Pharmaceutical, Biotech, and Consumer Products Consulting

Many start-up biotech companies work hard to gain market approval from the FDA, and a lucky few bring a New Drug Application (NDA) or Biologics License Application (BLA) filing to conclusion before funding runs out. A small venture capital funded biotech successfully navigated through the complex drug approval process and received approval to market its first product.

However, the company soon realized it was completely lacking in plans and capabilities to support the commercial launch of its new drug. Worse still, shareholders were placing intense pressure on this small team of researchers to get the product launched quickly so that shareholder returns could begin to be realized.

The client turned to NexGen Consulting Group, which helped plan and execute every phase of the launch. NexGen formed and led a multidisciplinary team that brought the product to successful commercialization in a matter of weeks, as opposed to the 12 to 18 months typically required for a commercial launch. Drawing from vast launch experience, NexGen supported activities such as:

1. Setting up production and warehousing facilities
2. Managing logistics for primary and secondary labeling
3. Establishing an advertising plan
4. Pursuing reimbursement policies

Results

Having in-depth experience in all phases of product development and launch, NexGen was able to execute on an aggressive timetable that required many overlapping tasks to be accomplished. This first launch was successful in reaching the market, and the client brought NexGen in to assist with its second product launch. The company is now a leader in its field, having beaten the difficult odds in the biotech industry.

Through an acquisition, a large, multi-national consumer products corporation had become one of the few suppliers of a medical product widely used by the general population. The company was suddenly faced with the loss of contract manufacturing services for this product line.

The company had little expertise or knowledge in the manufacturing techniques required to produce the product, which comes in a unique and antiquated dosage form. In fact, only a small handful of vendors around the world had either the capability or capacity to manufacture it. The company had searched to no avail for an alternative manufacturer.

Out of options, the client contacted NexGen Consulting Group. Because of its highly developed network of suppliers and relationships established in the industry, NexGen was able to develop a new vendor source for the client.

Transferring manufacturing to a new vendor is extremely complex, but NexGen worked closely with both parties to effect a smooth transition. Significant effort was spent educating the client about the requirements for manufacturing this type of product. Among other things, NexGen ensured that the appropriate contracts and documentation were put in place to support regulatory compliance. The client had a government contract for the product, which added to the complexity of the regulations.

Results

The transfer of manufacturing to the new vendor occurred in a timely manner and product supply was never interrupted, thereby averting a difficult situation in the market. In addition to broad experience and knowledge in manufacturing processes, NexGen’s ability to influence and facilitate relationships played a key role in the success of this project.

A small biotech entered into a joint venture with a very large, diversified Japanese pharmaceutical company to develop a unique therapeutic product. The terms of the agreement gave the Japanese partner the rights to manufacture the finished product, but the partner had no prior experience with its highly specialized dosage form.

Cultural differences and poor communication between the partners compounded the challenge. Recognizing that these limitations could affect successful commercialization of the product, the biotech partner contacted NexGen Consulting Group.

NexGen stepped in to bring the partners together, linking the two cultures while working out manufacturing logistics.

Taking into account issues ranging from time zone differences to cultural sensitivities, NexGen was able to smooth some of the barriers to communication. In addition to serving as liaison between the two partners, NexGen worked directly with senior management of the Japanese firm.

The Japanese facilities were geared for a very different type of manufacturing, so NexGen helped develop and implement plans for reconfiguring the production area, sourced the required new equipment, and trained over 200 employees on the new manufacturing methods.

Results

Although this was a highly complex, multifaceted project, it stayed on track during all phases, and the tight manufacturing schedule was met. NexGen’s experience not only with particular manufacturing methods but also in working with people of different cultures was essential to bringing this product to market on time and within budget.

A start-up biotech company’s first product included an active pharmaceutical ingredient containing platinum. The ingredient is quite costly to produce, in part, because it is potentially explosive and requires specialized expertise and equipment.

The company was able to produce small quantities sufficient for initial development, but realized that the quantity needed for the upcoming clinical trial was beyond its scope. They had logistics for the clinical study, including staffing, healthcare facilities, and enrolled patients in place, and any delays starting the trial would have been difficult for the patients and costly for the company.

Few CMOs have the capabilities to produce platinum-based ingredients due to the specialized nature and hazards of the process. The CMO selected by the biotech was being extremely inflexible, making the partnership difficult and delaying manufacturing. Costs were also becoming a major concern for the small venture capital funded company.

NexGen Consulting Group was brought in to facilitate the interaction between the client and the CMO, and to assure the needed quantity of drug product would be available in time to start the clinical trial.

NexGen conferred with organic chemistry experts who were able to overcome the manufacturing issues with the CMO’s chemists. Assisted by NexGen’s guidance, the client and CMO devised a solution to improve yields and timelines while keeping costs under control.

Results

NexGen's ability to negotiate with a difficult CMO yielded a positive outcome. The client received the drug product in time for the clinical trial as planned—an essential milestone on its road to product approval.

A local specialty food company determined that certain natural chemicals in one of its products could be extracted and potentially developed as an ethical pharmaceutical. Without the scientific expertise to extract and process the substances or the experience to navigate the drug approval process, the company contacted NexGen Consulting Group for assistance with product development.

NexGen analyzed the situation and offered alternative strategic advice rather than simply pursuing the initial request, which would have led the client down a path that was neither feasible nor profitable.

NexGen quickly recognized that the product had little chance of achieving regulatory approval as a prescription pharmaceutical. Moreover, the client would not have been able to patent the product, and large competitors would have easily overtaken the small company in the marketplace.

NexGen advised the client to market the compound as a dietary supplement for the consumer market rather than pursue approval as a pharmaceutical.

Results

Aided by NexGen, the company successfully manufactured and launched the product as a natural supplement that is well accepted in the marketplace.