CASE STUDIES
Case Studies
Strategic Projects
A U.S. FDA approved active pharmaceutical ingredient (API) drug manufacturer sought advice from WiTii Consulting on how to enter the generic finished product market (Solid oral and Injectables).
A manufacturer of active pharmaceutical ingredients (APIs), approved by the United States Food and Drug Administration (FDA), sought to enter the generic finished product market within the U.S. This manufacturer possessed a strategic advantage due to their access to API development and a well-established infrastructure for Good Manufacturing Practices (GMP). Nonetheless, they lacked expertise in ANDA drug development, understanding of the U.S. FDA regulatory requirements, and knowledge on how to effectively market their product to wholesalers based in the U.S. To address these specific needs promptly, WiTii Consulting offered short-term consultation services.
WiTii Consulting conducted a comprehensive assessment of a portfolio comprising approximately 20 APIs. Additionally, a thorough market analysis of these molecules was performed to determine their potential applications in ANDA submissions. The market analysis encompassed a diligent investigation of market trends and competitive intelligence activities. This involved compiling information on existing drug master file (DMF) holders, identifying the names of current ANDA holders listed in the orange book, evaluating product volumes over a five-year period, examining the generic pricing history from the past five years, constructing a calculated return-on-investment sheet for the subsequent five years, conducting competitive intelligence to anticipate future competition, and comparing the pricing of both branded and currently available generic alternatives.
Completing the entire project within a span of four weeks, WiTii Consulting provided their client with a robust foundation to make informed decisions regarding future investments. WiTii Consulting’s recommendations were meticulously crafted and supported by reliable data, instilling a high level of confidence in their client’s ability to navigate the market successfully.
A startup pharmaceutical company partnered with WiTii Consulting to assist with tech transfers and relaunching 12 approved ANDAs (Solid oral, Injectables and Liquid products).
A startup pharmaceutical company, supported by a select group of investors, acquired a portfolio of approved Abbreviated New Drug Applications (ANDAs) through a broker. WiTii Consulting, leveraging its robust global network of contract manufacturers and manufacturing partners approved by the U.S. FDA, played a pivotal role in expediting the tech transfer process. With immediate action, WiTiii Consulting initiated the necessary steps to facilitate a seamless transition.
To ensure compliance with Good Manufacturing Practices (GMP), WiTii Consulting diligently prepared a comprehensive report detailing the GMP compliance status of all potential manufacturing partners. This report, presented to the client, encompassed a thorough assessment of each partner’s current GMP status with the U.S. FDA. Additionally, it provided a concise summary of their inspection history, including the severity of all 483 observations, key findings extracted from their establishment inspection report (EIR), and references collected from trusted colleagues.
Recognizing the significance of quality control, WiTii Consulting facilitated an impartial third-party audit of three manufacturing sites shortlisted from a pool of nine potential partners and construct manufacturing organizations (CMOs). By conducting this audit, WiTii Consulting ensured transparency and accountability throughout the selection process.
Furthermore, WiTii Consulting actively supported the client in drafting comprehensive manufacturing and supply agreements with the selected contract manufacturing partners. Through skillful negotiation, WiTii Consulting sought to establish favorable contract terms and conditions, including cost of goods sold (COGS). With a commitment to excellence, WiTii Consulting provided end-to-end project management support for the entirety of the tech transfer, guiding and coordinating the various stakeholders involved.
Overall, WiTii Consulting’s involvement significantly contributed to the successful executions of the tech transfer process, enabling the startup pharmaceutical company to forge solid partnerships with reliable contract manufacturing partners while upholding the highest quality standards in compliance with GMP regulations.
Case Studies
Drug Development Projects
An innovative drug development company needed assistance from WiTii Consulting to validate their 505(b)(2) product idea and develop a solid execution strategy.
An innovative drug development company based in the United States was engaged in repurposing an approved generic drug molecule for a novel indication, utilizing a patented formulation. As their inaugural 505(b)(2) application, WiTii Consulting advised the client to pursue a provisional patent application in order to safeguard their intellectual property. Through an examination of the molecule’s regulatory history and a preliminary literature search, WiTii Consulting recommended conducting customer discovery to validate the viability of their 505(b)(2) concept. During the customer discovery process, WiTii Consulting facilitated constructive discussions between their client and various stakeholders such as doctors, nurses, pharmacists, pharmacies, hospitals, patients and other crucial participants within the supply chain. Additionally, WiTii Consulting conducted a comprehensive analysis of reimbursement considerations to ensure the practicality of the approved product from a payer’s perspective. Following the validation of the product concept and the identification of an unmet medical need, WiTii Consulting formed a team comprising technical experts, including clinical pharmacologists, toxicologists, and medical writers, alongside their client’s CMC (Chemistry, Manufacturing, and Controls) experts. WiTii Consulting diligently compiled a robust pre-IND (Investigational New Drug) package for submission to the FDA.
A California based early-stage life science company developing Cannabinoids based treatment for GI conditions hired WiTii for their drug development needs.
WITii assumed the responsibility of formulating their client’s comprehensive Chemistry, Manufacturing, and Controls (CMC) package while offering guidance on regulatory strategy. This virtual company engaged WiTii Consulting’s services to identify a suitable Contract Development Manufacturing Organization (CDMO) for their formulation and analytical development endeavors.
WiTii diligently procured competitive quotations from various CDMOs and presented them to their client, accompanied by thorough evaluations of the pros and cons associated with each option. Furthermore, WiTii Consulting undertook the management of the entire drug development project in collaboration with the chosen CDMO, from project initiation to technology transfer. This involved activities such as contract negotiation, contract execution, conducting audits of the CDMO facility, evaluating the technical capabilities of the CDMO, and providing ongoing project management on a weekly basis.
WiTii played a pivotal role in the procurement of Drug Master FIle (DMF) grade Active Pharmaceutical Ingredients (APIs) as well as United States Pharmacopeia/ National Formulary (USP/NF) grade inactive raw materials for their formulation development. Additionally WiTii Consulting made valuable contributions to the provisional patent filing and assisted in formulating the nonclinical/preclinical strategy for their client.
Case Studies
Technology Transfer Projects
A virtual pharma company needed assistance in finding a contract manufacturer to reduce their cost-of-goods (COGS) by 50%.
A virtual pharmaceutical company faced significant challenges in generating profits from their commercialized solid oral Abbreviated New Drug Application (ANDA) due to intense competition and price erosion. The market for this product included a total of 10 generic players, of which at least 3 possessed complete vertical integration. This meant that these particular ANDA holders had control over the active pharmaceutical ingredient (API) supply, owned the ANDA, and managed their own sales and marketing operations in the United States. Consequently, competing with these vertically integrated competitors proved to be exceedingly difficult, if not impossible.
WiTii Consulting’s initial focus was on evaluating the costs associated with raw materials and packaging (RM/PM). WiTii Consulting identified an opportunity for their client to engage in discussions with their API supplier, aiming to secure a minimum 10% price reduction. However, the primary issue their client faced lay in their manufacturing costs, which were exorbitantly high and unsustainable. Their product was manufactured at a contracted site in the European Union (EU), where the expenses incurred were nearly three times higher per bottle compared to other prominent contract manufacturers in Asia.
As a part of WiTii Consulting’s role of representing the best interests of their client, they actively negotiated prices with their contract manufacturing organizations (CMO), but unfortunately, they were unable to meet WiTii Consulting’s expectations. Assessing the market prices of other generic players, WiTii Consulting determined that their client’s product would not be financially viable unless manufacturing and quality assurance/quality control (QA/QC) costs were reduced by 50%. Such a reduction was unattainable with the EU or U.S.-based CMOs.
Leveraging their extensive network of FDA-approved Good Manufacturing Practice (GMP) manufacturers, WiTii Consulting identified manufacturing facilities in South Asia. Both CMOs possessed the necessary technological capabilities and demonstrated a strong track record with the FDA. Following further discussions between these two CMOs and the client, WiTIi Consulting successfully reached an agreement with one of the CMOs. As a result, the costs of goods sold (COGS) dropped by 40% compared to the existing COGS with the EU-based CMO.
A newly built sterile injectable facility wanted to trigger a US FDA inspection to kick start the contract manufacturing business for the US market.
Leveraging WiTii Consulting’s extensive network of generic drug developers, contract developers, and manufacturing partners, they successfully identified a terminally sterilized simple solution with an approved Abbreviated New Drug Application (ANDA). In order to expedite the technology transfer and facility approval processes, the terminally sterilized product was chosen over the sterile filtered alternative. The ANDA holder was already manufacturing this product at a different facility, ensuring minimal disruption to their market presence. Meanwhile their client served as a backup supplier for the said ANDA holder, resulting in a mutually beneficial arrangement due to the competitive cost of goods sold (COGS) offered by their client.
WiTii Consulting played a pivotal role in negotiating the deal, striving to minimize upfront investments from both parties. Given that their client’s facility was newly constructed and this marked their inaugural submission to the U.S. FDA, the application was submitted under a prior approval supplement (PAS) rather than the Changes Being Effected in 30 days (CBE-30) pathway.
Case Studies
Sales and Marketing Projects
An India-based Ophthalmic drug product manufacturer needed assistance from WiTii Consulting to enter the US market
A well-established ophthalmic company based in India, with a successful presence in the non-regulated market, expressed their desire to enter the highly regulated U.S. market. In their pursuit, they engaged the services of WiTii Consulting to conduct comprehensive market and competitive intelligence analysis on approximately six Ophthalmic Over-The-Counter (OTC) monograph products. Leveraging WiTii Consulting’s expertise, they diligently gathered crucial information regarding the number of competitors, pricing points for each Stock Keeping Unit (SKU), and offered valuable guidance on general sales and marketing strategies.
Furthermore, WiTii Consulting provided detailed assistance on essential administrative procedures, such as applying for DUNS (Data Universal Number Systems), EIN (Employed Identifications Number), and facility registration. Acting as their trusted U.S. agent, WiTii Consulting effectively facilitated the establishment registration process on behalf of their client. In addition, through their vast network and industry knowledge, WiTii Consulting successfully identified a reputable sales and marketing partner for their client, delivering comprehensive turnkey solutions within a remarkably short timeframe.
A mid-sized generic drug manufacturer sought out a reliable sales and marketing partner to commercialize their 1st ANDA in the US with WiTii Consulting.
Gradually, WiTii Consulting was able to secure a few modest accounts for their client, which experienced steady growth, eventually reaching a reasonable volume. Additionally, WiTii Consulting’s sales and marketing partner successfully secured a government contract, presenting reasonable favorable margins that contributed to the improvement of gross margins. However, it was necessary to discontinue two products from their client’s portfolio due to their cost of goods sold (COGS) surpassing the selling price of other generic competitors in the market.
In conclusion, their client effectively recovered their initial investment and maintained a healthy profit margin.
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