualification and quantification of repositioning projects 

1) opportunity identification;
2) project profitability analysis (market);
3) elaboration of the development plan (preclinical);
4) identification of technical partners (preclinical, CMC), a clinical CRO is required;
5) regulatory product and regional strategy;
6) creation/consolidation of business plans;
7) Business Development of the product/dossier (national/international);
8) identification of trade and development partners;
9) negotiations.