Nnenna Ihekoromadu, Md

Nnenna Ihekoromadu, Md Email and Phone Number

Independent Clinical Development Consultant @ Ocular Clinical Research Company (Ocular CRC)
United States
Nnenna Ihekoromadu, Md's Location
Southlake, Texas, United States, United States
Nnenna Ihekoromadu, Md's Contact Details

Nnenna Ihekoromadu, Md personal email

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About Nnenna Ihekoromadu, Md

Dr. Ihekoromadu is a physician with over 24 years experience in the Ophthalmology & Biopharmaceutical industry. She founded Ocular Clinical Research Company with a mission to improve the quality of medical talent and services available to ophthalmology drug and device companies. Dr. Nnenna provides executive medical consulting services, including medical monitoring, clinical development and protocol development to biotech and pharmaceutical companies. She is one of the executive coaches and faculty members of the ACCME provider, Ocular CRC College, where she trains and certifies medical professionals for a seamless transition from clinic to corporate, working in biopharmaceutical clinical development or drug safety. Previously, as VP of Clinical Research & Medical Affairs for AGTC, she led the Clinical Affairs, Medical Affairs, Drug Safety, Pharmacovigilance, Data Management and Biostatistics teams to successfully advance the XLRP and Achromatopsia gene therapy programs.Dr. Ihekoromadu has also successfully held different clinical leadership roles in other esteemed organizations. She spearheaded multiple Ophthalmology clinical programs at Syneos Health/INC Research, Santen Pharmaceuticals, Bausch & Lomb Pharmaceuticals and ISTA Pharmaceuticals.Her career in Pharmaceuticals which started in 2000 with Johnson & Johnson has excelled tremendously through a unique combination of outstanding medical, scientific, business and leadership skills. Being a strategic thinker with strong analytical skills, perseverance, and drive, Dr Nnenna has successfully been an integral part of multiple new product launches. She led the clinical development of multiple ocular drugs and has interfaced with the US FDA, Japanese PMDA and other regulatory authorities.Dr. Ihekoromadu gained her Ophthalmology clinical experience from UCLA, Jules Stein Eye Institute, and her Medical Degree from University of Nigeria.

Nnenna Ihekoromadu, Md's Current Company Details
Ocular Clinical Research Company (Ocular CRC)

Ocular Clinical Research Company (Ocular Crc)

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Independent Clinical Development Consultant
United States
Website:
ocularcrc.com
Employees:
5
Nnenna Ihekoromadu, Md Work Experience Details
  • Ocular Clinical Research Company (Ocular Crc)
    Independent Clinical Development Consultant
    Ocular Clinical Research Company (Ocular Crc)
    United States
  • Ocular Clinical Research Company (Ocular Crc)
    Chief Executive Officer
    Ocular Clinical Research Company (Ocular Crc) Apr 2020 - Present
    Ocular Clinical Research Company (Ocular CRC) is an Ophthalmology specialty consulting firm that focuses on providing: 1. Expert talent and services in Ophthalmology Clinical development 2. Advanced career training to professionals for Ophthalmology Clinical development jobs Our areas of expertise are specifically providing high quality executive leadership, medical monitoring,clinical research, safety and medical affairs. Our success as a consulting firm stems from our in-depth knowledge and expertise in all aspects of Ophthalmology Clinical research, and in the different sub-therapeutic areas.Ocular CRC Consultants are fully committed to elevating the medical research standards within the Ophthalmology pharmaceutical and biotechnology clinical development industry.We are MDs, Optometrists, Pharmacists/Pharm.Ds, and Ph.Ds focused on the science and medical aspects of Ocular drug and device development; from first in human trials to post-marketing trials. Ocular CRC consultants are trained experts that will support your CRO as the medical lead and subject matter experts.The Ocular CRC College training provides a unique and novel learning experience that combines;relevant Ophthalmology training, with a robust, function-specific Clinical Research training, garnished with soft-skills training. It is the perfect combination of learning theoretical concepts and applying them in real life through a mentored functional Ophthalmology clinical research training experience with the highest-quality faculty. Ocular CRC College has 2 currently available training programs:"Eye on Ocular CRC Ready" Consultants Program- https://www.ocularcrc.com/eyereadycourse"Ocular CRC Ready" Consultants Program- https://www.ocularcrc.com/readycourseTo learn more contact us email - info@ocularcrc.comwebsite- www.ocularcrc.comSchedule a chat- www.calendly.com/ocularcrc
  • Applied Genetic Technologies Corporation (Agtc)
    Vice President, Clinical Research & Medical Affairs
    Applied Genetic Technologies Corporation (Agtc) Nov 2019 - Feb 2021
    • Responsible for the following functions:o Clinical Affairs & Medical Writingo Medical Affairs & Medical Scienceo Safety and Pharmacovigilanceo Data Management & Biostatistics• Providing Executive Leadership for all AGTC Clinical programs•• Develop the clinical research strategy and clinical development plans for the Company’s product candidates: XLRP- Phase 1/ 2, Phase 2, NHS and Phase 2/3 programso Achromatopsia- NHS, Phase 1/ 2 programso Retinoschisis- Phase 1/ 2 program• Manage internal and external resources to ensure clinical research plans are executed on time and within budget. • Develop clinical trial protocols, IBs and other documents required to conduct clinical trials. • Oversee management of clinical trials, including investigators’ selection, analysis of patient recruitment strategies, milestones, coordination of lab samples, data collection and analysis. • Identify suitable clinical trial sites and develop effective working relationships with clinical investigators and KOLs. • Review all SAEs and safety data; ensure that sites and regulatory agencies are notified, and all company and regulatory procedures are compliant. • Manage CROs along with clinical operations team• Assist with regulatory filings, including drafting, editing and preparing of routine correspondence and sections of INDs, BLAs, NDAs, Annual Reports, Amendments, Supplements, Orphan Drug Applications and other regulatory submissions for the FDA• Oversee development and maintenance of clinical SOPs related to GCP activities• Develop the Medical Affairs plan and strategy for all 3 programs.• Provide executive oversight of all data management and biostatistics activities
  • Syneos Health Clinical Solutions (Previously Inc Research/Inventiv Health)
    Executive Medical Director, Clinical Development, Ophthalmology
    Syneos Health Clinical Solutions (Previously Inc Research/Inventiv Health) Mar 2016 - Nov 2019
    Morrisville, North Carolina, Us
  • Santen
    Senior Medical Director, Global Clinical Development & Medical Affairs
    Santen Nov 2012 - Feb 2016
    Osaka, Japan, Jp
    • Clinical Development-Providing strategic oversight and Clinical development leadership for Glaucoma, Wet AMD and Uveitis clinical development programs(Phase 1-3)-Providing medical/scientific input to Clinical Operations for clinical studies & Investigator Meetings. -Supporting Data Management to ensure relevance and utility of clinical data base. Serving as the primary source for interpretation of clinical study results and review of top line results.-Medical Monitoring of multiple clinical trials and Drug Safety support.-Assisting Medical Affairs in understanding and leveraging the results of clinical studies. -Protocol development, writing, reviewing and approving protocol amendments, IB and CSR.- Play a key role in the interaction with the FDA & EMA.-Coordinate and participate in Scientific Advisory boards, DMC and Steering Committee.- Support the Translational Research team for Retina and Glaucoma projects.• Leadership-Hiring and managing direct reports in Clinical Science and managing all of the Global Clinical Science Budget.-Providing leadership and Clinical input for Global Retina Strategy and Global Glaucoma Strategy -Providing partnership and collaboration with Japanese and European colleagues and all cross functional team members. -Attending regional and international scientific congresses and meetings. -Providing strong ophthalmology scientific expertise, utilizing aggressive timelines, integrating scientific rigor, medical need and commercial value into compelling clinical development plans. -Assisting with development and implementation of reliable and high-value publication strategies -Cultivating and maintaining relationships with KOLs in Ophthalmology so as to leverage expertise in optimizing successful clinical programs and obtaining insights into trial data. -Establishing and maintaining an environment of high morale and commitment through modeling leadership actions, behaviors, and professional ethics.
  • Bausch & Lomb
    Senior Medical Science Liaison
    Bausch & Lomb Mar 2009 - Nov 2012
    Bridgewater, Nj, Us
    KOL Management and Development: •Provide scientific support to KOLs, academic centers of excellence and HCP in TX, OK, AR, NM, KS, MO, NE, and CO •Maintain face-to-face scientific discussions with about 38 top KOLs.•Develop local Ophthalmologists into regional/national KOLs.•Train national/regional speakers on Besivance, Lotemax and Zirgan products. Research Support: •Site Identification for phase 4 trials, (IIS) and other trials from clinical operations.•Management of Phase 4 studies- Protocol design support •Facilitate phase IIb, III, IV trials, and IIS for different products. Manage Care Support: •Address formulary/P&T issues by delivering scientific presentations. •Collaborating with National Account managers to provide scientific presentations and support to MCOs, State Medicaid Committees and Pharmacy decision makers.Marketing Support: •Provide scientific content and support for speaker training initiatives•Identify potential influential speakers within the ophthalmology physician community•Provide scientific support to speakers prior to key presentations at major scientific meetings. •Develop scientific content for brand teams’ strategic and tactical plans •“priming” market for Lotemax gel US launch and providing competitive intelligence to Medical Marketing.•Collaborated with Medical Marketing to create pre-approval scientific messaging for Mapracorat, a first in class anti-inflammatory product. •Launched Besivance and Lotemax Ointment. •Provide post advisory board feedback to US marketing resulting to positive changes in brand strategy. Global Brand Team Support: •Scientific support of B&L Global team on Bromfenac launch in Europe. •Identify US KOLs to support EU launch of Bromfenac•Coordinate a successful professional US KOL video recording used for the Bromfenac EU launch. •Sales aid scientific content review for EU sales and marketing teams. •Provide clinical education support for Marketing and Sales teams
  • Ista Pharmaceuticals
    Medical Affairs Manager
    Ista Pharmaceuticals 2005 - Mar 2009
    Irvine, Ca, Us
    •Serve as the face of ISTA to Key opinion leaders in ophthalmology by building relationships with Ophthalmology and Retina Key Opinion Leaders in TX, OK, AR, NM, KS, MO, NE, and CO•Respond to unsolicited medical requests for information on Ophthalmic NSAID Bromfenac, Vitrase used in Retina, and Istalol for glaucoma. •Provide clinical and scientific presentations to healthcare audiences- Advisory boards, speaker training, and round table presentations.•Provide clinical and scientific support for formulary, contracting and clinical guideline decisions.•Participate on committees or project teams that support Clinical/Medical Affairs strategies and tactics as delegated by Medical Affairs leadership.•Support thought leaders in developing concepts and writing letters of intent and protocols for investigator initiated pre-clinical and clinical trials.•Project lead for Vitrase (Ovine Hyaluronidase injection) for supporting Phase 4 clinical research on off-label indications like –Enzymatic Vitreolysis with Vitrase, Management of Vitreous Hemorrhages, PVD and Floaters •Collaborated with Medical Marketing and created scientific messaging for pipeline products.•Coordinate collaboration with sites for phase IIIb and phase IV clinical trials•Provide support for investigator Initiated trials and phase 4 trails (from submission through internal review, approval and implementation)•Provide publication support for assigned clinical research projects •Scientific lead for Bromfenac use in combination with Lucentis for ARMD •Provide in-depth scientific support to sales and marketing teams via ongoing disease state training as well as current clinical trends•Provide scientific/clinical data presentation and support at advisory board meetings and coordination of scientific meeting (AAO, ASCRS, ASRS, ESRS, ARVO, AOA, SECO, and other regional ophthalmology association meetings)
  • Johnson & Johnson, Ortho Mcneil
    District Manager
    Johnson & Johnson, Ortho Mcneil 1999 - 2004
    Accomplishments as sales rep:•Thrived on challenges that came with new career, leveraged knowledge as physician and applied basic sales/business principles to become a winner with a never-giving up attitude.•2002 Rep of the 2nd cycle •2001 & 2002 Winner Topamax share movers contest- 3months consecutively •2002 Platinum winner Reminyl “All star” contest •2001 moved sales rankings to #9/149 in the Nation from #137/149 2003-Career Advancement / Accomplishments as a District Manager•Promoted to district manager after less than 2 years as sales rep. due to excellent sales performance, fast developmental track record and strong competencies. •Relocated to TX from CA by J&J with promotion, and trained by J&J leadership and management development. •Tasked to hire 11 reps in 1 month for new product launch. •Exceeded Corporate expectations for 3 years as district sales manager Sales accomplishments as District Manager•RANKED NO1 IN THE NATION-1ST Quarter 2005 •Finished #1 in the region Dec '03, Jan‘04, Feb ‘04, Sept ‘04 and Dec ‘04, Jan ‘05 •Finished No 2 in the region for Oct and Nov '04 & No 2 in the NATION for Dec '04 •No 1 position for the T.E.A.M contest for 2 months •#1 Winner Axert RBD contest 4th quarter 2003 •2 of my representatives made Pinnacle in 2003 •#1 Winner Western region Axert share movers contest 2003 •Successfully launched Topamax for migraine prevention in ‘04, Axert in ‘03, Reminyl in ‘01 Job DescriptionDirected and managed sales team of 11 direct reports Lead the team to success by applying scientific and technical knowledge, coaching, motivating, encouraging team work, strategic planning, flawless execution of business goals and being action and results oriented. Supervised creation of sales and marketing strategies/plans and ensured all expenses and operations were within budget constraints. Focused on company objectives of successfully launching new products. Managed team to become No 1 nationally during new product launch.
  • U.C.L.A Jules Stein Eye Institute
    Ophthalmic Research Associate
    U.C.L.A Jules Stein Eye Institute Dec 1997 - May 2000
    • Clinical Ophthalmology - History taking, eye exam, refraction, retinoscopy, eye pressure testing and various ophthalmic tests. • Laser eye surgery - Assisting the surgeons in the operating room during Lasik eye surgery, Intacs eye surgery, Keratoplasty and other eye surgeries, and calibration of the laser machine. • Presentations at Lasik seminars – Podium presentations at Laser eye surgery seminars conducted by UCLA utilizing audiovisual technology to an audience of more than 50 prospective patients.• Refractive surgery research: Support on going departmental clinical research projects.
  • E.K.O. Hospitals Plc
    Medical Intern
    E.K.O. Hospitals Plc Dec 1995 - Oct 1997
    • Clinical assessment and management of both inpatient and outpatient clinics. • Performing various minor surgical procedures • Implemented epidemiologic research projects on the incidence of HIV infection rates in Lagos.• Completed research project involving 356 patients afflicted with Kaposi’s sarcoma secondary to HIV AIDS infection. Published article- ‘MEDDIKKA’ an African Medical Journal, March 1997, p.34; Topic - ‘ KAPOSI’S SARCOMA AFFECTING AIDS PATIENTS IN LAGOS’

Nnenna Ihekoromadu, Md Skills

Ophthalmology Infectious Diseases Psychiatry Clinical Research Medicine Advisory Boards Healthcare Medical Affairs Pain Management Medical Education Pharmaceutical Industry Managed Markets Anti Inflammatory Neurology Sales Management Pharmaceutical Sales Retina Managed Care Clinical Trials Product Launch Clinical Development Internal Medicine Ctms Surgery Oncology Protocol Pharmaceutics Clinical Study Design Medical Writing Good Clinical Practice

Nnenna Ihekoromadu, Md Education Details

  • The University Of Texas At Dallas
    The University Of Texas At Dallas
    Global Leadership Executive Masters In Business Administration (Glemba)
  • College Of Medicine,U.N.N
    College Of Medicine,U.N.N
    Medicine And Surgery
  • Royal London Hospital Whitechapel
    Royal London Hospital Whitechapel

Frequently Asked Questions about Nnenna Ihekoromadu, Md

What company does Nnenna Ihekoromadu, Md work for?

Nnenna Ihekoromadu, Md works for Ocular Clinical Research Company (Ocular Crc)

What is Nnenna Ihekoromadu, Md's role at the current company?

Nnenna Ihekoromadu, Md's current role is Independent Clinical Development Consultant.

What is Nnenna Ihekoromadu, Md's email address?

Nnenna Ihekoromadu, Md's email address is nn****@****hoo.com

What is Nnenna Ihekoromadu, Md's direct phone number?

Nnenna Ihekoromadu, Md's direct phone number is (919) 876*****

What schools did Nnenna Ihekoromadu, Md attend?

Nnenna Ihekoromadu, Md attended The University Of Texas At Dallas, College Of Medicine,u.n.n, Royal London Hospital Whitechapel.

What skills is Nnenna Ihekoromadu, Md known for?

Nnenna Ihekoromadu, Md has skills like Ophthalmology, Infectious Diseases, Psychiatry, Clinical Research, Medicine, Advisory Boards, Healthcare, Medical Affairs, Pain Management, Medical Education, Pharmaceutical Industry, Managed Markets.

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