Emerging companies constitute about 90% of the total biopharmaceutical market by number of companies comprising 70% of the global clinical pipeline. Few of these companies have the experience or expertise to transition biopharmaceuticals from research through to approval. Furthermore, they generally lack the financial capital required to fund through to product approval. For these companies to be successful, they need to secure a combination of sophisticated investors, partners, and expert consultants with a track records of success in helping bring new, cost-effective therapies to market.
The critical questions that all biotech companies need to be able to answer is “How does a prospective buyer, partner or investor look at my program, and what do I need to do to optimize the probability of a successful deal?” The successful search for a buyer/partner/investor is only partly dependent on the intrinsic properties of the product you are developing. Multiple extrinsic factors can be just as or more important than the product itself and in many assessments the decision not to invest is driven by factors over which you have control.
The primary focus of due diligence is to look at risk, risk mitigation and probability of success. Our webinar will focus on showing you the process as seen through the lens used by due diligence experts that advise VC investors, in-licensing parties and partner deal makers. A cross-functional due diligence team pressure tests and quantifies risk in the following areas:
- CMC/Drug Substance/Drug Product and Supply Chain—drug substance, drug product characteristics and identity, manufacturability, quality, strength, and stability, commercial supply strategy
- Toxicology (safety)—have the required studies been conducted/planned, what are the key toxicities seen and how are they being monitored in the clinical program, implications for the development program
- Clinical Pharmacology—what is known about the interplay between what the body does to the drug and what the drug does to the body such as drug absorption, distribution, metabolism, and excretion (ADME); dose justification and need for dose adjustments are focus areas for the clinical pharmacology due diligence program
- Clinical Development and Clinical Safety—Evaluation of the planned clinical trials and study design and endpoint criteria are addressed along with safety analysis and evaluation of adverse events
- Therapeutic Area (TA)—expertise in the specific TA from both a scientific and commercial perspective is applied; what is the standard of care and comparator drugs either in the market or under development that the new drug will compete against
- Biostatistics—the evaluation of the statistical approaches to the clinical program including aspects such as trial design, stratification and key efficacy analyses relating to pivotal studies
- Regulatory—evaluation of regulatory strategy in all regions in which development is being pursued and review of all interactions between the sponsor and regulatory agencies in key regions
- Commercial—”Will the drug be profitable?” is the core impetus for investment in the program; understanding of the competitive landscape for the drug in its class, for assessing the strategy of a precision medicine product versus a blockbuster, and understanding the reimbursement potential is addressed
This webinar will provide insights that could immediately be used in your development programs and could improve your readiness for deal and investment engagements.
About Our Speaker
Dr. Fran Brown joined Certara Strategic Consulting in 2017 and is currently the SVP Integrated Drug Development and Business Operations in Certara’s Strategic Consulting Division. She is a highly respected professional with proven leadership skills and 25 years of broad experience within pharmaceutical development and due diligence. She has extensive experience with strategic and operational global drug development from early discovery to filing and post-marketing, acquired through working in multiple geographical locations including UK, Switzerland, Canada, Sweden and the USA. Fran possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of Model Informed Drug Development.
After obtaining a degree in pharmacy and a subsequent PhD in pharmacokinetics, Fran started her professional life in the clinical pharmacology department at Hoffman-La Roche progressing to various broader roles including clinical leader, project leader, and research and licensing liaison. Following a rich career at Roche, Fran joined Biovitrum (a Swedish biotech company) as Director of Clinical Operations. In 2010, Fran founded her own consultancy business with an emphasis on using her scientific, pharmacology and development experience to support small companies on the development pathway.
This webinar provided insights that could immediately be used in your development programs and could improve your readiness for deal and investment engagements.