Here’s what some of my clients have said about my work with them.
I am happy to provide references on request.
QAAM Pharmaceuticals LLC
Canandaigua, New York
Synthesis design and execution; patent filing (US, Canada, Mexico, and EU); scientific merit of the invention in various patent prosecution stages
Working with Okapi Chemtech far exceeded my expectations.
As a clinician-researcher, far removed from my education in organic chemistry, I was tentative about embarking on the synthesis and analysis of a new clinical molecule. Dr. Mobele led me through every step of the process but made sure I understood what we were doing as we went through RFPs, contractor selection, material sourcing, contracting and right through to synthesis, analysis, documentation and patenting.
At all times I felt informed and in-charge, even though I was outside my own comfort zone. The outcome was outstanding.
Okapi Chemtech has my strongest recommendation.
- Steven A. Rich MD, Managing Partner. QAAM Pharmaceuticals LLC
Process scaling; IP development; tech transfer; control strategy summaries in regulatory filings; RFP development, CMO selection & CMO liaison; crystallization improvement.
I have had the pleasure of working with JP since we founded Velicept. I have been able to watch him deftly navigate from initial tech transfer as we brought our assets out of big pharma all the way to now scaling to phase 3 and commercial. Along the way he helped us dramatically mature and improve our synthesis, craft effective filings and build a supply chain.
One of the most important contributions JP made to our program was the result of his deep knowledge of process chemistry. We needed to improve our crystallization and JP made recommendations to the CMO that not only allowed us to create a scalable process but resulted in valuable IP.
JP approaches our project with the passion and commitment that parallels that of the company founders.
- Raymond Stevens, COO, Velicept Therapeutics
Privately-held biopharmaceutical company
New York, NY
2017 - 2019
Early stage pipeline program management; CMO selection; process design & optimization; coordinate knowledge transfer between academia, CDMO and Biotech Sponsor; CMC strategy
I entrusted JP to lead CMC strategy and development of our early-stage pipeline programs after raising Series A financing for a privately-held biopharmaceutical company based in New York City. Several of these programs were being developed under the 505(b)(2) pathway, which required CMC expertise to deliver results within a substantially truncated timeframe relative to traditional drug development.
A key characteristic of working with JP, especially if building a nascent company or asset, is that he is an operator who will roll up his sleeves, accomplish tasks and continually strive to advance the program. Not only does he possess deep knowledge of synthetic chemistry, process chemistry and drug product development, but he is not afraid to make tough decisions and be held accountable.
JP is well-connected within the CRO/CMO space, which facilitates finding and contracting an ideal partner, particularly in cases requiring tailored services for a fledgling company. Under JP’s guidance, we signed manufacturing partnerships for two assets after diligently evaluating over 10 potential service providers and advanced the lead program into Phase 1 clinical trials. We also scaled and optimized a discovery-stage process, which had previously yielded less than 10 grams of product, to deliver a 100-gram batch under JP’s leadership.
Our company was acquired merely 14-months following the close of our Series A fundraising, largely due to accomplishments we made in manufacturing that enabled our programs to advance toward the clinic.
- ST, Chief Scientific Officer, Biotech Company
Three-person CMC development team
API development; CDMO selection; specification settings; process design & optimization; regulatory CMC strategy
As part of a three-person CMC development team at a small start-up biotech company, we have worked closely with JP over the past several years on topics to address key API development needs such as CDMO vendor selection, rationale on specification setting, impurity fate profiling, reaction optimization and scalability, cost-of-goods assessment, and other critical attributes of our program.
JP has consistently provided thoughtful, data-driven, and practical feedback that was critical to resolving a range of challenges on our projects. His contributions have helped to put our GMP drug substance and drug product manufacturing activities in great shape.
JP is highly responsive and personable and we will always think of him as an important extension of our CMC team.
- GK, VP Product Development, Biotech Company
Emerging pharmaceutical company
CMO liaison; crystallization experiments; process design; solvent-free API; IND filing through Phase 2 clinical trials
I had the great privilege of working with JP Mobele during my tenure as the Vice President of Chemistry at an emerging pharmaceutical company in Eastern Pennsylvania.
JP served as the liaison between our development team and the CMO selected for the manufacture of the drug substance. In this instance, the challenge for the team was that the drug substance existed in multiple polymorphic forms with the thermodynamic, crystalline form retaining high levels of residual organic solvent.
JP worked directly with the CMO to perform multiple crystallization experiments thus determining the optimal process for isolation of a single polymorphic form of the drug substance. And subsequently, provided a unique solution to provide a solvent-free form of the API. In addition, JP provided the needed expertise as we examined a variety of different salt forms of this clinical candidate.
The knowledge we gained through these investigations was critical for our IND filing and, eventually, for the successful development of this compound through Phase 2 clinical trials.
On a separate occasion, I had the opportunity to recruit JP onto another of our programs to serve as an advisor on the development of a novel solid form of a drug substance complex.
My experience working with JP Mobele has always been positive and I continue to reach out to him for support and advice on the characterization and process development of our drug substances. I recommend JP Mobele without hesitation.
- SC, VP Chemistry, Biotech Company