Direction. Magnitude. Results

Services

CMC Consulting

Areas of Expertise


process chemistry development

I have 29 years experience in process chemistry development both directly (hands-on as a chemist), and via leadership roles (leading chemistry groups and project teams). This includes lab development, scale-up to pilot plant, and introduction of new processes to GMP manufacturing facilities in the US, Europe and India. I am well versed in developing scalable chemical processes which deliver on quality, robustness, cost of goods (COG), and EHS requirements.

I can bring my experience to add value to your project: Modifying enabling synthetic routes, scouting and selecting a commercial route, sorting out scale-up challenges, optimizing processes for COG, reliability, yield, quality, waste generation, and simplicity.

Whether you need API supplies for Toxicology or Clinical studies or whether you want to develop a commercial process for regulatory approval and a sustainable commercial supply, an experienced process chemistry perspective is a key to success. Let me help with that.

 

 

 

 

 


cross-cultural business interactions

The US and India share many commonalities including the English language, excellent educational institutions, a love of science, and a deep investment in the Pharma and chemical industries. In particular, CRO and CMO arrangements and other collaborations between India and the US are increasingly common. Despite the commonalities, cultural differences in communication, (e.g. how less than favorable news is delivered), work styles, interpersonal values, and even differing holiday schedules can all complicate and sometimes frustrate relationships.

I have over 10 years intensive experience managing relationships between US and India sites including direct reporting relationships and CRO/CMO activities. I have travelled to India (16 times) and visited many CRO/CMO sites. This experience helps anticipate and avoid potential pitfalls in order to build and maintain a productive relationship. Achieving understanding, enhancing communication, cultivating respectful interactions all build trust and lead to higher functioning cross-cultural teams. Let me add my perspective to optimize your India CRO/CMO collaboration.


Regulartory (CMC) project progression

Successful CMC (Chemistry, Manufacturing and Controls) development requires a holistic approach in coordinating efforts of several scientific disciplines to ensure an integrated and approvable package. From regulatory starting materials (RSMs) and API, through excipients, drug product and packaging, and with sound analytical and quality control strategies, weak links must be avoided. Deep understanding of processes and methods is achieved through excellent experimentation, team transparency and trust, “give and take” at the interface between disciplines, good planning and execution, and the ability to implement practical solutions when problems arise. 

I have led over 20 CMC project teams ranging from pre-IND through to market launch resulting in 5 successful NCE (new chemical entities) approvals.

Another common challenge is balancing the need for a strong CMC package with other project needs (e.g. safety, efficacy) over multiple years and with finite resources. Understanding the amount and complexity of the CMC data package is essential to strike the optimal balance to achieve optimal results. I can help your team build and execute a coherent and phase-appropriate CMC plan to simultaneously mitigate CMC risks and keep CMC off the critical path.

Let me bring this experience and perspective to help advance your project through the rigors of CMC development.


FDA and regulatory authority interactions

Getting through the gauntlet of regulatory guidance, requirements, and queries to bring a new product to market is a complex and challenging endeavor where scientific rigor, negotiation, and judgement all come into play. Oh, and perseverance doesn’t hurt either.

I have been fortunate to be a part of 5 successful NCE approvals resulting in new product launches. I have experience in meeting with FDA, in writing and editing portions of CMC documents (for INDs, NDAs, corresponding EMEA documents), and responding to queries from regulatory authorities (US, EU, etc.). With this experience, I can help guide your project through development, filing, and review toward CMC approval.

 

 


API due Diligence (buying or Selling)

When companies look into purchasing a drug candidate, they typically perform due diligence on all aspects of the project including CMC to reach a comfort level and avoid bad surprises (caveat emptor). I have gained experience in assessing API packages on the buyer side, where the goal is to quickly understand the depth and quality of the package, and particularly, to identify any fatal flaws or potential showstopper issues. For API, these can include physicochemical concerns such as unresolved polymorph issues; lack of a commercializable synthetic route which can meet EHS, COG and commercial volume requirements; or a mismatch between API critical quality attributes and drug product requirements, to name a few.

My perspective on what potential suitors are looking for translates well to the selling side as well. A weak or problematic CMC package can siphon value from an otherwise attractive pharmaceutical asset. Early assessment of your API package with timely and judicious intervention to address any weak links or perceived risks can help reduce API-related concerns and increase the value of your asset.

Whether you are buying or selling an API asset, getting an experienced process chemistry assessment of the API package can help maximize the value of these big-ticket deals. Let me put my experience to use in your endeavor.