Michigan Grower and Processor Collaborations Can Eat Big Pharma’s Lunch

June 22, 2019 | 2:40 pm | Room 1 |

Many cannabis users are worried that Big Pharma and the FDA will dominate the cannabis
market and destroy small producers. In reality, the state-by-state legalization of cannabis has
opened the door to start-ups, while excluding large and long-time established drug companies.
The state regulations allow product experimentation that could never be achieved on the federal
level; .each state license allows the grower and processor to make whatever products they wish,
without federal regulatory review for safety/efficacy. Plus, the grower/processor can change their
products at their discretion, without federal regulatory review/approval. This contrasts with the
federal FDA system, where each product takes years to gain approval, costs immense amounts of
money and once approved, is never changed.

Stephen Goldner, a medical inventor and FDA lawyer, teamed up with Dr. Deb Kimless, a
cannabis physician and developed a method that can be used by any grower and processor to
create unique cannabis products and bring them to market faster and more cost effectively. Mr.
Goldner will describe the process they used in Michigan and demonstrate ROI and break-even
cost structures that can be used by any individual in any state. Dr. Kimless will show medical
proof and data points based on their multi-site clinical trials that CBD relieves pain more
efficiently and safely than any drug produced by Big Pharma for pain relief. They will
demonstrate how any cannabis grower and processor can introduce new products faster and
better than large pharmaceutical or consumer products companies.

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Debra Kimless, M.D., CMO, Pure Green Canna

Debra Kimless, M.D. graduated magna cum laude, Phi Beta Kappa from Muhlenberg College with a double major in Natural Sciences and Biology. She attended medical school at Rutgers, and residency at Temple University Hospital and is a board-certified Anesthesiologist with a subspecialty certification in Pain Medicine and is board certified by the American/International Lifestyle Medicine Board.

Dr. Kimless was motivated to learn about medical cannabis because her mother suffered from intractable pain and responded paradoxically to opiates. Dr. Kimless traveled the world to determine if medical cannabis could have been a treatment option. She studied under the most respected experts in cannabis medicine and research and has become a passionate champion for medical cannabis.

As the Chief Medical Officer for Pure Green, Dr. Kimless conducts clinical trials using Pure Green’s patent pending sublingual tablet formulations. She presents the data and results at national and international conferences and seminars.

Her goal is to use education to de-stigmatize medical cannabis and explain through the results of the clinical trials, how it may be used as an effective therapeutic option.

 

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Steve Goldner, Esq. RAC, CEO and Founder, Pure Green LLC

Steve served as Forensic Toxicologist at the New York Chief Medical Examiner’s office on 18,000 cases. In 1973, he and his mentor, John Broich, developed Methadone, the first oral liquid dose non-abuseable narcotic.  Stephen set records by gaining both FDA and DEA approvals in under a year, making Methadone the fastest to-market pharmaceutical launch ever. He then launched the modern-era of testing for recreational drugs by creating the first lab detection procedures and implemented them at scale with Mifflin Pharma and Spectrum Labs. After successful exits from both companies, Steve earned his law degree while getting more drugs and medical devices approved worldwide for Unilever. He went on to leverage his extensive medical science and FDA law expertise obtaining FDA approval for over 250 medical devices and a dozen drugs in forty countries. This facilitated 200 start-up companies that collectively employ over 10,000 people. He served as FDA advisor to NIH for many years and in 2016 was a representative to the UNGASS United Nations colloquium to adjust the ‘War on Drugs’ Policy. Founder/CEO of Regulatory Affairs Associates since 2000, his teams provide “invention to approval” regulatory consulting in toxicology, formulation, and clinical trial management. To study cannabis science directly, Steve co-founded Pinnacle Labs in Troy, Michigan as the first and only cannabis-testing laboratory to meet stringent FDA drug standards. He also served as Chairman of both the USA Cannabis Laboratory Standards Setting Committees and the Cannabis Clinical Trials Standards Setting Committees for FOCUS/ISO, the Foundation of Cannabis Unified Standards. 

Founder/CEO of Pure Green, Steve was awarded the first Michigan LARA cannabis-processing license to open his cannabis-centric consumer products company, July 2018 in Inkster, Michigan. Multiple additional cannabis growing licenses have been awarded within 10 months, head count exceeds 50, build out is adding 100,000 sq. ft. indoor cultivation + 40 acres outdoor cultivation in The Thumb region. Multiple patents are actively under review for breakthrough controlled drug dosing and consumer products. Pure Green has run 8 cannabis clinical trials and is currently running 4 additional studies.  Steve has begun the FDA review process for 4 cannabis drugs: for PTSD relief, opioid addiction and pain/anxiety relief for dogs. Always mentoring people, Steve’s TEDMED and TEDX-Detroit videos have encouraged many entrepreneurs.

 

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