As today’s biotechnology field expands, with new products in development and opportunities for growth both in the United States and abroad, even those with experience in the industry must be prepared for anything. Scientific knowledge, proper funding and marketing know-how are musts. In the event of a setback, such as a clinical trial failure, regulatory setback or drug recall, a robust risk management strategy and experienced managers are also key.

In their interview “Biotechnology Life Events: Survival of the Fittest,” Matthew Hudes, U.S. managing principal for biotechnology, Deloitte Consulting LLP, and Glenn Snyder, principal, Deloitte Consulting LLP, discuss what it takes to bring biotechnology products to market and the key life events companies face along the way that can affect success. They explain how a biotech company’s capability evolves as its “pipeline” advances from the discovery and validation stage of a product, to clinical trials, to the final marketing and distribution phase.

Does your company carefully manage business life events within the biotechnology and pharmaceutical industry? Do you pay special attention to possible major setbacks? Below are six development steps, discussed in the interview mentioned above, that you may encounter, and links to resources to help you understand and manage them more effectively:

1. Creating a product alliance
   A product-related strategic alliance is formed with a biotechnology or pharmaceutical company to codevelop, cocommercialize or copromote a product. This shares both development risk and commercial upsides.
2. Guiding product commitment
   You may want to provide more vigorous evidence of efficacy for your product and a stronger safety profile in obtaining regulatory approval.
3. Planning and building a plant
   You build a multiproduct plant and manufacture a commercial product. Planning may start before the Phase III trial and the plant may take five or six years to complete and pass regulatory inspection.
4. Commercialization
   Your company markets a drug after Food and Drug Administration approval. Commercial activities may include reimbursement sales, marketing and distribution, patient/customer service and postmarket surveillance.
5. Merger & acquisition
   Your company acquires or is acquired by a biotechnology or pharmaceutical company.
6. Major setback
   Your company suffers an unexpected and dramatic disruption. It may occur during development — for example, clinical trial failure; during manufacturing — such as a plant shutdown; or during commercialization — for example, a drug recall.

For more information on services pertaining to the life events described above, please contact us.