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Why Hire an Experienced CMC Consultant for Your Early Phase Studies

Why Hire an Experienced CMC Consultant for Your Early Phase Studies

01 Jul 2024

The simple answer is you save money, time and get an exciting new drug to the clinic for patients.

What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the epicenter of clinical development (see Figure 1), and with an experienced leader, connecting and navigating the various areas (or silos) in clinical development is essential.

Figure 1.  Components of Chemistry, Manufacturing and Controls (CMC)

What are some of the pitfalls an experienced Regulatory CMC Consultant can help you avoid?

  • Spending money on laboratory studies may not be needed for early phase studies and may need to be repeated later in development. For example, extractables and leachable studies are not needed until a final container closure system is chosen.
  • Not anticipating supply chain disruptions/changes and not having a regulatory strategy to manage. For instance, moving to a new manufacturer and not planning for regulatory comparability if needed in a timely manner
  • Inability to release drug product. For example, relying on inadequate analytical methods that required more method development and therefore quality issues such as out of specification events appear
  • Avoiding appropriate investing in early development on key CMC areas to streamline going into Phase 2 and Phase 3. For instance, limited number of batches manufactured using an early process and consistency has not been shown prior to moving to a new process
  • Unanticipated Clinical Hold based on CMC issues

Experience Matters and a Good Team Matters!  Syner-G has the Regulatory CMC Consultants with the experience you NEED to avoid the pitfalls that can negatively impact your development program.  Our experts can not only help get your IND/IMPDs cleared, but we can also do it while saving you time and money.

About The Authors

Marsha Marande, Ph.D.

Can provide winning global and country specific regulatory strategies both involving submission planning as well as providing guidance and assisting clients’ teams and SME’s for CMC development (meetings, writing, editing) to meet regulatory CMC data needs for new drugs at all stages of development as well as helping supply chain to plan and meet demands.

Unique experience as a scientist (Ph.D. and postdoctoral studies) who started in pharma as an analytical development SME team lead, moved into regulatory and was uniquely exposed to many different types and variations of submissions early in my career which included, drug substance forms, formulations.   All global CMC submissions came through our technical/regulatory group (200 plus a year type volume per individual). Worked at a contract manufacturer (one of two regulatory personnel on site in the plant) and helped build a business from 2 clients to 100 plus.  Reported to the head of quality and was involved in 20 audits/year both client audits and regulatory agency.

Also have unique experience within small pharma companies managing regulatory, quality compliance and manufacturing for multiple projects all a various stage of development at the same time each with their own set of vendors.

Have been involved with leading and managing Teams (comprised of internal members as well as partners and vendors) through complex global submissions, difficult supply issues, formal meetings and interactions with numerous global health authorities (including FDA, EMA, Health Canada & several regional health authorities).  Recent experience includes working on a new IND for a tissue-based combination product and well as combination products that require in depth knowledge in small molecules, biologics, novel excipients and device.

Extensive experience with agency requirements, needs and interactions as well as responses based on stage of development and clinical indication. Have also written/edited and overseen the preparation of regulatory documentation at early stage as well as successful submission of many marketing applications and post approval experience.