CMC Consulting

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DDA provides has teamed up with the industry leaders in consulting and can assist biotech and emerging pharmaceutical companies manage their CMC programs including managing supply chain, selection of API suppliers, help with audits of GMP and raw material manufacturing facilities globally, auditing of clinical trial sites. Please let us know how we can help you.

Drug Discovery Alliances works for a small portfolio of companies that offer a wide range of chemistry and biology services spanning from discovery to development. We work for each company exclusively in their niche. Their services include:

  • Research for novel route development and process research supporting pre-IND work to Phase 1
  • Technologies for API manufacturing from Phase 1 to commercial
  • Supporting formulation work, final dose and solid form supporting work for preclinical to commercial

Also, should you require consulting services to help manage some of your CMC efforts we offer this service too.

Case Studies

Task: Pharmaceutical Client in urgency of a stable & reliable API supplier to support Clinical Phase 3 and post-approval commercial batches.

Action: Drug Discovery Alliances was contractually assigned for this task and determined the current supplier would charge close to $2M for registration, almost double the competitive bids.

Results: We saved our client close to a million USD with the NDA batches and passed on an upwards potential savings of $10,000,000 for subsequent batches.

Task: Pharmaceutical Client urgently needed a patented compound synthesized and their existing CMO failed after 6-month attempt.

Action: Drug Discovery Alliances, we discovered that even if the contractor’s synthesis had worked it would have yielded an undesired compound.

Results: Drug Discovery Alliances assigned a partner to make the right compound within 6 weeks and saved our client $200,000 in additional contractors fees if they had stayed with the original contractor.

Task: Pharmaceutical Client urgently needed 10 Kg of a raw material from a Chinese supplier holding a DMF that had provided same material for years. Supplier demanded the client to order minimum of 50kgs though they only needed twenty percent of the minimum order threshold.

Action: Drug Discovery Alliances assigned partners to solve the problem quickly by working a route of synthesis and scale up for that raw material for a fraction of the cost as demanded by the Chinese supplier.

Results: Saved the client close to $200,000 for the initial batch and with a potential upward saving of over $1,000,000 for additional development batches and commercial.

Task: Pharmaceutical client had supplier to conduct X-RAY crystal structure analyses on 3 compounds and submitted these as Investigational New Drugs (INDs) to the FDA. After the IND’s had been filed, the client was experiencing inconsistencies with the compounds and correlating with biological activity.

Action: Working with Drug Discovery Alliances we were able to determine the original contractor had provided wrong X-RAY structural data for every compound and we were able assign a partner to rectify the problem.

Results: Drug Discovery Alliances helped the client to protect over $1,000,000 in their patent estate and intellectual property protection (IPP) by identifying the correct structures.

Task: Pharmaceutical client had tried 3 contractors to synthesize a pre-IND candidate for ovarian cancer and after two years of attempts yielded no desired compound.

Action: Drug Discovery Alliances selected the right partner to make desired compound for pre-IND needs and Phase 1 clinical trials.

Results: Only a matter of time this compound was licensed by a large pharmaceutical company with a three hundred million dollar upfront payment and close to a billion dollars in potential down stream revenue.

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