Katherine H. Email & Phone Number

Sarasota, Florida, United States

Matrix 24 Labs/Eversafe May 2016started as director of medical department: design, plan, conduct trial program in malaria and Zika prevention, assist sales in questions regarding product, then got offered CMO positionAlso, Consulting, since 2013 LC Cell- EU stem cell regulatory consulting;Peaklab- performed extensive physical examinations for sports stars;SDL services- protocol summaries etc.;GLG council CardioV project ;WebMD: German project

Researched the regulatory situation for human stem cells in US and EU. Market access. Strategy for a start-up biotech company. Unfortunately, the endeavor would have been too expensive.

Wrote 3 CDPs (long-acting G-CSF product including trials in NHL; breast cancer, combination anti-hypertensive drug for 505 (b) (2) NDA-submission, pediatric asthma inhalant), was essential part of a growth hormone NDA-submission (wrote 2.7.4 and REMS program, and reviewed 2.7.3, 2.5, 2.2, label, pediatric plan, narratives), reviewed many more NDA submissions (e.g. lipase product), assisted PXL’s clinical trials group e.g. presenting medical device regulations overview or assessing regulatory situation in questionable patients enrolled in a SIADH-trial, is an active member of PXL’s RAC-study group, and member of hem/oncology expert office

wrote Ph I protocol for an Immunocytokine in lung cancer, updated IBs, presented data to management, selected CRO, gave a bid defense presentation, selected CRO including RFP response, reviewed eCRF edit specs., wrote amendment, advised on strategy conducting trial in China, answered questions from Ethics committee, wrote clinical part of global strategy plan as well as important risk assessment document for portfolio, edited abstract for AACR

I partially was the only scientist fulfilling director duties as there was no MD, responsible for 5 major visibility projects, I wrote 1 report for PMA submission to FDA (integrated efficacy and safety report); 1 epidemiologic study for data analysis, abstract editing; 1 due diligence of a combination cardiovascular and hematologic product with presentation to board; 1 IDE stage product with many preclinical issues providing medical expertise and wrote strategy document; 1 launch-related post-marketing trial. I was essential in helping to build the Clinical affairs dept. for the global launch

For the most time, I was the only MD at the company, fulfilling Director of Dept. of Clinical Affairs and Regulatory (Oncology, anti-inflammatory/autoimmune) reporting to COO, CEO and CBO/President.Authoring clinical development plans including regulatory strategy for 2 antibodies (cancer, transplantation)& successful orphan filing. Hired people and mentored them in the process of drug developmentI led two antibody projects in the development and made major progress. Team members comprised an extensive network of CROs and internal members who were located in US, Europe and Japan. Resolved major issues in clinical design for the projects. Activities included pre-IND meeting and IND studies.In-licensing: responsible for identification, evaluation, due diligence with preclinical scientists and CMC. I managed Clinical operation, pharmacovigilance and regulatory writing, I later became Co-Medical monitor for 4 clinical trials (2 Ph II of small molecules anti-inflammatory TA (asthma, rA, interstitial cystitis), and 2 antibodies (1 PhI/II in transplantation and other ind., the other ab at pre-IND stage for hem/onc.) assisted in successful IND as well as orphan application and presentation for venture capital group for IPO, wrote safety surveillance plan

Medical Advisor in Medical affairs dept., Publications in Zeitschr. Kardiol., Clin Appl Thromb Hemost., SAGE, Aerzteblattinvolvement in all aspects of clin trials (Medical monitor and Project management of global (US) studies and local studies Phase 2-4, PMS and registries, where I was the only person working on studies from planning phase to evaluation (preparation of final protocols and CRFs, study manuals, printing mat., mngmt of CROs, CRAs and sites, study budgets, ensure timelines and budgets were met), EC/IRB application, Pharmacovigilance advisor, regulatory report writing, writing/ editing of multiple publications/ study reports etc., preparing advisory boards and workshops for Marketing, health economics advisor) Cardiovascular therapeutic area, responsible for 21 studies during my time, 2 global FDA-NDA studies with Lovenox (the most important sales and high visibility) for new indication and a new anti-Xa inhibitor for NDA and I functioned as back-up for multiple other PhIII trials

Nyc

Clinical research Fellow - Publications in Archives Derm.(protocol design, IRB, collaboration with engineers, nurses, MDs, poster presentation in Chicago- I was the only responsible person for medical device trial of in vivo confocal laser scanning microscopy in melanoma and in other skin lesions; involved in in-house residency teaching and weekly interdisciplinary workgroup meeting on melanoma with dept. heads of surgery, radiology, pathology and Medicine and took part in regular Grand rounds at Cornell University)

special immunology. most rotations at prestigious hospitals in the USA. Cleveland clinic, City of Hope, Cedars Sinai..