Excellent Start-up Guidance!
So many details! There is so much to learn, often in a timely manner on a limited budget. Indeed, running a start-up pharmaceutical company can be a daunting and lonely experience. It requires marked persistence, patience, wisdom, and detail orientation.
We can help! I am an ophthalmologist and since 2010 I have directed PRN PharmaFarm, LLC. Our mission is to fight blindness by assisting start-ups with their development processes. My team and I have personally assisted start-ups in the day-to-day activities of developing medicines, reviewed dozens of applications for funding with associated due diligence, published in the area of ophtha start-up business, and possess deep experience working in the pharmaceutical industry.
Our team can assist you in developing your company in either a turnkey or a la carte fashion. No, we do not have all the answers ourselves. No one in the development community knows everything! But what we do not know, we can contact our extensive network of professionals to find the person with the answer.
How Can We Help?
As you begin your start-up and mature the company, we can help you connect with specialists in different ophthalmic areas of development. Together, my team can help develop your medicine in a timely and cost efficient manner.
We can guide you with:
- Administration and organization
- Legal intellectual property protection
- Security and technical IT support
- Market assessment for your product
- Market research including surveys, KOL contacts, focus groups
- Safety and efficacy studies
- Regulatory advice and documents
- Clinical planning
- Clinical protocols and documents
- Safety review
- Turnkey clinical trial management
- Statistics and data management
- Medical writing
- Quality assurance
- Fundraising assistance and contacts
Dr. Stewart’s Experience
Directing an ophthalmic start-up is a complicated endeavor that involves much “on-the-job training.” Dr. Stewart’s experience as an ophthalmologist, researcher, day-to-day advisor to start-ups, and his deep experience in due diligence provide him with a unique perspective and knowledge to help CEOs manage their business. Talk to Dr. Stewart to let him help you guide your company to success!
Dr. Stewart has assisted start-ups in: lead product identification, pre-clinical non-GLP and GLP toxicology, and pharmacology planning. He has helped oversee product due diligence, drug substance and drug product development, regulatory planning, FDA document preparation (protocols, pre-IND briefing documents, INDs and Investigator Brochures), timeline creation, budget management, and clinical planning.
As a board-certified ophthalmologist Dr. Stewart has advised the ophthalmic pharmaceutical industry for more than 20 years. He has worked with 51 separate ophthalmic pharmaceutical and device companies in clinical planning, study design and global product development. Further, he has either directed or participated in 15 clinical advisory boards.
Leverage your success by gleaning from Dr. Stewart’s vast experience!
Disclaimer: Dr. Stewart is an advisor to ophthalmic start-ups for general development plans and goals. He is not trained as a lawyer or specifically in any one area of development. Specific development questions should be directed to appropriate experts in the field in question. In addition, Dr. Stewart also assists start-ups in identifying sources of potential investment funding for companies. Dr. Stewart is not a financial advisor. Each potential investor should gather information from multiple sources and use appropriate attorneys, financial advisors and available FDA regulations and guidance to make informed investment decisions. Dr Stewart does not make specific recommendations into which company to invest.