RAM B. RASTOGI, DVM, Ph. D. (US and Canada Citizen) (Expertise in Oncology, CNS, Infectious and Rheumatic Diseases)

*** ********* ****,

Holly Springs, North Carolina 27540

Tel: 919-***-****; Mobile: 267-***-****

E-mail: ad45gd@r.postjobfree.com

Profile and Key Accomplishments:

A seasoned executive and entrepreneur, with over 30 years of experience in Phase 1-4 clinical development, medical affairs/marketing, product life-cycle management, pharmacovigilance/safety data review/monitoring and reporting (IND safety update, PSUR etc.), project management, operation, business development and in-licensing at large pharma, biotech, CRO, medical food and start-up companies. Track record of building high performance teams. Taking entrepreneurial approaches, my goals have been to bring efficacious and safe drugs in the shortest time frame and at optimal development costs to market without ever compromising the quality.

As a program leader, I prepared and implemented dozens of global strategic clinical and regulatory plans (SCPs) in various therapeutic areas with inputs from various functional project teams and external stake holders, including KOLs and advisory boards to accomplish project objectives. Managed strategic partners and vendors including CRO and ensured adherence to ICH-GCP guidelines. Prepared/co-prepared with CRO the operational strategies, time lines for deliverables and robust risk management/contingency plan to ensure study completion on time and within budget.

Expertise in management of clinical studies globally, including US, Europe, Canada, Mexico, Japan, China, India, Hong Kong, Thailand, S. Africa and South America.

Designed and managed hundreds of Phase 1-4 clinical trials, including writing of the protocols, investigator brochures, integrated efficacy/safety reports, annual safety updates and clinical sections of INDs/CTA, and NDAs/BLAs/MAAs for submission to regulatory agencies world-wide.

Attended inter-phase meetings with regulatory agencies to secure their timely inputs, discussed data and participated in filing and approval of 22 NDAs/BLAs/MAAs and 59 INDs/CTA, which generated several hundreds of billions of dollars in combined sales during their life-cycles. Of these, 7 new drugs were approved in cancer (Aromasin for breast cancer, Irinotecan (camptosar) for colorectal cancer, Trelstar for prostate cancer, Targretin for basal cell carcinoma, Novantrone (mitoxantrone) for NHL and nasopharyngeal carcinoma, Bisantrene for CLL and Cytadren for breast cancer), 6 in neurology/psychiatry (Avonex for MS, Lioresal for muscle spasm, Tegretol for epilepsy, Trileptal for pediatric epilepsy, Ritalin for ADHD and Ludiomil for depression), 5 drugs (Fenbufen, Voltaren, Rengasil, Voltaren SR and Voltaren suppository) in rheumatic diseases RA, OA and AS, 2 in infectious diseases (Synagis for pediatric RSV and Flumist as a nasal Flu vaccine), 1 contrast enhancing agent (Echogen), and 1 drug (Trasicor) for hypertension. Accomplished successes in wide therapeutic fields.

In oncology, I designed protocols and managed Phase 1-3 trials of the first aromatase inhibitor Cytadren in breast cancer at Ciba-Geigy/Novartis (1980-85); 7 drugs with varying MoAs at American Cyanamid/Wyeth (1985-95) (Novantrone, zeniplatin, enloplatin, immunomodulator, MDR-reversal agent, colony stimulating factor and PIXY-321) in a variety of solid and hematological malignancies; and Phase 1-4 trials of 4 drugs at Pharmacia/Pfizer (2001-03) (Irinotecan, Aromasin, Trelstar and an orally active TOPO-1 inhibitor Capsure) in dozens of solid and hematological malignancies to expand indications and increase awareness.

Experience in writing Phase 1-4 protocols and management of trials in glioblastoma, melanoma, breast, ovarian, urinary bladder, prostate, endometrial, head and neck, esophageal, gastric, liver, pancreatic, colorectal, non-small cell lung cancer, small cell lung cancer, nasopharyngeal carcinoma, AML, CLL, NHL and multiple myeloma world-wide.

Chaired/co-chaired many investigators and steering committee meetings in US, Canada, EU, Thailand, Japan, India, Hong Kong and China, and expanded networks of KOLs and product advocates globally.

As a VP Global Product Development, at PPD Inc., a leading CRO (1995-98), I prepared the business plan for West Coast Operations in San Diego, and led the business unit with P&L, operational and business development responsibilities for drugs in oncology, CNS and Critical Care areas. Managed a staff of over 120.

Under my leadership in 1998, the West Coast business unit signed $64M in new businesses vs. $15M target, exceptional achievements in BD and expansion of client relationship.

At PPD, I remarkably increased the number of Phase 1-3 programs in solid and hematological malignancies from one program in year 1995 to 28 projects in 1998. I spear-headed the award of the largest contract of over $35M in the then company history from Protoderm in UK, a spin-off Roche, and acted as its virtual Program Director.

At PPD and Neeman Medical International, I led preparations of SOPs and policies, and implemented strategic initiatives to build additional functionality, and improved services, operations, client appeal, process flow, overall business functions, reputation, and financial performance.

Expertise in client relationship management for repeat business, and prioritizing and managing multiple responsibilities in parallel.

As VP Global Clinical Affairs at Maxim Pharmaceuticals in San Diego (1999-2000), I managed Clinical and Regulatory Affairs divisions, prepared strategic clinical and regulatory plans, protocols and managed international Phase 1-3 trials of an immunomodulator Maxamine in AML, melanoma and renal cancer, as well as Hepatitis-C in a combined total of over 950 patients. Chaired Hep-C investigators meeting in Budapest and melanoma in Sydney. Positive findings in Phase 2 Hep-C trials in 205 IFN-naïve patients markedly improved company valuation.

Presented business strategies to the Maxim Board of Directors in NY City. Visited investors and made presentations in NY City and Sweden, and raised $20M in new capital.

As a consultant to Salmedix, a start-up company in San Diego, in early 2001, I conducted the due diligence, recommended acquisition of bendamustine (Treanda) and designed Phase 1-2a safety, activity and PK/PD study. Bendamustine was subsequently acquired by Cephalon for late development and FDA approval for chronic lymphocytic leukemia indication with over $700M in annual sales; obviously a remarkable due diligence and recommendation for licensing.

At Pharmacia/Pfizer, as Senior Medical Director Global Medical Affairs Oncology (2001-2003), I managed medical affairs activities, and implemented brand optimization and life-cycle management strategies for Irinotecan, Aromasin, Trelstar and Capsure. Prepared strategic clinical and regulatory plans with input from various functional teams and KOLs, designed protocols and managed Phase 1-4 trials for new indications/revenue growth and enhancement of brand awareness. I prepared periodic safety updates for regulatory agencies world-wide, conducted risk-benefit analysis, managed publication planning, and identified, developed and maintained a network of KOLs.

I interacted with pharmacovigilance, outcomes research/health economics and commercial colleagues in generation of the needed differentiating data. I participated in development of scientifically accurate marketing, advertising and sales training materials, medical education programs, advisories and symposia. Prepared charters and led advisory board meetings together with KOLs, and co-chaired the Investigators and Steering Committee meetings for large global Phase 3 and 4 trials. I interacted with various functional and leadership teams and strategic pharma partners to achieve the business objectives.

Initiated clinical and pharmacogenomic research at strategically important cancer research institutes and leading treatment centers in the US and EU countries, provided research grants and trial drugs with remarkable outcomes.

At Pharmacia/Pfizer, taking an entrepreneurial approach, I designed and completed on-time a Phase 4 trial of Camptosar, and participated in presentation of results to FDA/ODAC that sustained the approval of Camptosar as the standard of care for first and second-line colorectal cancer, and received MVP award from the President.

At Pfizer-Japan, made a presentation to 16 KOLs, and then interacted with the regulatory agency in Japan through a few major KOLs, and I managed to negotiate a much smaller local Phase 3 trial of Aromasin in breast cancer than initially required for approval. This markedly reduced budget by over $30M and time-lines.

At Pfizer, co-designed with two major EU cooperative groups and managed Phase 3 SOFT/TEXT trials of Aromasin combined with Trelstar in 4700 pre-menopausal women with breast cancer that significantly improved 10-yr median survival. Results were initially reported at the very prestigious and selective Plenary Session of ASCO 2014 conference attended by over 30,000 oncologists, scientists and nurses, and published as “New Practice Changing Study” in The New York Times on June 1, 2014, and in JAMA on July 16, 2014. These studies markedly increased sales of both of our drugs Aromasin and Trelstar.

At Pharmacia/Pfizer, in a Phase 3 adjuvant breast cancer TEAM trial of Aromasin, I increased enrollment from average 176 patients/month over the previous 10 months before I took over the program to 386 patients/month over the next 10 months, and completed the enrollment of 5,467 patients in 20 months, 4 months ahead of initial time lines. In the side studies we also investigated the pharmacogenomics/biomarkers and Aromasin differentiating effects on bone health. Results were published in the top New England J Medicine, suggesting high quality performance of investigators and our team.

I designed/co-designed with KOLs and managed 39 company sponsored global Phase 1-4 trials of Camptosar, Aromasin, and Trelstar in a combined total of 46,000 cancer patients in 9 solid tumor types to explore new indications in advanced, neoadjuvant, adjuvant and prevention settings. Many of these trials were carried out by US and EU oncology co-operative groups and networks to achieve business strategies, grow KOLs pool, and reduce time lines and development costs for new indications.

Coordinated over 200 investigator-initiated Phase 1-4 trials world-wide in a variety of tumors in search of new claims as part of brand optimization/life-cycle management strategies, and managed publication of results.

Increased the submission of abstracts on camptosar alone from 118 to ASCO 2001 to 251 to ASCO 2003 conference, and participated in preparation of hundreds of full publications. This markedly increased the product awareness and potential for investigational use in other tumors.

Interacted weekly with 16 medical directors and 12 business managers at subsidiaries to update enrollments, address country specific operational challenges, opportunities, resolutions, data gaps, messaging needs and resources in achieving project objectives.

At Pharmacia/Pfizer, managed 11 Medical Science Liaisons (MSLs) to recruit KOLs to expand knowledge/understanding of our marketed anticancer drugs and develop and retain product advocates. Also coordinated various medical affairs activities with MSLs at UCB, Inc. in year 2013.

As CEO and Member of the Board at Neeman Medical International, 2005-06, I transformed this SMO to CRO, strengthened BD and operation functions, and added many new services, including clinical monitoring, QA and data management of Phase 1-4 trials in various therapeutic areas, including several studies in oncology in US, Mexico, Costa Rica, Panama City and India, and markedly increased revenue growth by over 5 folds. Visited Health Minister and Vice President of Guatemala and El Salvadore to discuss strategies for patient enrollments in clinical trials at major hospitals, and provide GCP-ICH and other study related training to potential investigators. Developed strategic partnership with a CRO in Europe. Managed a staff of 270 in US, Costa Rica and India.

At RR BioPharma Consulting (2007- to date), as an independent owner, I secured contracts to prepare strategic clinical and regulatory plan, pre-IND briefing document, design Phase 1-2 protocols, and write clinical summary report and clinical investigator brochure for a new drug delivery of TOPO-1 inhibitor, a MoAB in multiple myeloma, and most recently a chemo-sensitizing agent in advanced cancer patients.

I have expertise in strategic corporate development, new product evaluation, licensing, raising capital, and alliance development and management.

In neurology and psychiatric arena, I have over 25 years of experience in Phase 1-4 clinical development, medical affairs and regulatory activities of 30 compounds, 9 new molecules at pharmaceuticals companies and 21 at the CRO company PPD).

As Associate Medical Director At Ciba-Geigy/Novartis in Canada (1980-85), I participated in Phase 2-4 development and marketing approval of Lioresal for muscle spasm, Tegretol for epilepsy, Trileptal for pediatric epilepsy, Ritalin for ADHD and Ludiomil for depression.

At American Cyanamid, as a Global Project Director/Deputy Director, Clinical Development (1985-1995), I prepared strategic clinical and regulatory plan for a memory enhancing drug and interacted with functional teams in US and Italy. In addition, managed global programs for two lipid lowering agents with different MoAs, and many anticancer drugs, until the company was acquired by Wyeth.

Designed risk mitigation plan with input from multi-functional teams and managed early identification of activity and safety signals.

Prepared safety reports, and responses to IRBs and Independent Data Monitoring Committee. Interacted with KOLs and Scientific Advisory Boards to evaluate the risk-benefit.

At PPD, I co-designed with sponsors and KOLs, and managed Phase 1-4 trials of 21 CNS drugs in a variety of neurological and psychiatric diseases, and interacted with multi-functional in-house and sponsors teams.

At PPD, I co-designed and managed a Phase 3 trial of Avonex in multiple sclerosis (MS), the results of which led to FDA approval of a new major indication. The study was cited in Harvard Health Letter as “Top 10 Medical Advances of The Year”, and published in New England J Medicine.

As a Co-Founder, CTO and COO of Huntington Pharmaceuticals in San Diego in 2000, I conducted due-diligence at the investigator’s site by reviewing the case record forms of hundreds of Huntington’s disease patients treated with tetrabenazine under investigator IND by Joseph Jankovic, M.D., Professor of Neurology and Director, Movement Disorder Clinic, Baylor College of Medicine, Houston. Negotiated the licensing terms with Master Pharmaceuticals, Inc., based in Manchester UK. Participated in fund raising and secured commitments for $10 M from two VCs. However, Master Pharmaceuticals wanted to have commitment for $25M towards IND filing and Phase 1-2 clinical development before finalizing the licensing. In the meanwhile, I received a lucrative offer from Pharmacia that I could not refuse. The other members of Harrington team also left to start other endeavors. In subsequent years, Master Pharmaceuticals licensed tetrabenazine to Prestwick Pharmaceuticals, which was approved by the FDA in 2008, and marketed under the trade name Xenazine by Biovale/Bausch Health as the first and only treatment of chorea associated with Huntington’s disease, bagging over $130M in second year sales. Obviously, I made for a second time clinically sound decision in selecting a winner candidate, but regrettably failed to raise the required funding.

As a Medical Director (contractor) at UCB Inc. (2013), I interacted with various functional teams to accomplish the assigned project objectives. Prepared a Position Paper to justify first-line monotherapy claim for an anticonvulsant drug Vimpat, instead of initially planned “conversion to monotherapy” claim based on a completed Phase 3 conversion design trial in patients with partial-onset seizures. The proposed new and more lucrative claim became acceptable to the management team. The sNDA for indication as monotherapy was subsequently submitted and approved by the FDA. This resulted in achieving a much larger patient population/market share and revenue growth compared to the initially targeted “conversion to monotherapy” indication. In addition, I addressed a major safety issue of Vimpat which became acceptable to the FDA. Prepared a variety of marketing and training materials for MSLs and sales force.

At UCB, participated in Data Gap analysis and strategic planning of new Phase 2-4 sponsored and investigator-initiated trials of Vimpat for brand optimization, demonstrating competitive advantages, adding new claims, addressing market concerns and ultimately increasing the revenue growth.

At UCB, participated in review and finalization of the Academy of Managed Care Pharmacy (AMCP) formulary dossier to accelerate Vimpat revenue growth.

As a Co-founder and CEO of Myelinova, Inc. (2014-2017), I identified the business opportunity, led the acquisition and in-licensing of a novel immunomodulator with triple-action advantage. I co-assembled the leadership team, finalized the legal activities of the formation of the company and in-licensing of the technology and spearheaded the fund-raising activities.

Prepared the Myelinova business plan, strategic clinical and regulatory plan, and Phase 1-2 protocols for indications in primary and secondary progressive multiple sclerosis (MS). Many VCs and Pharma Ventures expressed interests in funding the Phase 1 development but only after completion of IND studies with acceptable toxicity profile in animals,

As a Director of Clinical and Medical Affairs (contractor) at Nestle Health Science (NHS)/Alfasigma (2016-17), prepared strategic development plan for a medical food. Co-designed a placebo-controlled Phase 2B trial with a KOL/principal investigator from Harvard Medical School in bipolar depression, with side study of biomarkers, SNPs and other predictors of clinical response. Finalized monitoring plan, protocol deviation review process and safety data flow and reporting plans. Managed regulatory, contractual and budgetary documents. In addition, managed patient enrollment and completion of several on-going Phase 2-3 trials in ADHD, autisms and other major neurological indications on-time and within budget.

At NHS, I participated in review, discussion and finalization of the Statistical Analysis Plan and Shells for data listings/tables/figures with the CRO for a large Phase 3 trial of a second medical food in diabetic neuropathy. Interacted with PI/KOLs for two very exciting side studies on peripheral nerve endings. Participated in finalization of the data generation and publication plan.

At NHS, presented to the management team a strategic clinical plan and secured approval for completion of the clinical outcomes analysis that had potential to launch a medical food for a new claim in ADHD in adults, at least 4 months ahead of the previously planned product launch date. Finalized statistical analysis plan (SAP), and prepared data generation plans for a Phase 2b trial. The study also investigated biomarkers, SNPs and other predictors of response. Prepared clinical evidence/strategic development plan for a novel agent in the anxiety disorder. Participated in generation of safety document for a product in pediatrics.

For the most recent contractual assignment in CNS, I prepared clinical summary report of a Phase 2 trial in migraine, and updated the clinical investigator brochure to support Phase 3 trial.

In infectious diseases, at PPD, managed Phase 2-3 trials of a nasal flu vaccine Flumist and Synagis for RSV infection. The team under my leadership enrolled 1502 pediatric RSV patients in Phase 3 NDA trial in a record 3.5-week period vs. targeted 4 months. Synagis rapidly became a multi-billion-dollar drug and remained the lead product for many years,

In rheumatic/auto-immune diseases, I managed the development and approval of 5 new drugs (Rengasil, Fenbufen, Voltaren (diclofenac), Voltaren SR and Voltaren suppository) in RA, OA and AS with huge sales. Prepared strategic clinical and regulatory development plan and designed Phase 1-2A trials of disease modifying anti-rheumatic drug (DMARD) at American Cyanamid and managed a Phase 3 trial of a second DMARD at PPD.

Global Project Management experience with proven leadership skills in leading cross functional teams, managing global resources, mitigating risks, making strategic decisions and transitioning many NCEs from IND optimization (Ph 0) through clinical development, registration and product launch. As global project director, I prepared dozens of world-wide high level strategic plans with inputs from various functional project teams and external stake holders, including KOLs and advisory board members to accomplish project objectives. I had responsibility for defining project’s scope, resource requirements, roadmaps, milestones and budget. I prepared and drove integrated product development plans, aligning tactics across various functional areas for attaining the target product profile. Led risk management with project teams, ensuring risks have appropriate mitigation and contingency plans. Tracked progress, identified resource conflicts and found solutions, and managed project knowledge. Provided updates to senior management to ensure that projects remain aligned to corporate strategies.

Implemented new initiatives and saved tens of millions of dollars at various companies.

Meticulous and strong people development and communication skills. Ability to rapidly adapt to different challenges and manage multiple projects simultaneously in multiple therapeutic areas.

Key Awards:

In 2006, National Leadership Award from the National Republican Congressional Committee, USA.

In 2002, Bravo Plus award from Carrie Cox, President of Pharmacia, in recognition of Shared Accountability and Transparency that Drive Business Results.

In 2001, MVP award in Oncology Team for FDA ODAC presentation from Carrie Cox, President of Pharmacia. Designed and conducted a new clinical trial and defended Irinotecan (camptosar) as the standard of care for treatment of first- and second-line colorectal cancer.

Member of Pharmacia Global Elite Leadership Team, recognized by Mr. Fred Hassan, Chairman/CEO (2001-03).

From 1982-85, served a member to Ciba Geigy (now Novartis) North American Dev. Executive Team.

In 1975, received the Paul Christie Memorial Award for Best Researcher in Mental Health Field in Province of Ontario, Canada.

In 1971, received Gold Medal from the President of India for setting a new academic record (DVM; OGPA 4.972 out of 5.0) in the then 29 years history of GB Pant University, Pant Nagar, India. At the time it was affiliated to the University of Illinois).

Professional Employments:

Independent Owner - RR Bio-Pharma Consulting, Inc., (2007-To Date)

The consulting services in clinical development include due diligence, strategic evaluation of unmet medical needs and commercial viability of NCEs and biologicals, with primary focus in oncological, neuro-psychiatric, auto-immune and infectious diseases.

Expertise includes preparation of global Strategic Clinical and Regulatory Development plan (SCP), IND/CTA documents, Phase I-IV protocols, clinical investigator brochures, clinical efficacy and safety summary reports for NDA, and interaction with regulatory agencies.

Services in Medical Affairs include strategic planning of clinical activities for medical commercialization, brand optimization/ life-cycle management to achieve revenue growth, safety monitoring, publication planning and data gap analysis to identify additional sponsored/investigator-initiated studies that will generate new claims and product growth.

Expertise in designing studies to show competitive advantages and enhance product awareness, development of product advocates, and preparation of Academy of Managed Care Pharmacy (AMCP) formulary dossier and sales training materials.

As a Founder and CEO, provided leadership roles at Prodeus Pharmaceuticals, Inc. in identifying 3 exciting anticancer licensing candidates in year 2010, including a new Herceptin type drug. Formed the management team, performed the due diligence, assessed competitive landscape and commercial viability, and negotiated and finalized the licensing terms for overall development of a new drug delivery technology for a marketed drug Irinotecan from a company based in Florida. Spearheaded the preparation of strategic clinical and regulatory development plan, and fund-raising activities.

In 2011, prepared strategic development plan, IND and Phase 1-2A protocol in advanced colorectal and non-small cell lung cancer.

Participated in preparation of preclinical and Phase I development plan for submission of Pre-IND briefing document for a novel anticancer compound to FDA.

In 2019, prepared strategic clinical development and regulatory plan and Phase 1 to 2a safety, dose-finding, pharmacokinetic/pharmacodynamic, activity study of a novel anticancer agent in patients with advanced multiple myeloma (MM). Also participated in preparation and filing of IND.

In 2020, prepared strategic plan to increase access to patients in emerging markets (India, LAM and E. Europe) for Phase II/III trials.

In 2021, prepared business plan and infrastructure for a Phase I unit for an Indian pharmaceutical company.

In 2021, prepared overall strategic development plan and Phase I protocol for a chemo-sensitizing agent in advanced cancer patients.

In 2022, prepared clinical summary report of a Phase 2 study in migraine and updated clinical investigator brochure for supporting Phase 3 trials.

CEO, Co-Founder and Member of the Board - Myelinova, Inc. (July 2014-Dec 2017)

Finalized the licensing terms for acquisition of a novel and exciting compound with triple-action advantage (immune modulating, remyelination and neuro-regeneration bioactivities in human disease models) for potential indications in primary and secondary progressive multiple sclerosis (MS), relapsing-remitting MS, optic neuritis and a rare disease neuromyelitis optica (NMO). In 2014, no drug was approved for primary progressive MS.

Participated in filing of research grants to NIH for early development.

Together with the management team/co-founders, I finalized the corporate governance/SOPs.

Spearheaded the preparation of the strategic product development and business plans, and designed Phase Ia/Ib and II (Proof of Concept) protocols.

Spearheaded capital raising activities and reached-out to investors, VCs and pharma/biotech ventures. Several VCs and pharma ventures expressed interest in funding the clinical development after completion of IND studies.

Director, Clinical and Medical Affairs (Contractor) –Nestle Health Science/Alfasigma (Aug 2016 - June 2017), (The period during which I distanced from Myelinova, Inc.)

Prepared strategic clinical development and regulatory plan for a novel agent for treatment of a major psychiatric disorder; completed its review and approval by the Senior Management Team, Global Nestle Health Science.

Participated in the design of a Phase 2b randomized, controlled trial of an exciting medical food in a major psychiatric disorder with a KoL. Finalized the contract and implemented the protocol at two world-class institutes in Harvard Medical School, Boston and Children Hospital, Philadelphia. The protocol is designed to also investigate the biomarkers, SNPs and other predictors of clinical response.

Participated in review, discussion and finalization of the Statistical Analysis Plan and Shells for data listings/tables/figures with the CRO for a large on-going Phase 3 trial of another medical food in a major pain disorder. Interacted with PI/KOLs for two very exciting side studies. Participated in finalization of the data generation and publication plan.

Presented to the management team a strategic clinical plan and secured approval for completion of the clinical outcomes analysis that had potential to launch a medical food for a new claim in a major neuro-psychiatric disorder in adults, at least 4 months ahead of the previously planned product launch date. Finalized statistical analysis plan (SAP), and prepared data generation plans for a Phase 2b trial. The study also investigated biomarkers, SNPs and other predictors of response. The trial was concluded in Feb 2017.

Prepared clinical evidence/strategic development plan for a novel agent in the anxiety disorder.

Prepared the strategic development plans and Phase 2b trial design for an agent in treatment of a new neurological disorder in children.

Presented to the Leadership Team a novel potentially lucrative indication for future development.

Implemented new initiatives to accelerate/improve overall product development process and add efficiency.

Participated in generation of safety document for a product in pediatrics.

Co-ordinated activities by interacting with the marketing and regulatory affairs teams.

Took over the additional clinical operations responsibilities towards the mid-half of my assignment.

Medical Director, CNS (Contractor) - UCB, Inc. (March 2013 to June 2013)

Initiated and completed various projects associated with: a) sNDA filing for a major new indication of conversion of treatment to Vimpat as monotherapy in subjects with partial- onset seizures treated with adjunctive therapy, and b) product label.

Prepared Phase 4 development strategies for Vimpat with goals to: a) impact product label/brand optimization, b) address brand/market concerns, and c)

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