Pharma Biotech Consultants
WHO WE ARE
Marie-Louise Jacques, M.D., M.B.A.
CEO and Founder
Marie-Louise is an Enterprising, Senior Pharmaceutical/Biotech Executive with global R&D leadership experience in all major areas of pharmaceutical drug development. These areas include new product development/regulatory affairs/medical affairs/drug safety.
She has directed global R&D programs and has a record of success in consistently building, developing and strengthening diversified therapeutic franchises across all lifecycle phases, including biologics.
Marie-Louise gained global marketing authorizations for 13 NCEs and built ophthalmic, cardiovascular/metabolic, neurology/pain, and critical care franchises through effective interdisciplinary integration and implementation of clinical, regulatory and business strategies. Major approvals include: Ozurdex™, Trivaris™, Ralivia™ ER & ODT, Glumetza® ER, Citalopram ODT, Visudyne®, Zaditor®, Rescula®, Early Access of Kinox™, Maxaquin®. She has led product lifecycle enhancement programs maximizing commercial value of in-market products through Phase II-IIIB clinical programs, resulting in 5 new label claims and 4 line-extensions.
She effectively contributed to cross-functional product portfolio planning, review and management; due diligence, market evaluation/risk assessment of in-licensing opportunities, including development of strategic alliances. While earning her M.B.A., she has assessed technical, strategic and business viability of new technologies on behalf of start-ups and life sciences venture capitalists.
Marie-Louise holds an M.D. from the University of Louvain and an M.B.A. from New York University-Stern School of Business.
Specialities:
Clinical Development
Regulatory Affairs
Ophthalmology
Metabolism/Cardiology
Product Life-Cycle Management
Licensing-in Due Diligences, Assess Technical and Business Viability of New Technologies
Medical Affairs
Trilingual: English, German, French
Challenges for Pharma, from Marie-Louise, CEO
"These are exciting but challenging times for the industry. Competition is tough. There are increasing regulatory and payers’ hurdles that must be negotiated. Securing drug approval does not automatically equate to marketing success anymore."
How to succeed (1), from Marie-Louise, CEO
"To succeed, the global drug regulatory development strategy must be based on evidence: science and data. Product development strategies must be driven by detailed knowledge of the medical need, deep understanding of the product and a thorough analysis and review of the available data. Discovering hidden associations and interactions may turnout to be critical for the product’s success, ignoring them may lead to failure.
Pharma Biotech Consultants has access to sophisticated data mining tools and improved techniques that will allow you to expand your product knowledge. These new insights will lead to higher chances of success through improved decision-making."
How to succeed (2), from Marie-Louise, CEO
"Sales of a product are driven by reimbursement. Since payers have different criteria from regulators to decide on the reimbursement of a drug, it is critical to devise and implement a pharmaco-economic strategy early to support Fair Market Value backing for pricing and reimbursement negotiations.
Pharma Biotech Consultants has access to the pharmaco-economic expertise of the CHAD department of Coimbra University for developing successful global value dossiers, PRO tools and appropriate models."
Christian Jacques, M.D., MSc
CSO and Co-Founder
Christian is an hematologist oncologist by background; he trained for both his M.D. degree and his Internal Medicine degree at the Catholic University of Louvain, Belgium. Christian has been a hospital practitioner for 10 years
In 1993, Christian embraced clinical development and has now more than 20 years of experience in clinical development of NCEs in hematology-oncology leading to approval of several new compounds that have changed the paradigm of cancer treatment
Major Oncology Clinical Development programs include Vinorelbine in metastatic breast cancer and NSCLC, CPT-11 (Campto or Camptosar) in 2nd line and 1st line metastatic CRC (colorectal cancer), CPT-11 in cancer patients with liver insufficiency and CPT- 11 in metastatic gastric cancer, Taxotere in metastatic gastric cancer, Procrit in solid tumors, PTK-ZK in metastatic colorectal cancer, ASA404 in non small cell lung cancer, Pomalidomide (Pomalyst or Imnovid) in relapsed and refractory multiple myeloma and Lenalidomide (Revlimid) in newly diagnosed multiple myeloma.
He designed several of these programs, negotiated them with Health Authorities (FDA and EMA), run the agreed programs and submitted the data for approval. Under his supervision, 13 phase III trials and numerous phase 2 and phase 1 trials were conducted and he participated in many due diligences for licensing-in purpose
This work led to numerous approvals worldwide (FDA, EMA and ROW). Major drugs approved include Navelbine in metastatic breast cancer, CPT-11 in first and second line metastatic colorectal cancer, CPT-11 in liver insufficiency, Taxotere in metastatic gastric cancer, safety submission for Procrit in MBC, Pomalidomide (Pomalyst or Imnovid) in Relapsed Refractory Multiple Myeloma and Revlimid in Newly Diagnosed Multiple Myeloma
Specialities:
Clinical Development
Phase I- Phase IV trials
Hematology-Oncology
Regulatory Affairs
Licensing-in due diligences
Life-cycle management
Bilingual: English, French
Pierpaolo Caravaggi
Business Counsel
Pierpaolo is a senior executive who gained experience in a variety of sectors including Life Sciences, Investment Banking, Finance and Information Technology, where he held different managerial roles. His breadth of expertise and strong quantitative skills enable him to provide key strategic insights for solving complex problems. He recently completed business development projects and a number of financial deals for leading companies in the Life Sciences sector.
Pierpaolo holds a Master of Science in Management and Economics Engineering and is a 2016 candidate for the Executive MBA at the Stern School of Business at New York University.
Specialities:
Business Development, Finance, IT, Marketing
Trilingual: Italian, English, French