We don’t simply offer advice.
B4D works alongside in-house management or can fill gaps in company management. Clients benefit from access to B4D’s core team and their network of preferred consultants within North America and Europe. Where appropriate, B4D will subcontract certain activities which can be adequately supported at a lower hourly rate and pass these savings on to the client.
HOW WE CAN HELP
Let us help catalyze your project at any stage of development.
B4D provides a flexible cross-functional team which can be brought into a project as necessary therefore eliminating the need to hire multiple functional positions into a start-up company. We prefer to be involved early in the process to work together with you to merge your science into a business strategy which will lead to commercial viability. Due to the breadth of our expertise, B4D can provide support at any stage as the project advances. This model overcomes the excessive burn rates experienced by traditional pharmaceutical/biotech companies that are associated with expenditures unrelated to actual asset development.
Why Choose Us
INTERNATIONAL EXPERIENCE
We are specialists in the international pharmaceutical and biotechnology sector with 25+ years proven expertise and success.
FLEXIBILITY
B4D has the experience, expertise and flexibility to fill the gaps in your company’s team or be your company’s entire management team.
CONSISTENT SUCCESS
Our team has a proven track record of successfully helping clients achieve their goals of product development, financing and outlicensing, on-time and on-budget.
COST EFFECTIVE
Employees with the right experience are expensive, and are generally not needed full-time at the early stages of the project. We provide access to senior experts on an as-needed basis, at a fraction of the cost of a full-time employee.
OUR EXPERIENCE
Our unique experience spans from preclinical to commercialization.
The B4D team is a highly experienced and innovative management team with expertise in identifying attractive drug candidates, target indications, designing and managing outsourced clinical development programs and negotiating licensing deals. Our experience is unique in that it spans discovery through preclinical and clinical all the way through to regulatory approval and marketing. We have expertise across a number of therapeutic areas with particular strength in inflammation, cancer and women’s health, working with proteins, peptides and small molecules.
Diane Kalina
Diane Kalina has more than 40 years experience as a biotech/pharma executive with proven skills in strategic alliances, marketing, strategy development, financing and managing start-up biotech companies.
Patricia Griffin
Patricia Griffin has more than 30 years of international experience, including establishing and managing strategic alliances, evaluating in-licensing opportunities and leading a variety of drug development programs for biologics, small molecules and drug conjugates.
Patricia was previously Managing Director and CEO and co-founder of PDC Biotech GmbH, an Austrian biotech company which successfully raised funding in Europe and advanced an early preclinical-stage drug candidate through cGMP manufacturing to clinical proof-of-concept. Other positions include Vice President, Business Development at GlycoDesign Inc., a Canadian biotechnology company, where she led commercialization efforts for the company’s cancer, vascular and inflammation programs and established and managed international strategic partnerships. As Director of International Product Development at Ferring based in Paris, Patricia led multi-disciplinary teams to successfully complete the development program (including scale-up of the peptide to support commercial needs) for two novel obstetrics products and managed the company’s strategic alliance with a major US pharmaceutical company. As an independent consultant, she conducted detailed assessments of potential in-licensing opportunities for pharmaceutical companies and created business plans and product development plans for various biotech companies.
Wendy Hill
Wendy Hill has over 30 years of experience in early nonclinical and clinical development and regulatory affairs in a variety of therapeutic areas including cancer, inflammation, wound care, infectious and cardiovascular disease.
Wendy started her career as an epidemiologist in cancer research with the design of early phase clinical trials. She has successfully achieved approval for a number of CTA/IND filings and NDS/NDA filings in Canada, the US and Europe. Previous positions include Director of Research at Knoll Canada where she was instrumental in the clinical development of several human monoclonal antibodies (Humira®), Senior Director, Clinical Research at GlycoDesign and R&D Director, Inflammation and Neurology at Amgen Canada. As a private consultant, she has assisted biotechnology companies in preparing and executing strategic clinical and regulatory development plans for products and devices and in performing due diligence on products for potential investors. In the past, Wendy has served as an advisor to start-up companies in the health sector through the MaRS network. She is currently the Director of Clinical Development for the International Consortium on Anti-Virals (ICAV), a not-for-profit drug development initiative focused on finding treatments for neglected and emerging viral diseases.
Joseph Cuatico
Joseph Cuatico is a business manager, financial analyst and entrepreneur. Joseph’s previous experience is a blend of financial analysis, technology implementation and operations and he has worked in a variety of industries including biopharma.
Joseph has held various positions in the biopharma sector including Manager, Financial Analysis & IT at Therapure Biopharma Inc, a biologics manufacturing company, and Manager of Accounting at GlycoDesign Inc.. He has also worked at Goodmans LLP, a corporate law firm where he was the finance lead on ERP system conversion. Joseph has a BA from the University of Toronto and is a graduate of the CMA Professional Program and has an EMBA from Ivey Business School.
Alfonzo Ruiz
Alfonso Ruiz is a QA consultant with an expertise in Quality Systems, QC Lab Controls, Manufacturing Processes, Process Validation, Supplier Quality, Incoming Inspection, CAPA Management, Complaint System, Deviation Management, QC and Manufacturing Investigations, Product Transfer Process, Regulatory Compliance and Production Management.
Alfonso has over 21 years experience working for the regulated industry. He has worked as Director, Quality Control/Quality Assurance, Executive Director of Operations and Director of Technical Operations for pharmaceutical top-notch companies. As a consultant, he has worked developing and implementing quality systems, implementing Interim Controls, and performing internal and supplier audits for domestic and international clients in the pharmaceutical, biopharmaceutical and medical device industries. Alfonso has a BS Chemistry from the University of Puerto Rico and has an MBA Management from the University of Phoenix. He is also ASQ Certified Quality Auditor.
