Timothy R. Allen, M.D., Ph.D.
I am a trained MD with clinical training in internal medicine and hematology-oncology with a Ph.D. in Biophysical Sciences and Epidemiology. A proven track record as an individual contributor and a leader in clinical development (pre- IND; phases I- III, launching; early-stage and late-stage growth, IND/NDA/BLA), as well as life- cycle activities. The primary therapeutic area included Oncology; IO and IO combinations, both in liquid tumors and solid tumors. A leader in the lifecycle management of product developments at Sanofi, Celgene, BMS, GSK, Genentech/Roche, and SP Corp. /Merck, among others in the past 14 years. A team leader and an individual contributor. The best three adjectives describing my performance have been: flexible, knowledgeable, and trustworthy. Open to relocation and travel. Please follow the provided links to my published peer review articles (68 papers) and two books:
Sanofi (Jul2017- Present): Multiple IO, Vaccines, as well as ADC in addition to combination early-stage development and late-stage launchings. Leading into ISS- ISE of joint construction as well as multiple early-stage development products, as their ongoing work including mRNA, and a TILs joint program. Lead medical monitor/ (MM). End - to- End lead Medical Monitor (MM) for clinical trials: Addressing patient eligibility, treatment questions, review safety data, trend review, clinical safety signals from the ongoing trials in working team (with the CRO- MMs, PIs, and internal cross-functional teams), answering clinical questions in coding, data cleaning with the clinical data management, providing specific therapeutic area expertise, working with the intelligence activities to enhance innovations, authoring clinical sections in regulatory documents including IND, NDA and BLA, working on the end- to- end study protocol development, investigator brochures, briefing documents, informed consent form, etc.; complete activities with the ethics and scientific committees, regulatory compliance, furthering into writing manuscripts, publications, external and internal audience functional documents, DMC charters, safety charters, risk mitigation plan with the safety team, REMS with the internal and external partners, supporting in data interpretation, contribution in active ongoing clinical and scientific lead with internal and external teams including commercial development, clinical strategic advisory boards, supporting the medical affairs and business development.
Celgene (JUN2015- JUN2017): Hematology & Solid Tumor teams in the last four submissions of their products, including the latest DLBCL as well as MMs. Of note: Phase III of R- CHOP combinations, and PD1, early-stage products, as well as the proceeding filings in MM, DLBCL. IO and IO combination of clinical development lead. DSMB, DMC, ICF, IB, IRB, Clinical Protocols, Safety, and efficacy data analysis, and interpretations, protocol development, filing of ISE and ISS, leading into a full panel of the end- to- end MM activities.
BMS (JUN2013- JUN2015): Anti- CD19, CD20, and CD22 ADC’s early-stage programs with the combination studies of PD1 + Anti- CTLA4, with/without cross over studies and life cycle programs. Clinical leader of the core development teams, labeling teams, daily review of the clinical material, analytical review of data into submission, external responses (HAs, IRBs, etc.). Lead- MMs’ activities; consistent work with the PIs, sites, and the KOLs in preparation of the DSMBs. Complete End- to- End activities of protocol development and implementation into filings of CSR, manuscripts, etc.
BMS (FEB2012- JUN2013): DLBCL, MCL, CLL as well as pediatric CLL have been my early development as well as late launching work. Latest launching participation and clinical leadership as clinical development- SME. Yervoy®, Optivo®. Provided clinical development leadership, individual contribution as the clinical development core- team leader, medical monitoring tasks as well as early-stage and later development study designs as a joint venture group leader. End- to- end MM lead.
GSK (MAY 2011- FEB2012): Early state development into the late stage, submission, and post-submission: current phase III’s of its life cycle and combination IO. Currently, I am associated with the Phase III efforts of PD1/PDL1 progress, its IO development combinations, and adjoin ADCs. Avastin’s life cycle launchings as well as its phase IV. Herceptin initial launching and progressive phase IV. Mekinist® (trametinib) in combination with Tafinlar® (dabrafenib). sNDA as well as HA- activities. Lead medical monitoring activities. End- to- End MM- lead.
BMS (FEB2008- MAY 2011): Early and late-stage development of phases II and III as well as the life cycle of ipilimumab and nivolumab (phase I/Expansion). Lead MM.
Merck(MAR2006-FEB2008): Early-stage development of Keytruda®, Votrient®, among others in IO/Oncology/Combination space. Assured clinical development ownership and leadership in producing the clinical and safety material in light of aggregate reports as well as submissions. MM activities.
The above were contract basis, all at two years or more, full time, and in-house. An individual leader/contributor.
Additional contracting positions as the Dir, Sr. Dir of clinical development; 2003-2006 with Schering- Plough, and 2002- MAY 2003 at GENE.
Global Allied Pharmaceuticals, LLC.
March 2001- Current.
A confounder and a member of the operational board. Complete phase I- IV process with multiple products. Combination therapy with Immunology combination. The full roll-out of a turnkey global clinical development group of a top-tier group into India’s business processing organization of the clinical development support. This project included: hiring, training, operational compliance assurance of a group of 468 professionals including medical review and aggregate review physicians, safety reviewers, clinical data reviewers, clinical trial professionals, and therapeutic communication and medical writers. Cost containment measures associated with this project exceeded 45 MM annually. Lead MD, co-founder of Nexus Alliance Biopharma. Safety and Post-Marketing activities, including the necessary Monitoring, Regional Surveillance. Report analysis, writing the actual reports as well as the cumulative study of products and safety signals and managing CRO and BPO logistics leadership.
Ph.D. in Epidemiology. Granted 2014.
University of Yerevan, Armenia. A WHO program under the University of Sacramento, School of Allied Health Science, Sacramento, California.
Doctorate of Medicine, USMLE I/II, ECFMG, Granted 1997.
Universidad Tecnología De Santiago, Dominican Republic. A WHO program under the University Of Sacramento School Of Allied Health Sciences, Sacramento, California. Clinical rotations in NY and CA. American Board of Internal Medicine training in Medicine and Research Fellowship in Hem. Onc. Kaiser Perm., CA (NIH Clinical Scientist Training Fellowship, 1997-2003).
Bachelor and Masters Science in Biophysical Sciences May 1992.
University at Buffalo, State University of New York.
Few Relevant Keywords:
Clinical Development, medical, submission, oncology, IO, combination, therapeutic lead, BLA, NDA, phase I- IV, RMP, REMS, and RISKMAP. COSTART, WHODrug, WHODRA, MedDRA. AERS, ARISg, DB4, SQL, SAS, Python analytics/RAVE analytics, and FoxPro.
References: Available upon request. Multi-lingual in Spanish, Russian, and Persian, with limited abilities in oral communication in Hebrew and Arabic.